Catalent Pharma Solutions, Inc. and ALK-Abello A/S have signed an agreement that will expand Zydis production capacity dedicated to ALK-Abello's immunotherapy products. Under the agreement, ALK-Abello will fund a new production line for current and future tablet-based allergy products, which will be based at Catalent's Swindon, UK facility. Commercial production on the new line is expected to begin in 2010.

ALK-Abello has launched Grazax, a tablet-based vaccine against grass pollen allergy, using Catalent's Zydis oral dissolving tablet technology, and Catalent is currently producing the Zydis formulation of Grazax in the Swindon facility.

"We are pleased to have reached this next important step in our relationship with ALK-Abello, which began more than four years ago," commented Thomas Stuart, group president of oral technologies for Catalent. "The clinical success of Grazax demonstrates that protein-based products such as allergens can be taken orally by patients rather than via injection, and we believe Zydis provides unique advantages to deliver these and other types of novel compounds. We look forward to supporting the further success of Grazax and additional ALK-Abello immunotherapy products."

"We are pleased to have reached this agreement with Catalent to provide important new production capacity, which we believe will be required to meet the expected future demand for our tablet-based allergy vaccines," said Jens Bager, president and chief executive officer of ALK-Abello. "We appreciate the consistent performance and dedication of the Catalent team in Swindon, and the valuable contribution the team and the Zydis technology is making to our product."

PDL BioPharma, Inc., following a business and portfolio review, has changed its strategic focus to the discovery and development of novel antibodies in oncology and select immunological diseases. According to a company statement, it will realign its organization this fall to support its new strategy.

As a result of this new strategic focus, which does not include cardiovascular disease, PDL plans to sell its commercial assets, including its Cardene, Retavase and IV Busulfex products, as well as the ularitide development-stage cardiovascular product. Also, following a recent Data Monitoring Committee evaluation of data from the ongoing RESTORE 1 trial, the company has decided to terminate the Nuvion (visilizumab) phase III program in ulcerative colitis due to insufficient efficacy and an inferior safety profile.

BioReliance Corp. has launched iNet, an IT system that enables customers to submit test article details via controlled and secure Internet access from any location worldwide. Clients can view the status of current and past studies, view expected completion dates, download reports, and allow colleagues to view testing status—all in one online environment and in real-time, according to the company.

Tim Derrington, president and chief executive officer of BioReliance, stated, “Our customers are now armed with a web-enabled application that offers a precise picture of their project’s current and future status. We look forward to greatly expanding our iNet user base in the upcoming months and continuing to develop and integrate new technologies that will enhance our customers’ service experiences with BioReliance.”

Judith Apshago, senior director of global IT, added, “A lot of effort was placed into making iNet user-friendly, secure and compliant. As a result, preliminary users have navigated through the submission process with little difficulty. In addition, we have implemented multiple layers of security both on the front end and the back end to create an extremely secure online environment that validates users and ensures data integrity.”

iNet is compliant with 21 CFR Part 11 for user authentication, and data exchange over the web is protected by VeriSign. It's compatible with both Windows and Mac operating systems.

News from our sister sites