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

Indian juggernaut up against Kiwi grit

first_imgBy S S RamaswamyMumbai, Oct 21 (PTI) Hardly challenged in a dominating run this season, India will once again start overwhelming favourites when they take on an inconsistent-but-gritty New Zealand in a three-match ODI series, starting here tomorrow.The Indians are on a high after comprehensively thrashing world champions Australia earlier this month. And the Black Caps will have to come up with really a special effort to make a mark against the rampaging hosts.Banking on settled batting and bowling combinations with most of the columns ticked, the hosts appear to be too well- groomed a unit for the comfort of the visitors.Although India suffered a resounding loss to South Africa on a belter of a track at this very venue three seasons ago, they went on to win three series on the trot in their backyard and are now a force to reckon with in the upcoming series.In fact, since surrendering to Australia back in 2009-10, India have lost only to Pakistan (2012) and South Africa in 16 bilateral rubbers, a clear indication of how dominant they have been in familiar conditions.Considering that the 4-1 result over Australia was achieved without skipper Virat Kohli being in top form and despite the absence of prolific opener Shikhar Dhawan, it was a huge achievement.Vice-captain Rohit Sharma scored 296 runs, including a century and two fifties at an average just below 60. The ever-dependable Ajinkya Rahane hit 244 runs that included four half-centuries, while all-rounder Hardik Pandya amassed 222 runs. The ever-reliable Mahendra Singh Dhoni had a subdued time with the bat against Australia.advertisementIf they continue to fire with the same intensity, it would be difficult for New Zealand to contain the home team on a Wankhede track, which is expected to provide the ideal pace and bounce for the batsmen to go for the shots.With a new-look spin attack with Chinaman Kuldeep Singh and orthodox leggie Yuzvendra Chahal, along with the left-arm orthodox Axar Patel as the back-up, Indias slow bowling too sports a supremely challenging look.Among the pacers, Bhuvneshwar Kumar and Jasprit Bumrah are expected to trouble the Kiwis in the opening as well as at death overs.However, New Zealanders will bank on their senior-most batsman and former captain Ross Taylor, who scored a cracking century at the Brabourne Stadium against the Indian Board Presidents XI in their second practice game.The form of Taylor, opener Martin Guptill and captain Kane Williamson are going to be crucial in the Kiwis trying to match the Indian batting might.Tom Latham, who also warmed up with a ton in the second practice game along with Taylor, offers some big-hitting option in the middle. But overall, the visitors batting pales in comparison to the home teams, especially in sub- continental conditions.The experienced pace duo of Trent Boult and Tim Southee will have to take up the responsibility of getting quick wickets at the top. The spinners in left-arm orthodox Mitchell Santner and leggie Ish Sodhi may have a tough time against the Indian batsmen in the middle overs.This will be the second series for India with the new ODI playing conditions after the one against Australia.Squads:India: Virat Kohli (captain), Rohit Sharma, Shikhar Dhawan, Ajinkya Rahane, Manish Pandey, Kedar Jadhav, Dinesh Karthik, MS Dhoni (wk), Hardik Pandya, Axar Patel, Kuldeep Yadav, Yuzvendra Chahal, Jasprit Bumrah, Bhuvneshwar Kumar and Shardul Thakur.New Zealand: Kane Williamson (captain), Trent Boult, Colin de Grandhomme, Martin Guptill, Matt Henry, Tom Latham, Henry Nicholls, Adam Milne, Colin Munro, Glenn Phillips, Mitchell Santner, Tim Southee, Ross Taylor, George Worker and Ish Sodhi.Match commences at 1:30 pm IST. PTI SSR CM PM CMlast_img read more