Ivax to Launch Generic Taxol

25 September 2000 00:00  [Source: ICB Americas]

Flush with victory after recent key legal battles with Bristol-Myers Squibb, Ivax Corporation has received final approval to market a generic version of the BMS's anti-cancer drug Taxol (paclitaxel).

Ivax had been battling BMS over patent infringement issues over the generic product. Ivax's most recent victory came earlier this month when BMS lost a legal effort to keep a related patent by American BioScience Inc. listed in FDA's Orange Book. Such a listing would have delayed the entry of a generic product. BMS countered that decision by filing a similar action in another federal court jurisdiction.

"Anyone who has followed Ivax's efforts to bring its generic version of Taxol to market in the US knows Ivax has had to overcome a succession of disruptive and delaying tactics," says Neil Flanzraich, vice chairman and president of Ivax.

Ivax says it will begin selling paclitaxel in at least three weeks. Ivax received first filer status for its abbreviated new drug application (ANDA) for paclitaxel, which entitles the company to 180 days of marketing exclusivity. Ivax received approval for paclitaxel 6 mg/ml (packaged in 30 mg/5 ml, 150 mg/25 ml and 300 mg/50 ml vials).

Last week, Ivax generics rival Mylan Laboratories received tentative FDA approval to manufacture and market paclitaxel injection 30 mg/5 ml (6 mg/ml). Ivax says that dosage is limited to the smallest vial size, which accounts for roughly 15 percent of the market.

Taxol is one of BMS's top-selling drugs. In 1999, it had sales of $1.48 billion. Last week, BMS announced that it will expand the company's share repurchase program by $2 billion to bring the program's total capacity to $12 billion.

Meanwhile, BMS moved forward with plans for further clinical development of Taxol as a combination therapy. Roche and BMS have formed a new European clinical research partnership that will facilitate the development of clinical trials involving Roche's Herceptin (trastuzumab) and BMS's Taxol.

The alliance is focusing on the combination therapy for these two drugs for treating metastatic breast cancer. Herceptin was approved in the US in 1998 and was approved for marketing in Europe last month.

Paclitaxel is derived from the yew tree, and BMS is also developing a way to make the compound using fermentation and genetic engineering. Last week, a partner in that effort, Cytoclonal Pharmaceutics Inc. received a key patent for a new gene coding for Taxus geranylgeranyl diphosphate synthase, a key enzyme in paclitaxel synthesis. The isolation of the gene, coupled with the discovery of previous Taxol genes prioprietary to Cytoclonal, are part of the company's program with BMS.

Another taxane undergoing combination development with a biotech product is Aventis's Taxotere (docetaxel). Seattle Genetics Inc. is initiating a second phase I clinical trial for its single chain immunotoxin, SGN-10 in combination with Taxotere.

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