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in patients taking exenatide. The company has been gathering data on adverse events since then and sharing it with the FDA, and hopes to answer the questions about pancreatitis through an update to the drug’s FDA-approved prescribing information, Bradbury says. Obviously, the company will push to make sure the tone of the update doesn’t freak out the average doc.
—No. 2. Bringing exenatide once-weekly to patients as quickly as possible. This means no screw-ups in the drug application, responding to FDA questions, or in the manufacturing process, where a lot of biotech companies stumble. If this factory isn’t ready to pass FDA scrutiny, then investors are going to ask some really hard questions about what the company spent the $500 million on. “It wouldn’t be useful for much else” besides making exenatide once-weekly, Bradbury says.
—No. 3. Growing revenue from the company’s second marketed diabetes drug, pramlintide (Symlin). This drug only generates a little more than 10 percent of Amylin’s sales, and its performance was flat in the second quarter compared with a year ago. I didn’t really bother to ask about it, and Bradbury didn’t say much about this.
—No. 4. Continuing development of potentially breakthrough therapies for obesity. This is one area that’s been overlooked by investors. Amylin has high hopes for its experimental combination of pramlintide and a genetically modified form of leptin, for obesity. This drug has the drawback of being injectable, competing against an emerging field of oral pills, although the Amylin treatment showed impressive clinical trial results in July, and just might be a dark horse to keep an eye on for the treatment of obesity.
—No. 5. Lowering expenses to shorten the path to profitability. Amylin made a big round of cuts in May when it eliminated 200 sales jobs with an eye toward saving $45 million a year starting in 2010. Amylin has also reworked its partnership will Eli Lilly so that Amylin’s small force of 325 reps calls on endocrinology specialists and other frequent prescribers of diabetes meds, while Lilly casts a wider net by focusing on primary care docs as well as endocrinologists.
To keep these partners on the same page, Amylin and Lilly have set up a shared business unit in San Diego called ExenatideOne. This attempt at more seamless partner relations was something dissident shareholders demanded from Amylin during their proxy challenge, although Bradbury, sounding a little irritated, pointed out that Amylin was already doing this in April, before the dissidents started making their demands. Regardless of who’s idea it was, he says having Lilly and Amylin people working together in a San Diego office will help with communication.
“I personally believe this will result in more effective and efficient decision making between Lilly and Amylin,” Bradbury says.
If Amylin can execute on even two or three of those five initiatives—or even just get the one big thing right with exenatide once-weekly—then shareholders will probably have pretty short memories about all the nasty things said during last spring’s proxy fight. Bradbury sure sounds like he wants to forget it. He repeated the company’s five-point plan to me not once, but twice yesterday, to drive home the point that he’s focused on operations instead of defending against palace coups.
“The five things that we have to do comes off the top of my head very quickly, because I’ve been saying it all year,” Bradbury says. “This is a mantra I’m driving through the organization. It’s crystal clear for everybody here what they need to do to make Amylin successful.”
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