Amylin Pharmaceuticals and Takeda Pharmaceutical have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize compounds for the treatment of obesity and related indications.

The agreement includes Amylin's pramlintide/metreleptin and davalintide, which are currently in Phase II development for treatment of obesity. The agreement also includes additional compounds from both companies' obesity research programs. Amylin will receive a one-time up-front payment of $75 million and is eligible to receive additional payments based on certain development, commercialization and sales milestones that could exceed $1 billion. The agreement also provides for future royalty payments to Amylin based on global product sales.

Amylin will be responsible for development activities through Phase II with the aim of regulatory approval in the U.S. Takeda will then take over further development in the U.S., and all development activities outside the U.S. Amylin will be responsible for 20% of development costs and Takeda will be responsible for 80%. Takeda will cover all development costs associated with obtaining approval for products outside the U.S. Takeda will be responsible for all product commercialization and costs. Amylin will have the option to co-commercialize the first two approved products in the U.S. and any follow-on products containing the identical active ingredients.

"Takeda is excited to realize this partnership with Amylin focused on the treatment of obesity and related indications. By leveraging Takeda's global development and commercial infrastructure we look forward to maximizing the significant potential of the products under this agreement," said Yasuchika Hasegawa, president and chief executive officer, Takeda. "Both Amylin and Takeda have extensive experience in the diabetes and metabolic disease area, and this collaboration should allow us to more quickly bring promising new treatments to patients in need."

"This collaboration will leverage Amylin's experience and expertise with peptide and protein science and Takeda's worldwide development and commercial expertise," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "Amylin recognizes the enormous potential of this collaboration to advance more options in obesity treatment more quickly than either company could do alone. Amylin and Takeda are excited about working together to address the significant unmet need for the millions of patients who need better solutions to manage obesity."

ICON has signed an extension to its strategic agreement with Lilly to manage the company’s clinical data outside the U.S. ICON will now also oversee Lilly’s needs in Japan in addition to those in Europe, Canada, Latin America, Australia and Asia.

“Today’s announcement is a continuation of a very successful partnership between ICON and Lilly,” commented Peter Gray, chief executive officer at ICON. “Through our existing data management partnership, we have brought significant process efficiencies to Lilly in helping them progress their drug development pipeline. That Lilly has chosen ICON to manage this important business function in such a key region as Japan is a measure of our global data management expertise and our local capabilities in the region.”

"With this transaction, Lilly Data Sciences and Solutions realizes its objective to leverage external, scalable clinical data management capabilities around the globe,” said Jeff Kasher, Lilly’s vice president and chief operating officer of Global Clinical Development. “We’re pleased to extend our relationship with ICON to include Japan, and their proven ability to reliably deliver work within differing cultural climates provided Lilly the opportunity to take another significant step in our ongoing agenda to increase flexibility, reduce fixed cost, and focus internal resources on core capabilities.”

Penn Pharma has completed the first phase of its $19.7 million expansion program with a $.5 million investment extending its facilities by 2,400m² and changing the transport and delivery infrastructure at its Tredegar headquarters.

Darren Hassey, chief operating officer at Penn Pharma, said, “The recent developments to the site only add to our established offerings. By altering the externals of the site and moving the delivery and collection points we have in turn altered the internal factory processes, ensuring the smooth flow of people, process and materials.”

Peter George, chief executive officer of Penn Pharma, said, “By heavily investing in our Tredegar site it strengthens our commitment to the local community and as a leading Welsh company we will endeavor to pay back the Assembly Government’s faith in us by driving sustainable growth and employment.”

Additional phases of the expansion will take place during the next five years.

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