Advanced BioScience Laboratories, a contract research organization, is marking its 50th anniversary this year with a new facility in Rockville, where it will host an open house Friday.
The company, owned by Institut Mérieux of Lyon, France, since 2001, finished moving in March from its former quarters in Kensington into the 72,000-square-foot facility.
“It was a strategic move, to have a new facility to build out the way we wanted to,” said spokeswoman Rebecca Harston.
The company, which provides research, manufacturing, testing and other services to the bioscience industry, spent about $12 million on the three-story project, located in the Shady Grove Life Sciences Center at 9800 Medical Center Drive. Advanced BioScience also has a separate 27,000-square-foot animal testing facility, also in Rockville. The company focuses on treatments for infectious and immunologic diseases.
Besides housing the company’s headquarters, the new facility has research labs and manufacturing space, where it produces biologics, including antibodies, proteins and vaccine components, Harston said.
“We wanted to stay in Montgomery County,” she said.
The company, which was founded in 1961 as Bionetics Research Laboratories, has 115 employees, with plans for at least 125 by the end of 2012, she said. It had revenues of 14 million euros in 2009, or $20.2 million at current rates, according to the Institut Mérieux website.
Friday’s open house will include tours of the manufacturing facilities and labs from 11 a.m. to noon and 2 to 4 p.m., with a program from noon to 1 p.m. and lunch from 1 to 2 p.m. Expected to attend are Alain Mérieux, president of Institut Mérieux; Thomas VanCott, president and CEO of Advanced BioScience; Robert Gallo, director of the Institute of Human Virology; Montgomery County Executive Isiah Leggett (D); and other bioscience executives and public officials.
In other Maryland bioscience industry news:
Human Genome Sciences of Rockville and its partner GlaxoSmithKline of London got a preliminary thumbs-up from a European regulatory for its new lupus drug, Benlysta.
The European Commission will have the final say on authorizing marketing of the drug in Europe. The Food and Drug Administration approved Benlysta for sale in the U.S. in March.
“We and GSK are committed to making Benlysta available in countries worldwide,” H. Thomas Watkins, CEO of Human Genome Sciences, said in a statement. “We are well along in building our own HGS commercialization team in Europe and, assuming a positive European Commission decision, we look forward to working alongside GSK to make Benlysta available to patients.”
Under their 2006 agreement, the companies share equally profits from sales.
Last year, dozens of small Maryland bioscience companies received a total of $48.77 million in grants and tax credits under the 2010 Patient Protection and Affordable Care Act.
Now, two U.S. House members want to make that an annual program, for at least several years, to boost the industry and accelerate medical advances.
“It’s important to encourage innovation in the areas in which it has a competitive advantage, such as biotechnology and medical device development,” said Rep. Susan Davis (D-Calif.) in a statement. “Medical technology industries create products that improve human health and help Americans to manage illnesses. Americans will ultimately live healthier and more productive lives with the investment made by the program. These fields also provide high-paying and stable employment, and investment will lead to additional hiring.”
Rep. Allyson Schwartz (D-Pa.) joined Davis in introducing the bill.
The Qualifying Therapeutic Discovery Project Program expired last year after providing $2 billion. The Davis-Schwartz bill reauthorizes the program through 2015, with $1 billion available annually.
The Biotechnology Industry Organization, a trade group, supports the bill.
“The legislation … extends the Therapeutic Discovery Project to support continued American innovation and accelerate the development of life-saving cures for numerous prominent diseases, such as cancers, mental illnesses, heart disease and Parkinson’s disease,” Jim Greenwood, CEO of BIO, said in a statement. “The bill provides much-needed support for biotechnology companies working on breakthrough therapies that could ultimately lower overall health care costs and cure these debilitating diseases within the next 30 years.”
Such grants “allow us in general to advance our technology and explore applications of it in a manner that doesn’t cost our shareholders that capital,” said Douglas J. Swirsky, CFO of GenVec, after his Gaithersburg company received $244,479 last year to help fund its cancer treatment program.
“It’s a wonderful way to evaluate the technology for applications that we may not be able to do in a capital-constrained environment,” Swirsky said.
Emergent BioSolutions reported that eight lots of its anthrax vaccine received regulatory release for delivery to the federal government.
That’s three months ahead of schedule, meaning the Rockville company should complete delivery of 14.5 million doses early this month, according to an Emergent statement.
BioThrax is the only FDA-approved vaccine to protect against anthrax infection.
"Upon completion of this delivery, … the company will focus on delivering the additional 3.42 million doses under the modified procurement contract,” COO Daniel J. Abdun-Nabi said in the statement. “With the recent request for proposal issued by the U.S. government, Emergent is also advancing discussions to supply 44.75 million doses of BioThrax over the next five years."
Emergent also reported that its wholly owned subsidiary Emergent Product Development Seattle amended a 2005 collaboration and license agreement with Pfizer under which Pfizer is developing Emergent’s candidate to treat rheumatoid arthritis, systemic lupus erythematosus and other autoimmune and inflammatory diseases.
The amendment removes certain restrictions; in exchange, Pfizer will pay Emergent $2.5 million up-front, plus potential sales royalties.
OpGen is collaborating with the University of Maryland Institute for Genome Sciences to develop a database of high-quality, finished, annotated microbial sequences, according to a statement from the Gaithersburg biotech.
OpGen is to provide optical maps and sequence finishing technology.
“Inclusion of optical mapping for the characterization of genomes will raise the standard of high quality genome sequence data and will be of extraordinary value given the unprecedented amount of next generation sequencing of clinically relevant organisms,” Claire Frasier-Liggett, director of the institute, said in the statement.
“We are using this technology for validation of our de novo sequencing projects, and anticipate that these will serve as an extraordinary set of reference organism templates to be used by the large number of resequencing efforts worldwide,” Frasier-Liggett said.
Cerecor, with a management team, board of directors and plans to raise $30 million in hand, has launched operations in Baltimore.
The pharmaceutical company focuses on discovering, developing and commercializing prescription pharmaceuticals for the human brain, according to a company statement. Its initial focus is therapies for cough and schizophrenia.
Cerecor’s goal is the rapid commercialization of proprietary technology platforms discovered at the Johns Hopkins University School of Medicine, Johns Hopkins Brain Science Institute and the Lieber Institute, all in Baltimore.
Its co-founders are Isaac Blech, Solomon Snyder, Barbara Slusher and Blake Paterson. Blech has worked for Celgene and Icos. Snyder is a professor of neuroscience, pharmacology and psychiatry at Johns Hopkins University School of Medicine. Slusher is director of the BSi NeuroTranslational Program and also worked for ICI Pharmaceuticals, AstraZeneca, Guilford Pharmaceuticals, MGI Pharma and the Eisai Research Institute. Paterson is a neuroanesthesiologist who practices at the Hopkins medical school and founded Alba Therapeutics, Fells Laboratories and Chesapeake BioDiscovery. He also worked for Eli Lilly, Pfizer and Warner Lambert.
The board comprises Blech, Paterson, John Catsimatidis, Robert Nowinski, Cary Sucoff and its chairman, Eugene Bauer, executive chairman of Medgenics and chairman of Vyteris.
Cerecor also reported that it acquired intellectual property assets comprising the drug product candidate FP01 from Fells Laboratories to treat cough. FP01 is an oral drug used for another disease and has been administered chronically to more than 4.5 million patients worldwide, according to Cerecor. The deal includes an upfront payment, plus milestone payments to Fells Labs.
Fells Labs licensed the intellectual property from Johns Hopkins University.
Profectus BioSciences of Baltimore reported that the AIDS Clinical Trials Group has immunized the first subject in a U.S. phase 1 clinical trial of Profectus’ multi-antigen HIV plasmid DNA vaccine.
The vaccine was administered with various doses of Genevax interleukin-12 pDNA adjuvant, via the electroporation-based TriGrid delivery system developed by Ichor Medical Systems.
The multi-center study, involving 60 HIV-subjects, is sponsored by the National Institutes of Allergy and Infectious Diseases.
“This study will provide important information as to the most adjuvant active dose of Genevax IL-12, and it will do so in combination with the Profectus therapeutic vaccine in HIV infected subjects,” John Eldridge, chief scientific officer with Profectus, said in a statement. “Improving the length and quality of life for those living with HIV infection is a goal we have been working toward for many years.”
Profectus also announced the beginning of a phase 1 clinical trial to evaluate the safety and immunogenicity of an HIV vaccine candidate involving a recombinant vesicular stomatitis virus, a type of arbovirus that can infect insects and mammals and is commonly used in laboratory settings to study viral evolution.
This trial is to involve 60 adults who are not infected with HIV.
Northwest Biotherapeutics said that it has accelerated the addition of clinical trial sites for its ongoing 240-patient phase 2 trial of its DCVax treatment for brain cancer.
That exceeds the Bethesda biotech’s projections for the doubling of such sites across the U.S. this quarter. Northwest previously announced four clinical sites for new enrollment, in Rochester, N.Y., Cleveland, Detroit and Minneapolis. It has now added New York University and UCLA in Los Angeles and is close to completing four more sites, in New Jersey, Michigan, Texas and Washington, according to a company statement.
The company now expects to have 10 clinical trial sites for new enrollment in this quarter. At least five more sites are expected in the third quarter, for a total of 15 sites.
“We are gratified to have received such strong interest and cooperation from clinical centers throughout the U.S., and pleased to be ahead of schedule in completing the lengthy and complex institutional processes to make these centers operational for enrollment of additional new patients into our ongoing … brain cancer clinical trial,” CEO Alton Boynton said in the statement.
SAIC-Frederick, which supports operations of the National Cancer Institute at Fort Detrick, has started a collaboration with Biomatrica of San Diego to improve molecular analysis of tumors.
Such analysis is becoming more important in cancer research and in designing the next generation of targeted therapies, according to an SAIC-Frederick statement.
The collaboration was developed under the cancer institute’s Advanced Technology Partnerships Initiative.
Celsion of Columbia planned to close by Thursday on an $8.6 million stock sale with institutional investors, plus company officers and directors, partly to help finance a phase 3 trial of its cancer treatment candidate.
"This offering is planned to provide Celsion with the resources necessary to fully enroll our phase 3 HEAT study of ThermoDox in primary liver cancer, complete the pre-planned interim efficacy analysis of this study and support the expansion of our ThermoDox program into other cancers, among other near-term goals," Michael H. Tardugno, Celsion CEO, said in a statement. "The offering also reduces our immediate reliance upon other capital sources, such as our committed equity financing facility, the use of which we plan to curtail for the foreseeable future."
Advanced Bionutrition of Columbia raised $1.15 million from two offerings last month, according to a regulatory filing.
The company raised $900,000 of a $1 million mixed offering, plus all of a $250,000 mixed offering.
Advanced Bionutrition has developed a delivery that can be applied to the areas of probiotics, oral vaccines and small molecules, according to company information.
Theranostics Health of Rockville raised $1.52 million from two offerings, according to a regulatory filing.
The company, which provides proteomic biomarker services for personalized therapies, raised all of a $1 million mixed-offering from a single investor, plus $515,000 in an equity offering from six investors.
Spherix of Bethesda, which develops treatments for metabolic disorders, reported that it has regained compliance with Nasdaq requirements regarding minimum bid price listing requirements.
Restorative Therapies has won FDA clearance of the world's first functional electrical stimulation rehabilitation therapy system for stepping and standing in patients with neurological impairments such as spinal cord injury, stroke, multiple sclerosis or cerebral palsy, according to a statement from the Baltimore company.
Its new RT600 system delivers electrical currents to stimulate nerves that activate core and leg muscles including the quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, abdominals and erector spinae to evoke stepping and standing activity, the company said. This enables a patient's paralyzed or weak legs to move through patterned physical activity using their own muscles while positioned in a partial body-weight supporting harness.
"It is the first truly practical rehabilitation system of this kind that I have seen. In addition to combining several valuable neuro-rehabilitation interventions, functional electrical stimulation, locomotor gait training and neuromuscular re-education, the RT600 is small and easy enough to use that I can one day envision it in the patient's home," said Cristina Sadowsky of the Kennedy Krieger Institute in Baltimore in the statement.