Message #13 From:
NewsBot Date: December 20, 2006 05:14:00 AM
ALTU News Altus Pharmaceuticals Enters into Exclusive Strategic Collaboration with Genentech to Develop and Commercialize Products for Growth Hormone Deficient Patients
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced today that it has
entered into an agreement with Genentech, Inc. to develop, manufacture
and commercialize Altus’ product candidate
ALTU-238. The strategic alliance is an exclusive North American
collaboration and license arrangement, with an option for a global
agreement. ALTU-238 is a subcutaneously administered, once-per-week
formulation of human growth hormone, which employs Altus’
proprietary protein crystallization and formulation technology, for
patients with growth hormone deficiencies.
As part of the North American agreement, Genentech will make a $15
million upfront payment to Altus with the potential for Altus to receive
additional payments of approximately $140 million based upon the
successful completion of certain development and commercialization
milestones. In conjunction with this agreement, Altus will receive a $15
million equity investment through the sale of 794,575 shares of its
common stock to Genentech. In addition, Genentech has obtained a global
commercialization option for ALTU-238. If Genentech exercises the global
option Altus could potentially receive additional payments of more than
$110 million, comprised of upfront and milestone payments.
“The Altus and Genentech alliance is an
important strategic move that we believe further validates ALTU-238 as a
long-acting product candidate for growth hormone deficient patients as
well as the value of our protein crystallization platform,”
stated Sheldon Berkle, President and CEO of Altus Pharmaceuticals. “Through
this agreement, we are now collaborating with a premier
biopharmaceutical company that is a leader in the United States growth
hormone market. We believe that Genentech’s
development experience as well as their knowledge of the regulatory and
commercial environments for growth hormone products should contribute to
even greater potential for ALTU-238.”
Terms of the Agreement
Under the terms of the agreement, Genentech obtains an exclusive license
to collaborate with Altus to develop, manufacture and market ALTU-238
throughout North America. Going forward, Genentech will be responsible
for ALTU-238 development and commercialization costs. In North America,
Altus and Genentech anticipate co-promoting and marketing ALTU-238. Upon
any commercialization, Altus expects to receive double digit royalties
on net sales of ALTU-238. The completion of the agreement may be subject
to Hart-Scott-Rodino approval under United States antitrust laws and
customary closing conditions.
Conference Call Access Information
Altus will hold a conference call and simultaneous webcast today,
Wednesday, December 20, 2006 at 11:00 a.m. eastern time. To participate
in the conference call, please dial (800) 289-0726 in the U.S. or (913)
981-5545 for international callers. A live audio webcast of the call
will be accessible at www.altus.com,
under the Investor Relations section of the website. Please connect to
Altus' website several minutes prior to the start of the broadcast to
ensure adequate time for any software download that may be necessary.
A replay of the webcast will be available on www.altus.com
through January 20, 2007. Alternatively, the replay will be available
starting at 3:00 p.m. eastern time today through 11:59 p.m. eastern time
Wednesday, December 27, 2006 by dialing (719) 457-0820 or (888)
203-1112. The replay passcode is 6959149.
About ALTU-238
ALTU-238 is a long-acting subcutaneous formulation of recombinant human
growth hormone, in a ready-to-use liquid suspension formulation, that
employs Altus' proprietary protein crystallization and formulation
technology. Altus' technology preserves the structure of the human
growth hormone molecule without the need for polymers or encapsulation
and enables administration through a fine gauge needle. Recombinant
human growth hormone is approved for treating multiple growth disorders
in children and adolescents and for growth hormone replacement in
adults. Global sales for all recombinant human growth hormone were
approximately $2.4 billion in 2005.
Altus recently reported results from a Phase II trial in growth hormone
deficient adults in which ALTU-238 demonstrated a pharmacokinetic and
pharmacodynamic profile that the Company believes is supportive of a
once-per-week growth hormone therapy. The study identified doses of
ALTU-238 that maintained IGF-1 levels within the normal range for age
and gender over the course of the study and a once-per-week dosing of
ALTU-238 appeared to result in a consistent, linear dose response of hGH
and IGF-1 levels in the blood.
About Growth Hormone Deficiency and Growth Failure
Growth hormone disorders occur when the production of growth hormone,
secreted via the hypothalamic–pituitary axis
is disrupted. Growth hormone plays a critical role in stimulating bone
growth and development and it is involved in the production of muscle
and in the breakdown of fats. In children, when there is a deficiency or
absence of growth hormone, growth failure occurs. Recombinant human
growth hormone (rhGH) products are currently approved to treat multiple
growth disorders, including pediatric hormone deficiency, Turner
Syndrome, chronic renal insufficiency, idiopathic short stature,
Prader-Willi Syndrome, short children born small for gestational age,
genetic SHOX abnormalities, as well as adult disorders of growth hormone
deficiency, short bowel syndrome and muscle wasting in patients with HIV.
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's
website is http://www.altus.com.
Altus Forward Looking 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 the continued development for ALTU-238,
payments to be received under the agreements with Genentech, issuance of
pending patents, and the ability of Altus' proprietary protein
crystallization technology to effectively deliver growth hormone therapy
through a once-weekly injection using a fine gauge needle. These
payments are dependant, in part, on the issuance of pending patents and
commercialization. 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 and other important factors, 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 important factors that could cause actual results
to materially differ from those in the forward-looking statements is
contained in Altus' reports filed with the Securities and Exchange
Commission, including its most recent Quarterly Report on Form 10-Q.
However, Altus undertakes no obligation to publicly update
forward-looking statements, whether because of new information, future
events or otherwise.
