Coming on the heels of a deal with Swiss pharma giant Novartis that could be worth more than $200 million, Gaithersburg biotech GenVec has raised more than $28 million in new equity offerings.
The company closed a $28 million offering on Monday, from which it expects proceeds of $26.2 million. It also completed a $2 million offering with a single, unnamed investor.
GenVec plans to use the proceeds to continue developing its lead candidate, TNFerade, as a treatment for advanced pancreatic cancer, plus for general purposes. TNFerade is in a phase 3 clinical trial, treating 330 patients.
The company plans to submit a biological license application with regulators in 2012, CFO Douglas J. Swirsky said in a statement.
Last month, GenVec announced a deal with Novartis to develop treatments for hearing loss and balance disorders.
GenVec is licensing the global rights to the program to Novartis. The deal includes an upfront payment of $5 million to GenVec, plus Novartis purchased $2 million in GenVec common stock. Novartis will also pay GenVec to develop more treatments for hearing loss. All told, GenVec could receive $213.6 million, in addition to royalties on future sales.
In other Maryland bioscience industry news:
Stem-cell company Osiris Therapeutics reported that it has received a $750,000 milestone payment from the Juvenile Diabetes Research Foundation for finishing enrollment in a phase 2 clinical trial evaluating Prochymal, an adult stem cell therapy, as a treatment for patients recently diagnosed with type 1 diabetes.
The payment is the fourth in a series in the foundation's partnership with the Columbia company to develop such a treatment.
All told, 63 patients were treated at 20 sites in the double-blind, placebo-controlled trial to study the safety and efficacy of Prochymal in preserving insulin production in diabetic patients. Initially, the trial included patients 18- to 30-years-old; in July, the Food and Drug Administration let Osiris include children, too.
"Completing the enrollment phase of this landmark trial represents a significant milestone for the development of stem cell therapies for type 1 diabetes," said CEO C. Randal Mills in a statement. "Osiris is deeply committed to developing safe and effective therapies for underserved patient populations, particularly in disease states that afflict children."
BioElectronics is moving into the Japanese market.
The Frederick company signed a deal with YesDTC Holdings to sell its electronic healing patches in Japan. It's the single largest product order and revenue commitment in BioElectronics' history.
Shipments are to begin this winter.
"We are very excited about our entry into the Japanese market as we believe consumers will be highly receptive to our drug-free pain relieving and healing technology," said Arnon Horev, BioElectronics vice president of marketing, in a statement. "The initial order being placed via our Japanese distributor is far and away our single biggest order we have ever received and well into six figures."
The company has "major initiatives under way in Latin America, Europe, Canada and China, among other international markets," Horev said. "We are expecting to begin airing television commercials in China during the first quarter of 2010 in support of our marketing efforts in that region."
YesDTC Holdings is a direct-to-consumer marketing company that specializes in direct response television and Internet marketing programs.
A privately held startup that's developing rapid diagnostic tests for multiple diseases has joined the University of Maryland's Maryland Technology Enterprise Institute Technology Advancement Program incubator in College Park.
Prognosys, with a $100,000 phase 1 contract from the National Institutes of Health's National Heart, Lung and Blood Institute, is working on a test for multiple cardiovascular diseases built on the company's proprietary bar code platform.
The test is designed to quickly and economically diagnose patients with acute cardiovascular diseases in emergency rooms, helping physicians quickly decide on treatment options, according to a company statement.
"When a person goes to a hospital with chest pain, the triage nurse or physician may initially have no idea what a patient has," said Kenneth Gabriel, Prognosys president, in a statement. "A blood sample is taken and shipped to the lab, where technicians work to process samples, but some tests can take up to two days for results, and in some cases patients die. Our test can be done in the ambulance on the way to the hospital, with results in as little as 10 minutes."
Prognosys said its patent-pending technology uses embedded multiple sensors on a bar code that react to certain indicators and show results when scanned with a standard bar code reader. Results are sent through the company's software to a Web-based portal accessible by nurses and physicians or to a handheld device.
The sensors can have many applications, according to Gabriel, including biological, chemical, physical and intelligence-gathering purposes, plus tracking devices and medical monitors.
"We can test for substances such as cocaine," he said. "We can test for temperature, radiation, humidity, pressure, vibration, and lethal substances such as anthrax."
Gabriel said Prognosys, founded in 2007, moved to the University of Maryland to collaborate with its "world-class faculty and student researchers."
"We liked the fact that it is co-located with bright people," he said. "It's not just the talent but the diversity of talent people in engineering, biomedical applications, and environmental health"
MedImmune's phase 3 trial of a new treatment to prevent respiratory disease in infants has shown mixed results, which were published in the peer-reviewed Pediatrics: Official Journal of the American Academy of Pediatrics.
Motavizumab is a monoclonal antibody being evaluated by the Food and Drug Administration for its potential to prevent serious disease caused by respiratory syncytial virus among high-risk babies, according to information from the Gaithersburg biotech, a subsidiary of AstraZeneca.
The trial evaluated the safety and hospitalization in 6,635 subjects. It compared the new candidate with Synagis, MedImmune's major money-maker, which is designed to prevent disease from this virus. Global sales of Synagis totaled $1.08 billion last year, down from $1.23 billion in 2008, according to AstraZeneca's latest earnings report. It's sold in 62 nations.
Up to 125,000 American infants are hospitalized annually with severe respiratory syncytial virus infections; it's the leading cause of lower respiratory tract infections in U.S. infants and the most common respiratory infection in children, according to company information.
The new candidate worked about as well as but no better than Synagis in meeting the primary endpoint, with a 26 percent reduction in hospitalizations, the company said in a statement.
However, motavizumab did demonstrate superiority over Synagis in one of the trial's secondary endpoints, with a 50 percent relative reduction in viral-related lower respiratory tract infections requiring outpatient management. Results in the other secondary endpoints were not statistically significant, MedImmune said. Adverse events were similar with both treatments.
In 2008, the FDA asked MedImmune for clarification on its biologic license application for motavizumab. The company responded in December and said it continues an "ongoing dialogue with the agency."
PharmAthene, the Annapolis biodefense company trying to win a federal contract for a next-generation anthrax vaccine, has submitted a "white paper" for advanced development funding for its SparVax candidate.
The paper was submitted in response to the announcement issued by the federal Biomedical Advanced Research and Development Authority for the Advanced Research and Development of Chemical, Biological, Radiological and Nuclear Medical Countermeasures. In December, this announcement was modified and extended to accommodate recombinant protective antigen-related submissions.
"We believe that, if awarded, funding provided under this [announcement], along with potential additional funding under our existing contract with BARDA, will be sufficient to advance SparVax to a stage where it will be eligible for consideration for a Project BioShield procurement contract," CEO David P. Wright said in a statement.
Phase 1 and 2 clinical trials in more than 750 healthy volunteers have shown SparVax to be well-tolerated and to induce a sufficient immune response, according to company information.
Arcion Therapeutics of Baltimore, which focuses on developing treatments for chronic pain, reported raising $5 million in debt securities.
The company raised $8.8 million in 2007 in an initial round led by CMEA Ventures and InterWest Partners. Arcion used those proceeds to continue developing a gel treatment for alleviating moderate and severe pain from diabetic neuropathy.
Lung Rx, a subsidiary of United Therapeutics of Silver Spring, is teaming up with a Swiss drug company to develop a treatment for pulmonary arterial hypertension, a disease for which United Therapeutics already markets several products.
MondoBiotech of Stans completed a phase 2 study of inhaled Aviptadil that showed promise as a long-term treatment for several lung conditions, including pulmonary arterial hypertension, according to a joint statement from the companies. The product could generate annual sales approaching $1 billion, they said.
"We are pleased to help MondoBiotech in its noble mission to accelerate the development of treatments for orphan diseases, of which there are many thousands with no approved medicines," said Martine Rothblatt, CEO of Lung Rx and United Therapeutics, in the statement. "Our role will be to do our best in demonstrating the safety and efficacy of Aviptadil for PAH and other indications which afflict fewer than 200,000 people worldwide."
Aviptadil is a synthetically produced version of the natural, endogenous human vasoactive intestinal peptide, which is naturally present in the lungs, intestines and genital tracts of humans and other mammals, according to company information.