Strides to acquire 18 abbreviated new drug applications from Pharmaceutics International

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

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

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 US 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 microdose 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.