Altus Pharmaceuticals Announces Presentation of Phase 3 Trizytek Efficacy Data at...

Altus Pharmaceuticals Announces Presentation of Phase 3 Trizytek Efficacy Data at the North American Cystic Fibrosis Conference

CAMBRIDGE, Mass.--(Business Wire)--
Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced today that the
Trizytek( TM) (liprotamase) Phase 3 efficacy study results will be
presented at oral and poster sessions at the 2008 North American
Cystic Fibrosis Conference (NACFC) in Orlando, FL on October 23 and
24. Trizytek is a non-porcine derived enzyme replacement therapy for
patients with pancreatic insufficiency. The Phase 3 Trizytek efficacy
results will be presented by Dr. Drucy Borowitz, Professor of Clinical
Pediatrics, State University of New York, Director, Cystic Fibrosis
Center, Women and Children's Hospital of Buffalo and principal
investigator for the Trizytek Phase 3 trials.

Altus' Phase 3 Trizytek efficacy trial in patients with cystic
fibrosis (CF) successfully met its primary endpoint of improvement in
fat absorption with statistical significance. In August 2008, the
Company released top-line results from its 163 patient, double-blind,
placebo-controlled trial of Trizytek, which is a stable and pure
combination of three active enzymes in a fixed-ratio that is designed
to improve fat, protein and carbohydrate absorption in pancreatic
insufficient individuals. (Click here to view the August 11, 2008
press release.) Trizytek was well-tolerated and had a favorable safety
profile in the trial. There were no serious adverse events attributed
to the Trizytek treatment. Altus' Trizytek Phase 3 clinical program is
the largest ever conducted to evaluate the efficacy and safety of
pancreatic enzyme replacement therapy in cystic fibrosis patients.

Commenting on Trizytek, Dr. Drucy Borowitz said, "I believe the
Trizytek data are very encouraging for cystic fibrosis patients who
need pancreatic enzyme replacement therapy. Despite the current
availability of porcine-derived enzyme products, I believe there is a
significant need for new FDA-approved options that may offer enhanced
safety and improve the overall quality of life for patients. Trizytek
is the pancreatic enzyme replacement therapy that has been the most
thoroughly studied, with clinical results from more than 300 patients.
I believe this innovative product has the potential to enhance
nutritional status for CF patients and provide a pure alternative to
porcine-derived enzymes."

"We are dedicated to driving Trizytek to commercialization,"
stated Dr. Georges Gemayel, President and Chief Executive Officer of
Altus Pharmaceuticals. "After extensive review of the entire Phase 3
efficacy data package as well as the ongoing long-term safety and
outcomes studies, we strongly believe that Trizytek can benefit
patients and we look forward to working with the FDA to make this drug
commercially available. We are focusing our Trizytek resources on
moving all aspects of the program forward and our objective is to file
a new drug application with the FDA in the first half of 2009."

The Company has a pre-NDA meeting scheduled for mid-November to
discuss the Trizytek data package with the FDA.

Dr. Gemayel continued, "For pancreatic insufficient patients, the
most relevant measure of success is long-term health outcomes, such as
weight and height maintenance or gain. We are looking at these as well
as other overall health outcomes in the Trizytek long-term studies
that are evaluating patients exposed to Trizytek for one year.
Preliminary data from the open-label long-term studies suggest that
adults are maintaining their weight and BMI percentiles and children
are maintaining their height and weight percentiles with continued
Trizytek treatment. We believe the information from more than the 200
patients from these studies will be extremely powerful in
differentiating Trizytek from all other enzyme replacement products.
We are on track to complete these studies, as expected, in the first
half of 2009."

In conjunction with this news release, Altus has produced an audio
news release for Trizytek. (Click here to listen to the audio news
release.)

About Trizytek(TM) (liprotamase)

Trizytek has the potential to be the first porcine-free enzyme
replacement therapy for patients with pancreatic insufficiency.
Pancreatic insufficiency is a condition that affects most cystic
fibrosis patients, as well as many patients with chronic pancreatitis.
In these diseases, a deficiency of pancreatic enzymes causes poor
absorption of essential nutrients, which often leads to malnutrition,
impaired growth and reduced survival. Trizytek is intended to replace
missing digestive enzymes with one capsule per-meal to promote and
maintain proper digestion and growth in affected patients. Altus is
developing Trizytek to enhance health outcomes by offering significant
patient advantages such as improved and more consistent dosing that we
expect will drive better long-term compliance. Utilizing recombinant
technology, Trizytek 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.

About Altus Pharmaceuticals Inc.

Altus Pharmaceuticals, headquartered in Cambridge, MA, 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 is
listed on the Nasdaq Global Market under the symbol ALTU.

Safe Harbor Statement

The statements in this press release regarding the assessment of
the Phase 3 data and its implications for remaining Phase 3 trials,
the future development of Trizytek, and our ability to file an NDA and
the timing of any filing of an NDA with the FDA for Trizytek are
forward-looking statements that are subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied by such statements. In particular, these
statements are subject to the risk that further analyses of the Phase
3 data may lead to different interpretations of the data than the
analyses conducted to date and/or may identify important implications
of the Phase 3 data that are not reflected in these statements. In
addition, further analyses of the Phase 3 data and discussion with
regulatory authorities may lead to important modifications to the
development plan for Trizytek, including delays in commercialization.
Our ability to file an NDA with the FDA for Trizytek will also depend
on our ability to commit sufficient financial resources to the
project, which resources may be unavailable to us or may be deployed
for other purposes. There can be no assurance that Trizytek will ever
receive regulatory approval or be successfully commercialized. Other
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by these forward-looking
statements include those detailed from time to time in the Company's
periodic reports filed with the Securities and Exchange Commission,
including the Company's current reports on Form 8-K, quarterly reports
on Form 10-Q and annual report on Form 10-K, particularly the
discussion under the caption "Item 1A, Risk Factors" in the Company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2008,
which was filed with the Securities and Exchange Commission on August
5, 2008. The forward-looking statements in this press release are
qualified by these risk factors. We assume no obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.

Altus and the Altus logo are the registered trademarks of Altus
Pharmaceuticals. Trizytek and DIGEST Trials are trademarks of Altus
Pharmaceuticals.

Altus Pharmaceuticals Inc.
John Jordan, 617-299-2852
Senior Director, Corporate Communications

Copyright Business Wire 2008