India, Mumbai, 15th September 2014: Cipla Limited, a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients today announced that it has signed a non-exclusive licensing agreement with Gilead Sciences, Inc. for manufacturing and distribution of Sofosbuvir mono, Ledipasvir mono, the fixed-dose combination of Ledipasvir/Sofosbuvir with each other and the combination of Sofosbuvir or Ledipasvir with other active substances, for the treatment of hepatitis C.
Under this licensing agreement, Cipla will be allowed to manufacture and market Sofosbuvir, Ledipasvir in 91 countries including its home markets India and South Africa under Cipla's own brand names. It also covers countries like Egypt which has a high incidence of Hepatitis C. The countries within the agreement account for more than 100 million people living with hepatitis C globally representing 54% of the total global infected population. As per the agreement, Cipla has the option of receiving a technology transfer of the manufacturing process from Gilead.
Mr. Subhanu Saxena, MD & Global CEO, Cipla Limited said, "We want to ensure that all patients, particularly those in developing countries, get access to the most innovative, breakthrough medicines available. This partnership with Gilead emphasizes our ongoingcommitment to provide access to medicines for patients when they need it. The prevalence of Hepatitis C is widely spread across the world and there is a need for Cipla to step in and provide broader access to medicines like Sofosbuvir, Ledipasvir. We look forward to manufacturing the drug in India and offer the drug to patients at a competitive price."
According to World Health Organization (WHO), 130-150 million people globally have Hepatitis C infection. In India alone, it is estimated that 10-20 million patients are infected with Hepatitis C which is several fold greater than those with HIV/AIDS. A significant proportion of the patients who are chronically infected develop liver cirrhosis and liver cancer. Sofosbuvir is a new antiviral drug which in combination therapy has shown to have higher cure rates. It represents a breakthrough in the treatment of hepatitis C.
Sofosbuvir was approved by the U.S. Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014. Sofosbuvir, in combination with other agents, offers a cure with a short-term course of treatment with few side effects and without the need for injections.
Earlier this year, Cipla licensed Raltegravir from MSD and there are already several patients on treatment who earlier would not have had access to third line therapy for HIV/AIDS. Cipla will continue to ensure access to medicines for patients suffering from infectious diseases across the world.
About Cipla LimitedCipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For more than 70 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 170 countries. Our portfolio includes 2000 products in 65 therapeutic categories with one quality standard globally. Cipla's turnover in 2013-14 was 1.7 billion USD.
Whilst delivering a long-term sustainable business, Cipla recognises its duty to provide affordable medicines. Cipla's emphasis on access for patients was recognized globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination antiretroviral (ARV) in Africa at less than one dollar a day and thereby treating many millions of patients since 2001.
Cipla's research and development focuses on developing innovative products and drug delivery systems and has given India and the world many 'firsts' for instance Triomune. In a tightly regulated environment, the company's manufacturing facilities have approvals from all the main regulators including US FDA, UK MHRA, WHO, MCC, ANVISA, and PMDA which means the company provides one universal standard both domestically and internationally.
Charlotte Chunawala Jaisingh Balakrishnan
Corporate Communications Corporate Communications
Mobile: +91 7506257377 Mobile: +91 9833836185
Except for the historical information contained herein, statements in this release and the subsequent discussions may constitute "forward-looking statements". These forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to our ability to successfully implement our strategy, our growth and expansion plans, our ability to obtain regulatory approvals, technological changes, cash flow projections, our exposure to market risks as well as other risks. Cipla Limited does not undertake any obligation to update forward-looking statements to reflect events or circumstancesafter the date thereof.