Altus Announces Selection of TheraCLEC Into the FDA's Continuous Marketing Application Pilot 2 Program.

CAMBRIDGE, Mass. -- Altus Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has selected TheraCLEC(TM) for participation in the Continuous Marketing Application (CMA) Pilot 2 program. The Pilot 2 program is designed to expedite the development and eventual marketing of fast track products. Under CMA Pilot 2, the FDA and applicants enter into agreements to engage in frequent scientific feedback and interactions during the IND phase of product development. Participation in the Pilot 2 Program is limited to one fast track product for each review division and TheraCLEC is the applicant selected into the program by CDER's Division of Gastrointestinal and Coagulation Drug Products.

"We are very pleased that the FDA's Division of Gastrointestinal and Coagulant Drug Products has accepted TheraCLEC to be part of this pilot project under which Altus and the FDA will engage in frequent collaborative interactions during the development of this novel product," commented Don G. Burstyn, Ph.D., Vice-President of Regulatory Affairs at Altus. "This frequent communication between the FDA and Altus should help us clarify and define the appropriate development pathway and may ultimately enable the expedited review and approval of TheraCLEC by the Agency."

TheraCLEC is under development for the treatment of malabsorption as a result of pancreatic insufficiency. Pancreatic insufficiency is a condition often observed in people with cystic fibrosis, chronic pancreatitis, pancreatic cancer as well as other diseases where the pancreas is not producing sufficient amounts of endogenous enzymes required for proper digestion. The selection of TheraCLEC into the CMA Pilot 2 program is based, in part, on its "fast track" designation due to the life-threatening nature of pancreatic insufficiency, an unmet medical need which often results in malabsorption of nutrients and reduced life expectancy. TheraCLEC is currently being evaluated in a large multi-center Phase II clinical trial. Altus received US orphan drug designation for TheraCLEC in January 2002 and Fast Track designation in December 2003.

The CMA Pilot 2 program is an initiative by the FDA to evaluate the costs and benefits of increased sponsor access to guidance and feedback from the FDA for fast track products. Eligibility is limited to developmental stage products that have fast track designation and have been subject to an end of Phase I or equivalent meeting. An independent consultant under contract with the FDA will evaluate the value of the program after reviewing whether the Pilot 2 related activities actually improved the efficiency of the drug development and review process.

About TheraCLEC

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 exocrine pancreatic insufficiency, a condition that affects people with cystic fibrosis, chronic pancreatitis, pancreatic cancer as well as a number of other diseases where the pancreas is not producing sufficient amounts of endogenous enzymes. 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 to promote and maintain proper digestion, nutrition and growth in affected patients. TheraCLEC is the first in a portfolio of products under development applying Altus' technology and expertise to orally delivered and parenteral protein therapies to treat gastrointestinal and metabolic diseases. Protein therapeutics delivered as oral lumenal therapies offer distinct advantages over systemically delivered proteins because they are directly and more readily delivered to the site of action, which may lead to a significant therapeutic effect and an improved safety profile.

About Altus Pharmaceuticals Inc.

Altus Pharmaceuticals is focused on developing and commercializing novel protein therapeutics for patients with chronic gastrointestinal and metabolic diseases. Altus' in-depth knowledge of protein crystallization has resulted in a proprietary pipeline of orally delivered and injectable protein replacement products. As a company, Altus is committed to improving the quality of life of patients. More information about Altus and its clinical development programs can be found at www.altus.com.