MedImmune has taken its nasal flu vaccine to the next level.
The Food and Drug Administration on Wednesday approved the Gaithersburg biotech’s application to market the first quadrivalent flu vaccine, which is designed to protect against four influenza strains. The company’s previous version of FluMist and other, injected vaccines protect against three strains.
Two types of influenza virus — A and B — can cause illness and death in people, according to the FDA, which each year approves seasonal vaccines that are designed to confer immunity to the two A strains and one B strain that scientists say are most likely to infect people that season.
Typically, however, there may be two different B strains circulating, or the B strain in that season’s trivalent vaccine may not be the right one. In half of the flu seasons from 2001 to 2011, the B strains selected for the vaccine were different from the ones that predominantly circulated that season, according to Stan Block, professor of clinical pediatrics at the University of Kentucky College of Medicine in Lexington and at the University of Louisville (Ky.) School of Medicine.
Including a second B strain in FluMist Quadrivalent increases the likelihood of successfully protecting the public, the FDA said.
“Illness caused by Influenza B virus affects children, particularly young and school-aged, more than any other population,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in an agency statement. “A vaccine containing the four virus strains most likely to spread and cause illness during the influenza season offers an additional option to aid in influenza prevention efforts.”
According to the Centers for Disease Control and Prevention, from 2001 to 2009, 2.7 million fewer Americans would have gotten the flu if all vaccines had been quadrivalent, Block said in a MedImmune statement.
Like MedImmune’s three-strain version, the new vaccine is for people ages 2 through 49. And like the previous version, it is made from weakened forms of virus strains; most vaccines are made from killed strains. In clinical trials, adverse reactions to both MedImmune vaccines were similar.
"This is the first quadrivalent influenza vaccine approved and MedImmune is pleased to be able to take the next steps in making this product available to the public. We believe that the inclusion of an additional B strain in an annual influenza vaccine could provide a direct health benefit to individual vaccine recipients in the event that the correct B lineage either is not selected for inclusion in a trivalent vaccine, or if both lineages co-circulate," said Bahija Jallal, executive vice president of research and development for MedImmune, the global biologics division of AstraZeneca of the U.K.
In other Maryland bioscience industry news:
A Rockville company is poised for more sales of its breath test for bacterial infections after the FDA cleared the test’s use in children ages 3 to 17.
Since 1996, Otsuka America Pharmaceutical has had regulatory approval to market the test, called BreathTek UBT, for adults. The test is designed to Helicobacter pylori infections, which are responsible for chronic stomach inflammation and ulcers, according to an FDA statement.
The FDA approved the test for children after a multicenter study of 176 patients.
H. pylori causes more than 90 percent of duodenal ulcers and up to 80 percent of gastric ulcers, according to the federal Centers for Disease Control and Prevention. About two-thirds of the world’s population is infected by it; in the U.S., it is more common among older adults, blacks, Hispanics and lower socioeconomic groups.
Most infected people never have any symptoms, but do have a two- to six-fold increased risk of developing gastric cancer and a type of lymphoma, according to the CDC. About 25 million Americans have a peptic ulcer at some point in their lives. The usual treatment is antibiotics or a proton pump inhibitor.
Noxilizer is licensing its sterilization technology to a Washington, D.C., company that plans to develop units for the military, disaster response and developing world markets.
Eniware will use the Baltimore company’s proprietary nitrogen dioxide technology to develop, manufacture and commercialize the portable, power-independent units, according to a joint statement.
The need for such units is growing as access to health care increases in developing countries, as more simple surgery is performed in less-than-ideal settings, the companies say. Eniware is finalizing funding for the project.
“This licensing agreement further validates Noxilizer’s technology and its importance in solving a variety of sterilization needs — including the most challenging of environments,” Lawrence Bruder, president and CEO of Noxilizer, said in the statement. “Our partnership with Eniware will enable sterilization solutions that improve the quality of medical care and reduce the incidence of infection for people who do not have immediate access to a fully equipped hospital.”
Noxilizer is in the University of Maryland, Baltimore County Technology Center.
The University of Maryland BioPark in Baltimore has added two small bioscience companies that have moved from Columbia.
Vigilant Bioservices provides biorepository, cold chain logistics and related services to the biotech, pharma, tissue banking and health care industries, while Quality Solutions is a specialized validation, engineering and compliance services provider, according to a university statement.
“We are bringing together two distinct companies to support our clients’ operational, quality, and compliance goals,” said Brian Frederick, Quality Solutions’ president and one of Vigilant’s managing partners, in the statement. “Our newly constructed facility in the BioPark gives us access to a dynamic, diverse community in research, academia and industry that will benefit from our service offerings, while we establish a foundation to expand our global client base.”
Micromet, the Rockville biotech that’s developing a novel leukemia treatment, has won a couple of court battles in its effort to sell itself for $1.16 billion to Amgen.
Stockholders sued Micromet over the proposed deal, claiming it shortchanges them. The company agreed to sell itself for $11 a share; the plaintiffs claim the stock is worth at least $12 a share.
Seven suits were filed in the Delaware Court of Chancery, which at a hearing Monday denied the plaintiffs’ motion for a preliminary injunction, according to a Micromet filing with the Securities and Exchange Commission. Also, two of the five plaintiffs that sued in Montgomery County Circuit Court agreed to stay their cases and withdrew their motion for a temporary restraining order, according to the filing. Another suit, filed in U.S. District Court in Maryland, is pending.