Manufacturing Issue Results in "Complete Response" Letter For Warner Chilcott Contraceptive
This article was originally published in The Pink Sheet Daily
Executive Summary
Warner Chilcott hopes to receive FDA approval for the low-dose product within six months.
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A third-party manufacturing problem is behind a regulatory delay on Warner Chilcott's new low-dose oral contraceptive, but the firm hopes the matter can be resolved within six months. Warner Chilcott announced that FDA had issued a "complete response" letter for the product, known as WC 3016, after the markets closed on Jan. 27. The agency found deficiencies during inspections of the third-party drug substance manufacturing facility and control testing laboratory. "Satisfactory resolution of these deficiencies is required before the application can be approved," the company said. However, the company was clear that "no efficacy or safety issues were raised by the FDA in the letter." "We did not anticipate this particular issue," Roger Boissonneault, president and CEO of the Irish specialty pharma, said during a conference call with investors Jan. 29. Boissonneault added that the problem was not under Warner Chilcott's control, and that the firm is continuing to work with the "high-quality" supplier as well as FDA to resolve it. "If you looked at FDA guidance, you would say now we have a six-month clock, but we've always talked to the FDA, and you can get it approved within that six months." Meanwhile, the company said its primary promotional focus within the U.S. hormonal contraceptive market continues to be Loestrin 24 (norethindrone/ethinyl estradiol). Women's health is a focus of the company. It has a full portfolio of oral contraceptive products, and also markets Sarafem (fluoxetine) for premenstrual dysphoric disorder and the overactive bladder therapy Enablex (darifenacin). Another pipeline project in the company's women's health franchise is a delayed-release formulation of the bisphosphonate Actonel , a product the company acquired last year as part of the $3.1 billion purchase of Procter & Gamble's pharmaceutical unit (Also see "Warner Chilcott Transformation Underway With Integration Of P&G's Pharma Biz" - Pink Sheet, 9 Nov, 2009.). -Martin Berman-Gorvine ( [email protected] ) |