Pharmaceuticals Tailor-Made For You
Firm hopes targeted plan will cut development costs
By Ken Alltucker
The Arizona Republic
Systems Medicine Inc. has staked out the ambitious goal of paving a new path to drug development.
With the industry's backdrop of failure and high costs, startup companies such as Systems Medicine want to figure out a more direct way to get drugs to patients based on their genes.
The most expensive aspect of developing a drug is paying for clinical trials that test its safety and effectiveness.
Pharmaceutical companies halt development of such drugs if clinical trials show they work on just a small percentage of patients.
But the idea behind Systems Medicine is that these drugs could be useful for a smaller group of patients.
The key is developing the right molecular tests to identify these patients.
"The whole idea tied to Systems Medicine is we want to apply molecular intelligence to our drug development," said CEO Jeff Jacob. "We want to get the right drug to the right patients at the right time."
Big Pharma's playbook could be described as all or nothing.
Pipeline Challenge
A report by Pharmaceutical Research and Manufacturers of America found that it takes up to 15 years and $1.7 billion to shepherd a drug from a lab to U.S. medicine cabinets. The number of new drug applications submitted for federal approval has dropped 50 percent over the last decade.
The challenge is compounded by the high-stakes failure of drugs such as the painkiller Vioxx, which was approved by the Food and Drug Administration but later pulled from the market after it was linked to heart failure.
Systems Medicine's executives split time between an office at the Mayo Clinic campus in Scottsdale, Ariz., and a second office next to the Critical Path Institute (C-Path), a Tucson, Ariz., nonprofit group dedicated to helping pharmaceutical companies navigate the long and laborious path to drug and medical device approval.
The startup pharmaceutical company will rely on the genomics know-how of Phoenix research institute TGen and its sister research group, International Genomics Consortium, to test the theory.
"I think Jeff (Jacob) is approaching this with a real understanding of the challenge," said Ray Woosley, president and chief executive officer of C-Path.
"He is really innovative in the way he approaches drug development. It's basically what we are trying to do."
Systems Medicine's plan to tailor drugs to individual patients is not a new concept.
Genentech, a San Francisco Bay Area-based biotech company, developed a breast-cancer drug for patients with a certain genetic marker. The drug, Herceptin, is administered to patients with a tumor that has a protein called HER2. An estimated 8,000 to 10,000 women die each year in the United States of this type of tumor.
Other researchers and companies, too, are pursuing plans to use drugs that work on patients based on their genes.
"The hope is that you are fishing in a barrel rather than fishing in a pond," said Emanuel Petricoin, a co-director of the Center for Applied Proteomics and Molecular Medicine at George Mason University in Virginia. "There are a lot of drugs sitting on pharmaceutical companies' shelves that could resurrect themselves."
On Trial
Systems Medicine now is spending most of its time and energy developing a potential cancer drug called Brostallicin.
The company plans a trio of clinical trials with Brostallicin to test its business plan of targeting patients who are most likely to respond to the drug.
"We will only select patients that have a certain molecular marker," Jacob said.
Jacob still is trying to raise $25 million in venture financing to help the small company expand and pay for the clinical trials.
A lead investor has committed $10 million, but Jacob said the company still needs "another big fish at the table."
Systems Medicine Chairman Richard Love said the company, if successful, would make Arizona a pioneer in a new approach to developing drugs.
"The (pharmaceutical) industry is making a huge shift," Love said. "It doesn't turn on a dime. A small company can turn on a dime. That is why we are taking this approach."
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