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Biotech / Medical : Oscient Pharmaceuticals Corp. (OSCI) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (1116)	12/22/2005 8:11:56 AM
From: nigel bates	Read Replies (1) \| Respond to of 1154

NHS 'failing' on lethal infection C. difficile - which can prove fatal NHS trusts are not doing enough to stop patients contracting a potentially fatal infection, watchdogs say. Clostridium difficile caused just under 1,000 deaths in 2003, figures for England show. The Health Protection Agency and the Healthcare Commission found a third of the English trusts surveyed do not routinely follow official guidelines. Key measures to reduce risk include careful use of antibiotics and being able to isolate infected patients. The organisations' full report is set to be published in the spring. But interim results have been released now, prior to the peak time for C.difficile infections. C.difficile is a common hospital-acquired infection which usually causes diarrhoea but can lead to fevers or more serious infections. The first set of data from a mandatory reporting scheme last year showed there had been over 44,000 cases of the infection in hospitals in England. CLOSTRIDIUM DIFFICILE The bacteria are naturally present in the intestine but kept under control by other bacteria Antibiotics can kill some of these, allowing C.difficile to take hold Overuse of antibiotics is linked to the infection's rise C.difficile is not resistant to treatment, but some cases are difficult to treat The strain seen at Stoke Mandeville hospital is related to one which has emerged in the US and Canada The Healthcare Commission and the Health Protection Agency surveyed directors of infection prevention and control at 118 of the 173 trusts in England. Most directors felt the incidence of C.difficile was rising. However 38% did not have restrictions on the use of antibiotics. The Healthcare Commission's Marcia Fry, who headed the survey, told BBC Radio 4's Today programme that the overuse of antibiotics was a major problem. "What they [antibiotics] do is destroy the good bacteria in the gut and allow the infection with the C.difficile to take hold. "You want more targeted antibiotics to the specific problem being treated - but to get control of antibiotic prescription across a trust or across a community is not an easy thing to do." In addition, over a third of the trusts surveyed said they could not isolate patients routinely, and only 11% of trusts have a ward that can be used for isolating patients with C.difficile. Isolation call The survey even found that hospitals do not agree on what constitutes an outbreak. And many said their trusts did not follow guidelines on who should be informed when they did have an outbreak. Sixty-five per cent admitted their trusts do not routinely record information on deaths from C.difficile. The results of this survey will help us to improve our surveillance of C. difficile and learn more about how trusts treat patients and tackle outbreaks Peter Borriello Health Protection Agency Nigel Edwards, policy director of the NHS confederation representing NHS trusts, said trusts had been put under "very high pressure" by a "very large push" to take care of other priorities. "If you're short of facilities and you're really anxious to get your elective surgery patients in and your cancer patients in, some trade-offs may be being made there," he told Today. This made implementation of guidance "difficult in particular circumstances", he added. 'Most advanced' The HPA and the commission recommend trusts adhere to "best practice" guidelines on antibiotic prescribing, review their ability to isolate patients and to ensure they comply with the requirement to report all C.difficile infections in over 65s. Professor Peter Borriello, director of the Centre for Infections at the Health Protection Agency, added: "The results of this survey will help us to improve our surveillance of C. difficile and learn more about how trusts treat patients and tackle outbreaks." Health Minister, Jane Kennedy, said the NHS system of C.difficile surveillance was "now the most advanced in the world". But she accepted some trusts still had work to do. "The new Hygiene Code currently undergoing scrutiny in Parliament will make it a statutory duty for trusts to have all these systems in place; and the Healthcare Commission will have the power to issue improvement notices if hospitals are failing to carry out these measures." Ms Kennedy added that the Chief Medical Officer had written a "firm reminder" to all trusts, reminding them of the steps they should be taking to minimise the risk of C. difficile. Shadow Health Secretary Andrew Lansley said: "Every hospital should achieve the highest level of cleanliness. Despite countless government initiatives, standards remain unacceptably low." Steve Webb, Liberal Democrat health spokesman, said the government was "guilty of gross complacency on this issue and should sit up and take notice of their own inspectors". C. difficile hit the headlines in June after it emerged that more than 300 patients at Stoke Mandeville Hospital, in Buckinghamshire, had contracted the infection and 12 elderly patients had died after contracting it since 2003....

To: Ian@SI who wrote (1116)	2/8/2006 2:14:52 PM
From: tuck	Respond to of 1154

>>WALTHAM, Mass.--(BUSINESS WIRE)--Feb. 8, 2006--Oscient Pharmaceuticals Corporation (Nasdaq: OSCI - News) and Pfizer Inc subsidiary Vicuron Pharmaceuticals Inc., have restructured the business relationship for Oscient's lead clinical candidate, Ramoplanin, currently in development for the potential treatment of Clostridium difficile-associated disease (CDAD). As part of the new arrangement, Oscient, which previously licensed Ramoplanin from Vicuron for the U.S. and Canada only, acquired worldwide rights and assumes full control of Ramoplanin manufacturing, development and commercialization on a global basis. Oscient recently agreed on a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration for the Phase III program of Ramoplanin. "Acquiring worldwide rights to Ramoplanin is a major milestone for Oscient," stated Steven M. Rauscher, President and Chief Executive Officer of Oscient Pharmaceuticals. "With full ownership of Ramoplanin, we have significantly strengthened our asset portfolio and, after securing a long-term source of product supply, will be poised to advance the product candidate into Phase III development." As announced previously, the SPA from the FDA calls for two, pivotal Phase III trials to study Ramoplanin in CDAD. The two non-inferiority studies will enroll, in each trial, approximately 490 patients diagnosed with CDAD, from centers in the United States, Canada and other parts of the world. Each patient will be randomly assigned to one of two treatment arms, in a double-blind regimen: Ramoplanin 200 mg orally twice daily or vancomycin 125 mg orally four times daily for ten days. The primary endpoint will be the response rate at end of therapy. In exchange for the expanded worldwide rights, Oscient has made a one-time, up-front payment to Pfizer, and will make additional payments upon the achievement of specified regulatory milestones and for royalties on net sales. Additionally, Oscient has assumed all responsibility for drug manufacture and is currently in discussions with potential third-party manufacturers for Ramoplanin. Royalty obligations to Vicuron have been adjusted to reflect the elimination of Vicuron's manufacturing responsibility. Pfizer has agreed to transfer the technological know-how related to the manufacture of Ramoplanin. About C. difficile-Associated Disease C. difficile is a spore-forming bacterium known to cause diarrhea and colitis. In the past, C. difficile-associated disease has been mainly a concern in patients who have had recent antibiotic therapy and/or are hospitalized. In recent years, the incidence and severity of CDAD has increased and anecdotal cases are being reported where no antibiotic therapy or exposure to hospitals has occurred. Many countries across the globe have reported rising numbers of CDAD cases, including Australia, Canada and the United Kingdom. Currently, it is estimated that 400,000-500,000 cases of CDAD occur each year in the U.S. The disease generates an estimated $1.1 billion in hospital health care costs annually in the U.S., and can prolong hospital stays by one to three days. Presently, vancomycin and metronidazole are used to treat CDAD, although only vancomycin is FDA-approved for such use. About Ramoplanin Oscient Pharmaceuticals' Ramoplanin is an investigational new drug being studied for the treatment of Clostridium difficile-associated disease (CDAD). Ramoplanin has been shown to be bactericidal in vitro against Clostridium difficile. Because it is not absorbed systemically from the gastrointestinal (GI) tract following oral dosing and exerts its bactericidal activity in the GI tract, Ramoplanin represents a potential new method for managing certain pathogens commonly found in the hospital.<< snip Market doesn't seem pleased by the news; ramoplanin considered a marginal candidate on its own merits or is it just the Street inferring that because Pfizer gave up the rest of the world rights? Personally, I'd think Pfizer did this simply to rid of itself of a market too small for a behemoth to bother with. But for OSCI and a medium sized pharma, it still seems to have potential, BWDIK. Cheers, Tuck