Panacea Biotec, India's highly progressive research based health management Company, has expanded its existing collaboration with Apotex Inc., the largest Canadian-owned pharmaceutical company, for sales & distribution of Prasugrel 5mg and 10mg tablets (generic version of Eli Lilly's Effient) in the USA.
The Company has signed an exclusive License and Supply Agreement with Apotex for this purpose. Under the terms of the agreement, Apotex shall be responsible for sales & distribution of the product in the USA and Panacea Biotec shall be responsible for manufacturing and supply.
Panacea Biotec has already received tentative approval from USFDAfor its Paragraph - IV first to file ANDA of Prasugrel Hydrochloride 5mg and 10 mg tablets. Under the provisions of the Hatch-Waxman Act, Panacea Biotec will be entitled to 180 days of shared marketing exclusivity for Prasugrel Hydrochloride upon USFDA approval.
Prasugrel is currently having annual sales of approximately $ 600 million in USA and is indicated for reduction of thrombotic cardiovascular events (including stent thrombosis) in people with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI).
Panacea Biotec and Apotex are also working on two drug delivery technology based, high barrier to entry anti-cancer generic products under their existing collaboration.
Speaking on the occasion Dr. Rajesh Jain, Joint Managing Director, Panacea Biotec Ltd said "We are excited to further strengthen the collaboration with Apotex by making Prasugrel as part of our existing relationship."
