It”™s been a very good year for Biodel Inc. in Danbury. The startup biopharmaceutical company completed its initial public offering in May, giving it net proceeds of $80 million; moved its headquarters to a 20,000-square-foot facility on the city”™s West Side in October; was issued a crucial patent for its insulin product, now in phase 3 of clinical trials in the United States and, since September, in Europe and Asia; and two weeks ago announced plans to build a 20,000-square-foot laboratory next to its new headquarters.
Biodel”™s founder, Solomon S. Steiner, had said when he moved the offices to the 100 Saw Mill Road site that future plans called for an additional building for expanded laboratory space. “The future is now,” he said. “We are growing at a rapid rate, and have made a lot of progress in developing our VIAject,” the company”™s injectable insulin that, he said, more closely mimics the body”™s normal use of insulin than anything else on the market.
VIAject, he said, has grown into a line of products and strengths to meet different needs among people with type 1 and type 2 diabetes. Should all go as planned, and pending U.S. Federal Drug Administration approval of its rapid-acting mealtime insulin, VIAject could be on the market in late 2009 or early 2010, challenging pharmaceutical giants such as Eli Lilley for a major share of the annual global market Steiner estimates at between $3 billion and $6 billion. “That”™s the market we”™re selling into, and we think we have a superior product,” Steiner said. “That”™s what our data says.”
Steiner said his company is still working out details and options for the manufacture, marketing, distribution and sale of its VIAject insulin. “We”™ve been talking with a number of major pharmaceutical companies in the insulin space. It may wind up that they would do marketing, sales and distribution and we would hold onto promoting and selling in restricted markets, like North America or the pediatric market.”
As for manufacturing, “We haven”™t disclosed what we”™re going to do with that,” he said. “We don”™t expect to make a deal until the latter half of next year. That”™s when we”™ll have our clinical trials in hand and that”™s the best time to make a deal. We could partner with a company in one part of the world, with another in another part. We have a lot of options.”
Biodel doesn”™t plan to manufacture the insulin in Danbury, but will concentrate on research and development of new pharmaceuticals. It already has in the pipeline an under-the-tongue insulation formulation in phase 1 clinical studies, and therapies to treat osteoporosis. “Just one class of osteoporosis drugs has a market of something like $4 billion,” Steiner said.
The new 20,000-square-foot laboratory will replace the existing 7,000-square-foot lab at the site of Biodel”™s combined office-lab facility a few miles from the company”™s new site. “We”™re going to start drawing up plans and discussing the building with city officials,” he said. Tentative plans call for the new laboratory to be completed next year. Biodel currently has 42 employees “and we will probably increase that number after we consolidate our operations into one location.
“We”™ve put together teams that are working very well together,” he said. “The clinical team has made great steady progress for finishing the phase 3 trials; the regulatory team is making sure we do it right in dealing with the FDA; our intellectual properties team saw our main patent issued and has filed roughly 32 international patents; our administrative team did a successful IPO and moved into our new facility; and our laboratory group scaled up to the point where we could manufacture” VIAject, he said.
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“We have a bunch of bright, creative people working in a pleasant environment, and they come up with ideas every day. But we don”™t talk about it until we have some data.”
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Topex harnesses rays to new ends
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This past January the U.S. Food and Drug Administration approved a next-generation radiation machine for treating skin cancer developed by Anthony Pellegrino, who 23 years earlier designed the world famous LORAD digital mammography machine.
Pellegrino had hoped his TOPEX low energy, superficial radiotherapy system might follow a similar international path during the next few years. He”™s way ahead of schedule. By the end of this month he”™ll have shipped nine of the machines, including units to Romania, Australia and South Africa. “We seem to making some headway with sales,” he said.
That”™s quite an accomplishment, “considering we got all the domestic and international approvals this year between January and March,” said John Brenna, president of the Danbury-based TOPEX. “We”™re very pleased with the results so far,” he said of the sales.
The fledgling company has another dozen major projects in the pipeline that could turn into orders, he said, and distributors and dealers are beginning to line up for an opportunity to market the machine in various part of the country and world. The company has 15 dealers on board already, with a goal of between 75 and 100 by the end of 2009.
“From the interest level we have now, I would say a year from now we could be filling one order a week,” Brenna said. “Anything is possible, but we”™re kind of treading into new territory. Not much has been done in product development in this area for 25 years.”
Pellegrino created TOPEX Inc. four years ago about a half mile from LORAD, which was sold in 1999. His goal was to improve vastly the aging technology for treating some skin cancers, replacing large components bolted to the floor or wall with a unit that was mobile and flexible. “You just roll it into the treatment room,” he said earlier this year.
The system treats basal cell and squamous cell cancers with superficial radiation therapy that eliminates the unpleasant side effects of surgery. Pellegrino saw a need for a new generation therapy because of aging baby boomers and the incidence of skin cancer among older people. More than 50 percent of the population that has skin cancer is over 55, and more than 1 million cases of skin cancer are diagnosed annually in the United States alone. Most of those cancers are in the head and neck, and small, concentrated doses of radiation are ideal for the eyelids, ears and lips. “Treating skin cancer with radiation has been used for many, many years,” Pellegrino said. “The cure rates are more than 90 percent” for basal cell and squamous cell cancers.
Initial demand for the new-generation units is coming from areas with a high incidence of skin cancer, like Florida, California, Western states where the cancer is prevalent among farmers and ranchers, and Australia and Europe, Brenna said. And if demand is sufficient enough, the small TOPEX crew could assemble two units a week for shipment around the world next year. “If we had to, we could do that with the people we currently have,” he said.
“We have six employees and four part-time people,” said Brenna.
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Casting an eye on Big Easy
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Brian Opert is a bit behind schedule in getting his precast concrete houses on the market in Katrina-ravaged New Orleans. “We”™re about six months behind schedule because things take a long time here,” he said. “People here work to play, and keeping people working is a new challenge. We can”™t use unlicensed people for the trades, and they don”™t work on Friday afternoon. They go fishing, so it just takes longer.”
Opert had hoped to have already unveiled his concrete houses that are impervious to high winds, high water, termites, rodents and ”“ “because this is New Orleans” ”“ bullets. But if all goes well, he hopes to finish his model house and unveil it the second week of January.
Once the precast homes for working couples begin to sell, his company ”“ Precast Building Solutions Inc. ”“ should be able to complete a house and put it on the market in just 21 days. A 1,500-square-foot, fully-furnished house should sell for about $185,000. “We”™re targeting the middle class couple still living in that FEMA trailer that FEMA won”™t even allow their own personnel to go into,” he said.
Opert and his Canadian partner, John Polsoni, created the building company earlier this year in response to the catastrophic destruction from Hurricane Katrina. Their first model house is in the Ninth Ward, historically the city”™s poor inner-city district. Ground has been broken for a second modular house in another ward and a closing is scheduled for property for a third house. Each house will be a different model, and Opert has plans for a village of modular townhouses.
Next year, “We”™d like to see 50 houses on scattered sites,” said Opert, who has a goal of building 400 homes a year. He and his wife sold their house in Trumbull this past summer and moved to New Orleans to oversee what Opert foresees as a building operation that will last well into the foreseeable future.
Katrina destroyed more than 245,000 houses in an area that, if the same destruction occurred in Connecticut, would stretch along the entire Connecticut shoreline into Rhode Island and Massachusetts.
Opert said he feels almost alone in his efforts to provide new housing for New Orleans residents. “The city has done nothing; private developers have done nothing. Except for a couple dozen houses, no new housing is being built. Brad Pitt has put together a very interesting program of innovatively designed wood structures, and is planning to build 150 houses. But Brad Pitt and I are the only guys building houses down here. None of the myriad of housing plans has come to fruition.”
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