Byetta Manufacturer Reportedly at a Crossroads

May 2, 2012, 1:30PM. By Gordon Gibb

San Diego, CAThose with a thirst for corporate entanglement have lots of fodder thanks to various issues surrounding Amylin Pharmaceuticals Inc., now the sole manufacturer and distributor of Byetta. Various legal tidings have taken, for now, the focus away from concerns over Byetta acute pancreatitis, and whether once-weekly injectable Bydureon has the potential to suffer the same fate.

Byetta side effects—many of which have led to a Byetta lawsuit—are thought to lead to impaired kidney dysfunction, thyroid cancer and the aforementioned Byetta acute pancreatitis. Health advocates remain concerned that Bydureon—a new formulation of Byetta that requires weekly injections, rather than daily—can lead to similar concerns.

However, that's not the focus right now. Various corporate issues and Byetta lawsuits of a corporate (not medicinal) nature have shifted the spotlight.

For one, Amylin has ended its partnership with Eli Lilly & Co., which now gives Amylin exclusive rights to Byetta and Bydureon. But that comes with a price, in that Amylin, according to various sources, must reimburse Lilly 15 percent on global sales of Byetta and Bydureon up to $1.2 billion, plus interest.

Neither report specified what happens when the $1.2 billion plateau is achieved. However, a further payment of $250 million to Lilly over a lawsuit Amylin had launched over Lilly's collaboration with German drug manufacturer Boehringer Ingelheim comes at a pivotal time for Amylin.

The Byetta manufacturer is losing money. Last year, Amylin was in the red to the tune of $543.4 million.

The most recent loss was due in part to one-time charges related to its re-acquisition of Byetta and Bydureon—products in which Amylin continues to have faith, in spite of concerns over the potential for Byetta side effects. Once Bydureon gains traction in the market, its revenue will help—although Amylin has to give up 15 percent of Bydureon and Byetta income to Eli Lilly, further impacting their bottom line.

Meanwhile, the Boston Globe (4/10/12) reports that billionaire investor Carl Icahn launched a lawsuit against Amylin in April, in a bid to force the company to allow shareholders more time to nominate candidates to the Amylin Board of Directors. At issue is a position, which Icahn shares, that Amylin is at a crossroads and that the company should be receptive to acquisition offers.

In early April, Bloomberg News is reported to have revealed an offer for Amylin by Bristol-Meyers Squibb Co. worth $3.5 billion. Icahn opined that Amylin should have told shareholders about the reported acquisition offer that remains unconfirmed by either company.

While various Byetta lawsuits continue to percolate, the industry continues to watch Bydureon. And while the once-weekly injectable Bydureon was long anticipated and appears to be a savior for diabetes patients who have issues with daily injections, its approval by the US Food and Drug Administration (FDA) earlier this year came with strings attached: the need for Amylin to conduct a clinical trial to assess the impact of potential side effects Bydureon may have in common with known Byetta side effects—namely Byetta acute pancreatitis, and other concerns relating to the heart and thyroid.

Both drugs have a common formulation and active ingredient: exanatide. Bydureon is, in effect, Byetta that can be injected once per week, rather than twice daily. Will the Byetta news be similar for both drugs? Time will tell. In the meantime, the drama continues to play out in the Amylin boardroom, as the company struggles to find new partnerships and, ultimately, long-term viability.