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Altus Earns Milestone In Cystic Fibrosis Foundation Collaboration.


Business Editors/Health/Medical Writers

BIOWIRE2K

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 19, 2003

ma Altus(R) Biologics Inc. announced today that it has successfully accomplished a development milestone in its collaboration with the Cystic Fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males.  Foundation's drug development affiliate, Cystic Fibrosis Foundation The Cystic Fibrosis Foundation (CFF) is a non-profit organization in the United States established to provide the means to cure and control cystic fibrosis. The Foundation provides information about cystic fibrosis (CF) and finances CF research that aims to improve the  Therapeutics, Inc. (CFFT CFFT Complex Fast Fourier Transform
CFFT Civitavecchia Fruit & Forest Terminal (Italy)
CFFT Central Florida Floor Tech, Inc (Florida) 
), for TheraCLEC(TM). This milestone is part of the agreement announced in February 2001, which covers the development of TheraCLEC to treat malabsorption malabsorption /mal·ab·sorp·tion/ (mal?ab-sorp´shun) impaired intestinal absorption of nutrients.

mal·ab·sorp·tion
n.
Defective or inadequate absorption of nutrients from the intestinal tract.
 as a result of exocrine pancreatic insufficiency Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. This disease is found frequently in dogs. EPI is also found in humans afflicted with cystic fibrosis.  in people with cystic fibrosis (CF).

Altus received the undisclosed milestone payment from the CFFT based on the successful completion of its Phase I clinical study in patients with CF. The data from this multi-center study indicated that TheraCLEC was well tolerated at all dose levels and also showed clinical activity for fat and protein absorption with as little as one capsule per meal. Altus plans to initiate a pivotal international multi-center Phase II trial in the first quarter of 2004 in patients with pancreatic insufficiency pancreatic insufficiency A relative or absolute lack of pancreatic enzymes, a finding typical of cystic fibrosis. See Cystic fibrosis.  due to CF.

Robert J. Beall, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of the Cystic Fibrosis Foundation, commented on the recent milestone, "Pancreatic insufficiency is a significant problem faced by most who battle CF. These recent data indicate that TheraCLEC holds promise in treating this complication. We are enthusiastic about the new Phase II clinical study that is underway to move us closer to bringing another new therapy to people with cystic fibrosis."

TheraCLEC is the first in a new class of oral enzyme replacement therapies from Altus and is intended to treat malabsorption as a result of pancreatic insufficiency, a condition that affects people with CF as well as people with chronic pancreatitis chronic pancreatitis Chronic relapsing pancreatitis GI disease Recurrent pancreatitis linked to alcohol abuse or hemochromatosis, which may worsen with time. See Pancreatitis. . In each of these diseases, a deficiency of pancreatic enzymes causes poor absorption of essential nutrients, which often leads to impaired growth and malnutrition, a life-threatening condition. TheraCLEC is intended to replace digestive enzymes Digestive enzymes
Molecules that catalyze the breakdown of large molecules (usually food) into smaller molecules.

Mentioned in: Heartburn

digestive enzymes
 to promote and maintain proper digestion, nutrition and growth in affected patients.

"The collaboration with the Cystic Fibrosis Foundation for the development of TheraCLEC continues to make excellent progress," said Peter Lanciano, President and CEO of Altus. "The achievement of this particular milestone further validates Altus' and the CF Foundation's commitment to improving the care of people with cystic fibrosis. We look forward to rapidly completing the clinical development of TheraCLEC and working closely with the Cystic Fibrosis Foundation and the Food and Drug Administration to provide an innovative treatment for pancreatic insufficiency."

About Cystic Fibrosis

Cystic fibrosis (CF) is a life-threatening disease in which mucus secretions become abnormally thick, impairing the normal functioning of the digestive, respiratory, hepatic and reproductive systems. Malnutrition results causing poor growth and weight gain. CF affects nearly 30,000 people in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and 35,000 people in Europe. In the US, nearly 90 percent of people with CF experience pancreatic insufficiency; the median age of survival is the early thirties, however, CF patients without pancreatic insufficiency have a life expectancy Life Expectancy

1. The age until which a person is expected to live.

2. The remaining number of years an individual is expected to live, based on IRS issued life expectancy tables.
 of about 50 years.

About Altus

Altus is a pharmaceutical company that uses its proprietary protein crystallization Crystallization

The formation of a solid from a solution, melt, vapor, or a different solid phase. Crystallization from solution is an important industrial operation because of the large number of materials marketed as crystalline particles.
 technology to develop innovative, orally delivered enzyme replacement therapies to treat a number of significant unmet medical needs in the areas of gastrointestinal and metabolic diseases. Altus' protein crystallization technology, known as Crystalomics(TM), enables the rapid commercialization of high-value orally delivered protein-based products by creating highly stable and potent protein therapeutics. The technology enables oral delivery of the protein to the gastrointestinal tract gastrointestinal tract
n.
The part of the digestive system consisting of the stomach, small intestine, and large intestine.


Gastrointestinal tract 
 to provide a localized or topical effect within the gastrointestinal lumen. These products are novel therapies that are designed to be safe, effective and convenient for patients. Through its product portfolio, the Company's vision is to be the worldwide leader in the rapid and efficient development of valuable oral enzyme replacement therapies for the treatment of gastrointestinal and metabolic diseases. The Company has a series of products in various stages of research and development, all leveraging the Crystalomics technology. Altus has numerous development partners and is constantly evaluating the opportunity to expand its product development efforts through partnering opportunities.

About The Cystic Fibrosis Foundation

Established in 1955, the mission of the Cystic Fibrosis Foundation is to assure the development of the means to cure and control CF and to improve the quality of life for those with the disease. The Cystic Fibrosis Foundation supports a broad range of medical research to achieve its mission and an innovative Therapeutics Development Program. The Cystic Fibrosis Foundation Therapeutics Inc. was established to provide oversight and governance of the CF Foundation's drug discovery and development efforts. Total funding for CFFT is provided by the CF Foundation.

For more information about TheraCLEC and for upcoming clinical trials you can contact the Altus Medical Product Information Department at 1(617) 299-2900 or at clinicaltrials@altus.com.
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