Altus Pharmaceuticals Inc. (ALTU)

[surf1944]

Altus Pharmaceuticals Secures Long-Term Growth Hormone Supply For ALTU-238 Clinical Development and Commercialization
Wednesday July 9, 4:07 pm ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News), a biopharmaceutical company focused on oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders, announced today that it signed a long-term agreement to purchase recombinant human growth hormone (rhGH) for ALTU-238 for development and commercialization. Altus is developing ALTU-238 as a subcutaneously administered, long-acting formulation of rhGH that employs the Company’s proprietary protein crystallization and formulation technology.

The agreement was signed with Sandoz GmbH, a Novartis company. Sandoz supplied rhGH for Altus’ completed Phase 1 clinical trial in healthy adults and the Phase 2 clinical trial in adults with growth hormone deficiency.

“This long-term supply agreement is an important achievement that provides increased strategic options for the ALTU-238 program,” stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “We are targeting early 2009 to start an ALTU-238 Phase 2 pediatric trial. With this goal in mind, we expect to initiate a Phase 1c study in the third quarter of 2008. We believe that achieving these program milestones can establish ALTU-238 as a significant future entrant into the $2.8 billion growth hormone market by providing a long-acting alternative that has a high degree of patient acceptability.”

About ALTU-238 Phase 1c and Phase 2 Pediatric Trials

The ALTU-238 Phase 1c trial is planned to be initiated by the end of the third quarter of 2008 and is expected to include 36 subjects. The safety and pharmacokinetic profile of ALTU-238 will be evaluated over 1 week. The trial is designed to confirm that the ALTU-238 material produced at Althea Technologies at approximately 75 percent of commercial scale performs similarly to the material used in the previous Phase 1 and Phase 2 trials. This will be followed by the Phase 2 pediatric trial, which will assess the change in 6-month annualized height velocity in pediatric growth hormone-deficient children, and will be used to finalize the Phase 3 study design.

About ALTU-238

ALTU-238 is a long-acting subcutaneous formulation of rhGH 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. Daily rhGH products are currently approved for the treatment of various growth disorders in children and adolescents and for growth hormone replacement in adults. Global sales for all rhGH products were approximately $2.8 billion in 2007.





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