Dr Reddy’s Lab shares gain on signing licencing agreement with Ingenus Pharma

Dr Reddy’s Laboratories Ltd shares gained on Thursday after the company announced that its step down wholly-owned subsidiary in the United States has entered into an agreement to commercialise Cyclophosphamide Injection RTD.

The pharmaceutical major’s step down wholly owned subsidiary, Dr Reddy’s USA, has signed a license agreement with a Delawar-based firm Ingenus Pharmaceuticals, obtaining the exclusive rights for commercialising Cyclophosphamide Injection RTD in the US market, the company informed the stock exchanges in a filing. The injection will be available in three doses of 500 mg/2.5mL, 1g/5mL, and 2g/10mL.

As per the details of the deal, 50% of the calculated profit share will be paid by Dr Reddy’s USA to Ingenus, while no other consideration will be payable.

The nondisclosure agreement (NDA) covering the product will be assigned to Dr. Reddy’s USA, and both the parties will enter into a commercial supply agreement pursuant to which Ingenus will supply the product to Dr. Reddy’s USA, the pharma giant stated in an exchange filing on June 12, 2024.

As per IQVIA MAT data for March 2024, the Ingenus product Cyclophosphamide Injection RTD has garnered annual sales of $51.8 million in the United States over the past 12 months.

Last week, the United States Food and Drug Administration (USFDA) issued a Form 483 with four observations to Dr Reddy’s Laboratories’ Active Pharmaceutical Ingredient (API) manufacturing unit in Andhra Pradesh.

The US health regulator conducted a Good Manufacturing Practices (GMP) inspection at the pharma giant’s API manufacturing unit (CTO-6) located in Srikakulam, Andhra Pradesh, from May 30 to June 7, following the completion of which, a Form 483 was issued to Dr Reddy’s Laboratories with 4 observations.

Shares of Dr Reddy’s Laboratories were trading 0.25% higher at ₹6,075 per piece on the NSE at 12:51 pm.