Mumbai: Cipla Ltd, Strides Arcolab Ltd, Mylan Laboratories Ltd and Emcure Pharmaceuticals Ltd are among six generic drug makers that are likely to sign licensing deals with Gilead Sciences Inc. to sell a low-cost version of its $1000-a-day Hepatitis C drug Sovaldi.
The licensing agreements, expected to be announced on Monday, will allow the generic drug companies to make and sell copies of the expensive pill for low- and middle-income countries at lower prices, according to three people familiar with the development.
By signing the licensing agreements with generic drug makers, Gilead is responding to criticism from governments and advocacy groups about the high pricing of the drug that has put it beyond the reach of most patients, particularly those in developing nations. The once-a-day pill used in combination with other antivirals is, however, the most effective therapy to counter Hepatitis C, which kills about 350,000 people a year globally. The drug’s steep price makes it nearly inaccessible to a majority of the 180 million patients diagnosed with the disease across the world.
Bloomberg first reported that Gilead is in talks with Cipla, India’s second largest drug maker by domestic market share, Mylan Inc. and Hetero Drugs Ltd to sign licensing agreements for a low-cost version of Sovaldi on 5 September.
The low-cost version will probably be sold in India at $2,000 for a three-month therapy, said one of the people cited above, requesting anonymity. Gilead will follow a tiered pricing system in other developing countries, the person said.
A Cipla spokesperson declined to comment on the development, while Strides, Mylan and Emcure did not respond to emails seeking comment. Gilead did not reply to an emailed query at the time of going to press.
Critics say the generic partnerships in India, through voluntary licensing deals, are an attempt by Gilead to ward off criticism by patient groups.
“These deals are very restrictive in nature and typically the companies will not disclose the details of the terms and conditions," said a person associated with a global patient access group who did not want to be identified due to a conflict of interest with his company.
Gilead, which already holds the patent for this drug in the US and many other developed markets, has applied for a patent in India, too. However, the patent claim has been opposed by three parties—the Indian Pharmaceutical Alliance (IPA), global patient access group I-Mak, and an Indian generic company.
“We have opposed the Gilead patent for the new Hepatitis drug in India as it is violative of Section 3(d) of the country’s patent Act," said IPA secretary general D.G. Shah.
Section 3(d) of India’s Patent Act denies patent rights for drugs that are merely modified versions of previously known molecules or substances, and are less inventive in nature.
According to an 8 September Wall Street Journal (WSJ) report citing Gregg Alton, Gilead’s executive vice-president for corporate and medical affairs, the US company is already negotiating with several countries to supply the drug at lower prices.
“Gilead charges less for Sovaldi in developing countries, for example, $1,800 for a typical course of treatment in Egypt," the WSJ report said.
A large number of not-for-profit organizations and patient access groups, including Médecins Sans Frontières and I-Mak, had in an August letter to Cipla requested it not to sign any voluntary deals with Gilead for making Sovaldi (sofosbuvir) under restrictive terms and conditions.