Controversial Hepatitis C Drug Patent Rejected by China-TBPIn June 2015, China rejected Gilead Sciences, Inc.’s patent application for a drug related to its controversial but highly curative hepatitis medication, Solvadi. China rejected the application for the sofosbuvir prodrug, although it had previously granted a patent to Gilead for the base compound in the drug, also identified by its generic name, sofosbuvir.

A prodrug is a precursor of a drug. It is inactive or partially inactive until it is metabolically converted within the body. The Initiative for Medicines, Access & Knowledge, a group of lawyers and scientists based in New York, opposed the patent application on the grounds that the drug is not a new invention; it is “old science” derived from a line of antiretroviral drugs. I-MAK and Natco Pharma Ltd. did the same in India when Gilead’s hepatitis C drug patent request was turned down in January. I-MAK also legally challenged Gilead’s patents or patent applications in Argentina, Brazil, Russia and Ukraine. Such challenges are hoped to enable the production of a much less expensive generic version of Solvadi.

Gilead, a California-based firm, has been criticized for its pricing of Solvadi at $1,000 a pill in the United States. The 12-week course of treatment costs $84,000, a prohibitive cost for rich and poor alike. Adding to the cost, Solvadi must also be used in combination with at least one other antiviral drug. Since December 2013, when sofosbuvir was first approved in the United States, Gilead was sufficiently pressured to lower the price, agreeing to do so in 2014 for 91 developing countries.

Hepatitis C is found around the world but is most prevalent in developing countries, especially Central and East Asia and North Africa. The World Health Organization (WHO) estimates that as many as 150 million people are infected with chronic hepatitis C. The influential organization recently added Sovaldi to its list of essential medicines and pressed for lower prices.

Solvaldi/sofosbuvir offers a far better treatment plan than drugs currently in use: a 12- to 24-week course of once-daily pills with few minor side effects and a superior rate of cure. The currently used drug, interferon, is administered by injection several times a week for at least six months with a number of major side effects, and most patients suffer a relapse requiring more treatment.

According to Doctor’s Without Borders’ Director of Policy and Analysis, Rohit Malpani, Gilead’s price should reflect the cost of research and development, but, instead, it reflects what it believes the market will bear. This is because, he adds, Gilead paid $11 billion to acquire Pharmasset, the original producer of the drug. Other countries have made agreements with Gilead for lower prices. Egypt, which has the highest prevalence of the disease, has a deal with Gilead to lower its price by 99% after rejecting Gilead’s bid for a patent. India has also been in talks with Gilead to reduce the price since 2014.

No vaccine exists to prevent hepatitis C. According to the WHO, 350,000 to 500,000 people die every year due to liver diseases resulting from hepatitis C. Without a much less expensive generic version of Solvadi, it is unlikely that this figure will change any time soon.

– Janet Quinn

Sources: BioPharmaDIVE, IRIN, Reuters 1, Reuters 2, World Health Organization,
Photo: Everyday Health

Gilead Sciences Inc., a drug company based in California, has licensed Sovaldi, its highly effective but expensive Hepatitis C drug, to seven Indian drug companies to distribute the drug to 91 developing countries at a much lower cost.

With approximately 180 million people suffering from Hepatitis C and nearly 350,000 dying each year in countries of low- and middle-income, the licensing will allow many of these people to receive treatment they most likely would not have been able to receive at the original cost.

The licensing agreement provides the Indian companies with direct access to Gilead’s manufacturing process so that production can be scaled up immediately and as quickly as possible.

Hepatitis C is typically transmitted through medical procedures, intravenous drug use or sexual intercourse, and it can remain undetected and unnoticed for a number years, eventually causing liver scarring and failure.

Chemically known as sofosbuvir, Sovaldi is radically more effective than previous injection regimens. Clinical trials showed a 90 percent cure rate after 12 weeks of treatment, a substantial increase over the 60 percent cure rate of previous treatments. Moreover, previous treatments had typically required taking numerous pills a day and antiviral injections, making the routine of Sovaldi, one pill a day, particularly appealing as well.

However, Gilead has received criticism regarding how extraordinarily expensive the drug is, costing $1,000 for one pill or $84,000 for a 12-week course in the United States. Its next-generation is expected to cost even more.

Gilead is planning to release its own brand of the drug in India for about $10 a pill or 1 percent of the cost in the United States. With India accounting for more than half of the world’s affected population, the cheap price is especially promising. In addition, Egypt, having the highest prevalence of Hepatitis C in the world, is also going to be provided with Sovaldi at $10 a pill by Gilead.

The seven Indian generic producers are allowed to set their own prices, and Gilead’s planned prices are expected to force the seven Indian companies to charge even lower prices to compete. They are also to pay royalties based on their sales to Gilead under the licensing agreement.

The licensing agreement also includes the next generation of Sovaldi, which is a combination of sofosbuvir and the experimental therapy ledipasvir, currently being tested by U.S. regulators.

In the U.S., officials have said Gilead’s drug could drain Medicaid budgets and increase private insurance premiums. In addition to the intense criticism the company has attracted domestically, Gilead’s licensing choices have attracted criticism due to their omission of middle-income countries that struggle to afford Sovaldi as well.

In more developed countries that were not included in the licensing agreements, such as China and Brazil, Gregg Alton, Gilead’s executive vice president, has stated Gilead will sell the drug at more than $10 a pill.

Regardless of the controversial nature of the Gilead’s licensing choices, the provision of a cheaper Hepatitis C drug to much of the world’s affect population is going to make a powerful impact and serve to help alleviate poverty around the world.

– William Ying

Sources: Gilead, Reuters, New York Times, Time, Wall Street Journal
Photo: Flickr