The US Food and Drug Administration approved the first generic version of the anticoagulant drug enoxaprin sodium injection on last Friday, July 23. Lovenox is the drug’s brand name, and it’s manufacturer, sanofi Aventis (Paris), was not happy about FDA’s decision.
On July 23, sanofi released a statement expressing concern about FDA’s decision to approve a generic version of Lovenox because of the “potential implications for patient safety.” Sanofi said the generic version, manufactured by Momenta Pharmaceuticals (Cambridge, MA) and Novartis’s generic-drug unit, Sandoz (Broomfield, CO), was not subject to the same extensive testing for safety and efficacy that Lovenox has undergone and therefore cannot be considered an equivalent drug. “By nature, Lovenox is a complex biological product and its efficacy and safety profile relies heavily on the strict adherence to the specific processes applied in its manufacturing as well as its traceability from the animal mucosa to the finished product,” according to the company statement.
FDA’s announcement of the drug’s approval acknowledges the challenges in producing the generic version and emphasizes that the appropriate precautions were taken before making its decision. “Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product,” said Keith Webber, PhD, deputy director of the FDA’s Office of Pharmaceutical Science.
Early this week, sanofi filed a lawsuit in the United States District Court for the District of Columbia seeking to overturn FDA’s approval of the generic Lovenox. Momenta Pharmaceuticals released an update on Tuesday that said sanofi’s suit sought a temporary restraining order and preliminary injunction forcing FDA to suspend and withdraw its approval of the abbreviated new drug application filed by Momenta and Sandoz. The court set a date for a hearing on Aug. 17, and in the meantime there are no restrictions on Momenta and Sandoz to market their generic version of enoxaparin sodium injection. The companies say they plan to “vigorously oppose” sanofi’s suit.
In other sanofi news, reports around the web, such as this one from the New York Times, speculate that sanofi is on the verge of making an unsolicited $18-billion bid for Genzyme. The bid represents an offer of roughly $70 per share of the Cambridge, Massachusetts-based biotech firm. Analysts are eagerly awaiting the release of a letter from sanofi detailing its offer for Genzyme. Rumors of the deal have been circulating for several weeks, as PharmTech editor Patricia Van Arnum described in her blog post from early July.