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A Baltimore company has won a key federal regulatory approval for its diabetes management software system, which it plans to start marketing early next year.

"This is a big milestone," said Christopher Bergstrom, chief strategy and commercial development officer for WellDoc, in an interview Monday.

WellDoc, which also has offices in Wilmington, Del., and Bangalore, India, said Monday it has received what's known as 501(k) clearance from the Food and Drug Administration for its DiabetesManager System. The system is designed to provide patients who have type 2 diabetes and their physicians and other providers with real-time data about blood-sugar levels and other indicators, along with immediate nutritional and other guidelines to manage the disease.

There are other diabetes systems available, but WellDoc's goes further than they do, Bergstrom said.

"A lot of great solutions and companies are out there, but some don't have FDA clearance," he said. "Many just collect data and push it and report it. But we analyze it and turn it into knowledge based on clinical guidelines."

For example, according to a presentation on WellDoc's website, a diabetes patient might test his blood in the morning. The data are fed into the WellDoc Internet and cell phone system, which immediately gives him feedback on what he should eat for breakfast.

"It's like having a GPS in your car that just says there's a traffic jam ahead" but doesn't give the driver directions to avoid the jam, Bergstrom said of other diabetes software systems. "Today's monitors just give a number. We provide what to with that information in real time."

In a clinical study involving 30 patients with type 2 diabetes, patients who used the WellDoc system had a 2.0 percent decrease in A1c, indicating better control of blood sugar versus 0.7 percent among the control group. Also, 84 percent of the patients who used the system had their medication adjusted, compared with 23 percent of the control group patients.

Privately held WellDoc, founded in 2005, is funded by angel investors, Bergstrom said. Its revenues have grown "significantly three years in row," he said, without disclosing specifics. The company already works with some large pharmaceutical companies on cell-phone programs on medication adherence and "virtual coaching."

The company has between 50 and 100 employees, twice what it had a year ago, he said, with plans to hire 10 more in Baltimore during the next six months.

"We have four starting today," Bergstrom said. Clinicians make up about half of its work force, with most of the other employees developing software and behavior techniques.

With other nations often relying on FDA approval as "benchmark" for licensing medical devices, the company is eyeing international markets, he said.

"Our president is overseas today," talking with government and other officials about marketing DiabetesManager abroad, Bergstrom said.

With about 20 million Americans with type 2 diabetes, the market potential is significant.

"With type 2 diabetes reaching epidemic rates and limited time for care, healthcare providers need new tools to more efficiently engage their patients between and during office visits," said Dr. Richard Bergenstal, executive director of the International Diabetes Center at Park Nicollet and president of the American Diabetes Association, in a statement. "WellDoc's System addresses this need by delivering real-time, evidence-based education and behavioral coaching. This enhanced engagement and communication is intended to enable providers to support positive patient behavior and improved health."

WellDoc officials foresee applying the technology to helping manage other chronic conditions that involve medication adherence or behavior changes, Bergstrom said, including cardiac heart failure, oncology and asthma.

He pointed to last week's announcement by the FDA and Federal Trade Commission of their joint support for combining medical and wireless technologies to manage disease.

"Here we are at the beginning of a tsunami," Bergstrom said. "WellDoc is well-positioned at the crux of that storm."

In other Maryland bioscience industry news:

Amplimmune has struck an agreement with GlaxoSmithKline that could mean $485 million to the Rockville company, which is developing cancer treatments.

The British pharma giant will pay Amplimmune $23 million upfront for exclusive global rights to AMP-224 and other potential next-generation fusion proteins that target PD-1, according to an Amplimmune statement. Further payments would be made for achieving regulatory, development and sales milestones, including those associated with conducting a phase 1 trial of AMP-224. Amplimmune also would be eligible for royalties of at least 10 percent on worldwide sales.

Amplimmune expects to launch a phase 1 trial in cancer patients in 2011 and complete manufacturing and toxicology studies. Both companies will conduct research.

"We are very pleased to establish this broad alliance with GSK on our AMP-224 program," said Michael S. Richman, Amplimmune president and CEO, in a statement. "This partnership is an example of pharma and biotech companies working together towards a common goal of developing novel therapies for patients with unmet medical need and we look forward to advancing AMP-224 into clinical testing."

PD-1 helps regulate T-cell mediated immune responses, according to company information. High levels can result in impaired immunity.

Amplimmune, founded in 2007, is funded by InterWest Partners and The Wellcome Trust.

Privately held Symphony Icon of Rockville, which develops treatments for irritable bowel syndrome, other gastrointestinal disorders and cognitive disorders such as Alzheimer's disease, schizophrenia and vascular dementia, has been acquired by Lexicon Pharmaceuticals of The Woodlands, Texas.

Lexicon paid $10 million and agreed to pay $80 million in additional deferred and contingent payments, based on licensing, commercialization and other milestones.

Symphony Icon was a collaboration between Lexicon and Symphony's primary investor, Symphony Capital of New York.

MedImmune has begun shipping the first of an expected 15 million doses of its trivalent nasal flu vaccine, FluMist, for the upcoming influenza season, according to a statement from the Gaithersburg biotech.

MedImmune is one of seven companies approved by the FDA to provide the vaccines, all of which are designed to confer immunity against the H1N1 pandemic flu strain. That means patients will need only one vaccination; during last year's flu season, patients needed one for seasonal flu and one for the H1N1 strain.

FluMist accounted for 34 percent of seasonal flu vaccines given to children ages 2 through 18 years during last year's flu season, based on insurance surveys, MedImmune said.

The flu strikes from 5 percent to 20 percent of Americans annually, resulting in more than 200,000 hospitalizations from complications and about 36,000 deaths, according to the Centers for Disease Control and Prevention.

PharmAthene, the Annapolis company developing a next-generation anthrax vaccine, reported notification from the Nasdaq exchange that it faces delisting for failing to meet requirements for stockholder equity requirements and/or operating margins in recent years.

PharmAthene said it plans to submit by Aug. 26 a plan to regain compliance by Jan. 26, 2012.

Akonni Biosystems of Frederick has won a $435,000 grant from the National Institutes of Health to develop a low-cost, point-of-care system to diagnose multidrug-resistant strains of mycobacterium tuberculosis.

The grant is designed to provide high-quality testing to underserved populations, particularly minorities, according to a company statement.

For each white American with tuberculosis, there are an estimated 23 people of East Asian descent, 21 native Hawaiian or Pacific Islanders, nine blacks, eight Latinos and six American Indians with the disease.

"Using Akonni's TruArray gel-drop microarray as the basis for the test gives us the ability to simultaneously interrogate tens to hundreds of genetic markers from a single patient sample to identify the most common drug resistant strains" of mycobacterium tuberculosis, Chris Cooney, the company's principal investigator on the grant, said in the statement. The technology "also gives us the ability to manufacture and deliver the tests at a price point that is affordable for lower cost settings."

Collaborating with Akonni will be Laboratorios Medicos Especializados in Juarez, Mexico.

Akonni also announced it has received a U.S. patent for its method for rapidly purifying nucleic acids.

Novavax said it has been issued a U.S. patent for functional influenza virus-like particles, covering the use of influenza gene sequences for high-yield production of vaccines.

The process "promotes rapid and efficient production of [virus-like particles] that have a more uniform shape and size, which Novavax believes will add to the consistency and safety of its vaccines," according to a statement by the Rockville company.

"Our ... technology overcomes a major limitation of the current influenza virus vaccine technology that depends on strain selection and optimization every year. It enables faster production of vaccine for the target influenza strain than the existing, egg-based process which resulted in significant delays in the manufacture of vaccines during the 2009 H1N1 pandemic emergency," said Gale Smith, vice president of vaccine development and one of the senior inventors of the technology.

Preclinical findings show thymosin beta 4 is essential to healthy heart development and embryonic survival, according to researchers at the Molecular Medicine Unit at UCL-Institute of Child Health in London, RegeneRx Biopharmaceuticals announced.

The Rockville company is developing the compound as a treatment for heart disease and other conditions.

"These findings are important in that they establish the molecular mechanism by which [thymosin beta 4] stimulates vascular growth of the embryo and opens up the possibility of utilizing [it] to potentially correct serious heart defects in utero," said Allan Goldstein, professor of biochemistry and molecular biology at George Washington University School of Medicine and founder and chief scientific adviser of RegeneRx, in a statement.

"We believe this research further supports development of RGN-352, an injectable formulation of [thymosin beta 4], in acute myocardial infarction," CEO J.J. Finkelstein said. "We plan to begin a phase 2 study in [acute myocardial infarction] later this year."

Thymosin beta 4 is a synthetic version of a naturally occurring peptide present in almost all human cells.

BioElectronics of Frederick recently filed four federal grant applications totaling $1.1 million to fund clinical studies on using its electronic healing patch for diabetic neuropathic foot ulcers, oral surgery pain, plantar fasciitis and menstrual pain, according to a company statement.

Data from the studies will be used for submissions to the Food and Drug Administration to gain additional clearances and support BioElectronics' sales and marketing operations, company officials.

Maryland Sustainable Mariculture, a biotech startup in Baltimore, has a licensing agreement with University System of Maryland researchers who have developed an environmentally sustainable and cost-efficient way to increase the world's supply of high-quality seafood, according to a university statement.

The Recirculating Marine Aquaculture System was developed at the former University of Maryland Biotechnology Institute and its Center of Marine Biotechnology by then-center Director Yonathan Zohar and his team.

"As our oceans run out of fish, the world is in dire need of a consistent supply of high-quality seafood," Zohar said. "The development of this technology marks the culmination of a multi-disciplinary effort, spanning a decade, to develop the next wave of aquaculture technology that produces healthy and clean seafood while having no adverse effect on the marine or coastal environments."

The system is designed to protect marine species from disease. A byproduct of the system is methane, which is used as a supplemental energy source.

A marine aquaculture facility that uses the system could be in urban or rural locations or next to airports or markets, "thus reducing the carbon footprint of seafood production," according to the statement.

"As a result, clean and healthy fish can be made available wherever there is a demand," said Jon Gottlieb, former UMBI director of technology transfer.

Prolias of Frederick has spun out Prolias Technologies, a life sciences research reagent supplier for cancer research. Prolias Technologies will operate as a products and services company, according to company information.

"Spinning Prolias Technologies ... out of Prolias LLC was a natural move for us," Prolias chairman Joe Hernandez said in a statement. "It allows us to deliver a higher degree of customer service to our valued customers and allows us to move into new, previously untapped cancer research reagent markets. In addition, the location of Prolias Technologies ... gives us an innate ability to reach, and ultimately supply, the world class cancer researchers at the [National Institutes of Health] and [National Cancer Institute] with the high-quality reagents their work requires."

Women in Bio, a Bethesda group for female bioscience professionals, has established a scholarship fund to support the educational development of women pursuing careers in the industry.

The Robbie Melton Scholarship Fund, named for the group's co-founder, targets business education, including participation in seminars and workshops. It will offer two $1,000 scholarships this year: one for a woman already in the industry and one for a student in a life science field.

Information: www.womeninbio.org.

WellDoc of Baltimore

-Founded in 2005

-Privately held

-Lead product: DiabetesManager System

-Doubled its work force in past year, with plans to hire more during next six months