STERLING TO COMPLETE NDA FILING FOR MILRINONE I.V. THIS SUMMER, SEQUENTIAL NDA FILING IS UNDERWAY; FIRM ALSO DESCRIBES ACQUISITION PLANS AT ANNUAL MEETING
Sterling plans to complete its NDA filing for milrinone I.V. this summer, the company indicated at its annual meeting. At the May 7 stockholders meeting in Wilmington, Delaware, Sterling President and CEO John Pietruski said that "a sequential NDA is now being filed on the intravenous form of this advanced cardiotonic; a marketing application will be filed on the oral form as soon as broad-scale, multi-center clinical investigations are completed and tabulated." Sterling said it hopes to complete the filing by "mid-year." The company did not make any projections on when it would be ready to file for oral milrinone. Sterling accelerated the milrinone clinical program in January 1984, after the firm terminated development of oral amrinone (Inocor). In his speech to shareholders, Pietruski hailed milrinone as the company's "most exciting" new product. He noted that the second generation inotropic agent has vasodilating properties and is "10 to 30 times more potent than amrinone and subject to relatively few side effects." At the American Heart Assn. meeting in November 1984, investigators presenting the results of Phase II studies repeatedly cited milrinone's efficacy in improving hemodynamics in severe congestive heart failure patients as well as the drug's minimal side effects. The drug's side effects apparently do not include the gastrointestinal symptoms associated with amrinone. Two concerns that surfaced at the meeting, however, were the possibility of an association between milrinone and an increased rate of arrhythmias, and the drug's failure in early clinicals to demonstrate a significant improvement in mortality among congestive heart failure patients. Commenting on the recent launch of the bronchodilator Tornalate (bitolterol), Pietruski declared that the first quarter sell-in of the agent "exceeded our optimistic projections; the medical profession has enthusiastically accepted Tornalate, the first bronchodilator avaialble in this country for both the prevention and prolonged relief of bronchospasm" in a sustained release dosage form. Sterling Wants To Recycle Funds From Divestitures Into Acquisitions In Line With Its Core Businesses At the annual meeting, Pietruski also discussed Sterling's corporate strategy. "It is our intention to focus on our core businesses -- pharmaceutical medicines, proprietary medicines and household and personal products," Pietruski stated. "Sterling management is committed to a program of redeploying and adding selected assets into these three areas and possibly a fourth -- a health care business other than medicines." Pietruski told the shareholders that Sterling has "undertaken to divest those businesses that do not fit our long-term strategy or which do not provide acceptable sales and earnings growth potential." In 1984 and 1985, the firm divested its environmental control business; its in-house advertising agency; Parfums Givenchy; poultry vaccines producer Sterwin Labs; and Nilok Chemicals "a one-product company supplying the farm industry," Pietruski reported. The company also sold to Mentholatum 11 mature proprietary medicines, which Pietruski described as not being "part of . . . future plans for this part of [Sterling's] business." Pietruski noted that "on balance, we made money on these transactions." He said that the funds from the divestitures would be applied "to acquisitions of products or companies that fit" within the firm's long-term strategy. "As a matter of fact," Pietruski said, "we have already engaged in several serious high-level negotiations, which, if consummated, would have been considered substantial in size." The Sterling exec also reported that the firm plans to build on its product licensing program and is now actively searching for someone to head that effort. "We are working actively on several licensing opportunities around the world." Pietruski stated. "Both in-licensing of compounds which would complement our existing franchises as well as out-licensing those compounds of our own discovery which do not place in high priority for internal development and commercialization by Sterling." According to Sterling's 1984 annual report, the firm had $355.3 mil. in cash and short-term investments available at the end of the year. Sterling also finished the year with a very strong working capital position as measured by a current assets to current liabilities ratio of 2.64 to 1. In addition, the company reported that it had unused short-term lines of credit aggregating $37 mil. as of Dec. 31, 1984. Commenting on the merger of Winthrop and Breon in late 1983, Pietruski declared: "The consolidation and expansion of our ethical pharmaceutical business in the U.S. has been accomplished successfully." Sterling now has "over 450" sales reps in the U.S., Pietruski added, "all with Inocor I.V. experience." In a separate announcement on May 10, Sterling said that its board of directors had elected Pietruski, 52, as chairman of the board succeeding outgoing Clark Wescoe, MD, whose retirement becomes effective at the end of May. Pietruski assumed the chief executive officer title in February. Moving in line for the top spot behind Pietruski is Exec VP James Andress who assumes the title of president and chief operating officer. Andress, 46, was elected to the Sterling board in February when he assumed responsibility of both Sterling's internatl. operations and its worldwide pharmaceutical business. Andress joined Sterling as exec VP-internatl. in 1984. Prior to joining Sterling, Andress had been with Abbott for 10 years, where his last position was VP-homecare.
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