UPJOHN PUTTING GLOSS ON MINOXIDIL NDA SUBMISSION FOR BALDNESS WITH TWO KEY CLINICALS REQUESTED BY FDA; FIRM PREDICTS NDA FILING BY OCTOBER 1985
Upjohn is nearing completion of two key clinical trials with topical minoxidil in preparation for the firm's NDA for a baldness indication, Upjohn President Lawrence Hoff told analysts at Goldman Sachs' sixth annual Health Care Seminar in NYC on April 10. Hoff noted that Upjohn is doing two clinical studies requested by FDA in addition to its 28-center Phase III efficacy trials for topical minoxidil. The company is doing a dose-response trial to determine whether 2% minoxidil lotion is the best formulation. Also, the firm is "now completing" a study in patients with high blood pressure who are using other antihypertensives to see if topical minoxidil interferes with other blood pressure medications, Hoff said. "That study looks clean," he commented. Upjohn is now looking at an October 1985 NDA filing date for topical minoxidil for the treatment of male pattern baldness, Hoff said. The dose response study requested by FDA is "more difficult," Hoff acknowledged. "They wanted to know that if 2% [minoxidil formulation] works, would 1.5% or 1% . . . Our guess is that 1% will work in some people, but with a lower rate of efficacy, probably 10-15%." He noted that Upjohn expects the final product to be the 2% formulation of minoxodil lotion now in Phase IIIs. Downplaying the company's excitement over the anti-baldness drug, Hoff said that Upjohn remains "cautiously optimistic about this product until the clinical data are analyzed." However, he noted "clinical results are promising as to the efficacy of the drug with cosmetically acceptable hair growth occurring in one-third of the patients." He added that Upjohn, "so far, [has] seen no significant side effects." Best Patient May Be In 25-40 Year Range: Prophylactic Prevention Of Hair Loss Possible During Q-&-A, Hoff was asked to clarify the one-third effectiveness rate for minoxidil. "When I say 'cosmetically acceptable,'" Hoff noted, "I'm saying we have terminal hair as [that] which [once] covered the area we're looking at, which in these cases was the crown." Hoff pointed out that vellous hair growth and modest growth around the crown were not considered in the "cosmetically acceptable" range. Asked what the chances are that the minoxidil NDA might be held up at FDA, Hoff responded with a prediction that the agency "will move it through quickly: (a) because we've already talked about the questions in their minds; and (b) because they don't like the ad hoc prescribing of the tablets for hair." In addition, Hoff observed that the company is "still looking for that profile of the best candidate" for the minoxidil treatment. "We have to know whether [the ideal candidate's] a young male age 25 to 40 who has started to lose his hair," Hoff said. or someone older. "Our guess is that the best result will be in those earlier years," he added. "My feeling is that we will find a segment cohort where you will have significantly better hair growth." Although the minoxidil patent is due to expire in 1986, Hoff noted, that company has a use patent for minoxidil lotion in treating baldness "that goes to 1996." Responding to a question on the potential for a prophylaxis indication for minoxidil, Hoff said: "What we've seen are individuals who are 25, 30, 32 who are expected to lose their hair. They've been on the drug and they've not lost it." Hoff said that it was his "personal opinion . . . that at some point in the future there will be a prophylactic use for topical minoxidil." On Motrin, which now faces price competition from OTC ibuprofen and Boots Rufen, and will likely face generic competition this summer, Hoff said that the drug has "leveled off with about a 22% marketshare of new Rxs filed." In order to hold onto marketshare once generic ibuprofen hits the market, Hoff said the firm is looking to line extensions such as a soon to be marketed 800 mg dosage form as well as sustained release, liquid, combination and I.V. forms in development. Hoff asserted that generic price pressure will not affect Motrin pricing. "Motrin at the beginning was not really a high gross profit item and now it is definitely quite lower," Hoff pointed out. "I think last year we moved to a generic pricing level," he noted. "We're selling one hundred 400 mg at roughly $10; Boots is selling at $7. It would appear to me that there is not much room for other generic mfrs. to come in and really shake up the market." In his formal presentation, Hoff highlighted the progress of Upjohn's two major psychotherapeutic products, Halcion and Xanax. In February, Hoff noted that Xanax held a 16.5% share of the U.S. benzodiazapine new Rxs, second only to Valium, and was first in new Rxs written by psychiatrists with a 43% share. Commenting on Halcion, he said that the sedative had closed to only 9 share points behind Roche's Dalmane in new Rxs in the U.S. by January 1985. The Upjohn exec also noted that the firm's second generation oral hypoglycemic, Micronase, is making up for Tolinase marketshare losses to generic competition. "By year end 1984, combined new Rx share of Micronase and Tolinase equalled the share held by Tolinase alone in the beginning of the year," Hoff said. Noting that "real growth" for Micronase will come with an expanding oral antidiabetes market, Hoff pointed out that new Rxs for oral hypoglycemics jumped from an average of 355,000 a month in 1983 to 424,000 recently. Questioned on the status of Upjohn's prostaglandin anti-ulcer compound Arbacet, Hoff said that the firm is having "some problems" with Arbacet. Observing that Upjohn originally planned on a May NDA filing for the compound, Hoff said that "it's doubtful now whether we will make that." However, the Upjohn exec still projected a 1985 filing for Arbacet. "We've run into a few snags that hopefully won't be serious, but we don't know yet," he stated.
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