According to a regulatory filing, pharma giant Dr. Reddy’s Laboratories, announced has acquired the trademark rights of the breast cancer drug PRIMCYV from Pfizer Products India Pvt Ltd for use in the Indian market.
PRIMCYV is a targeted therapy containing the active constituent palbociclib, a 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.
Since May 2022, Dr. Reddy’s has been marketing the drug in collaboration with Pfizer Products India Pvt Ltd under the brand name PRIMCYV® in India. The drug comes in the form of hard capsules in strengths of 75 mg, 100 mg and 125 mg.
Following the trademark rights acquisition, Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient (API) and finished drug at its state-of-the-art facilities approved by the United States Food and Drug Administration (USFDA). Dr. Reddy’s is amongst select companies in the world to have conducted a bioequivalence study and received tentative approval from the USFDA for palbociclib.
The in-house product will be retailed in the Indian market at a reduction of 85% from the current MRP to increase affordability and access to palbociclib. Dr. Reddy’s plans to roll out a unique Patient Assistance Programme to support long-term therapy of the patients on PRIMCYV.
