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BioXell and Lay Line Genomics announce License Agreement for Anti-TrkA Antibody against Pain


Milan, Rome, Italy, February 13th, 2006 –BioXell S.p.A. and Lay Line Genomics S.p.A. (LLG) today announced an exclusive, worldwide license agreement for the development of MNAC13, a novel humanized monoclonal antibody that binds to TrkA receptors, blocking the action of Nerve Growth Factor (NGF), a key mediator of pain. According to the agreement, BioXell will take MNAC13 through development and potential commercialisation, in exchange for an undisclosed upfront payment, milestones and royalties to LLG.

Pain is the most common symptom for which patients seek medical assistance, though its effective management remains inadequate, particularly for chronic pain. MNAC13 belongs to a new class of pain therapeutics that might represent a promising alternative to opioids such as morphine. Among its potential advantages are an improved safety profile and higher specificity which allow for improved efficacy and enhanced compliance.

“I am very proud of our team for moving MNAC13 to this advanced stage. We are extremely pleased that BioXell shares our excitement about MNAC13 and will be bringing its resources and expertise to the development of a novel potential pain therapeutic,” said Antonino Cattaneo , President and CSO of LLG. “This agreement further validates the power of LLG’s antibody technologies and will allow us to concentrate our efforts on the development of LLG’s Alzheimer’s disease therapeutic and diagnostics programmes.”

“This exciting programme perfectly fits into our pipeline and provides a near-term clinical development opportunity,” said Francesco Sinigaglia , CEO of BioXell. “NGF and its high affinity receptor TrkA are validated targets for pain, and we intend to explore the therapeutic potential of MNAC13 in specific conditions for which current therapeutic options are largely unsatisfactory. In addition to oncological pain and chronic inflammatory conditions such as osteoarthritis, we believe that MNAC13 may find an extremely promising field of application in Chronic Pelvic Pain Syndromes (CPPS), such as interstitial cystitis and chronic non-bacterial prostatitis.”

About NGF/TrkA
NGF and its high affinity receptor TrkA represent two extremely interesting candidates as target molecules for a newly conceived treatment against chronic pain. The NGF/TrkA system appears to be a sort of master control system in the spread of inflammation and pain, since it is functionally placed upstream of several molecular pathways involved in the inflammatory process. As a target, the inhibition of NGF/TrkA can be applicable to the treatment of various forms of chronic pain (i.e. inflammatory, neuropathic, cancer pain) as well as other pathological conditions associated with inflammation and persistent pain (i.e. CPPS in interstitial cystitis and chronic non-bacterial prostatitis).

About MNAC13
MNAC13 is a fully humanized monoclonal antibody that binds to TrkA receptors, blocking the action of NGF, a key mediator in acute and chronic pain. In particular, scientists at LLG have recently shown the significant and long-lasting analgesic effects of MNAC13 in several animal models of persistent pain. The availability of a fully humanized version of MNAC13 is particularly helpful in the perspective of its future clinical use, since humanization dramatically reduces the risk of adverse immune response in patients.

About BioXell
BioXell is a private biopharmaceutical company focusing on the discovery and development of new treatments for urological and inflammatory disorders that represent large, currently underserved markets. The Company’s goal is to become a market leader in urology through maximizing the commercial potential of it’s lead compound, BXL628; building a leading urology franchise, and leveraging existing platforms into profitable collaborations.

With analogues based on its proprietary Vitamin D3 technology platform, BioXell has three Phase II clinical programmes underway, specifically evaluating BXL628 for benign prostatic hyperplasia, overactive bladder, and non-bacterial chronic prostatitis. In May 2005, BioXell announced a partnership with Merck to advance its TREM receptor biology programme into the clinic. BioXell is also collaborating with ProStrakan to develop Vitamin D3 drug candidates to treat osteoporosis and secondary hyperparathyroidism. To date, BioXell has raised a total of over €70m Euro through world-class specialised healthcare investors including MPM Capital, Index Ventures, BB BIOTECH, AlpInvest Partners and Life Sciences Partners, as well as government funding. BioXell currently employs 63 people and has sites in Milan , Italy and Nutley , NJ , USA .

About LLG
Lay Line Genomics (LLG) is a private biotechnology company focused on the discovery and development of new drugs and innovative therapies for Alzheimer’s and other neurological diseases. Founded in 2001 as a spin out of the International School of Advanced Studies (SISSA) in Trieste , LLG has developed an innovative pipeline of small molecules and biopharmaceuticals to take into clinical development for Alzheimer’s and other neurodegenerative diseases. LLG’s approach to Alzheimer’s disease pursues therapeutic and diagnostic developments in parallel.

LLG draws its strength from its unique know-how on NGF and neurotrophic factor neurobiology as well as on a proprietary antibody technology platform. LLG’s SPLINT technology allows the rapid generation of a broad range of recombinant fully human antibodies, showing superior stability, solubility and production yields, as well as remarkable specificity and selectivity, that fuel the LLG pipeline. LLG’s business model represents a sustainable and balanced mix between short-term revenues from the pharmaceutical industry and long-term growth potential from its own R&D pipeline. LLG currently employs 20 people and has sites in Rome and Trieste , Italy .

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