Fuad El-Hibri, CEO of Emergent BioSolutions of Rockville.

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Among the state’s bioscience companies that announced significant deals this month, the big winner was Rockville's MacroGenics.

The privately held biotech, which is developing antibody therapeutics to treat solid tumors, entered into a license agreement with Servier of France worth up to $500 million, including an upfront payment of $20 million.

Servier is France's largest privately held pharmaceutical company.

The agreement grants MacroGenics full development and commercial rights to a monoclonal antibody in the U.S., Canada, Mexico, Japan, Korea and India, while Servier receives the option to an exclusive license covering the rest of the world. MacroGenics could receive additional early development and milestone payments worth $60 million, plus an additional $390 million in clinical, regulatory and commercialization milestone payments, with tiered, double-digit royalties on future net sales.

"It's nice to get an influx of money into the company. It's quite unusual for an early-stage program, especially preceding the start of clinical study," said Scott Koenig, president and CEO of MacroGenics. "This will allow us to accelerate the ultimate commercialization, if the trials are successful."

MacroGenic's antibody, MGA271, uses enhanced immuno-stimulatory properties to target the B7-H3 target that is overexpressed in several malignant tumors, according to MacroGenics information. It is being studied in a phase 1 clinical trial.

Servier has shown interest in many of MacroGenic's candidates, although the companies have focused on MGA271 for the past six months, Koenig said. Servier may come back to MacroGencs for other discussions, should this agreement prove fruitful, he said.

MacroGenics doesn’t plan a major increase in its work force through the agreement, although it may add a few positions for various projects, Koenig said.

MacroGenics also reported it will receive a milestone payment from Boehringer Ingelheim, triggered by their 2010 agreement to discover, develop and commercialize antibody-based therapeutics based on MacroGenics' Dual-Affinity Re-Targeting platform. The amount of the payment was not disclosed.

In other Maryland bioscience industry news:

BrainScope, a Bethesda company that is developing technology to assess traumatic brain injuries, has won a $7.5 million Pentagon research contract plus an initial investment of $250,000 from the Maryland Department of Business and Economic Development through the Maryland Venture Fund

The 18-month federal deal will help BrainScope continue developing its technology, a handheld, noninvasive medical device that doesn’t emit radiation, and that the company says could provide “a rapid and objective assessment and categorization of brain injury, based on patterns identified in brain electrical activity.”

It is intended to be used along with standard clinical practice to help rapidly assess military service members suspected of traumatic brain injury, according to a company statement.

“We are excited to work with the U.S. military on this very serious issue and are looking forward to commencing our trial in emergency departments across the country,” CEO and President Michael Singer said in the statement.

BrainScope is one of the first Maryland companies to receive funding from the State Small Business Credit Initiative, a federal initiative that was part of the Small Business Jobs Act of 2010, according to DBED. This year, Maryland won $23 million in federal funding to be invested in businesses through four existing finance programs, including the Maryland Venture Fund.

The company plans to use the new funding “to hire top quality technical and clinical staff,” Singer said.

Fuad El-Hibri is stepping down as CEO of Emergent BioSolutions, effective April 1, but will continue as executive chairman.

He will be succeeded as CEO by Daniel J. Abdun-Nabi, who has been president and COO since 2008. Abdun-Nabi will remain president.

El-Hibri has been chairman and CEO since the company’s founding in 1998.

Since then, Emergent has grown into a $600 million biopharmaceutical company that sells the only federally approved anthrax vaccine and is developing a next-generation anthrax vaccine, plus vaccines and therapeutics for a variety of other diseases, including influenza, tuberculosis, leukemia, arthritis and lupus.

“Dan and I have worked closely together for six years, in which time he has proven to be an accomplished leader with an extraordinary capacity to act both decisively and strategically in the Company’s best interests,” El-Hibri said in a statement.

Profectus BioSciences snagged a $5.4 million grant from the National Institute of Allergy and Infectious Diseases to support preclinical development of m102.4, an antibody intended as a post-exposure prophylactic against Nipah or Hendra virus infection.

The related viruses can cause a respiratory and encephalitis disease in animal hosts and humans, according to a statement from the Baltimore biotech. The natural reservoir for these viruses is thought to be flying foxes in Southeast Asia and Malaysia. Human infection can occur after exposure to tissues and secretions from infected horses, pigs and bats.

There are no approved therapeutics for the viruses, which are deadly in about 75 percent of cases. The viruses are classified as biothreat agents by the National Institutes of Health and Centers for Disease Control and Prevention, and an agriculture threat agent by the U.S. Department of Agriculture.

GenVec reported that it has achieved the second milestone in its collaboration with Novartis to develop treatments for hearing loss and balance disorders.

The Gaithersburg biotech completed certain preclinical development activities to achieve the milestone.

Under its January 2010 agreement, GenVec could receive $213.6 million, including upfront and milestone payments, plus sales royalties.

The company also announced that Paul H. Fischer, 62, is retiring as president and CEO. He plans to continue until a successor is hired.

"I am proud to have served GenVec, our employees, our Board of Directors and our stockholders, as a director, President and Chief Executive Officer, since 1996," Fischer said in a statement. "Our dedicated employees, management team and Board have put GenVec on a solid footing, and I am confident that the company is well-positioned for its next phase of growth and development.”

Chairman Zola Horovitz called Fischer “an outstanding leader in both good and challenging times.”

"On behalf of the Board and everyone at GenVec, I want to thank Paul for the leadership, dedication and commitment that he has given the Company over the last 15 years," Horovitz said.

Vanda Pharmaceuticals has struck an exclusive license agreement with Israeli biotech Megapharm to commercialize the Rockville company’s schizophrenia drug, Fanapt, in Israel.

"This marks another important milestone for the Fanapt brand as we continue to grow its presence around the world," CEO Mihael Polymeropoulos said in a statement.

Under the agreement, Megapharm is seeking regulatory approval for Fanapt in Israel and will promote it to psychiatrists there. An application for regulatory approval of Fanapt in Israel was filed in May.

Five bioscience companies each received $200,000 from the Maryland Biotechnology Center to help spur commercialization of treatments for cancer and other diseases.

Translational Research Awards went to NexImmune and BetaCat, both of which are in Gaithersburg and are developing cancer treatments, and GrayBug of Baltimore, which is working on an age-related macular degeneration therapy.

Biotechnology Commercialization Awards went to Harpoon, a University of Maryland spinoff focusing on mitral valve heart repair, and PathSensors of Baltimore, which develops environmental and food tests.

In three years, $3.1 million in these state awards have gone to 13 Maryland life sciences companies and three university research projects, according to state information.

Companies may apply for the next round of awards by Feb. 15 at marylandbiocenter.org.

Human Genome Sciences and partner GlaxoSmithKline have launched a phase 3 clinical trial of their lupus drug in a subcutaneous formulation given once a week.

Benlysta, approved by the Food and Drug Administration in March, is the first new lupus drug in 50 years. It is now administered as a one-hour intravenous infusion given at two-week intervals for the first three doses and at four-week intervals thereafter.

The Rockville biotech and British pharma giant plan to enroll 816 adult lupus patients in the yearlong study, which will compare Benlysta plus standard of care against a placebo plus standard of care, according to a joint statement.

“Initiation of this new trial investigating a subcutaneous formulation of Benlysta represents an important step in our ongoing clinical development program,” said H. Thomas Watkins, president and CEO of HGS, said in the statement.

Annapolis biodefense company PharmAthene scored another victory in its ongoing legal battle with a New York drug-maker over a smallpox therapy.

The decision could be worth $1 billion to PharmAthene.

The Delaware Court of Chancery denied Siga Technologies' motion for re-argument that it filed in October. That ruling upholds the court's initial decision in September that PharmAthene is entitled to half the profits from sale of the drug for 10 years, after Siga receives the first $40 million in profits.

PharmAthene also is entitled to one-third of its legal costs, the court said.

"The Court's decision to award 50 percent of the net profits of ST-246 to PharmAthene represents a tremendous victory for our Company," CEO Eric I. Richman said in a statement. "The significant economic interest and near-term revenue we expect to recognize following this decision will enable us to accelerate our path to profitability and generate immediate value for investors.”

The court now must determine just what constitutes “net profits,” Richman said.

In May, Siga estimated the total value for the U.S. civilian market at about $2.8 billion, according to PharmAthene.

Siga won a base contract from the Biomedical Advanced Research and Development Authority for the initial procurement of 1.7 million treatment courses of ST-246. The five-year base contract award is worth $433 million, of which $412.5 million is for purchase of the product, PharmAthene said.

Siga plans to appeal.

“Once the Court enters a final judgment implementing the post-trial decision, Siga intends to appeal the decision and judgment to the Delaware Supreme Court,” the company said in a statement.

PharmAthene also reported that a phase 1 clinical trial showed its Valortim antibody treatment and prophylaxis for anthrax infection was safe and well tolerated. The results were reported in the December issue of Clinical and Vaccine Immunology, published by the American Society for Microbiology.

The results "demonstrate that a single dose of Valortim can provide levels of antibodies in humans that correspond to protective levels in animal models and is well tolerated,” Thomas Fuerst, executive vice president and chief scientific officer, said in a statement. “Based on the accumulating human safety and animal efficacy data for Valortim, we believe that it could represent an important addition to the nation's anthrax armamentarium."

Micromet, the Rockville company that is developing cancer treatments, reported positive results from trials involving patients with leukemia and lymphoma.

The biotech’s blinatumomab antibody is designed to harness the body’s own T-cells to kill cancer cells.

In a phase 2 study, 75 percent of patients with relapsed or refractory B-precursor acute lymphoblastic leukemia who received blinatumomab achieved complete remission, with no detectable leukemic cells remaining, Micromet reported.

Also, all responders also achieved a molecular response — “or in other words, had no evidence of remaining leukemic cells detectable in the blood or bone marrow,” according to a company statement.

"In this study, blinatumomab has meaningfully altered the treatment outcome for patients with relapsed B-precursor [acute lymphoblastic leukemia],” professor Max Topp of the University of Wuerzburg (Germany) and chairman of the study, said in the statement. "The difference in efficacy and improved tolerability that I have seen has been impressive compared to the standard of care."

Based on these results, Micromet last month launched a global phase 2 study in this patient population.

About 5,300 Americans have this kind of leukemia, with a mortality rate of about 24 percent, with a five-year survival rate among adults of 7.4 percent, according to Micromet.

Also, a phase 1 trial of blinatumomab showed that it induced durable responses in patients with extensively pre-treated diffuse large B cell lymphoma.

"The level of activity observed with a single agent in this heavily pre-treated patient population is unusual," said Andreas Viardot of the University of Ulm (Germany).

The company plans to start a phase 2 trial next year in patients with this kind of lymphoma.

Therapies being developed by GlycoMimetics of Gaithersburg were the subject of three oral presentations at the annual meeting of the American Society of Hematology, highlighting their use in treating vaso-occlusive crises associated sickle cell disease and leukemia.

GlycoMimetics is developing GMI-1070 to treat the sickle cell disease condition under an exclusive worldwide licensing agreement with Pfizer.

"We continue to make significant progress with our pipeline programs,” CEO Rachel King said in a statement. “Data from GMI-1070 provide additional support for testing the drug candidate in sickle cell crisis, and the phase 2 trial is now under way.”

Celek Pharmaceuticals has won a $176,266 phase 1 Small Business Innovation Research contract from the National Cancer Institute to help it develop its candidate to treat bladder cancer.

CEL-031, as the drug is called, is a small-molecule compound that selectively induces apoptosis, or programmed cell death, in cancer cells. It is designed to target phosphodiesterase enzymes, which are overexpressed in human tumor cells, according to a statement from the privately held Rockville biotech. Studies have shown evidence of efficacy and a favorable safety profile.

Celek wants to enhance the drug's commercial potential by developing it for non-muscle-invasive bladder cancer.

Bladder cancer is the fifth most common cancer in the U.S., with more than 70,000 new diagnoses and 14,000 deaths in 2010, according to Celek. Most cases — 70 percent — are diagnosed at the non-muscle-invasive stage, when tumors are confined to the bladder lining or have started to grow into connective tissue, but have not penetrated the muscle layer.

Certis USA of Columbia signed a license agreement with Montana State University-Bozeman and Montana BioAgriculture of Missoula to develop and commercialize new plant disease control technologies based on Bacillus mycoides isolate BmJ.

The naturally occurring, nonpathogenic bacterium triggers a plant's immune response to pathogenic fungi, bacteria and viruses resulting in systemic acquired resistance to diseases, according to a Certis statement.

Certis plans to commercialize technology developed by the Montana school and company worldwide in an expanded range of crops and diseases.

BioElectronics of Frederick reported that it was awarded a Chinese patent for elements of its electronic healing patch.

"This patent protects our technology in both the manufacturing and future product sales in China in addition to our relentless manufacturing cost reductions, constant innovations in the design, and our aggressive disruptive pricing strategy," John Martinez, director of engineering, said in a statement.