AMLN: Did very well today. It was up 3 17/32 (41.39%) on volume of 669,900.It closed today above the December H, but still is below the November H (12 5/8 on Nov.3)
Will see if it can get over that hurdle. It seems to me is due for some consolidation after coming up from the Jan.9 low at 5. It has more than doubled in the last 4 trading days!
The last news that I had seen was last Friday from the JP Morgan H&Q conference in S.Francisco:
SAN FRANCISCO, Jan. 12 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - news) summarized its major accomplishments for 2000 and also outlined its corporate goals for 2001 in a presentation given by Joseph C. Cook, Jr., Chairman and CEO, at the JP Morgan H&Q Healthcare conference held this week in San Francisco, California.
The major accomplishments for 2000 included:
-- SYMLIN(TM) (pramlintide acetate) New Drug Application (NDA) submitted
to the US FDA
-- SYMLIN commercialization plan established, including the formation of
an internal US sales and marketing function
-- AC2993 (synthetic exendin-4) results reported from two Phase 2 studies
-- AC2993 30-day, multi-center, Phase 2 study initiated, and plans for
Phase 3 program announced
-- AC3056 IND filed and first Phase 1 study completed
-- Completed feasibility study on AC2993 LAR (long acting release)
-- Initiated a development program for AC2993 LAR in collaboration with
Alkermes using their proprietary Medisorb® technology
Amylin also estimated that at the end of 2000 it held over $80 million in cash and that its cash burn for the year was less than $36 million. Complete financial results for the fourth quarter and the fiscal year ended December 31, 2000 are planned for release near the end of February.
In the presentation, Mr. Cook also summarized the following goals for 2001:
SYMLIN(TM) (pramlintide acetate):
-- Acceptance of SYMLIN New Drug Application for filing by FDA
[1st quarter]
-- Submission of Regulatory Application in Europe (MAA) [2nd quarter]
-- Completion of SYMLIN NDA review by FDA [2nd half]
-- US launch of SYMLIN, pending FDA approval [2nd half]
AC2993 (synthetic exendin-4):
-- Initiate Phase 3 development program, pending positive Phase 2 results
[2nd half]
AC2993 LAR:
-- Initiate Phase 1 development program [1st quarter]
-- Initiate Phase 2 development program, pending positive Phase 1 results
[2nd half]
AC3056:
-- Report additional study results [2nd half]
Drug Discovery:
-- Identify new product candidate [2nd half]
Amylin Pharmaceuticals is engaged in the discovery, development and commercialization of potential drug candidates for the treatment of metabolic disorders. The Company submitted a New Drug Application in December 2000 for approval to market its lead diabetes drug candidate, SYMLIN(TM) (pramlintide acetate), in the US for the treatment of people with diabetes who use insulin. The regulatory submission process for SYMLIN in Europe is underway and submission is planned for the second quarter of 2001. Amylin Pharmaceuticals' second diabetes drug candidate, AC2993, is in Phase 2 evaluation for the treatment of type 2 diabetes, and a long acting release formulation, AC2993 LAR, is in preclinical development. The Company's third drug candidate, AC3056, is currently in Phase 1 evaluation as a potential treatment for metabolic disorders relating to cardiovascular disease. The Company has adopted a commercialization plan for SYMLIN that includes establishment of an internal commercial organization. The Company continues to evaluate partnerships with companies that may add value to its commercial efforts for SYMLIN in the US as well as in Europe, Japan and other markets. Amylin Pharmaceuticals is based in San Diego, California and has approximately 130 employees. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at www.amylin.com.
Bernard |
