Pharmacia & Upjohn Rogaine Extra Strength marketing exclusivity award likely.

PHARMACIA & UPJOHN ROGAINE EXTRA STRENGTH EXCLUSIVITY AWARD LIKELY in light of new clinical trials the company conducted for its over-the-counter switch NDA (20-834) for the 5% minoxidil solution for hair regrowth. Marketing exclusivity for the stronger concentration Rogaine solution would provide Pharmacia & Upjohn an advantage the company did not receive for the switch of the original 2% OTC Rogaine. The extra strength version of the antibaldness treatment will be on shelves around Dec. 16, P&U said Nov. 17. Print ads supporting the launch of Rogaine 5% will break in January.

The stronger formulation of minoxidil solution received FDA approval Nov. 14 for treatment of hereditary male pattern baldness, adding to the list of OTC products marketed under NDAs that have leapfrogged the Rx marketing phase. Regular-strength Rogaine, approved for OTC use for men in 1996, contains 2% minoxidil. Pharmacia & Upjohn submitted the NDA for Rogaine Extra Strength in February.

The denial of marketing exclusivity by FDA following the February 1996 approval of Rogaine 2% as an OTC resulted in a slew of generic versions of the drug. The lack of exclusivity also prompted the filing of a lawsuit by P&U, as well as the issuance of a restraining order against companies that wanted to introduce private-label versions of the drug.

In an April 30, 1996 decision, a federal court ruled that a P&U consumer-use study conducted for Rogaine, although new, was not essential for the switch of the product. The qualities of newness and essentialness are both requirements for an award of three years of Waxman/Hatch exclusivity.

Rogaine Extra Strength clinical trial data showed a 46% increase in hair growth at 48 weeks. At its July 16 consideration of Rogaine Extra Strength's NDA, FDA's Nonprescription Drugs Advisory Committee agreed that faster hair growth claims would be unsubstantiated because faster regrowth was not a primary endpoint of the trial in which the pattern was observed ("The Rose Sheet" July 21, p. 5). FDA Office of Drug Evaluation V Director Michael Weintraub, MD, expressed confidence at the meeting that inclusion in the label of the onset of effect could be worked out with P&U.

Packaging makes clear Rogaine Extra Strength is not for use by women, as recommended by the committee. A separate 5% minoxidil product for women is being pursued by Pharmacia & Upjohn, which has clinicals under way for the indication. Clinicals conducted thus far have not shown statistically significant effects in women, according to P&U.

The advisory committee members acknowledged Rogaine Extra Strength likely will be purchased by some women, but they felt the potential health risk to be acceptable. The most frequently reported adverse events seen with use of Rogaine Extra Strength in the P&U safety data were dermatological in nature, including itching, erythema and dryness, although there were also reported incidences of tachycardia, or rapid heart beat.