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Clinical Data, Avalon Pharmaceuticals, Aetna, US Centers for Disease Control and Prevention, University of California - San Diego, Nuffield Council on Bioethics, Strategic Diagnostics, University of Delaware, Helen F. Graham Cancer Center

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Clinical Data to Acquire Avalon Pharmaceuticals for $10M; Aetna to Reimburse for Cardiac Test
 
Clinical Data this week said that it has entered into a definitive agreement to acquire Avalon Pharmaceuticals for $10 million, providing Clinical Data with a pipeline of oncology biomarkers and a biomarker discovery platform that will be used to identify diagnostic and therapeutic candidates.
 
Newton, Mass.-based Clinical Data will issue stock to Avalon’s shareholders based on a 15-day volume weighted average price of $12.49 per common share. Clinical Data also will issue to Avalon’s shareholders up to $2.5 million of additional shares of Clinical Data’s common stock if certain milestone payments are met under Avalon’s collaborations with Merck and the Novartis Institute for Biomedical Research prior to June 30, 2010.
 
Avalon’s board has approved the deal, which must also receive the approval of Avalon’s shareholders.
 
The merger pact was part of a series of four agreements between the companies, which included a private placement, a secured term loan agreement, and an exclusive license to Avalon’s drug and biomarker discovery platform.
 
Drew Fromkin, president and CEO of Clinical Data, said in a statement that Avalon’s “extensive library of biomarkers and compounds, and oncology expertise, add to our growing estate of proprietary oncology biomarkers and in-depth knowledge of biomarker and pharmacogenetic test development.”
 
Separately, Clinical Data division PGxHealth this week said that Aetna would provide coverage for its Familion family of genetic tests that are used for detecting inherited forms of cardiac channelopathies and cardiomyopathies.
 
The Newton, Mass.-based firm did not provide financial details of the reimbursement, but it noted that with the in-network coverage for Aetna patients, its Familion tests have positive reimbursement policies from private and public insurers covering an estimated 155 million lives. It also noted that PGxHealth is an approved Medicare provider for its genetic testing services and a Medicaid provider in 37 states and the District of Columbia.
 
The Familion tests detect genetic mutations that can cause cardiac channelopathies and cardiomyopathies, said Clinical Data. The tests can be used by physicians to help guide treatment and reduce the incidence of fatal cardiac events, the firm said.
 

 
UCSD to Lead CDC Effort to Spread PGx Awareness to Pharmacists
 
A new program funded by the US Centers for Disease Control and Prevention will seek to promote education among pharmacists, medical students, and other healthcare workers about new advances in personalized medicine, according to the University of California, San Diego, which is a lead partner in the program.
 
The CDC has funded the Pharmacogenomics Education Program, which aims to provide education to over 100,000 pharmacists and others throughout the country, with around $1 million.
 
Along with UCSD’s Skaggs School of Pharmacy and Pharmaceutical Sciences, the PharmGenEd collaboration will involve the American Pharmacists Association, the American Society of Health-System Pharmacists, and the American Association of Colleges of Pharmacy, and will include partners at Purdue University and at the Karolinska Institute in Sweden.
 
The collaboration, which is funded for three years, will work with the CDC to develop a curriculum that is focused on “basic pharmacogenomics concepts, as well as their clinical applications,” which will include live and web-based approaches.
 
“Pharmacogenomics has a promising potential to increase the response rate of drug therapy and decrease the events of adverse drug reactions,” UCSD principal investigator Grace Kuo said in a statement.
 
“Currently, however, pharmacogenomics education materials are not readily available to healthcare professionals, and there appears to be a gap between healthcare providers’ knowledge and the expectations of patients regarding pharmacogenomics testing,” the school said.
 
The collaborators also will attempt to describe genetic sequence differences to pharmacists and healthcare practitioners and how those differences could affect therapeutic outcomes.
 

 
UK Bioethics Council to Review Personalized Medicine Policies
 
The United Kingdom’s Nuffield Council on Bioethics is starting a one-year study that will look into the ethical issues that have begun percolating as personalized medical technologies have rapidly advanced, NCB said last week. 
 
The NCB has created a working group with varying backgrounds in medicine, law, philosophy, and sociology, which will gather evidence and will hold a public consultation in the spring of 2009 to bring together a wide range of views on issues raised by personalized medicine. NCB expects to issue a report with recommendations for policy and practice in early 2010.
 
The launch of this program coincides with the release of the Healthcare Commission’s annual report on the performance of the National Health Service, NCB said. 
 
Personalized genomics is at the center of the ethical issues that the council wants to review, but the working group also will look into medical imaging technologies such as CT or MRI scans, as well as the field of telemedicine.
 
“Imagine a future situation where a young woman has her entire genome sequenced and this tells her that she has an increased risk of developing Alzheimer’s disease later in life,” University of Oxford professor and NCB council member Christopher Hood said in a statement.
 
“Would she have been better off not knowing? How might it affect her insurance policies, and might it increase the burden on the NHS?,” Hood inquired. “We will be advising policy makers on the impact of this kind of technology and how it might be regulated,” he said.
 
Low-cost genome sequencing, which is now on the horizon, could lead to an age of unique problems, Hood suggested. He said that companies “may exaggerate the risk of disease to cover themselves against possible legal action, which may cause unnecessary anxiety and an increased burden on NHS services as people follow-up,” Hood continued.
 
He also said that confidentiality issues and who will have access to personal genetic information that come from genetic tests also are important issues the working group will discuss.
 

 
Strategic Diagnostics Joins Delaware Collaboration to Find Prostate Cancer Biomarkers
 
Strategic Diagnostics will collaborate with the University of Delaware and the Helen F. Graham Cancer Center to develop protein biomarkers that could be used to detect metastasis in prostate cancer patients, the company said last week.
 
SDI said it will work with UD to develop antibodies that identify protein fragments that break away from primary tumors when cancer is spreading. Diagnostic tests using these antibodies could help doctors determine the stage and the severity of the cancer, and could help them develop effective treatment options specifically for metastasized cancer cases.
 
SDI President and CEO Francis DiNuzzo said in a statement that the company will use its Genomic Antibody Technology to develop the biomarker tests.
 
Additional details of the alliance were not disclosed.
 
The Helen F. Graham Cancer Center is one of 14 National Cancer Institute centers in the US.

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