BioWorld International Correspondent

Nitec Pharma AG closed a CHF32 million (US$26.3 million) Series B round to fund ongoing development of its lead product, Lodotra, a night-time release formulation of the corticosteroid prednisone in development for rheumatoid arthritis and other inflammatory conditions.

New York-based NGN Capital led the round. Existing investors London-based Atlas Venture and Munich, Germany-based Global Life Sciences Ventures also participated.

"This will fund us easily until the end of 2008," Jochen Mattis, co-founder and head of sales at Basel, Switzerland-based Nitec, told BioWorld International. "It's mainly to cover all additional development plans for Lodotra."

These include additional trials in the product's lead indication, rheumatoid arthritis, and trials in other inflammatory indications, including polymyalgia rheumatica - a condition most common in elderly people - and severe asthma.

The compound is based on GeoClock technology from London-based SkyePharma Plc. It is designed to deliver a single dose of the active drug during the night, to reduce the morning symptoms of rheumatoid arthritis associated with night-time release of inflammatory cytokines, such as interleukin-6.

"All the patients have this circadian rhythm. They have morning symptoms," Mattis said. These can persist for several hours and can interfere significantly with normal functioning.

Administration of prednisone at around 2 a.m. can offset development of morning symptoms but disturbs sleeping patterns. Lodotra, administered at around 10 p.m. simulates the same process. "There is no [other available] formulation that can do that kind of burst release," Mattis said.

The product hit the endpoint of a Phase III clinical trial in Europe. Those receiving a night-time dose of Lodotra exhibited a significant reduction in the duration of morning stiffness as compared with those who received a morning dose of prednisone. More than half experienced a reduction of more than one hour, which represents about one-third of the typical duration of morning symptoms.

Nitec filed a marketing application authorization with the London-based European Medicines Agency last fall and could gain approval this summer. It hopes to launch the product in Germany before the year end. Darmstadt-based Merck KGaA, from which Nitec was spun out in 2004, will market the product in that territory. Nitec has yet to sign commercialization agreements for other countries and may itself undertake marketing in selected territories, Mattis said.

The company also will seek approval in the U.S. "We should be able to get approval in the U.S. based on the current studies," Mattis said. It aims to submit a 505(b)(2) filing to the FDA and could launch the product in the U.S. by the end of 2008.