Thursday, February 20, 2014

Breaking News In India: Merck Smartly Finds "A Zen Master's Third Path" In The Compulsory License Vs. IP Battles, On HIV Med Isentress® (Raltegravir)


I applaud Whitehouse Station's bold (and yet luminously Zen-like) move here. That comes first.

The Cipla deal just announced is a non-exclusive, in India. Thus, Merck will still be able to sell Isentress® to the richest Indians who are HIV+, directly. No middleman. [I suspect even they, though, will choose the much cheaper Cipla "authorized" generic.]

This is a smart business decision, given the current IP climate in India (see our backgrounders). Cipla will have to market Isentress under a different brand name -- to make it easily distiguishable from the genuine article out of Whitehouse Station. Cipla wins what it set out for, back in the Spring of 2011 -- the right to medicate AIDS patients in India more affordably; Merck doesn't surrender all the revenue, in country. Condor's Context®?: This may be the new model, for PhRMA members to avoid "compulsory license" imposition -- by courts, regulators & ministries, in country.

From India's BusinessWorld, overnight -- a bit -- but do go read it all:

. . . .[UPDATED: [In a]nnouncing the partnership, KG Ananthakrishnan, MD MSD India said, "We are proud to have entered into a strategic, India-specific partnership with Cipla. This partnership is aligned with our commitment towards patients in India and also addressing treatment challenges for high-risk patients by providing broader access to our innovative medicines and vaccines. It is a complementary partnership as MSD brings the research and scientific excellence for raltegravir, and Cipla brings their marketing excellence, significant reach among key clinician categories to drive product access". . . .]

Cipla will have a non-exclusive license to market, promote and distribute MSD’s raltegravir 400mg tablet, under a different brand name in India. Raltegravir is now approved in combination therapy in more than 76 countries for use in treatment-na├»ve adult patients with HIV-1 and in more than 114 countries for use in treatment-experienced adult patients with HIV-1.

Merck has a product patent for the drug in India since February 2008. The Chennai patent office had allowed the application filed in 2004. The US FDA allowed sale of this drug in 2007. . . . Global sales of the drug in 2012 were $1.5 billion, an 11 per cent increase over the previous year.

Interestingly, in April 2011, Cipla had moved an application to issue a compulsory license for the drug in India, citing the drug is overpriced and not affordable for Indian patients. . . .

"The deal demonstrates our commitment to working with partners globally who share the same pro access philosophy of Cipla. We want to ensure that all patients, particularly in developing countries, get access to the most innovative, breakthrough medicines available", said Subhanu Saxena, managing director and global CEO, Cipla.

The total number of people living with HIV/AIDS (PLHIV) in India is estimated at around 20.9 lakh in 2011. . . .


Again, for translational context, on the burden of AIDS in India -- a "lakh" is 100,000 of anything. That means there are 2.09 million people, living with HIV/AIDS, in India. (So that is over one fifth of all the people living. . . in Hungary, PhRMA! This is a very high burden malady -- in India.)

Even so, I am mindful of the billions Merck invested to create Isentress. And the company has already made a handsome profit on the admittedly life-saving drug, globally. This is the Zen master's answer to calls for nationalization of IP: find a third way. Well-done, Merck. Well done.

2 comments:

Anonymous said...

I'm sure you are monitoring this:
http://www.fiercepharma.com/story/reuters-bayer-novartis-reckitt-eye-10b-12b-bids-merck-consumer-unit/2014-02-20

Condor said...

I am.

I do find it rather silly that the figure keeps rising -- to now a maybe $12 billion value?

That must mean the leaks are from Merck's side of the table -- not Reckitt's.

In my view -- at $12 billion, that is $6 billion. . . too high.

Or. . . double the fair price.

Even if we count lots of synergy value -- for Reckitt's (and for that buyer, there certainly should be a good chunk of synergy) -- I still only get to about $7.5 billion, as a fair price (taking 3X sales, and adding in $1.5 billion of savings value, or synergy value).

Your mileage may vary. In fact I'm sure it does.

Namaste -- do stop back!