Strides Pharma arm inks pact with Pharmaceutics International to acquire 18 ANDA

"Strides...announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has entered into a definitive asset transfer and licensing agreement with Pharmaceutics International, Inc (Pii) to acquire 18 ANDAs for the US market," the company said in a filing to BSE.

New Delhi: Strides Pharma Science Ltd on Friday said its arm has entered into a pact with Pharmaceutics International, Inc to acquire 18 abbreviated new drug applications (ANDAs) for the US market.

"Strides...announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has entered into a definitive asset transfer and licensing agreement with Pharmaceutics International, Inc (Pii) to acquire 18 ANDAs for the US market," the company said in a filing to BSE.

With access to these products, Strides will significantly expand its niche offerings on its front-end, which has grown multi-fold to attain a quarterly revenue size of USD 66 million.

Of the 18 products successfully developed by Pii with their Pharmaceutics know-how, 11 are currently approved by USFDA while the remaining seven products are submitted and are under different stages of review with the agency, it said.

In addition, Strides will also have exclusive marketing rights for Levothyroxine Sodium Tablets, a narrow niche microdose product indicated as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism with a market opportunity of USD 2.5 billion.

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"Pii has developed the product for submission as ANDA and has completed the bioequivalence studies for four reference listed drugs - Synthroid, Unithroid, Levoxy and Thyro - tabs covering the entire addressable market opportunity," it said.

The total aggregate consideration of USD 6.1 million payable to Pii towards the transferred assets, of which USD four million is paid upfront and the remainder is payable on achievement of the agreed milestones, it said.

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