Amylin Pharmaceuticals helps diabetics gain the upper hand in their battle with the disease. The company makes and markets injectable diabetes drugs Byetta and Symlin, which are approved as adjunct therapies to other diabetes treatments such as metformin and insulin. Byetta is also approved as a stand-alone diabetes therapy. Amylin gained FDA approval for Bydureon, a once-weekly version of Byetta, in 2012, and it is developing additional drugs for metabolic conditions. The company's US sales force markets its products to patients and physicians; development partner Eli Lilly markets Byetta internationally, although Amylin and Lilly are ending their partnership. Amylin was acquired by Bristol-Myers Squibb in 2012.
Amylin was acquired by global drugmaker BMS in mid-2012 in a $7 billion deal ($5.3 billion in cash plus $1.7 billion in debt and contractual obligations to Eli Lilly). The purchase expanded BMS' diabetes portfolio; it also gave Amylin access to BMS' broad global marketing and distribution network. As a follow-on to the deal, BMS and another top pharma company, AstraZeneca, extended their existing diabetes collaboration partnership to develop additional drugs based on Amylin's technologies; immediately following Amylin's acquisition by BMS, AstraZeneca paid some $3.2 billion to gain access to those R&D programs.
Previously, in 2011, Amylin and Lilly announced plans to end their partnership, with Amylin agreeing to purchase rights to all of the exenatide products (Byetta, Bydureon, and development-stage products) from Lilly for some $250 million, plus future revenue sharing and milestone payments of about $1.2 billion. Amylin took immediate control of marketing for Byetta in the US (where the two companies previously co-marketed the drug), while responsibility for the 70-plus international markets will be transferred gradually to Amylin by the end of 2013. As part of the breakup agreement, Amylin dropped a lawsuit alleging that Lilly breached their alliance agreements by striking a competing development deal with another drug firm.
During the term of their partnership, Amylin and Lilly steadily grew the geographic markets in which Byetta is sold. The companies also widened the drug's uses; for instance, in 2009 Byetta gained its FDA approval as a monotherapy (stand-alone therapy) for diabetes. Amylin plans to continue to pursue Byetta's approval in new markets and for additional indications.
In addition, Amylin successfully developed a weekly version of Byetta, Bydureon (also known as exenatide once weekly), with drug delivery expert Alkermes that controls blood sugar better than the existing twice-a-day version. (Lilly was part of the development collaboration until 2011.) Amylin finally gained FDA approval for Bydureon in early 2012 and revved up sales of the drug shortly after; the firm had originally hoped to launch Bydureon in the US in 2010 or 2011 but those plans were delayed as the FDA requested additional information. Bydureon was approved for sale in the European Union in June 2011; it is being marketed by Lilly -- for now -- in several countries.
Amylin and Alkermes are also working on a pen delivery system for Bydureon, as well as a once-monthly version of exenatide. In addition, Amylin entered into a partnership with development firm Biocon to work on a separate line of potential diabetes treatments in 2009.
In order to decrease its dependence on diabetes products, Amylin has also expanded its development pipeline into therapeutic areas including obesity and severe lipodystrophy, a rare metabolic condition. Amylin has an agreement with Takeda Pharmaceutical to develop obesity therapies; however, the companies discontinued their lead clinical candidate in 2011 and are evaluating other candidates for further development.
The company's diversification efforts have aimed to reverse the fact that despite having successfully commercialized products, Amylin has continued to experience operating losses each year since its inception in 1987 (a state typical of development-stage companies). Amylin had counted on revenue from Byetta and Symlin to help it become profitable; however, sales of top product Byetta have weakened since 2008 when concerns emerged over Byetta's possible link to pancreatitis (a potentially deadly disease of the pancreas), and in 2009 sales of Byetta weakened further due to the launch of a competing product. The company has also been challenged by high development costs and regulatory approval delays.
As a result Amylin has accumulated a deficit of about $2.6 billion over the years. Its profits took an especially hard hit in 2011 when it reported net income losses of some $540 million due to the expense of purchasing Lilly's share of the exenatide line. Revenues decreased about 3% that year due to lower Byetta sales, compared to 12% in 2010.
In response, Amylin has undergone corporate restructuring efforts to rein in operating expenses, including workforce reductions (consisting of sales, R&D, and other operational staff) of about 16% in 2009, 7% in 2010, and 7% in 2011. Like many midsized drugmakers, Amylin already outsources much of its manufacturing operations. The company hopes that it can become more profitable by teaming up with BMS.
Prior to its acquisition by BMS, billionaire corporate raider Carl Icahn owned a 9% stake in Amylin. Icahn and another shareholder, Eastbourne Capital Management, put pressure on the company over its declining sales and continued unprofitability in 2009 and managed to shake up Amylin's board of directors as a result. (Eastbourne Capital Management sold off its 12% stake in Amylin later that year.) The company's other institutional investors do not hold secured seats on the board.