P&G Chairman-CEO A.G. Lafley said last week at a Cincinnati investor conference that its trans-dermal testosterone patch, Intrinsa, is in late-stage clinical trials that could result in U.S. Food and Drug Administration approval within a year.
Mark Collar, president-global pharmaceuticals for P&G, called Intrinsa "a potential blockbuster." The patch initially would be indicated for 12 million post-menopausal women to restore sex drive, he said. But a broader range of women could ultimately use the product, according to Bruce Byrnes, president-global health, beauty and feminine care.
"There are currently no approved drugs for female sexual dysfunction," Mr. Collar said. A "very small" number of women are making off-label use of topical creams with testosterone to address the problem, but the patch technology, which P&G is licensing from Watson Pharmaceuticals, is critical for delivering the drug in even amounts without side effects, he added.
Asked by Deutsche Bank Securities analyst Andrew Shore whether P&G, given its puritanical reputation, could reach beyond 12 million post-menopausal women to market Intrinsa successfully to the other 2.9 billion women in the world, Mr. Lafley, laughed and said, "We certainly hope so. We serve them certainly in a lot of other product categories."
P&G did not comment on potential spending, but drugs P&G in the past has termed "blockbusters" have received launch budgets of $100 million or more, including osteoporosis drug Actonel and the recent Prilosec OTC conversion of AstraZeneca's popular heartburn drug.
Mr. Collar said later that an agency has been selected for the brand, but was not prepared to announce which one. He did, however, drop an enticing clue in saying P&G would look to build Intrinsa into a "trustmark," using a term favored by Kevin Roberts, CEO of Publicis Groupe's Saatchi & Saatchi and point man for P&G's business throughout the holding company.
A person familiar with the situation later confirmed various Publicis Groupe shops are preparing Intrinsa marketing plans that will be put in place should the product receive FDA approval. The person said no one Publicis shop could handle the entire range of what promises to be a multi-faceted and intriguing marketing effort, but that the launch would be ideally suited to Publicis Groupe CEO Maurice Levy's "one roof, many doors" philosophy.
Amazon, San Francisco, owned 50% by Publicis' Leo Burnett Co., handled an initial publicity and medical-professional marketing blitz two years ago as P&G sought enrollees for clinical testing.
Executives of Publicis Groupe and Grey Global Group, whose Grey Healthcare handles Actonel, declined to comment. Aside from Actonel, which Mr. Collar said is closing fast on $1 billion in global sales, Publicis' Saatchi and Publicis already handle the bulk of P&G's health care business.
contributing: claire atkinson, lisa sanders, rich thomaselli