HHS awards $102 million for new flu drug

first_imgJan 5, 2007 (CIDRAP News) – In an effort to expand the pool of antiviral drugs for influenza, the US government yesterday awarded a $102.6 million contract to BioCryst Pharmaceuticals Inc. of Birmingham, Ala., to develop peramivir, a new neuraminidase inhibitor.The Department of Health and Human Services (HHS), in a press release, said peramivir has been effective against several influenza strains in laboratory studies. HHS said the contract will cover production of the investigational drug, phase 2 and 3 clinical studies, and validation of manufacturing processes.Research under the contract will include tests involving the deadly H5N1 avian flu virus and may include research on the possible preventive use of the drug, according to HHS. BioCryst officials said the drug has been shown to help animals survive H5N1 infection.”Antivirals are an important element of our pandemic influenza preparedness efforts,” said HHS secretary Mike Leavitt in the press release. “Our antiviral strategy includes not only stockpiling existing antiviral drugs but also seeking out new antiviral medications to further broaden our capabilities to treat and prevent all forms of influenza.”Licensed drugs in the neuraminidase inhibitor class are taken orally (oseltamivir) or by an inhaler (zanamivir). However, peramivir is under development as a parenterally administered drug, meaning it can be given through intramuscular and intravenous routes.HHS said a parenteral neuraminidase inhibitor may be particularly useful in hospital emergency departments for treatment of patients who have life-threatening flu. Parenteral injection could permit rapid buildup of peramivir to high levels throughout the body and allow treatment of people too ill to take medications by mouth, the agency said.In a news release, BioCryst said its laboratory tests have shown that peramivir, an inhibitor of influenza A and B neuraminidases, is more potent than currently available drugs in its class and is active against antiviral-resistant flu strains. The company said high doses of injectable formulations have been safely administered to healthy people, and the drug has been found to promote survival in animals infected with the H5N1 virus.At a BioCryst teleconference that followed the HHS announcement, Charles Bugg, PhD, the company’s chairman and chief executive officer, said the contract allows the company to move peramivir as quickly as possible through clinical development.HHS said awarding the contract to BioCryst is part of a larger initiative to support the development of new treatments and vaccines that would allow the United States to respond quickly to a flu pandemic.Bugg said both the intramuscular and intravenous formulations of peramivir will go through phase 2 and 3 clinical trials. The intramuscular formulation will be tested against a placebo in outpatients, and the intravenous trial will likely test peramivir against oseltamivir in hospitals.Enrollment of patients for the phase 2 trials will begin this flu season in the United States, Canada, and Europe, Bugg said, adding that the company has identified sites in the southern hemisphere that could be used to fill this year’s phase 2 study groups or facilitate an early start on phase 3 studies. He said BioCryst is also identifying sites in Southeast Asia, where flu outbreaks occur year-round, that might be added to the study.Bugg said the HHS contract to develop peramivir is subject to an emergency use authorization that would allow the department to stockpile the drug before approval by the Food and Drug Administration (FDA) if clinical data show it to be beneficial.Jonathan Nugent, vice president of corporate communications at BioCryst, told CIDRAP News that the company hasn’t ruled out developing oral or inhalational formulations of peramivir in the future. He said the company couldn’t speculate on how long it might take for the drug to win FDA approval. HHS said the FDA has given peramivir “fast track” status, which would expedite the agency’s review of BioCryst’s application.See also:Jan 4 HHS press releasehttp://www.hhs.gov/news/press/2007pres/01/20070104a.htmlJan 4 BioCryst press releasehttp://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=224367last_img read more

Overcrowded prisons pose serious health risk – report

first_imgWhen it comes to health matters, an Inter-American Development Bank (IDB) report has found that the overcrowding at Guyana’s prisons put inmates at risk of contracting contagious diseases.Data suggests the importance of reducing prison overcrowdingIt is a situation that the Citizen Security and Strengthening Programme (CSSP) Prison Survey report zeroed in on. Completed and handed over to the Government recently, the report found that 44.1 per cent of inmates had been stricken with the flu and other chest infections.The report states that 8.9 per cent of prisoners had gastro-intestinal problems; 4.5 per cent were affected by tuberculosis; 2.4 per cent suffered from depression and anxiety, 0.8 per cent were infected with HIV/AIDS and the remainder had other conditions such as malaria and chicken pox.“During their stay in prison, 67.4 per cent of inmates got sick. Besides, 45.9 per cent of the inmates said that HIV/AIDS tests were performed on them to verify whether they were infected or not,” the report states, adding that 53 per cent were not tested.According to the report, 80.6 per cent of the inmates, after being diagnosed with an illness, continued to share a cell with other inmates. Approximately 18.1 per cent responded in the negative, while the question was not applicable to the remainder.Meanwhile, the survey found that 46 per cent of inmates were taken to the hospital at some point during their incarceration. This was not so for 53.1 per cent of the prison population, while the question was not applicable for a select few.“In summary, given on the one hand the overcrowded and poor state of facilities, and the scope and type of diseases reported by the inmates, it is very likely that some inmates get sick from contagious diseases.“Authorities should pay special attention, because care and medicines are mostly in place, the overcrowding may be the trigger for the large reported cases of diseases,” the report also states.PopulationAs of January 2017, there were a total of 2043 inmates in Guyana’s five jails, although the largest one – the Camp Street Prison – was subsequently gutted in a fire. At the time, the Georgetown prison had 963 inmates, 521 of whom were on remand; Lusignan had 153, of which 32 were remanded; Mazaruni, 360 and Timehri, 130 inmates, including 28 remand prisoners.All of the prisoners were male, while New Amsterdam Prison had a male prison population of 352 and a female population of 85. One and fifty of these men and 31 women were on remand.In 2016, a fire had raged through the Camp Street Prison and claimed the lives of 17 prisoners. Afterwards, a Commission of Inquiry (CoI), which cost the treasury some $13 million was ordered by President David Granger.According to the report compiled by the Commissioners, the combination of overcrowded, uncomfortable and unhygienic confinement are all ideal conditions for epidemics, for gangs to prosper and to propagate discontent.Moreover, the CoI found that reducing numbers in prisons to manageable levels is the single most important priority for establishing safe, humane and purposeful prisons. In the wake of another fire in July, which gutted the wooden section of the Camp Street Prison, the need to reduce the prison population was further emphasised to the Government.Since last year, Government had received a loan from the IDB to support its Criminal Justice System Project. The key objective of the Project is reducing the prison population.last_img read more