For those who follow the pharma industry, another blockbuster drug has burst.  As was reported in FiercePharmaMarketing last week, Gilead Sciences, Inc., California-based maker of antiviral meds, sold $140 million of its new oral hepatitis C drug, Sovaldi (sofosbuvir), in its first month, and industry analysts who once predicted $3 billion are now talking about $5 billion or even $7 billion for this year’s sales (FPM article).  It is expensive with a list price of $84,000 per 12-week treatment course, but it works much better than the standard therapy, a combination of interferon and ribavirin that has debilitating side effects, has cure rates of 60-90% depending on the viral genotype being treated (Gilead press release in FierceBiotech), and is less expensive than a liver transplant and immune suppression (upwards of $300,000).  Sovaldi will have competition soon that may put payers in a better position to negotiate its price.  Bristol-Myers-Squibb’s daclatasvir, which has launched in Europe, is pending US approval as is a three-drug combination pill from AbbiVie.  Gilead has also been working on its own combo drug (sofosbuvir and another antiviral) and has recently submitted it for FDA approval; it that has cure rates of up to 96% (FierceBiotech article).

Of course, hepatitis C infection, which spreads by blood contact such though injected drugs, sex, or transfusions, is a global disease.  Around the world about 170 million people are infected (including 3.2 million in the US and 12 million in India), and 60-80% of these will advance to chronic and debilitating disease.  Nearly 350,000 people die of the results of chronic infection annually.  For sound business reasons, Gilead is in discussions with several Indian pharmaceutical about licensing sofosbuvir to them for manufacture as a generic drug.  As was reported in the Hindu Business Line in an interview with Gregg Alton, Gilead’s EVP for Corporate and Medical Affairs (HBL article), the proposed licenses will permit sale in about 60 low and middle-income countries and include an unspecified royalty on sales to Gilead.  Gilead will secure Indian approval of sofosbuvir and is currently setting up Phase III trials in India.  It also plans to sell its Sovaldi in India for about $2,000 per treatment course (the current standard therapy with existing generic products costs $2,500).  If this strategy of nonexclusive licensing and allowing the generic manufacturers to compete and the market to determine the lowest price sounds familiar, it is because Gilead used it before to increase access to its anti-HIV drugs in low- and mid-income countries (see my post, “Victory!”).  In its HIV licensing program, Gilead also transferred manufacturing technology and provided funding to assist with decreasing licensees’ manufacturing costs (Gilead press release); it will be interesting to see if similar terms are given to sofosbuvir licensees.

For not really sound reasons, two “advocacy” groups, Initiative for Medicines, Access & Knowledge (IMAK) and Médecins Sans Frontières (MSF), are sniping at Gilead due to the drug.  The Delaware-based IMAK has filed an opposition in India to Gilead’s sofosbuvir patent application late last year.  According to a report in FiercePharma, IMAK, backed by MSF, are contesting the granting of a patent because Indian patients will need access to the breakthrough drug, especially the many co-infected with hepatitis C and HIV (true), and, to be affordable, the price on Sovaldi would have to be less than $500 (why not free?) (FiercePharma article).

At the IMAK website, I learned the group is in favor of patents on “true innovation” and argues its cases on legal grounds and not on the issue of equity or pricing (which are not relevant in a patent case):  “We don’t argue on grounds of health or equity, and don’t mention how companies are pricing the drugs out of reach for patients. We stick to the science and the evidence, since these are technical determinations” (IMAK FAQs).  The group is funded by contributions from individuals and the Columbia Public Interest Law Foundation and provides a list its cases and its filings (IMAK Cases).  I read through the filing for the sofosbuvir opposition and the most substantial argument seems to be that Gllead (or actually the company Gilead had acquired, Pharmasset) had filed an earlier patent in India that claimed a molecule with  the same (similar?) structure as sofosbuvir and the pending application did not cite the earlier application.  I’m not a patent attorney (thankfully) but I don’t see much merit in this case since both applications have a common owner.  Regardless, if IMAK succeeds in denying Gilead a patent, more than the several manufacturers with whom Gilead is negotiating licenses may choose to make the drug and its price may be lower than that achieved through competition among Gilead’s licensees.  But this will require some company other than Gilead to complete clinical trials and secure registration, work likely costing billions of rupees.

It seems to me that the interests of the hepatitis patients in India would be better served if IMAK and MSF stopped shooting at Gilead and instead advocated for swift approval of sofosbuvir and Gilead’s licensing program.  The Indian pharmaceutical industry makes a good percentage of the world’s generic drugs (e.g., 40% of the US supply) but has problems meeting quality standards, and India’s regulatory system needs improvement.  According to an article on the USFDA commissioner’s recent meeting with her Indian counterparts (NY Times article), 12 to 20% of India’s domestic drugs may be inactive by accident or intention, and the main regulatory agency, the Central Drugs Standard Control Organization, needs help.  It has a staff of 323 (the USFDA staff is about 16,000), and its authority is limited to new drugs:  four years after launch, a drug’s manufacture is overseen by state health departments, “many of which are corrupt or lack the expertise to oversee a sophisticated industry,” according to the NYT.  Perhaps, IMAK should file a suit opposing the government’s failure to enforce drug safety and quality laws.

Fortunately, IMAK’s suit is not likely to deter Gilead from the non-exclusive licensing of generic sofosbuvir manufacture to get the drug to non-US, rest-of-the-world patients.  The company has been successful in inventing and acquiring new and better antiviral drugs (true innovation) and getting them tested, approved, manufactured, and distributed globally, making a real impact on the lives of millions.



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