Friday, May 29, 2015

FDA Approval For Merck's Latest Hep C Challenger Could Come By Late July. . . But Maybe A Lil' Later, Too.

With a coveted breakthrough designation from FDA for this sub-set indication, things should move quite-swiftly at FDA. However, that is -- as ever -- a relative term. And this is just as we had earlier predicted -- except that Merck is a few weeks late (or at least, later than we guessed) in getting the NDA actually on file with the staffers in Silver Spring, Maryland.

Merck will reach the market as the third entrant in this generation of Hep C all oral combos. Whether it reaches by late July-, or late September 2015, it will face daunting competition from Abbvie's and Gilead's offerings. So, Merck will likely have to "buy share" -- by cutting price. And that will be very good for health care insurers, and plan participants -- the patients with chronic Hep C. The enhanced cash-flow won't hurt Kenilworth, either. Here's a bit from The Wall Street Journal, today:

. . . .Merck said in April that the combination for treating chronic hepatitis C patients demonstrated a 95% effective rate in a late-stage study. . . .

The combined tablet poses a potential threat to hepatitis market leader Gilead Sciences Inc., which analysts estimate raked in at least $12 billion in combined sales in 2014 from the blockbuster drug Sovaldi and the first all-oral combination drug, Harvoni. Another competitor is AbbVie Inc., which recently launched its Viekira Pak. . . .

This is quite good news for Kenilworth -- and now lays open a highly-likely path to similar approvals -- all across the western world, perhaps even by the end of 2015. Onward.

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