Under the agreement, Nycomed Russia-CIS will market and distribute ZENPEP® (pancrelipase) Delayed-Release Capsules in Russia and CIS, as well as Georgia and Mongolia, subject to regulatory review and approval of the product in those territories. ZENPEP is an FDA-approved pancreatic enzyme product (PEP) indicated for the treatment of pancreatic insufficiency in patients with cystic fibrosis or other conditions, such as chronic pancreatitis, gastrointestinal surgery and pancreatic cancer. Eurand markets ZENPEP directly in the U.S. through its own sales force.
"This agreement represents an important development in our international marketing strategy for ZENPEP," said Andrew Thompson, Eurand's Vice President, Commercial Operations. "Nycomed is one of the fastest-growing pharmaceutical companies in Russia, and we are very confident of their ability to maximize the value of ZENPEP in that market. We look forward to working with Nycomed in pursuing regulatory approval for this product in the important Russia-CIS region."
"Nycomed is excited at the prospect of launching ZENPEP into the Russia-CIS market, where we are launching our recently established gastrointestinal product portfolio," said Jostein Davidson, Senior Vice President, Nycomed Group, and President, Nycomed Russia-CIS. "We believe ZENPEP, which has been specifically formulated to meet the FDA's stringent guidelines for PEPs, will offer physicians an important new treatment option for their patients with pancreatic insufficiency."
Russia-CIS is a significant market for PEPs, which is dominated by digestive disorders such as chronic pancreatitis. According to data provided by IMS Health Incorporated, the PEP market in this region was estimated to be approximately EUR 93.5 million ($130.5 million) in 2009.
Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies. Eurand has had six products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles and taste-masking/ orally disintegrating tablet (ODT) formulations. Eurand is a global company with facilities in the U.S. and Europe.
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.
Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy.
Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets. One of the leading branches of the Nycomed Group, Nycomed Russia-CIS, operates in more than 120 cities and regions of Russia and CIS.
Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2009 and an adjusted EBITDA of €1.1 billion.