Duramed Takes New Tack In Premarin Bid

Duramed has decided to seek approval for a branded alternative toWyeth-Ayerst's Premarin (conjugated estrogens) hormone replacement therapy, after being stymied in its bid to get a generic equivalent onto the US market (Marketletters August 4 and May 12).

The company has filed an Investigational New Drug application with the US Food and Drug Administration to start a clinical trial which will evaluate Duramed's product in the treatment of postmenopausal symptoms. As the FDA has not accepted that Duramed's product is bioequivalent, the firm intends to provide the safety and efficacy data which will form the basis of a New Drug Application, scheduled for first-quarter 1998.

Duramed stresses that the new trial does not mean that it has stopped its efforts to persuade the FDA to approve its generic version. Observers have commented that Duramed has a lot invested in the product, and seeking NDA approval increases the chance of getting it to market and earning revenues for the firm. Even if generic approvals are ultimately granted, having a branded generic with proven efficacy data could turn out to be a significant marketing advantage.