Takeda Signs Option Agreement with Ascentage Pharma to Enter into Exclusive Global License for Olverembatinib, a Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI)

Rhea-AI Summary

Takeda has signed an option agreement with Ascentage Pharma for an exclusive global license to olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI) for treating chronic myeloid leukemia (CML) and other hematological cancers.

The agreement gives Takeda the option to license and commercialize olverembatinib outside of mainland China, Hong Kong, Macau, Taiwan, and Russia. Ascentage Pharma will continue late-stage clinical development before Takeda exercises the option.

Ascentage Pharma will receive a $100 million option payment, a potential option exercise fee, and additional milestone and royalty payments. Takeda will also make a minority equity investment in Ascentage Pharma. Olverembatinib has shown promising clinical results, addressing a significant unmet need for CML patients resistant to current TKIs.

Positive

• Takeda secures the option to globally license olverembatinib, potentially expanding its oncology portfolio.
• Olverembatinib addresses unmet needs in CML treatment, including patients resistant to current TKIs.
• Ascentage Pharma receives a $100 million option payment, providing significant capital.
• Potential additional milestone and royalty payments can further benefit Ascentage Pharma.
• Takeda's minority equity investment strengthens the partnership between the two companies.
• Promising clinical results of olverembatinib suggest potential for significant market impact.

Negative

• Takeda's exercise of the option is subject to regulatory approvals, creating uncertainty.
• The financial burden of milestone and royalty payments could limit Ascentage Pharma's profit margins.
• Dependence on late-stage clinical development success introduces risk for both companies.
• Geographical restrictions limit Takeda's license area, excluding key markets like mainland China.

Insights

Financial Analyst

Takeda’s option agreement with Ascentage Pharma to license olverembatinib signals a significant investment in expanding their oncology portfolio. The $100 million option payment and potential milestone payments show Takeda's confidence in the drug's commercial viability outside of China and associated territories. This move, however, places financial risk on Ascentage Pharma to advance the clinical development of olverembatinib independently before Takeda decides to exercise the option. Investors should consider the impact of such financial commitments on Takeda’s cash flow and the potential for high returns if the drug demonstrates strong clinical results and gains regulatory approval. The market for third-generation TKIs is growing, addressing a niche but critical unmet need in chronic myeloid leukemia (CML) treatment. The financial implications for Takeda look favorable in the long term, contingent on successful clinical outcomes.

Oncology Doctor

Olverembatinib’s potential as a third-generation TKI for treating CML is significant, particularly for patients with the T315I mutation who have limited treatment options. The drug's approval in China for TKI-resistant CML patients is promising, indicating its potential efficacy and safety. The ongoing POLARIS-2 Phase 3 study will be important in determining its global applicability. For patients, this could herald a new era in CML treatment, offering hope where first- and second-generation TKIs fail. However, clinical uncertainties remain until more data is available, especially concerning long-term outcomes and side effects. This development is a positive step in oncology, particularly in hematological cancers where treatment gaps exist.

Market Research Analyst

The global market for targeted cancer therapies is highly competitive, with significant interest in newer, more effective treatments for resistant types of leukemia. Takeda’s strategic partnership with Ascentage Pharma is a calculated move to strengthen its position in the oncology market. Ascentage's responsibility to advance clinical development before Takeda's option exercise indicates a cautious yet opportunistic approach by Takeda to mitigate risk. The minority equity investment is also a strategic step to align interests. For investors, this signals a potential high-reward scenario hinging on clinical trial success and regulatory approvals. Monitoring competitor advancements in third-generation TKIs and patient response to olverembatinib will be critical in assessing the market impact and profitability of this agreement.

− Takeda to Receive Exclusive Option to License Global Rights to Olverembatinib in All Territories Outside of Mainland China, Hong Kong, Macau, Taiwan and Russia

− Olverembatinib Has the Potential to Address Significant Unmet Need for Patients with Chronic Myeloid Leukemia Following Treatment with Currently Approved TKIs

− Ascentage Pharma to Advance Late-Stage Clinical Development of Olverembatinib Prior to Potential Exercise of the Option to License

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) today announced the signing of an option agreement with Ascentage Pharma to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.

Despite the impact TKIs have had in the treatment of patients with CML, there remains significant unmet need for patients whose disease is resistant or refractory to these therapies or who develop hard-to-treat mutations following these treatments.

“Takeda has a long history of driving important treatment advances for patients, particularly those with hematological cancers facing treatment gaps,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “We are highly encouraged by the promising results olverembatinib has shown in the clinic to date and excited to have the opportunity to potentially further develop and deliver it to patients with chronic myeloid leukemia and other hematological cancers. This agreement aligns with our goal to support the advancement of both internal and external innovation to best serve patients.”

As part of the agreement, Ascentage Pharma will continue to be solely responsible for all clinical development of olverembatinib prior to potential exercise of the option to license. Olverembatinib is currently approved and marketed in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation and in adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs.

"We are thrilled to enter into this agreement with Takeda, which would allow us to leverage the global commercial expertise of an organization with a proven track record and global oncology footprint to potentially broaden the impact olverembatinib could have on patients in need around the world,” said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. “We have seen the impact olverembatinib has had on patients with CML in China and look forward to progressing development of olverembatinib in POLARIS-2, the global registrational Phase 3 study in previously treated adult patients with CP-CML with or without the T315I mutation.”

Under the terms of this agreement, Ascentage Pharma will receive an option payment of $100 million upon signing of the exclusive option to license agreement and will be eligible for an option exercise fee and additional potential milestone and royalty payments if Takeda exercises the option to license olverembatinib, with the exercise of the option being subject to customary regulatory approvals. Additionally, Ascentage Pharma will receive a minority equity investment from Takeda.

About Olverembatinib

Olverembatinib is an oral, third-generation BCR-ABL tyrosine kinase inhibitor (TKI). Olverembatinib is currently approved and marketed in China for the treatment of adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation and in adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs. Ascentage Pharma is investigating olverembatinib in multiple clinical studies in several types of cancer. Olverembatinib has been granted orphan drug designation and Fast Track designation by the U.S. Food and Drug Administration (FDA) and orphan designation by the European Medicines Agency (EMA).

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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Medical Information

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View source version on businesswire.com: https://www.businesswire.com/news/home/20240614852542/en/

Media:

Japanese Media

Jun Saito

jun.saito@takeda.com

U.S. and International Media

Jennifer Anderson

jennifer.anderson@takeda.com

Source: Takeda Pharmaceutical Company Limited

FAQ

What is Takeda's partnership with Ascentage Pharma about?

Takeda signed an option agreement with Ascentage Pharma for an exclusive global license to olverembatinib, a TKI for CML.

When was the Takeda and Ascentage Pharma agreement announced?

The agreement was announced on a recent date, with details specified in the press release.

What is olverembatinib?

Olverembatinib is a third-generation BCR-ABL tyrosine kinase inhibitor (TKI) for treating chronic myeloid leukemia (CML).

What markets are excluded from Takeda's license option for olverembatinib?

The option excludes mainland China, Hong Kong, Macau, Taiwan, and Russia.

How much will Ascentage Pharma receive from Takeda upon signing?

Ascentage Pharma will receive an option payment of $100 million.

What are the potential financial benefits for Ascentage Pharma from this agreement?

Ascentage Pharma could receive additional milestone and royalty payments if Takeda exercises the option.

Why is olverembatinib significant for CML treatment?

Olverembatinib addresses unmet needs in CML patients who are resistant to or intolerant of currently approved TKIs.

Who will continue the clinical development of olverembatinib?

Ascentage Pharma will continue late-stage clinical development of olverembatinib.