Critical stage for biotechs
This is the year that several Maryland biotechnology companies hope to usher new drugs through final rounds of clinical testing and, for some, to make a profit.
Advancis has launched two separate Phase 3 trials - one focusing on adults, and the other on children - involving its new method of delivering the ubiquitous antibiotic amoxicillin. The company's Pulsys technology is designed to deliver the antibiotic in powerful, well-defined bursts maximizing the drug's effectiveness and enabling adults and children to take lower doses.
Guilford, a 10-year-old company, has two products on the market: its internally developed Gliadel wafer for certain types of brain cancer and Aggrastat, an injectable treatment for heart-attack patients that it purchased from Merck & Co.
But, like Advancis, Guilford has never turned an annual profit, though it has been around for more than a decade. That has raised the stakes for Guilford's Aquavan anesthesia candidate. The drug is in three sets of late-stage trials for use as a sedative in diagnostic and surgical procedures - a colonoscopy, for instance - that require the patient to be anesthetized for short periods, said William F. Spengler, Guilford's chief financial officer. Another test will start - and all four will finish - this year, the company said.
Because Aquavan is said to have fewer side effects and wear off more quickly than products in use, some analysts have said it could become a $200 million- a-year drug for Guilford if it's approved and brought to market.
Propofol, one of two anesthetic agents Aquavan will challenge in the marketplace, has estimated annual sales of more than $750 million. Midazolam, the other drug used for procedural sedation, has annual sales of more than $300 million, Guilford said.
The company's goal is to introduce Aquavan for sale in early 2007.
The challenge ahead is one reason that Guilford has brought in a new top management team with expertise in bringing drugs to market.
Inside Guilford, "the hope is that there is a rather large market opportunity awaiting us," said Spengler, the financial officer. "For Guilford, this is really a core program, making it [extremely] important as we enter 2005."
Although a substantial number of Maryland's life sciences firms have yet to deliver their first commercially approved product - let alone any sales or profits - the fact that so many firms have reached the last set of testing is promising for the state economy, said Bill Gust, a local venture capitalist.
"This is not at all trivial," said Gust, managing general partner for Anthem Capital Management, a Baltimore-based venture firm with headquarters in Locust Point. "When you consider how long it takes to get through drug discovery, and then Phase 1 and Phase 2 trials, just to get to get into Phase 3, the reality is that the seeds for this [emergence] were planted six, eight or even 10 years ago."