Altus and Dr. Falk Pharma Announce TheraCLEC Granted Orphan Drug Designation by the EMEA.

CAMBRIDGE, Mass. and FREIBURG, Germany -- Altus Pharmaceuticals Inc. and Dr. Falk Pharma GmbH announced today that TheraCLEC(TM) was granted orphan drug designation by the European Medicines Evaluation Agency (EMEA). TheraCLEC was granted designation for the treatment of malabsorption due to exocrine pancreatic insufficiency, a condition most often found in patients suffering from cystic fibrosis (CF), chronic pancreatitis (CP), pancreatic cancer as well as other diseases where the pancreas is not producing sufficient amounts of endogenous enzymes required for proper nutrition.

The Committee for Orphan Medical Products (COMP) of the EMEA grants orphan drug status in the European Union (EU). The decision is based upon a series of criteria that require the product to be intended to treat a life-threatening or chronically debilitating condition. Orphan drug designation is limited to diseases with prevalence in the EU of less than 5 cases for every 10,000 people. Additionally, it requires that there is no satisfactory method of treating the condition with an authorized medicinal product. Designation provides the product with 10 years of EU market exclusivity for a particular indication against other products with the same molecular structure operating by the same mechanism. The decision by the EMEA also allows Altus and Falk to receive regulatory assistance related to the development process and reduced regulatory fees throughout the product's life.

"Receipt of orphan drug designation in the European Union (EU), in addition to the previously granted orphan drug status in the United States, underscores our belief that TheraCLEC has the potential to meet a significant unmet medical need across the world," said Robert Gallotto, Vice President of Commercial Development at Altus. "Along with our European marketing partner, Dr. Falk Pharma, we feel this will help facilitate the more expeditious approval of a product that we believe will represent a significant advance in this underserved market."

Dr. Roland Greinwald, Head of Research and Development at Dr. Falk noted, "We are pleased with the EMEA's decision and look forward to engaging in frequent collaborative interactions during the development of this novel product. The selection of TheraCLEC into the Orphan Drug program is based, in part, on 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. It was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) in January 2002, fast track status in December 2003, and was accepted into the FDA's continuous marketing application Pilot 2 program in August 2004.

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.

About Dr. Falk Pharma GmbH

Dr. Falk Pharma GmbH, a privately held company, and the Falk Foundation e.V. are located in Freiburg, Germany. Since 1960 Dr. Falk Pharma has been a worldwide leader in the field of gastroenterology and hepatology, with distribution partners in over 60 countries. In 1978 Dr. Falk Pharma established the Falk Foundation to organize international Falk Symposia and Workshops, and up to 2003 has sponsored over 197 such events in 25 countries, which were attended by in total more than 93,000 physicians and scientists from 110 countries. The aim of the Falk Foundation is to support scientific research in the fields of gastroenterology and hepatology, to promote national and international awards for scientists, and offer a wide range of literature for physicians, pharmacists, and patients.