Natco Pips Rivals To Launch Sovaldi Generics In Nepal

In a stunning move, last week Indian drug maker Natco launched generic copies of hepatitis C treatment Sovaldi in Nepal. The rollout signals a launch exercise in several other markets and may lead to an aggressive pricing battle between multiple Indian drug makers that signed licensing deals with Gilead.

MUMBAI – Hyderabad-based Natco Pharma Ltd. has launched generic versions of Gilead Sciences Inc.’s hepatitis C treatment Sovaldi (sofosbuvir) in Nepal, becoming the first of a slew of Indian companies that licensed the product under a royalty-based extensive deal struck with the originator last year to reach the market.

Natco has named its generic brand Hepcinat but its price could not be immediately ascertained.

Sources in the industry said the first Nepal launch was on March 2 and was part of the agreement with Gilead that entitles exports to as many as 90 countries. In a March 9 notification to the Bombay stock Exchange, Natco said it will price its drug at INR 19900 for a bottle of 28 tablets in Nepal (about $317). In the U.S., Sovaldi was launched with an wholesale acquisition price of $28,000 for 28 400 mg tablets, a four-week supply; treatment regimens in labeling are 12, 24 or 48 weeks, depending on patient genotype and medical condition (Also see "FDA Approval Of Gilead’s Sofosbuvir Shows Flexibility On HCV Combos" - Pink Sheet, 6 Dec, 2013.).

The Dark Horse

Notably Natco was the last of the pack of at least nine Indian companies that included big names like Ranbaxy Laboratories Ltd., Biocon Ltd. and Cipla Ltd. to have entered into a deal with Gilead, but has been perhaps the most efficient in developing the product and beating its peers vying for a share of the HCV sector. India itself is seen as a huge market for the debilitating liver disease that experts say goes largely undiagnosed.

Experts said Natco’s swift launch in Nepal and preparedness ahead of its local rivals may be understood from the fact that it was the only Indian company to have challenged Gilead’s Sovaldi patent in India. “The company may have conducted stability tests and taken all the necessary steps to launch in case it emerged as a winner in the drawn out patent battle,” one patent expert noted.

It was not immediately known if Natco will continue to pursue the patent opposition case in India but experts believed that the case will become redundant with the two opponents agreeing to a licensing deal. I-MAK or Initiative for Medicines Access and Knowledge, a non-profit group has challenged the Sovaldi patent in India (Also see "Patient Groups Raise Ante Against Gilead’s India Deals" - Scrip, 29 Jan, 2015.).

Earlier this year, Gilead lost an Indian patent claim on the drug but vowed to defend its position, deciding to appeal at the Delhi High Court (Also see "Can Gilead Win In India Where Novartis Failed?" - Scrip, 22 Jan, 2015.).

The race for the launch of Sovaldi generics in India is picking up pace. Natco, Cipla and Mylan Pharmaceuticals Inc. are said to be neck-and-neck in their efforts to secure approvals from the Indian regulatory agencies (Also see "Sovaldi Deal Tames Hardliners But India’s Sec 3(d) Lingers On" - Scrip, 18 Sep, 2014.). Natco said it hopes to launch Hepcinat in India soon, subject to approval from the Drugs Controller General of India.

The first approval for a sofosbuvir tablet was granted by the DCGI on Jan. 13, which market experts believe is for Gilead’s original product Sovaldi. The drug is listed to be given, “in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.”

Market experts believe the price of the generic drug may see a gradual downward spiral as firms move in to capture gains as part of the initial push.

Sources also said Mylan, which will be exclusively selling Sovaldi in India on behalf of Gilead, is streamlining a few last mile infrastructure-related issues, while Cipla recently told media representatives that it will be launching the product in India under the brand name HepCvir.

Interestingly, Natco is not the first company in the world to launch a generic of Sovaldi. PharmAsia News’ affiliated publication Scrip Intelligence reported Feb. 23 that Incepta Pharmaceuticals of Bangladesh locally launched the generic product under the brand name of Hopetavir 400 mg, although not under any collaboration with Gilead.

[Editor's note: This story was contributed by PharmAsia News, which provides close coverage and in-depth analysis of Asia business and regulatory developments.]