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To its organizers, it's "The Epicenter of Bioscience, Capital, and Policy." More formally, it's known as the 2009 Mid-Atlantic Bio Conference, to be held Wednesday through next Friday at the Washington Convention Center.

Some two dozen bioscience companies from around the region are slated to make presentations to venture capitalists at the fifth annual conference, whose sponsors include the Tech Council of Maryland, the Mid-Atlantic Venture Association and the Virginia Biotechnology Association.

Among the presenting companies are Arginetix, Gliknik and Profectus BioSciences, all of Baltimore; Cylex of Columbia; OpGen, DioGenix and Immunomic Therapeutics, all of Gaithersburg; Celek Pharmaceuticals of Darnestown; and Principio of Rockville.

The companies were chosen through an industry review process, with input from more than 40 investment institutions and industry professionals, according to a statement from organizers.

The conference will also feature talks by H. Thomas Watkins, CEO of Human Genome Sciences of Rockville and chairman of the Maryland Life Sciences Advisory Board; Tony Zook, president of AstraZeneca's MedImmune in Gaithersburg; Sen. Benjamin L. Cardin (D) of Pikseville; Rep. Anna G. Eshoo (D) of Calif., a leading proponent of a 12-year data exclusivity period for biosimilars; and Howard Dean, a physician and former governor of Vermont.

"This is a critical year for the bioscience industry in Maryland as the economy improves," said Richard A. Zakour, executive director of Tech Council of Maryland's MdBio division, in an e-mail. "It is important for the industry to be prepared."

Information on the conference is available at www.midatlanticbio.org and 866-482-7691.

In other Maryland bioscience industry news:

Human Genome Sciences was dealt a setback this week when a Food and Drug Administration advisory panel said it needed more data on the Rockville company's anthrax treatment candidate before it could recommend approving it, according to published reports.

Raxibacumab, which HGS sells as ABthrax, differs from other treatments in that it targets the toxins produced by the anthrax bacterium in the body, rather than the bacterium itself. But the company's own studies in monkeys and rabbits show that adding it to the conventional regimen of antimicrobials had little or no benefit.

Currently, the antibiotics known as Cipro and Levaquin are most often prescribed for the potentially lethal inhalation anthrax.

The FDA has also raised questions about the reliability and quality of human pharmacokinetic data in the HGS application. Those data include how the body absorbs and metabolizes ABthrax.

An HGS spokesman did not return a phone message seeking comment on the company's plans.

This summer, the Department of Health and Human Services ordered 45,000 more doses of ABthrax for the Strategic National Stockpile, to be delivered over three years, for $151 million. Previously, HGS sold $162 million worth of ABthrax to the agency.

Under the Project BioShield Act of 2004, the federal government may purchase products such as ABthrax that have not received FDA approval. If the FDA approves the treatment, HGS stands to collect an extra $10 million under its contract with the health department.

In other company news, HGS on Monday plans to announce the results of its second, and final, pivotal phase 3 clinical trial of Benlysta, the lupus treatment it is developing with GlaxoSmithKline. Last week, HGS announced positive results from the first phase 3 trial.

Pending results of the second trial, the companies plan to submit marketing applications for the treatment in the U.S., Europe and elsewhere in the first half of 2010.

No new treatment for lupus has been approved by regulators in more than 50 years, according to HGS.

Emergent BioSolutions of Rockville is buying space from the MdBio Foundation, a biotech advocacy group, on Lombard Street in Baltimore near Johns Hopkins Bayview Medical Center.

The company said it plans to hire from 25 to 50 employees at the facility. It also plans to invest from $15 million to $20 million in the 56,000-square-foot property, according to published reports.

"Our anticipated acquisition of the manufacturing facility underscores our commitment to creating jobs within the state," said CFO Don Elsey in a statement. He said Emergent hopes to close the deal "as soon as possible."

This summer, the biotech said it planned to expand its infrastructure while reducing its debts and expenses by selling two facilities in Frederick and buying new manufacturing and laboratory facilities in Gaithersburg.

The company manufactures BioThrax, the only anthrax vaccine approved by the Food and Drug Administration, and is developing a newer version that would require fewer doses.

RegeneRx Biopharmaceuticals of Bethesda raised $1 million in a securities offering, according to its filing with the Securities and Exchange Commission. The company is developing tissue protection and repair treatments.

Wellstat Therapeutics of Gaithersburg is teaming up with French pharma giant sanofi-aventis to develop, manufacture and commercialize PN2034, a first-in-class oral insulin sensitizer for treating type 2 diabetes. PN2034, discovered by Wellstat, is in phase 2 clinical trials to reverse insulin resistance in the liver of diabetic patients.

Sanofi-aventis will receive an exclusive worldwide license to develop, manufacture and commercialize PN2034 and related compounds. Wellstat will receive an upfront cash payment and be eligible to receive development and regulatory milestones, for a potential total of $350 million. Wellstat is also to receive payments when specified commercial milestones are met and will receive royalties on worldwide product sales.

"The capabilities that sanofi-aventis brings to the continuing development of PN2034 promise to maximize the significant potential of this compound for patients needing new therapeutic options," David M. Wohlstadter, Wellstat's vice president of licensing and business development, said in a statement. "This agreement further validates Wellstat's drug discovery, research and development proficiencies."

Regulators have approved applications from Celsion Corp. of Columbia to include sites in China, the Philippines and Malaysia for its phase 3 clinical trial of ThermoDox, its candidate to treat primary liver cancer.

Celsion plans to enroll up to 600 patients in the global trial, which is now being conducted in the U.S., Canada, Japan, Hong Kong, Korea, Taiwan and Italy. The company said it also expects to receive approval to conduct the trial at sites in Thailand, for a total of 60 sites by the end of the year, with up to 600 patients expected to be enrolled in the first half of 2010.

The Chinese action "is an important milestone for Celsion because China represents a significant market opportunity for ThermoDox," CEO Michael H. Tardugno said in a statement. The incidence of primary liver cancer in China "is growing faster than any other country, at over 350,000 patients per year," or 55 percent of the world's total incidence.

"Our goal is to enroll patients in key markets outside of the United States to facilitate regulatory approval in multiple countries, mainly East Asia, where the incidence is among the highest in the world," Tardugno said.

Celsion and its Japanese partner Yakult Honsha this week reported enrolling and treating the first patient in Japan as part of the ThermoDox trial.

BioServe of Beltsville was selected by the state of Andhra Pradesh, India, and the Institute of Preventive Medicine Hyderabad to test samples of H1N1 flu in infected patients.

BioServe will conduct the work at its genomic laboratory in Hyderabad, according to a company statement. The company is also developing a one-step diagnostic test for H1N1 flu, at a price designed for mass screenings in India.

As of Sunday, there had been 13,370 confirmed cases of H1N1 flu and 444 deaths from the virus in India, according to Indian officials.

Rockville vaccine developer Novavax is teaming up with Xcellerex of Marlborough, Mass., to accelerate development of Novavax's vaccine-manufacturing process to commercial scale and begin production of its novel 2009 H1N1 flu vaccine for potential commercial sale.

The companies will use Novavax's virus-like particle vaccine technology to produce initial commercial quantities of H1N1 vaccine with Xcellerex's FlexFactory biomanufacturing platform, according to a Novavax statement. Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing supply fees from Novavax.

"Our technology offers Novavax a cost-effective and flexible manufacturing solution for this public health crisis by achieving full commercial-scale production of VLP-based vaccines much more rapidly than traditional vaccine production methods," Xcellerex CEO Joseph Zakrzewski said in a statement.

The partnership "will allow us to increase the scale of our VLP vaccine manufacturing process and expand capacity to satisfy potential demand for our H1N1 VLP vaccine in Mexico," Novavax CEO Rahul Singhvi said in a statement. "This alliance will also enable us to establish commercial-scale production capabilities for our VLP-based seasonal influenza vaccine program and significantly advance our timeline for full scale manufacturing."

Also this month, Novavax, working with Laboratorio Avi-Mex S.A. de C.V., launched a two-stage, 4,000-patient clinical study of the H1N1 vaccine in Mexico to support registration there.

Novavax also announced that it has broken ground on a 25,000-square-foot plant in India that will be running in four months and will be able to produce 60 million vaccine doses annually.

The company is building the facility through CPL Biologicals, its new joint venture with Cadila Pharmaceuticals in India. Besides flu vaccines, the plant will be used to produce other novel vaccines being developed by CPL Biologicals, based on Novavax's VLP vaccine technology.

"This new facility is being 100 percent supported financially by our partner, Cadila Pharmaceuticals Ltd. We anticipate creating sufficient capacity for CPL Biologicals to sell influenza vaccines in India and at the same time become a potential supplier to Novavax for sale of vaccines in other markets where Novavax maintains complete commercial rights," said John Trizzino, senior vice president, international and government alliances for Novavax and interim CEO of CPL Biologicals, in a statement.

Rexahn Pharmaceuticals of Rockville, which develops treatments for cancer and central nervous system disorders, has raised about $5 million in a stock offering to institutional investors. Rexahn plans to use the proceeds for research and development and general corporate purposes.

Rexahn also reported "top-line results" from a phase 2a clinical study of Serdaxin, its drug candidate for major depressive disorder.

The study on 77 patients showed that patients ages 18 to 65 with the disorder showed "clinically meaningful improvement" over baseline in a rating scale, according to a company statement.

"Serdaxin exhibited an onset of action in fewer than two weeks, and was found to be safe and well tolerated with no appearance of serious side effects commonly linked to currently marketed antidepressant drugs," said Robert A. Riesenberg, a psychiatrist and principal investigator at the Atlanta Center for Medical Research.

"Serdaxin clinical trials continue to demonstrate unprecedented efficacy, much faster onset of action compared to currently marketed drugs, and lifestyle benefits for patients with major depressive disorder," said CEO Chang Ahn.

Rexahn is seeking a strategic partner in global development and planned commercialization of Serdaxin. It expects to begin a phase 2b trial early next year.

Rexahn also announced positive results from an animal study showing that its phase 2 oncology drug, Archexin, may target and treat multiple life-threatening cancers.

Researchers at the University of Texas Southwestern Medical Center, Texas Christian University and Rexahn discovered that the primary compound in Archexin "significantly" reduced the expression of AKT1 and inhibited the growth of human cancer cells at the cellular level and in in-vivo models. AKT1 is promote cell survival and is implicated in tumor growth in a wide range of cancers, according to company information.

The study results are to be published Sunday in the Journal of Cellular Biochemistry.

In March, Rexahn began testing Archexin to treat pancreatic cancer, with preliminary data in humans expected next year.

Nabi Biopharmaceuticals is participating in a phase 2b study of its NicVax smoking vaccine, testing its safety and efficacy in helping prevent ex-smokers who took varenicline to help them quit from relapsing .

The study will be conducted at the Maastricht (Netherlands) University Medical Center, funded primarily by the Netherlands Organization for Health Research and Development and Maastricht University, with Nabi providing some support.

Varenicline is marketed by Pfizer under the brand name Chantix.

OriGene Technologies of Rockville has acquired Marligen Biosciences of Ijamsville. Both privately held companies specialize in gene assays and other gene products for the life sciences industry.

"Leveraging OriGene's high throughput monoclonal antibody production capability, OriGene intends to complete its development of high quality assay panels and custom assays for researchers that will dramatically hasten and increase efficiencies for drug discovery," OriGene said in a statement.

KPL Inc. of Gaithersburg signed a multiyear agreement to directly supply its bioscience products to VWR International, a global laboratory supply and distribution company with worldwide sales exceeding $3.7 billion.

KPL also announced a partnership with Syngene of Frederick to help serve the needs of researchers engaged in fluorescent and chemiluminescent blotting techniques. KPL specializes in supplying protein detection tools; Syngene manufactures imaging instrumentation and analysis software for biological research.

Precision Antibody of Columbia was selected to develop antibodies for a component of the National Cancer Institute Clinical Proteomic Technologies for Cancer, a five-year, $104 million program to develop new proteomics tools and technologies to accelerate discovery and clinical research in cancer.

The contract was awarded through a competitive bidding process managed by Science Applications International Corp.-Frederick, which operates the cancer institute in Frederick.

"Our goal is to rapidly develop and optimize antibodies for the target cancer-related antigens we have been assigned, which will help accelerate the NCI's creation of a public resource of gold-standard antibodies to advance proteomics research," said Jun Hayashi, vice president of Precision Antibody, in a statement.

Precision Antibody is a wholly owned service division of A&G Pharmaceutical, also of Columbia.

Asthmatx of Gaithersburg reported that a Food and Drug Administration advisory panel recommended that its Alair System for treating severe persistent asthma in patients 18 years and older, be approved, with conditions.

The Anesthesiology and Respiratory Therapy Devices Panel voted 6-1 in favor. Conditions mostly relate to labeling and post-approval studies. The FDA usually follows the recommendations of its advisory committees.

This week's vote "marks a major step in bringing this new and important treatment option to patients with severe asthma," said CEO Glen French in a statement. "We look forward to working with FDA through the next steps to product approval."

The Alair System uses thermal energy to reduce the muscle associated with airway constriction in asthma patients. It involves inserting a flexible tube through the patient's nose or mouth and into the lungs. The procedure is performed under light anesthesia on an out-patient basis.

The committee found the system improves patients' quality of life by reducing severe asthma attacks by 32 percent, emergency room visits for respiratory problems by 84 percent and sick days at work or school by 66 percent.