Rogaine OTC switch generates excitement

Drug Store News, April 29, 1996

KALAMAZOO, Mich. - Hair care buyers struggling with scores of low margin hair care hair care products now have something to smile about. This month Pharmacia & Upjohn started shipping the OTC version of Rogaine, a hair regrowth treatment.

About 40 million men and 20 million women suffer hair loss. Until now there have not been any medically proven over-the-counter products to regrow hair for men and women who have common hereditary hair loss.

Rogaine works, but only if men and women continue using it. And with a $29.50 suggested retail price that's a huge ring for a hair care item.

That price is half of the former prescription price (great news for consumers) and about $6 more than the wholesale price (great news for retailers).

Rogaine was introduced as a prescription hair regrowth treatment in 1988 for men and in 1991 for women. Last year sales reached $124 million worldwide. Since the OTC and prescription formulations are exactly the same, this should prove to be a hot hair care item.

"The level of anticipation for OTC Rogaine is very high throughout the trade," asserted Thomas Laughlin, senior vice president worldwide and general manager U.S. for Pharmacia & Upjohn Consumer Healthcare. Even before the company began shipping the product this month, many retailers, including CVS, displayed a shelf talker in the hair care section that read "Rogaine Coming Soon' in anticipation of the first shipment. The shelf unit includes educational brochures with information about the products.

Rogaine for Men and Rogaine for Women are packaged separately, but the product in each bottle is identical. Cartons carry gender-specific instructions and illustrations to ensure that men and women accurately identify the causes and degree of their hair loss prior to using Rogaine.

The company has a major marketing blitz planned to support the OTC switch. The campaign, which kicks off the end of this month, includes television commercials, educational kits for 20,000 pharmacists and 40,000 physicians, newsletters for users, freestanding inserts, in-store circular ads and coupons.

A major part of the marketing program is focused inside the box of Roggaine itself. Those who fill out enrollment cards included in the box will receive coupons and a quarterly newsletter with hair care and styling tips, as well as information from users, dermatologists and other experts.

Rogaine investments

During the past four years, Pharmacia & Upjohn has spent $1 million to bring OTC Rogaine to market. That investment included, among other things, conducting an intravenous clinical safety study on minoxidil, the product's active ingredient, and creating new labeling and consumer educational materials.

Having taken these steps, the company expected the Food & Drug Administration to grant it a three-year period of market exclusivity for OTC Rogaine. However, in early April, the FDA denied Pharmacia & Upjohn's request and gave two other companies, Alpharma and Lemmon Co., approval to manufacture and market OTC minoxidil, which are generic equivalents to Rogaine. Pharmacia & Upjohn has consequently sued the FDA in an attempt to order the agency to defer the approval of the competing products.

"OTC Rogaine would not be on the market today had we not conducted the intravenous minoxidil safety study and six labeling studies, and had we not developed the venous communications tools - all of which the FDA demanded of us as a prerequisite for OTC approval," Laughlin said.

The FDA denied the company's request for market exclusivity because the safety study was not necessary for the agency to approve the OTC switch, said FDA spokesperson Ivy Kupec.

At press time, a federal judge in Michigan had issued a temporary restraining order requiring the FDA to suspend the effective dates of the two approved generic versions of Rogaine and to prevent the agency from approving any other generic versions.