Anticipating new clinical trial, AlleCure doubles research staff. (Up Front).

With final clinical trials for greatly anticipated allergy vaccines expected next year, startup biotech AlleCure Corp. has doubled its staff of research scientists in an effort to hit the market with its first products by 2004.

The Valencia-based company has hired 46 new employees, most research scientists, since January and plans to add about a dozen more by the end of the year to assist the company during critical final clinical trials for its vaccines, said AlleCure CEO Stephen J. McCormack. The company had a staff of 42 at the beginning of the year.

The company is developing vaccines for hay fever, bee venom and other allergies.

Bill Robbins, managing director of Convergent Ventures LLC, a venture capital firm in Los Angeles that funds biotechs, estimated the company added about $2 million to its payroll with the new hires. He noted that these costs will probably pay off despite the fact the company has yet to make a dollar.

"They're in a very particular niche with products that, if they work the way they say, they'll be very, very big," he said.

After three years of research and development, AlleCure officials say they are close to bringing an allergy vaccine to market. The company, owned by biotech pioneer Alfred E. Mann's MannKind Corp., has about $200 million at its disposal for research with the estimated 50 million Americans who suffer from allergy-related problems as its target market.

AlleCure officials also estimate the market they are aiming for, which they would have a considerable share of from the start, should be worth about $8 billion a year.

"It's not unreasonable to say that their products could be worth hundreds of millions of dollars in annual revenue," said Brent Reinke, an attorney with the law firm Crosby, Heafey, Roach & May, which has put together a number of funding deals with biotech firms in the San Fernando Valley and Central Coast.

With two allergy vaccines in the pipeline Reinke said, the company is poised to become a market leader almost from the start.

Although officials won't say more than "next year" when asked about the third and final stage of clinical trials, the company is looking toward 2004 as the earliest its vaccines will become available.

Perhaps the first to hit the market would be the bee-venom vaccine, Bee AlleVax. The vaccine would desensitize allergic patients with as few as four shots over a six-month period.

Allergies to these venoms are common, causing sometimes severe reactions, resulting in death in some cases. Altogether, an estimated 40 to 100 people die from such stings each year, according to statistics from the American Academy of Allergy, Asthma and Immunology.

Two more AlleCure vaccines, TGP AlleVax and MGP AlleVax, treat seasonal allergic rhinitis, or hay fever, which affects about 25 percent of the U.S. population.

The hires are part of a continuing growth pattern aimed at strengthening the company's research and marketing efforts, McCormack said.

"The hiring is really about continuing to develop the products that we have and help formulate a product that is safe and efficacious," McCormack said.

"We are working with consultants and marketing experts to develop a marketing plan for us," McCormack said.

Delivering a long-lasting vaccine for an allergy was seeming lunacy just a decade ago, said Ahmed Enany, executive director of the Southern California Biotech Council.

"That's what makes this kind of work so exciting to the biotech community," he said.

By taking just one shot, an allergy sufferer could see symptoms erased for weeks, instead of hours, McCormack said. Existing vaccines must often be used on an ongoing basis, several times a week to alleviate symptoms, while AlleVax would be used once every few weeks.