BioWorld Today Correspondent

LONDON - Alizyme plc landed the speciality pharma company Norgine BV as a European marketing partner for Colal-Pred, its treatment for ulcerative colitis. The deal has a headline value of €42.75 million (US$67.4 million), of which €2 million will be paid up front.

In addition to the up-front and development milestones, Cambridge, UK-based Alizyme will receive double digit royalty rates that increase with higher annual net sales levels. Norgine will be responsible for all further development and commercialization costs. The license with Norgine, a gastroenterology specialist, also covers South Africa, Australia and New Zealand.

Tim McCarthy, CEO of Alizyme, said the deal "is very heavily geared toward sales, and that [will] foster a partnership between us and Norgine."

In January, Alizyme completed recruitment into the European pivotal registration Phase III trial of Colal-Pred in patients with active moderate-to-severe ulcerative colitis. Topline results are due this July. If positive, it is expected that the product will be submitted to European regulators later this year, but Peter Stein, CEO of Norgine, said the full filing strategy is yet to be decided.

Norgine has affiliates in the other territories covered by the license, and Stein said filings in those countries will take place after European submissions.

In December 2007, Alizyme licensed U.S. rights to Colal-Pred to Prometheus Laboratories, of San Diego, for a $2.5 million downpayment followed by $15 million in milestones up to filing in 2011.

Like the Norgine deal, royalty rates are in the double digits. Since signing the deal, Promethueus has started Phase II U.S. trials.

At present, the ulcerative colitis market is dominated by anti-inflammatory steroids and 5-ASA products, all of which have safety and/or efficacy issues. Colal-Pred is a combination of Alizyme's colonic drug delivery system, Colal, with the marketed steroid prednisolone metasulfobenzoate sodium, an approved steroid in Europe.

The Colal coating, consisting of glassy amylase and ethylcellulose, is broken down only in the colon, by locally occurring bacteria, leading to topical delivery. It was shown in a Phase II trial to provide levels of efficacy comparable to that reported for conventional oral prednisolone, but without the debilitating side effects usually associated with steroids.

"It treats the whole of the colon with once daily oral administration," McCarthy said.

Currently about 2 million people in the major pharmaceutical markets suffer from ulcerative colitis, and Alizyme said projected sales of Colal-Pred in those territories would be in excess of $250 million per annum.

McCarthy said, "We believe that Norgine, with its focus on gastroenterology and a strong and balanced pan-European presence, is uniquely positioned to maximize the commercial potential of Colal-Pred in Europe as well as in the other territories included in this deal."

Stein said Alizyme has taken Colal-Pred very successfully through to Phase III. "We are excited to have entered into this partnership with Alizyme. Colal-Pred is a therapeutically and commercially attractive late-stage development product."

He also said that Norgine will be able to add Colal-Pred seamlessly to its existing portfolio, selling to specialists across Europe. "Our therapeutic area is exactly the right group of physicians."

Published  June 30, 2008