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Emergent BioSolutions hit a jackpot of sorts when the Food and Drug Administration approved extending the shelf life of its anthrax vaccine from three to four years.

The milestone approval means that the vaccines that the Rockville biotech has already sold to the Department of Health and Human Services' Strategic National Stockpile are worth $30 million more than the original price. In a statement, Emergent said it plans to record that extra income in the current quarter.

Furthermore, the extended shelf life means that the value of the company's contract for 14.5 million additional doses has increased to $405 million.

"We are pleased that the FDA has approved the 4-year expiry dating of BioThrax as this extends the ability of the U.S. government to store our product in the nation's Strategic National Stockpile," said Fuad El-Hibri, chairman and CEO.

"This is a critically important product feature that we believe will increase the attractiveness of BioThrax to the U.S. government as it increases BioThrax's life cycle value. We are continuing our efforts to further enhance the attributes of BioThrax, including research toward a further reduction in the vaccination schedule and an expanded label indication for post-exposure prophylaxis. We believe these enhancements, if approved, will advance the U.S. government's preparedness efforts in response to anthrax as a potential weapon of bioterrorism."

Emergent has supplied more than 33 million doses of BioThrax, the only FDA-approved anthrax vaccine, to the federal government, with more deliveries scheduled through the third quarter of 2011.

Also this week, Emergent sued privately held Protein Sciences Corp. of Meriden, Conn., which it planned to acquire last year, according to a filing with the Securities and Exchange Commission. In connection with the planned acquisition, Emergent made a $10 million loan to Protein Sciences, which used its assets as collateral. A May 31 deadline for repayment passed, prompting the suit, Emergent said.

Emergent also plans to proceed with its pending lawsuits against Protein Sciences and its management, including claims for breach of contract, fraud and unfair business practices.

For its part, Protein Sciences last month issued a statement saying it had signed a repayment agreement with Emergent.

"We are pleased to have an agreement in place with Emergent covering repayment of the loan and resolution of the litigation," Daniel D. Adams, president and CEO of Protein Sciences, said.

In other Maryland bioscience news:

BioReliance, a 62-year-old Rockville company that tests health care products on animals for the bioscience industry, violated federal animal safety regulations seven times in two incidents last summer.

The violations were made public by an animal rights group, Stop Animal Exploitation Now! of Milford, Ohio.

"The negligence at BioReliance may have killed as many as 19 animals," said the group's executive director, Michael A. Budkie, in a statement. "This facility should face serious consequences."

The incidents, which BioReliance self-reported to the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, involved at least three, and possibly about 20, hamsters.

One hamster was found running around inside a walk-in refrigerator, while another was found alive in a euthanasia bag. An investigation indicated that "an experienced lab assistant failed to follow standard operating procedures for euthanizing hamsters," according to the USDA report.

Failure to follow procedures "caused undue pain and distress for 2 hamsters and possibly 18 other hamsters," the report said.

In the other incident, also last summer, a hamster was found dead in a cage after the cage was removed from a sterilizing autoclave. "It is assumed the animal was alive prior to being placed into the autoclave …," the report said.

All told, the USDA found seven violations stemming from the two incidents.

"BioReliance acknowledges that isolated events involving small animals the Company uses in mandated medical safety testing occurred last year," David Walker, the company's vice president and CFO, wrote in an e-mail to The Gazette.

"Any event of this nature is taken very seriously by the Company. The company self reported the events and requested inspections by the USDA. The issues surrounding the events have been corrected and disciplinary actions were taken. Since these events, the Company has received two clean inspections by the USDA," Walker wrote.

Budkie called the violations "outrageous" and "very distressing," and called for an inspection of BioReliance's facility "by an independent authority other than the USDA" — namely himself, accompanied by news media.

A USDA spokeswoman said no enforcement action or penalties have been levied against BioReliance and confirmed that two subsequent inspections found the company complying with regulations.

Rexahn Pharmaceuticals, which is developing drugs for cancer, erectile dysfunction and other nervous system disorders, closed a direct offering of common stock and warrants, grossing $3 million. Also, one institutional investor received warrants to buy an additional $7 million in stock.

The Rockville company plans to use the proceeds for research and development and general corporate purposes.

First the good news from Neuralstem, a Rockville biotech whose technology helps produce neural stem cells of the human brain and spinal cord in commercial quantities: The company won a U.S. Patent on four new chemical products that boost the generation of new neurons.

"The ability to promote neurogenesis — the birth of new neurons in the adult brain — has recently been a focus of intense research by scientists and pharmaceutical companies worldwide," president and CEO Richard Garr said in a statement. "These four compounds, with potent demonstrated neurogenic activity, are first-in-class compounds, were discovered entirely in-house and are owned by the Company. These are the only drugs we are aware of with the demonstrated ability to stimulate neurogenesis of normal adult brain cells, which indicates that they are truly neurogenic."

The chemicals may help treat diseases including depression, Alzheimer's disease, stroke and traumatic brain injury. Neuralstem plans to launch a phase 1 safety trial for using its lead compound to treat major depression by early next year.

Now for the bad news: Neuralstem's shareholder equity dropped below the $2 million limit required by the NYSE Amex for continued listing. Also, the company posted net losses in two of its most recent fiscal years — $11.8 million in 2008 and $6.2 million in 2007 — violating another listing requirement.

The company has until July 6 to submit a plan to regain compliance by Dec. 6, 2010.

Fisher BioServices of Rockville, which provides repository and other services to the bioscience industry, is expanding its presence in Montgomery County.

The company, a division of Thermo Fisher Scientific of Waltham, Mass., signed a seven-year lease for 20,249 square feet at 20439 Seneca Meadows Parkway, a 53,054-square-foot building in the Seneca Meadows Corporate Center in Germantown, where it already has a location.

Fisher is moving into space being vacated by MiddleBrook Pharmaceuticals, as it shifts more operations to Texas following its acquisition last year.

Scheer Partners of Rockville, a commercial real estate services company that has begun a specialty in bioscience properties, represented MiddleBrook. Minkoff Development Corp. of Germantown is the landlord.

Clinical Data of Newton, Mass., has completed its $10 million acquisition of Avalon Pharmaceuticals of Germantown in an all-stock deal.

Both companies have focused on diagnostics and therapeutics in oncology.

Human Genome Sciences has reported positive results from a long-term phase 2 continuation trial of the lupus treatment it is developing with GlaxoSmithKline.

Benlysta, formerly known as LymphoStat-B, showed "sustained improvement in disease activity across multiple clinical measures, decreased frequency of disease flares, and was generally well tolerated through four years on treatment in combination with standard of care in patients with serologically active systemic lupus erythematosus," the Rockville biotech said in a statement.

About 5 million people, including 1.5 million Americans, have various forms of lupus. Phase 3 trials are ongoing for Benlysta, which the companies are developing under a 2006 agreement.

This report originally appeared in The Business Gazette.