BioWatch: PharmAthene to work with HHS on anthrax vaccine
Annapolis biodefense firm will negotiate on developing next-generation candidate
Last month, two Maryland biotechs were dealt a blow when federal health officials canceled their agency's request for proposals for a new, second-generation anthrax vaccine.
Both PharmAthene of Annapolis and Emergent BioSolutions of Rockville have been working for years to win the contract with the Biomedical Advanced Research and Development Authority. But BARDA officials said they did not think the companies could have a vaccine ready for Food and Drug Administration approval within eight years.
Rather than issue a new request, the agency, part of the Department of Health and Human Services, said it would ask vaccine developers to submit new product development plans.
On Dec. 29, BARDA announced plans to negotiate with PharmAthene to help develop its vaccine candidate, called SparVax, which has been tested in phase 1 and 2 clinical trials on 700 individuals.
"We look forward to working closely with BARDA to meet their needs and the critical needs of the Strategic National Stockpile as quickly as possible," CEO David P. Wright said in a statement Tuesday. "We believe the Special Notice reflects BARDA's commitment to work with companies to provide funding to advance the development of rPA vaccines and ensure the maintenance of the timeline set under [the request for proposals] as if a contract had been awarded for our rPA anthrax vaccine candidate under that solicitation."
According to the BARDA notice, a contract would include manufacturing activities such as process scale-up and validation, assay validation and non-clinical safety assessment and study plans.
PharmAthene plans to respond to BARDA by Feb. 1.
Currently, the only FDA-approved anthrax vaccine is Emergent's BioThrax. CEO Fuad El-Hibri has previously said that the company's candidate for a new vaccine is "well-positioned to obtain a development contract" under the new BARDA guidelines.
Emergent has a $400 million contract with the Centers for Disease Control and Prevention to manufacture 14.5 million doses of BioThrax for the Strategic National Stockpile.
BARDA is seeking a new vaccine that requires fewer doses than BioThrax, which requires five doses over 18 months to confer immunity. Also, unlike BioThrax, the new vaccine would not need refrigeration.
In other Maryland bioscience industry news:
BioElectronics is taking its menstrual cramp treatment to China.
The Frederick company, which makes disposable, drug-free electronic skin patches for a variety of uses, is working with its partner Project Asia to begin test marketing a new direct response television campaign for Allay, according to a company statement.
The test marketing is to being next month, followed soon by a full marketing campaign.
"For the past few months we have been working very hard to finalize our relationship with several Chinese partners, in conjunction with Project Asia, all of whom have a high level of interest in marketing the Allay product within the People's Republic of China," CEO Andrew Whelan said in the statement. "Last week, we finished shooting our direct response television campaign spots in Mandarin and we have recently finalized e-commerce Web designs and methodologies for fulfillment operations. We will be traveling to China with representatives from Project Asia in mid-January to meet with government representatives and television station executives to finalize details of the marketing campaign."
"We believe the Allay product is perfect for the Chinese marketplace and a direct response television-oriented marketing campaign," said Marc Weiss, president of Project Asia. "Credit card usage within the People's Republic of China is growing at a very fast rate, especially within the large urban areas where we will be placing our emphasis."
BioElectronics also plans to launch marketing campaigns in Canada, Latin America, Western Europe and Japan.
Champions Biotechnology reported raising $2.1 million of a $10 million equity offering, according to a company filing with the Securities and Exchange Commission.
The Baltimore company develops preclinical platforms and predictive tumor-specific data to improve and accelerate the value of cancer drug candidates. Its platform involves taking primary human tumors and within hours implanting them in immune deficient mice. Champions plans to sell, partner or license these candidates to other pharmaceutical or biotech companies.
Gaithersburg biotech GenVec reported that it has regained compliance with Nasdaq minimum bid price listing requirements.
GenVec had received a deficiency notice in September because the bid price of its common stock had closed below the required minimum of $1 per share for the previous 30 consecutive business days. GenVec regained compliance when its stock closed above $1 for 10 consecutive days.