Pfizer, Ranbaxy deal to delay generic Lipitor.
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Pfizer said on Wednesday that Ranbaxy Laboratories can begin selling a US generic form of its Lipitor cholesterol fighter by late 2011 under a settlement deal, some five months later than Wall Street expectations.
Industry analysts have long expected Lipitor's US marketing exclusivity to lapse no later than June 2011, and for cheaper generic forms of the world's best-selling drug to then immediately flood US drugstores.
But under Pfizer's settlement with India's Ranbaxy, which has long challenged Lipitor's patents in the courts, US patients will not have access to Ranbaxy's copycat product until November 30, 2011.
Pfizer's shares rose 3 percent to $18.25 in premarket trading. Ranbaxy shares were up nearly 3 percent in India.
The delay would buy a little extra time for Pfizer, whose earnings are expected to plunge once a generic form of its $12 billion-a-year flagship product arrives and starts hammering away at Lipitor sales.
Asked if the delay could spark a backlash among patients and insurers who favor cheaper generics, David Reid, Pfizer's acting general counsel, said: "We're pleased with this settlement and we actually think it is pro-patient, pro-competitive and pro-intellectual property."
"This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes," Malvinder Mohan Singh, chief executive and managing director of Ranbaxy, said in a statement.
Pfizer, whose shares are at a 10-year low due to anemic revenue from its other medicines and worries about Lipitor's looming patent expiration, also described the deal as a potential balm to its long-suffering shareholders.
"It gives substantial certainty regarding the potential date for entry of a generic version of Lipitor in the United States," Reid said in an interview.
Ranbaxy, as the first drugmaker to seek approval of generic Lipitor, would be entitled under federal law to 180 days of marketing exclusivity before other generics could be introduced, he said.
US prices of branded medicines typically fall 20 percent or more once the first generic hits the market, and can tumble 80 percent or more after other generics are launched.
The deal, while ending Pfizer's long-standing attempts to block Ranbaxy's product in the United States, would leave Pfizer free to eventually launch its own authorised generic form of Lipitor, Reid said.
Reid said the agreement would benefit consumers because some less-well-known Lipitor patents extend as far out as 2017, and could have blocked generics until then. Analysts, however, have discounted that possibility.
The settlement will also entitle Ranbaxy to begin selling generic versions of Caduet -- a Pfizer drug that combines Lipitor with the company's Norvasc blood pressure treatment -- in the United States by November 2011.
Although Pfizer will not pay Ranbaxy any monies under the deal, Reid said Ranbaxy would profit because its US generic now has a guaranteed path and because Pfizer will drop efforts to stop ongoing sales of its Lipitor generics in Malaysia, Brunei, Peru and Vietnam.
The arrangement would also allow Ranbaxy to sell generic Lipitor in Canada, Belgium, the Netherlands, Germany, Sweden, Italy and Australia near the time of respective patent expirations in those countries.
Patent battles between the companies over Lipitor would continue, however, in Finland, Spain, Portugal, Denmark and Romania, Pfizer said.
The deal would also end ongoing US patent disputes between the companies relating to Pfizer's Accupril blood pressure drug, and a dispute in Ecuador involving Pfizer's Viagra anti-impotence pill.
Although Pfizer will submit the deal to the US Federal Trade Commission, Reid said it does not require the agency's approval.
The FTC in February filed suit against Cephalon, alleging the US biotechnology company broke the law by paying generic drug makers to keep copycat versions of its Provigil sleep disorder medicine off the market.
The agency has been battling similar agreements among drugmakers for years, arguing they violate antitrust law and keep drug prices high. Reid said Pfizer's agreement with Ranbaxy should not raise such concerns at the FTC because it involves no payments and complies with all applicable laws.
Last week, India's Business Standard newspaper said Pfizer may bid for Ranbaxy, countering a $4.6 billion offer from Daiichi Sankyo Co Ltd, Japan's third-biggest drug maker. - Reuters
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