By Kim Coghill

Washington Editor

The FDA issued Amylin an ¿approvable letter¿ for Symlin, the company¿s lead drug candidate for both Type I and insulin-dependent Type II diabetes patients.

The FDA called for additional tests before it will clear Symlin for marketing. Symlin is an analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas. Amylin proposes injecting diabetes patients with Symlin three times a day in conjunction with insulin. The product controls blood sugar and helps reduce weight gain.

Amylin¿s stock (NASDAQ:AMLN) closed Friday at $8.59, up $1.27, or 17.4 percent.

In addition to the news on Symlin, Amylin Friday released a statement saying it plans to enter Phase III trials by the end of 2001 for its second product, AC2993 (synthetic exendin-4). AC2993 is a 39-amino-acid peptide being studied for non-insulin-dependent Type II diabetes patients.

Depending on the extent of additional trials, Symlin likely will enter the market in 2003 and is expected to generate about $260 million worldwide at peak sales, Fariba Ghodsian, managing director of health care research at Roth Capital Partners Inc. in Los Angeles, told BioWorld Today.

¿We are always pleased when we make a positive step forward with the FDA, as all biotech companies are,¿ said Joe Cook, Amylin¿s chairman and CEO. ¿I think this signals that when you work with the FDA and provide data and manage that data in a professional way, that they show a similar kind of response back and they want to work with you.¿

Cook would not speculate on details of what the FDA may require until the company sits down with the agency to discuss a plan. ¿The one thing that is important to understand is that the agency has taken a position that they believe Symlin can be approved provided we meet the requirements they feel need to be met,¿ he said.

He did not go into details about when Amylin representatives and the FDA will meet, except to say that ¿this is an ongoing process. We will obviously be in conversation with them via telephone, we will be exchanging letters and we¿ll probably have a meeting with them.¿

Cook kept his positive attitude even back in July when the Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval of Symlin. Following the meeting, Cook told reporters that he viewed Symlin as a business opportunity and ¿the jury is still out.¿

Apparently he was right.

The panel voted 8 to 1 against using Symlin for Type I patients and 6 to 3 against use for Type II patients. However, in an 8-to-1 vote, the panel said the trials proved efficacy, but in another 8-to-1 vote, the panel said Symlin did not appear to be safe. (See BioWorld Today, July 27, 2001.)

Traditionally, the FDA follows the advice of its panels, but not this time.

The new drug application for Symlin contained 13 years of research, 660,000 pages of material, six trials ¿ some that failed ¿ and thousands of patients, including almost 3,500 who participated in the most recent Phase III trials, one for Type I patients and the other for Type II.

Panel members and FDA reviewers had concerns surrounding severe hypoglycemia that was associated with major trauma like automobile accidents.

¿I think one thing that came out of the advisory meeting was the safety,¿ Ghodsian said. ¿Hypoglycemia was especially higher in the first month so the company has suggested that maybe if they adjust the does initially, patients will be introduced to the drug gradually.¿

She added that Symlin appears to show modest efficacy.

¿Some physicians could argue that you could achieve the same glucose control that Symlin provides through a more aggressive insulin therapy,¿ Ghodsian said.

A few more bumps in the road would be nothing new to Amylin.

The company started running into trouble in 1997 when Amylin and then-partner Johnson & Johnson, of New Brunswick, N.J., determined that an initial Phase III trial for Type II diabetes failed to show lower glucose on an intent-to-treat basis after 12 months. (See BioWorld Today, Aug. 9, 1997.)

Johnson & Johnson eventually pulled out of the deal after investing $175 million. (See BioWorld Today, March 3, 1998.)

No Comments