• Agreement with UN-backed group provides wider access to drug
  • Daklinza approved in Europe for most common hepatitis subtypes

Bristol-Myers Squibb Co. has signed a broad agreement with Medicines Patent Pool, allowing the United Nations-backed organization to distribute licenses for generic-drug companies to copy its hepatitis C treatment in more than 100 developing and middle-income nations.

The agreement allows the generics makers to produce copies of the drug Daklinza, known chemically as daclatasvir, without paying any royalties, Medicines Patent Pool said in a statement Monday. The liver ailment is a new treatment area for the organization, which has helped developing nations gain access to HIV medicines.

Almost two-thirds of all patients living with hepatitis C reside in the countries included in the pact, giving residents access to treatments at reduced costs. The expense of hepatitis C drugs in the U.S. has garnered criticism by insurers and politicians, and the IMS Institute for Healthcare Informatics estimates that the treatments will cost $48 billion by 2020, out of a $1.4 trillion global pharmaceuticals bill.

About 130 million to 150 million people worldwide are infected with hepatitis C, and 500,000 die each year, according to the World Health Organization.

Drugmakers in India have been wanting to make cocktails combining the Bristol Myers medicine with Gilead Sciences Inc.’s Sovaldi. That combination pill would be impossible in western nations due to patent protections. Gilead last year licensed 11 generic drugmakers including Hetero Labs Ltd., Cipla Ltd. and Aurobindo Pharma Ltd. to make and sell generic version of the Gilead drug, known chemically as sofosbuvir, in 101 developing countries. Those agreements also allow the development of combination medicines with other companies’ drugs, Gilead said in October.

Bristol-Myers has dialed back its virology program after Gilead and AbbVie Inc. came to dominate the Western market with their treatments. The New York-based drugmaker has treated more than 50,000 Japanese patients with a combination of daclatasvir and another drug called asunaprevir, and is seeking to build a market in China, according to spokesman Robert Perry.

“The MPP royalty-free agreement is one key element of Bristol-Myers Squibb’s broad plan to support global access to Daklinza,” Perry said in an e-mail. “There were a number of factors that we considered when determining which countries to include in the licensing territory, including economic development, burden of disease and government health systems’ resources for addressing treatment and care.”

The European Commission in August last year approved Daklinza for use in combination therapy across subtypes of the virus 1, 2, 3 and 4, which together account for 94 percent of the world’s hepatitis C cases -- meaning that a combined regimen could be effective in a wide swath of patients.

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