Message #9 From:
NewsBot Date: November 17, 2006 06:00:00 AM
ALTU News Altus Pharmaceuticals Secures ALTU-135 Commercial Manufacturer
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU), a biopharmaceutical company
focused on oral and injectable protein therapeutics for patients with
gastrointestinal and metabolic disorders, announced today that it has
signed a long-term agreement with Lonza Group Ltd (SWX: LONN), to
commercially manufacture Altus’ ALTU-135 drug
substances at Lonza’s facility in Kouřím,
Czech Republic. ALTU-135, the Company’s orally
administered enzyme replacement therapy in development for patients with
pancreatic insufficiency, is the drug product that results after
blending three drug substance enzymes: protease, lipase and amylase.
This consistent and pure enzyme combination is designed to improve fat,
protein and carbohydrate absorption in pancreatic insufficient
individuals. ALTU-135 is intended to replace missing digestive enzymes
to promote and maintain proper digestion and growth in affected patients.
On November 15, 2006, Altus Pharmaceuticals announced that it plans to
initiate its ALTU-135 Phase III clinical trial in the second quarter of
2007. Altus will continue to utilize its current contract manufacturer
for the drug substances to be used in the ALTU-135 Phase III clinical
trial. In preparation for the ALTU-135 commercial launch, Altus and
Lonza will coordinate and manage the technology transfer as well as the
installation and qualification of the key equipment necessary for the
production of ALTU-135 while the Phase III trial is being conducted.
“We are pleased to be collaborating with
Lonza, which is an organization with significant expertise in
biopharmaceutical production, microbial fermentation, process
optimization and quality systems,” commented
Sheldon Berkle, President and CEO of Altus. “We
believe selecting Lonza is a significant milestone for the ALTU-135
program. We continue to work towards putting the pieces in place for a
successful ALTU-135 commercial launch.”
Lonza’s CEO, Stefan Borgas said, “Lonza
is gratified to be partnering with Altus Pharmaceuticals and to be
awarded this significant manufacturing agreement. We believe this
relationship will significantly benefit both organizations and will
ultimately result in a valuable therapy for patients in need.”
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of oral and injectable protein
therapeutics for patients with gastrointestinal and metabolic disorders.
The company has headquarters in Cambridge, Massachusetts, and is listed
on the NASDAQ Global Market under the symbol ALTU. For additional
information about the company, please visit www.altus.com.
About Lonza
Lonza Group Ltd is one of the world's leading suppliers to the
pharmaceutical, healthcare and life science industries. Its products and
services span its customers’ needs from
research to final product manufacture. Lonza is the global leader in the
production and support of pharmaceutical active ingredients both
chemically as well as biotechnologically. Lonza has strong capabilities
in large and small molecules, peptides, amino acids and niche
bioproducts. Lonza is also a leading provider of value chemical and
biotech ingredients to the nutrition, hygiene, preservation, agro and
personal care markets. Lonza is headquartered in Basel, Switzerland and
is listed on the SWX Swiss Exchange. Further information can be found at www.lonza.com.
Safe Harbor Statement
Certain statements in this news release concerning Altus’
business are considered “forward-looking
statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements include, but
are not limited to, those relating to the planned initiation of Phase
III clinical trials for ALTU-135. Any or all of the forward-looking
statements in this press release may turn out to be wrong. They can be
affected by inaccurate assumptions Altus might make or by known or
unknown risks and uncertainties, including, but not limited to
uncertainties as to the future success of ongoing and planned clinical
trials; and the unproven safety and efficacy of products under
development. Consequently, no forward-looking statement can be
guaranteed, and actual results may vary materially. Additional
information concerning factors that could cause actual results to
materially differ from those in the forward-looking statements is
contained in Altus’ reports to the Securities
and Exchange Commission, including its Annual Report on Form 10-K for
the fiscal year ended December 31, 2005. However, Altus undertakes no
obligation to publicly update forward-looking statements, whether
because of new information, future events or otherwise.
