Dr. Reddy’s Laboratories (DRL) on Friday said it had acquired trademark rights of breast cancer drug Primcyv from Pfizer Products India.
DRL has been already marketing the drug, containing the active constituent palbociclib under the Primcyv brand, in the country since May 2022. With acquisition of the rights, the active pharmaceutical ingredient (API) and finished drug will be manufactured at its U.S. Food and Drug Administration approved facilities. The in-house product will be retailed in the domestic market at a reduction of 85% from the current MRP, thus increasing affordability and access to palbociclib, Dr. Reddy’s said.
Dr. Reddy’s said it was among select companies in the world to have conducted a bioequivalence study and received tentative approval from the U.S. FDA for palbociclib. The drug is first-in-class CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of adult patients with HR+, HER2- metastatic breast cancer, the company said.