Merck Cholesterol Drug Delayed Until 2013
8 CommentsBy Ed Silverman // June 20th, 2008 // 9:48 am
This is big setback for the drugmaker, although not unexpected. You may recall, the FDA issued a non-approval letter two months ago for Cordaptive, which Merck hoped would revive its cholesterol franchise, now that Zocor is beset by generic rivals and Vytorin is under siege due to the controversial Enhance study.
Now, after meeting with the FDA, Merck is saying the agency suggests the drugmaker wait for the results of a cardiovascular outcomes study called THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events), which is expected to be completed in January 2013. One Wall Street analyst forecast this development last month (read here). The pill, by the way, contains an extended-release form of niacin, which is a vitamin, and a chemical called laropiprant to stop flushing, a common reaction to niacin.
In a statement, the drugmaker says it will continue to discuss with the FDA whether data on the drug, known as MK-0524A, in hopes of addressing the agency’s issues earlier than that far-off date. But even then, the earliest Merck would file a complete response to the agency would be 2010.
“We are disappointed, but continue to have confidence in the potential of MK-0524A to provide physicians with an important option to manage their patients’ cholesterol,” Peter Kim, president of Merck Research Laboratories, says in the statement. Merck’s loss is Abbott’s gain - Abbott sells the Simcor cholesterol pill that was approved a few months ago.
Nathan
Wow — a 5 year delay! Does anyone know how long the patent on this drug lasts? For many drugs, a 5 year delay is essentially a death-sentence because the patent life becomes so short that it isn’t worth the development costs just to bring a drug to the market for 2 or 3 years of exclusivity.
Condor
And speaking of Merck/Schering-Plough woes — consider that, once again, Schering chose to dump the new IMS May 2008 scrips data into the Firday night news “Memory Hole” — releasing long after Wall Street had gone to the bars in lower Manhattan. . . .
Yep — new monthly Vytorin/Zetia IMS scrips were released last night by Schering-Plough, once again on a back-water page of its website — with no front page reference, link or mention.
All new graphics — take a look here:
http://shearlingsplowed.blogspot.com/2008/06/may-2008-cholesterol-franchise-scrips.html
Perhaps the most important development to emerge from this new data is that the IMS numbers (now on file with the SEC) indicate the overall Cholesterol marketplace in the United States EXPANDED by about 1.3 percent in May 2008 — but with its essentially flat May 2008 scrips, the Merck/Schering-Plough Joint Venture effectively lost market-share to competitors’ drugs (albeit at a lower rate than in January through April 2008).
I guess the only thing surprising, here — is that they (Merck and Schering) just keep playing the same old games — So, I propose a game of “New Rules” (a la Bill Maher):
[You make those "new rules" up, below!]
Namaste
Bob Freeman
Nathan, I don’t know when the original patent(s) expire(s). Merck can recover up to 5 years of patent life due to time “lost” in FDA review. (Patent Term Restoration Act, 1984, (I think.))
Condor
I think that is right, Bob — and more directly on the subject of Merck, now — I should note that its April 21, 2008 projection of a $700 million 2008 fall-off (compared to 2007 levels) in Equity Income “solely attributable” to Cholesterol J/V downturns, looks to be a little too low.
I guessed it would be closer to $900 million, back in early April 2008 — and if the 23 percent downturn persists (but gets no worse) for all of 2008 — it will be more like $850 million fall-off in income:
http://shearlingsplowed.blogspot.com/2008/06/pretty-good-guess-here-at-2008-equity.html
Namaste
Nathan
Bob - no, I don’t believe that you are correct. The way I understand it is a company can claim lost “review time” only when the actual FDA review is delayed. (ie if the FDA is running behind schedule) This 5 years is ADDITIONAL TESTING that the FDA is requiring — not additional time to review the current application. This is 5 years that will never be recovered.
Condor
Nathan — I think the FDA would disagree with you:
“. . . .6. What are the criteria for determining whether a patent for a human drug product is eligible for patent extension?
The term of a patent which claims a human drug product, a method of using the product or a method of manufacturing the product will be extended from the original expiration date if it satisfies six conditions.
First, the applicant must show that the patent has not expired.
Second, the applicant must establish that the patent has not previously been extended.
Third, the patent owner or its agent must submit an application for patent term restoration that includes details about the patent and the activities undertaken to secure FDA approval.
Fourth, the applicant must establish the product was subject to a regulatory review period before its commercial marketing or use.
Fifth, the applicant must show that the product either represents the first permitted commercial marketing or use of the product after such regulatory review period or, in the case of a product manufactured under a process patent that primarily uses recombinant deoxribonucleic acid (DNA) technology, represents the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent.
Finally, the applicant must submit the application for patent term restoration to PTO within 60 days of FDA approval of the commercial marketing application. . . .”
Note that the most important requirement for getting a five-year patent extension is that the drug NOT have been PREVIOUSLY approved for some other indication, disease or condition.
Thus, I believe Merck’s compound qualifies.
FDA recites no “due to FDA’s delay” requirement among the six it considers.
FDA will reduce the five years if Merck is deemed not to act swiftly enough — but that should not be a problem, here:
“. . . .[E]ach phase of the regulatory review period is reduced by any time that the applicant did act not act with due diligence during that phase. The reduction in time would only occur after an FDA finding that the company did not act with due diligence. . . .”
SOURCE:
http://www.fda.gov/CDER/about/smallbiz/patent_term.htm
Nathan
Condor - that’s interesting. I hope you are right. I wasn’t aware that extensions would be allowed in these type of cases. Thanks for the info.
Bob Freeman
Thanks for the clarification, Condor, very helpful.