31 May 1999 00:00 [Source: ICB Americas]By Feliza Mirasol
Despite generic competition for the past two years, Coumadin, DuPont Pharmaceuticals' anti-coagulant drug, is still posting robust sales. On the opposite side of the battle between branded and generic products, Barr Laboratories continues its state-by-state campaign to win petitions for the substitutability of its generic form of warfarin sodium.
Analysts estimate that Coumadin has maintained a 74 percent market share, versus a typical 70 to 80 percent drop-off during the first few months after a new generic is launched. In 1998, Coumadin had sales of roughly $550 million, according to DuPont, which had $1.1 billion in pharmaceutical sales.
DuPont says the total warfarin sodium market, including generics, grew in 1998, with Coumadin sales rising by a high single-digit percentage. The company attributes the drug's depressed margins to promotional expenses and pricing pressure to fend of generic competition.
Because of such competition, BT Alex. Brown expects sales of Coumadin to slow. The brokerage estimates that the drug will post sales of $450 million in 1999 and $430 million in 2000. But thanks to its status as a narrow therapeutic index (NTI) drug, Coumadin's sales should not suffer as severely from competition as typically happens when a medication comes off patent.
An NTI drug must be carefully administered and monitored because there is little difference between an effective dose and a toxic one. NTI classification gives Cou-madin a marketing advantage over generic versions because it is perceived as safer and more effective.
Because of the massive market for anti-coagulant drugs, Barr expects to benefit considerably once its generic warfarin sodium wins full acceptance as a substitute for Coumadin. Massachusetts, New Jersey, Minnesota, Virginia, Illinois and Indiana have already approved the product. In addition, the Department of Defense's Pharmacy and Therapeutics Committee unanimously approved the substitutability of generic warfarin for Coumadin last December.
Recently, Barr temporarily withdrew its application to the Florida Board of Pharmacy, charging that its action was triggered by "a relentless misinformation campaign by [DuPont]."
Since Barr launched its warfarin sodium in August 1997, the company's product has filled more than 3.8 million prescriptions. The drug is used for treating complications associated with atrial fibrillation. In its third quarter earnings, Barr reported a 67 percent increase in warfarin sodium sales.
The two companies are awaiting trial for an antitrust suit Barr filed against DuPont in March 1998. Barr is accusing DuPont of anti-competitive practices that have allegedly slowed market acceptance of generic warfarin. Barr estimates that it holds nearly 12 percent of the market.
Last December, Judge Sue L. Robinson of the US District Court for the District of Delaware dismissed Barr's claim that DuPont violated federal antitrust law by publicly advocating, before state legislatures, for patients' right to know if their medication is being switched without their approval. In a related pre-trial ruling, Judge Robinson also dismissed three consolidated consumer class-action suits alleging that DuPont monopolized the oral anti-coagulant market.
The December ruling said, however, that Barr could proceed with its suit on a number of grounds, including its contention that during state regulatory hearings, DuPont gave false and misleading testimony to prevent or delay regulatory approval of Barr's generic warfarin sodium.
In February, Barr won a pre-trial victory when Judge Robinson rejected a motion by DuPont to rehear a previous court decision. That decision held that false and misleading testimony given in regulatory hearings is not protected by the First Amendment and is subject to antitrust laws.
The rest of the case is moving forward, although a trial date has not yet been set.
"I imagine we won't see any kind of court date set for another 18 to 24 months," a Barr spokesperson says.
"Nothing new has happened since that February ruling," a DuPont spokesperson adds.
The case is proceeding on numerous grounds. These include Sherman Act monopolization, Lanham Act commercial disparagement, the Robinson-Patman anti-bribery statute, the New York State Deceptive Practices Act, New York State common law trade disparagement and New York State common law interference with prospective business relations.
CLOZAPINE--A recent study states that Zenith Goldline Pharmaceuticals' generic form of clozapine can be used interchangeably with Novartis Pharmaceuticals Corporation's Clozaril for the treatment of severe schizophrenia. Results of the study were presented at a recent meeting of the American Psychiatric Association in Washington, D.C., by Vinod Kumar, professor of psychiatry and neurology and director of the Florida Institute of Neurology.
INFLIXIMAB--The European Union's Committee for Proprietary Medicinal Products has recommended European marketing approval of Remicade (infliximab), Malvern, Pa.-based Centocor Inc.'s treatment for Crohn's disease. Following approval from international regulatory agencies, Schering-Plough Corporation will sell Remicade in all countries throughout the world, except Japan and parts of the Far East, where the product will be marketed by Tanabe Seiyaku Ltd. Centocor has exclusive marketing rights in the US.
METHYLPHENIDATE--Noven Pharmaceuticals Inc., Miami, Fla., is developing a transdermal patch that delivers a therapeutic dose of methylphenidate for up to 24 hours. Methylphenidate is the active ingredient in Novartis' Ritalin tablets. It is most commonly prescribed for attention deficit hyperactivity disorder.
METRIFONATE--Bayer Corporation is resubmitting a new drug application for ProMem (metrifonate), based on a meeting with the Food and Drug Administration. Bayer expects to complete the resubmission this summer.
PERINDOPRIL ERBUMINE--Sol-vay Pharmaceuticals Inc., Marietta, Ga., has entered the US cardiovascular market by acquiring the US rights for Aceon (perindopril erbumine) tablets, an angiotensin converting enzyme for the treatment of essential hypertension.
PIMAGEDINE--Alteon Inc., Ramsey, N.J., is seeking a new corporate partner to help fund the continued development of pimagedine, a compound for the treatment of kidney disease in type 1 diabetic patients. The compound is currently in Phase III clinical trials.
POLOXAMER--CytRx Corporation has received the second and final installment of an FDA grant to support the company's ongoing study of Flocor (purified poloxamer 188) for the treatment of sickle cell vaso-occlusive crisis. The grant, originally issued in 1997, was designed to provide total funding of $400,000 over a two-year period. Flocor has orphan drug status.
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