Rogaine Extra Strength marketing exclusivity lasts to nearly 2001.

P&U ROGAINE EXTRA STRENGTH EXCLUSIVITY AWARD will protect the company's new 5% minoxidil hair regrowth solution from private label competition through Nov. 14, 2000. Pharmacia & Upjohn announced FDA's award of Waxman/Hatch marketing exclusivity Feb. 2. The direct-to-OTC Rogaine Extra Strength approval was granted Nov. 14 ("The Tan Sheet" Nov. 24, 1997, pp. 1-3).

FDA's decision "gives us a sound business rationale to fully develop and capitalize on this largely untapped market," and the company expects "to do very well by offering the safest and most effective hair regrowth treatment on the OTC market today," P&U noted.

The award of exclusivity will provide the 5% anti-baldness product a boost in the market that 2% "regular strength" Rogaine did not receive.

FDA denied marketing exclusivity for the lower strength product on the grounds the studies conducted by P&U in support of the switch application were not deemed by the agency to be "necessary" for its approval, a requirement for a drug Waxman/Hatch exclusivity ("The Tan Sheet" April 8, 1996, p. 1).

The denial of exclusivity prompted Pharmacia & Upjohn to file suit against FDA in Grand Rapids, Mich. federal court. Judge Robert Holmes Bell issued restraining orders preventing private label competitors from putting their minoxidil products on the market. But Bell ultimately sided with FDA, saying the studies conducted by P&U did not meet the requirements for Waxman/Hatch exclusivity, and lifted the restraining order on the private label products ("The Tan Sheet" May 6, 1996, p. 1).

First-year sales for original OTC Rogaine were about $100 mil. ("The Tan Sheet" Jan. 20, 1997, p. 12). P&U estimated five-year sales of Rogaine would total $650 mil., reduced from the original $1 bil. projection for sale of the product without private label competition ("The Tan Sheet" May 13, 1996, In Brief). The availability of Rogaine Extra Strength will further affect sales for the 2% product.

Exclusivity for Rogaine Extra Strength will allow P&U "to invest in the future of the Rogaine franchise by intensifying the R&D activities that support this brand," the company noted, possibly an allusion to the continuing P&U research on a stronger minoxidil product for women, for which only a 2% minoxidil solution is approved.

A "Frequently Asked Questions" page on P&U's Rogaine Web site (www.rogaine.com) notes the absence of a "Extra Strength" product for women on the market. The "Extra Strength formula has not been clinically demonstrated to work more effectively for women than Regular Strength Rogaine for Women. However, Pharmacia & Upjohn is working to develop a stronger, more effective product for women," P&U says.

An $80 mil. marketing campaign should give Rogaine Extra Strength strong competition against Merck's recently approved Rx oral anti-baldness treatment Propecia (finasteride) ("The Tan Sheet" Jan. 5, pp. 14-16). Rogaine Extra Strength ads to date have featured user testimonials including one from Green Bay Packers head coach Mike Holmgren. The company also announced Karl Malone would represent the product, although ads featuring the basketball All- Star have yet to run. The ads claim 45% more hair regrowth in men than regular strength Rogaine ("The Tan Sheet" Jan. 5, p. 13).

Merck's product will benefit from FDA's relaxed requirements for direct-to-consumer ads issued last August and likely will take lessons from P&U's past marketing efforts for Rogaine. Professional journal ads focus on three main points: maintaining hair count, with "83% of men taking Propecia in vertex studies maintain[ing] or `increas[ing] hair count; regrowing "natural, visible hair"; and finasteride's "excellent safety profile," as well as the convenience of once a day oral dosing. Sexual dysfunction is a small risk from Propecia. The journal ads are tagged: "Helping make hair loss history."