Saturday June 8, 2013
British drug maker GlaxoSmithKline (GSK) could receive up to $200 million more from the U.S. Department of Health and Human Services (HHS) to develop new antibiotics for two different purposes: combating bio-terrorism and antibiotic resistant infections.
The work will be done in collaboration with the health department's Biomedical Advanced Research and Development Authority, or BARDA, under a special agreement that gives GSK flexibility to test multiple potential drugs, and add new antibiotic candidates, to the research portfolio. The agency previously contracted with GSK in September 2011 with a two-year, $38.5 million award for the development of a multi-use antibiotic for resistant infections and bio-threat pathogens.
Under the latest agreement announced by GSK and HHS in late May, the company will receive $40 million over the next 18 months, and up to $200 million over the next five years.
BARDA has contracted with several firms for multi-use antibiotics over the past couple of years. In addition to the GSK contracts:
In August 2010 BARDA awarded a three-year, $64 million contract to San Francisco-CA-based Achaogen Inc. to develop a novel antibiotic to fight bio-threats and antibiotic resistance. That contract was extended in 2012 and again in April 2013. The total value of the contract will be $103 million, according to a Health and Human Services press release.
In January 2010, BARDA contracted with CUBRC Inc., of Buffalo, NY, and Tetraphase Pharmaceuticals of Watertown, Mass., on a four-year, $67.2 million project to develop the companies' novel antibiotic agent for countering biological threats, like anthrax and plague, as well as bacterial pneumonia and other life-threatening infections.
HHS awarded GSK and its partner Texas A&M another $91 million grant this spring, this time for construction of a flu vaccine production facility.
According to BioNews Texas, the facility grant is "a down-payment on a long-term federal funding effort that will amount to a billion-dollar effort, which in turn will bring a tremendous amount of new jobs and revenue to the Texas biotech sector."
Friday June 7, 2013
Bayer received U.S. FDA approval for Xofigo (radium Ra 223 dichloride) for advanced prostate cancer, on May 15, 2013. Image: Bayer HealthCare Pharmaceuticals Inc.
Over the last 30 days a new advanced prostate treatment drug was approved, an immunotherapy trial for brain cancer was expanded to include Europe, and trials for two therapies for esophagogastric cancer yielded disappointing results.
On May 15 the FDA approved Xofigo ("zoh-fee-go") for the treatment of advanced prostate cancer with bone metastases. Manufactured by Baxter, Xofigo is an alpha-particle emitting drug which targets the bone and is approved for use in men whose metatases has not responded to other treatment options including chemotherapy or hormone therapy.
King's College Hospital announced May 16 it is joining as collaborator on a phase 3 trial of DCVax-L, an immunotherapy agent, for newly diagnosed glioblastoma multiforme (GBM), the most common and lethal type of brain cancer. The trial is underway at 46 U.S. sites. With the addition of King's College, the trial will enroll up to 312 patients in the United States and Europe.
DCVax-L, developed by Bethesda, MD-based Northwest Biotherapeutics, is a dendritic cell-based vaccine, which has also received FDA clearance for testing in patients with prostate cancer, metastatic ovarian cancer, and other forms of cancer. Phase 1 and 2 trials in the United States have generated some enthusiasm for the vaccine since data from these smaller trials of brain cancer patients showed the vaccine delayed disease progression and reduced toxic side effects.
Two experimental drugs for treating advanced esophagogastric cancer -- panitumumab and cetuximab -- were simultaneously reported in Lancet Oncology, May 14, to have a harmful or no effect on cancer patients when added to other chemotherapy treatment regimens. The results of these phase 3 trials may dim future interest in epidermal growth factor receptor (EGFR)-targeted therapies for esophagogastric cancer.
Currently, trastuzumab is the only approved adjunct therapy for advanced esophagogastric cancer.
Wednesday May 29, 2013
NoJabNoPlay campiagn banner launched by The Telegraph, Australia
A couple weeks ago I wrote about HealthMap, an online surveillance tool developed by US and UK scientists that tracks news and rumors about disease outbreaks around the world.
The public war over vaccinations continues and now a national newspaper has gotten involved. The Sunday Telegraph and The Telegraph of Australia cited the tool when promoting its new #NoJabNoPlay campaign. The article leads readers to a petition to the New South Wales state government and the federal Australian government to allow childcare centers to ban unvaccinated children and "stop paying childcare rebate and family tax benefit to parents who claim they are 'conscientious objectors.'"
US public health officials are also concerned about parents who delay or refuse routine vaccinations for their children. A survey of 700 American pediatricians found that depending on location, up to 50 percent of parents were delaying or denying the recommended vaccine schedule due to concerns about health risks. Over 20 percent of the pediatricians surveyed said they had stopped treating families that continued to refuse vaccines.
Sunday May 26, 2013
The industry research consulting firm GlobalData predicts the value of the U.S. pharmaceutical market will grow from $359 billion in 2012 to $476 billion in 2020 as a result of the Patient Protection and Affordable Care Act (PPACA). The increase represents a 33 percent growth in profits over eight years.
While the pharmaceutical industry takes some financial losses under the reform law (in terms of rebates and new excise taxes for higher volume drug sellers) under the negotiated health reform law, the benefits to the industry's bottom line far outweigh the losses.
According to GlobalData's new report, under the Affordable Care Act:
- Pharma will gain about $115 billion in new business over the next decade.
- 32 million formerly uninsured people will become potential new customers.
- Medicaid health insurance program enrollment is forecast to grow by about 19.5 million people.
- The pharmaceutical industry will gain between $10 billion and $35 billion in additional profits over the next 10 years.
"Like many other countries around the world, the US is expected to experience growth in its elderly population, climbing from a 19% share of all Americans in 2012 to more than 22% by 2020," according to a GlobalData press statement. "The expansion of the 60 and over age demographic is another factor that will inevitably drive the US pharmaceuticals industry, owing to the corresponding increase in healthcare demand."