"Under this agreement, Cipla will get exclusive marketing rights for five years in India for critical limb ischemia due to atherosclerotic peripheral arterial disease (CLI-PAD) with Stempeutics manufacturing and supplying the product to Cipla," the company said in a statement.
"The Drugs Controller General (India) has granted limited approval for manufacturing & marketing of stem cell based biological product Stempeucel for the treatment of Buerger's Disease," Cipla, which has investments in Stempeutics, said in a statement.
An orphan designation allows a company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market.
Fearing that unscrupulous use may hijack this promising field, stakeholders are racing to regulate its applications. Are they swift enough?