RALEIGH … Biologics, the only specialty pharmacy dispensing only anti-cancer drugs, is adding another pill to its drug cabinet.

Baxter Healthcare (NYSE:BAX) signed Biologics to provide wholesale distribution of its oral formulation of Mesnex tablets this week. The drug, also called Mesna, protects the bladder from the effects of two anti-cancer chemotherapy treatments.

Raleigh-based Biologics carved itself a profitable niche in the $5 billion specialty pharmacy market, without taking or seeking venture capital. It is an example of what can be done in business via that old fashioned route of finding a need and filling it.

Biologics handled only four anti-cancer formulations when it began in 1994 and now dispenses more than 60. President, Chief Executive and founder Robin Smith, 42, says the company earned $8 million in revenue last year.

When Smith first applied for a small business loan to start the company in 1994, however, the banker said he considered denying her application. But, because his daughter was being treated for cancer, he knew firsthand how tough it could be obtaining specialty anti-cancer drugs and approved the loan.

Smith, who acquired 12 years of pharmaceutical sales experience at Reed and Carnick and Schering-Plough before starting Biologics, says the 15-employee company is “very profitable and debt free.”

Not one disease, but 300
Other specialty pharmacy companies tend to specialize in providing their services for a number of different diseases such as multiple sclerosis, hemophilia and HIV.

Cancer, Smith says, “is such a broad and difficult model, it’s difficult to be good at it and at others, too. Cancer is not one disease, it is 300.

“A lot of these drugs are time and temperature sensitive, and they are dispensed according to an individual’s height, weight, and body surface area. Every patient can have a different prescription.”

Also, she says, cancers are treated differently at different stages.

Biologics not only dispenses the drugs, it monitors patients to make sure they take the drug properly and do not experience side effects.

Baxter came to Biologics shortly after the oral formulation of Mesnex was approved in May. “We had a relationship with Bristol-Myers, working with them a year prior to the expected launch of a drug that was not approved. They passed our name onto Baxter,” Smith says.

There is plenty of room for Biologics to expand its niche while remaining a dispenser of only anti-cancer medications, she notes. “There are over 400 anti-cancer drugs in manufacturer’s pipelines,” she says.

Trimeris Success Has Good News, Bad News Aspect
Better-than-expected results from its latest clinical trial grabbed headlines for Durham-based Trimeris (Nasdaq:TRMS) and its new type of anti-HIV drug, Fuzeon, but success is not without its drawbacks.

The drug, which prevents HIV from infecting cells, is a large, complex molecule that required Trimeris and its development partner, Roche, to invent a manufacturing process at a cost of $500,000. While the two companies say they will spend even more to increase production capacity, they may not have enough to meet demand when the drug is introduced.

“We developed the manufacturing process starting with a blank sheet of paper,” says Roche spokeswoman Heather Van Ness. “The equipment had to be specially made and (needed) specialty materials never made before in the amounts needed commercially for Fuzeon.”

Fuzeon is the largest molecule ever used as a drug. Trimeris and Roche give press a CD-ROM outlining the manufacturing process that says the Fuzeon molecule is a 36 amino acid-peptide chain that “dwarfs” other HIV drugs in complexity. The average drug requires 10 steps to make. Fuzeon requires 106 separate steps.

Fuzeon needs 44 different raw materials, three times the amount most drugs need. One of the world’s largest peptide synthesizers is used to attach the amino acids, making a crude form of Fuzeon that has to be purified by a blast of water at pressures equal to those 1,000 feet under the ocean. An additional nine steps move the drug through packaging for shipment. The entire process takes months.

While one knowledgeable local biotech executive says Roche will develop efficiencies in the process as time goes on, the company is “focusing first on making sure the process works,” says Van Ness.

Because many AIDS patients have developed resistance to current drugs, new treatments are eagerly awaited. Van Ness says the company noted in a news release that demand may exceed supply following approval to “temper expectations.”

Reporting the story, several media outlets, including LocalTechWire, confused the number of patients it expects to treat by March 2003 with the number of drug units it will have on hand at that time.

Van Ness says that counting people currently in clinical trials of the drug and early access patients, 3,000 patients will receive the treatment by March 2003 prior to the drug’s U.S. Food and Drug Administration approval. “We anticipate we’ll have the capacity to treat 25,000 patients by the end of 2003,” Van Ness says.

Both Trimeris and Roche say that figures bandied about by analysts and others regarding the eventual cost of the drug to consumers and how much the companies will make the first year are speculative at this point.

Biologics: www.biologicstoday.com

Trimeris: www.trimeris.com