SGX Pharmaceuticals Announces Strategic Collaboration to Develop and Commercialize BCR-ABL Inhibitors for the Treatment of Chronic Myelogenous Leukemi
Posted by rob on March 28, 2006 under Uncategorized | 
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SAN DIEGO, March 27 /PRNewswire-FirstCall/ -- SGX Pharmaceuticals, Inc.(Nasdaq: SGXP) announced today that it has entered into a license andcollaboration agreement with Novartis focused on the development andcommercialization of BCR-ABL inhibitors for the treatment of drug resistantChronic Myelogenous Leukemia (CML). Under the terms of the agreement, SGX will receive from Novartis $25million in upfront payments and the purchase of SGX common stock. Along withsuccess-based milestones, but excluding royalties, total payments to SGX couldexceed $515 million, including a minimum of two years of research funding. The success of Gleevec(TM) (imatinib), the first targeted therapy inPhiladelphia Positive (Ph+CML) proven to inhibit BCR-ABL, has fundamentallychanged the treatment of Ph+CML. However, a subset of patients developsresistance to Gleevec or cannot tolerate therapy. For these patients thereare currently no other approved treatment options. Drug candidates from SGX'slead series, developed from its FAST(TM) proprietary drug discovery platform,have exhibited activity against wild-type and drug resistant BCR-ABL mutants,including the most challenging T315I mutant. "Novartis is the leader in developing novel targeted therapies to treatCML," said Mike Grey, president and chief executive officer of SGXPharmaceuticals. "With their extensive experience developing andcommercializing Gleevec as well as development of the novel investigationalcompound, nilotinib/AMN107, we believe they are the ideal partner with whom todevelop our series of next-generation BCR-ABL inhibitors. This is atremendous validation of our FAST technology for generation of novel leadmolecules for key therapeutic targets." Background on the Agreement SGX will be responsible for completing preclinical development of the leadcandidate and submitting an Investigational New Drug application with the Foodand Drug Administration. SGX will also be responsible for the completion ofan initial phase I clinical study, after which time Novartis will beresponsible for conducting further clinical development and commercializationof the compound. In addition to the upfront and milestone payments, SGX will receiveroyalty payments upon successful commercialization of products developed underthe collaboration. SGX retains an option to co-commercialize, in the U.S.,oncology products developed under the agreement. If exercised, the optionwould enable SGX to reinforce the commercial presence in the North Americanhematology markets which the company plans to establish with the potentiallaunch of Troxatyl(TM) in the second half of 2007, assuming the successfulcompletion of the ongoing Phase II/III clinical trial for the treatment ofthird-line acute myelogenous leukemia and regulatory approval of Troxatyl forthis initial indication in 2007. Background on CML: Prognosis and Treatments Chronic myelogenous leukemia is a malignant cancer of the bone marrowcausing rapid and abnormal growth of white blood cells. According to theNational Institutes of Health, approximately 4,600 new cases of CML arediagnosed annually, accounting for 7 to 20 percent of leukemia cases. CML isassociated with a chromosome abnormality called the Philadelphia chromosome.Since its approval in 2001, Gleevec has become the standard of care for Ph+CML. Results from the IRIS study (International Randomized Interferon versusSTI571), the largest clinical trial to date for newly diagnosed adult patientswith Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) inchronic phase, show that 90.3 percent of patients who were initiallyrandomized to take Gleevec were still alive after 54 months. The prevalence of CML has increased substantially because Gleevec therapymakes it possible for patients with CML to live with the disease much longerthan possible with previously used treatments. Gleevec works directly onleukemic cells by inhibiting the action of BCR-ABL tyrosine kinase, the enzymeresponsible for uncontrolled growth of leukemic cells. Despite this clinicalsuccess, resistance to Gleevec has emerged in a subset of patients. Oncepatients lose response to optimized doses of Gleevec, the only currentlyapproved treatment is bone marrow transplantation preceded by high-dosechemotherapy and radiation, for which many CML patients are not eligible. "We believe that a BCR-ABL inhibitor developed through this collaborationcould have the potential to be used both as a monotherapy in second-linetreatment of refractory or relapsed CML, and in combination with Gleevec oranother agent in first-line treatment of CML," added Dr. Stephen Burley, chiefscientific officer of SGX Pharmaceuticals. About FAST(TM) Drug Discovery FAST, short for Fragments of Active Structures, is SGX's proprietaryfragment-based drug discovery platform for rapid identification of novel,potent and selective small molecule inhibitors of drug targets. FASTaddresses many of the limitations of traditional approaches utilized by largepharmaceutical companies to find lead compounds, making it an attractivetechnology for targets that have not yielded promising leads fromhigh-throughput screening. FAST is based on a proprietary fragment library of approximately 1,000structurally diverse, low molecular weight compounds. FAST integrates aseries of technologies, including: * A high-throughput capability to generate many different crystal structures of a target protein in parallel; * The evaluation of the library of fragments and direct visualization of bound fragments utilizing X-ray crystallography; and * The use of novel computational and structure-based design methods and iterative synthetic chemistry to optimize these fragments into drug candidates. SGX believes these combined technologies generate an efficient platformfor drug discovery that delivers lead compounds active against a wide range oftargets, while accessing high chemical diversity and the potential for gooddrug-like properties. About SGX Pharmaceuticals SGX Pharmaceuticals is a biotechnology company focused on the discovery,development and commercialization of innovative cancer therapeutics. TheCompany's lead product candidate, Troxatyl(TM), is currently being evaluatedin a pivotal phase II/III trial for the treatment of third-line acutemyelogenous leukemia, an indication for which there is currently no approvedtherapy or standard of care. SGX has developed a pipeline of oncology drugcandidates based on its enabling, proprietary FAST(TM) drug discoveryplatform, including a portfolio of next generation BCR-ABL inhibitors. FASTallows for the rapid identification of novel, potent and selective smallmolecule compounds for well validated but challenging targets. Moreinformation on SGX's pipeline and drug discovery platform can be found athttp://www.sgxpharma.com . SGX Pharmaceuticals Forward-Looking Statements Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but are notlimited to statements related to SGX's research and drug discovery anddevelopment programs and statements regarding the potential value and scope ofthe collaboration with Novartis, SGX's receipt of potential research andmilestone payments, royalty payments or profits from sales of productsdeveloped under the collaboration, SGX's co-commercialization options andcommercialization strategies, expectations regarding the timing of initiationand completion of development, including clinical trials, and product launchmilestones with respect to drug candidates under the collaboration,expectations with respect to the further development and potential regulatoryapproval of Troxatyl, the activity of BCR-ABL inhibitors, the potential ofBCR-ABL-based therapies as treatments for CML alone or in combination withother treatments, the expansion of treatment options available to patientswith CML, future plans and activities regarding the collaboration and SGX'sBCR-ABL program, the effectiveness and efficiency of SGX's FAST technology togenerate novel lead molecules for key therapeutic targets and SGX's ability todiscover, develop and commercialize cancer therapeutics. These statements areonly predictions based on current information and expectations and involve anumber of risks and uncertainties. Actual events or results may differmaterially from those projected in any of such statements due to variousfactors, including the risks and uncertainties inherent in drug discovery,development and commercialization, collaborations with others, and litigation.In particular, the results of early clinical trials may not be predictive offuture results, and SGX cannot provide any assurances that any of its productcandidates will have favorable results in future clinical trials or receiveregulatory approval. In addition, SGX's results may be affected by risks thatthe required regulatory approvals will be received in a timely manner, or atall, risks related to the implementation of its collaboration with Novartis,competition from other biotechnology and pharmaceutical companies, itseffectiveness at managing its financial resources, its ability to successfullydevelop and market products, the level of efforts that its collaborativepartners devote to development and commercialization of its productcandidates, difficulties or delays in its clinical trials, difficulties ordelays in manufacturing its clinical trials materials, the scope and validityof patent protection for its products, regulatory developments involvingfuture products and its ability to obtain additional funding to support itsoperations. For a discussion of these and other factors, please refer to therisk factors section of the final prospectus from SGX's initial publicoffering filed with the United States Securities and Exchange Commission onFebruary 1, 2006 as well as other subsequent filings with the Securities andExchange Commission. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date hereof. Thiscaution is made under the safe harbor provisions of the Private SecuritiesLitigation Reform Act of 1995. All forward-looking statements are qualifiedin their entirety by this cautionary statement and SGX undertakes noobligation to revise or update this press release to reflect events orcircumstances after the date hereof.