FDA ADVISORY PANEL BACKS NEW AMGEN DRUG.Byline: Kristin Reed Bloomberg News Amgen Inc. won the backing of an expert government panel for its Stemgen drug to boost the number of special cells needed for an immune-system rebuilding procedure used to fight late-stage cancer. ``The benefits are not trivial TRIVIAL. Of small importance. It is a rule in equity that a demurrer will lie to a bill on the ground of the triviality of the matter in dispute, as being below the dignity of the court. 4 Bouv. Inst. n. 4237. See Hopk. R. 112; 4 John. Ch. 183; 4 Paige, 364. ; they are substantial,'' said John Glaspy, one of the clinical investigators A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under who performed the company trials for Thousand Oaks-based Amgen. ``This represents an enabling technology which will help the field to move forward.'' The advisory panel for the U.S. Food and Drug Administration voted 10 to 1 to recommend that the full FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approve the No. 1 biotechnology company's drug. The FDA generally follows the advice of its expert panels but isn't required to. The panel voted to recommend a more narrow approval than Amgen asked for, saying that the risks carried by the drug outweighed the benefits except in cases where patients wouldn't otherwise be able to generate enough of the special cells to undergo the immune-boosting transplant transplant or graft Partial or complete organ or other body part removed from one site and attached at another. It may come from the same or a different person or an animal. One from the same person—most often a skin graft—is not rejected. procedure. Shares in the Amgen rose $1.0625 to close at $76. While analysts expected the recommendation, they said Stemgen will serve a small number of patients and is unlikely to make much difference in Amgen's overall sales. ``It's good in terms of telling people that they can produce a new drug a year,'' said Meg Malloy, an analyst with Hambrecht & Quist. However, Malloy said existing Amgen drugs ``Epogen and Neupogen are far more influential to the valuation than Stemgen would be.'' Epogen and Neupogen had combined sales of about $2.4 billion in 1997. If approved by the full FDA, Stemgen could see only a fraction of that, with sales expected around $100 million, analysts said. Amgen has benefited from recently eased restrictions on Medicare payments Noun 1. medicare payment - a check reimbursing an aged person for the expenses of health care medicare check bank check, check, cheque - a written order directing a bank to pay money; "he paid all his bills by check" for its drug Epogen, which boosts patients' red blood cell counts red blood cell count, n the number of red blood cells (erthrocytes) in 1 mm3 of blood; a useful diagnostic tool in the determination of several kinds of anemia. See also mean corpuscular hemoglobin. , and reported second quarter earnings last week that beat analysts' estimates. Epogen is primarily used in anemic anemic pertaining to anemia. kidney-dialysis patients and is almost always paid for by Medicare. The Medicare restrictions had worried investors and increased pressure on Amgen to produce another drug with blockbuster block·bust·er n. 1. Something, such as a film or book, that sustains widespread popularity and achieves enormous sales. 2. A high-explosive bomb used for demolition purposes. 3. potential. The pressure eased with the earnings released last week and the government's retreat from its earlier restrictions. With only a fraction of the sales potential of Amgen's existing drugs, Stemgen is ``moderately important,'' adding to Amgen's track record, said Elise Wang, a senior biotechnology analyst with PaineWebber Inc., who has an ``attractive'' rating on Amgen. |
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