BOSTON, June 27, 2023 /PRNewswire/ — AVEO Oncology, an LG Chem company, (“AVEO”), announced today that it has completed enrollment in the pivotal Phase 3 TiNivo-2 study in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure. The study is evaluating FOTIVDA® (tivozanib) in combination with OPDIVO® (nivolumab), Bristol Myers Squibb’s anti-PD-1 immunotherapy. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) approved for the treatment of adult patients with RCC following two or more prior systemic therapies.
There are currently no National Comprehensive Cancer Network® (NCCN) Category 1 recommended agents for patients with advanced RCC who were previously treated with prior immunotherapy. All currently available treatment options for advanced RCC were approved based on clinical studies conducted prior to the introduction of frontline immunotherapy combinations. There is an unmet need to improve the understanding of treatment sequencing and provide new treatment regimens for advanced RCC.
The randomized, controlled, open-label TiNivo-2 Phase 3 study enrolled patients with RCC who have progressed following prior immunotherapy treatment. Patients were randomized 1:1 to receive either low dose FOTIVDA in combination with OPDIVO or standard dose FOTIVDA alone. The TiNivo-2 study’s primary endpoint is progression free survival, with key secondary endpoints to include overall survival, overall response rate, duration of response and safety.
The TiNivo-2 study enrolled across clinical sites in the United States, Canada, Mexico, Europe and South America. “We are very excited to have achieved this interim milestone in the TiNivo-2 study and we are grateful to our global investigators, our AVEO development staff, and especially to the patients who are participating in the study. The TiNivo-2 study addresses an important question in the treatment of RCC, and we continue to work diligently to deliver the study results once data mature,” said AVEO’s Chief Medical Officer, Dr. Martin Birkhofer.
“The TiNivo-2 study will provide us with a robust Phase 3 dataset to answer the outstanding question of whether adding a PD-1 Inhibitor (nivolumab) to a VEGF TKI (tivozanib), provides additional efficacy and acceptable safety over a single agent VEGF TKI following prior immunotherapy,” said Toni Choueiri, M.D., Director, Lank Center for Genitourinary Oncology; Director, Kidney Cancer Center; Jerome and Nancy Kohlberg Chair and Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. “TiNivo-2 is a particularly important study for understanding appropriate sequencing strategies for RCC patients following immunotherapy given the presentation at the 2023 ASCO Annual Meeting of the CONTACT-03 study where adding a PD-L1 inhibitor (atezolizumab) to full dose cabozantinib failed to show a benefit over cabozantinib alone in RCC patients treated with prior immunotherapy.”
The Company expects to share initial results from the TiNivo-2 study when the data mature, which is anticipated in the second half of 2024.
About FOTIVDA® (tivozanib)
FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.4 FOTIVDA was discovered by Kyowa Kirin.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTION
Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.
Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.
Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.
Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.
Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.
Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.
Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.
Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.
ADVERSE REACTIONS
The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.
DRUG INTERACTIONS
Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. Females and Males of Reproductive Potential: Can impair fertility. Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.
To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see FOTIVDA Full Prescribing Information which is available at www.AVEOoncology.com.
About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences Innovation Center, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name.
References
ClinicalTrials.gov. Study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma. Accessed December 21, 2021. https://clinicaltrials.gov/ct2/show/NCT04987203
AVEO to Become the U.S. Foundation for LG Chem Life Sciences’ Oncology Division
SEOUL, South Korea, Jan. 19, 2023 (GLOBE NEWSWIRE) — LG Chem, Ltd. (“LG Chem”) (KOSPI: 051910) today announced that it has completed its previously announced acquisition of AVEO Oncology (“AVEO”), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, in an all-cash transaction with an implied equity value of $571M on a fully diluted basis.
“We are excited to complete LG Chem’s acquisition of AVEO, which will position us to deliver on our mission of becoming one of the world’s leading oncology companies with a robust clinical pipeline of innovative therapies,” said Shin Hak-Cheol, Chief Executive Officer of LG Chem.
AVEO plans to accelerate the commercialization of new anti-cancer drugs developed by LG Chem Life Sciences. With strong capabilities in early-stage R&D and production process, LG Chem Life Sciences will be positioned to pursue promising anti-cancer therapies and commercial processes for pre-clinical and early clinical trials, while AVEO, with its broad expertise in clinical development and sales in the U.S. market, will oversee clinical development and commercialization.
“The merger extends LG Chem Life Sciences’ commercial footprint to the U.S., diversifies our pipeline and advances our combined capabilities with AVEO, accelerating our ability to develop, commercialize and acquire world-class cancer therapies,” said Dr. Son Jeewoong, President of LG Chem Life Sciences. “We look forward to working closely with AVEO’s experienced and talented team as we welcome them to the LG Chem family.”
“This transaction delivered significant value to our shareholders and AVEO is now positioned to benefit from the support and resources of LG Chem as we advance our mission of improving the lives of patients with cancer,” said Michael Bailey, President and Chief Executive Officer of AVEO. “We look forward to our next chapter of growth as we realize the tremendous potential of our promising pipeline and leverage our combined capabilities to deliver continued progress across our clinical and pre-clinical stage anti-cancer therapies.”
AVEO Leadership Updates
AVEO will continue to be led by President and Chief Executive Officer Michael Bailey, Chief Commercial Officer Mike Ferraresso, Chief Operating Officer Jeb Ledell and Senior Vice President, General Counsel Danielle Holland. AVEO is also welcoming Martin Birkhofer, M.D. as its Chief Medical Officer and will have Erick Lucera serve as its Chief Financial Officer during a temporary transition period. A new Chief Financial Officer is expected to be appointed by LG Chem.
While AVEO is now a wholly owned subsidiary of LG Chem Life Sciences Innovation Center, Inc., AVEO will continue to operate under the AVEO Oncology name. The combined company will fully maintain operations in Boston and Cambridge, Massachusetts, where both AVEO and LG Chem Life Sciences Innovation Center are based.
About Martin Birkhofer, M.D.
Dr. Birkhofer is an oncologist and seasoned business executive with more than 30 years of life sciences management experience. Dr. Birkhofer joins AVEO with proven leadership abilities and extensive global clinical development, business development, regulatory and medical affairs experience with both small molecules and biologics. Dr. Birkhofer most recently served as Senior Vice President and Chief Medical Officer of Taiho Oncology Inc. Prior to joining Taiho Oncology, he served as Chief Medical Officer of Gradalis, Inc. and NuCana BioMed Ltd. Between 1994 and 2013, he served in various leadership roles within Research and Development and Business Development at Bristol-Myers Squibb (BMS).
Dr. Birkhofer is Board Certified in Internal Medicine and Medical Oncology. He obtained his M.D. from New York Medical College in Valhalla, New York.
Advisors BofA Securities served as exclusive financial advisor to LG Chem, and Latham & Watkins LLP served as LG Chem’s legal counsel. Moelis & Company LLC served as exclusive financial advisor to AVEO, and WilmerHale LLP served as AVEO’s legal counsel.
About LG Chem LG Chem is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences, engaged in the development, manufacture and global commercialization of pharmaceutical products, is committed to expanding its global presence by focusing on the key core therapeutic areas of immunology, oncology, and metabolic diseases (specifically, diabetes and related metabolic diseases). For more information, please visit www.lgchem.com.
BOSTON, Jan. 05, 2023 (GLOBE NEWSWIRE) — AVEO Oncology (“AVEO”) (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, announced that at a special meeting of stockholders (the “Special Meeting”) held today, AVEO stockholders approved the adoption of the Agreement and Plan of Merger among LG Chem, Ltd. (“LG Chem”), a subsidiary of LG Chem and AVEO (the “merger agreement”). As previously announced, under the terms of the merger agreement, AVEO stockholders will receive $15.00 per share in cash upon the closing of the transaction.
“Today’s approval is a significant step toward the completion of AVEO’s transaction with LG Chem, and I thank our stockholders for their strong support,” said Michael Bailey, President and Chief Executive Officer of AVEO. “As the U.S. late stage development and commercial foundation for LG Chem Life Sciences’ oncology segment, we believe AVEO will be well positioned to advance its mission of passionately pursuing a better life for patients with cancer.”
The final voting results will be reported in a Current Report on Form 8-K to be filed by AVEO with the Securities and Exchange Commission after certification by AVEO’s inspector of elections. The stockholders also approved a non-binding, advisory proposal relating to certain compensation that may be paid or become payable to certain of AVEO’s executive officers that is based on or otherwise relates to the merger between AVEO and LG Chem.
Completion of the transaction remains subject to certain customary closing conditions, including clearance of the transaction by the Committee on Foreign Investment in the United States, and the transaction is expected to close in early 2023.
Advisors
BofA Securities is serving as exclusive financial advisor to LG Chem, and Latham & Watkins LLP is serving as LG Chem’s legal counsel. Moelis & Company LLC is serving as exclusive financial advisor to AVEO, and WilmerHale LLP is serving as AVEO’s legal counsel.
About AVEO Pharmaceuticals, Inc. AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. These forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume” and “continue” as well as variations of such words and similar expressions. By their nature, forward-looking statements involve risks and uncertainty because they relate to events and depend on circumstances that will occur in the future, and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed acquisition of AVEO by LG Chem (the “proposed transaction”); the ability of the parties to complete the proposed transaction and the expected timing of completion of the proposed transaction as well as any assumptions underlying any of the foregoing. These statements are not guarantees of future performance and they involve certain risks, uncertainties and assumptions that are difficult to predict. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. There can be no guarantee that the proposed transaction will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that AVEO will achieve any particular future financial results. In particular, our expectations could be affected by, among other things: the risk that the proposed transaction may not be completed in a timely manner or at all; the possibility that competing offers or acquisition proposals for AVEO will be made; the possibility that required regulatory or other approvals or conditions to the consummation of proposed transaction may not be satisfied on a timely basis or at all (and the risk that such approvals may result in the imposition of conditions that could adversely affect LG Chem or AVEO or the expected benefits of the proposed transaction); regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential transaction; the occurrence of any event, change or other circumstance that could give rise to the right of LG Chem or AVEO to terminate the definitive merger agreement governing the terms and conditions of the proposed transaction; effects of the announcement, pendency or consummation of the proposed transaction on AVEO’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, its business generally or its stock price; risks related to the diversion of management’s attention from ongoing business operations and opportunities; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; the possibility that the proposed transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; and other risks and factors referred to from time to time in AVEO’s filings with the Securities and Exchange Commission, including AVEO’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, including those related to the uncertainties inherent in the research and development of new and existing healthcare products, including clinical and regulatory developments and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues or delays; changes in expected or existing competition; and domestic and global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures. The effects of the COVID-19 pandemic may give rise to risks that are currently unknown or amplify the risks associated with many of these factors. AVEO is providing the information in this communication as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
Leading Independent Proxy Advisory Firms ISS and Glass Lewis Recommend that AVEO Stockholders Vote “FOR” the Transaction
BOSTON, Jan. 03, 2023 (GLOBE NEWSWIRE) — AVEO Oncology (“AVEO”) (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, reminds all AVEO stockholders to vote before AVEO’s Special Meeting of Stockholders (the “Special Meeting”) “FOR” the adoption of the Agreement and Plan of Merger among LG Chem, Ltd. (“LG Chem”), a subsidiary of LG Chem and AVEO (the “merger agreement”). Subject to the terms and conditions of the merger agreement, including obtaining requisite AVEO stockholder approval at the Special Meeting, LG Chem will acquire AVEO for merger consideration of $15.00 per share in cash. The Special Meeting is scheduled for January 5, 2023 at 10:00 a.m. Eastern Time.
As previously announced, the Board of Directors of AVEO unanimously recommends that stockholders vote “FOR” the adoption of the merger agreement and each of the other proposals to be voted upon at the Special Meeting. The merger consideration represents a compelling 43% premium to AVEO’s closing price on October 17, 2022.
Your Vote is Important – No Matter How Few or Many Shares You Own. AVEO is also pleased to announce that leading proxy advisor firms Institutional Shareholder Services Inc. and Glass, Lewis & Co. both recommend that AVEO stockholders vote “FOR” the adoption of the merger agreement and each of the other proposals to be voted upon at the Special Meeting.
How to Vote AVEO stockholders of record as of the close of business on November 18, 2022 (the “Record Date”) that have not yet voted are urged to submit their votes by telephone at 1-866-230-6355 or internet at www.proxypush.com/AVEO following the instructions shown on their proxy or voting instruction forms. Stockholders must submit their vote by proxy by no later than 9:59 a.m. Eastern Time on January 5, 2023, the day of the Special Meeting.
Stockholders as of the Record Date who have not received their voting materials or who need assistance in completing the proxy card or voting instruction form or have questions regarding the special meeting may contact AVEO’s proxy solicitor, Morrow Sodali LLC by phone: (800) 662-5200 or email AVEO@investor.morrowsodali.com.
About AVEO Pharmaceuticals, Inc. AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
Additional Information This communication may be deemed solicitation material in respect of the proposed acquisition of AVEO by LG Chem. On November 25, 2022, AVEO filed with the Securities and Exchange Commission (“SEC”) a definitive proxy statement and has filed or may file with the SEC other relevant documents with respect to a special meeting of the stockholders of AVEO to approve the proposed merger. Investors of AVEO are urged to read the definitive proxy statement and other relevant materials carefully and in their entirety because they do or will, when filed, contain important information about AVEO, LG Chem and the proposed merger. Investors may obtain a free copy of these materials and other documents filed by AVEO with the SEC at the SEC’s website at www.sec.gov, at AVEO’s website at www.aveooncology.com or by sending a written request to AVEO at 30 Winter Street, Boston, Massachusetts 02108. The information contained on, or accessible through, AVEO’s website is not incorporated by reference into this communication and you should not consider any information contained in, or that can be accessed through, AVEO’s website as part of this communication or in deciding whether to support the approval of the proposed merger. AVEO has included its website in this communication solely as an inactive textual reference.
Participants in the Solicitation AVEO and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from AVEO’s stockholders in connection with the proposed merger. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of AVEO’s stockholders in connection with the proposed merger is set forth in AVEO’s definitive proxy statement for its special stockholders meeting. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed merger may be set forth in subsequent documents to be filed with the SEC and which can be obtained free of charge from the sources indicated above.
Cautionary Note Regarding Forward-Looking Statements This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. These forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume” and “continue” as well as variations of such words and similar expressions. By their nature, forward-looking statements involve risks and uncertainty because they relate to events and depend on circumstances that will occur in the future, and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed acquisition of AVEO by LG Chem (the “proposed transaction”); the ability of the parties to complete the proposed transaction and the expected timing of completion of the proposed transaction as well as any assumptions underlying any of the foregoing. These statements are not guarantees of future performance and they involve certain risks, uncertainties and assumptions that are difficult to predict. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. There can be no guarantee that the proposed transaction will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that AVEO will achieve any particular future financial results. In particular, our expectations could be affected by, among other things: the risk that the proposed transaction may not be completed in a timely manner or at all; the possibility that competing offers or acquisition proposals for AVEO will be made; the possibility that required regulatory, stockholder or other approvals or other conditions to the consummation of proposed transaction may not be satisfied on a timely basis or at all (and the risk that such approvals may result in the imposition of conditions that could adversely affect LG Chem or AVEO or the expected benefits of the proposed transaction); regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential transaction; the occurrence of any event, change or other circumstance that could give rise to the right of LG Chem or AVEO to terminate the definitive merger agreement governing the terms and conditions of the proposed transaction; effects of the announcement, pendency or consummation of the proposed transaction on AVEO’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, its business generally or its stock price; risks related to the diversion of management’s attention from ongoing business operations and opportunities; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; the possibility that the proposed transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; and other risks and factors referred to from time to time in AVEO’s filings with the Securities and Exchange Commission, including AVEO’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, including those related to the uncertainties inherent in the research and development of new and existing healthcare products, including clinical and regulatory developments and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues or delays; changes in expected or existing competition; and domestic and global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures. The effects of the COVID-19 pandemic may give rise to risks that are currently unknown or amplify the risks associated with many of these factors. AVEO is providing the information in this communication as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
Total Q3 2022 Net Revenue of $30.4 million, including $30.2 million of FOTIVDA® (tivozanib) U.S. Net Product Revenue –
– Announced entering a definitive agreement under which LG Chem will acquire AVEO for $15.00 per share in an all-cash transaction with an implied equity value of $566 million on a fully diluted basis –
BOSTON, Nov. 07, 2022 (GLOBE NEWSWIRE) — AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, today reported financial results for the third quarter ended September 30, 2022.
Third Quarter 2022 Financial Highlights
At September 30, 2022, AVEO reported $77.4 million in cash, cash equivalents and marketable securities, as compared with $77.2 million at the end of June 30, 2022 and $87.3 million at December 31, 2021.
Total revenue for the third quarter of 2022 was approximately $30.4 million compared with $15.2 million for the third quarter of 2021.
FOTIVDA U.S. net product revenue was $30.2 million for the third quarter of 2022 compared with $25.0 million in the second quarter of 2022 and $14.3 million for the third quarter of 2021.
In the third quarter of 2022, 1,284 commercial prescriptions were filled, representing an 11% increase compared with 1,157 filled in the second quarter of 2022 and a 107% increase compared with 619 filled in the third quarter of 2021.
Research and development expense for the third quarter of 2022 was $11.1 million compared with $7.5 million for the third quarter of 2021.
Selling, general and administrative expense for the third quarter of 2022 was $17.6 million compared with $15.1 million for the third quarter of 2021.
Net loss for the third quarter of 2022 was $3.3 million, or net loss of $0.09 per basic and diluted share, compared with a net loss of $10.4 million for the third quarter of 2021, or net loss of $0.30 per basic and diluted share.
Recent Highlights
The United States Patent and Trademark Office is expected to grant AVEO’s patent application directed to methods of treating subjects with refractory advanced renal cell carcinoma using tivozanib on November 22, 2022. AVEO plans to list this patent in the United States Food and Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as it relates to FOTIVDA with an expiration date of November 5, 2039.
Proposed LG Chem Transaction
On October 18, 2022, AVEO and LG Chem, Ltd. (LG Chem) announced that they have entered into a definitive agreement under which LG Chem will acquire AVEO for $15.00 per share in an all-cash transaction with an implied equity value of $566 million on a fully diluted basis. The combination of LG Chem’s Life Sciences division and AVEO is expected to create a global oncology organization with a robust portfolio of innovative products supported by full capabilities from discovery to clinical, biologics manufacturing and U.S. commercialization, at a scale capable of broadly delivering on its mission to improve the lives of patients with cancer.
The transaction, which was unanimously approved by both companies’ Boards of Directors, is expected to close in early 2023, subject to customary closing conditions, including approval by AVEO shareholders and receipt of regulatory approvals. The transaction is not subject to any financing condition. LG Chem expects to finance the transaction with existing and available cash resources. Upon completion of the transaction, AVEO’s shares will no longer trade on the Nasdaq.
Due to the pending transaction, AVEO will not host a conference call to discuss its quarterly financial results and withdraws its previously issued financial guidance for fiscal year 2022, last updated on August 4, 2022.
About FOTIVDA® (tivozanib)
FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2 and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.2 FOTIVDA was discovered by Kyowa Kirin.
INDICATIONS
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.
Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.
Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.
Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.
Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.
Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.
Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.
Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.
ADVERSE REACTIONS
The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.
DRUG INTERACTIONS
Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. Females and Males of Reproductive Potential: Can impair fertility. Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.
To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.
About Advanced Renal Cell Carcinoma
According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.3 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,4 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.
About AVEO Pharmaceuticals, Inc.
AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
Additional Information
This communication may be deemed solicitation material in respect of the proposed acquisition of AVEO by LG Chem. AVEO expects to file with the U.S Securities and Exchange Commission (SEC) a proxy statement and other relevant documents with respect to a special meeting of the stockholders of AVEO to approve the proposed merger. Investors of AVEO are urged to read the definitive proxy statement and other relevant materials carefully and in their entirety when they become available because they will contain important information about AVEO, LG Chem and the proposed merger. Investors may obtain a free copy of these materials (when they are available) and other documents filed by AVEO with the SEC at the SEC’s website at www.sec.gov, at AVEO’s website at www.aveooncology.com or by sending a written request to AVEO at 30 Winter Street, Boston, Massachusetts 02108. The information contained on, or accessible through, AVEO’s website is not incorporated by reference into this communication, and you should not consider any information contained in, or that can be accessed through, AVEO’s website as part of this communication or in deciding whether to support the approval of the proposed merger. AVEO has included its website in this communication solely as an inactive textual reference.
Participants in the Solicitation
AVEO and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from AVEO’s stockholders in connection with the proposed merger. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of AVEO’s stockholders in connection with the proposed merger will be set forth in AVEO’s definitive proxy statement for its special stockholders meeting. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed merger will be set forth in the definitive proxy statement when and if it is filed with the SEC in connection with the proposed merger.
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. These forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume” and “continue” as well as variations of such words and similar expressions. By their nature, forward-looking statements involve risks and uncertainty because they relate to events and depend on circumstances that will occur in the future, and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed acquisition of AVEO by LG Chem (the “proposed transaction”); the prospective performance and outlook of AVEO’s business, performance and opportunities; any potential strategic benefits, synergies or opportunities expected as a result of the proposed transaction; the ability of the parties to complete the proposed transaction and the expected timing of completion of the proposed transaction; as well as any assumptions underlying any of the foregoing.
These statements are not guarantees of future performance and they involve certain risks, uncertainties and assumptions that are difficult to predict. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. There can be no guarantee that the proposed transaction will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that AVEO will achieve any particular future financial results. In particular, our expectations could be affected by, among other things: the risk that the proposed transaction may not be completed in a timely manner or at all; the possibility that competing offers or acquisition proposals for AVEO will be made; the possibility that required regulatory, stockholder or other approvals or other conditions to the consummation of proposed transaction may not be satisfied on a timely basis or at all (and the risk that such approvals may result in the imposition of conditions that could adversely affect LG Chem or AVEO or the expected benefits of the proposed transaction); regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential transaction; the occurrence of any event, change or other circumstance that could give rise to the right of LG Chem or AVEO to terminate the definitive merger agreement governing the terms and conditions of the proposed transaction; effects of the announcement, pendency or consummation of the proposed transaction on AVEO’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, its business generally or its stock price; risks related to the diversion of management’s attention from ongoing business operations and opportunities; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; the possibility that the proposed transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; and other risks and factors referred to from time to time in AVEO’s filings with the Securities and Exchange Commission, including AVEO’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, including those related to the uncertainties inherent in the research and development of new and existing healthcare products, including clinical and regulatory developments and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues or delays; changes in expected or existing competition; and domestic and global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures. The effects of the COVID-19 pandemic may give rise to risks that are currently unknown or amplify the risks associated with many of these factors. AVEO is providing the information in this communication as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
References
ZS Associates. US emerging pharma and biotech first launches: A story of over-and underperformance. June 21, 2022.
Pawlowski N et al. AACR 2013. Poster 3971.
J Angulo and O Shapiro, Cancers (Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227]
Decision Resources. RCC landscape and forecast. December 12, 2019.
Acquisition Provides LG Chem’s Life Sciences Division a Commercial Footprint in the U.S., Diversifies its Pipeline with a Broad Range of Oncology Therapies and Accelerates LG Chem’s Efforts to Deliver Continued Growth
AVEO Will Have Enhanced Ability to Deliver on its Mission to Improve the Lives of Patients with Cancer
AVEO to Establish and Operate as the U.S. Commercial Foundation for LG Chem Life Sciences’ Oncology Segment
Transaction Price Represents a 43% Premium to AVEO’s Closing Price on October 17, 2022
SEOUL, South Korea and CAMBRIDGE, Mass. and BOSTON, Oct. 18, 2022 (GLOBE NEWSWIRE) — LG Chem, Ltd. (“LG Chem”) (KOSPI: 051910) and AVEO Oncology (“AVEO”) (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, announced today that they have entered into a definitive agreement under which LG Chem will acquire AVEO for $15.00 per share in an all-cash transaction with an implied equity value of $566 million on a fully diluted basis.
The combination of LG Chem’s Life Sciences division and AVEO is expected to create a global oncology organization with a robust portfolio of innovative products supported by full capabilities from discovery to clinical, biologics manufacturing and U.S. commercialization, at a scale capable of broadly delivering on its mission to improve the lives of patients with cancer. Bringing together AVEO and LG Chem is expected to extend LG Chem Life Sciences’ commercial footprint to the U.S., diversify its pipeline with a broad range of oncology therapies and accelerate LG Chem’s efforts to deliver continued growth through the development and commercialization of world-class cancer therapies.
Through this transaction, AVEO will immediately establish LG Chem’s commercial presence in oncology through AVEO’s lead product, FOTIVDA® (tivozanib), which received U.S. Food and Drug Administration (FDA) approval in March 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. In addition, the combined company will have significantly greater resources to develop and commercialize both companies’ robust clinical pipelines of innovative oncology medicines.
Upon completion of the transaction, AVEO will establish and operate as the U.S. commercial foundation for LG Chem Life Sciences’ oncology segment. Through this transaction, the combined company will expand its high-value and sustainable pipelines in oncology and bring cancer therapies to patients in need.
“With its track record of clinical success, deep pipeline of innovative therapies and continued growth trajectory following the successful commercialization of FOTIVDA®, AVEO is the perfect partner for LG Chem Life Sciences,” said Shin Hak-Cheol, Chief Executive Officer of LG Chem. “This transaction represents the next step in our portfolio transformation towards higher growth markets and provides a strong commercial foundation in oncology as we continue to develop our anti-cancer offerings. We remain focused on prudently investing in our R&D capabilities, continuing to build a leading portfolio of therapies and transforming lives through inspiring science and leading innovation. With our shared values of collaboration, agility and passion, we are excited to welcome AVEO and its talented employees to LG Chem as we continue to advance our sustainable goal of becoming one of the top global pharmaceutical companies.”
“We are thrilled to announce this transaction, which delivers a compelling all-cash premium to our shareholders, while positioning AVEO to accelerate our strong momentum to the benefit of the oncology patients we serve,” said Michael Bailey, President and Chief Executive Officer of AVEO. “By joining forces with LG Chem, AVEO expects to have significant financial and development resources to help AVEO fully realize the tremendous potential of our promising pipeline. LG Chem shares AVEO’s deep commitment to patients and vision of developing innovative therapies designed to provide substantial impact in the lives of cancer patients with clear unmet medical needs. This transaction is a testament to the extraordinary efforts of our employees, who will play an integral role in the success of the combined company. We look forward to entering our next chapter of growth with the support of LG Chem.”
“This transaction represents the culmination of a thorough review of opportunities by the Board to maximize shareholder value and delivers compelling value to AVEO shareholders,” said Kenneth Bate, AVEO’s Chairman of the Board. “We are confident that with the support and resources of LG Chem, AVEO will continue advancing its mission of passionately pursuing a better life for patients with cancer.”
LG Chem is actively advancing multiple clinical and pre-clinical stage anti-cancer therapies. LG Chem will be able to harness the full potential in oncology through this transaction and become a global, fully integrated – from R&D to commercial stage – pharmaceutical company.
Transaction Terms and Closing
The transaction price represents a 43% premium to AVEO’s closing share price on October 17, 2022, as well as a 71% premium to its 30 trading day volume-weighted average price. The transaction, which was unanimously approved by both companies’ Boards of Directors, is expected to close in early 2023, subject to customary closing conditions, including approval by AVEO shareholders and receipt of regulatory approvals. The transaction is not subject to any financing condition. LG Chem expects to finance the transaction with existing and available cash resources. Upon completion of the transaction, AVEO’s shares will no longer trade on the Nasdaq.
The combined company will be headquartered in Seoul, South Korea, and LG Chem also expects to maintain a significant presence in Boston and Cambridge, Massachusetts, the location of the LG Chem Life Sciences Innovation Center.
AVEO Third Quarter 2022 Financial Results
AVEO expects to report third quarter 2022 financial results on Monday, November 7, 2022. Given the transaction announced today, AVEO will not conduct an earnings conference call or provide financial guidance in conjunction with its third quarter 2022 earnings release.
Advisors
BofA Securities is serving as exclusive financial advisor to LG Chem, and Latham & Watkins LLP is serving as LG Chem’s legal counsel. Moelis & Company LLC is serving as exclusive financial advisor to AVEO, and WilmerHale LLP is serving as AVEO’s legal counsel.
About LG Chem LG Chem is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences, engaged in development, manufacturing and global commercialization of pharmaceutical products, seeks to expand and make global presence by focusing on key core therapeutic areas of Immunology, Oncology, and Metabolic Diseases (specifically, diabetes and related metabolic diseases). For more information, please visit www.lgchem.com.
About AVEO Pharmaceuticals, Inc. AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
Additional Information
This communication may be deemed solicitation material in respect of the proposed acquisition of AVEO by LG Chem. AVEO expects to file with the SEC a proxy statement and other relevant documents with respect to a special meeting of the stockholders of AVEO to approve the proposed merger. Investors of AVEO are urged to read the definitive proxy statement and other relevant materials carefully and in their entirety when they become available because they will contain important information about AVEO, LG Chem and the proposed merger. Investors may obtain a free copy of these materials (when they are available) and other documents filed by AVEO with the SEC at the SEC’s website at www.sec.gov, at AVEO’s website at www.aveooncology.com or by sending a written request to AVEO at 30 Winter Street, Boston, Massachusetts 02108. The information contained on, or accessible through, AVEO’s website is not incorporated by reference into this communication, and you should not consider any information contained in, or that can be accessed through, AVEO’s website as part of this communication or in deciding whether to support the approval of the proposed merger. AVEO has included its website in this communication solely as an inactive textual reference.
Participants in the Solicitation
AVEO and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from AVEO’s stockholders in connection with the proposed merger. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of AVEO’s stockholders in connection with the proposed merger will be set forth in AVEO’s definitive proxy statement for its special stockholders meeting. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed merger will be set forth in the definitive proxy statement when and if it is filed with the SEC in connection with the proposed merger.
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. These forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume” and “continue” as well as variations of such words and similar expressions. By their nature, forward-looking statements involve risks and uncertainty because they relate to events and depend on circumstances that will occur in the future, and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed acquisition of AVEO by LG Chem (the “proposed transaction”); the prospective performance and outlook of AVEO’s business, performance and opportunities; any potential strategic benefits, synergies or opportunities expected as a result of the proposed transaction; the ability of the parties to complete the proposed transaction and the expected timing of completion of the proposed transaction; as well as any assumptions underlying any of the foregoing. These statements are not guarantees of future performance and they involve certain risks, uncertainties and assumptions that are difficult to predict. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. There can be no guarantee that the proposed transaction will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that AVEO will achieve any particular future financial results. In particular, our expectations could be affected by, among other things: the risk that the proposed transaction may not be completed in a timely manner or at all; the possibility that competing offers or acquisition proposals for AVEO will be made; the possibility that required regulatory, stockholder or other approvals or other conditions to the consummation of proposed transaction may not be satisfied on a timely basis or at all (and the risk that such approvals may result in the imposition of conditions that could adversely affect LG Chem or AVEO or the expected benefits of the proposed transaction); regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential transaction; the occurrence of any event, change or other circumstance that could give rise to the right of LG Chem or AVEO to terminate the definitive merger agreement governing the terms and conditions of the proposed transaction; effects of the announcement, pendency or consummation of the proposed transaction on AVEO’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, its business generally or its stock price; risks related to the diversion of management’s attention from ongoing business operations and opportunities; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; the possibility that the proposed transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; and other risks and factors referred to from time to time in AVEO’s filings with the Securities and Exchange Commission, including AVEO’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, including those related to the uncertainties inherent in the research and development of new and existing healthcare products, including clinical and regulatory developments and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues or delays; changes in expected or existing competition; and domestic and global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures. The effects of the COVID-19 pandemic may give rise to risks that are currently unknown or amplify the risks associated with many of these factors. AVEO is providing the information in this communication as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
BOSTON, Oct. 12, 2022 (GLOBE NEWSWIRE) — AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, announced today that, as disclosed on uspto.gov, the United States Patent and Trademark Office (“USPTO”) has allowed U.S. Patent Application No. 17/720,619, titled “Use of Tivozanib to Treat Subjects with Refractory Cancer” (the “Application”). AVEO expects to receive a Notice of Allowance for this Application. This Application will potentially issue as a patent in 2022 and will provide patent protection in the United States for the claimed methods of use of FOTIVDA into 2039.
A Notice of Allowance is issued after the USPTO decides that a patent can be granted from a patent application. The majority of patent applications that receive a Notice of Allowance will issue as a U.S. patent once the issue fee is paid. However, a Notice of Allowance is not a guarantee of patent issuance.
“We are pleased by the progress we have made at the United States Patent and Trademark Office and the continued recognition of FOTIVDA to treat refractory advanced RCC in subjects who have received at least two prior anti-cancer therapies,” said Michael Bailey, AVEO’s president and chief executive officer. “When issued, this patent is expected to provide a potential barrier for generic entry. It is part of our broader life cycle management strategy and is designed to extend the commercial opportunity of FOTIVDA, following a long development path and a relatively short exclusivity period since FOTIVDA’s approval by the U.S. Food and Drug Administration in March 2021.”
If issued, AVEO plans to list this patent in the United States Food and Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as it relates to FOTIVDA with an expiration date of November 5, 2039.
About FOTIVDA® (tivozanib)
FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.2 FOTIVDA was discovered by Kyowa Kirin.
About Advanced Renal Cell Carcinoma
According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.3 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,4 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.
About AVEO Pharmaceuticals, Inc.
AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “advance,” “aim,” “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “goal,” “intend,” “look forward,” “may,” “plan,” “potential,” “project,” “promising,” “seek,” “should,” “strategy,” “will,” “would,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: AVEO’s expectation that the USPTO will issue a patent from the allowed application in 2022; AVEO’s patent portfolio and life cycle management strategy; the potential for FOTIVDA as a treatment option for patients with relapsed or refractory advanced RCC; the potential efficacy, safety and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in other indications; AVEO’s ability to advance FOTIVDA’s use and approval as a monotherapy or in combination with other products through clinical trials; and AVEO’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection for FOTIVDA and its other product candidates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to FOTIVDA and its product candidates; unplanned capital requirements; adverse general economic, political and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO’s business continuity, financial condition, results of operations, liquidity and ability to commercialize FOTIVDA, manufacture clinical and commercial product and timely initiate new trials or complete its ongoing clinical trials; competitive factors; and those risks discussed in the sections titled “Risk Factor Summary,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.
Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.
References
ZS Associates. US emerging pharma and biotech first launches: A story of over-and underperformance. June 21, 2022.
Pawlowski N et al. AACR 2013. Poster 3971.
J Angulo and O Shapiro, Cancers (Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227]
Decision Resources. RCC landscape and forecast. December 12, 2019.
BOSTON, Sept. 21, 2022 (GLOBE NEWSWIRE) — AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, today announced that Michael Bailey, president and chief executive officer, will participate in a panel discussion at the Cantor Fitzgerald Oncology & HemOnc Conference. The panel titled “Building Combinations: What are the Novel Ideas?” will be held on Wednesday, September 28th, at 10:40 a.m. eastern time.
If you are interested in arranging a 1×1 meeting at the conference, please contact your Cantor representative. For more details, please see the Calendar of Events section of AVEO Oncology’s corporate website.
About AVEO Pharmaceuticals, Inc.
AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Actual results or events could differ materially due to a number of important factors, including risks discussed in the sections titled “Risk Factor Summary,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.
BOSTON, Aug. 31, 2022 (GLOBE NEWSWIRE) — AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, today announced that members of its senior management team are scheduled to participate in three investor conferences in September, including:
2022 Wells Fargo Healthcare Conference
Date:
Wednesday – Friday, September 7th – 9th
Format:
1×1 Investor Meetings
H.C. Wainwright 24th Annual Global Investment Conference
Date:
Monday, September 12th at 5:00 p.m. Eastern Time
Format:
Fireside Chat and 1×1 Investor Meetings
Details:
A live webcast of the H.C. Wainwright fireside chat can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 90 days following the presentation date.
Baird 2022 Global Healthcare Conference
Date:
Tuesday, September 13th at 11:25 a.m. Eastern Time
Format:
Presentation and 1×1 Investor Meetings
About AVEO Pharmaceuticals, Inc.
AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Actual results or events could differ materially due to a number of important factors, including risks discussed in the sections titled “Risk Factor Summary,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.
– Total Q2 2022 Net Revenue of $25.3 million including $25.0 million of FOTIVDA® (tivozanib) U.S. Net Product Revenue –
– Q2 2022 FOTIVDA U.S. Net Product Revenue Growth of 24% Compared with Q1 2022 –
– Company Reaffirms Full Year 2022 FOTIVDA U.S. Net Product Revenue Guidance of $100.0 million to $110.0 million –
– Company Streamlines Planned R&D Spending and Lowers Guidance to $50.0 million from $60.0 million to $70.0 million –
– Company to host conference call today at 4:30 p.m. ET –
BOSTON, Aug. 04, 2022 (GLOBE NEWSWIRE) — AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, today reported financial results for the second quarter ended June 30, 2022.
“At the beginning of April 2022, we entered the second year of the FOTIVDA commercial launch with increased momentum and confidence as demonstrated by continued sales growth and, most recently, FOTIVDA’s elevated status by the National Comprehensive Cancer Network® (NCCN). We believe this momentum will continue to build in the second half of 2022 and we continue to be confident in our FOTIVDA U.S. net product revenue guidance for fiscal year 2022 of $100.0 million to $110.0 million,” stated Michael Bailey, President and Chief Executive Officer of AVEO. “In addition to the strong sales momentum and elevated NCCN status, we were pleased to see the success of the FOTIVDA commercial launch recently recognized as having ‘overperformed’ in an independent market analysis1 of first launches by emerging pharmaceutical and biotech companies. With this growing external recognition of our commercial acumen, we believe that we can further leverage our capabilities by identifying potential additional commercial stage assets to add to our portfolio.”
“On the clinical development front, our Phase 3 TiNivo-2 trial, remains on track to complete patient enrollment in the second quarter of 2023. For the balance of the portfolio, we have reduced our planned R&D spend to focus exclusively on development initiatives that we believe will effectively position our pipeline assets to create partnering opportunities. This partnering focused R&D strategy is consistent with our overall strategy of leveraging partners to provide funding for the development of our portfolio and minimizing R&D investment from AVEO while retaining all, or a portion of, the North American oncology commercial rights related to these product candidates,” said Mr. Bailey.
Second Quarter 2022 and Recent Highlights
Continued quarter over quarter growth of FOTIVDA U.S. net product revenue and prescriptions in Q2 2022.
Second quarter 2022 U.S. net product revenue increased 24% to $25.0 million compared with U.S. net product revenue of $20.1 million in the first quarter of 2022, and increased 271% compared with $6.7 million of U.S. net product revenue in the second quarter of 2021.
Second quarter 2022 gross-to-net estimate of 17.8%.
In the second quarter of 2022, 1,157 commercial prescriptions were filled, representing an 18% increase compared with 977 filled in the first quarter of 2022 and a 309% increase compared with 283 filled in the second quarter of 2021.
Based on third party data, AVEO continues to be a leader in the number of new third-line R/R RCC patient starts during the second quarter of 2022.
AVEO was recognized by ZS Associates for its commercial launch and received the “Distinguished Excellence” Award at the 28th Annual Communicator Awards sponsored by the Academy of Interactive and Visual Arts for AVEO’s Multi-Media/Public Relations Campaign that supported the commercial launch of FOTIVDA.
Announced Updated National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines Elevating FOTIVDA® (tivozanib) to Category 1 Treatment for R/R RCC Patients.
FOTIVDA elevated to Category 1 status as a subsequent therapy for RCC patients who have received two or more prior therapies in the latest Kidney Cancer Treatment Guidelines released on June 17, 2022.
NCCN is a recognized standard for clinical policy in cancer care, which impacts physician treatment decisions, reimbursement and treatment pathways.
In a recent third party market research survey, 80% of respondents indicated that the elevation of FOTIVDA to Category 1 status would positively impact their prescribing decisions.
Presented additional analysis on overall survival (OS) from the TIVO-3 trial and tivozanib activity and safety profile in non-clear cell (ncc) RCC at the 2022 ASCO Annual Meeting.
Exploratory long-term OS analyses of data from the TIVO-3 trial continues to trend in favor of tivozanib demonstrating an OS hazard ratio of 0.89.
A conditional survival analysis was performed at the 12 month progression free survival landmark, showing a statistically significant 55% relative reduction (HR 0.45; 95% CI 0.22–0.91) in the risk of death with tivozanib over sorafenib in this third- and fourth-line treatment population and a median OS of 48.3 months in patients receiving tivozanib compared with a median OS of 32.8 months in patients receiving sorafenib, a non-selective VEGFR-TKI.
Tivozanib demonstrated activity and a favorable safety profile in a subgroup analysis of patients with nccRCC from the 2010 Phase 2 randomized discontinuation trial evaluating tivozanib in patients with nccRCC.
Enrollment ongoing for Phase 3 TiNivo-2 Trial in R/R RCC following prior immunotherapy; Expect tocomplete enrollment in the second quarter of 2023.
AVEO continues to enroll patients in the Phase 3 TiNivo-2 clinical trial evaluating tivozanib in combination with nivolumab (OPDIVO®), Bristol Myers Squibb’s antibody directed against PD-1, as compared with tivozanib monotherapy in patients with R/R RCC who have progressed following prior immune checkpoint inhibitor therapy. If successful, the company believes data from this trial has the potential to support U.S. Food and Drug Administration (FDA) approval of tivozanib in combination with nivolumab in R/R RCC and expand the market opportunity for FOTIVDA into the larger second line R/R RCC setting. AVEO currently expects enrollment in the TiNivo-2 trial to be completed in the second quarter of 2023.
Completed drug substance manufacturing for Ficlatuzumab and entered into a clinical trial collaboration and supply agreement in North America with Eli Lilly and Company (Lilly) to provide ERBITUX® (cetuximab).
AVEO completed drug substance manufacturing for ficlatuzumab in the second quarter of 2022. The drug substance is expected to be used in connection with a potential Phase 3 registrational clinical trial in human papillomavirus (HPV) negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the first half of 2023.
The Lilly agreement is similar to the clinical trial collaboration and supply agreement the company entered into with Merck KGaA, Darmstadt, Germany earlier this year to provide ERBITUX® (cetuximab), an anti-EGFR antibody, clinical drug supply outside of North America for the potential Phase 3 registrational trial.
AVEO expects to continue to discuss potential registrational clinical trial designs with the FDA and to continue to seek a strategic partner to fund development expenses. In September 2021, AVEO announced that the FDA granted Fast Track designation for the investigation of the combination of ficlatuzumab and cetuximab for the treatment of patients with R/R HNSCC.
Second Quarter 2022 Financial Highlights
At June 30, 2022, AVEO reported $77.2 million in cash, cash equivalents and marketable securities, as compared with $87.3 million at December 31, 2021.
Total revenue for the second quarter of 2022 was approximately $25.3 million compared with $7.6 million for the second quarter of 2021.
FOTIVDA U.S. net product revenue was $25.0 million for the second quarter of 2022 compared with $6.7 million for the second quarter of 2021.
Research and development expense for the second quarter of 2022 was $12.3 million compared with $6.9 million for the second quarter of 2021.
Selling, general and administrative expense for the second quarter of 2022 was $17.1 million compared with $14.9 million for the second quarter of 2021.
Net loss for the second quarter of 2022 was $8.3 million, or net loss of $0.24 per basic and diluted share, compared with a net loss of $13.6 million for the second quarter of 2021, or net loss of $0.40 per basic and diluted share.
Financial Guidance
AVEO believes that its $77.2 million in cash, cash equivalents and marketable securities as of June 30, 2022, along with expected net product revenues from the sales of FOTIVDA in the United States, will enable AVEO to maintain its current operations for a period of more than 12 months from the date of filing of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2022.
AVEO has reaffirmed its full year 2022 FOTIVDA U.S. net product revenue guidance of $100.0 million to $110.0 million. AVEO expects that commercial expenses will be approximately $50.0 million in 2022. AVEO expects general and administrative expenses will remain at approximately $20.0 million for the year. Research and development expenses are now expected to be approximately $50.0 million in 2022, a reduction from the prior range of $60.0 million to $70.0 million as the company will focus its spending on clinical development programs to expand the commercial opportunity of tivozanib for the treatment of RCC and to position the company’s other product candidates for further development by partners and minimize R&D investment from AVEO while retaining all, or a portion of, the North American oncology commercial rights related to these product candidates. One of these initiatives includes the company’s decision, along with its partner at AstraZeneca, to close further enrollment in the second-line cohort of the DEDUCTIVE trial, a Phase 1b/2 clinical trial studying the combination of IMFINZI (durvalumab) and tivozanib in patients with advanced, unresectable hepatocellular carcinoma as part of its efforts to streamline R&D spend. In addition, AVEO expects that gross margins will continue to be in the mid-to-high 80th percentile in 2022.
Conference Call and Webcast
In connection with this announcement, AVEO will host a conference call and audio webcast today, August 4, 2022, at 4:30 P.M. Eastern Time. The call can be accessed by dialing (877) 423-9813 (U.S. and Canada) or (201) 689-8573 (international). The passcode for the conference call is 13730553. To access the live webcast, or the subsequent archived recording, please visit the Calendar of Events sub-section within the Investors section of the AVEO website at www.aveooncology.com.
About FOTIVDA® (tivozanib)
FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.2 FOTIVDA was discovered by Kyowa Kirin.
INDICATIONS
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.
Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.
Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.
Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.
Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.
Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.
Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.
Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.
ADVERSE REACTIONS The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.
DRUG INTERACTIONS
Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. Females and Males of Reproductive Potential: Can impair fertility. Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.
To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.
About Advanced Renal Cell Carcinoma
According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.3 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,4 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.
About AVEO Pharmaceuticals, Inc.
AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “advance,” “aim,” “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “goal,” “intend,” “look forward,” “may,” “plan,” “potential,” “project,” “promising,” “seek,” “should,” “strategy,” “will,” “would,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: FOTIVDA’s elevated status by the National Comprehensive Cancer Network® (NCCN) and AVEO’s expectations that FOTIVDA’s elevated status in the NCCN will impact the commercialization of FOTIVDA; AVEO’s expectations of achieving quarter over quarter sales growth and an increase in the sales ramp of FOTIVDA in future periods; AVEO’s plans, strategies and ability to successfully sell and distribute FOTIVDA to patients in the United States; AVEO’s expectations for its fiscal year 2022 FOTIVDA U.S. net product revenue, commercial expenses, general and administrative expenses, research and development spend and gross margins; the potential for FOTIVDA as a treatment option for patients with relapsed or refractory advanced RCC; the potential efficacy, safety and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in other indications; AVEO’s plans and strategies to leverage its commercial capacity and potentially acquire or in-license additional commercial stage assets to its portfolio; FOTIVDA’s ability to maintain a leadership position in new patient starts in the R/R RCC third-line setting; the date enrollment will be completed for AVEO’s pivotal Phase 3 TiNivo-2 trial; AVEO’s plans, strategies and execution for current and future clinical trials and preclinical studies of tivozanib and ficlatuzumab; the availability of clinical supplies of ficlatuzumab; the potential efficacy, safety and tolerability of ficlatuzumab, both as a stand-alone drug candidate and in combination with other therapies in R/M HNSCC and other indications; AVEO’s ability to pursue regulatory strategies based on the results of clinical trials and preclinical studies of its product candidates, including AVEO’s ability to obtain FDA approval of tivozanib in combination with nivolumab for the treatment of R/R RCC; AVEO’s strategy, prospects, plans and objectives for FOTIVDA and its product candidates and for AVEO generally; AVEO’s plans and ability to position each of its product candidates for partnership opportunities outside of North America that may fund further development of these product candidates while retaining a portion, or all, of the North American commercial rights; the potential commercial opportunity of FOTIVDA and AVEO’s other product candidates; AVEO’s estimates for its cash runway and the contingencies on which such runway is dependent; and statements regarding AVEO’s performance, including but not limited to statements in the section titled “Financial Guidance.” AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to achieve quarter over quarter sales growth of FOTIVDA; the percentage of FOTIVDA prescriptions being made to patients who are in the third- and fourth-line treatment setting maintaining or increasing over time; AVEO’s ability to successfully implement its strategic plans, including its ability to successfully commercialize FOTIVDA and to obtain and maintain market and third party payor acceptance of FOTIVDA; AVEO’s ability, and the ability of its licensees and collaborators, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy, and clinically meaningful benefit of AVEO’s product candidates, and risks relating to the timing and costs of seeking and obtaining regulatory approvals; AVEO’s dependence on third-party vendors for the development, manufacture, supply, storage and distribution of FOTIVDA, ficlatuzumab, AV-380 and its other product candidates; AVEO’s ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; AVEO’s ability to maintain compliance with regulatory requirements applicable to FOTIVDA and its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to FOTIVDA and its product candidates; unplanned capital requirements; adverse general economic, political and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO’s business continuity, financial condition, results of operations, liquidity and ability to commercialize FOTIVDA, manufacture clinical and commercial product and timely initiate new trials or complete its ongoing clinical trials; competitive factors; and those risks discussed in the sections titled “Risk Factor Summary,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.
Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.
References
ZS Associates. US emerging pharma and biotech first launches: A story of over-and underperformance. June 21, 2022.
Pawlowski N et al. AACR 2013. Poster 3971.
J Angulo and O Shapiro, Cancers (Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227]
Decision Resources. RCC landscape and forecast. December 12, 2019.
TIVO-3: Final OS Analysis Of A Phase III, Randomized, Controlled, Multicenter, Open-Label Study To Compare Tivozanib To Sorafenib In Subjects With Metastatic Renal Cell Carcinoma (RCC)
