Editor’s note: BioWatch is a regular feature on Fridays.Inspire Pharmaceuticals (Nasdaq:INSP) had an up and down year in 2003 as it pushed to get its dry eye drug approved by the U.S. Food and Drug Administration.

But Inspire’s chief executive officer Christy Shaffer told institutional investors at Thursday’s NC Invest Conference in Chapel Hill, “Over time, Inspire intends to be North Carolina’s Amgen.”

Inspire was one of nine North Carolina biotech and pharmaceutical companies out of 16 presenters at the second annual NC Invest event created by the Triangle Chapter of the National Investor Relations Institute (NIRI), which has 5,000 members nationally.

Shaffer told a break-out session open to questions that Inspire’s troubles with its dry-eye drug and the FDA in 2003 resulted because of administrative changes at the agency. “If we had known they wanted another clinical trial, we would have done one,” said a somewhat exasperated Shaffer.

“The FDA is not a monolith, its decisions often come down to subjective judgments,” she said. “Nothing in drug development is straight-forward. A new decision-maker came into the FDA and said we needed a new trial.” As a result, Inspire’s stock price bobbled up and down in 2003, forcing the company to make organizational changes.

Still, she said that 150-employee Inspire is hiring several experienced new executives and “never cut our research staff.” She said the company stays lean by requiring even senior executives to “be entrepreneurial,” meaning even senior executives will likely have to do without a secretary and similar amenities.

Other biotech companies presenting at the conference included: Embrex, (Nasdaq:EMBX);Sci Quest,(Nasdaq:SQST); Closure Medical, (Nasdaq:CLSR);TriPath Imaging,(Nasdaq:TPTH) Inspire Pharmaceuticals, (Nasdaq:INSP); Salix Pharmaceuticals,(Nasdaq:SLXP); Trimeris, (Nasdaq:TRMS); Pozen (Nasdaq: POZN); and Paradigm Genetics (Nasdaq:PRDM).

Senior executives, primarily company CEOs, made the presentations to the institutional investor audience.

Presentation highlights

Organizers tightened the already packed morning presentation schedule due to the threat of snow, so it was impossible to catch all of them. But highlights from some of the biotech and pharmaceutical presenters include:

Embrex President and Chief Executive Officer Randall Marcuson told the investors, “We think the next three quarters this year is going to be as profitable as it’s been for a long time.”

Embrex has the highest Standard & Poor’s rating of any of the presenting biotech-related firms at 112, which S&P says is “higher than 73 percent of all companies.” Embrex makes a device that injects chicken eggs with vaccines automatically through the shell before they hatch. It also makes and sells several bird vaccines.

Marcuson told Local Tech Wire the company has no plans to make any vaccines to combat the deadly bird flu viruses much in the news recently. The viruses change rapidly and birds are not valued the way people are, he said, so it would be impossible to make commercially viable products.

Packaging matters

It was apparent at the conference that companies selling drugs have to consider factors beyond how well their product works.

Pozen, which uses its technology to combine existing migraine drugs with non-steroidal anti-inflammatory drugs (NSAIDS) to increase their efficiency, said it found that even the way they package their new product counts.

The company expects to have FDA approval of its first migraine drug, M-100, by summer and hopes to be selling it by the end of the year.

The drug, developed with GlaxoSmithKline, increases the effectiveness of GSK’s current product four-fold and gives five times better sustained relief. The company said that with GSK’s muscle behind it, the new drug is likely to be the “dominant migraine product for a long time.”

Since Pozen’s marketing research shows 80 percent of migraine suffers want a better drug, it expects doctors and patients to adopt its new product readily. But marketing also revealed that how the drug will be packaged matters.

Pozen found that migraine sufferers tend to carry their medication with them stashed in a purse or pocket and that poses a problem if it’s packaged in the conventional punch cards, which can be hard to open without scissors. So the company put the drug in foil pouches instead and customers who saw it said, “Thanks, someone is listening to us.”

Once a month doses?

Trimeris, which is wrestling with acceptance of its first offering in a new class of anti-HIV drugs, Fuzeon, said it is focusing its efforts on decreasing how often the drug must be injected and on educational marketing efforts.

The company met with some initial market resistance to the introduction of Fuzeon last year due to the complex 106-step manufacturing process that makes the drug expensive and the need to inject it twice a day.

Trimeris has staked its survival on Fuzeon, since it has nothing else in its pipeline at the moment. The company said sales increased from 3,000 30-day kits in the first quarter they were available to 9,000 kits in the fourth quarter of 2003.

The company hopes to make a new form of Fuzeon that needs to be injected only once a day. By the end of the decade, it hopes to have a long-lasting form of the drug that may only need to be injected once a week or even once a month.

TriPath Imaging CEO Paul Sohmer pointed to his company’s steady growth in revenues from the reagents used in its new cervical cancer tests and to its pipeline products in clinical trials.

Sohmer said TriPath’s continuing efforts to gain manufacturing efficiencies allow it to sell its cervical cancer tests more than $1 cheaper than its competitors.

The company has a pipeline of other innovative cancer tests in the works, including two in clinical trials. Sohmer said results from a Phase I clinical trial of its test for deadly melanoma skin cancer will be presented in March at the U.S. & Canadian Academy of Pathology annual meeting.