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The future of national health insurance reform was thrown into further doubt this week with the election of Massachusetts Republican Scott Brown to the Senate, but a handful of politicians, including two from Maryland, have urged passage of the proposed biosimilars regulatory pathway that was approved in both the Senate and House reform bills.

The measure would afford a period of 12 years of data exclusivity for biotechs that produce and market biologic treatments. Biologics, unlike conventional drugs, are made from living cells, such as proteins. The biotech industry argues that 12 years are needed to protect their research and development data from manufacturers of biosimilars, or generic versions of biologics. Currently, there is no regulatory system to approve such versions.

Without such protection, biotech executives say, their ability to turn a profit would be greatly diminished. That, in turn, would cause venture capital, upon which the industry heavily relies, to dry up. And without venture capital, fewer cutting-edge treatments for cancer and other life-threatening diseases would be developed, the industry claims.

Makers of generic drugs dispute the 12-year period, saying five years is sufficient, and that the sooner their less expensive versions hit the market, the more patients can receive them. But their proponents in the House and Senate lost out in committee to the biotech backers.

On Tuesday, Gov. Martin O'Malley, along with his fellow Democratic governors of Colorado, Delaware, Massachusetts, North Carolina and Rhode Island, wrote to President Obama, urging him to help usher the proposed system through Congress.

"We urge you to consider the jobs and investment that are at stake," the governors wrote. "Innovation drives one of our nation's strongest economic engines — the bioscience industry. ... The biopharmaceutical and life sciences workforce in this country is nearly 700,000 strong and supports more than 3.2 million total jobs in associated sectors of our nation's economy."

The letter to Obama follows two other similar pleas: one to Senate Majority Leader Harry Reid (D-Nev.) from eight Senate Democrats, including Barbara Mikulski of Baltimore; and one to House Speaker Nancy Pelosi (D-Calif.) and Majority Leader Steny H. Hoyer (D-Dist. 5) of Mechanicsville from 45 House members.

In addition, Reid and Pelosi received a similar letter signed by 38 organizations, including groups representing surgeons plus advocacy groups such as Easter Seals, the Parkinson's Disease Foundation and the Muscular Dystrophy Association.

In other Maryland bioscience industry news:

Gaithersburg biotech GenVec recently announced developments on two very different fronts, one of which could be worth more than $200 million.

The company is teaming with Swiss pharma giant Novartis to develop treatments for hearing loss and balance disorders. Preclinical results suggest that delivery of the atonal gene using GenVec's adenovector technology could restore hearing and balance function, the company said.

GenVec is licensing the global rights to the program to Novartis. The deal calls for an upfront payment of $5 million to GenVec, plus Novartis has purchased $2 million in GenVec common stock. GenVec will receive funding from Novartis to develop additional adenovectors for hearing loss. All told, GenVec could receive $213.6 million, in addition to royalties on future sales.

"Hearing loss is a significant and growing problem for millions of people," said GenVec CEO Paul Fischer in a statement. "Our technology has great promise and this collaboration provides an excellent mechanism to move the development of new treatments forward. We believe Novartis is an ideal collaborator for GenVec. They have the experience, expertise, and resources to develop and commercialize innovative products on a world-wide basis."

Meanwhile, in what the company calls a "significant milestone," 184 deaths have been reported in GenVec's ongoing phase 3 clinical trial of TNFerade to treat 330 patients with locally advanced pancreatic cancer. This "key event," representing two-thirds of the total deaths expected in the trial, triggers the next interim analysis of overall survival in the trial.

Those data are expected in about 12 weeks.

"This is another significant milestone for the PACT trial," said Mark Thornton, senior vice president for product development, in a statement. "The data released at the last interim look were encouraging and we are looking forward to the top-line results of the upcoming data analysis."

The first interim analysis of overall survival in the trial, released in November 2008, showed a lower death risk of about 25 percent in the TNFerade plus standard of care, versus standard of care alone. The next and final analysis will be conducted once 276 deaths — the total number expected — have occurred.

TNFerade is a DNA carrier that contains the gene for tumor necrosis factor-alpha, an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors, according to GenVec information.

Neuralstem of Rockville said that the first patient with amyotrophic lateral sclerosis — Lou Gehrig's disease — was treated with its spinal cord stem cells in a clinical trial this week at the Emory University's ALS Center in Atlanta.

Researchers plan to treat up to 18 patients in this first clinical trial in the U.S. to evaluate human neural stem cells for treating ALS, which affects about 30,000 Americans, according to the ALS Association.

"The treatment of the first patient with our spinal cord stem cells represents a significant milestone for the Company," CEO Richard Garr said in a statement.

"This trial aims to establish the safety and feasibility of using our cells to treat ALS," said Karl Johe, chairman and chief scientific officer, who invented the technology. "For now, we are focused on the safe and speedy recovery of the first patient, and we wish to thank him and his family for their courageous participation in the trial."

BioFactura has won $500,000 through the Army's Small Business Innovative Research Phase II Enhancement Program to continue preclinical development of its smallpox treatment.

The Rockville company said it plans to use the grant to expand its efficacy studies in animal models and to accelerate development of a scalable manufacturing process for commercial production.

BioFactura has also renewed for three more years its agreement with the Army Research Institute of Infectious Diseases at Fort Detrick in Frederick.

Biologics contract manufacturer Omnia Biologics of Rockville signed a deal for manufacturing and process development services with Biotech Experts of Clarksburg, which provides biologics manufacturing and process development consulting services.

"Dr. Vladimir Slepushkin and his team's breadth of experience in biologics from R&D through clinical development in a wide variety of disease targets and platforms make Biotech Experts services truly unique and valuable," said Omnia CEO Dale VanderPutten in a statement. "Their pioneering work in adenovirus and lentivirus vectors, and cell line development was crucial to moving several novel products from bench to clinic."

Fyodor Biotechnologies has moved into a new facility in the BioInnovation Center at the University of Maryland BioPark in Baltimore. The location includes executive office and laboratory space for research and development, including for Fyodor's urine-based malaria diagnostic assay.

"Fyodor is now able to conduct its own research and development activities, in addition to the considerable effort currently underway at our contract development laboratory," said CEO Eddy Agbo in a statement. "The advantages offered by the University of Maryland BioPark go beyond the tangible amenities such as access to core facilities. It also provides the opportunity to interact with other organizations at varying stages of development, providing valuable insight and experience."

With two more startups expected soon, the center will be nearly full, with one laboratory suite still available.

Rexahn Pharmaceuticals reported that the European Patent Office has granted a patent for its novel anti-cancer compound, RX-3117.

"In addition to our co-development partnership with Teva, this European patent award further validates the commercial potential of RX-3117," said Chang Ahn, CEO of the Rockville biotech, in a statement.

Potential indications for RX-3117 are colon, lung and pancreatic cancers.

In September, Rexahn announced a commercialization and development agreement with Teva for RX-3117. Rexahn will be eligible to receive milestone payments and royalties on net sales worldwide.

BioElectronics of Frederick has applied to the Food and Drug Administration for approval of over-the-counter sales in the U.S. of its electronic healing patches. The company is seeking a reclassification from Class 3 approval, which it received in 2002, to Class 2.

"While international marketing efforts are expanding at a very rapid pace, with major DirecTV commercial initiatives currently being launched in Canada, Western Europe, Turkey, Latin America and China, in addition to other areas, domestic clearance to market our products remains an important objective for BioElectronics," CEO Andrew Whelan said in a statement.

BioElectronics products are cleared for sale in dozens of countries, including Canada, China, Japan, South Korea and Australia. They also have the European Common Market certification for over-the-counter sales and have been approved by Health Canada, the company said.

The devices are considered thermal-pulsed electromagnetic field therapy devices, but evidence shows they do not produce heat and should be classified as non-thermal devices, according to the company's statement.

"We have assembled a substantial amount of compelling documentation to present to FDA that outlines not only the extreme safety of our products, but also the high level of efficacy," Whelan said. "Our products have been used by hundreds of thousands of individuals worldwide without a single safety complaint. The vast majority of these users had enjoyed substantial pain relief and decreased recovery intervals after injury or surgery. Thousands of others have received pain relief and accelerated healing of chronic musculoskeletal complaints."

Rockville biotech Prolias, which works to discover novel therapeutic proteins and antibodies to treat disease, has acquired from the University of Maryland Biotechnology Institute new technology to extend Prolias' discovery platform. The new technology provides a platform to create fully human, recombinant antibodies from diverse, endogenous antibody sources.

"This acquisition gives Prolias access to a method of developing full human antibodies to the novel targets we have discovered via our existing FioNA technology," Joe Hernandez, Prolias chairman, said in a statement. "This provides us with the ability to discover new targets and develop antibodies to those targets in a seamless manner."

Seegene of Rockville said it has received a medical device license from Health Canada for its diarrhea detection test, clearing the way for use in the Canadian health care system.

The test for viral diarrhea is already permitted in more than 30 countries, but Canada is the first in North America to allow its use.

Up to 80 percent of diarrhea cases are caused by viruses, according to a company statement. Rotavirus, which usually infects children younger than 5, causes 2.7 million cases of severe gastroenteritis, almost 60,000 hospitalizations and an average of 37 deaths annually in the U.S.

Novavax has announced positive preclinical results for its vaccine for respiratory syncytial virus, which proved effective in cotton rats.

The study results are needed to support an investigational new drug application from the Rockville biotech.

"We are excited to report steady progress towards the development of a vaccine against RSV, an important virus that is the leading cause of viral death in infants," said CEO Rahul Singhvi in a statement. "A safe and effective vaccine against RSV is especially needed in very young children since RSV infection does not provoke lasting immunity. An effective vaccine would also be important in adults, especially the elderly, where RSV illness is common. There is currently no approved vaccine for the prevention of RSV and the market potential for such a vaccine could exceed $1 billion annually."

Novavax also announced the successful scale-up of the manufacturing process for the vaccine candidate.

More than 8.5 million adults are infected with the disease annually, causing about 900,000 hospitalizations annually in the U.S. and major European countries, according to Novavax.

Spherix of Bethesda has completed patient enrollment in its global phase 3 clinical trial to test the safety and efficacy of D-tagatose as an oral treatment for type 2 diabetes mellitus. Efficacy results are expected by mid-year.

"This next year will potentially be the most exciting and gratifying time in our Company's history," CEO Claire Kruger said in a statement. "If successful and approved by the FDA, D-tagatose will offer a unique oral drug to improve glycemic control in Type 2 diabetes patients."

The trial involves 332 patients at more than 40 sites in the U.S. and India.

RegeneRx Biopharmaceuticals plans to move today from Bethesda to Rockville.

The new headquarters on Shady Grove Road will house seven of the company's nine full-time employees and provide potential expansion space. RegeneRx develops products for organ and tissue repair.

"While we continue to operate a lean, outsourced business model, our new location provides us with larger office space that is better suited to our operations, at reduced cost," CFO C. Neil Lyons said in a statement. "Additionally, positioning ourselves in closer proximity to some of our vendors, peer bioscience companies, and industry colleagues greatly facilitates our ability to transact business."

Generic drug maker Lupin Pharmaceuticals of Baltimore said it has received tentative approval from the FDA for its memantine hydrochloride tablets to treat moderate to severe Alzheimer's dementia.

The drug had annual sales of about $1.1 billion in the year ended in September, according to a statement from Lupin, a wholly owned subsidiary of Lupin Ltd. of Mumbai, India.

"We are pleased to receive this tentative approval and look forward to bringing Memantine HCl tablets to the U.S. market as an affordable generic alternative post patent expiry," CEO Vinita Gupta said in a statement.

EntreMed, which develops cancer treatments, has not regained compliance with Nasdaq's minimum price requirement and faces delisting on Thursday unless it requests a hearing to appeal.

The Rockville biotech said it plans to request a hearing, which would stay any delisting action. EntreMed will present a plan to regain compliance.