Axcan updates product pipeline, sees third-quarter revenues rise 29%

By Lisa Kerner

Charlotte, N.C., Aug. 10 - Axcan Pharma Inc. provided an update on its major products in the company's drug pipeline in conjunction with the release of its third-quarter earnings on Thursday.

Axcan said it filed an amendment to its New Drug Application for Helizide for eradication of Helicobacter pylori and expects to launch the product in North America during the first half of 2007.

Phase 3 studies to confirm the efficacy and safety of a new mesalamine rectal gel (Salofalk) in the treatment of distal ulcerative colitis are complete. With no clinical difference found between the gel and the enema formulations, and manufacturing issues, Axcan will not seek regulatory approval in the territories for which rights were acquired. Instead, the company said it will reallocate resources to ongoing development of better alternative formulations of mesalamine products.

Axcan and its partner, NicOx SA, are developing NCX-1000, a patented, nitric oxide-donating derivative of ursodiol, for the treatment of portal hypertension, a complication of liver disease. Enrollment continues in the phase 2a randomized, double-blind, dose-escalating study to compare NCX-1000 and a placebo.

A single ascending dose phase 1 study evaluating the safety, tolerability and preliminary pharmacokinetics of ursodiol disulfate is complete, with multiple dose phase 1 and phase 2a studies planned, according to the company.

Axcan has also completed phase 3 studies of Ultrase and Viokase in the treatment of exocrine pancreatic insufficiency, which will serve as the basis for its New Drug Applications. Additional phase 2 and phase 3 Ultrase studies are ongoing.

In collaboration with the German pharmaceutical firm Nordmark GmbH, Axcan is developing NMK 150, a new high protease pancrelipase preparation developed for the relief of pain in small duct chronic pancreatitis. A dose-ranging, animal preclinical study assessing the toxicity of NMK 150 is complete. A phase 1 clinical trial is expected to be completed in the second half of calendar 2006.

For the third-quarter ended June 30, Axcan's revenue grew 29% to $76.7 million from $59.4 million in the prior-year period.

Axcan reported net income for the third quarter of fiscal 2006 of $13.3 million, or $0.26 per share, compared with net income of $4.1 million, or $0.09 per share, for the third-quarter 2005.

"We are very pleased to announce another very strong quarter, representing the highest quarterly revenue and income in our history," president and chief executive officer Frank Verwiel said in a company news release.

Axcan is a specialty pharmaceutical company located in Mont-Saint-Hilaire, Quebec.

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