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SYNTEX HAS SIX COMPOUNDS NEARING END OF R&D PIPELINE INCLUDING THREE AT FDA AND THREE IN PHASE III TRIALS; RECORD 28 DRUGS NOW IN DEVELOPMENT AT FIRM

Executive Summary

Syntex has at least five new drugs in the U.S. pharmaceutical pipeline which reached the NDA stage or entered final Phase III clinical trials during fiscal 1985, the company said in its recently-issued annual report for 1985 (year ended July 31). In addition, Syntex has had an NDA for butaconazole pending at FDA since 1984. NDAs for enprostil and nicardipine were filed during the year, and three pharmaceutical agents reached the final stages of clinical study. The Palo Alto firm has 28 compounds in clinical and pre-clinical development. The three products in the late-stages of development include ketorolac, a nonaddicting pain reliever that does not act on the central nervous system; ticlopidine, a platelet-aggregation inhibitor for the possible treatment and prevention of stroke; and the LHRH analog nafarelin, which may be useful in treating endometriosis as well as prostatic cancer. "We increased research and development spending 9% to $128 mil.," the Syntex annual report states. Recently, Syntex has been paring down its non-pharmaceutical/diagnostic operations. On Nov. 12, Syntex announced the sale of its contact lens business to the U.K. firm, Pilkington Brothers, PLC, for $60 mil. in cash. Last fall, the firm divested its relatively small cosmetics business. In FY 1985, human pharmaceuticals accounted for 74% of Syntex' $949 mil. in sales, generating volume of $678.7 mil. Under the terms of the contact lens deal, which is expected to be completed by the end of the calendar year, Syntex Ophthalmics will be merged into Pilkington's SOLA Optical subsidiary in Adelaide, Australia. For fiscal 1985, Syntex Ophthalmics sales were flat at $47.6 mil., or about 7% of corporate sales. Gardrin Data To FDA In March 1986; Naprosyn/Anaprox U.S. Sales Approach $300 Mil. In FY 1985, Worldwide $400 Mil. With regard to Gardrin (enprostil), the company filed the technical portion of its NDA for duodenal ulcer and gastritis indications in July and is following up with clinical efficacy submissions. "The FDA has requested some additional clinical data and will resume its review of the company's NDA when these data are submitted," the annual report states. Syntex explained that FDA is seeking efficacy data for other gastrointestinal diseases not well treated with current therapies and/or uterine data. The firm indicated that it will submit the data to FDA by March 1986. Syntex also noted that it is currently conducting Phase III trials to study the effectiveness of enprostil in preventing ulcer disease and in treating gastric ulcer disease, gastritis, esophagitis, and acute gastrointestinal bleeding. The company said that it plans to sponsor a medical symposium in Toronto, Canada this month, where it will present findings from some of these studies. Syntex said that it has submitted the pharmacology, chemistry and production controls portions of its NDA for the calcium channel blocker nicardipine. According to the annual report, the company will complete its application for an angina indication during fiscal 1986. Licensed from the Japanese firm Yamanouchi, nicardipine will be marketed in the U.S. under the brand name Cardene. With both enprostil and nicardipine NDA filings, Syntex has taken advantage of a new provision under the NDA rewrite that allows submission of the chemistry and pharmacy section of an NDA 90 to 120 days in advance of the remainder of the application. Commenting on Bristol-Myers' acquisition of Genetic Systems, Syntex said it is "unclear at this time how such a merger might affect the Syntex/Genetic Systems . . . and the ongoing relationship between the companies." Last August, Syntex announced that it had reached an agreement to invest up to $20 mil. in the biotech firm, Genetic Systems, and to purchase over the next five years roughly 4.7 mil. shares of that company's common stock for roughly $40 mil. Subsequently, in October, Bristol-Myers announced that it had signed an agreement in principle to acquire Genetic Systems in a $300 mil. stock swap ("The Pink Sheet" Oct. 27, p. 7) During the year, Syntex added another 50 people to its U.S. sales force, which now totals approximately 650 persons. "Strong marketing efforts and an expanded U.S. sales force helped Naprosyn become the fifth best selling of all prescription pharmaceuticals marketed in the U.S. in fiscal 1985," the annual report states. "In addition, Naprosyn maintained its number one position as the best-selling prescription nonsteroidal anti-inflammatory product in the U.S.," Syntex added. In the U.S., sales of Naprosyn and Anaprox jumped 23.8% to $287.2 mil. in fiscal 1985. The Naprosyn/Anaprox anti-arthritis/analgesic line continues to contribute the lion's share of Syntex' sales. In FY 1985, worldwide sales of naproxen/naproxen sodium were up 14.5% to $419.6 mil. The firm noted that it is awaiting regulatory approval in the U.S. for new naproxen and naproxen sodium formulations and dosage regimens, "including a new 550 mg dosage form of Anaprox." In addition, FDA approval of a migraine indication for Anaprox is pending, Syntex said. Syntex Cites Tri-Norinyl, Wallette Dispenser For Growth In U.S. Oral Contraceptive Sales: Up 1% To $90 Mil. The firm also reported a 1% increase in domestic sales of oral contraceptives to $90.1 mil., despite a $7 mil. decline in sales to the U.S. Agency for International Development. This slight gain helped move Syntex into the number three position among oral contraceptive manufacturers in U.S. pharmacy sales, the annual report said. Syntex credited "good demand" for its triphasic oral contraceptive Tri-Norinyl, and the "continued success of the Wallette oral contraceptive pill dispenser" for the improved performance of its U.S. birth control pill sales. "Sales of dermatological products in the U.S. increased 10% over 1984," the company said, "partly reflecting the introduction of a new dosage form of Lidex, a topical steroid." However, overall worldwide sales of dermatologics was up only 2% to $88.1 mil. Syntex added that U.S. sales of Nasalide (flunisolide nasal), an anti-inflammatory steroid used to treat hay fever and allergic rhinitis, increased 43% to $17.7 mil. in fiscal 1985, "strengthening the position of Nasalide as the number one selling product in its market." The company reported that while sales of diagnostic products declined 3% to $89.3 mil. in fiscal 1985, diagnostics sales during the second half of the year were 4% higher than sales during the last six months of fiscal 1984. "Increased sales of products to screen for drugs-of-abuse and to detect sexually transmissible diseases were primarily responsible for diagnostics' improved performance in the second half of fiscal 1985," the report stated. "Improvements in performance of the diagnostics division were largely due to lower inventory adjustments and a restructuring of the organization undertaken early in fiscal 1985 to stem operating losses and to reposition the business to more effectively meet current and future customers' needs," the annual report explains. "The company focused its efforts on those customers which represent high volume and good profit potential; consolidated and strengthened sales and marketing activities for its principal product lines; instituted strong cost controls; and divested or discontinued several product lines which no longer met Syntex' sales and profits objectives." As a result, Syntex' diagnostics div. showed a modest operating profit in the fourth quarter.
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