BioWatch: BioElectronics eyes growth in U.S., international patch market
Frederick firm hires consultant as it increases staff, marketing efforts
BioElectronics, which makes drug-free skin patches for a variety of medical conditions, wants to expand its small domestic presence while also continuing to improve its larger international sales.
To that end, the 14-employee Frederick company, which reported losing almost $1 million in the third quarter, has contracted with Scarsdale Equities of New York for financial and strategic consulting services. Andrew J. Whelan, BioElectronics' president, said he previously has worked with Scarsdale.
Whelan wants to add sales and marketing staff to handle the company's ramped-up marketing plans. Its over-the-counter patches, which contain an electronic chip, are designed to treat maladies such as back pain and menstrual pain. They also are used to speed healing of surgical wounds.
The company also has entered the veterinary market through a 2009 distribution agreement with eMarkets Group, a New Jersey company owned by Whelan's sister, Mary K. Whelan, who also is a BioElectronics director, according to regulatory filings. Veterinary sales, for horses, cats and dogs, accounted for 24 percent of all sales in 2009.
At this point, BioElectronics is not actively seeking a sale, Whelan said.
"I'll sell the company when I get an obscene offer, and so far the offers we've received have been nowhere near obscene," he said.
BioElectronics is "primarily focused outside the United States," Whelan said, with a presence in 44 nations, largely in Canada and the U.K. The company has done some advertising with satellite TV provider DirecTV and is looking to increase its print advertising in Canada.
U.S. Food and Drug Administration approval of four pending applications for over-the-counter and prescription products for menstrual pain, heel pain and muscle soreness will help BioElectronics improve its domestic profile, Whelan said.
"Despite the inefficiencies in the system, BioElectronics is well on its way to gaining [FDA] 501(k) approval for its ActiPatch devices," Whelan wrote in a letter to investors in November.
BioElectronics posted a third-quarter net loss of $948,351, compared with a net loss of $87,135 in the third quarter of 2009, according to its filing with the Securities and Exchange Commission. Quarterly sales fell to $50,470 from $74,874 a year earlier. As of Sept. 30, the company's assets totaled $1.6 million, up from $1.2 million at the beginning of last year. From its inception in 2000 through Sept. 30, BioElectronics had a cumulative net loss of $12.6 million.
Judith A. Britz, executive director of the Maryland Biotechnology Center, said products from companies such as BioElectronics help address conditions faced by an aging population. The company has been an active participant at international biotechnology conferences, she said.
"They are reaching out to international markets and they are very responsive," Britz said of BioElectronics. "It's always good news when a company can grow large enough to manufacture products and export them and help raise Maryland's profile internationally."
Scarsdale officials did not return a phone call seeking comment.
In other Maryland bioscience industry news:
Neuralstem has received orphan drug designation from the FDA for its stem cell treatment for amyotrophic lateral sclerosis.
The candidate, which uses human spinal cord-derived neural stem cells, is now in a phase 1 safety study with patients.
"Congress passed the Orphan Drug Act because it recognized that adequate drugs for many rare diseases have not been developed," Richard Garr, president and CEO of the Rockville company, said in a statement. "The designation of our spinal cord stem cells as an orphan drug underscores the importance of developing effective treatments for patients with ALS."
The designation provides seven years of market exclusivity for the treatment, if it is approved by the FDA. It also makes the company eligible for certain government grants to help finance clinical trials, provides tax breaks and waives certain fees.
"It is an important step forward for the company," Garr said.
The company also announced progress in its phase 1 clinical trial of the treatment at Emory University in Atlanta. The trial's safety monitoring board, after reviewing initial results, unanimously approved moving to the last group of three patients. These ambulatory patients will each receive 10 injections in the lumbar section of their spinal cords.
"We have been pleased with the smooth progress of the trial thus far, from non-ambulatory to ambulatory patients who have an earlier stage of the disease," Eva Feldman, a company consultant and principal investigator, said in a statement.
The trial began in January 2010, with plans to enroll 18 patients.
The company also is developing the stem cell treatment for other major central nervous system diseases, plus traumatic spinal cord injury.
In other Neuralstem news, the company settled its 2008 lawsuit against a British biotech, ReNeuron. Neuralstem claimed that ReNeuron stole trade secrets and breached their contract.
Neuralstem sought an injunction and unspecified damages in the suit, which was filed in U.S. District Court in California. A trial had been scheduled for April.
According to the settlement, the terms of which are confidential, "ReNeuron has agreed to immediately compensate Neuralstem, as well as to make future milestone and royalty payments to Neuralstem based on ReNeuron's development of certain products at issue in the case," according to a Neuralstem statement. Each company paid its own legal fees.
"We are pleased to have settled this dispute and that the parties have put this matter behind them," Garr said.
MedImmune has won regulatory approval to market its nasal flu vaccine in Europe to children between 2 and 18 years old. Initial availability is expected for the 2012-13 flu season, according a statement from the Gaithersburg biologics subsidiary of AstraZeneca of the U.K.
"We are delighted that Fluenz has received regulatory approval in Europe since influenza creates a significant medical and economic burden there and throughout the world. We hope that the availability of this nasal spray influenza vaccine with its novel mechanism of action will help reduce the spread of influenza," Alex Zukiwski, executive vice president and chief medical officer of MedImmune, said in the statement.
The regulatory approval by the European Commission applies to 27 member nations and three economic area countries of the European Union.
The approval was based on data from 73 global clinical studies and U.S. post-marketing studies of more than 141,000 subjects in 38 countries, the company said.
Privately held Alba Therapeutics of Baltimore, which develops treatments for autoimmune and inflammatory diseases, has agreed to provide Cephalon an option to acquire Alba's assets related to its candidate for treating celiac disease.
The terms call for Cephalon of Frazer, Pa., to pay $7 million upfront, plus provide loans to help Alba finance its phase 2b clinical trial of the candidate, larazotide acetate, according to a Cephalon statement.
Cephalon may exercise the option after the final study report from the trial is issued. If it does, it will pay $15 million for the assets, and Alba could receive additional regulatory and sales milestone payments.
"We are encouraged by the data that we have evaluated," Cephalon CEO Kevin Buchi said in the statement. "Alba will now initiate a Phase IIb trial utilizing a more disease specific primary endpoint. If successful, larazotide acetate will add to our pipeline in immunology and has the potential to be the first pharmacologic therapy available to treat patients who endure this often serious condition."
About 3 million Americans and 15 million people worldwide are affected by celiac disease, according to Alba information. The autoimmune disorder is triggered by the ingestion of gluten, which is primarily found in bread, pasta, cookies, pizza crust and other foods containing wheat, barley or rye. Symptoms include intestinal pain, bloating and diarrhea.
United Therapeutics of Silver Spring has completed patient enrollment in a clinical study of its oral treatment for pulmonary arterial hypertension.
The study, called Freedom-M, is a 12-week, multicenter international study. The target enrollment was 315 patients; 349 were enrolled. The trial's primary endpoint is change in six-minute walk distance at week 12 in the treatment group compared with placebo.
United Therapeutics expects to announce preliminary analysis of the results later this year.
A new paper published in the British medical journal The Lancet touts the lupus treatment that Human Genome Sciences is developing.
The Rockville biotech is seeking FDA approval of Benlysta in the U.S. An FDA advisory panel has recommended approval, and the agency will consider that recommendation next month.
Based on results from a phase 3 clinical trial involving 867 patients, the paper concludes that Benlysta "has the potential to be the first targeted biological treatment that is approved specifically for systemic lupus erythematosus, providing a new option for the management of this important prototypic autoimmune disease."
No new lupus drug has been approved in the U.S. in more than 50 years.
A Rockville company's technology to control arterial bleeding got a thumbs-up in a study it conducted with the Army Institute of Surgical Research that was published in the Journal of Trauma, Injury, Infection and Critical Care.
STB Lifesaving Technologies' dressing "showed the highest efficacy" when compared with other dressings applied to wounds in pigs that simulated a gunshot wound, according to the study. The STB dressing resulted in less blood loss and longer survival times.
"This technology is unaffected by the coagulation state of the patient and therefore functions when other types of products cannot. This has significant implications for the treatment of both military and civilian casualties," Martin MacPhee, the privately held company's chief scientific officer, said in a statement.
A Baltimore company that is developing a rapid urine test for malaria and a Frederick company that is working with the Army to design and develop a system to track stock of infectious agents each won $50,000 in a new round of grants from the Maryland Technology Development Corp.
The awards were among the final three in a program called the Fort Detrick Technology Transfer Initiative that Tedco administered in partnership with the Frederick County Office of Economic Development. All told, grants totaling $1.3 million went to 26 startups that are developing innovative technologies to help meet the Army's medical needs, according to a Tedco statement.
Fyodor Biotechnologies of Baltimore has been working with the Walter Reed Army Institute of Research to develop and commercialize its single and recombinant antibody-based urine test to quickly diagnose malaria. The new grant helped finance a field test in Kenya.
Foxspire in Frederick developed the infectious agent tracking system for the Army's Medical Research Institute for Infectious Diseases at Fort Detrick and is working to commercialize it.
"Fort Detrick is extremely pleased" with the accomplishments of the program, Paul Mele, director of the Office of Research and Technology Applications at the research institute, said in the statement. "We are thankful to Tedco for overseeing the program and for connecting us to 26 companies which are creating and further developing medical technologies that contribute to the health and wellbeing of the modern war fighter."
Also this week, Akonni Biosystems of Frederick announced that it has signed a license agreement with the infectious diseases institute at Fort Detrick. The agreement gives Akonni access, under patents owned or licensed by the institute and its affiliates, to the nucleic acid sequences, primers and probes for many biological threat agents.
In a statement, the company said it expects the access to help it "more rapidly commercialize ... tests for research and in vitro diagnostics" for anthrax, smallpox, plague, Venezuelan equine encephalitis, influenza and other diseases. Financial terms were not disclosed.
"We are excited to partner with [the institute] on developing a series of low-cost, multiplex testing products to protect our war-fighters, first responders and citizens from many of the most dangerous bio-threat agents known to man," CEO Charles Daitch said in the statement.
MacroGenics has raised all of a $12 million equity offering, according to a SEC filing.
The Rockville biotech is developing products to treat cancer and autoimmune diseases.
Supernus Pharmaceuticals of Rockville, which develops treatments for epilepsy and attention deficit hyperactivity, has raised $15 million of a $25 million mixed offering, according to an SEC filing.
The company, formerly known as Shire Laboratories, notified the SEC in December that it plans an initial public offering of $100 million.
Vanda Pharmaceuticals of Rockville, which focuses on developing and commercializing products to treat central nervous system disorders, filed a shelf registration statement with the SEC that allows it to sell up to $50 million of common stock and other instruments.
RegeneRx Biopharmaceuticals of Rockville said it has been notified by the Australian Patent and Trademark Office that the agency plans to approve its patent application for using thymosin beta 4 and derivatives to prevent the tissue buildup that leads to scarring from injuries or diseases of the heart, skin, brain or eye, among others.
The patent is to expire in 2025. RegeneRx has similar patents pending in the U.S., and nations in Asia and Europe.
OpGen of Gaithersburg, a genomics and DNA analysis company, sold its Argus Optical Mapping System to the Beijing Genomics Institute, the largest genomics organization in the world, according to an OpGen statement.
"We are very encouraged by the success of our large genome collaboration and are incorporating the Argus Optical Mapping System into our current workflow for our microbial genome sequence assembly work. We believe that optical mapping will reduce the time and cost to produce complete, validated sequenced microbial genomes. We look forward to continuing this important collaboration with OpGen," Xu Xun, vice president of research and development at the institute, said in the statement.