Strides Pharma Global Pte. Ltd, Singapore, a wholly-owned subsidiary of Strides Pharma Science Ltd, has entered into a definitive asset transfer and licensing agreement with Pharmaceutics International Inc (Pii) to acquire 18 Abbreviated New Drug Application (ANDA) for the US market.

The total aggregate consideration of $6.1 million is payable to Pii towards the transferred assets, of which $4 million was paid upfront and the remainder on achievement of set milestones.

With access to these products, Strides will significantly expand its niche offerings on its front-end, which has grown multi-folds to attain a quarterly revenue size of $66 million. Of the 18 products successfully developed by Pii, 11 are currently approved by USFDA while the remaining seven products are submitted and are under different stages of review, the company said in a statement.

Out of the 11 approved ANDAs, Strides is currently commercializing two ANDAs with product supply from Pii, while the remaining approved ANDAs will be transferred to Strides’ global manufacturing facilities and commercialised over the next 18-24 months.

In addition, Strides will also have exclusive marketing rights for Levothyroxine Sodium Tablets, a narrow-niche micro dose product indicated as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism with a market opportunity of $2.5 billion. Pii has developed the products for submission as ANDAs and has completed the bioequivalence studies for four reference listed drugs, it said.

 

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