Strides To Acquire 18 Abbreviated New Drug Applications From Pharmaceutics International
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 for the U.S. 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 to acquire 18 ANDAs for the U.S. 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 $66 million.
Of the 18 products successfully developed by Pii with their Pharmaceutics know-how, 11 are currently approved by U.S. FDA 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 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 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 $6.1 million payable to Pii towards the transferred assets, of which $4 million is paid upfront and the remainder is payable on achievement of the agreed milestones, it said.
Shares of Strides Pharma Science were trading at Rs 496.15 a piece in the morning trade on BSE, up 0.51 percent from the previous close.