U.S.-based drug firm Gilead Sciences (GILD, Financial) has been a pioneer in the introduction of drugs like Sovaldi and Harvoni for the treatment of hepatitis C-infected patients in the developed countries. Currently, the drug giant is focusing on extending the drug regime to the developing countries which account for more than half of the global population of hepatitis C virus-infected patients. In the venture to extend its helping hand to the needy lot in the developing countries, Gilead has taken some concrete steps which have been discussed in length in the upcoming sections. Let’s quickly dig in to find out what Gilead in planning for India and the other developing countries, in its endeavor to serve the hepatitis C infected community worldwide.
The driving force for serving developing countries
Way back in September 2014, Gilead had announced its partnership with eight Indian firms for manufacturing generic versions of the HCV medicine – Biocon (BIOCON, Financial) Limited, Cadila Healthcare (CADILAHC, Financial), Cipla, Hetero Labs, Mylan Laboratories (MYL, Financial), Ranbaxy Laboratories (RBXD, Financial), Sequent Scientific Limited and Strides Arcolab Limited.
However, soon thereafter the biopharmaceutical major sensed the huge market demand for its hepatitis C drugs in the 91 developing countries across the globe. For serving such patients better, in January 2015 Gilead Sciences announced the expansion of its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is presently under Phase III clinical trials and can be used for treatment of all six genotypes of hepatitis C.
Under this expansion program, once the regulatory authorities approve such a move, the eight India-based pharmaceutical firms holding the exclusive licensing agreement can not only manufacture the generic version of Sovaldi for distribution in India and other developing countries, but can also manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS-5816. Since the sofosbuvir/GS-5816 combination in the form of all-oral single regimen tablet could be used for treatment of all six genotypes of the HCV virus, it would possibly become the best therapeutic option available for HCV treatment in most of the developing countries where genotype testing is either unavailable or is unreliable.
During the press release, Gregg H. Alton, executive vice president, Corporate and Medical Affairs, Gilead Sciences, stated, “Today’s announcement marks an important milestone in Gilead’s effort to make effective hepatitis C treatment accessible to as many patients, in as many places, as quickly as possible… Developing countries are home to a diverse mix of hepatitis C genotypes, and the development of a medicine that has the potential to cure any patient, regardless of genotype, could help accelerate access to treatment.”
Exclusive distribution agreement signed for serving the Indian masses
Besides focusing on Indian partnerships for manufacturing generic variants of the U.S. patented drugs for the developing countries, Gilead has also shown special interest in serving the Indian hepatitis C market which presently has a count of 12 million infected HCV patients.
On February 23, Gilead Sciences and Mylan Pharmaceuticals Private Limited (the Indian subsidiary of U.S.-based Mylan Labs) signed a deal which offers the latter exclusive rights for distribution of Sovaldi and Harvoni in India. News sources have also confirmed that the Indian subsidiary of Mylan Labs would probably begin marketing the branded medications from the second quarter of this fiscal year.
In fact, it is notable that Sovaldi’s approval in the Asian continent was first in India where regulatory authorities were prompt to approve the distribution of the life-saving drug in January 2015.
Concluding note
With hepatitis C becoming a growing concern in developing countries where generic drug versions are more welcome than patents because of the affordability factor, Gilead’s moves seem to be a blessing for the millions of HCV patients requiring access to high-quality, effective and affordable medicines for their treatment. Let’s stay tuned and watch how Gilead gradually carves its niche, going forward, in the HCV market of such developing countries.
