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Biophytis grants Blanver Exclusive Rights to BIO101 in Latin America in Deal Valued at up to €108 Million

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Biophytis has signed an exclusive license agreement with Blanver for the commercialization of BIO101 in Latin America, including countries such as Brazil, Mexico, Argentina, and Colombia. The deal is valued at up to €108 million, comprising upfront and milestone payments, along with double-digit royalties on future sales.

Blanver will handle the registration, marketing, and commercialization of BIO101 for various indications like obesity, respiratory infections due to Covid-19, sarcopenia, and Duchenne Muscular Dystrophy, contingent on successful clinical trials by Biophytis.

This partnership aims to leverage Blanver's extensive distribution network and expertise in infectious diseases and metabolic disorders, highlighting the promising potential of BIO101 based on positive clinical results.

Biophytis anticipates this collaboration will significantly contribute to its strategic goals, especially in addressing obesity in a rapidly growing pharmaceutical market like Brazil.

Positive
  • Biophytis to receive up to €108 million in payments.
  • Agreement includes double-digit royalties on future BIO101 sales.
  • Blanver responsible for BIO101 registration, marketing, and commercialization.
  • Blanver's distribution network covers the entire Latin America region.
  • Deal leverages Blanver's expertise in infectious diseases and metabolic disorders.
Negative
  • Future earnings contingent on successful clinical trials for BIO101.
  • Dependence on obtaining marketing authorizations for royalty income.

Insights

The deal between Biophytis and Blanver is significant financially. The agreement, worth up to €108 million, includes both upfront and milestone payments, which indicates a strong initial cash inflow for Biophytis. Double-digit royalties on future sales add further revenue potential, providing a steady income stream post-commercialization.

This partnership with Blanver positions Biophytis to capitalize on the large and growing pharmaceutical market in Latin America, particularly in Brazil. With Brazil’s pharmaceutical market valued at $23 billion in 2023, tapping into this market can significantly enhance Biophytis' revenue prospects. Additionally, the financial structure of the deal—upfront and milestone payments—helps mitigate financial risk, diversifying Biophytis' income sources beyond potential sales. In the short term, this collaboration boosts Biophytis' liquidity and can support ongoing clinical trials. Long-term, the continued revenue from royalties can provide sustainable growth.

Investors should also consider the potential risks, such as the dependence on successfully completing clinical trials and obtaining market authorizations, both of which are prerequisites for realizing the full financial benefits of the deal.

The expertise of Biophytis in developing therapeutics for age-related diseases aligns well with Blanver’s focus on infectious diseases and metabolic disorders. This synergy can expedite the clinical development and regulatory processes for BIO101.

Given the diverse indications for BIO101—such as obesity, respiratory infections due to Covid-19, sarcopenia and Duchenne Muscular Dystrophy (DMD)—this collaboration can address multiple high-need areas. BIO101’s potential in treating obesity is particularly noteworthy, considering the high prevalence in Latin America. The clinical success in these indications can drive significant market demand. However, the clinical and regulatory pathway remains a critical hurdle. Success in early clinical results provides a positive outlook, but ongoing trials must continue to demonstrate efficacy and safety to secure market authorization.

  • Biophytis to receive upfront and milestones payments for a total amount up to €108 million, as well as double-digit royaltieson future sales of the product
  • Agreement covers commercialization of BIO101 in Latin America
  • Biophytis and Blanver intend to collaborate on manufacturing and joint clinical development for Latin America

PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / June 20, 2024 / Biophytis SA (Euronext Growth Paris:ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in thedevelopment oftherapeutics for age-related diseases, today announces the signature of an exclusive license agreement with Blanver, one of the leading and most trusted pharmaceutical company in Brazil, for BIO101 (20-Hydroxyecdysone) in Latin American including, but not limited to Brazil, Mexico, Argentina and Colombia.

The agreement provides that Blanver will be responsible for the registration, marketing and commercialization of BIO 101 (20-Hydroxyecdysone) in its various indications: obesity, respiratory infections due to Covid-19, sarcopenia and Duchenne Muscular Dystrophy (DMD) - once Biophytis has successfully completed the planned clinical development programmes for its drug candidate. With 40 years of history, Blanver has become an expert in infectious diseases, osteoporosis and metabolic disorders, which is a perfect match with Biophytis. In addition of Brazil, Blanver has an extensive network of unique distributors that covers the whole Latin America region.

Under the terms of this partnership, Biophytis will be able to receive up to €108 million including an upfront payment and further additional payments if certain objectives are achieved. Biophytis is also eligible to receive double-digit royalties on net sales of BIO101 (20-Hydroxyecdysone) generated in the collaboration territory, after obtaining future marketing authorisations.

This collaboration in one of the main pharma regions in the world, underscores the potential of BIO101 (20-Hydroxyecdysone) which is based on the positive clinical results already obtained in several indications.

Stanislas Veillet, CEO of Biophytis, stated: "I warmly welcome this new partnership which is a key milestone that will enable Biophytis to further deploy its strategic roadmap, especially in obesity. This is a unique opportunity for both companies and comes at a crucial time as Brazil is the most fast-growing pharmaceutical market, representing more than $23 billion in 2023. In the LATAM region, 100 million of patients are suffering from obesity. We look forward to continuing our clinical and regulatory development work with Blanver over the coming months and to exploring with them early market access opportunities for our most advanced indications. Together, we aim to deliver solutions to patients and physicians over the years ahead."

Sergio Frangioni, CEO of Blanver, commented: "Innovation is part of the Blanver DNA, and we are thrilled to partner with Biophytis, to bring this unique medicine in Latin America. We are very confident that the clinical study of the novel BIO101 (20-hydroxyecdysone), will show encouraging results, which will support the medical community to obesity, their effects and bring health and quality of life to so many patients who suffer from this condition."

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About BIOPHYTIS

Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular (sarcopenia, phase 3 ready and Duchenne muscular dystrophy), respiratory (Covid-19 phase 2-3 completed) and metabolic diseases (obesity, phase 2 to be started). The company is based in Paris, France, and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825). For more information, visit www.biophytis.com

About BLANVER

Blanver Farmoquímica e Farmacêutica S.A. is a Brazilian company, founded in 1984, focused on R&D, manufacture and sale of innovative medicines and active pharmaceutical ingredients (APIs). The company plays in the segments of HIV, Hepatitis, Oncology, Hematology and Rare Disease, providing high quality products for expanding the population's access to medicines through partnerships with the Ministry of Health and official laboratories. Blanver is committed in always looking for innovations that will improve people's health and quality of life.

Forward-looking statements

This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook,""believes,""expects,""potential,""continues,""may,""will,""should,""could,""seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of thesewords or other comparable words. Such forward-looking statements are based on assumptions that Biophytis considers to be reasonable.However, there can be no assurance that the statements contained in such forward-looking statements will be verified, which are subject to various risks and uncertainties. The forward- looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Please also refer to the "Risk and uncertainties the Company is to face» section from the Company's 2023 Financial Report available on BIOPHYTIS website (www.biophytis.com) and as exposed in the "Risk Factors" section of form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

Biophytis contacts

Investor relations
Nicolas Fellmann, CFO
Investors@biophytis.com

Pharma partners
Edouard Bieth, CBO
edouard.bieth@biophytis.com

Media

Antoine Denry:antoine.denry@taddeo.fr- +33 6 18 07 83 27
Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50

Blanver contacts

Investor relations
Sergio José Frangioni, CEO

Media

Herbert Silva: Herbert.silva@blanver.com.br
Lilia Lima de Almeida: lilia.almeida@blanver.com.br

SOURCE: Biophytis



View the original press release on accesswire.com

FAQ

What is the value of the Biophytis and Blanver deal?

The deal is valued at up to €108 million, including upfront and milestone payments.

What will Blanver be responsible for under the agreement with Biophytis?

Blanver will handle the registration, marketing, and commercialization of BIO101 in Latin America.

Which countries in Latin America are included in the Biophytis and Blanver agreement?

The agreement includes countries such as Brazil, Mexico, Argentina, and Colombia.

What indications will BIO101 be marketed for in Latin America?

BIO101 will be marketed for obesity, respiratory infections due to Covid-19, sarcopenia, and Duchenne Muscular Dystrophy.

What potential earnings does Biophytis expect from the Blanver agreement?

Biophytis expects to receive up to €108 million in payments and double-digit royalties on future BIO101 sales.

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