Replies to post #58118 on Biotech Values

[DewDiligence]

Because H-W exclusivity would apply to OTC Mevacor, MRK has been willing to keep trying and trying… and trying. But it looks like it’s not in the cards.

[DewDiligence]

PFE is pondering OTC Lipitor, depending on the outcome of a large clinical trial:

http://online.wsj.com/news/article_email/SB10001424052702304071004579410930136742414-lMyQjAxMTA0MDAwMjEwNDIyWj

Pfizer Inc. is forging ahead in its quest to sell an over-the-counter version of blockbuster cholesterol pill Lipitor, hoping to overcome skepticism that consumers can take the drug appropriately without doctor guidance.

…Pfizer recently started a 1,200-patient clinical trial to test if consumers taking a nonprescription Lipitor get their own blood tests to see if the medicine is improving their cholesterol and then make the right decisions based on the results… The trial, which is recruiting patients through more than 35 U.S. pharmacies, is expected to be completed by year-end.

The FDA rejected MRK’s application to sell an OTC version of Mevacor in 2008 (#msg-26287401), which was the last attempt at an OTC statin.

Prescription Lipitor is still a big-selling product ($2.3B in 2013), even though it is off-patent everywhere, thanks to the power of branded generics in emerging markets.