Mar 13, 2008 - Cubist Pharmaceuticals (NASDAQ: CBST) said today that it believes that no generic manufacturer acted last September to secure a potential "first to file" advantage, by filing an abbreviated new drug application (ANDA) for daptomycin. If such a filing had occurred, the generic company would have had to notify Cubist within 20 days of acceptance of the ANDA by the FDA. It is now a full six months since September 12, 2007--the first opportunity for a generic company to file an ANDA and the only date on which a generic company could be assured of securing the "first to file" advantages available under the Hatch-Waxman legislation--and Cubist has received no notification.
As of March 11, 2008, the FDA Office of Generic Drugs (OGD) web site had listed twenty-six accepted filings for ANDAs filed since September 12, 2007. The March 11, 2008 update to the OGD web site (http://www.fda.gov/cder/ogd/ppiv.htm) included seven ANDAs submitted between November, 2007 and mid-January, 2008.
The company believes it is significant that no generic company appears to have assured itself of the "first to file" advantage by filing on September 12, 2007. Cubist President and CEO, Mike Bonney, cited two key challenges that may have created hurdles for a generic manufacturer considering such a filing: "First of all, to file an ANDA, a generic company would have to believe they could successfully challenge the daptomycin patents listed in the FDA Orange Book." The Orange Book patents for CUBICIN(R) (daptomycin for injection) include two method-of-administration patents based on the discovery by Cubist scientists Drs. Tally and Oleson. This discovery made it possible to complete clinical trials for daptomycin as an I.V. antibiotic at doses high enough to treat serious skin and bloodstream infections caused by Gram-positive pathogens, including MRSA. "CUBICIN, which as of year-end 2007 had been used in the treatment of an estimated 460,000 patients, would not have become a drug without the discovery on which these patents are based," Bonney pointed out. "We stand behind these patents and are prepared to defend them vigorously if they are challenged."
The company also noted that only three of the twenty-six ANDA filings accepted by the FDA since September 12 have been for intravenously delivered products. "Making an I.V. drug is almost always more costly than making an oral therapy such as a pill," said Bonney. "In the case of daptomycin there are some unique challenges in the purification process that add to the cost of manufacture. This would impact margins if a generic manufacturer determined that it would need to price a 'generic CUBICIN' at or near the acquisition price of the existing generic I.V. therapy in this market, vancomycin."
Under the terms of the Hatch-Waxman legislation enacted in 1984, a generic manufacturer has the right to challenge the U.S. patent protection of a drug, by filing an ANDA with a paragraph IV certification, one year prior to the expiration of FDA-granted data exclusivity. For CUBICIN, that date was September 12, 2007. The Hatch-Waxman legislation provides an incentive to encourage such filings. A generic manufacturer who is the first to file an ANDA with a paragraph IV certification and who prevails in patent litigation is eligible for 180 days of exclusivity, during which the FDA will not authorize another generic drug for marketing in the U.S.
Further information about the intellectual property protection for CUBICIN, including information on the three FDA Orange Book listed patents, is available on the Investor Relations page at www.cubist.com
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