Startup biopharmaceutical company Biodel Inc. in Danbury will move its headquarters office operations to a 20,000-square-foot building on the city”™s west side this fall, and plans to add another 20,000-square-foot facility on the property in about a year to house its laboratories and pilot manufacturing operations.
Both buildings will be leased from Mulvaney Properties in Danbury, which owns the existing building and the surrounding 23 acres. “It”™s not a good idea for a company of our nature to invest a lot of its capital in buildings,” said Solomon S. Steiner, Biodel”™s founder, chairman and CEO.
Instead, Biodel could either sign a marketing agreement with a pharmaceutical partner “and they will do the manufacturing,” or farm out the production to a major national manufacturer that produces drugs for pharmaceutical giants and small companies such as Biodel. “When large pharmaceutical companies go over capacity, they sometimes go to these guys” to meet demand or until new production facilities can be built, he said.
“We won”™t produce large-scale commercial lots here; that”™s not part of our plan at the moment,” Steiner said. Instead, the company will concentrate on conducting research and development of new products, using the pilot manufacturing facility to produce small quantities of new drugs for phase 1 and phase 2 clinical trials.
Biodel is in phase 3 clinical trials with an injectable insulin for treating diabetes it calls VIAject, and will go head-to-head with pharmaceutical giant Lilly, which has an 80 percent market share of an insulin used at mealtime. It is also in phase 1 clinical trials for a tablet formulation of insulin that would be placed under the tongue, and has two pre-clinical under-the-tongue products to treat osteoporosis it plans to submit to the U.S. Food and Drug Administration (FDA) next year.
“We expect to finish the clinical trials (for VIAject) and file the New Drug application with the FDA by the end of 2008,” Solomon said ”“ just about the same time the new laboratory and pilot facility could be completed on the company”™s new site on Saw Mill Road. FDA approval could come by the end of 2009, when commercial production of VIAject could begin.
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Attractive target
Biodel and its 30 employees are currently housed in two buildings about three miles from the new site. The buildings, totaling about 9,000 square feet on Christopher Columbus Boulevard, are also leased from Mulvaney Properties. Once the corporate offices are moved to the new Saw Mill Road site, the laboratory operations will be expanded, “if only temporarily,” Solomon said.
Biodel will be the fifth tenant in the Saw Mill Road building originally constructed for the Sapolin Paint headquarters, said George Mulvaney of Mulvaney Properties. He purchased the property in 1997 from the second tenant, Micronosis, which developed hardware and software for Wall Street firms before moving to Manhattan to be closer to its clients. That company was followed by a relocation company and, most recently, by Connex International, which moved much of its conference call operations to Kansas, he said.
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The site is approximately less than a mile from two other pharmaceutical companies, Boehringer Ingelheim, with 2,300 employees, and Penwest Pharmaceuticals, with offices in the former Union Carbide building and research-and-development facilities in nearby Putnam County, N.Y.
Biodel went public in May, its stock jumping from $15 to $18 on its opening day. It rose to just shy of $22 in mid-June, and was trading at a bit more than $17 at the end of July. One possibility Solomon is not discounting is that once Biodel is marketing its VIAject insulin, it may be an attractive target for purchase. “If a very large pharmaceutical company came along and made an offer we couldn”™t refuse, we wouldn”™t refuse it,” he said. “It”™s a bad business plan to plan on something like that, but with few exceptions, companies like this wind up getting bought by a larger company.”
Solomon started two other pharmaceutical companies before Biodel. The first, now called Emisphere Technologies Inc. in Tarrytown, N.Y., pioneered a way to deliver injectable medications orally; the second is now called MannKind Pharmaceuticals in Danbury, where inhalable insulin he developed is in phase 3 clinical studies.
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