Companies claim merger will broaden geographic reach, pipeline, and manufacturing capabilities.

Axcan will buy specialty pharmaceuticals firm Eurand for about $583 million. The $12 per share transaction is expected to close during the second quarter of 2011.

Eurand is focused on the research, development, and U.S. commercialization of products for use in the treatment of cystic fibrosis and gastrointestinal-related diseases. The firm is exploiting its specialist platforms for formulating products with enhanced efficacy, safety, and convenient dosing.

Eurand has an FDA-approved therapeutic product on the market and is developing a pipeline of candidates both in house and through collaboration with partners. The firm’s flagship pancreatic enzyme product (PEP), Zenpep® (pancrelipase) delayed-release capsules, is approved in the U.S. for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis. Zenpep has been clinically studied in patients as young as one year. Eurand separately introduced an authorized generic product, Pancrelipase™ delayed-release capsules, in the U.S. in December 2009.

Eurand’s subsidiary, SourceCF, develops and markets multivitamin products specifically for use by adult and pediatric/infant patients with cystic fibrosis.

“Through combining the organizations, we look to create a new organization with an enhanced product portfolio, broader geographic reach, a robust research and development pipeline, innovative pharmaceutical development and manufacturing platforms, and a world-class sales force,” states Frank Verwiel, M.D., Axcan president and CEO.

Eurand’s pipeline products include an AB-rated generic formulation of the long-acting propanolol drug Inderal LA, which has been developed using Eurand’s Diffucaps® drug-release technology. The drug is in development in partnership with GlaxoSmithKline, and an ANDA is currently under FDA review. Eurand is separately developing a Diffucaps-formulated once-daily ondansetron product for the treatment of nausea and vomiting, which is undergoing Phase III evaluation. Meanwhile, the firm is looking for partners to market Zenpep in non-U.S. markets. The firm, in addition, has a portfolio of Rx and OTC products available for licensing.

Historically Eurand has manufactured and supplied a coated PEP, Ultrase® MT, for marketing by Axcan Pharma, in return for manufacturing revenues and sales royalties. However, the PEP market became complicated earlier this year, when in late March FDA confirmed that all marketed PEPs were required to have gained regulatory approval by April 28, 2010. Axcan consequently had to stop distributing Ultrase-MT as the drug did not achieve authorization in the U.S. by the cut-off date. Moreover, as recently as August the firm stated it could not provide any guidance as to when the NDA for Ultrase-MT might be approved Eurand notes.

Eurand recently reported what it called record revenues of €41.7 million ($56.7 million) for the third quarter of 2010, an increase of 33% in constant currency on revenues during third quarter of 2009. Product sales were up 47% at constant currency rates to €37.9 million ($51.6 million), primarily due to sales of Zenpep and its authorized generic, which reached €21.8 million ($29.7 million).

The firm has a personnel base of over 600, and operates integrated manufacturing and R&D facilities in the U.S. and Europe. It says data from IMS Health suggest PEPs generated approximately $1.3 billion in worldwide sales and approximately $403 million in U.S. sales during 2009.

Axcan develops and markets a wide range of products to treat gastrointestinal diseases and disorders, including inflammatory bowel disease, cholestatic liver diseases, irritable bowel syndrome, and complications related to pancreatic insufficiency. Currently, the company markets more than 40 products and dosage strengths worldwide in the field of gastroenterology. The firm is focused heavily on the North American gastroenterology market, which is responsible for just under 85% of the company’s overall sales business.

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