The US Department of Defense (DoD) has had a busy week, signing three new deals and announcing the results from a fourth.
GlaxoSmithKline (GSK) will receive up to $41m from the Defense Threat Reduction Agency (DTRA) of the DoD, to identify and develop a new class of antibacterials targeting both Gram negative biothreats and conventional Gram negative hospital pathogens.
The research will focus on such Gram negative pathogens as Pseudomonas, Klebsiella and Acinetobacter, which are increasingly resistant to all known classes of antibiotics. These bacteria can cause a significant health threat to patients, particularly those in intensive care units. Gram negative infection is associated with an increase in morbidity, and in severe cases can lead on to septic shock and an increase in mortality. Though there are antibiotics in development from established classes, there is only one novel class systemic agent in clinical trials to address this mounting problem.
Morphotek, a subsidiary of Eisai, announced that the company has received $2.3m funding approval from the DoD to support the development of biologic-based monoclonal antibody (mAb) therapies against Botulinum neurotoxins (BNTs), which are used in biowarfare agents.
AVI Biopharma is also celebrating a new contract with the DoD, concerning its Neugene antisense drug that targets dengue virus infections. The $2.66m deal is the fourth contract related to an $11m DoD budget for antisense drugs, of which AVI expects to receive up to $9.8m. The other three contracts between the DoD and AVI relate to developing drugs against Ebola virus, Marburg virus, and exposure to anthrax (Bacillus anthracis) and Ricin toxins.
UK-based EpiStem has completed the first year of mucositis efficacy-testing services for potential biodefense drugs, and said it is about to embark upon an extensive drug screening programme over the coming year. The company provides assays that to help identify novel drugs that can improve the repair of the gastrointestinal (GI) tract following exposure to irradiation.
Merck & Co and Alnylam Pharmaceuticals have terminated their RNA interference (RNAi) collaboration by mutual consent.
"It is fundamentally in our best interests to terminate our Merck collaboration," said Dr John Maraganore, CEO of Alnylam. "We wish our colleagues at Merck the best of luck in their efforts."
Merck & Co. now has its own RNAi programme thanks to its recent $1.1bn (€850m) acquisition of Sirna Therapeutics.
NanoViricides will present new preclinical data at the 5th International Bird Flu Conference in Las Vegas next week, on its drugs of the same name. The nanoviricide compounds, like antibodies, have ligands that attach to the virus particle but differ from antibodies in that they also complete the task of taking the virus apart, according to Dr Anil Diwan, president of the company.
"We feel that nanoviricides are the next great advance beyond immunotherapeutics," explained Dr Eugene Seymour, Nanoviricide's CEO. "We have already shown that nanoviricides are superior to FDA approved antibodies in a rabies animal model."
FluCide-I is based on a well-known ligand that binds to all types of influenza viruses, as well as other viruses.
A second drug, FluCide-HP, is based on well known 'signature regions' called 'polybasic sites' on all HPAI influenzas including H5N1 and H7N3. If the virus mutates in this region to escape FluCide-HP, its pathogenicity will decrease and it will no longer be a dangerous epidemic threat.
"Our next step will be to perform animal studies against H5N1 to further validate our results," said Dr. Seymour, adding, "There have been delays in the commissioning of the BSL3+ animal facility in Vietnam. We are currently exploring other options that would permit the studies to be done in the US with the latest available H5N1 strain."
Depomed has cut around one-fourth of its staff. Carl Pelzel, Depomed's CEO, explained the reason for the job cuts.
"It was necessary in order to conserve cash and align our workforce to our needs in light of the disappointing results of our Phase III study in postherpetic neuralgi," he said.
"The reduction in force is in addition to other ongoing cost-cutting initiatives."
A letter signed by 45 members of the US House of Representatives will be delivered today to the US Drug Enforcement Administration (DEA) demanding an end to the obstruction of scientific research aimed at developing marijuana as a legal prescription medicine.
"The DEA is ignoring the vast scientific evidence that clearly shows medicinal use of marijuana benefits patients who are extremely ill," said Congressman Nadler today. "When it comes to providing the best treatment options to sick Americans, we should trust doctors and medical researchers and not federal bureaucrats."