Amylin Pharmaceuticals helped diabetics gain the upper hand in their battle with the disease. The company made and marketed injectable diabetes drugs Byetta and Symlin, which were approved as adjunct therapies to other diabetes treatments such as metformin and insulin. Byetta was also approved as a stand-alone diabetes therapy. Amylin gained FDA approval for Bydureon, a once-weekly version of Byetta, in 2012, and it began developing additional drugs for metabolic conditions. The company's US sales force marketed its products to patients and physicians; development partner Eli Lilly marketed Byetta internationally, although Amylin and Lilly ended their partnership. Amylin was acquired by Bristol-Myers Squibb (BMS) and then by AstraZeneca the following year.
Change in Company Type
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 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. AstraZeneca acquired BMS's diabetes business, including Amylin, in 2013. The two pharmaceutical giants had held a diabetes alliance consisting of three global development and commercialization agreements (covering Onglyza, Forxiga/Farxiga, and Amylin's portfolio of products).
The company's diversification efforts were aimed to reverse the fact that despite having successfully commercialized products, Amylin 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 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 was also challenged by high development costs and regulatory approval delays.
As a result Amylin 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 underwent 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 outsourced much of its manufacturing operations. The company hoped that it could become more profitable by teaming up with BMS.
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 was transferred gradually to Amylin. 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 was 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 planned 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 controlled 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 was being marketed by Lilly in several countries.
Amylin and Alkermes also worked 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 expanded its development pipeline into therapeutic areas including obesity and severe lipodystrophy, a rare metabolic condition. Amylin had an agreement with Takeda Pharmaceutical to develop obesity therapies; however, the companies discontinued their lead clinical candidate in 2011 and began evaluating other candidates for further development.
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.)