Recordati's original drug for U.S. market
An agreement with Forest Laboratories for the marketing of Lercanidipine (Zanidip®) in the U.S.
Milan and New York, November 8, 2000
Recordati (Reuters RECI.MI, RECIr.MI, Bloomberg's REC IM, RECNC IM) and Forest Laboratories, Inc. (NYSE: FRX) announced they have entered into a license agreement for the registration and marketing in the U.S. of lercanidipine, a calcium channel blocker discovered and developed by Recordati for the treatment of patients with hypertension.
Hypertension is a very common condition affecting over 50 million people in the U.S. The U.S. market for antihypertensive drugs exceeds $10 billion in sales annually and is one of the largest U.S. pharmaceutical markets. Lercanidipine belongs to one of the most widely used class of antihypertensives.
Lercanidipine, approved in 26 countries, is currently marketed by Recordati and its licensees in 19, among which are Germany, Italy, the Netherlands, Spain, Sweden and the United Kingdom. It will be launched in France in the first quarter of 2001.
Recordati and Forest will collaborate in preparing the filing which is planned to be submitted to the FDA (Food and Drug Administration) in mid 2001 to seek U.S. marketing approval.
"The US pharmaceutical market represents about 40% of the world market" - said Giovanni Recordati, Chairman and Chief Executive Officer - "Access to the U.S. market, once a marketing approval is obtained, is a great opportunity for our company both in terms of sales and profitability. Moreover, the agreement is a further recognition of the value of Recordati research, and proves that companies of our size are capable of developing global pharmaceutical products. We look forward to working with Forest Laboratories, a committed and capable partner with a long record of successful market introductions."
Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "The acquisition of marketing rights to lercanidipine will allow Forest to build upon its already established presence in the cardiovascular market. We believe that our collaboration with Recordati has many of the elements that have made our agreements with our other European partners so successful."
Recordati, established in l926, is a European pharmaceutical group, quoted on the Milan Stock Exchange, dedicated to the research, development, manufacturing and marketing of pharmaceuticals and pharmaceutical chemicals, with headquarters in Milan, Italy and operating subsidiaries in France, Portugal, Spain, Switzerland and the United States.
Statements contained in this release, other than historical facts, are "forward-looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company's control. Hence, actual results may differ materially from those expressed or implied by such forward-looking statements. |