GlaxoSmithKline and Archemix Corp. have entered a worldwide strategic alliance to discover, develop and commercialize aptamer therapeutics to treat inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease. Aptamers are synthetized oligonucleotides, or short nucleic acid sequences, that bind to proteins with high affinity and specificity.
   
The alliance leverages Archemix’s expertise and intellectual property in the discovery and development of aptamer therapeutics and provides GSK with an option to license product candidates directed at seven different aptamer targets related to inflammatory disease.
   
Under the terms of the agreement, Archemix will receive $27.5 million in upfront payments, including a $6.5 million equity investment by GSK in the company. Archemix could also be eligible to receive as much as $200 million in development, regulatory and sales milestones for each of the seven aptamer therapeutics which may be discovered and developed as part of the alliance. Archemix would also receive tiered royalties on worldwide sales of products that may result from the alliance.
   
Archemix will be responsible for the discovery and development of the aptamer therapeutics through clinical proof of mechanism, unless GSK chooses to exercise its option earlier. GSK would then have an exclusive license to drug candidates developed under each program for further development and commercialization on a worldwide basis. Archemix will have the right to develop and commercialize any aptamer therapeutics that GSK does not select.
   
“We are very excited about this collaboration with GSK. GSK is an outstanding partner with leadership and expertise in inflammation, and we look forward to expanding our efforts in inflammation where aptamers could offer novel options to treat disease,” said Errol DeSouza, Ph.D., president and chief executive officer of Archemix. “This is another step forward in our strategy to leverage our intellectual property estate together with our significant internal capabilities in order to develop aptamers for a variety of therapeutic areas with key partners who are experts in their field.”
   
"This innovative multi-target drug-discovery deal is an important extension of our externalization strategy and provides GSK with an outstanding opportunity to work with the world leader in aptamer discovery and development," said Jose Carlos Gutierrez-Ramos, Ph.D., senior vice president and Head of the Immuno-Inflammation Centre of Excellence for Drug Discovery in GSK. "The application of aptamers with their unique properties is an exciting opportunity that holds enormous potential for the treatment of many devastating diseases of the immune system."

Forest Laboratories, Inc. and Pierre Fabre Medicament have entered into a definitive collaboration agreement to develop and commercialize F2695 in the U.S. and Canada. F2695 is a selective norepinephrine and serotonin reuptake inhibitor being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.
   
Under the terms of the agreement, Pierre Fabre will receive an upfront payment of $75 million and is eligible to receive milestone payments and royalties on sales. Forest will be responsible for the clinical development and commercialization of F2695 in the U.S. and Canada, while Pierre Fabre will fund all preclinical development and drug substance manufacturing activities worldwide.
   
"We are pleased to expand our relationship with Pierre Fabre to include this collaboration on the development of F2695 for the treatment of depression. Pierre Fabre has been an outstanding partner for Forest since we commenced our alliance in 2004," commented Howard Solomon, chairman and chief executive officer of Forest. "We are highly encouraged by the strong clinical antidepressant activity and good tolerability exhibited by F2695 in the recently completed placebo-controlled, double-blind Phase II study. We look forward to initiating Phase III studies with F2695 next year. F2695 is the second late-stage product candidate we have licensed this quarter, underscoring our commitment to further building our pipeline and bringing novel therapeutics to the market."
   
"Pierre Fabre is looking forward to working with Forest on this exciting product opportunity," said Jean-Pierre Garnier, chief executive officer of Pierre Fabre Medicament. "Forest has an excellent record of developing and commercializing products for the treatment of depression and we are happy to extend our existing partnership to include F2695."
   
In a recently completed Phase II study in more than 550 patients with major depressive disorder, F2695 demonstrated statistically significant improvement compared to placebo on the primary endpoint, change from baseline in total score on the Montgomery-Asberg Depression Rating Scale ("MADRS"). Statistically significant improvement for F2695 compared to placebo was also demonstrated using the change from baseline in the Hamilton Depression Rating Scale ("HAMD-17") and in response and remission rates using both the MADRS and HAMD-17. In addition, F2695 demonstrated improvement compared to placebo within two weeks after treatment.

Kerri Schoedel, Ph.D. has been promoted to scientific director, clinical pharmacology for Kendle's Early Stage unit in Toronto. Dr. Schoedel will provide overall scientific direction and leadership to the clinical pharmacology group, as well as lead strategic planning and policy development as it relates to scientific assessment.  She is experienced in the field of psychopharmacology and the assessment of drug abuse liability, and also has experience in pre-clinical and clinical studies and working with regulatory authorities.
   
“I am thrilled to announce Kerri’s appointment to scientific director, clinical pharmacology,” said Phil Davies, vice president, Early Stage.  “We look forward to Kerri's continued contributions and leadership as Kendle further advances its established position as the leading authority in Early Stage psychopharmacology and human abuse liability. This appointment also reinforces our commitment to grow and advance our global Early Stage team and capabilities.”
   
Dr. Schoedel joined DecisionLine, formerly Ventana Clinical Research Corp. and now part of Kendle, in 2004. She began her career as a research scientist and was promoted to senior research scientist. In these positions, she was responsible for providing scientific input to project teams, assisted with clinical study and protocol design and provided project management for clinical research projects.

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