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Bethesda, MD and Cambridge, MA - March 7, 2001 - The Cystic Fibrosis Foundation announced today that its subsidiary, the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFTI), and Altus Biologics Inc. have formed an alliance to expedite the development of a new drug, TheraCLEC-Total, to treat pancreatic insufficiency, a condition that affects most people with cystic fibrosis (CF). CFFTI, the drug development affiliate of the Cystic Fibrosis Foundation, will provide Altus with up to $25 million in grant funding as well as access to its Therapeutics Development Network. This alliance agreement represents the largest drug development grant in the history of the CF Foundation and of the CFFTI.
TheraCLEC-Total is being developed as an orally delivered enzyme product to replace missing digestive enzymes in people with CF. TheraCLEC-Total is based on Altus' revolutionary and proprietary Crystalomics technology. Using advanced protein crystallization technology, scientists at Altus have discovered and developed TheraCLEC-Total as a pure, stable and highly potent enzyme product that can be manufactured both as a capsule and as a liquid for young patients. This technology has the potential to transform enzymes into effective therapeutic products that are both fully active and stable against degradation by acid and proteolytic (protein-degrading) enzymes without the use of a polymer coating, which has been used traditionally to protect replacement enzymes while in the digestive tract. These product features, as compared to existing enzyme replacement therapies, are expected to translate into a highly effective and safe product with a lower daily dosage requirement and better compliance by people with CF.
In people with CF, pancreatic insufficiency occurs when thick mucus obstructs the pancreas, preventing enzymes from reaching the intestine where they help to break down and digest food. Nearly 90 percent of the 30,000 Americans with CF ultimately develop pancreatic insufficiency; most take multiple porcine-based capsules with every meal to treat the symptoms. Pancreatic insufficiency also affects those who have pancreatic dysfunction or illness due to viral or chemical injury.
"Pancreatic insufficiency is a significant complication for people living with cystic fibrosis," said Robert J. Beall, Ph.D., president and CEO of the CF Foundation. TheraCLEC-Total fulfills its promise in future clinical trials, the compound will mark a significant improvement in treatment over current enzyme therapies and a major improvement in the quality of life for people with CF."
Initial pre-clinical studies of TheraCLEC-Total at the Mayo Clinic in Rochester, MN and at Altus Biologics have produced early positive results. Human clinical trials on TheraCLEC-Total are expected to begin in late 2001 or early 2002. Grant payments from CFFTI are tied to successful completion of specified development milestones. This jointly funded partnership will serve to support four years of this clinical research.
"We believe that this new product could offer significant advantages over existing therapies to treat pancreatic insufficiency, and in the long run, improve nutrition for patients with cystic fibrosis," said Beall. "What is particularly exciting is that researchers will be applying the latest advances that biotechnology has to offer to create the first novel enzyme product in years."
Peter Lanciano, president and CEO of Altus Biologics Inc., added, "The partnership with the CF Foundation is a terrific opportunity to work together to accelerate the development of this promising new drug for CF patients. We are especially excited about the chance to create an effective pediatric formulation of the drug so that the medical impact of pancreatic insufficiency can be managed effectively and early in life. Altus' goal in working with the CF Foundation is to ensure successful product development and product launch within North America under the Altus brand."
The Cystic Fibrosis Foundation was founded in 1955 to assure the development of the means to cure and control cystic fibrosis (CF) and to improve the quality of life for people with the disease. The CF Foundation carries out an innovative Therapeutics Development Program that supports the full spectrum of CF drug development from discovery of a promising drug through clinical evaluation. Potential drugs are studied in the laboratory, and if successful, evaluated for clinical trials. Matching milestone-driven grants to support CF drug development are offered to biotechnology companies and academic institutions through this program.
The Cystic Fibrosis Foundation Therapeutics, Inc. (CFFTI) was established to provide additional oversight and governance of the CF Foundation's drug discovery and drug evaluation efforts. Total support of CFFTI is provided by the CF Foundation The purpose of CFFTI is to guide and assure the direction of new therapies for CF. For more information on the CF Foundation and CFFTI, please visit www.cff.org.
Altus is a privately held life sciences company which has developed a unique, powerful and proprietary protein crystallization technology, known as Crystalomics, to enable the rapid commercialization of high-value protein-based products. Altus has built a patented portfolio of products and technologies based on the crystalline solid state of proteins and peptides. In the therapeutic field, Altus has product candidates advancing into the clinic to treat metabolic and gastrointestinal disorders. In addition, Altus has numerous collaborative development programs with both pharmaceutical and biotechnology companies using its Crystalomics technology platform to deliver, formulate and manufacture protein drugs to treat a variety of diseases. SG Cowen Securities served as Altus' financial advisor and the exclusive placement agent for the financing. Altus is a registered trademark of Altus Biologics Inc. and Crystalomics™ is a trademark of Altus Biologics Inc. For more information on Altus, please visit www.altus.com.
Altus Pharmaceuticals Inc.
Robert Gallotto
Vice President of Commercial Development and Alliance Management
617-299-2900