Alembic Ltd, the Gujarat-based pharma major, has entered into a licensing agreement with the Belgium-based biopharmaceutical company, UCB Inc. for its Novel Drug Delivery Platform for the latter's Keppra XR, a levetiracetam extended release antiepileptic tablets.
Alembic would receive the milestone payments of USD 11 million and royalty on future worldwide net sales of Keppra XR subject to necessary legal and regulatory approvals. The company expects a boost in the turnover from around US $ 40 to 50 million with the royalty and milestone payments in future, according to Pranav Amin, Business Development head, Alembic.
The company expects to gain the first part of the milestone payment in the current fiscal, where as the total milestone payments would be delivered in a timeframe of three years depending on the development of the new delivery system.
The phase III clinical trials on Keppra XR, the once daily formulation of Keppra, are ongoing and results are expected in the fourth quarter of 2007. Keppra, which recorded sales of Euro 761 million (USD 1 billion) in 2006, is expected to meet patent expiry in 2009. The addition of new delivery system would extend the exclusivity of the drug to another approximately 10 years. With this, the new form of product may have exclusivity up to 5 or 6 years, subject to the patent expiry laws applicable.
"With this agreement, we are into the NDDS segment with our own strength. Few other systems are in advanced stages of development and are protected by suitable patents and will be shortly available for commercialization," Chirayu R Amin, chairman and managing director, Alembic told the press.
The development of Levetiracetam XR marks a milestone for the company's NDDS programme. The company is currently focussing on more developments in R&D and formulation segments, to win the regulated market. Alembic expects a US FDA inspection in its formulation facility, which would boost up its presence in US market. The company has filed three ANDAs in US till date and is expecting to complete 12-15 ANDA filings every year for the next three years. It has already filed 13 DMFs with US FDA, in which six were filed in FY 07. The company expects to file 8-12 DMFs in every year in the recent future.
Leveraging the opportunities including the growth in domestic market, exports to regulated market and the strength in R&D pipeline, the company, which recorded more than Rs 700 crore turnover in the last fiscal and is expecting to hit Rs 1000 crore turnover in FY 08, said Pranav Amin.
Headquartered in Brussels, UCB is focussing on securing a leading position in the severe disease categories. Employing more than 8,400 people in over 40 countries, UCB achieved revenue of 2.5 billion euro in 2006.