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Executive Summary

Johnson & Johnson, with three NDAs pending at FDA that have cleared advisory committees, appears to be well positioned to receive several end-of-the-year drug approvals. In addition to the three products that have received advisory committee approval recommendations (Leustatin, Propulsid and Renova), J&J's systemic antifungal Sporanox (itraconazole) is understood to be close to FDA approval. The firm also holds marketing rights to two biologicals that have been recommended for approval by advisory committees (Xoma's CD5+ and Centocor's Myoscint). Earlier this year, J&J received approval for the injectable form of the quinolone antibiotic Floxin IV ("The Pink Sheet" May 18, In Brief). To date, FDA has approved five new molecular entities. That total marks a substantial decline from the 11 cleared by the agency through July 20 of last year. The 1991 total, however, was exceptionally high: in recent years, FDA generally has approved between three and seven NMEs by mid-July. The five NME approvals include Burroughs Wellcome's Mivacron (mivacurium), Searle's Maxaquin (lomefloxacin), Merck's Proscar (finasteride), Hoffmann-La Roche's Hivid (ddc) and Abbott's Omniflox (temafloxacin). The antibiotic Omniflox was withdrawn in June due to an unexpectedly high rate of serious adverse reactions ("The Pink Sheet" June 8, T&G-1). FDA's new drug approvals total in the first half of 1991 was inflated by an unusual number of approvals in January and February, perhaps resulting, in part, from holdovers caused by FDA's pre-approval inspection policy instituted in late 1990. FDA ultimately cleared 30 NMEs in 1991, tying its all-time high set in 1985. In recent years, FDA generally has approved between 20-25 new drugs with the majority of the approvals coming in an eleventh- hour surge. This year appears to be shaping up according to pattern. J&J is no stranger to the December rush. Three J&J products were approved in the final days of 1990: the calcium channel blocker Vascor (bepridil), Floxin (ofloxacin) and the biological Procrit (epoetin alfa). In 1991, the orphan gonadotropin-releasing hormone agonist Supprelin (histrelin acetate) was approved on Dec. 24. Ortho's hairy cell leukemia drug Leustatin (2CdA) appears most likely to receive approval by year-end. FDA designated Leustatin for expedited review and granted it Group C/Treatment IND status. In June, about six months after the NDA was filed, FDA's Oncologic Drugs Advisory Committee unanimously recommended approval for 2CdA ("The Pink Sheet" June 22, p. 6). Janssen's gastric motility agent Propulsid (cisapride) received a unanimous approval recommendation from FDA's Gastrointestinal Drugs Advisory Committee in April for treatment of gastroesophageal reflux disease ("The Pink Sheet" April 20, p. 3). Ortho's Renova (tretinoin, marketed as an acne treatment under the name Retin-A) was designated as safe and effective for the cosmetic treatment of photodamaged skin by the Dermatologic Drugs Advisory Committee on April 9 ("The Pink Sheet" April 13, p. 3). While public attention has been focused on Renova as potentially the first FDA-approved anti-wrinkling agent, Propulsid could capitalize on recent interest in GERD treatments. Many older anti-ulcer products, including Glaxo's Zantac and SmithKline Beecham's Tagamet, have been adding GERD indications as possible tickets to OTC use. Searle, which already has received an approval in 1992 for the quinolone antibiotic Maxaquin, is another possibility to receive more than one approval in the second half of the year. Searle's nonsteroidal anti-inflammatory drug Daypro (oxaprozin) cleared an "NDA Day" in June, usually a sign that a drug is nearing approval ("The Pink Sheet" June 22, In Brief). The Daypro NDA, licensed from Wyeth-Ayerst, has been pending since 1982. The Searle-Synthelabo joint venture Lorex has two possible approval candidates. Ambien (zolpidem), a non-benzodiazepine hypnotic, has been "approvable" at FDA since April 21. The beta- blocker/diuretic combination Kerlidex (betaxolol/chlorthalidone) was recommended for approval in December 1990. As an alternative to benzodiazepines such as Upjohn's Halcion, Ambien could have significant commercial potential if it is perceived to offer a side effect advantage. The drug's appearance on the market could be delayed, however, by the need to obtain Drug Enforcement Agency scheduling as a controlled substance. FDA's Drug Abuse Advisory Committee voted five-to-four in favor of Schedule V (the least regulated category for controlled substances) on Feb. 27. Benzodiazepines are Schedule IV. The committee's close vote, however, leaves open the possibility that Ambien could receive a Schedule IV designation ("The Pink Sheet" March 2, T&G-5). In addition to the February approval of Maxaquin, Searle has shared in an important generic approval in 1992. The Schiapparelli-Searle joint venture received the first approval for a generic equivalent to Pfizer's NSAID Feldene (piroxicam) in May ("The Pink Sheet" June 8, T&G-4). The company has not yet announced commercial availability of the product. Other companies that appear to have more than one candidate for approval in the latter half of 1992 include Bristol-Myers Squibb, Connaught, Glaxo and Lederle (see chart on next page for a list of possible late-1992 approvals). Glaxo's migraine treatment Imitrex (sumatriptan) is among the high-visibility new drugs nearing approval at FDA. The injectable form was recommended for approval by an FDA advisory committee in October ("The Pink Sheet" Oct. 28, 1991, p. 16); an oral form is also pending. Concerns raised in Europe about the potential cost of the treatment as well as the issue of cardiovascular side effects in certain sumatriptan users, however, have tempered investment community enthusiasm for the drug. Glaxo's Volmax, an Alza-developed formulation of albuterol, has been approvable since Oct. 31, 1991. Pfizer's Norvasc (amlodipine) is another candidate for late 1992 approval that could make a significant market splash. The calcium channel blocker was recommended for approval on June 7, 1991 and was designated "approvable" on April 22 of this year. Pfizer has been plugging Norvasc as a followup to its $1 bil.- plus nifedipine line (Procardia and Procardia XL). Pfizer's nonsedating antihistamine Reactine (cetirizine) also has been through an advisory committee: FDA's Pulmonary-Allergy Advisory Committee concluded in June 1991 that the drug is "not likely" to be a carcinogen in humans. Neither the panel nor FDA addressed other safety or efficacy considerations, however. Schering-Plough's long-awaited Claritin (loratadine) was cleared as unlikely to be carcinogenic at the same committee meeting; the drug had been recommended for approval by the committee in 1987. With the recent news of added drug-interaction labeling for Marion Merrell Dow's Seldane, FDA may be taking another look at pending antihistamines. Two recombinant Factor VIII products, Miles' KoGENate and Baxter's Recombinate, could be among the significant biological approvals in late 1992. Both products were recommended for approval on Dec. 12 by the Blood Products Advisory Committee ("The Pink Sheet" Dec. 16, 1991, p. 13 & 14). The committee favored a more general indication for the Miles product, licensed from Genentech. Baxter's Recombinate, licensed from Genetics Institute, was recommended for use only in patients previously treated with human-derived Factor VIII; KoGENate was cleared for use in all hemophiliacs. The two biologicals for which J&J holds marketing rights, Myoscint and CD5+, may face additional obstacles to approval in spite of the advisory committee approval recommendations. There are indications that Centocor's monoclonal antibody-based cardiac imaging agent Myoscint has been slowed by data concerns similar to those that torpedoed the company's Centoxin (HA-1A) application earlier this year. Centocor recently said it is auditing all of its PLAs ("The Pink Sheet" June 29, p. 2). If approved, Centoxin will now be marketed by Lilly's hospital force (see related T&G, this issue). Xoma's CD5+ was recommended for approval in June 1991 as a treatment for graft versus host disease despite FDA's statement at the meeting that it was not approvable. J&J recently returned marketing rights for other CD5+ indications to Xoma.

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