Amylin in Talks With FDA
The chief executive of Amylin Pharmaceuticals Inc. on Monday said the company was in talks with the Food and Drug Administration about its beleaguered experimental diabetes drug Symlin.
The FDA told Amylin on Dec. 17 that it would not approve Symlin without more information about its safety. Amylin, a San Diego biotechnology firm with no products, has been working on Symlin for 16 years.
Amylin CEO Ginger Graham told investors at a health-care conference here that discussions with the agency were underway “to clarify and understand what it takes to get Symlin approved.”
Graham’s comments were her first about Symlin since Dec. 19, when the company disclosed a Securities and Exchange Commission inquiry into a conference call Amylin had had about the drug. Graham said Monday that the company was cooperating with the SEC but refused to provide any details.
Amylin has said the SEC inquiry dealt with the agency’s fair disclosure rules, which prohibit companies from selectively disclosing information that could affect their stock prices.
The company participated in a private call with clients of brokerage Goldman Sachs & Co. the morning after the FDA refused to approve Symlin, pending the receipt of more data.
Amylin held a second investor call that same day, but after the markets had closed. The second call was broadcast over the Internet.
Graham said the company wouldn’t make the transcript of the Goldman Sachs call available to investors.
Graham made her comments in a formal investor presentation and in a separate question-and-answer session broadcast over the Internet. The company said it also would broadcast a cocktail reception and discussion with analysts planned for today.
Although formal company presentations at the conference are often broadcast over the Internet, Q&A; sessions and cocktail parties generally are not, said Nancy Israel, spokeswoman for conference sponsor J.P. Morgan Chase & Co.
Amylin has spent $300 million on Symlin. It was developed to regulate insulin uptake in patients with Type 1 diabetes, a form of the disease that typically strikes in childhood or adolescence. The company has conducted three late-stage trials of the drug.
“To say this has not been an easy path would be a ridiculous understatement,” Graham said.
The company nonetheless remained dedicated to obtaining approval for Symlin as a diabetes drug, she said.
In addition, the company plans to begin tests of Symlin as an obesity treatment for non-diabetics, Graham said. Participants in the Symlin trial lost weight.
On Monday, Amylin shares closed at $21.93 on Nasdaq, down 6 cents.
