Hoping to cash in on a market that appears to favor diagnostics over therapeutics, Bayer Diagnostics and Genaissance Pharmaceuticals intend to co-develop SNP-based diagnostic assays for a trio of common and potentially lucrative disease areas.
One of these areas, antihypercholesterolemia, will reacquaint Bayer with statins, a drug category the company chose to abandon two years ago after its entrant Baycol became linked to patient deaths.
The goals of the partnership, announced last week, are twofold: Bayer will use its marketing strength to sell the diagnostic assays to hospitals and large institutional health-care providers, and encourage physicians to prescribe these assays along with new and existing drugs to patients who otherwise would have abandoned their regimens due to adverse events.
“Genaissance has a very substantial haplotyping technology and a broad experience in genetic statistics,” said William Wallen, senior VP of research at Bayer Diagnostics. “Their platform will greatly simplify the testing configurations we have put together to identify SNP arrays that will be useful in identifying specific disease sequelae.”
In its New Haven, Conn., labs, Genaissance will use its HAP platform to identify the pharmacogenomics markers for the assays. These will include markers related to safety and efficacy of drugs used to treat infectious disease, certain cancers, and hyperlipidemia.
In Bayer’s eyes, as additional pharmacogenomics platforms become available “it will become more and more imperative” they are used to predict adverse events, said Wallen. “Running 3,000 to 5,000 patients in a clinical trial may not be sufficient for the FDA after a while. The reason is that adverse reactions can occur at a rate that [regulators] may not recognize them as significant,” he said.
“Since the cost of doing 100,000 patients is unreasonable, the only way to do it is to come up with genomic arrays that identify patients who are associated with the disease and get them out of the way,” Wallen added.
In this case in particular, it was Genaissance’s experience with the pharmacogenomics of hyperlipidemia, or high cholesterol, that brought in Bayer, according to insiders.
To be sure, both companies have rich — and hugely different — experience with cholesterol-lowering drugs, the so-called statins. While Genaissance cut its pharmacogenomics teeth on a pioneering and highly successful clinical trial of four statins, Bayer’s pharmaceutical arm suffered a severe blow in August 2001 when its own statin, Baycol, became linked to patient deaths. The drug, known also as Lipobay, had become Bayer’s fastest growing product and was expected to earn $900 million in revenues in 2001. Bayer would go on to voluntarily remove the drug from the market and turn its back on the statin category.
Coincidentally, Baycol was one of the four statins being tested in the Genaissance trial, known as STRENGTH, or Statin Response Examined by Genetic Hap markers. Similar in design to a phase II study, the STRENGTH project was to uncover how 1,500 haplotypes on roughly 100 genes from a variety of pathways influence the way patients respond to the drugs. The three other drugs in the trial — Merck’s Zocor, Pfizer’s Lipitor, and Bristol-Myers Squibb’s Pravachol — were tested on more than 150 patients at 60 centers around the country.
After Bayer pulled Baycol, Genaissance launched a new study, STRENGTH II, which would investigate a new statin, Merck’s Mevacor. This new study would complement the ongoing STRENGTH trial. STRENGTH II, which studied 150 patients at 45 US centers, has recently ended, according to Genaissance President and CEO Kevin Rakin.
Wallen admitted Bayer chose Genaissance because of its experience with statins, and, like most of its big-pharma brethren, Bayer covets a chunk of the antihypercholesterolemia market, which has grown to mind-numbing heights: Most analysts predict worldwide statin consumption will surpass $16 billion this year. Lipitor, Mevacor, and Zocor account for more than a third of that figure. Bayer, meantime, is gambling that its powerful sales and marketing strength will convince hospitals and managed-care groups that its assays will afford them some savings.
If You Can’t Beat ‘em …
“Big independent health networks such as Mayo and Kaiser Permanente, because they’re self-insured, have to pay for the consequences” of adverse events and poor efficacy, Wallen told SNPtech Reporter. “And the consequences are pretty substantial.” As SNP Consortium Chairman Arthur Holden says, for every dollar US-based hospitals spend on a single drug, they spend that same dollar treating its adverse events. [See accompanying interview, page 6]
The plan also is to ensure that adverse events and poor responders are caught before they occur. “Physicians who now believe that statins don’t work very well because they have some patients that don’t respond very well will move to another drug,” said Wallen. “They don’t understand the genomic reason behind that.”
Bayer Diagnostics hopes in one year to have a prototype assay with which it can clinically validate “rare adverse events,” said Wallen. He said he believes it will take another three to four years before an assay is approved by the FDA. Once approved, Bayer will have exclusive rights to sell the tests while Genaissance will pocket royalties and receive rights to perform these tests in its own CLIA-certified labs.
For Genaissance, the deal is the latest in a handful of similar pharmacogenomics alliances signed in recent weeks: In early January, the company penned an R&D collaboration with Millennium Pharmaceuticals, and in late December it hooked up with Pharmacia. Genaissance also has pharmacogenomics deals with AstraZeneca, Biogen, Johnson & Johnson, and Pfizer.
Despite his company’s extensive collaborations, Rakin said he believes pharmacogenomics-technology providers are only now beginning to round a very long corner. “Sooner or later, pharmaceutical companies will recognize they need pharmacogenomics,” he said. “They will have to realize that this technology will help them develop safer and better drugs.”
Sarah Stalling, a Sloan Industry Center fellow at MIT’s Program on the Pharmaceutical Industry, said Bayer may sidestep a tough therapeutics market and thrive in the rapidly growing area of pharmacogenomics-assisted diagnostics.
“People have predicted that pharmacogenomics could reduce blockbuster revenue,” she said in an interview with SNPtech Reporter. “One of the positive sides, though, is that there is a whole new market for diagnostics. Because in order to make pharmacogenomics work you have to have assays that will give you data for each patient. And people who develop and build those assays are going to benefit.
“It’s a new product stream, to some extent, for pharmaceutical companies,” added Stalling. “It’s a product stream [with which] many pharmaceutical companies haven’t really done as much.”
For Bayer, the partnership comes at a critical moment as US regulators begin focusing more on drug safety and efficacy. “The FDA has allowed some products out there because they’re needed,” said Wallen. But the FDA “is cracking down on safety and efficacy,” he said — and in the process making the regulatory climate ripe for pharmacogenomics.
“I think it’s a coming trend,” Wallen added. “I think pharmacogenomics will be a renaissance for diagnostics.”