Gene Logic, Inc. has entered into a drug repositioning and development agreement with Merck Serono to seek alternative development paths for several Merck Serono drug candidates that were discontinued or de-prioritized in clinical trials for reasons other than safety.
   
Under the agreement Gene Logic will receive success-based milestones and royalties similar to those paid for development-stage in-licensing deals. Gene Logic also has the option gain exclusive license to any drug candidate it identifies that Merck Serono chooses not to develop. If Gene Logic obtains such a license, Merck Serono would be entitled to receive success-based milestone and royalty payments.
   
Gene Logic's Drug Repositioning Program offers the potential for pharmaceutical partners to bolster their pipelines with high-quality drug candidates that originated from their own R&D efforts. The program evaluates drug candidates for potential use across a wide range of disease indications by applying a diverse set of drug discovery technologies.
   
Charles L. Dimmler, III, Gene Logic's chief executive officer and president, said, "Merck Serono is a world leader in reproductive health and has strong market positions in several other therapeutic areas. We look forward to applying our Drug Repositioning Program to complement their internal efforts to determine new uses for their clinical-stage, de-prioritized drug candidates. Our partnership with Merck Serono is our seventh drug development agreement, further substantiating the industry's recognition of our systematic approach to identifying novel therapeutic indications for drug candidates."

MedImmune has opened a new, state-of-the-art pilot lab facility at its Gaithersburg site headquarters. The facility features the latest equipment and process automation systems and will support the company's clinical product pipeline with additional capacity and flexibility.

MedImmune, David M. Mott, president and chief executive officer, stated, "Completing this new facility is an important milestone, signaling our continued growth and success as a world-class biopharmaceuticals company. The opening of this facility, alongside the expansion work underway on our new biologics facility in Frederick, Maryland, reaffirms our leadership role within the state's biotechnology industry and demonstrates our ongoing commitment to the region."

The new pilot lab's 5,000 liters of bioreactor capacity increases production capabilities four-fold. The expanded facility enables the company to produce clinical trial materials at a greater scale and in larger quantities, helping with the testing of potential new products.

"This substantial increase in MedImmune's clinical production infrastructure supports our robust pipeline of product candidates," said Gail Folena-Wasserman, Ph.D., senior vice president, development. "The pilot lab facility is intended to meet our current and future needs, not just through its increased capacity but also through design flexibility, which efficiently allows us to produce multiple clinical products in the same space. We can drive efficiency and meet rigorous quality standards by incorporating the latest technology, including an advanced process control system."

Bengt Danielsson, M.D., Ph.D., has been appointed vice president, PharmaNet Consulting. He joins the company from the Swedish Medical Product Agency where he served as scientific director/professor in pharmacology and toxicology for the past three years. During that time he also served as a member and the EU Pharmacology and Toxicology representative of the EMEA/CHMP Innovative Medicine Task Force group and a member and Swedish representative of the CHMP/EU Safety and CHMP/EU Cell-based Products working parties. Dr. Danielsson previously worked for Astra AB and AstraZeneca where he served as global director, clinical interface support and global science leader, reproductive toxicology.
   
"We are extremely pleased to have someone of Dr. Danielsson's stature join PharmaNet Development Group," commented Dr. James Burns, senior vice president, PharmaNet Consulting. "He adds to an already impressive team of experts in our drug development consulting practice, which includes a number of senior former-FDA officials, and will bring significant technical and regulatory experience to assist our clients who are developing products in Europe."

News from our sister sites