AMYLIN PHARMACEUTICALS INC.
CEO: Daniel M. Bradbury.
Revenue: $650.7 million in 2011; $651.1 million in 2010.
Net loss: $543.4 million in 2011; $152.3 million in 2010.
No. of local employees: 650.
Headquarters: San Diego.
Year founded: 1987.
Stock symbol and exchange: AMLN on Nasdaq.
Company description: A biopharmaceutical company dedicated to improving the lives of patients through the discovery, development and commercialization of innovative medicines.
Key factors for success: Amylin has brought to market three therapies for the treatment of diabetes. Its two first-in-class diabetes treatments Byetta injection and Symlin injection and the first once-weekly diabetes treatment Bydureon are helping patients better control their disease. Amylin’s pipeline is focused on bringing treatment options to patients with metabolic disorders, including the life-threatening, ultra-orphan disease lipodystrophy.
Speculation continues about whether San Diego-based Amylin Pharmaceuticals Inc. could be sold as the company introduces a third diabetes treatment into the market with the recent approval of Bydureon, the first and only once-weekly treatment for type 2 diabetes.
First approved in Europe in June 2011 and then FDA-approved in the U.S. in January 2012, Bydureon has been available to U.S. pharmacies since February. Bydureon builds upon Amylin’s Byetta, which has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide.
The active ingredient in both Bydureon and Byetta is exenatide, which was developed by Amylin in partnership with Alkermes through an agreement in May 2000. Compared with the twice-daily Byetta, Amylin Executive Director of Corporate Affairs Alice Izzo said the once-weekly Bydureon offers improvements in efficacy and continuous glycemic control in a single weekly dose. Bydureon is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes, and should be used along with diet and exercise, she said.
The trio of treatments in Amylin’s arsenal also includes Symlin, a synthetic analogue of human amylin, which is a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin.
Market Potential is Wide Open
“In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, beta cells in the pancreas that make both insulin and amylin are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals,” Izzo said, in a statement. “Amylin deficiency can make it harder to control glucose levels after meals; therefore, using Symlin can help patients to spend more time in their normal glycemic range.”
The market potential for Bydureon is wide open, according to Izzo, who says diabetes affects an estimated 347 million adults worldwide and nearly 26 million people in the U.S. As many as 90 percent to 95 percent of those affected have type 2 diabetes, she said.
With about 1,500 employees across the U.S., Amylin boosted its staff with the Bydureon launch by hiring an additional 325 diabetes sales specialists, which now totals 650.
“These diabetes sales specialists cover physicians who write more than 60 percent of all branded diabetes prescriptions, which today accounts for more than 90 percent of all GLP-1 prescriptions,” Izzo said.
Byetta was the first GLP-1 receptor agonist to be approved by the FDA for the treatment of type 2 diabetes, and it is the first and only GLP-1 receptor agonist approved for use in the U.S. as an adjunct to insulin glargine with or without metformin and/or thiazolidinedione.
Reporting $650.7 million in revenues in 2011 compared to $651.1 million in revenues in 2010, Amylin is ranked No. 16 on the San Diego Business Journal’s Largest Public Companies list among companies based in the region. It’s a far cry from its roots in 1987, when New Zealand scientist Garth Cooper founded Amylin with designs on exploring the therapeutic potential of a hormone he discovered while doing postdoctorate research at Oxford. Cooper named the new hormone “amylin” and the company was named for the hormone. The startup was based in San Diego and financed by Howard “Ted” Greene, who is a leader in the San Diego biotech community.
Potential Takeover Target
In current news, Bloomberg is reporting that Amylin is preparing for a second round of bids after attracting purchase offers that value the diabetes drugmaker at $25 to $29 a share. Amylin shares, traded on the Nasdaq under the symbol AMLN, were trading at $27.32 as of June 13. First-round proposals have already been made by AstraZeneca Plc, Sanofi, Merck & Co., and Bristol-Myers Squibb Co., according to Bloomberg, which declined to identify sources as talks are private.
Thomas J. Russo, senior research analyst with Robert W. Baird & Co., said it’s been no surprise Amylin had been seeking to secure a U.S. partnership to bolster its commercialization effort of Bydureon since a split with longtime partner Eli Lilly and Co. in November 2011. Russo said the relationship deteriorated when Lilly signed with Boehringer Ingelheim in early 2011 to develop and commercialize drugs in direct competition with Bydureon and Byetta.
“From that point forward a relationship that was never too good to begin with got worse,” Russo said. “Ultimately it resulted in a divorce of the two companies.
“It’s public knowledge that Amylin was looking for a U.S. partner and there’s been a drumbeat of speculation in the press that those talks have turned into takeout talks,” he said.
Russo said the speculation has been striking in its consistency and specificity in terms of ranges of offers and interested players. He believes a buyout is a likely outcome as Amylin presents an attractive asset and an attractive product.
Russo described Bydureon’s launch as positive, saying it complements Byetta well and offers a unique and differentiated product in a class that has some unique benefits and is growing as a whole.
“The segment has been continuing to grow and we believe it is a product with significant potential in the area of blockbuster status,” he said. “We believe on the whole it’s off to a good start.”