FORMATECH TO DONATE SERVICES TO MANUFACTURE KAI PHARMACEUTICALS' CLINICAL CANDIDATE UNDER ITS "FILLANTHROPYTM PROGRAM"
ANDOVER - November 18, 2009 - Today, Formatech announced that they have selected KAI Pharmaceuticals, Inc. and their KAI-4169 compound as the second clinical candidate to receive Formatech's manufacturing services under its Fillanthropy Program. KAI-4169 is being evaluated for use in the treatment of secondary hyperparathyroidism. Under the Fillanthropy Program, Formatech will donate the services required to aseptically fill and finish one lot of the drug product for use in support of KAI's upcoming clinical trials.
Formatech plans to complete the production run of KAI-4169 in the first quarter of 2010. "We're excited to have the opportunity to work with KAI on this program," said Jeffrey Bernard, Formatech's Director of Business Development. "KAI's technology for developing selective Protein C Kinase inhibitors is very promising and has the potential to be very impactful in the treatment of a number of diseases. We're pleased to donate our services for this program and we wish KAI success with this candidate."
"It is an honor to receive this award from Formatech as part of their philanthropic effort," said Steve James, President and Chief Executive Officer of KAI Pharmaceuticals. "We appreciate Formatech's commitment to this program. Secondary hyperparathyroidism is leading cause of morbidity and mortality in patients with chronic kidney disease. This fill will help support our '4169 program and we look forward to exciting results in the year ahead."
To obtain more information or to submit an application for the Fillanthropy program, companies are encouraged to contact Jeffrey Bernard, Director of Business Development at 978-725-9077 ext. 3164 or firstname.lastname@example.org.
About the Fillanthropy Program
Each month beginning in January 2010, Formatech will donate the services required to aseptically fill and finish one lot of drug product for selected therapeutic candidates that are entering or being evaluated in human clinical trials. To be eligible, companies must be developing a clinical candidate that is delivered as a sterile injectable product. When selecting a candidate, Formatech considers both the product's potential therapeutic benefit and the financial need of the sponsor.
Formatech, founded in 1993, is based in Andover, Massachusetts. The company provides contract services that deliver unique solutions to product development/manufacturing challenges, including preformulation/formulation development of all common dosage forms, such as lyophilized dosage forms, cell culture/fermentation process development and purification/downstream process optimization.
Their aseptic manufacturing facility produces liquid and lyophilized dosage units for clinical supplies or small-scale commercial products. Manufacturing support services include compounding/formulation, diafiltration/concentration (UF/DF), release testing, and ICH conforming stability programs.
Formatech's goal is to "Help make new drugs happen at the speed of science."
About KAI Pharmaceuticals, Inc.
KAI is a drug discovery and development company with novel clinical-stage programs in cardiovascular disease and pain. KAI's lead product candidate, KAI-9803, is currently in a Phase 2b study (PROTECTION AMI) designed to assess the effect of KAI-9803 on reducing myocardial injury in heart attack patients. KAI's second clinical program, KAI-1678, has the potential to address both the inflammatory and neuropathic pain markets and currently is in multiple Phase 2a studies.
KAI is the leader in the selective modulation of intracellular protein: protein interactions and delivery of peptides into the cell. This approach has broad potential and has been validated clinically. The Company has applied its core expertise to discover highly potent and selective inhibitors and activators for PKC protein kinase C (PKC) isozymes. KAI is based in South San Francisco, California, and can be found online at www.kaipharma.com.
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