Thought I'd bring this to the attention of the thread, which has on occasion discussed the impact of pharmacogenomics and personalized medicine.
Perlegen has inlicensed a late stage PPAR agonist for diabetes and the like, with the aim of tailoring it a particular genetically screened population.
>>MOUNTAIN VIEW, Calif. & OSAKA, Japan--(BUSINESS WIRE)--April 12, 2005--Perlegen Sciences, Inc. and Mitsubishi Pharma Corporation today announced a licensing agreement for the late-stage development and commercialization of MCC-555 (a peroxisome proliferator activated receptor (PPAR) agonist) for the treatment of diabetes and other metabolic disorders. Perlegen intends to apply its leading whole genome pharmacogenomics technology to improve upon the demonstrated efficacy and safety profile of MCC-555, which has been tested in over 1,000 patients. By guiding treatment to patients most likely to benefit, the companies expect this "personalization" of the drug to provide superior therapeutic benefit in an area of significant medical need.
An estimated 200 million people worldwide have diabetes, with over 20 million patients in the United States and approximately 6 million in Japan. Despite the availability of different diabetes treatments, many patients still fail to achieve adequate glycemic control, which can lead to serious complications including retinopathy, neuropathy and nephropathy. Moreover, patients are often not prescribed their optimal treatment regimen immediately, resulting in potentially months of inadequate glycemic control. The availability of a personalized PPAR agonist for diabetes can contribute significantly to the quality of care for these patients.
Under the terms of the agreement, Perlegen will have exclusive worldwide rights, excluding Asia, to develop and commercialize MCC-555. Mitsubishi will receive an upfront cash payment and could receive additional cash and equity payments upon the achievement of certain milestones. Mitsubishi will also receive an exclusive license to use Perlegen identified predictive genetic markers for use with the therapeutic in Asia. Perlegen and Mitsubishi will each receive royalties from product sales of the drug in the respective territories of the other party.
"We are entering an era in which we can provide medicines to patients that reflect their individual genetic differences, rather than a one-size-fits-all approach. The introduction of this compound into the Perlegen portfolio establishes the foundation of our personalized medicine pipeline in metabolic diseases," said Brad Margus, Chief Executive Officer of Perlegen. "Through our expertise with genetics, we expect to move this compound rapidly forward to pivotal clinic trials. We are proud to partner with Mitsubishi Pharma, a leading Japanese pharmaceutical company with expansive capabilities and a vision of tailored medicines."
"Mitsubishi has made 'tailored medicine' an integral part of its strategy, and we are excited to partner with Perlegen," said Takeshi Komine, President of Mitsubishi Pharma Corporation. "Perlegen was our partner of choice for this important therapeutic and companion diagnostic program because of Perlegen's technological leadership in pharmacogenomics, expertise in the disease area, and commitment to the program. By licensing MCC-555 to Perlegen, we have given it a renewed opportunity to achieve significant commercial success."
About Perlegen Sciences
Perlegen Sciences, Inc. is working to provide safe and effective personalized medicines to the world. The company quickly and cost effectively analyzes millions of unique genetic variations in DNA samples obtained from clinical trial participants. This information is used to explain and predict the efficacy and adverse effect profiles of prescription drugs. Perlegen also applies this expertise to discovering genetic variants associated with disease for potential new therapeutics and diagnostics. For years, scientists and drug manufacturers have been eager to comprehensively examine entire genomes; through Perlegen, this has been made possible. Perlegen is able to bring pharmaceutical products to the market whose clinical development would otherwise have been discontinued.
Based in Mountain View, California, Perlegen was formed in late 2000 as a spin-off from Affymetrix, Inc. (Nasdaq:AFFX - News). For more information about the company and its technologies, visit Perlegen's website at www.perlegen.com. Perlegen Sciences, Perlegen, and the Perlegen logo are trademarks of Perlegen Sciences, Inc. <<
Not mention of who is doing the clinical development, though there are several possibilities. One is build the ability in-house as expeditiously as possible, another is to partner with a CRO. The former would indicate this is not just a flyer, but a permanent change in business plan. It wouldn't surprise if this was motivated by VC and bankers telling the company that to go public (and we want you to! think of the money we'll all make!) it needed a compound -- or a few. Fancy arrays and data doesn't cut it in today's IPO marketplace, we know that. I don't know what "portfolio" means in Margus' statement. They have talked a bit about doing this, but this is the first public move. Regardless, the Milleniums of the world have some competition here.
edit: they recently scored a third or fourth venture round for this purpose, a few months ago, so apparently they're morphing into therapeutic company, and likely are building their clinical development team inhouse.
Cheers, Tuck |
