Date: 2012-08-09
Type of information: Collaboration agreement
Compound: Onglyza® (saxagliptin - DPP-4 inhibitor), Kombiglyze® (saxagliptin and metformin HCI extended-release), Forxiga (dapagliflozin - SGLT2 inhibitor), other Almylin's assets
Company: AstraZeneca (UK) BMS (USA)
Therapeutic area: Metabolic diseases
Type agreement: collaboration
Action mechanism:
Disease: diabetes
Details: * On June 29, 2012, BMS and Amylin Pharmaceuticals have announced that BMS will acquire Amylin for $31.00 per share in cash, pursuant to a cash tender offer and second step merger, or an aggregate purchase price of approximately $5.3 billion. The total value of the transaction, including Amylin’s net debt and a contractual payment obligation to Eli Lilly, together totaling about $1.7 billion, is approximately $7 billion.
Following the completion of Bristol-Myers Squibb’s acquisition of Amylin, BMS and AstraZeneca have announced that the companies will enter into collaboration arrangements, based on the framework of the existing diabetes alliance, regarding the development and commercialization of Amylin’s portfolio of products. BMS and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes. This diabetes collaboration is focused around Onglyza® (saxagliptin - DPP-4 inhibitor), Kombiglyze® (saxagliptin and metformin HCI extended-release) and Forxiga (dapagliflozin - SGLT2 inhibitor). Dapagliflozin received a positive opinion from the CHMP in Europe in April 2012.
Amylin’s assets include:
• A GLP-1 agonist franchise, including two treatments for type 2 diabetes, Byetta® (exenatide) injection and Bydureon® (exenatide extended-release for injectable suspension/exenatide 2 mg powder and solvent for prolonged release suspension for injection), approved for use in both the U.S. and Europe, and a life-cycle management pipeline, including delivery devices and formulation improvements. The addition of the Amylin GLP-1 franchise complements Bristol-Myers Squibb’s and AstraZeneca’s current diabetes portfolio creating a comprehensive disease management platform;
• Metreleptin, a leptin analog currently under review at the FDA for the treatment of diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in patients with rare forms of inherited or acquired lipodystrophy;
• Symlin® (pramlintide acetate) injection an amylin analog, approved by the FDA for the treatment of type 1 and type 2 diabetes patients with inadequate glycemic control on meal-time insulin; and
• A state-of-the-art sterile production facility in Ohio.
Financial terms: Following completion of BMS’s acquisition of Amylin, AstraZeneca will make a payment to Amylin, as a wholly owned subsidiary of BMS, in the amount of approximately $3.4 billion in cash. Profits and losses arising from the collaboration will be shared equally. In addition, AstraZeneca has the option, exercisable at its sole discretion following the closing of the acquisition, to establish equal governance rights over key strategic and financial decisions regarding the collaboration, upon the payment to BMS of an additional $135 million. These collaboration arrangements have been approved by the boards of directors of BMS and AstraZeneca.
* On August 9, 2012, AstraZeneca and BMS have announced that following the successful completion of the acquisition of Amylin Pharmaceuticals by BMS, AstraZeneca has made an initial payment of approximately $3.2 billion to Amylin Pharmaceuticals, now a wholly-owned subsidiary of BMS. As previously disclosed, the payment is being made in connection with the expansion of the diabetes alliance between AstraZeneca and BMS to incorporate the development and marketing of Amylin’s portfolio of diabetes products, and profits and losses arising from the collaboration will be shared equally.
AstraZeneca has also informed BMS of its intention to exercise its option to acquire certain additional governance rights over key strategic and financial decisions regarding Amylin’s portfolio. The rights to this option will become effective once the applicable anti-trust and competition approvals are received by AstraZeneca. Upon the exercise of the option an additional payment of $135 million will be made to BMS.
Latest news: * On July 10, 2012, BMS has begun a cash tender offer to purchase all outstanding shares of common stock of Amylin Pharmaceuticals. Upon the successful closing of the tender offer, stockholders of Amylin will receive $31.00 in cash for each share of Amylin common stock validly tendered and not validly withdrawn in the offer, without interest and less any applicable withholding taxes. Following the purchase of shares in the tender offer, Amylin will become a subsidiary of BMS.
