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STERLING's OMNIPAQUE U.S. SALES EXPECTED TO EXCEED $50 MIL IN FIRST YEAR; ORAL MILRINONE NDA WILL BE FILED IN NEXT FEW MONTHS, COMPANY TELLS ANALYSTS

Executive Summary

Sterling's Omnipaque (iohexol) nonionic contrast medium is headed toward first-year U.S. sales of over $50 mil., Winthrop-Breon President Harry Shoff reported at a recent meeting with financial analysts. "Omnipaque is a pure success story," Shoff declared. In nine months, he noted, Sterling has created "an awareness level exceeding 90% with usage in excess of 65%." Crediting the company's experience with the first generation nonionic contrast medium Amipaque, Shoff said that Omnipaque is "making dramatic inroads into the vascular segment of the radiographic market." About 70% of Omipaque sales are now coming from vascular uses, he reported. Approved by FDA in December 1985, Omnipaque is currently outselling Squibb's Isovue, Shoff maintained, "on a better than two-to-one ratio." Combined sales of Amipaque and Omnipaque will be up over 20% in 1986. Omnipaque is licensed from the Norwegian firm, Nycomed A/S. Sterling's other recent U.S. Rx launch has not performed as well. The bronchodilator Tornalate (bitolterol), which was introduced into the U.S. market in March 1985, "has yet to meet sales expectations, and patient acceptability of the formulation has been cited as a major limiting factor to a greater marketshare," Sterling acknowledged. The company said it is working on a dry powder aerosol and has NDAs pending for a solution for nebulization (filed in December 1985) and a pediatric metered-dose aerosol (filed in October 1986). Shoff said that Sterling will continue to back Omnipaque with a "high level of promotional investment" as well as with an R&D program to add new uses for the product. Currently approved for several adult intravascular indications, including angiocardiography, cerebral and peripheral arteriography, digital subtraction angiography, urography, phlebography and lumbar myelography, Omnipaque has a supplemental NDA pending for cervical and total columnar myelography that is expected to be approved by the end of the year. In addition, Sterling said it plans to file for a "series of additional indications" beginning with a claim for use with computerized tomography followed by several pediatric indications and adult arthrography. "The end result of these efforts will be a drug with the most comprehensive list of approved indications of any contrast medium on the market," Sterling Research Group Exec VP Denis Bailey stated. Sterling's major short-term R&D effort is for the oral inotropic agent Corotrope (milrinone). A sequential NDA filing will begin "shortly" for the drug, Sterling Research Group President Lawrence Chakrin, PhD, reported at the Oct. 23 meeting. The complete NDA is expected to be filed "within the next few months," he noted. An NDA for I.V. milrinone has been pending at FDA since June 1985. The efficacy section of the oral Corotrope NDA will include results from three multicenter trials, including two in the U.S., involving a total of 570 patients. Two of the studies, one U.S. and one done in Africa and South America, were randomized trials that looked at oral milrinone as replacement or concomitant therapy for digitalis. In the 230-patient U.S. trial, conducted at 32 medical centers, milrinone "was found superior to digitalis and placebo in patients completing the protocol, and superior to placebo and equivalent to digitalis in all patients," Chakrin noted. A third Phase III study focused on the effects of chronic administration of milrinone on hemodynamic function of the heart in 155 patients in 20 U.S. centers to determine if the inotropic activity of the drug reduced hemodynamic response. Chakrin said that the 12-week trial confirmed "a clinically significant improvement over time" and "demonstrated that oral milrinone had a favorable effect on cardiac hemodynamics." However, he added that baseline hemodynamics in the milrinone group "were slightly reduced" at three months. In order to resolve questions concerning the long term effects of milrinone, Sterling is putting together a six-month comparative trial with the ACE inhibitor Capoten involving 250 patients at over 20 centers. In addition, the company has plans for a "much larger trial," Chakrin told the analysts, to examine the effect of oral milrinone therapy on survival over several years. He noted that Sterling is also in "the advanced stages of development" of a twice-a-day, controlled release dosage form of oral milrinone. Further back, Sterling has a third inotropic agent in development, after amrinone and milrinone, called medorinone. Chakrin said that an IND will be filed "shorty" for the chemically novel naphthyridine compound. Sterling management also discussed three anti-infective compounds in early clinical trials -- the antibacterial octenidine, the quinolone analog amifloxacin, and the antiviral disoxaril. Sterling said its work on octenidine as a skin cleanser formulation has been discontinued "because of lack of demonstrable clinical superiority over marketed products." However, the company noted that a mouth rinse formulation is the Phase II clinicals. Licensed to Procter & Gamble, octenidine "was found to exhibit efficacy in clinical models designed to monitor anti-plaque and antigingivitis activity," Bailey said. Amifloxacin, Sterling's second quinolone derivative antibacterial to reach clinicals after Eradacil (rosoxacin), is nearing completion of Phase I studies. Sterling anticipates that Phase II studies of oral amifloxacin "will be started early in 1987 with the intravenous Phase II studies to follow." Oral amifloxacin will be stdied "for the treatment of urinary tract, gonococcal and other outpatient infections" while the I.V. form will be targeted at "serious systemic gram negative infections in hospitalized patients," Bailey explained. Sterling's lead quinolone compound, Eradacil, is pending FDA approval for treatment of gonorrhea. The third anti-infective in development, disoxaril, has been shown to be active in preclinical studies against the picornavirus family, which includes enteroviruses that can cause neonatal sepsis, polio, hepatitis A, and certain forms of conjunctivitis and meningitis, as well as rhinoviruses that can cause colds. Bailey said that disoxaril prevents viral replication by blocking "an early essential step in viral reproduction -- the shedding of the outer protein coat." Disoxaril is currently in Phase I study. Other research compounds highlighted in the presentation to analysts were: Modrastane for the treatment of breast cancer; Epostane, an analog of Modrastane, in early clinicals for hormonal disorders; the hypolipodemic ciprofibrate, for which clinicals have been suspended in the U.S. pending further rat toxicity studies; two antidepressants in early clinicals -- fezolamine and napamezole; and the analgesics, tonazocine and WIN-48098/6. Sterling will increase its budget for drug R&D 15-20% in 1987 over the current R&D spending level of nearly $100 mil. In order to focus on priority compounds, Sterling is condsidering outlicensing or codeveloping several of its compounds, including Epostane, fezolamine, and tonazocine. The company said it is de-emphasizing the benzazocine-class painkiller, tonazocine, in order to concentrate its resources on WIN-48098/6, now in Phase II study. Sterling said that based on preclinical results, the new analgesic may "control pain of mild-to moderately severe intensity, without gastrointestinal side effects and without the expectation of physical dependence." The company suggested that the drug is able to do this by inhibiting brain prostaglandin synthesis, "while only partially inhibiting stomach prostaglandin synthesis." The drug is currently in a tripe-blind, multicenter trial in post-operative patients versus placebo, acetaminophen, and acetaminophen/codeine.
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