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Surprising and sizable injection
SAN DIEGO—A diabetes partnership initiated in 2007 by Bristol-Myers Squibb Co. (BMS) and AstraZeneca PLC received a huge boost last month in the unlikely form of a multi-billion-dollar acquisition—of Amylin Pharmaceuticals Inc. by BMS for $31 per share in cash, or approximately $5.3 billion.
The acquisition is pursuant to a cash tender offer and second-step merger, and its total value—including Amylin's net debt and a contractual payment obligation to Eli Lilly & Co.—could be about $7 billion.
The acquisition is part of an ongoing diabetes alliance between BMS and AstraZeneca that will now will develop and commercialize Amylin's portfolio of products, which primarily consists of a franchise of GLP-1 agonists for the treatment of type 2 diabetes. That franchise is anchored by two such treatments: Byetta (exenatide) injection and Bydureon (exenatide extended-release for injectable suspension/exenatide 2 mg powder and solvent for prolonged release suspension for injection), both of which are approved for use in the United States and Europe.
"Our view is that to date, the GLP-1 class has been predominately prescribed by endocrinologists in the United States," says Jennifer Fron Mauer, director of BMS business communications. "However, we believe that there are many patients not treated by endocrinologists who could benefit from these medicines."
Other assets included in the acquisition are Metreleptin, a leptin analog currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes and/or hypertriglyceridemia 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 types 1 and 2 diabetes patients with inadequate glycemic control on meal-time insulin; and a state-of-the-art sterile production facility in Ohio.
These assets are a good complement to BMS' portfolio of Onglyza, Kombiglyze and Forxiga, the diabetes drugs that BMS and AstraZeneca have been working on, says Mauer.
"By leveraging the existing AZ/BMS diabetes sales force, our capabilities in access/affordability and our marketing experience, we expect that we will be able to significantly broaden the prescriber base and drive increased adoption of Amylin's GLP-1 franchise," she adds. "We also believe that Amylin's U.S. endocrinology capability has the potential to enhance the promotion of our Onglyza franchise business."
Following completion of the acquisition, AstraZeneca will make a $3.4-billion cash payment to Amylin as a wholly owned subsidiary of BMS. All of Amylin's physical assets will be owned by BMS, and AstraZeneca will be entitled to 50 percent of the profits and losses arising from Amylin's business, as well as ownership of certain Amylin assets. Profits and losses arising from the collaboration will be shared equally. In addition, AstraZeneca has the option to establish equal governance rights over key strategic and financial decisions regarding the collaboration upon an additional $135-million payment to BMS.
"This is a compelling proposition that will have an immediate positive impact on revenues and is fully in line with our stated partnering strategy to enhance top-line growth and strengthen our late stage pipeline," said Simon Lowth, AstraZeneca's interim CEO, in a statement. "The broadening of our diabetes collaboration with Bristol-Myers Squibb is another important step towards creating a leadership position in the treatment of a disease with growing unmet medical need that is reaching epidemic proportions in many areas of the world. The combined development, regulatory and commercial strengths of the AstraZeneca and Bristol Myers-Squibb alliance for diabetes provides an excellent platform to unlock the potential of Amylin's differentiated treatments for the benefit of patients worldwide and for our shareholders."
The boards of directors of BMS and Amylin have unanimously approved the acquisition. At press time, Amylin's board had unanimously recommended that Amylin's stockholders tender their shares into the tender offer. The deal was expected to close by the end of July.
BMS will finance the acquisition from its existing cash resources and credit facilities. The pharma said it expected the transactions to be dilutive to non-GAAP earnings per share (EPS) in 2012 and 2013 by approximately 3 cents, becoming slightly accretive starting in 2014 and followed by meaningful accretion in the later part of the decade.
As we went to press, no decisions had been made about how Amylin's San Diego headquarters will be incorporated into New York-based BMS or how the acquisition will affect Amylin's employees.
"After the close of the acquisition, we plan to work closely with Amylin's leaders to gain a thorough understanding of the portfolio, facilities and employees, and quickly make decisions. Our goal is to ensure the rapid integration of assets into our operations," says Mauer.
As to whether BMS is eyeing other potential collaborations or add-ons in the area of diabetes, Mauer notes, "As part of our capital allocation strategy, business development is a priority for Bristol-Myers Squibb. We continue to look for opportunities that can deliver long-term growth. We focus on transactions that are strategically, scientifically and economically sound."
Amylin declined to comment on the acquisition.
BMS in clinical trial partnership with Emory U
ATLANTA—Bristol-Myers Squibb Co. (BMS) also recently announced that it has formed a "strategic partnership" with Emory University to conduct clinical trials involving BMS' investigational compounds.
Investigators from Emory and affiliated institutions will conduct Phase II, Phase III and pediatric clinical trials in the metropolitan Atlanta area to support the ongoing development of investigational medicines from across BMS' portfolio, particularly in oncology, metabolics, hepatitis C and immunoscience.
According to the partners, their agreement builds on recent experiences between the two organizations in conducting clinical trials in organ transplantation and cancer. Initially, researchers from Emory's Winship Cancer Institute will work with BMS scientists on multiple clinical trial programs in oncology.
"Through this partnership, we are working to provide a framework to improve clinical trials efficiency and to enhance the development of academic and industry collaborations that solve health care problems," said Dr. David S. Stephens, vice president of research in Emory's Woodruff Health Sciences Center and principal investigator of the Atlanta Clinical and Translational Science Institute (ACTSI). "Emory's successful partnership with Bristol-Myers Squibb in developing drugs for organ transplantation is an excellent example of the benefits of these kinds of collaborations."