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Clinical Data to Focus on Growing PGx Tests, Expanding FCGR Collaborations in ’09

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Clinical Data in the coming year plans to drive adoption of its Familion and PGxPredict brand of assays in the cardiovascular disease market, and establish research collaborations to discover and validate genetic variants in the Fc gamma receptor pathways (FCGR) that predict response for monoclonal antibodies, a company official said this week.
 
“Our goal in 2009 is to expand our Familion and PGxPredict offerings by continuing to drive physician adoption through our cardiovascular sales force, expanding coverage, and increasing test sales,” Theresa McNeely, Clinical Data’s VP of corporate communications, told Pharmacogenomics Reporter. “We also plan to expand the distribution of our Familion texts beyond the US.”
 
McNeely added that next year, Clinical Data plans to establish additional research collaborations to expand its FCGR biomarker program into other targeted monoclonal antibodies and to personalize treatments beyond oncology, such as in rheumatoid arthritis.
 
Earlier this month, Clinical Data announced a collaboration under its PGxHealth FCGR program with the University Hospital of Parma, Italy, to validate the use of genetic variants in the FCGR pathways associated with response to the breast cancer drug Herceptin (Genentech’s trastuzumab). The collaborators will conduct a clinical trial to evaluate the how the FCGR3A F158V genotype impacts 300 breast cancer patients’ response to Herceptin.
 
“This program has the potential to yield a fully validated pharmacogenetic test for targeted therapy in solid tumors,” McNeely said.
 
Initially, PGxHealth's FCGR program led to the development of Clinical Data’s rituximab test, which detects a variant in the FCGR3A gene associated with response to rituximab monotherapy in follicular non-Hodgkin's lymphoma. “We believe the FCGR pathway has the potential to be as exciting an area as KRAS testing has become and that it may be applicable across an entire class of monoclonal antibody therapeutics including Herceptin and Erbitux,” McNeely added.
 
Over the past two years, in an effort to transform itself into a personalized medicine company, Clinical Data has internally expanded its R&D efforts – specifically with clinical programs for the depression drug vilazodone – and aggressively acquired several specialty pharmaceutical and diagnostic firms.
 
Vilazodone, a selective serotonin-reuptake inhibitor and a 5-HT1A partial agonist in Phase III studies, has a companion diagnostic associated with it. The company is planning to complete a second Phase III registration trial in the second quarter of 2009, and submit an NDA to the US Food and Drug Administration in the latter part of the coming year.
 

Although the economic crisis might present challenges for the company and the healthcare industry as a whole in the coming year, the company is maintaining an optimistic outlook for 2009.

In 2008, Clinical Data announced plans to acquire two pharmaceutical companies that might help it delve further into personalized medicine: Adenosine Therapeutics in August and Avalon Pharmaceuticals in October.
 
In acquiring Adenosine Therapeutics for $11 million in cash, Clinical Data further bolstered PGxHealth’s pipeline of therapeutics by adding drug candidates in cardiology, diabetes, inflammatory diseases, and sickle cell anemia. Clinical Data CEO Drew Fromkin noted at the time that the acquisition could produce targeted therapeutics and companion biomarker tests in a number of therapeutic areas.
 
Regarding its proposed acquisition of Avalon Pharmaceuticals for $10 million, Clinical Data said in a statement that the combined company “will have a significantly expanded oncology business with a pipeline of promising oncology biomarkers and compounds, and a biomarker discovery platform to identify additional therapeutic and diagnostic candidates.” McNeely could not elaborate on this acquisition since the deal has not yet closed.
 
In the coming year, “strategic acquisitions and partnerships will continue to be a core part of our business strategy,” McNeely said. Particularly, the company intends to establish collaborations with academic research institutions and industry for its FCGR program, and is looking to expand its cardiovascular franchise with new tests.
 
In the quarter ended Sept. 30, the company’s genetic testing revenue under the PGxHealth division grew 127 percent, led by sales of its Familion tests for inherited cardiac disorders. In 2008, the company launched two new Familion tests for hypertrophic cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy.
 
Helping drive adoption of Clinical Data’s genetic tests was Aetna’s decision in October to provide “in-network” coverage of Familion tests. “There are now over 150 million covered lives to date, up from 100 million in the beginning of calendar year 2008,” McNeely noted. PGxHealth’s genetic testing services have Medicare coverage and Medicaid coverage in 37 states.
 
Other than the HCM and ARVC tests, Clinical Data also markets under its Familion brand tests for long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic ventricular tachycardia.
 
In addition to PGxPredict:Rituximab for non-Hodgkin’s lymphoma, Clinical Data markets pharmacogenetic tests for warfarin sensitivity. The company is developing pharmacogenetic tests for Herceptin and Erbitux under its FCGR program, as well as tests for conditions of the central nervous system, rheumatoid arthritis, and diabetes.
 
In 2009, Clinical Data’s focus will remain focused on CNS, cardiovascular disorders, and oncology. Particularly with the acquisition of Adenosine, “we now have additional highly selective molecules … some of which are partnered and others which we may bring forward ourselves or with partners,” McNeely said.
 
Although the economic crisis might present challenges for the company and the healthcare industry as a whole in the coming year, the company is maintaining an optimistic outlook for the new year.
 
“While 2009 is likely to continue to pose challenges for companies operating in this difficult and often unpredictable economic climate … we will continue to take steps to maintain Clinical Data’s leadership position among specialty biotech companies, and within the pharmacogenomics/genetics arena, and these may include M&A, partnering, and establishing additional collaborations with academic and industry leaders,” McNeely said.

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