Under the agreement, Glenmark will be responsible for preclinical development, will manage the clinical trials and manufacture the products; Glenmark will be responsible for filing the abbreviated new drug applications (ANDAs) and, upon approval, marketing the products in the US.
In return for an investment of up to $27 million, Paul Royalty will receive undisclosed royalties on net sales following FDA approval, and launch of each product. The products in the portfolio currently have a total US market revenue of about $1 billion.
Clinical trials for two of the products in the portfolio have already been initiated and ANDA filings will commence from the end of 2006 and continue over the next two years. All 16 products are expected to be launched over the next five years, with the first product launch occurring in 2007.
“This deal marks many firsts including the first time an Indian company is entering the US market with an entire portfolio of dermatology products, a unique deal structure and the first risk-sharing financing deal of its kind,” noted Glenn Saldanha, managing director and CEO of Glenmark Pharmaceuticals.
Glenmark’s previous efforts to accelerate its portfolio build-up have involved in-licensing generics from US-based manufacturers, collaboration agreements for joint development with other companies and acquisition of ANDAs.