Ranbaxy may sale Generic rights of Lipitor if the approval gets delayed

Ranbaxy may sell rights to make a generic version of Pfizer’s Lipitor, the world’s best-selling medicine, should it fail to win timely U.S. approval for the cholesterol pill, said Credit Suisse. 

A legal settlement with Pfizer gave Ranbaxy six months’ exclusivity to market generic Lipitor in the U.S.    Delays in USFDA  approval may prevent Ranbaxy from selling its copies as planned from Nov. 2011.   Lipitor is the highest-selling drug of all time, generating $10.7 billion last year. The most likely outcome will involve Ranbaxy paying a hefty fine to the FDA, which would subsequently clear the path for Lipitor approval.The company and most industry experts remain confident a resolution will be reached in time for Ranbaxy to launch on Nov. 30. 
If the Nov. 30 deadline isn’t met, Ranbaxy may postpone the release of its copycat Lipitor, said  the Credit Suisse report .  This would also delay the timeline for other generic manufacturers wanting to sell their own copies, as Ranbaxy’s 180-day exclusivity period does not start until it begins commercial marketing.   This  delay may  benefit Watson Pharmaceuticals which negotiated with Pfizer to begin selling a so-called authorized generic by Nov. 30. Alternatively, Ranbaxy may waive exclusivity in exchange for payment from a rival generic-drug maker, Credit Suisse said.

Drug R&D spending fell in 2010, and heading lower

The global drug industry cut its research spending for the first time ever in 2010 and the pace of decline looks set to quicken this year. Expenditure on discovering and developing new medicines  estimated to be  $68 billion  in 2010, down nearly 3 percent on the $70 billion spent in both 2008 and 2009, according to Thomson Reuters. 

Since 2000,  investment by drug companies   for NCE  is almost  80 percent of the industry's total R&D  spend  which has increased by more 50 percent ,  but output of  NCE has actually gone down. Last year ,  21  NCE were launched on the global market against 26 in 2009.

 Between 2008 and 2010 there were 55 terminations of projects that had already reached the final Phase III stage of clinical testing, more than double the level of 2005-07, reflecting the growing difficulty of developing new drugs that are better than existing ones.

India looses one rank in world competitiveness

India slipped one rank, to 32nd position in overall competitiveness among 59 nations, according to the ‘World Competitiveness Rankings’

The recovery of financial markets pushed the US and Hong Kong to first two  places, followed by last year’s topper, Singapore, which fell to third spot. In 2010, the US and Hong Kong ranked second and third, respectively.  Sweden jumped to fourth, from sixth and Germany came sixth

China,  slipped one rank, to 19th and Japan went up one rank to 26th slot .  Though India’s ranking is below the midway mark, it still did better than Indonesia (37) Philippines (41), Brazil (44) and Russia (49).