BackNatco signs pact to make and sell hepatitis-C drug in 112 countries
Natco signed a pact with Medicines Patent Pool and Bristol-Myers Squibb to make and sell identical version of Daclatasvir, a drug used to treat hepatitis C
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Hyderabad: Drug maker Natco Pharma Ltd has signed a pact with Medicines Patent Pool and US-based pharma company Bristol-Myers Squibb Co. to make and sell identical or bioequivalent version of Daclatasvir Dihydrochloride (Daclatasvir), a drug used to treat chronic hepatitis C.
MPP is a United Nations (UN)-backed public health organisation that works towards increasing access for drugs that treat HIV, hepatitis C and tuberculosis by negotiating for public-health driven licences with patent holders.
“This agreement allows Natco to expand access to these chronic hepatitis C medicines in 112 developing countries," Natco said in a statement on Thursday. Natco will set its own price for the generic product it produces.
The company will market generic daclatasvir under its own brand NATDAC, and through its strategic partners in India, the company said.
Bristol-Myers Squibb and MPP signed a royalty-free licensing agreement in November allowing generic manufacturers to develop daclatasvir for 112 low- and middle-income countries.
As per the agreement, Bristol-Myers Squibb also helps generic manufacturers with technology and information needed for the manufacture and registration of the product.
MPP announced its first round of sub-licences for the generic production of daclatasvir with Indian drug makers, including Cipla Ltd, Emcure Pharmaceuticals Ltd, Hetero Drugs Ltd and Natco Pharma Ltd.
MPP said it is assessing applications from several other companies and expects to grant further sub-licences soon. The MPP licence allows generic manufacturers to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of hepatitis C (HCV).
Daclatasvir, in combination with sofosbuvir, for example, produces high cure rates after 12 weeks of treatment, with recent phase III studies demonstrating that the regimen could cure up to 100% of hepatitis C patients depending on genotype and stage of liver disease.
Hepatitis C is a major public health threat affecting up to 150 million people globally, with the vast majority living in low- and middle-income countries (LMICs). The World Health Organization (WHO) added several new hepatitis C treatments, including daclatasvir, to its Essential Medicines List, underscoring the urgent need to promote equitable access to innovative medicines.
Shares of Natco gained 3.97% and were trading at ₹ 527 at 12.50pm on the BSE, while the benchmark Sensex index declined 0.69% and was trading at 23,904.61 points.
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