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AMYLIN PHARMACEUTICALS INC Click to find out why . . .



Keywords & Phrases
CaseNo: API136140, CourtName: CLASS ACTION CASES, State: CA California, UniqueCaseRef: LCD>API136140, Amylin Pharmaceuticals, Symlin, Drug, Diabetes, Fda, Treatment, Pramlintide Acetate, Drug Candidate, Commercialization, Metabolic Disorders, Review, Securities, Class Action, Advisory Committee, Insulin, Administration, Statisticians, Hypoglycemia, Advisory Committee Meeting, Symlintm, Private Placement, Submission, Nda, Medical Practice, Common Stock, Regulatory, Purchasers, Adverse Events, Development Program , ContentID: 120246195

Case Documents
1   COMPLAINT
[ see first page and extracted highlights below  ] ItemID: 114267
29 pages
PDF
Total Documents: 1 document , 29 pages
Price: $ 19.95


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1 . COMPLAINT

EXTRACTED KEY WORDS
SYMLIN
DRUG
DIABETES
FDA
TREATMENT
PRAMLINTIDE ACETATE
DRUG CANDIDATE
COMMERCIALIZATION
METABOLIC DISORDERS
REVIEW
SECURITIES
CLASS ACTION
ADVISORY COMMITTEE
INSULIN
ADMINISTRATION
STATISTICIANS
HYPOGLYCEMIA
ADVISORY COMMITTEE MEETING
SYMLINTM
DEFENDANTS
PRIVATE PLACEMENT
SUBMISSION
NDA
MEDICAL PRACTICE
COMMON STOCK
REGULATORY
PURCHASERS
ADVERSE EVENTS
DEVELOPMENT PROGRAM
 1 MILBERG WEISS BERSHAD
        HYNES & LERACH LLP
 2 WILLIAM S. LERACH (68581)
      DARREN J. ROBBINS (168593)
 3 600 West Broadway, Suite 1800
      San Diego, CA  92101
 4 Telephone:  619/231-1058
      619/231-7423 (fax)
 5 Attorneys for Plaintiff
 6

 7

 8                          UNITED STATES DISTRICT COURT

 9                     SOUTHERN DISTRICT OF CALIFORNIA

10 HARVEY RASKIND, On Behalf of             ) No.
11 Himself and All Others Similarly )
      Situated,                             ) CLASS ACTION
12                                          )
                              Plaintiff,    ) COMPLAINT FOR VIOLATION OF THE
13                                          ) FEDERAL SECURITIES LAWS
           vs.                              )
14                                          )
      AMYLIN PHARMACEUTICALS, INC. and )
15 JOSEPH C. COOK, JR.,                     ))
16                            Defendants. )) DEMAND FOR JURY TRIAL
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SNIPPETS:
  • This is a class action on behalf of purchasers of Amylin
  • commercialization of potential drug candidates for the treatment of
  • On July 25, 2001, the Food and Drug
  • Administration released medical and statistical reviews
  • regarding Amylin's diabetes drug pramlintide acetate prior
  • 10 to the FDA Advisory Committee Meeting scheduled for July 26,
  • 11 This review cited major concerns regarding the safety and lack of
  • 12 efficacy of SYMLIN.
  • 13 stated there were major adverse events upon treatment with SYMLIN
  • 20 all along had claimed that one advantage of SYMLIN over insulin was
  • 21 that it did not increase the risk of hypoglycemia.
  • 23 Securities Exchange Act of 1934 and Rule 10b-5.
  • 25 monies to fund its cash-starved operations and defendants induced
  • 25 any such private placement offering,
  • insulin dose would deviate from good medical practice.
  • "Amylin Pharmaceuticals Announces Additional Data from
  • 23 Amylin Pharmaceuticals, Inc. today announced that its lead diabetes drug candidate,
  • pharmaceutical company focused on metabolic disorders, 17 and specializing in preclinical
  • 11 effective as of February 10, 2000, the Company's common stock will resume trading on the
  • 18 The Company is developing SYMLINTM (pramlintide acetate) for the treatment of people with
  • The Company is planning for mid-2000 regulatory submissions for the marketing of SYMLIN in
  • 16 Progress on SYMLIN NDA Submission."
  • With this more comprehensive project plan, our target date for the NDA submission has 2 moved
  • No major safety concerns were noted in the suggested 18 therapeutic range during the
  • SYMLIN is scheduled for review by the FDA's 16 Endocrinologic and Metabolic Drugs Advisory
  • "As SYMLIN is the first drug in a new 11 therapeutic class, we anticipated that the FDA would
  • Committee members are scientific experts 17 such as physician-researchers and statisticians,
  •    |