Silver Springer
February 19th, 2007, 03:48 PM
Ready or not ...
Meet three companies to watch as they navigate the potential pitfalls of product launches and clinical trials
Baltimore Business Journal - February 9, 2007by Robert J. TerryStaff
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Last year, it was companies such as Alba Therapeutics, Profectus Biosciences and Lentigen Corp. -- bioscience firms that caught the eye of people in Greater Baltimore and beyond.
In 2006, these three startups, and a handful of other firms, won millions of dollars in funding from investors, passed muster with federal regulators, lured top-flight executives away from other jobs -- or did all three.
Elected officials and business leaders consider biotechnology a key to Greater Baltimore's economic development future. Maryland Gov. Martin O'Malley has proposed a new strategy to spur investment in the state's life sciences industry, including creating a new statewide life sciences authority and allocating $100 million over five years for taxpayer-backed venture capital funding.
That intense focus makes the successes and failures of these companies that much more magnified.
Who are 2007's up-and-comers? A couple have already been in the news of late.
Cardioxyl Therapeutics, a Towson biotech founded to commercialize research into heart failure by Johns Hopkins cardiologists, raised $14.5 million in a first round of venture capital funding. The five-employee company is working on a way to deliver nitroxyl, a gaseous chemical, directly into the bloodstream through an intravenous therapy.
Columbia's A&G Pharmaceutical Inc., meanwhile, just closed on a $2.2 million financing round it plans to fuel the product launch of its cornerstone cancer detection test. The company's won about $8 million total from investors who believe in its breast cancer detection kit, which works by scanning cells for certain protein found in 80 percent of breast cancer victims.
A&G is nearing the end of clinical trials on the test and hopes to start marketing the kit in the second half of the year.
Here are three other companies that, while not yet generating revenue, still hold a lot of promise, industry observers say -- and find themselves at critical turning points this year in their development.
Nora LLC
An estimated 2 million women in the U.S. suffer from recurrent pregnancy loss, a series of miscarriages caused by a protein imbalance in the mother's immune system.
Dr. Darryl Carter was expecting to find out Feb. 6 if he'd get the green light from the Food and Drug Administration to start clinical trials on his solution to what he calls a "devastating problem."
His company, Nora LLC, is developing a recombinant protein drug that could help shift foreign proteins introduced by the fetus to the mother's immune system so the body does not reject the pregnancy.
Carter, a Johns Hopkins-trained immunologist, had a hunch that a drug developed by Amgen to fight bacterial infection in bone marrow transplants could be used in reproductive immunology -- and he knew that Amgen's patents were going to expire.
Nora filed a patent application in 2003, officially launched as a company in 2004 and has worked with obstetricians around the country doing what the industry calls "off-label prescribing." One patient in Arizona, after seven consecutive miscarriages at the end of her first trimester, did a one-month course of Nora's treatment and delivered a healthy baby girl, Carter said.
"It's good evidence that the approach works, but the goal is to get it through the FDA process," said Carter, who runs Nora as a two-man firm with his partner, Chris McClain, a former Silicon Valley entrepreneur.
Such a lean operation probably isn't ideal to elected officials and bureaucrats who envision growing biotechs creating hundreds of jobs. But the model has enabled Nora to stay afloat -- and go after what it estimates to be an $800 million market opportunity -- with less than $1 million in startup capital from angel investors and small business grants.
"From an economic development standpoint, it's probably not what the city wants to see, but in the long run it'll benefit these companies because they'll be more cash-efficient," said Elizabeth Good, the former director of the state-backed Maryland Venture Fund who is now director of strategic investments for the University of Maryland, Baltimore. As for Nora and its approach, "there's a huge market need," she added.
Carter was meeting with FDA officials Feb. 6 in hopes of getting the go-ahead to file an Investigational New Drug application, or IND, the process by which a drug's safety and effectiveness is monitored by federal regulators. Nora hopes to launch a clinical trial this summer and, given the need for a recurrent pregnancy loss treatment, Carter thinks the FDA will fast track Nora's application.
Ravgen Inc.
On Feb. 1, a small biotech firm in Columbia, quietly and methodically working on a new non-invasive test for expectant mothers, pulled back the curtain a little further.
Ravgen Inc., launched in September 2000 by Dr. Ravinder Dhallan, published a study in the Lancet, a medical journal, describing its prenatal test, which screens blood samples for signs in fetal DNA indicating chromosomal abnormalities.
Ravgen analyzed 60 samples and found that 57 were normal. The other three samples showed an extra 21st chromosome, the cause of Down's syndrome. Those results were compared to other prenatal tests, and Ravgen's approach was found to be accurate in 56 of the 57 normal samples and two of the three that showed signs of Down's syndrome, the company wrote.
Using genomic data in a non-invasive test could be a significant breakthrough, Dhallan and medical observers say, because amniocentesis and other invasive methods increase the risk of miscarriage. Ravgen, which employs 11, scans for variants in the human genome called single nucleotide polymorphisms, or SNPs, which impact how humans develop diseases and respond to drug treatments.
"What's needed is something in between, something non-invasive that's built on fetal DNA," said Dhallan, a former emergency room physician who's raised $16 million from angel investors to design just such an approach.
Ravgen is planning a larger study to build on the Lancet findings, Dhallan said, and he's also tackling his primary business development challenge: Determining the optimal way to get his test to market. He may cut a deal with a strategic partner for a commercial launch.
"We're not going to rush it," he said. "I don't want to compromise on quality, but at the same time we understand there are patients waiting for this technology. It's always a balancing act."
CSA Medical Inc.
Furthest along the commercial pipeline is Baltimore-based CSA Medical, which has developed a device to cryogenically freeze and destroy cancer cells.
The company, which employs nine, has patents in place and clinical trial results to back up its approach -- now it's time to begin selling the device, which it will start doing in the U.S. this quarter.
CSA CEO Tim Askew and his team are targeting 150 cancer and gastrointestinal researchers and treatment centers to get the product -- a console and catheter kit that costs about $28,000 total -- into their hands. Three prototypes are already in use, including one at the University of Maryland Medical Center, and 90 patients have been treated.
The company also is planning to double its sales staff from two to four, a lean team of representatives but one with a presence in Atlanta, Boston, Chicago and Los Angeles, all major medical centers.
"We are doing a rapid but clinically responsible roll out, and that's important to understand," Askew said.
The technology is similar to the way dermatologists use liquid nitrogen to freeze and remove, say, a plantar wart. In this case, liquid nitrogen is sprayed through a catheter attached to an endoscope across an area believed to be home to cancerous or pre-cancerous cells.
Three to seven days after the treatment, Askew said, the cells die. CSA Medical has tested it on patients with Barrett's esophagus, a condition resulting from acid reflux disease which often leads to esophageal cancer.
The device was invented in the late-1990s by Dr. Mark Johnston, a gastroenterologist.
CSA estimates the market for this type of treatment to be worth about $3.5 billion, and says the technology holds promise for treating other cancers. So far, 30 physicians at 20 institutions have been trained on the device; by the end of May, CSA expects 50 doctors at 40 locations to be using it.
Meet three companies to watch as they navigate the potential pitfalls of product launches and clinical trials
Baltimore Business Journal - February 9, 2007by Robert J. TerryStaff
Print this Article Email this Article Reprints RSS Feeds Most Viewed Most Emailed
Last year, it was companies such as Alba Therapeutics, Profectus Biosciences and Lentigen Corp. -- bioscience firms that caught the eye of people in Greater Baltimore and beyond.
In 2006, these three startups, and a handful of other firms, won millions of dollars in funding from investors, passed muster with federal regulators, lured top-flight executives away from other jobs -- or did all three.
Elected officials and business leaders consider biotechnology a key to Greater Baltimore's economic development future. Maryland Gov. Martin O'Malley has proposed a new strategy to spur investment in the state's life sciences industry, including creating a new statewide life sciences authority and allocating $100 million over five years for taxpayer-backed venture capital funding.
That intense focus makes the successes and failures of these companies that much more magnified.
Who are 2007's up-and-comers? A couple have already been in the news of late.
Cardioxyl Therapeutics, a Towson biotech founded to commercialize research into heart failure by Johns Hopkins cardiologists, raised $14.5 million in a first round of venture capital funding. The five-employee company is working on a way to deliver nitroxyl, a gaseous chemical, directly into the bloodstream through an intravenous therapy.
Columbia's A&G Pharmaceutical Inc., meanwhile, just closed on a $2.2 million financing round it plans to fuel the product launch of its cornerstone cancer detection test. The company's won about $8 million total from investors who believe in its breast cancer detection kit, which works by scanning cells for certain protein found in 80 percent of breast cancer victims.
A&G is nearing the end of clinical trials on the test and hopes to start marketing the kit in the second half of the year.
Here are three other companies that, while not yet generating revenue, still hold a lot of promise, industry observers say -- and find themselves at critical turning points this year in their development.
Nora LLC
An estimated 2 million women in the U.S. suffer from recurrent pregnancy loss, a series of miscarriages caused by a protein imbalance in the mother's immune system.
Dr. Darryl Carter was expecting to find out Feb. 6 if he'd get the green light from the Food and Drug Administration to start clinical trials on his solution to what he calls a "devastating problem."
His company, Nora LLC, is developing a recombinant protein drug that could help shift foreign proteins introduced by the fetus to the mother's immune system so the body does not reject the pregnancy.
Carter, a Johns Hopkins-trained immunologist, had a hunch that a drug developed by Amgen to fight bacterial infection in bone marrow transplants could be used in reproductive immunology -- and he knew that Amgen's patents were going to expire.
Nora filed a patent application in 2003, officially launched as a company in 2004 and has worked with obstetricians around the country doing what the industry calls "off-label prescribing." One patient in Arizona, after seven consecutive miscarriages at the end of her first trimester, did a one-month course of Nora's treatment and delivered a healthy baby girl, Carter said.
"It's good evidence that the approach works, but the goal is to get it through the FDA process," said Carter, who runs Nora as a two-man firm with his partner, Chris McClain, a former Silicon Valley entrepreneur.
Such a lean operation probably isn't ideal to elected officials and bureaucrats who envision growing biotechs creating hundreds of jobs. But the model has enabled Nora to stay afloat -- and go after what it estimates to be an $800 million market opportunity -- with less than $1 million in startup capital from angel investors and small business grants.
"From an economic development standpoint, it's probably not what the city wants to see, but in the long run it'll benefit these companies because they'll be more cash-efficient," said Elizabeth Good, the former director of the state-backed Maryland Venture Fund who is now director of strategic investments for the University of Maryland, Baltimore. As for Nora and its approach, "there's a huge market need," she added.
Carter was meeting with FDA officials Feb. 6 in hopes of getting the go-ahead to file an Investigational New Drug application, or IND, the process by which a drug's safety and effectiveness is monitored by federal regulators. Nora hopes to launch a clinical trial this summer and, given the need for a recurrent pregnancy loss treatment, Carter thinks the FDA will fast track Nora's application.
Ravgen Inc.
On Feb. 1, a small biotech firm in Columbia, quietly and methodically working on a new non-invasive test for expectant mothers, pulled back the curtain a little further.
Ravgen Inc., launched in September 2000 by Dr. Ravinder Dhallan, published a study in the Lancet, a medical journal, describing its prenatal test, which screens blood samples for signs in fetal DNA indicating chromosomal abnormalities.
Ravgen analyzed 60 samples and found that 57 were normal. The other three samples showed an extra 21st chromosome, the cause of Down's syndrome. Those results were compared to other prenatal tests, and Ravgen's approach was found to be accurate in 56 of the 57 normal samples and two of the three that showed signs of Down's syndrome, the company wrote.
Using genomic data in a non-invasive test could be a significant breakthrough, Dhallan and medical observers say, because amniocentesis and other invasive methods increase the risk of miscarriage. Ravgen, which employs 11, scans for variants in the human genome called single nucleotide polymorphisms, or SNPs, which impact how humans develop diseases and respond to drug treatments.
"What's needed is something in between, something non-invasive that's built on fetal DNA," said Dhallan, a former emergency room physician who's raised $16 million from angel investors to design just such an approach.
Ravgen is planning a larger study to build on the Lancet findings, Dhallan said, and he's also tackling his primary business development challenge: Determining the optimal way to get his test to market. He may cut a deal with a strategic partner for a commercial launch.
"We're not going to rush it," he said. "I don't want to compromise on quality, but at the same time we understand there are patients waiting for this technology. It's always a balancing act."
CSA Medical Inc.
Furthest along the commercial pipeline is Baltimore-based CSA Medical, which has developed a device to cryogenically freeze and destroy cancer cells.
The company, which employs nine, has patents in place and clinical trial results to back up its approach -- now it's time to begin selling the device, which it will start doing in the U.S. this quarter.
CSA CEO Tim Askew and his team are targeting 150 cancer and gastrointestinal researchers and treatment centers to get the product -- a console and catheter kit that costs about $28,000 total -- into their hands. Three prototypes are already in use, including one at the University of Maryland Medical Center, and 90 patients have been treated.
The company also is planning to double its sales staff from two to four, a lean team of representatives but one with a presence in Atlanta, Boston, Chicago and Los Angeles, all major medical centers.
"We are doing a rapid but clinically responsible roll out, and that's important to understand," Askew said.
The technology is similar to the way dermatologists use liquid nitrogen to freeze and remove, say, a plantar wart. In this case, liquid nitrogen is sprayed through a catheter attached to an endoscope across an area believed to be home to cancerous or pre-cancerous cells.
Three to seven days after the treatment, Askew said, the cells die. CSA Medical has tested it on patients with Barrett's esophagus, a condition resulting from acid reflux disease which often leads to esophageal cancer.
The device was invented in the late-1990s by Dr. Mark Johnston, a gastroenterologist.
CSA estimates the market for this type of treatment to be worth about $3.5 billion, and says the technology holds promise for treating other cancers. So far, 30 physicians at 20 institutions have been trained on the device; by the end of May, CSA expects 50 doctors at 40 locations to be using it.