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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.

In other Maryland bioscience industry news:

Novavax has raised about $21 million in a stock sale, which the Rockville biotech plans to spend on advancing its virus-like particle vaccine candidates, including one for the H1N1 flu strain.

The company has enrolled 1,000 people in the first stage of a clinical study of the H1N1 vaccine in Mexico, where the influenza strain initially surfaced early this year. The second stage is to involve 3,000 subjects.

"We are encouraged by the recommendation of the data and safety monitoring board to continue the trial and plan to begin subjects' enrollment in the second phase of the study as soon as possible," said CEO Rahul Singhvi in a statement. "This pivotal trial is advancing rapidly toward completion with the ability to evaluate results early next year. If our findings are positive, Novavax and our partners plan to seek immediate approval to market our VLP-based 2009 H1N1 VLP pandemic influenza vaccine in Mexico, which currently faces a critical shortage of H1N1 influenza vaccine."

Nabi Biopharmaceuticals may have hit the half-billion-dollar jackpot last week when it agreed to license its nicotine vaccine candidate to British pharma giant GlaxoSmithKline.

The Rockville company will receive an upfront fee of $40 million, with other fees and milestone payments potentially reaching $500 million, according to a Nabi statement.

The company's NicVax is designed to treat nicotine addiction and prevent smoking relapse. The GSK deal also includes royalties on sales of any next-generation nicotine vaccines that Nabi develops.

NicVax recently entered the first of two phase 3 clinical trials, whose cost Nabi is covering.

"If approved, this smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent; a habit that is well documented to be very hard to stop permanently," said Jean Stephenne, president of GSK Biologicals, in a statement. "This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio."

"We are very pleased with this deal and proud it is with GSK, one of the world's leading vaccine companies, to further develop and commercialise NicVAX," said Nabi CEO Raafat Fahim in the statement. "We look forward to addressing one of the largest unmet medical needs of our time with what we believe will be an effective tool to help people quit smoking and remain smoke-fee for the rest of their lives."

The deal with GlaxoSmithKline means a $250,000 bonus for Fahim, according to a Nabi filing with the Securities and Exchange Commission on Wednesday.

There are 1.2 billion smokers in the world, and smoking causes 5.4 million deaths annually, according to the Centers for Disease Control and Prevention. Tobacco is as addictive as heroin and cocaine, according to the British Royal College of Physicians.

NicVax is designed to work by stimulating the immune system to produce antibodies that bind to nicotine, which is then too large to cross the blood-brain barrier and cannot reach receptors in the brain, thus preventing addiction.

Sucampo Pharmaceuticals of Bethesda has received Swiss regulatory approval to market its Amitiza gel capsules for treating chronic idiopathic constipation.

It's the company's first European regulatory approval and Amitiza is the first prescription medicine to be approved in Switzerland for long-term treatment of the disorder, Sucampo said in a statement. The Food and Drug Administration has already approved Amitiza to treat the disorder in adults and to treat irritable bowel syndrome with constipation in women. The drug is the only FDA-approved prescription treatment for either of these indications.

"This decision further validates Amitiza's position as a safe and effective therapy for a chronic condition," CEO Ryuji Ueno said in the statement.

Expression Pathology of Rockville said the Mayo Clinic in Rochester, Minn., has licensed non-exclusive rights to its Liquid Tissue patent for diagnosing systemic amyloidosis in formalin-fixed tissue.

With 50,000 cases diagnosed annually, amyloidosis can be a localized or systemic disease, characterized by organ function impairment, sometimes as severe as cardiac and/or renal failure, according to company information.

Rockville pharmaceutical developer EntreMed reported that its candidate for treating leukemia, ENMD-2076, was well-tolerated, according to initial data from a phase 1 clinical trial.

EntreMed also said that it has selected ovarian cancer as an initial phase 2 indication, despite "encouraging" results from the phase 1 study.

"This decision is supported by data from the ongoing Phase 1 study with ENMD-2076 in patients with solid tumors where of the 20 ovarian cancer patients, tumor and tumor marker responses were demonstrated in 45 percent of patients," the company said in a statement. "In addition, another 15 percent have shown clinical benefit including reductions in tumor size, improvement in symptoms, or both. The decision is further supported by robust preclinical data and the need for additional active agents for ovarian cancer patients who have failed current standard of care."

EntreMed has received orphan drug designation from the FDA for using ENMD-2076 in ovarian cancer patients. It expects to begin the phase 2 study in the spring.

Spherix of Bethesda has reported positive interim phase 3 clinical results for D-tagatose, its candidate for treating diabetes.

"The interim results and overall study progress are very encouraging," CEO Claire Kruger said in a statement. "The interim analysis results are significant because they indicate that if this study continues as anticipated, results will support the efficacy and safety of D-tagatose as a new and important therapy for Type 2 diabetes."

The results indicated "significant" reductions in body mass index, serum triglycerides and HDL and LDL cholesterol.

"Some of the currently marketed drugs to control glucose levels may cause patients with Type 2 diabetes to experience significant discomfort, and develop serious side effects, including cardiovascular disease. We believe our therapeutic approach has the potential to offer patients and clinicians an alternative for achieving their therapeutic goals without some of the attendant risks of currently available medications," Kruger said.

If the trial continues to yield positive results, Spherix plans to submit a new drug application to the Food and Drug Administration next year.

D-tagatose, which prevents the stimulation of insulin secretion and lowers blood glucose levels, already has been recognized by the FDA as a safe artificial sweetener for use in food and beverages since 2001.

About 23.6 million Americans have diabetes, mostly type 2, according to the Centers for Disease Control and Prevention. As its prevalence doubled from 1990 to 2005, the CDC has characterized the increase as an epidemic.

Micromet said it entered into an agreement with Lonza, which will manufacture blinatumomab, the Bethesda biopharmaceutical company's candidate for treating cancers, including leukemia and non-Hodgkin's lymphoma.

The Basel, Switzerland, company will manufacture blinatumomab for use in clinical trials, plus develop the commercial scale process and supply blinatumomab for the market if requested by Micromet, according to a Micromet statement.

Blinatumomab has achieved the primary endpoint in a phase 2 clinical trial for treating patients with acute lymphoblastic leukemia and has shown "significant clinical activity" in an ongoing phase 1 clinical trial for treating patients with non-Hodgkin's lymphoma, the company said.

Micromet controls the worldwide rights to develop and commercialize the product after it reacquired MedImmune's remaining rights to it this month.