HBV market: This is a follow-up to the recent NYT story on the high prevalence of disease among east Asian immigrants in NYC, which suggests that the magnitude of chronic HBV in the U.S. (and Western Europe) may be under- estimated to a significant degree.
>> A Queens Doctor Finds Fighting Hepatitis B Is a Frustrating Task
May 13, 2006 By COREY KILGANNON
Dr. Sing Chan, a hepatologist in Flushing, Queens, has been getting more and more invitations for lunch lately from pharmaceutical representatives seeking to interest him in new drugs developed to treat the hepatitis B virus.
As the number of new cases reaches a staggeringly high rate among recent Chinese immigrants in New York City, drug companies are descending upon doctors and pharmacists; marketers of fancy herbal remedies are pushing their products on Chinese radio; and the many shops along Flushing's Main Street that sell traditional Chinese herbs are stocking products with natural ingredients that claim to purify the liver.
A study released this week reported that east Asian immigrants in New York City run a far greater risk than other Americans for the hepatitis B virus. The study, led by researchers at the New York University School of Medicine, was certainly not news to Dr. Chan, whose client list has come to be dominated by Chinese immigrants living around Main Street in whom the virus has been detected.
The virus, which can lead to diseases like liver cancer and cirrhosis, has plagued Asian immigrants for decades, and the number of patients who test positive for it keeps rising in areas like Flushing.
"The numbers are going up all the time," Dr. Chan said. "Doctors are just not doing enough to test patients for hepatitis B. Infected patients tell me, 'I've had plenty of blood tests but they never checked for hepatitis B.' "
Because hepatitis B is endemic in many Asian countries, where it is transmitted largely from mother to child, growth in the number of Asian immigrants in New York and across the country has made the disease a broad, expensive health problem. In the 2000 census, there were 800,000 Asians in the city, with roughly half from China.
Hepatitis B, like hepatitis C, is generally contracted through the blood, and is not transmitted through casual contact with infected people. Hepatitis A, which is caused by a different virus, can be transmitted through food, but hepatitis B cannot, with very rare exceptions.
"They spent one day teaching us about this in medical school," Dr. Chan said. But now doctors and authorities can not ignore the scores of patients flocking to the modest medical clinics and offices tucked away in commercial suites just off Main Street, above noodle shops, bubble tea lounges and karaoke bars.
Dr. Chan and his colleagues in Flushing are frustrated. They are scrambling to introduce a reluctant population of recent Chinese immigrants to medical advances in treatment of the virus, including early detection and medication that can suppress it.
"New patients say they are shocked when they find out they have the virus," he said. "Then they admit that many of their friends and relatives have it. You get a lot of old people who come and know they have it, but they say, 'My doctor always said nothing can be done for it.' "
That is no longer so. Over the past decade, an array of new drugs has become available to treat chronic infection and suppress the virus so that it causes little or no harm. Usually, they must be taken for a lifetime.
"When I tell young Chinese people they have to take a lifetime worth of drugs for a virus that is currently giving them no symptoms, they don't understand that," he said. "Then they refuse and they remain carriers and can pass the virus on."
For many Chinese immigrants, he said, hepatitis B has long carried a stigma. Many people were told it is incurable and not to speak about it for fear one would be vilified as a carrier.
"A lot of people don't want to come forward because they are undocumented and can't get health insurance," said Ming-der Chang, vice president of Asian initiatives for the American Cancer Society, which reports high incidence of liver cancer among Asian immigrants in New York City. "They don't want to be seen as carriers of the virus."
A 45-year-old man who emigrated from China 10 years ago said he avoided being tested for the virus because he lacked money and health insurance. Getting a hepatitis B diagnosis would mean a stigma that would affect his ability to rent a room, get work and make friends, he said.
"I was worried I would be discriminated against," said the man, who was granted anonymity because of his illegal status and his reluctance to reveal to his friends that he has hepatitis B. "People still think the virus can be spread by food and contact. Many poor immigrants come and live close together in small rooms and don't want to live close to someone who has it."
In January 2005, the man developed liver cancer, caused by untreated hepatitis B, doctors told him. A yearlong regimen of chemotherapy has shrunk his tumors to the point where his doctors are optimistic about his survival, he said.
Dr. King-Chen Hon, a gastroenterologist with an office on Main Street, said that a steady stream of new patients now come in complaining of the virus. By then, they are yellow from jaundice or have liver problems, including cirrhosis or cancer. But many come in with no clue that they are infected and no real symptoms. Then they test positive.
Dr. Pat Basu, a hepatologist in Forest Hills, Queens, said there is a high incidence of hepatitis B among the Bukharan immigrants who live near his office. There is also a high rate among the South Asian populations of Indians, Pakistanis and Bengalis in Elmhurst and Bukharans in Forest Hills, doctors there say.
But it is among Chinese immigrants that the numbers are highest. The study found that 15 percent of east Asians in New York — as many as 100,000 people — are chronic hepatitis carriers, an infection rate 35 times the rate found in the general population.
Some people with hepatitis B cannot afford Western medicine or had no success with it, and turn to traditional Chinese herbal medicine, seeking to restore their health among the pungent aromas of the stores that sell lotus seeds, ginseng root, ginkgo, shark cartilage and fish oil.
Sam Zhang, 33, walked into one such store on Main Street and browsed among the glass jars of dried fish, seahorses and hundreds of varieties of tea. He bought $200 worth of herbal liver purifier for his mother, Li, 53, who has hepatitis B. He bought a month's supply of an herbal remedy to purify the liver, for $200.
"Our doctor said not to try any traditional Chinese medicine because it's not approved by the F.D.A.," said Mr. Zhang, who emigrated from Fujian Province in 1990 and owns a restaurant in Flushing. "But nothing else worked, so we'll give it a try." <<
- Next Steps are Advisory Panel Meeting in U.S. and Compiling Stability Data for Reformulated Product in Europe -
ROCKVILLE, Md., May 30 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI ) provided updates today on its progress with regulators toward the licensure of its antibody product to prevent re-infection with hepatitis B in liver transplant patients in the U.S. and Europe.
U.S. Update
The company announced that its Biologic License Application (BLA) for Nabi-HB Intravenous will be reviewed and discussed by the Food and Drug Administration's (FDA) Blood Products Advisory Committee (BPAC) at a meeting scheduled for July 13, 2006 in Gaithersburg, Maryland. The BPAC meeting represents the culmination of lengthy discussions between the FDA and Nabi Biopharmaceuticals concerning the data that might be accepted to support the BLA. BPAC is expected to render its view as to whether the BLA for Nabi-HB Intravenous for the prevention of recurrence of hepatitis B after liver transplant should be approved based on a combination of prospective and retrospective clinical data. Nabi Biopharmaceuticals believes that such data should be sufficient for approval given Nabi-HB's widely accepted off-label use in liver transplant patients.
Currently, Nabi-HB® [Hepatitis B Immune Globulin (Human)] is licensed in the U.S. to provide protection from infection after accidental exposure to the hepatitis B virus. However, it is acknowledged as a standard-of-care in liver transplant patients at risk for re-infection. Because this use of the product is off-label, there are no FDA-approved guidelines for how such a product should be dosed to optimize patient outcomes. If approved, the intravenous formulation of Nabi-HB would be the only product in the U.S. indicated for preventing re-infection of the transplanted liver in HBV-positive patients. Previously, the FDA granted orphan drug designation to Nabi-HB Intravenous. Nabi Biopharmaceuticals believes the BPAC meeting will not only advance a thorough consideration of the relevant clinical data, it will also provide the opportunity to establish clear standards for how the product should be used in liver transplant patients. The company is particularly encouraged about the outcome for this meeting because the same clinical data set was acceptable for licensure in Europe.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "We believe the benefits from using Nabi-HB in liver transplant patients have been amply demonstrated in thousands of liver transplant patients. The clinical data we have compiled supports using Nabi-HB at the time of transplant, a time when no other drugs can be used effectively. The data also demonstrate the importance of using Nabi-HB in combination with anti-virals on a long-term maintenance basis to prevent re-infection. If they approve the product's use in these patients, the FDA would be providing physicians with the information they need to make the best treatment and dosing decisions for their patients. In addition, we believe this indication will build physician awareness and understanding about the positive long-term prognosis for liver transplants in hepatitis B-positive patients. That in turn may help to increase the numbers of patients helped each year."
EU Update
The company also announced that as a result of discussions about its Marketing Authorization Application (MAA) for HEBIG with regulators of the Reference Member State (RMS), it has made certain improvements in the formulation of the product to comply with EU standards. As a result of this agreement with regulators of the RMS, the company has voluntarily withdrawn its MAA in Europe while it compiles 12 months of stability data for the reformulated product. Nabi Biopharmaceuticals expects to resubmit its MAA with this data during the first half of 2007. It is important to emphasize that all other pieces of the MAA have already been reviewed and accepted by the RMS and that the RMS has committed to an accelerated turn-around upon re- submission of the MAA. The company believes that this new formulation will yield several benefits for the intravenous product in Europe and the U.S. These improvements will increase the product's shelf-life, benefiting hospital pharmacies and product distributors. In addition, the formulation changes are designed to enhance the product's safety profile by providing additional viral inactivation benefits and further differentiating HEBIG from other hepatitis B immune globulin products. Finally, these changes are a first step in the company's 2006 program to capture yield improvements in the production of polyclonal antibody products and product candidates like Nabi-HB, Civacir® [Hepatitis C Immune Globulin (Human)], Altastaph® [Staphylococcus aureus Immune Globulin Intravenous (Human)] and IVIG in its biological manufacturing facility in Florida. When fully implemented, these improvements are intended to leverage the value of the full supply chain within Nabi Biopharmaceuticals, from sourcing plasma at its antibody collection centers, through production in its plant, and finally to the distribution of final products to hospitals and distributors in the U.S. using its sales force.
Dr. Rasmussen continued, "The intravenous formulation of HEBIG will provide competitive differentiation from other licensed products approved in the European market today. Its launch in Europe will increase the opportunity to leverage our integrated manufacturing platform. We are encouraged that European regulators have offered that, upon this resubmission, the MAA will be granted an immediate and accelerated review, as the other components of the application, that is the preclinical, toxicological and clinical pieces, as well as other parts of the quality dossier, have been reviewed and accepted by the regulators. We are particularly pleased that the RMS agrees that the clinical data are acceptable for licensure."
A Significant Medical Need
Nabi-HB Intravenous (U.S.) and HEBIG (Europe) are being developed to prevent hepatitis B disease in HBV-positive liver transplant patients. According to the World Health Organization (WHO), of the two billion people who have been infected with HBV, more than 350 million have chronic infections and are at high risk of death from cirrhosis of the liver and liver cancer; and as a result, many of these patients are in need of a liver transplant. Recurrence of HBV infection following liver transplant is almost universal if left untreated, and most often leads to rapid deterioration of liver function, often resulting in death or the need for re-transplantation. The U.S. Centers for Disease Control (CDC) currently estimates that in the U.S. alone there are approximately 1.2 million chronic hepatitis B carriers, 8,500 new hepatitis B infections per year, and 5,000 individuals who die annually from hepatitis B or its complications.[Please see #msg-11099728 and #msg-11058133 for related background info on this.]
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Hepatitis B remains a serious, global healthcare threat. The commitments from regulators that we have announced today significantly advance our efforts to make this safe and efficacious product available to patients in the U.S. and Europe. We believe that the steps we will undertake for HEBIG will also build added value in this important and highly needed product, and may even contribute to an increased number of transplants that take place because of the benefits it can provide to patients. In addition, the formulation enhancements will advance our efforts to build the value of our integrated supply chain for the manufacture and distribution of not only Nabi-HB and HEBIG, but also our portfolio of high- value products including Civacir and Altastaph, as well as IVIG."
Nabi-HB Intravenous and HEBIG are purified human polyclonal antibody products manufactured using plasma collected from donors who have been previously vaccinated with a hepatitis B vaccine. This plasma is sourced at Nabi Biopharmaceuticals' antibody collection centers and the product is manufactured at the company's state-of-the-art fractionation facility in Florida. When administered, the anti-hepatitis B antibodies contained in Nabi-HB Intravenous and HEBIG bind to the hepatitis B virus and trigger its clearance by the body's immune system.
Nabi-HB, currently marketed in the U.S., provides passive immunization, or short-term protection, following exposure to the hepatitis B virus. Nabi-HB is indicated for the treatment of:
* acute exposure to blood containing hepatitis B surface antigen (HBsAg)
* perinatal exposure of infants born to HBsAg-positive mothers
* sexual exposure to HBsAg-positive persons
* household exposure to persons with acute HBV infection
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo® (calcium acetate), Nabi-HB® [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: Gram-positive bacterial infections, hepatitis and transplant, kidney disease (nephrology) and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php . The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit our Website at: http://www.nabi.com . <<
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