Adhesion Barrier News ~ BioXell acquires novel compound from Roche

BioXell S.p.A.1/12/2007 10:23:45 AM
BXL746 to enter Phase II trials for post-surgical adhesions
Milan, Italy, January 12th, 2007 - BioXell S.p.A. (SWX: BXLN) today announced its decision to exercise the option rights it acquired from Roche for BXL746, a novel vitamin D3 analogue. Based on promising preclinical data, BXL746 will be moved into Phase II clinical development for the treatment of post-surgical adhesions. Financial terms of this exclusive license agreement were already disclosed in the offering memorandum, and include an upfront payment as well as milestone payments and royalties.
Adhesions are bands of scar tissue that connect anatomic sites not normally connected. They develop through an inflammatory process when the body’s repair mechanisms respond to tissue disturbances, as the result for example of surgery, infection, trauma or radiation. A third of surgical patients and 60-90% of patients undergoing major gynecological surgery experience post-surgical abdominal adhesions, which account for 40% of all cases of intestinal obstruction and increase operating times and post-operative complications. In the US alone, more than 2 million adults are affected annually.
Current methods to prevent adhesion formation are only marginally effective. Nonetheless, worldwide sales of products for the prevention of surgical adhesions, including physical/bioresorbable barrier films and viscous polymer solutions, were estimated at $400 million in 2005, and are expected to exceed $1 billion by 2011.
BXL746, which belongs to a novel family of VD3 super-agonists called “Gemini”, has completed Phase I clinical studies at Roche for another, non-surgical indication. Data generated by BioXell in animal models of post-surgical adhesions have demonstrated a significant reduction in adhesion scores as well as an extremely favourable safety profile. The pharmaco-dynamic profile of BXL746 was superior to that of other analogues tested.
BioXell CEO Francesco Sinigaglia commented “We are very pleased to have identified a novel indication for BXL746, and we look forward to making this compound the drug of choice for the treatment of one of the most clinically relevant and currently unresolved complications of any kind of surgery. This new agreement is also a further sign of the strong, productive links we have maintained with Roche, and shows the great potential of our VD3 platform to address a range of important indications.”
About BioXell
BioXell (SWX: BXLN) is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat important urological, inflammatory, and related disorders with significant unmet medical needs. The Company was founded in 2002 as a spin-out from Roche. BioXell’s strategic goal is to become a fully integrated pharmaceutical company by maximizing the commercial potential of its product portfolio and leveraging existing platforms into profitable partnerships.
BioXell’s lead compound, Elocalcitol, derived from its proprietary VD3 (Vitamin D3) technology platform, is in Phase II clinical trials for Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB). In addition, the Company has several follow-on programs based on both VD3 and other technological platforms. BXL746 is to enter Phase II trials for post-surgical adhesions. Since 2005 BioXell has a TREM-1 fusion protein in development for the treatment of septic shock in an exclusive partnership with Merck & Co., Inc. Furthermore, in 2006 BioXell in-licensed from Lay Line Genomics S.p.A. a novel anti-TrkA monoclonal antibody, MNAC13, which represents a potential new approach to the treatment of pain.
In June 2006, BioXell listed its shares on the main segment of the SWX Swiss Exchange. BioXell currently employs 60 people and has sites in Milan, Italy and Nutley, NJ, USA.
More information on BioXell can be found at: http://www.bioxell.com
Disclaimer
This press release does not constitute or form part, or all, of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities, nor shall part, or all, of these materials or their distribution form the basis of, or be relied on in connection with, any contract or investment decision in relation to any securities. This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of BioXell, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of BioXell, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on these forward-looking statements. BioXell disclaims any obligation to update these forward-looking statements to reflect future events or developments.
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