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Biotech / Medical : AMLN (DIABETES DRUGS) -- Ignore unavailable to you. Want to Upgrade?

To: arnie h who wrote (1561)	1/11/1999 8:19:00 AM
From: celeryroot.com	Read Replies (2) \| Respond to of 2173

SAN DIEGO, Jan. 11 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced its regulatory filing strategy for pramlintide, a diabetes drug candidate currently being studied in two, one-year, U.S. Phase 3 trials. The Company believes that, if results from these U.S. trials are positive, it should be possible to file for regulatory approval for type 1 and insulin-using type 2 diabetes in both the U.S. and Europe in mid-2000. The Company today also reported new clinical data from completed Phase 3 trials of pramlintide. Further data analysis has revealed that patients who derived substantial benefit in terms of glucose control from pramlintide can be identified by their glucose response at four weeks of therapy. In addition, Amylin released data demonstrating pramlintide's durability of effect over a two-year study period. Regulatory Filing Strategy After extensive review with U.S. and European clinical and regulatory consultants, the Company believes that positive results from the ongoing, one-year U.S. Phase 3 trial in type 1 diabetes, in conjunction with results from previously completed Phase 3 trials, should form the basis of a filing package for pramlintide in the treatment of people with type 1 diabetes. For insulin-using type 2 diabetes, positive results from the ongoing, one-year U.S. Phase 3 trial, in conjunction with data from completed Phase 3 trials, would provide the basis for a discussion of filing options with regulatory authorities. The Company expects to report the results from the ongoing U.S. Phase 3 trials in the second half of 1999. Accordingly, the Company is planning for a mid-2000 submission of pramlintide regulatory filings in the U.S. and Europe for type 1 and insulin-using type 2 diabetes. Early Identification of Better Responding Patients In addition to the intent-to-treat clinical results reported previously, the Company has conducted further data analysis of the four completed Phase 3 trials. These additional analyses have led to a method to better identify those patients who derived a greater benefit from pramlintide therapy. In these four trials, approximately 50% of all participants (with either type 1 diabetes or insulin-using type 2 diabetes) who received pramlintide achieved a greater than or equal to 0.5% glycated hemoglobin (HbA1c) reduction at four weeks. These patients, "responders", continued to realize clinically important benefits from pramlintide therapy, with an HbA1c reduction of greater than or equal to 0.5% over the entire course of the study. In type 1 diabetes, those responders who received the well tolerated dosages of 30 ug QID or 60 ug TID also had no increase in severe hypoglycemia and showed a reduction in body weight over the course of the studies. In insulin-using type 2 diabetes, responding patients also achieved and maintained a clinically significant weight reduction during treatment with pramlintide. Durability of Drug Effect In the previously reported U.S. Phase 3 study involving people with type 1 diabetes, approximately 70% of the participants receiving pramlintide voluntarily continued using pramlintide in an open label extension of the study. All of these patients who continued on the open label portion of the trial achieved a clinically meaningful improvement in glucose control (an average 0.4% HbA1c reduction) through twenty-four months of pramlintide therapy. Furthermore, "responders", as defined above, exhibited average HbA1c reductions of 1.0%, 0.7% and 0.9% following six, twelve and twenty-four months of therapy, respectively. This observation indicates that patients who respond to pramlintide may achieve the benefit of long term improved glucose control. Effect on Bone Metabolism New information has also been gleaned from data from the previous one-year study indicating a potential effect of pramlintide on bone metabolism in post-menopausal women with type 1 diabetes. Changes in important markers of bone health suggest that the addition of pramlintide to patients' insulin regimen may lead to positive effects on bone metabolism. This finding is potentially important in view of the long-standing observation that female patients with type 1 diabetes have decreased bone mass referred to as "diabetic osteopenia." "We are optimistic about the ongoing U.S. Phase 3 trials in part because the dosages that produced the greatest glucose lowering effect in the previous studies are replicated in the ongoing U.S. Phase 3 trials," stated Joseph C. Cook, Jr., Amylin Pharmaceuticals' Chairman and Chief Executive Officer. "The intent-to-treat analysis is the primary focus for regulatory purposes; however, the data from patients who achieved the greater than or equal to 0.5% HbA1c reduction at four weeks may be used to characterize the clinical use of the drug and potentially help physicians use pramlintide in their practice. All along we have been driven in our pursuit by the goal of helping the millions of people with diabetes. Benefits seen thus far in all patients receiving pramlintide and in particular the responder group are very motivating to us." Amylin Pharmaceuticals, Inc. is focused on metabolic disorders and specializes in preclinical characterization of lead molecules and demonstration of proof of principle in humans. The Company has pioneered research of the hormone amylin, which is believed to play an important role in metabolic control and is missing or deficient in millions of people with diabetes. The Company is developing pramlintide, its patented synthetic analog of human amylin, for the treatment of diabetes. Two, one-year U.S. Phase 3 clinical studies of pramlintide in type 1 and insulin-using type 2 diabetes are ongoing. AC2993 (synthetic exendin-4, a peptide initially derived from the salivary secretions of the Gila monster), an investigational drug for type 2 diabetes and related metabolic disorders, has successfully completed a Phase 1 safety and tolerability trial. An initial Phase 2 study for AC2993 is planned for the first quarter of 1999. The Company is currently engaged in partnership discussions for pramlintide and AC2993. Amylin Pharmaceuticals is headquartered in San Diego, California and has a European office in Oxford, U.K.

To: arnie h who wrote (1561)	1/11/1999 4:41:00 PM
From: LLCF	Read Replies (2) \| Respond to of 2173

<Rudy: The possibility of somebody buying on Murphy's recommendation didn't occur to me since he's been wrong consistently on AMLN. It's hard to believe the bump up on Friday had any connection to him.> I bought a bunch for "tax selling season" based on his reco, and now consider myself lucky since I've found out how cold he's been. Some of these stocks are deeply oversold however (especially his! ha ha) and thats really why I made the purchase on this one. dAK