| To: Biomaven who wrote (1120) | 1/20/2006 2:58:19 PM | | From: MJ | | | | I am out also started selling about a month ago------found this stock too stressful to deal with----hope OSCI will do well for others .
mj |
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| To: Biomaven who wrote (1120) | 1/20/2006 3:17:49 PM | | From: fred hayes | | | | Peter: ABS was my main reason for being in OSCI, so I bailed too. Now I'm wondering about whether to consider getting back in at a lower price. Care to give odds on the possibility of FDA eventually reconsidering? From the feel I have, its maybe 30 percent. But I had the feeling you don't think there's much chance at all...
fred hayes |
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| To: fred hayes who wrote (1122) | 1/20/2006 3:54:03 PM | | From: Biomaven | | | | I didn't listen to the CC, but going on the language used it's hard to see the FDA budging anytime soon. They already have a large study showing the rash was pretty insignificant if you just used the drug for a short time, so it's hard to see what more the company can do.
The trouble is there are rashes and there are rashes. The rashes produced in the studies have all been harmless, but at the back of the FDA's mind is that some drug rashes can be very serious or even fatal. Why the FDA didn't state their position before approving the ABS trials I have no idea, unless something in the trial results worried them.
The company could of course request an AC meeting on this and I think they could have a chance of getting the FDA overruled.
I shouldn't really be speaking without listening to the CC, but I just don't have time to do so.
Peter |
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| To: fred hayes who wrote (1124) | 1/20/2006 10:45:29 PM | | From: fred hayes | | | | OSCI CC re factive refusal to file for ABS. Sorry, but not anything significant that is new...
..................................
CC lead by Steven Rauscher, President and CEO.
SR indicted much surprise at rejection. FDA indicated that factive did not exhibit an acceptable risk versus benefit profile, and believed it was not feasible to demonstrate acceptable risk.
Will seek path towards approval based on discussion with FDA. Submission includes data on 1,800 of original 7,000 trial patients, plus off label use, resulted in strong supplement for ABS label.
Some Q & A stuff:
Rash about 2 percent for 5 day treatment, increasing with longer treatment.
Partner effect on rejection? Partner focus has been for non-US. Impact "unclear".
Dodged questions on specifically what path to approval might be considering extensive data already submitted and negative FDA statements even tho had volunteered an extensive P4 program.
OSCI will provide update in March CC. |
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| To: fred hayes who wrote (1125) | 1/21/2006 1:02:11 AM | | From: fred hayes | | | | Ya, but no rash...
----------------------------------------
Sanofi Antibiotic May Be Tied
To Liver Problems, Doctors Say
By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
January 21, 2006; Page A6
Doctors at Carolinas Medical Center in Charlotte, N.C., on Friday said one patient died from liver failure and another required a liver transplant in cases that might be linked to an antibiotic marketed by Sanofi-Aventis SA, of France.
Doctors also said one patient developed drug-induced hepatitis but recovered. The antibiotic is sold under the brand name Ketek and was approved by the Food and Drug Administration on April 1, 2004.
The three case reports were released Friday in an online edition of edition of the Annals of Internal Medicine1. The article describing the liver problems will appear in the March 21 print edition.
See the FDA's advisory2 for Sanofi-Aventis antibiotic Ketek."These cases could represent an unusual clustering of a rare, idiosyncratic drug reaction at one medical center," said John Hanson, one of the article's authors and hepatologist with the liver-transplant center at Carolinas Medical Center. "However, the severity of liver injury in two of our patients warrants this report in the medical literature and will alert other physicians to this possible link with telithromycin," which Ketek is known as generically.
All of the cases have been reported to the FDA. Susan Bro, an agency spokeswoman, said the FDA is reviewing the reports and conducting a review of other reported adverse events related to Ketek. She said, for now, that the FDA isn't making any new recommendations regarding the prescribing practices for Ketek. She said patients shouldn't stop the medication, but should contact their physician if they notice yellowing of their eyes or skin or other problems such as blurry vision. (See the FDA health advisory.3)
"At this time, FDA advises health-care providers to monitor patients taking telithromycin (Ketek) for symptoms of possible liver problems including jaundice or elevated liver enzymes," the agency said in a statement.
The drug's label, which is aimed at physicians, discusses the possibility of liver dysfunction. Rare liver problems have been seen with Ketek and similar antibiotics. A Sanofi spokesman didn't return calls for comment.
The three cases of liver problems involved patients who weren't on other medications, but two of the three reported regular alcohol use.
Researchers said there is no proof that Ketek caused the liver problems but that "caution is advised in prescribing this drug pending additional postmarketing surveillance data." Dr. Hanson said, despite the three reports, that there is "not enough data to indicate major changes in prescribing habits."
According to the article, 10 reports of liver problems had been reported to the FDA involving Ketek as of June. However, researchers said in eight of those cases patients were also on other medications.
Ketek was approved to kill bacteria that cause sinus infections, bronchitis and pneumonia. It is in a group of medicine known as macrolides, which include erythromycin, Pfizer Inc.'s Zithromax and Abbott Laboratories' Biaxin. The drug's label said cases of liver problems had been reported but that they were "generally reversible." The label warns of possible vision problems.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com4 |
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| To: fred hayes who wrote (1126) | 1/21/2006 12:16:40 PM | | From: MJ | | | | Just a note on erythromycin-----------developed a rash and skin peeled after taking it in early 90's.
Can never take it again as I could die from the reaction per doctor.
What happen to basic pencillin------now about 20 cents a tablet----------takes care of strep----still the miracle medicine imo. Works everytime for a strep throat for me.
mj |
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| From: nigel bates | 2/7/2006 9:56:11 AM | | | | | | Oscient Pharmaceuticals and Pfizer Enter Agreement for FACTIVE Tablets in Mexico
WALTHAM, Mass.--(BUSINESS WIRE)--Feb. 7, 2006--Oscient Pharmaceuticals Corporation (Nasdaq: OSCI - News) has sublicensed the commercialization rights to FACTIVE® (gemifloxacin mesylate) tablets in Mexico to Pfizer, S.A. de C.V. (Pfizer Mexico), the largest pharmaceutical company in that country. In exchange for those rights, Pfizer Mexico has agreed to pay Oscient an up-front payment, milestones for attaining certain regulatory and sales goals as well as royalties on future sales. Specific financial terms were not disclosed.
FACTIVE is currently approved in the U.S. for the treatment of community-acquired pneumonia of mild to moderate severity (CAP) and acute bacterial exacerbations of chronic bronchitis (AECB).
"FACTIVE represents an important addition to our antibiotic portfolio in Mexico," stated Jorge Bracero, Regional President & General Manager, Northern Latin America, Pfizer. "We look forward to pursuing registration of this important antibiotic and making it available to local physicians and patients in Mexico dealing with often serious respiratory tract infections."
"For us, this partnership with Pfizer in Mexico underscores the potential of FACTIVE," stated Steven M. Rauscher, President and Chief Executive Officer of Oscient Pharmaceuticals. "Our business strategy, outside of the U.S., is to build the FACTIVE brand through partnerships with leading pharmaceutical companies in our licensed territories. This deal represents the first of similar agreements that we hope to establish in Canada and in certain European countries."
Pfizer will work with the regulatory agency in Mexico to facilitate the marketing approval of FACTIVE. Oscient will be the sole provider of product to Pfizer Mexico. |
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| To: nigel bates who wrote (1128) | 2/7/2006 4:14:35 PM | | From: OldAIMGuy | | | | Thanks for the update Mr. Bates,
I consider this excellent news in that it carries with it the very strong "partnership" aspect of Factive's reputation with it.
It would be nice if the market appreciates the news, too.
Best regards, Tom |
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| To: Ian@SI who wrote (1116) | 2/8/2006 2:14:52 PM | | From: tuck | | | | >>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 |
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