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SCHERING ADDING THREE MORE NDA FILINGS TO PIPELINE; FOUR COMPOUNDS TO MOVE INTO CLINICALS IN 1987 AS COMPANY EXAMINES INTRON FOR NEW INDICATIONS

Executive Summary

Schering-Plough has recently filed NDAs for two drugs and plans a third filing before year end, the company told security analysts in a Dec. 3 presentation at its pharmaceutical headquarters in Kenilworth, New Jersey. Applications for the once-a-day, nonsedating antihistamine loratadine and for a new medium-to-high potency topical steroid, mometasone, are now pending at FDA, and an NDA for the beta blocker dilevalol will be filed "within a few weeks," the firm said. Loratadine's once daily dosing is designed to differentiate the product from Merrell Dow's Seldane (terfenadine). Schering also claims loratadine has a more rapid onset of action than J&J's Hismanal (astemizole), for which an NDA is pending. The mometasone NDA covers both cream and ointment dosage forms; the company expects approval in 1987. "Our clinical trials have demonstrated a complete avoidance of renal suppression with this compound," Schering-Plough President Richard Kogan emphasized. "It is as safe as hydrocortisone, more potent than Valisone (betamethasone) and only has to be applied once a day." During 1987, Schering will move four new compounds into clinical trials, seek additional indications for its recombinant interferon product, Intron A, and continue to develop products for its recently acquired Key Pharmaceuticals subsidiary. Slated for clincials in 1987 are: SCH-37224, a leukotriene inhibitor for treatment of allergies; SCH-35852, a topical antifungal agent; SCH-34826, an enkephalinase inhibitor analgesic; and granulocyte macrophage colony stimulating factor (GM-CSF), a DNAX compound which will be initially evaluated as an adjuvant for cancer chemotherapy. Key's Theo-Dur Becomes Schering's Top Selling Product In 1986 Schering expects that the next Intron A approval will be for genital warts. "We feel confident that our product license for the venereal warts indication will be approved shortly," VP-clinical research Jonathan Spicehandler, MD, predicted. He maintained that more doctor visits in the U.S. have resulted from genital warts than from herpes. The company also said it plans to develop a sustained release formulation of Intron for this indication. Currently approved in the U.S. for hairy cell leukemia, Intron A is expected to generate between $8-$10 mil. worldwide its first year on the market, the company said. License applications for Kaposi's sarcoma, malignant melanoma, and multiple myeloma are pending at FDA, as is one for prophylaxis of the common cold. "We are actively investigating the efficacy of Intron A in two new cancer indications this year, myelogenous leukemia and basal cell carcinoma," Spicehandler added. The company, which has begun early clinical studies for both indications, noted that the drug achieved 50% and 90% clinical response rates in the two respective forms of cancer. Other antiviral applications are also being explored. "Over the past year, we have been actively involved in evaluating Intron A in chronic hepatitis B therapy," Spicehandler said. "A large, multicenter Phase III trial will be initiated shortly." He noted that Schering is also evaluating the drug in acute hepatitis, non-A/non-B hepatitis, and as a therapy for post-infusion hepatitis. Among the Key Pharmaceuticals research products that Schering has targeted for 1987 clinicals are nalmafene, as a therapy for chronic pruritis and allergies, a sustained-release dosage form of the anti-arrhythmic procainamide and buccal and transdermal forms of estradiol, for treatment of osteoporosis. Under a licensing agreement with Schering, Sandoz is currently conducting "extensive" Phase III trials with the ACE inhibitor SCH-33844, Spicehandler noted. The agreement gives Sandoz worldwide marketing rights in exchange for product royalties, with Schering retaining U.S. comarketing rights. Schering is also developing a gamma interferon product in conjunction with the Japanese firm Suntory. While the compound is currently in Phase II for ovarian cancer and carcinoma, the company does not appear overly optimistic. "I think it's safe to say we have not seen a tremendous amount of activity with gamma," Schering Chairman Robert Luciano remarked. While the company has an NDA for Eulexin (flutamide) pending in the U.S., the oral drug is being marketed as a treatment for prostatic cancer in 14 countries including West Germany and Canada. Schering said it expects the drug's worldwide sales to total $15 mil. in 1986. Spicehandler noted that the National Cancer Institute has been conducting a large multicenter trial comparing the combination of Eulexin and a LHRH agonist in advanced prostate cancer. Preliminary evaluation of response rate data is expected to take place in early 1987. Of the company's currently marketed pharmaceuticals, Key's Theo-Dur sustained release theophylline product leads all others, with 1986 sales projected to exceed $100 mil. Referring to the Key acquisition as "a very nice strategic fit," Schering-Plough Chairman Robert Luciano noted that Theo-Dur is indicated as first-line treatment for asthma; Schering's Proventil (albuterol) is a second-line therapy. Schering plans to extend the Proventil line with Proventil Repetabs, "the only b.i.d. beta agonist to be marketed in the U.S.," according to the company. FDA marketing approval is expected "shortly," the firm said. Approval for an inhalator dosage form of Proventil is also expected in 1987. Schering is on target to surpass the $2 bil. revenue mark for the first time in 1986, having reached almost $1.8 bil. through the first nine months. Pharmaceutical sales were up 24% to $1.2 bil. during the nine months. Sales by the firm's largest pharmaceutical component, the allergy, asthma and cough/cold division, rose 18% during the first three quarters to $403 mil. That segment, which includes both Rx and OTC products, was followed by "other pharmaceuticals" at $216 mil., dermatologicals at $214 mil., anticancer/anti-infectives at $168 mil., and cardiovasculars at $72 mil. Commenting on cardiovascular volume, which rose 39% during the nine-month period, Kogan noted that Key's line of Nitro-Dur nitroglycerin patches rose 22% and currently enjoy a roughly 30% share of the patch market. The company recently introduced K-Dur into the potassium supplement market and expects to introduce its beta blocker/diuretic combo Normozide in 1987. Schering's Normodyne (labetalol) will achieve sales of $25 mil. in 1986, the firm predicted. At that level, Normodyne would represent about one quarter of the company's cardiovascular business. Pharmaceutical sales account for roughly 25% of Schering's operating earnings, Luciano reported. Net earnings for the first three quarters rose 42% to $62.3 mil. The firm's selling, general and administrative expense declined slightly even though promotion expenses increased 12% and field sales expenditures increased 8%.
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