Mumbai: Cipla Ltd , which competed with multinational drug firms by cutting HIV treatment cost to a fraction of the prevailing rate, is hoping to make a similar impact with a new four-drug combination to treat HIV/AIDS in infants and children.
The drug is in the advanced stage of development.
The Indian firm led by Y.K. Hamied, which will own the intellectual property rights of the first-line antiretroviral (ARV) combination therapy, plans to put the technology in a free access patent pool, two company executives said, requesting anonymity.
“This will not only make the drugs free from an otherwise monopolistic regime but also help other companies to access the technology to come into the market,” one of them said.
The first such open access platform for HIV/AIDS treatment was created in 2010 with the creation of Medicines Patent Pool (MPP), an organization backed by the United Nations that offered a public health-driven business model to lower the prices of HIV medicines. MPP also facilitates the development of better-adapted HIV medicines in developing countries.
Drug makers, including ViiV Healthcare, a joint venture owned by GlaxoSmithKline Plc., Pfizer Inc. and Shionogi Inc., and US drug makers Bristol-Myers Squibb Co. and Gilead Sciences have signed partnerships in this initiative with MPP. Certain HIV drugs developed by these firms are licensed to MPP to be manufactured in selected global markets.
“It is too early to say the route that Cipla will choose to make this technology, which is path-breaking, into the open access pool and for how many markets,” said the first executive cited earlier.
Cipla had in 2012 announced a new collaboration with the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development organization working to deliver new treatments for neglected diseases, to develop and produce an improved first-line ARV combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV/AIDS.
Once delivered, this new paediatric ARV combination could help accelerate the provision of care to the world’s youngest children living with HIV/AIDS, who are at very high risk of dying without treatment.
With the four-in-one combination, the firm is trying to develop a combination of ARV drugs such as Abacavir, Lamivudine, Lopinavir and Ritonavir into a formulation that is best suited to children under 15 years of age.
“This is going to be something very novel in the world and the major research project in this direction at present globally, as the delivery method, taste and easy-to-use elements are very critical in case of children’s therapy,” Cipla’s chief medical officer Jaideep A. Gogtay said.
“The product is under development and progressing, though we don’t have a time frame for the completion as yet,” said Gogtay, who declined to share details about the intellectual property ownership and future plans of the company in this regard.
An estimated 3.4 million children have HIV/AIDS, but less than a quarter have access to antiretroviral therapy, compared with 54% adults, according to a 2012 data by DNDi.
According to Cipla, the current therapeutic options for HIV-positive infants and young children are insufficient in certain key circumstances. For example, ARV brands such as Triomune Baby and Triomune Junior produced by Cipla in 2007, which are used in much of Africa, are not optimal for the younger children who have very high levels of virus in their blood and have already been exposed to some of these drugs from their mother.
Research to develop better treatment options for infants and children has been slow because the drugs can be tested in children only when they are proven to be safe and effective with adults, Gogtay said.