Roche R&D chief affirms $10B peak potential for HDL drug

Who says the mega-blockbuster is dead? Certainly not , as per, Roche research chief Jean-Jacques Garaud, who believes that despite the troubled history of CETP inhibitors.Roche’s HDL drug “dalcetrapib” has the potential to earn upwards of $10 billion a year. And Garaud shrugged off the prospects of Merck's rival HDL drug "anacetrapib", which has done even better in the clinic at boosting levels of "good" cholesterol.

Even though their (anacetrapib's) HDL elevation is higher, that might not be the best marker for potential activity,. "What is important is how much cholesterol we pull from the blood. We think ours is better than any other drug , he said.

But even more importantly than the positive data on HDL levels, Roche's investigators recently were able to reassure observers that in mid-stage studies the drug appeared safe, with no spike in blood pressure.

Merck, of course, may not be ready to take a back seat to dalcetrapib. In a Phase II trial their drug was linked to a whopping 138% rise in good cholesterol and a 40% drop in LDL levels.  That's a much better result than the 31% boost in HDL levels seen in a mid-stage study for dalcetrapib. Vontobel  estimated potential sales of $5 billion a year whereas. UBS projected peak sales at $6.8 billion.

Reuters

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.