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Emergent BioSolutions has won up to $28.7 million from the National Institute of Allergy and Infectious Diseases to help develop its next-generation anthrax vaccine candidate.

The new contract means the Rockville biotech could receive a total of more than $58 million from the agency to work on the vaccine, according to a company statement.

The candidate is one of two third-generation anthrax vaccines Emergent is developing. It consists of its BioThrax vaccine, which is the only federally approved anthrax vaccine, and a novel immunostimulatory compound called VaxImmune. The company's main money-maker is BioThrax; last year it recorded $216.4 million in sales of the vaccine to the federal government.

"Emergent applauds the U.S. government's commitment to protecting the nation against biological threats by supporting critical development of advanced vaccine and therapeutic candidates," COO Daniel J. Abdun-Nabi said in the statement. "We believe our vaccine candidate addresses key criteria established by the government for a third generation anthrax vaccine. If successfully developed, we believe this product would strengthen the government's portfolio of biodefense medical countermeasures."

The new, four-year contract comprises a two-year base worth $9.1 million, plus milestone-based options worth up to $19.6 million. The base contract will fund activities related to manufacturing and stability studies of phase 2 clinical trial lots and clinical trial preparation. The milestones include continued stability testing of phase 2 clinical trial lots and a clinical study to evaluate the candidate's safety and immunogenicity. Emergent expects to start the phase 2 trial in the first quarter of 2012, with preliminary data expected in the second half of 2012.

Two years ago, Emergent received a development contract for the candidate from the federal Biomedical Advanced Research and Development Authority and the infectious disease agency worth up to $29.7 million.

In other Maryland bioscience industry news:

Federal regulators want more clinical data from MedImmune before it approves its new candidate to help prevent serious respiratory syncytial virus disease in children.

The Gaithersburg biotech said the "FDA has requested evidence from an additional clinical trial that supports a satisfactory risk/benefit profile in the population(s) for which the prophylaxis indication is being requested."

"The company continues to believe in the clinical benefit of motavizumab, and it will conduct a complete review of the [FDA letter], continue ongoing constructive dialogue with FDA, as well as make a decision regarding next steps in due course," MedImmune said in a statement.

Motavizumab is MedImmune's follow-up to its biggest seller, Synagis, which also helps prevent the pediatric respiratory disease. Synagis sales last year fell 12 percent to $1.08 billion from 2008, according to the 2009 annual report of MedImmune's parent, AstraZeneca of London.

MedImmune filed a biologics license application for motavizumab in January 2008. But this spring, an FDA advisory panel voted 14-3 to reject the application.

Among the panel's concerns was that motavizumab has a higher degree of hypersensitivity than Synagis, "with some questions about motavizumab's efficacy," according to FDA documents. Up to 125,000 American infants are hospitalized each year with severe respiratory syncytial virus disease infections.

AstraZeneca reported it holds intangible assets of $445 million relating specifically to motavizumab.

Vanda Pharmaceuticals has started a phase 3 trial of its candidate to treat sleep disorders.

The Rockville company will evaluate tasimelteon in patients with non-24-hour sleep-wake disorder, which is mostly experienced by totally blind people. It affects from 65,000 to 95,000 Americans and results in abnormal night sleep patterns and chronic daytime sleepiness, according to a Vanda statement.

Tasimelteon binds to high-affinity melatonin receptors in the brain that may regulate circadian rhythms, or sleep-wake cycles.

"Blind individuals with no light perception do not receive external light and darkness signals that synchronize our internal body clocks," CEO Mihael H. Polymeropoulos said in the statement. "As a result, these individuals can live lives in a constant state of circadian misalignment. Tasimelteon has the potential to be the first in the class of circadian regulators, drugs that may offer clinical benefits to patients with aberrant timing of the sleep/wake cycle."

The phase 3 trial has a target enrollment of 160 subjects and is slated to run for six months. Results are expected by the end of 2011.

BioServe has launched the BioServe Network of academic, medical and industry biosample repositories that creates, according to the Beltsville company, the largest resource of high-quality biosamples for the life science industry.

The group's charter members are Fox Chase Cancer Center of Philadelphia, the Fairbanks Institute for Healthy Communities of Indianapolis, the University of Massachusetts Medical School and the Windber (Pa.) Research Institute.

"Biosamples are an important research tool that can dramatically accelerate basic science, clinical research and translational studies. However, scientists' ability to consistently obtain high quality biosamples in the quantity and disease type they need is very challenging," said Rama Modali, president of BioServe, in a statement.

"Tapping into the inventories of BioServe's own Global BioRepository and the Network members, scientists are assured of getting the highest quality biosamples they need for their research," Modali said.

"The BioServe Network will open new opportunities for researchers to take advantage of tissue samples in their research, while making the process of sample procurement more efficient," said Mitch Martin, global head of DNA Sciences & Genetics at Roche. "The promise of comprehensive availability for biosamples is compelling. For this reason alone The Network should quickly become the de facto source of biosamples for researchers investigating a wide variety of diseases."

Danish bioinformatics company CLC bio is expanding its U.S. operations with a new office in Germantown.

The company, with its Americas headquarters in Cambridge, Mass., is opening the Germantown and other offices to support its sales and marketing efforts. The Germantown office will focus on the government sector.

"Our new office in Germantown ... provides us with a strong base for supporting our U.S. consulting customers, as well as our growing list of customers within the federal government and in the Maryland biotech sector," said Saul A. Kravitz, director of CLC's North American consulting services, in a statement.

CLC reported a 130 percent increase in global sales last year over 2008, with a 200 percent increase in the Americas. The company develops and markets bioinformatics software, hardware, data analysis and custom-designed algorithms.

Nabi Biopharmaceuticals of Rockville reported two developments related to its NicVax vaccine to treat and prevent nicotine addiction.

The company received its fifth U.S. patent, which "complements our already issued composition-of-matter patents by providing for the exclusive use by Nabi and/or its licensors a method to treat and prevent nicotine addiction using NicVax as well as a wide variety of potential nicotine vaccines," CEO Raafat Fahim said in a statement. "The patent makes it more difficult for a competitor to develop a related vaccine."

NicVax is in phase 3 clinical testing, with final data from a first trial expected by the end of 2011 and from a second trial in early 2012.

Nabi also entered into a long-term commercial manufacturing agreement with Diosynth RTP to manufacture a compound needed to produce NicVax. The five-year deal has optional extensions.

Diosynth, in North Carolina's Research Triangle Park, is part of the Merck BioManufacturing Network of Merck & Co.

"This agreement is an important and exciting step in the event that the phase 3 trials for NicVax are positive and we subsequently receive regulatory approval," Fahim said.

In March, Nabi closed a development and commercialization deal for NicVax with GlaxoSmithKline Biologicals, potentially worth more than $500 million to Nabi. The deal included a nonrefundable $40 million upfront payment, plus potential royalties.

Celsion has received "fast-track" designation from the Food and Drug Administration for its liver cancer treatment development program.

The Columbia company is studying ThermoDox in combination with radiofrequency ablation. ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, which often is used to treat cancer, according to a company statement. Heating the injected area to about 106 degrees releases the drug into the targeted tumor.

Under a special protocol assessment agreement with the FDA, Celsion is testing the treatment in a global phase 3 trial in patients with primary liver cancer. Almost 70 percent of the 600 projected patients have been enrolled, with enrollment expected to be finished this year.

"We are very pleased to receive the Agency's Fast Track Designation for ThermoDox," CEO Michael H. Tardugno said in the statement. "Fast Track Designation is an acknowledgement that [primary liver cancer] is a significant unmet medical need representing a life threatening disorder. It also recognizes the challenges facing pharmaceutical companies to develop effective new treatments for this difficult disease."

Under the FDA designation, Celsion can apply for marketing approval on a rolling basis, which means regulators can review sections of the application before receiving it in its entirety.

Primary liver cancer is the fifth most common solid tumor cancer, with about 20,000 new cases per year in the U.S. and about 1 million worldwide, because of the prevalence of hepatitis B and C in developing nations, according to Celsion.

Celsion also reported that it received a $200,000 phase 1 Small Business Innovation Research grant from the National Institutes of Health to support its efforts to develop its proprietary heat-activated liposomal technology in combination with carboplatin, an approved and frequently used oncology drug.

Neuralstem has applied to the FDA for permission to launch a phase 1 safety clinical trial of its stem cell candidate for chronic spinal cord injury.

The multicenter trial will enroll 16 spinal cord injury patients with complete paralysis, one or two years following their injury, according to a statement from the Rockville company. Neuralstem's treatment does not use embryonic stem cells.

"We are filing an application with the FDA to test our spinal cord stem cells in a second medical condition with substantial unmet needs," CEO Richard Garr said in the statement.

"We are very encouraged by what we have learned transplanting the first six amyotrophic lateral sclerosis patients in our FDA-approved trial in Atlanta," said Karl Johe, the company's chairman and chief scientific officer. "We believe that it is the right time to leverage what we have learned with ALS in spinal cord injury. We will be looking at secondary endpoints as well, by which we hope to measure some degree of functional recovery. As in the ALS trial, we are proposing to transplant patients with injuries in the thoracic (mid-back) regions first. Once the safety of the surgeries has been established, we plan to transplant patients whose injuries are in the cervical (upper spinal cord) region."

More than 10,000 spinal cord injuries are reported in the U.S. annually. All told, about 840,000 people have such injuries.

Areva of Bethesda and its subsidiary Areva Med, which develop nuclear treatments for cancer, have formed an advisory committee to support its growth.

The members are Darrell R. Fisher, a medical physicist and lead for the isotope sciences program at Pacific Northwest National Laboratory in Richland, Wash.; Dr. Olivier Rixe, director of the experimental therapeutics program at the University of Cincinnati; Dr. Brenda M. Sandmaier, oncologist at Fred Hutchinson Cancer Research Center and University of Washington, Seattle; George Sgouros, director of the radiopharmaceutical dosimetry section, Johns Hopkins University in Baltimore; and Dr. Christine A. White, an oncologist and hematologist.

EntreMed of Rockville reported that it received notification from the Nasdaq exchange that it is not in compliance with the minimum market value requirement for continued listing.

That criterion requires companies to have a minimum value of $35 million for at least 30 consecutive business days. EntreMed, which develops cancer treatments, was given 180 days, until Feb. 14, to regain compliance.

Precision Antibody of Columbia said it was chosen by the Environmental Protection Agency to develop monoclonal antibodies to two species of Cryptosporidium, an intestinal parasite that causes waterborne illness.

From 2006 to 2008, the parasite was responsible for 42 percent of reported recreational water-associated gastroenteritis in the U.S., and 6 percent of reported drinking water-associated outbreaks, the company said, citing federal data.

Precision, which is a division of A&G Pharmaceutical of Columbia, said its work may result in better tests for the parasite and more effective treatments for infected people.

"With increasing numbers of people worldwide contracting illness from Crypto-contaminated water, we are excited that the EPA has awarded Precision Antibody a contract to develop these important antibodies," said Jun Hayashi, company vice president, in a statement. "Our goal is to deliver highly specific antibodies that will substantially improve the detection of Crypto and allow a better understanding of this tenacious parasite."

BrainScope Co. of Bethesda said a newly published study in patients presenting to emergency departments following a closed head injury shows its technology might provide clinically useful, when compared with computed tomography.

The study was published in the peer-reviewed journal Brain Injury, the official journal of the International Brain Injury Association.

"This study suggests that clinical presentation alone may not be sufficient to make a prediction regarding the presence of abnormal brain function," said

"Having completed this study, there is great promise that this portable technology will be able to predict which patients are abnormal after a closed head injury," Dr. Rosanne S. Naunheim, associate professor of emergency medicine at the Washington University School of Medicine in St. Louis and the study's lead author, said in a statement.

"We found the device easy to use and predictive of whether CT scans were positive or negative which could be exceptionally useful in triaging patients, whether on the sidelines in sports, the battlefield or the urban Emergency Department," Naunheim said.

Rexahn Pharmaceuticals reported new preclinical research data for a cancer treatment it is developing shows "potent anti-tumor properties."

The data, which involved colorectal cancer cells, were reported in Bioorganic & Medicinal Chemistry Letters.

Gliknik of Baltimore has raised $1.9 million of a $4 million offering in equity, warrants and options, according to a company filing with the Securities and Exchange Commission.

The biotech, which develops treatments for autoimmune diseases and cancer, previously raised $2.9 million of a $3.6 million offering.

BioFortis of Columbia and Catholic Health Initiatives' Institute for Research and Innovation's Center for Translational Research in Towson are launching a partnership to focus on the nonprofit's personalized health care efforts for its 70-plus community hospitals.

The research center will used BioFortis' Labmatrix software to meet its informatics needs in the areas of workflow-driven protocols, specimen biobanking, next-generation diagnostics, biomarker discovery and translational research, according to a joint statement.

The BioFortis system will help produce faster formulation and better utilization of health care information stemming from complementary clinical and specimen-derived molecular assay data, according to the statement. It also will protect sensitive patient information, and help maintain regulatory compliance and accountability through an audit trail infrastructure.