Message #8 From:
NewsBot Date: November 15, 2006 04:03:00 AM
ALTU News Altus Pharmaceuticals Plans to Initiate ALTU-135 Phase III Trial in the Second Quarter of 2007
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 the
Company plans to initiate a Phase III clinical trial of ALTU-135 in
Cystic Fibrosis patients with pancreatic insufficiency in the second
quarter of 2007.
“I am pleased that we have now established and
demonstrated consistent production and processes to support our Phase
III trial of ALTU-135. Our goal is to initiate this trial in the second
quarter of 2007,” stated Sheldon Berkle,
President and CEO of Altus Pharmaceuticals.
ALTU-135, the Company’s orally administered
enzyme replacement therapy for patients with pancreatic insufficiency,
is manufactured by blending three drug substance enzymes: lipase,
protease and amylase. This consistent and pure enzyme combination is
designed to improve fat, protein and carbohydrate absorption in
pancreatic insufficient individuals.
In July of this year, the Company announced that one of three blended
ALTU-135 lots showed an unexpected reduction in lipase activity. During
the past three months, Altus initiated an investigation and conducted
additional manufacturing development work to support its intended Phase
III clinical trial. Work carried out during the investigation
established that the observed lower potency was due to characteristics
of the assay used to measure activity and not a result of a loss of
enzyme activity. This assay, which is the standard for measuring lipase
activity, is specified for porcine material and has been in existence
for more than 50 years. Altus’ proprietary
technology produces a consistent and pure enzyme combination unrelated
to porcine material. As a result of the investigation, Altus modified
the assay to enable it to more accurately determine lipase activity for
its cross-linked, microbially-derived lipase. Since August, the Company
has produced, blended and tested additional lots to confirm that the
manufacturing process for material to be used in the Phase III trial
results in a consistent product that is intended to be representative of
the commercial material.
Berkle continued, “As a result of our
additional ALTU-135 process testing and investigations, we have
increased our manufacturing and technical operations core competencies.
In fact, we believe we have strengthened the overall ALTU-135 program
through a greater understanding of activity measurements, process
controls, drug blending and the effects of cross-linking on enzyme
activity, stability and solubility. During the next few months we plan
to finalize with regulators, investigational review boards and
investigators the remaining few components that we expect will enable us
to initiate the ALTU-135 Phase III clinical trial in the second quarter
of next year.”
Update on ALTU-238
ALTU-238 is a once-per-week formulation of human growth hormone that
employs Altus’ proprietary protein
crystallization and formulation technology. ALTU-238 is designed to
require fewer injections without the use of polymer encapsulation,
chemical modification or fusion proteins, which the Company believes to
be a significant advantage over other long-acting therapies in
development.
In July of this year, the Company announced that delivery of certain
production equipment for ALTU-238 was delayed. During the past several
months, Altus continued to develop and qualify additional assays of
ALTU-238 to ensure process reproducibility and product consistency. The
completion of the equipment fabrication is expected to occur in December
of this year. During the first several months of 2007, the equipment and
the manufacturing processes will be qualified at Altus’
contract manufacturer.
“We are very pleased to see the ALTU-238
program back on track,” continued Berkle. “The
equipment that was delayed was an essential component to the production
of our ALTU-238 product. In fact, this equipment was developed and built
exclusively for our unique crystallization technology. Following the
qualification of this new equipment and processes, we will provide
future guidance as to the anticipated ALTU-238 clinical program timeline.”
Berkle concluded, “2007 is shaping up to be a
very important and exciting year for Altus. I am very proud of the Altus
team for its ability to take on the challenges of both development
programs and deliver the needed solutions.”
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 Stock Exchange under the symbol ALTU. For additional
information about the company, please visit www.altus.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 timing for completion of
equipment fabrication and qualification of manufacturing processes for
ALTU-238, and the timing for 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.
