The field of predictive medicine, one subsector in which the largely faded near-term promise of genomics maintains its color, is just where Myriad Genetics Inc. has wanted to be from the start - but not the only place.
With a handful of tests on the market to determine disease susceptibility, Myriad also has a pipeline of potential therapeutic products, all of which the company aims to boost with $57.3 million raised last week in a stock offering pursuant to a shelf registration.
"We're one of the very few companies in genomics or in biotech, probably, in which the story hasn't changed much," said William Hockett, vice president of corporate communications for Myriad. "Our [initial public offering] prospectus in 1995 basically says what we say today, which is that we want to do both." The company's oversubscribed initial public offering grossed $46.8 million in the fall of that year.
Times have changed - and, for Myriad, improved. The company already had enough cash, about $104 million as of Sept. 30, to operate for at least three years. That amount, although hardy, was down from $136 million at Sept. 30, 2001, and down from $124 million as of June 30, due mainly to spending on the completion of a new research facility, as well as the timing of payments from collaborators.
Myriad's most advanced therapeutic is Flurizan (MPC-7869), licensed from Encore Pharmaceuticals Inc., of Loma Linda, Calif., in December 2000, which is in Phase II/III trials for early stage prostate cancer. It's a component of the marketed non-steroidal anti-inflammatory drug flurbiprofen, sold generically and under the brand name Ansaid by Pharmacia Corp., of Peapack, N.J.
That's just the sort of thing investors like to hear, having spurned genomics tools companies (or those with products in preclinical trials) in favor of firms with the possibility of more immediate payoffs.
Yet, Hockett noted, Myriad is uniquely strong in the area of predictive medicine - an area that edges ever nearer to the zone of therapeutics.
"We see them merging [eventually]," he told BioWorld Financial Watch. "We think there will be a number of medicines developed which are preventive in nature, and you would give them to individuals with a high risk. There are [other companies] moving in this direction, but they have the desire - not products on the market."
Myriad has five, and reported $7.9 million in sales for the recently reported quarter ending Sept. 30, a growth of 43 percent from the previous year's period.
The tests include the BRACAnalysis product for breast and ovarian cancer; Colaris in two versions, for colon and uterine cancer; Melaris for hereditary melanoma; and CardiaRisk, which identifies patients with high blood pressure who are more likely to benefit from ACE inhibitor or aII receptor blocker classes of drugs. Others are in development for prostate cancer susceptibility and diabetes.
With its patents on the breast-cancer susceptibility gene BRCA1, Myriad has run into some trouble in France. Several medical establishments in October said they are challenging a third patent issued on the gene by the European Patent Office. The complaint was lodged jointly by the cancer center Institut Curie of Paris, the Paris public hospital authority and the Institut Gustave Roussy, of Villejuif, which is the leading cancer clinic in Europe. Backing the complaint are the French Hospital Federation, France's National Federation of Anti-Cancer Centers, the Dutch and Austrian health ministries, and human genetics companies and research organizations in 11 European countries.
Claude Huriet, president of the Institut Curie, said Myriad's moves represent "the first time a company has displayed such monopolistic designs." Although he said he was "not hostile to the principle of patents," those as broad as Myriad's "can hamper whole swathes of genetics research."
Peter Meldrum, Myriad's president and CEO, disagreed, telling BioWorld Financial Watch the company is only seeking to bring about "what a patent is designed to do - reward someone who invests a lot of time and financial resources, and give them a window of time during the life of the patent to recoup that investment."
He said four patents have been awarded in Europe, where authorities provide a nine-month window after the granting of the patent when it can be challenged.
"The first was not opposed and has been perfected in every major country in Europe," he said. "Of the other three, two have been opposed and the time period has not expired on the third. We expect it will be opposed also."
Myriad will respond to the challenges as they are made.
"We'll file our dissents," Meldrum said. "It's pretty routine. It's not legal action or expensive to the company. Whether or not the other three are successfully opposed doesn't affect our intellectual property position."
The company, meanwhile, will continue to funnel money raised through its predictive medicine programs to the therapeutic pipeline. Just the same, David Webber, biotechnology analyst with First Albany Corp., lowered his rating from "strong buy" to "buy," based on a conference call with Myriad this month.
Webber noted the "sluggish pipeline" in his research report.
"The pace just wasn't great enough to justify a strong buy rating, and I was talking about the therapeutic pipeline," he told BioWorld Financial Watch. "They're still doing fine with the predictive medicine tests."
Just the same, Myriad is advancing its marketing efforts for the BRACAnalysis test with Laboratory Corporation of America Holdings. A direct-to-consumer advertising campaign began in September in Denver and Atlanta, which analysts expect to bear fruit in the second half of 2003. At that point, Myriad is expected to decide whether to expand the campaign nationally. In Europe, revenue is expected from the predictive medicine products in fiscal 2004.
Therapeutic efforts continue apace. "Our therapeutic and predictive medicine strategies go hand in hand," Meldrum said. Myriad's R-flurbiprofen, familiar from the prostate cancer effort, also is being evaluated in a Phase I trial to prevent and treat Alzheimer's disease.
Gene discovery remains part of the big, two-part picture. In late October, Myriad said it had discovered the novel obesity gene HOB1, mutations in which apparently increase function rather than lessen it. That's considered good news, since research on blocking a drug target has proven mostly easier than trying to renew function. Along with obesity, HOB1 is implicated in Type II diabetes - a major and potentially very lucrative indication.
The two conditions long have been known to have a connection, but the gene represents "the first evidence they are linked at the molecular level," Meldrum noted.