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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (22275)	12/20/2006 8:54:09 AM
From: dr.praveen	Read Replies (2) \| Respond to of 52153

Altus Pharmaceuticals Enters into Exclusive Strategic Collaboration with Genentech to Develop and Commercialize Products for Growth Hormone Deficient Patients Wednesday December 20, 8:14 am ET -- Genentech Obtains North American Development And Commercialization Collaboration License With Global Option For ALTU-238 -- -- Altus To Receive $30 Million From Upfront Payment And Equity Investment -- CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) 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.

To: rkrw who wrote (22275)	2/12/2007 6:12:58 PM
From: dr.praveen	Respond to of 52153

Ambrx, Inc. Initiates Phase I/II Clinical Trial Of Novel Human Growth Hormone Product Candidate <With Ref to Altus> SAN DIEGO, Feb. 12 /PRNewswire/ -- Ambrx, Inc., announced today that it has initiated a Phase I/II clinical trial of ARX201, a novel, next-generation human growth hormone product candidate. The Phase I/II dose-finding study in adult patients with growth hormone deficiency will investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ARX201 following single-escalation and repeated dosing. Ambrx expects to complete the trial by the end of 2007. "With ARX201, we believe that we have the opportunity to develop a product that will significantly benefit patients suffering from growth hormone deficiency by reducing the frequency of dosing from daily to once-weekly or, potentially, even less frequently," said Martin Mattingly, Pharm.D., president and CEO of Ambrx. "We selected ARX201 as our first clinical candidate because we believe it had the greatest potential to rapidly and effectively demonstrate the power of our ReCODE(TM) technology platform." Richard A. DiMarchi, Ph.D., chairman of Ambrx's board added: "The application of Ambrx's core technology to develop a pharmacologically optimized form of human growth hormone represents an opportunity to significantly improve a limitation of current therapies. The company's ability to move this product candidate into the clinic so quickly is a testament to the skill of its employees and the power of the technology." About ARX201 Ambrx's ARX201 (PEG-ahGH) product candidate is a recombinant form of human growth hormone that has been modified using the company's patented ReCODE(TM) technology to achieve precise spatial positioning of the site of poly(ethylene) glycol (PEG) attachment, by biosynthetic incorporation of a chemically unique amino acid (ahGH). The Company believes that ARX201 may have improved pharmacological performance over existing growth hormone products, including requiring less frequent dosing. ARX201 was selected through a lead optimization process that evaluated a number of molecules generated through the application of protein medicinal chemistry, or ReCODE(TM), technology. These molecules were characterized and screened to select for increased potency and improved pharmacological and pharmacodynamic performance. In pre-clinical studies, ARX201 met or exceeded key end-points in assays predictive of human pharmacokinetics and biological response.