(Bloomberg) -- In three recent deals, drugmakers are betting that personal genetic maps will finally fulfill their early promise to unlock secrets and cure diseases.
At the same time, the agreements revived questions about privacy protections and how useful personal genetic data will prove to be.
Roche Holding AG committed $1 billion to take control of Foundation Medicine Inc., which sequences genes of cancer patients, aiming to customize treatment. Roche’s Genentech unit said it would pay as much as $60 million for access to 23andMe Inc.’s data on customers with Parkinson’s disease. And Pfizer Inc. reached a deal that will allow the drugmaker to analyze personal genetic information from 650,000 23andMe customers, without giving terms.
The pacts, together with 23andMe’s announcement that it will enter into partnerships with eight other companies this year, boosted confidence in the commercial value of gene mapping. Since the first draft of a full human genome was deciphered in 2001, researchers have predicted breakthroughs in understanding the origins of disease, only to be frustrated as business developed slowly and regulatory issues cropped up.
Foundation Medicine and 23andMe were created to serve consumers directly and are not developing medicines. Foundation Medicine’s clients pay to have more than 300 genes in their tumors sequenced, and then receive counseling about voluntarily entering trials of drugs that may address genetic abnormalities in their cancers. Customers of 23andMe, on the other hand, are encouraged to “learn about yourself” through genetics.
Now drugmakers are seeing research value in the genetic databases the companies have created.
“Core to our mission is making data available to other researchers to advance genetic discoveries, and we are committed to doing so in the most responsible way possible,” said Angela Calman-Wonson, a spokeswoman for Mountain View, California-based 23andMe.
Roche’s purchase of control of Foundation Medicine shows how integral genetic testing has become to cancer treatment, said Eric Topol, chief academic officer at Scripps Health, a health-care system in San Diego.
“This is the biggest commercial validation that sequencing in cancer is getting legs,” he said in a telephone interview. “We’re starting to see the beginning of the cancer sequencing story play out.”
Companies are betting that sharing data on patients, their conditions and response to treatments will make health care more effective and efficient. Closely held Sophia Genetics, based in Lausanne, Switzerland, is building a secure network of patients’ genomic data that can be shared among hospitals and clinicians in Europe.
“The 10, 20 minutes that the specialist spends analyzing one case is very valuable for every other patient who may come out with the same genetic variance,” said Jurgi Camblong, Sophia’s chief executive officer, in a telephone interview. “Sharing this information and knowledge is fundamental to leveraging this technology and enabling the entire field to take off.”
The field has gone through some growing pains. The U.S. Food and Drug Administration told closely held 23andMe, co- founded by Anne Wojcicki with backing from Google Inc., to stop giving customers health-related interpretations of its Personal Genome Service in 2013 because it lacked “marketing clearance or approval.”
After announcing the deals with Genentech and Pfizer, Wojcicki, married to Google co-founder Sergey Brin, said the company is trying to repair relations with the FDA and has submitted an application for the approval of a genetic test.
Privacy issues have also been raised. “I’m concerned about the rhetoric that 23andMe uses regarding giving people access and democratizing the genome,” said James Evans, a geneticist at the University of North Carolina in Chapel Hill. “I wonder how people will feel about what I guess is the sale of their genomic information and accompanying data.”
Personal information and genetic data are stored separately at 23andMe, with software, hardware and security measures employed to protect customer privacy, Calman-Wonson said. Pfizer is interested in developing diagnostics and treatments from the data.
Foundation Medicine, based in Cambridge, Massachusetts, follows government privacy standards, uses firewalls and lets patients know how their data are used and protected through an informed-consent process, Chief Executive Officer and President Michael Pellini said in an e-mail.
And the usefulness of the data is still uncertain, as other companies have discovered. DeCode Genetics Inc. generated data on patients suited to certain drugs from genetic analysis of DNA and the medical data of thousands of residents of Iceland, where the company was based.
DeCode hasn’t produced any drugs, and Amgen Inc. bought the company in 2012. While new genetic and analytic tools, bigger DNA databases, and longer study may help, the strategy needs to be proven fruitful.
After the recent deals, Evans said he hoped Pfizer “didn’t pay too much” for 23andMe’s data.
Amgen declined to comment immediately. Sean Harper the company’s head of research and development said at an October conference that DeCode’s information has helped the company move forward on drug candidates for heart disease and asthma. Some advances have given the industry confidence in personal genetic maps as a research tool. Genetic research has already played a role in discovering and targeting treatments for lung cancer and other lethal diseases.
Roche wants to expand its capacity in the personalized medicine field, using genetic tests to determine the specific treatment an individual is most likely to respond to, said Samir Devani, a biotech analyst at Rx Securities in London.
“If you look down the global R&D pipeline and those requiring testing for gene mutations, more and more drugs are going down that route,” he said in a telephone interview. “Pharma companies are increasingly looking for patient populations that are going to benefit most from their drugs, and diagnostics is an integral part of that process.”
Huge data sets are attractive for looking for patient commonalities. Medical centers in Boston, St. Louis and Washington are storing patient DNA tests and medical records with an eye to analyzing them for clues to new diagnostics and treatments.
“There’s always this tension between sharing data broadly and keeping that privacy and confidentiality structure as rigid as possible,” said Robert Green, a Harvard Medical School geneticist at Brigham and Women’s Hospital in Boston.
Genentech plans to mine 23andMe’s data for clues to understanding Parkinson’s disease. While Pfizer hasn’t specified which disease area it will be looking at, the company has said it is planning to build a community of patients affected by lupus, an autoimmune disease.
--With assistance from Caroline Chen in San Francisco.
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