As lead product Flurizan is being tested in a Phase III trial for Alzheimer's disease, Myriad Genetics Inc. priced a public offering of its common stock to raise $129.5 million.
The Salt Lake City-based company is offering 7 million shares at $18.50 apiece, and could raise another $19.4 million if the underwriters exercise in full an overallotment option for another about 1.1 million shares.
"It is very significant for Myriad because it allows us to stay on track with the best course of development for our therapeutic candidates that are in human clinical trials now," said Bill Hockett, Myriad's executive vice president of corporate communications.
According to the company's prospectus, net proceeds will go toward general corporate purposes, including advancing preclinical and clinical drug development, and building Myriad's predictive medicine business. The funds will last the company "for the next two or three years at the very least," Hockett said.
Flurizan (R-flurbiprofen), is in a two-arm Phase III study evaluating 800 mild Alzheimer's disease patients randomized to receive 800 mg twice daily or placebo at more than 130 centers in the U.S. The trial is designed to assess the ability of Flurizan to reduce the rate of cognitive decline and decline in activities of daily living. While the product failed to reach statistical significance in a Phase II trial, it did demonstrate a 34 percent to 45 percent slowing in decline on the three primary endpoints: activities of daily living, overall function and cognitive ability. Generally, a 20 percent or greater slowing of decline is regarded as clinically relevant.
Flurizan, the first in a new class of drugs called selective amyloid beta-lowering agents (SALAs), appeared to be well tolerated in the Phase II trial, and the company is conducting a follow-on study with those patients. It also has Flurizan in a Phase IIb trial designed to see if the product can delay the onset of metastases in patients with prostate cancer. The three-arm study of 800 mg twice daily, 800 mg once daily or placebo, is enrolling 82 patients per arm at centers throughout the U.S. and Canada.
Myriad licensed Flurizan in December 2000 from Encore Pharmaceuticals Inc., of Riverside, Calif.
Another product in Myriad's pipeline, MPC-6827, is a small-molecule tubulin inhibitor in two Phase I trials to evaluate its safety and pharmacokinetic profile in patients with advanced solid tumors and metastatic brain tumors. In preclinical studies, MPC-6827 has demonstrated activity against tumors of the prostate, breast, pancreas, colon and skin.
A third clinical product, MPC-2130, an apoptosis-inducing small molecule, is in a Phase I trial in patients with advanced metastatic tumors or blood cancers, as well as refractory cancer that has progressed despite previous chemotherapy. It has shown activity in killing ovarian and prostate cancer cells, as well as two lymphoma cell lines.
"We're excited about all of [our products] and the additional financial resources will make certain we stay on track," Hockett said, adding that an additional Phase III trial of Flurizan is planned in Europe.
That trial would support a European filing, and possibly support the U.S. trial in gaining FDA approval.
At the preclinical stage, Myriad is studying MPI-49839 for AIDS, MPC-0920 for thrombosis and MPC-4505 for chemotherapy-induced emesis. The company may file investigational new drug applications for the first two preclinical candidates as early as the middle part of 2006.
On top of its pipeline, Myriad markets four predictive medicine products that analyze genes and their mutations to assess a person's risk for developing disease later in life. Through a 115-person sales force in the U.S., the company has pulled in $71.3 million in revenues for the year ended June 30. The products include: BRACAnalysis for breast and ovarian cancers, Colaris for colon and uterine cancers, Colaris AP for colon cancer, and Melaris for melanoma.
Myriad has exclusive rights to all of its products, including those in clinical trials. It expects to take its cancer products to market alone, using its current sales force for the predictive medicine products.
"Flurizan, we would likely partner," Hockett said, "after Phase III, when we have good data and it becomes most valuable to the company."
Myriad also plans to enter strategic alliances with pharmaceutical companies for products outside the areas of cancer, Alzheimer's disease and viral disease. Already, it has licensed certain drug targets and candidates to Abbott Laboratories, of Abbott Park, Ill.; Novartis AG, of Basel, Switzerland; Schering-Plough Corp., of Kenilworth, N.J.; Indianapolis-based Eli Lilly and Co.; and Cephalon Inc., of Frazer, Pa. And it is working with a number of organizations, including the National Institutes of Health, to discover genes and proteins associated with human disease, to elucidate protein networks and disease pathways and to sequence the genome of entire organisms.
The company raised $50.2 million in June 2004. (See BioWorld Today, June 7, 2004.)
For the latest financing, JP Morgan Securities Inc. is acting as the sole book-running manager, while Bear Stearns & Co. Inc. and UBS Securities LLC are acting as co-lead managers. Co-managers include Piper Jaffray & Co., First Albany Capital Inc. and JMP Securities LLC. All firms are in New York, except for Minneapolis-based Piper Jaffray.
Following the offering, Myriad will have almost 38 million shares outstanding. As of Sept. 30, the company had about $103 million in cash, cash equivalents and marketable securities.
Its stock (NASDAQ:MYGN) fell 35 cents Friday to close at $18.60.