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Rockville company hopeful for $500M haul after positive trial results.
As expected, Human Genome Sciences has applied for federal regulatory approval to market its new treatment for hepatitis C.
The Rockville biotech is collaborating with Swiss pharma giant Novartis on developing and commercializing the product — to be marketed as Zalbin in the U.S. and Joulferon in the rest of the world — under an agreement that could mean a total of $507.5 million for HGS.
The application comes after HGS reported positive results from two phase 3 clinical trials that showed Zalbin works as well as Roche's Pegasys treatment for chronic hepatitis C with only half the injections administered. Rates of side effects were also comparable, according to HGS. The two studies treated a total of 2,255 patients.
"We look forward to continuing to work closely with Novartis to advance albinterferon alfa-2b to the market under the brand name Zalbin in the United States," said H. Thomas Watkins, president and CEO of HGS, in a statement.
Novartis plans to apply for marketing approval in the rest of the world, starting in Europe this year.
Under their 2006 agreement, the companies will co-commercialize the treatment — formerly called Albuferon — in the U.S. and will equally share clinical development costs, U.S. commercialization costs and U.S. profits. Novartis will be responsible for commercializing the treatment elsewhere in the world, and will have responsibility for commercial manufacturing of the finished product.
Total payments to HGS, including $207.5 million already paid, could total $507.5 million, HGS said.
The drug is made by genetically fusing human albumin, the body's most prevalent blood protein, with interferon alfa, using HGS's proprietary technology. According to HGS, the fusion prolongs the half-life of the therapeutic proteins.
It's a potentially lucrative market for HGS and Novartis. In the first half of the year, Roche reported sales of Pegasys for hepatitis B and C rose 10 percent over last year to $829.9 million.
Hepatitis C is a viral liver disease that usually becomes a chronic condition that can result in cirrhosis of the liver and liver cancer, according to the federal Centers for Disease Control and Prevention. It is spread through contact with infected blood, primarily through sharing hypodermic needles. There is no vaccine for it. About 4.1 million Americans either have an ongoing infection or previously had one, according to the National Institutes of Health, with about 11,000 Americans dying from it annually.
The World Health Organization reports that hepatitis C has been compared to a "viral time bomb." Worldwide, about 180 million people are infected; upward of 4 million people are infected annually. Hepatitis C is responsible for 50 percent to 75 percent of all liver cancer cases, and two-thirds of all liver transplants in the developed world.
HGS also recently announced that, along with Aegera Therapeutics of Montreal, it has begun a phase 1 clinical trial to evaluate the safety and tolerability of its candidate to treat patients with advanced lymphoid tumors.
HGS acquired exclusive worldwide rights, excluding Japan, to develop and commercialize HGS1029 from Aegera Therapeutics two years ago.
In another development, HGS reported that it has officially received a request from the FDA for more information about its anthrax treatment, for which the company seeks marketing approval.
An FDA advisory panel in October raised questions about raxibacumab after studies showed it didn't significantly help infected monkeys and rabbits recover from anthrax any more than conventional antibiotic treatment.
"We have responded to all of FDA's previous questions. We plan to address the current questions as well," said Sally D. Bolmer, senior vice president, development and regulatory affairs, in a statement. "In certain respects, the Complete Response Letter appears to be inconsistent with the FDA's published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible."
In April, HGS completed delivery of 20,000 doses of raxibacumab, known as ABthrax, to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalational anthrax. In July, HGS secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the stockpile over three years, starting this year.
The company applied for FDA marketing approval in May.
http://www.gazette.net/stories/11272009 ... 2526.shtml
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