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About Romark and Alinia
Thought some might like to see this article about Romark and Alinia. Nothing new, just some background stuff. jm
TAMPA - Digestive disease specialist David Heiman has dozens of chronic hepatitis C patients who do not respond to the drugs now available. Their only hope is a transplant before their liver gives out.
"If only I had something new to offer them," the Tampa doctor said.
Soon, maybe, he will.
Romark Laboratories, an emerging drug-development company on the eastern end of Courtney Campbell Parkway, is testing a new treatment for the potentially fatal liver disease.
"Their data are astounding," said Heiman, who discussed overseas study results with Romark's medical director. "It blew my socks off."
Romark has been testing its diarrhea drug Alinia, approved for use against intestinal parasites, to combat a host of demons: Crohn's disease, a chronic inflammation of the digestive tract; Clostridium difficile, a common hospital-acquired infection, and the now-epidemic hepatitis C.
Because Alinia has received Food and Drug Administration approval as safe for both children and adults, Romark is seeking FDA permission for a fast-track route to approve the drug for other diseases.
"We're fixing to explode the indications on it," said Romark adviser Seymour Holt, who has a stake in the company. "I think we've got a blockbuster."
A Secret Until Recently
It would be highly unusual to find a drug that kills not only protozoa but also two entirely different types of organisms -a virus, which in this case is just a strand of RNA, and C. difficile, bacteria that have developed resistance to most antibiotics.
"It doesn't sound plausible," said Tampa gastroenterologist Hunter Eubanks. "It sounds way out on a limb."
Romark's experiments with Alinia on hepatitis C during the past year have been a well-kept secret. As a closely held company, Romark has not had to report to stockholders.
Word began to get out last month, though, when Romark sent its plans for clinical studies to university review boards and to the FDA, said Marc Ayers, president and chief executive officer.
The Tampa company began posting its hepatitis C results in January on its Web site, www.romark.com, to make sure that accurate information trumped the rumors.
Romark, a little more than 12 years old, has until recently concentrated research on gastrointestinal illnesses. The company didn't think of trying its compound on viruses until late in 2004, when it was being tested on a parasite that afflicts AIDS patients, said chairman and chief scientist Jean-Francois Rossignol.
Researchers who were doing work under federal grants reported to the company that the compound seemed to be attacking not only the parasite, but also the virus. Test-tube studies on other viruses found it active against hepatitis.
So in early 2005, Romark began limited clinical trials of the compound in hepatitis patients at its Digestive Disease Research Center in Egypt.
Last month, the company announced the results were encouraging and that it soon will begin clinical trials in the United States - although skeptics point out that the viral strains are different in Egypt than in the United States, thus the results may not apply here.
Company officials, however, say basic research on how the drug works suggests it may be active on all strains.
"Fifteen months ago, this was not on our radar screen," Ayers said. "It's changing the direction of the company."
An Overwhelming Prospect
Hepatitis C virus, or HCV, is passed through blood and usually shows no symptoms for years or decades. It is estimated to have infected almost 4 million Americans - most of whom don't know it.
When patients develop jaundice and other symptoms, the disease is often well-advanced. Long-term therapy combines two antivirals, including one - interferon - that requires frequent shots.
Hepatitis C, more serious than its better-known namesakes A and B, accounts for about half of cirrhosis cases, end-stage liver disease and liver cancers. Hepatitis C kills 10,000 Americans each year.
TAMPA - Digestive disease specialist David Heiman has dozens of chronic hepatitis C patients who do not respond to the drugs now available. Their only hope is a transplant before their liver gives out.
"If only I had something new to offer them," the Tampa doctor said.
Soon, maybe, he will.
Romark Laboratories, an emerging drug-development company on the eastern end of Courtney Campbell Parkway, is testing a new treatment for the potentially fatal liver disease.
"Their data are astounding," said Heiman, who discussed overseas study results with Romark's medical director. "It blew my socks off."
Romark has been testing its diarrhea drug Alinia, approved for use against intestinal parasites, to combat a host of demons: Crohn's disease, a chronic inflammation of the digestive tract; Clostridium difficile, a common hospital-acquired infection, and the now-epidemic hepatitis C.
Because Alinia has received Food and Drug Administration approval as safe for both children and adults, Romark is seeking FDA permission for a fast-track route to approve the drug for other diseases.
"We're fixing to explode the indications on it," said Romark adviser Seymour Holt, who has a stake in the company. "I think we've got a blockbuster."
A Secret Until Recently
It would be highly unusual to find a drug that kills not only protozoa but also two entirely different types of organisms -a virus, which in this case is just a strand of RNA, and C. difficile, bacteria that have developed resistance to most antibiotics.
"It doesn't sound plausible," said Tampa gastroenterologist Hunter Eubanks. "It sounds way out on a limb."
Romark's experiments with Alinia on hepatitis C during the past year have been a well-kept secret. As a closely held company, Romark has not had to report to stockholders.
Word began to get out last month, though, when Romark sent its plans for clinical studies to university review boards and to the FDA, said Marc Ayers, president and chief executive officer.
The Tampa company began posting its hepatitis C results in January on its Web site, www.romark.com, to make sure that accurate information trumped the rumors.
Romark, a little more than 12 years old, has until recently concentrated research on gastrointestinal illnesses. The company didn't think of trying its compound on viruses until late in 2004, when it was being tested on a parasite that afflicts AIDS patients, said chairman and chief scientist Jean-Francois Rossignol.
Researchers who were doing work under federal grants reported to the company that the compound seemed to be attacking not only the parasite, but also the virus. Test-tube studies on other viruses found it active against hepatitis.
So in early 2005, Romark began limited clinical trials of the compound in hepatitis patients at its Digestive Disease Research Center in Egypt.
Last month, the company announced the results were encouraging and that it soon will begin clinical trials in the United States - although skeptics point out that the viral strains are different in Egypt than in the United States, thus the results may not apply here.
Company officials, however, say basic research on how the drug works suggests it may be active on all strains.
"Fifteen months ago, this was not on our radar screen," Ayers said. "It's changing the direction of the company."
An Overwhelming Prospect
Hepatitis C virus, or HCV, is passed through blood and usually shows no symptoms for years or decades. It is estimated to have infected almost 4 million Americans - most of whom don't know it.
When patients develop jaundice and other symptoms, the disease is often well-advanced. Long-term therapy combines two antivirals, including one - interferon - that requires frequent shots.
Hepatitis C, more serious than its better-known namesakes A and B, accounts for about half of cirrhosis cases, end-stage liver disease and liver cancers. Hepatitis C kills 10,000 Americans each year.
this drug has been used for diarrhea, pediatric use. I posted some information about this company and yours is written so much better. I just cut and pasted from the pharmaceutical web page. I wrote a small "opinion" aboutsome grape vine stuff I had heard about the company being well "cheap" It seems from your great article they may get flush with some funds and that would be great, but if this is the answer for us , it's a real lotto ticket long shot. thank you for the great information.
I don't know if your one of the ones who piled on for HR, if so just ignore this and accept a genuine thanks, I got a new name from this article that is interesting.
Lanier
I don't know if your one of the ones who piled on for HR, if so just ignore this and accept a genuine thanks, I got a new name from this article that is interesting.
Lanier
Sorry, this si how I should have posted this-----Many of today's patients were infected before 1990, when an effective screening test for HCV became commercially available. The global total of those infected may be 150 million.
The idea that they may have unwittingly been sitting on a treatment for a major worldwide killer has Ayers and Rossignol, who together own 80 percent of the company, both excited and a bit overwhelmed.
"The market for an oral drug that could treat hepatitis C could clearly be billions [of dollars] in the United States alone," Ayers said.
Ayers said Romark's sales are about $15 million a year and that it has just reached the point of breaking even.
Over A Dining Table
For nitazoxanide, the compound that lies at the heart of the excitement, this is just the latest twist in a strange history. Rossignol, a French chemist, discovered the compound and its family of drugs, the thiazolides, in 1974. The parasite treatment didn't seem to offer anything more than existing treatments.
He left chemistry to go to medical school, and afterward moved to the United States to lead drug development against tropical diseases for major pharmaceutical companies. Rossignol is credited as a key figure in developing the antiparasitic blockbuster albendazole while working for the company now known as Glaxo- SmithKline.
When he retired in 1994, he remembered nitazoxanide and wondered whether it might be useful in fighting parasites that plagued AIDS patients. With that kind of market, it would be worth the cost of developing.
He approached Ayers, a Tampa-based investment banker who knew a lot about the pharmaceutical business, and the two started a drug-development company over Ayers' dining room table.
They found a few investors, including C. Stan Harrell, who had sold a Tampa-based health company, Pharmacy Management Services Inc., for a handsome profit in December 1994. Holt, who had been a leading developer of Prozac for Eli Lilly, also invested in Romark and served as part-time adviser. He stayed on when Harrell and others sold their shares back to the co-founders in 2000.
Meanwhile, Rossignol used his international connections to find scientists, clinical study programs and manufacturers. That's how a small Tampa company can claim a global reach, with a dedicated research laboratory in Liverpool, a research center in Egypt, drug manufacturing in Belgium and packaging in Latin America.
Medication Spreads
From 1995 to 2000, Romark obtained 10 U.S. patents for nitazoxanide, along with others abroad, for use against parasites. It was sold first in 1996 in Mexico under the name Daxon, then spread to other countries.
The next year, Romark licensed the drug to another company, IDEXX Pharmaceuticals, for veterinary use.
In November 2002, the leading British medical journal, The Lancet, reported that Alinia reduced illness and deaths from diarrhea among malnourished children. The FDA approved the drug for pediatric use, and later, for adults, against Giardia Lamblia and Cryptosporidium parvum.
Then, the hint that the compound might have antiviral properties spurred the studies in Egypt. According to company officials, nitazoxanide stamped out signs of virus in the blood of half the hepatitis C patients who received it, while there was no effect in those who received placebo.
It is important to note that these results have merely been posted on the company's Web site, not subjected to scrutiny, much less published in a peer-reviewed journal. The company says the results will be prepared for publication and presented at a digestive disorders meeting later this year.
'A Second Bullet'
Even if the hepatitis C application doesn't work out, Romark executives say they have plenty of other indications on which to try Alinia before its patent expires in 2017. The company can also develop the other thiazolides, to which Romark has exclusive rights.
Romark president Ayers said he spends much of his time these days talking to prospective strategic partners, larger companies that "have the muscle" to market a major drug in this country, Europe and Asia.
As it goes about the business of marketing Alinia to gastroenterologists, Romark has to be mindful of the FDA rule against promoting any use for which it has not yet received approval. The federal agency can and has imposed big fines for this.
On the other hand, there's nothing to prevent doctors from prescribing Alinia for uses that are still under clinical study.
"It's done all the time," an FDA spokeswoman said.
As for Heiman, he's counseling his patients who've failed existing treatment to have a little more patience until some solid data emerge publicly from Romark at medical meetings later this year.
"If they even get a poster at a national meeting, I'll be offering this," he said. "I need a second bullet for my gun."
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The idea that they may have unwittingly been sitting on a treatment for a major worldwide killer has Ayers and Rossignol, who together own 80 percent of the company, both excited and a bit overwhelmed.
"The market for an oral drug that could treat hepatitis C could clearly be billions [of dollars] in the United States alone," Ayers said.
Ayers said Romark's sales are about $15 million a year and that it has just reached the point of breaking even.
Over A Dining Table
For nitazoxanide, the compound that lies at the heart of the excitement, this is just the latest twist in a strange history. Rossignol, a French chemist, discovered the compound and its family of drugs, the thiazolides, in 1974. The parasite treatment didn't seem to offer anything more than existing treatments.
He left chemistry to go to medical school, and afterward moved to the United States to lead drug development against tropical diseases for major pharmaceutical companies. Rossignol is credited as a key figure in developing the antiparasitic blockbuster albendazole while working for the company now known as Glaxo- SmithKline.
When he retired in 1994, he remembered nitazoxanide and wondered whether it might be useful in fighting parasites that plagued AIDS patients. With that kind of market, it would be worth the cost of developing.
He approached Ayers, a Tampa-based investment banker who knew a lot about the pharmaceutical business, and the two started a drug-development company over Ayers' dining room table.
They found a few investors, including C. Stan Harrell, who had sold a Tampa-based health company, Pharmacy Management Services Inc., for a handsome profit in December 1994. Holt, who had been a leading developer of Prozac for Eli Lilly, also invested in Romark and served as part-time adviser. He stayed on when Harrell and others sold their shares back to the co-founders in 2000.
Meanwhile, Rossignol used his international connections to find scientists, clinical study programs and manufacturers. That's how a small Tampa company can claim a global reach, with a dedicated research laboratory in Liverpool, a research center in Egypt, drug manufacturing in Belgium and packaging in Latin America.
Medication Spreads
From 1995 to 2000, Romark obtained 10 U.S. patents for nitazoxanide, along with others abroad, for use against parasites. It was sold first in 1996 in Mexico under the name Daxon, then spread to other countries.
The next year, Romark licensed the drug to another company, IDEXX Pharmaceuticals, for veterinary use.
In November 2002, the leading British medical journal, The Lancet, reported that Alinia reduced illness and deaths from diarrhea among malnourished children. The FDA approved the drug for pediatric use, and later, for adults, against Giardia Lamblia and Cryptosporidium parvum.
Then, the hint that the compound might have antiviral properties spurred the studies in Egypt. According to company officials, nitazoxanide stamped out signs of virus in the blood of half the hepatitis C patients who received it, while there was no effect in those who received placebo.
It is important to note that these results have merely been posted on the company's Web site, not subjected to scrutiny, much less published in a peer-reviewed journal. The company says the results will be prepared for publication and presented at a digestive disorders meeting later this year.
'A Second Bullet'
Even if the hepatitis C application doesn't work out, Romark executives say they have plenty of other indications on which to try Alinia before its patent expires in 2017. The company can also develop the other thiazolides, to which Romark has exclusive rights.
Romark president Ayers said he spends much of his time these days talking to prospective strategic partners, larger companies that "have the muscle" to market a major drug in this country, Europe and Asia.
As it goes about the business of marketing Alinia to gastroenterologists, Romark has to be mindful of the FDA rule against promoting any use for which it has not yet received approval. The federal agency can and has imposed big fines for this.
On the other hand, there's nothing to prevent doctors from prescribing Alinia for uses that are still under clinical study.
"It's done all the time," an FDA spokeswoman said.
As for Heiman, he's counseling his patients who've failed existing treatment to have a little more patience until some solid data emerge publicly from Romark at medical meetings later this year.
"If they even get a poster at a national meeting, I'll be offering this," he said. "I need a second bullet for my gun."
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