Pharma major Cipla plans to name its hepatitis C
drug with Gilead Sciences as Hepcvir, its chairman Yusuf K Hamied on
Wednesday. Last year Gilead Sciences has licensed its hepatitis C drug
Sovaldi (chemically known as sofosbuvir) to seven India-based drugmakers
including Cipla which will sell the cheap generic versions of the drug
in 91 developing nations. Hepcvir is the brand name and we are working
on it. We will apply probably for regulatory approval in the next couple
of months and hopefully by middle of the year we will be in market for
India. We have the stocks of the raw materials, we are already started
making the raw materials. We have to put the stability data of active
pharmaceutical ingredients, stability data of the formulation, we have
to do bioequivalence of the originator product, so these takes around
six months and this is already in process," he said.
The Mumbai-based drug maker has signed a non-exclusive licensing
agreement with Gilead 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.
All companies have been allowed to set their own prices for the generic drug and will pay Gilead a royalty on their sales.
Read more...
Labels: Hepcvir (sofosbuvir), India