Through nearly two decades since founding NPS Pharmaceuticals, the former University of Utah School of Medicine anatomy instructor has sought venture capitalists, recruited research fellows and waited for the company's books to transform from red ink to black.
"This is a tremendously exciting time," Hunter says. "We're finally at that certain coming of age. All of us who have been involved with this company could soon be able to feel as though we have done all we set out to do back in 1986."
And, NPS finally is on the threshold of profitability - welcome news for patient investors. In the past five years alone, NPS reported net losses totaling nearly $508 million, with 2000-2004 revenues a shade under $44.3 million. During that time, more than $430 million was poured into research and development on a dozen compounds.
Net losses for fiscal 2005, if trends from the first three quarters hold true, could near 2004's $168.25 million. But now, Jackson can deliver that news with a smile. With the addition last month of its promotion of the chronic dry eye medicine Restasis, NPS has partnered in marketing four new drugs - Sensipar and Mimpara for secondary hyperparathyroidism, and arthritis medicine Kineret - in the past 19 months.
In the coming year, NPS could transform from being a big-spending pharmaceutical R&D company to one wading into domestic and global markets worth billions of dollars. The company's osteoporosis compound, Preos, is the flagship. Clinical trials have shown the drug effective in halting, and even reversing, bone loss associated with the disease, and Preos was accepted for review by the Food and Drug Administration this past May.
The drug may hit pharmacy shelves in Europe before it does in the United States. In the European Union, where Preos will be sold under the brand name Preotact, NPS partner Nycomed Danmark filed for regulatory approval in March.
"Success will give us more control over our destiny," Jackson says. "That has always been part of our drive to become an integrated biopharmaceutical company - one that not only controls what happens to our technology in the public marketplace, but reaps the financial return on that technology."
Utah optimism: NPS' flirtation with profitability is not unique. Brian Moss, president and executive director of the Utah Life Science Association, says a number of Utah biotech and biomedical companies can see hard-fought-for payoffs coming.
"I see tremendous growth ahead for the sector through the rest of this decade," he says. "And our companies are very closely tiered to their intellectual roots, the universities who spawned us."
A lot of the sector's coming growth will be market-sustained. But strengthening Utah's position as one of the nation's top biotech and biopharmaceutical locales will take a closer partnership of state government and industry, Moss says.
The association is pushing the Utah Science, Technology and Research (USTAR) economic development initiative to further seed that growth.
A legislative-business proposal, USTAR calls for a total, joint public-private sector investment of about $500 million over the next 10 years to help the U. of U. and Utah State promote tech-based startups, and to encourage private business innovation.
Proponents contend the payoff for that investment will be huge: Nearly $5 billion in federal and commercial contracts and grants over the next 30 years, along with more than 420 new companies employing 123,000 Utahns.
"With our research institutions and the nature of our people, we are highly entrepreneurial and inventive," Moss says. "And look at the mapping of the human genome. A lot of that happened here, [so] we already have a core competency in genetics."
A good portion of that biocellular intellect resides at Myriad Genetics Inc., which has become a world leader for genetically based cancer predictive tests such as BRACAnalysis (breast and ovarian cancer), Melaris (hereditary melanoma) and Colaris (colorectal cancers).
That suite of tests provides the bulk of Myriad's sales. In fiscal 2005, ending June 30, worldwide sales of the tests topped $71.3 million, comprising all but about $9 million of company revenues.
But Myriad's pharmaceutical wing is poised to take flight. The company's Alzheimer's disease compound, Flurizan, has exceeded expectations in clinical trials: Tests indicate the compound can halt the memory-robbing disease in its early stages.
In September, Myriad reported that a follow-up to its recently completed Phase II study showed that patients with mild Alzheimer's who received twice-daily, 800-mg doses of the drug Flurizan showed up to a 45 percent slowing of the disease-caused memory deterioration.
"This is real progress. Alzheimer's is fatal, and the newly diagnosed patient today has a life expectancy of 10 years," says Peter Meldrum, Myriad's president and CEO. "If you slow the progress of the disease 45 percent, that's four to five additional years you might delay the patient going into a nursing home."
Just how long that benefit might last will be addressed in a Phase 3 study at 130 sites, including Utah.
Final clinical trials pointing to FDA approval are expected to begin in mid-2006. Sometime in 2008, Myriad hopes to see Flurizan enter a market that is addressing the needs of a growing number of people. More than 4 million Americans have Alzheimer's - a number expected to grow to 16 million by 2050.
Utah, with more than 22,000 Alzheimer's cases, is expected to top 50,000 by 2025, a 127 percent increase.
Other drugs in the testing-FDA approval pipeline ensure that Myriad could transition from a 14-year corporate life span of net losses to a profitable player in biotech within the next couple of years. They also give the company an open-ended period of "sustainable growth," Meldrum says.
That will translate to new jobs. Myriad, with 725 employees, plans to add 100 more in 2006. NPS, too, expects to increase its work force of about 350, but is reticent about providing actual figures until prospects are clearer.
Diverse strategy: Myriad is pegging its hopes on more than its predictive testing and Flurizan. The company also has research under way on compounds aimed at various cancers, thrombosis and HIV/AIDS. The candidate drug MPC-7869 is next up in Myriad's FDA batting list. The drug, targeting prostate cancer, is midway through Phase 2 testing with a possible market release in 2008 or thereafter.
Another compound, first-phase testing candidate MPC-6827, holds breakthrough-level promise in the treatment of metastatic brain cancer, Meldrum says.
"It is showing very effective in inhibiting the growth of tumors, and it appears to easily cross the blood-brain barrier, allowing higher and more effective concentrations of the drug in the brain," he explains. "There really are no drugs today to treat metastatic brain cancer. This would be the first, if approved."
The potential for profits is enormous. Along with its popular cancer-risk tests, Myriad is preparing for the challenge of handling not just one big drug in Flurizan, but several, as the company's other compounds wend their way through testing.
"There are 170,000 new cases of metastic brain cancer each year. Patients so diagnosed have a life expectancy of three to six months, so it is a huge problem," Meldrum says.
While NPS, Myriad and others work hard to develop the next generations of drugs, Lipocine Inc. hopes to cash in by providing better technology to deliver them - and with fewer side effects. For example, Lipocine's solutions include improvements to compounds to improve the rate at which they can be absorbed orally, a benefit that can both boost effectiveness and reduce dosages needed to obtain results.
The company has seven of its products in pre- or early clinical testing, ranging from cardiac, cancer and pain management to diabetic and obesity treatment applications. With many of the company's projects under license and confidential, Lipocine is limited in what it can boast.
Still, what President and CEO Mahesh Patel can say is titillating.
"Lipocine is poised to commercialize several products," he says. "These products are expected to be highly profitable [because] they are designed to offer distinct therapeutic benefits over the existing" competitors.
With the eight-year-old company confident of its niche and a growing portfolio of its own biotech patents to speed commercialization, Patel is confident his company will be among the state's leaders in providing "lucrative returns to its investors and the community over the next few years."
bmims@sltrib.com
Biotech facts
Utah's biotechnology/ biomedical sector
currently employs at least 30,000 Utahns.
* Utah has more than 20 biotech companies,
ranking the state No. 15 nationally.
* Figures on the overall economic impact of
biotech are rare, but the direct contribution of Utah's biopharmaceutical industry alone topped $330 million in 2003.
* From development through clinical trials and final approval by the Food and Drug Administration, approval of a new drug can take 3-8 years. Preclinical trials are typically followed by at least three phases of trials, and then a New Drug Application. From there, it takes about a year to gain approval - or orders for more testing.
Sources: Utah Workforce Services, Utah Life Science Association, Milkin Institute, FDA
