| To: fred hayes who wrote (1131) | 7/25/2006 10:16:12 AM | | From: OldAIMGuy | | | | Thanks Fred, Some of OSCI's decline is from its business results and some of it is tied to the generally unexciting action in biotech in general this year.
Any good news is welcome but until biotechs turn, probably not to be much noticed.
I recently had a "buy" in the biotech index fund after a very long time of not much activity. I'd like to think that maybe it might just bottom out here. Wishful thinking aside, there's cash reserved enough to continue buying more of the index fund should we see deeper discounts.
As you can see, this sector has been pretty quiet since the end of 2003. Even the speculators have gone to play in other areas.
It would seem to be a good idea for me to buy the individual stocks in concert with buying signals I get in the index fund.
Best regards, Tom |
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| From: Ian@SI | 7/25/2006 9:33:15 PM | | | | | | A little more on this morning's upgrade. a very aggressive target...
09:47 am Oscient Pharma: JMP Securities upgrades Mkt Outperform to Strong Buy. Target $3.50. Firm upgrades as the acquisition of cardiovascular drug Antara should be immediately accretive for Oscient, it fits well with the target audience for the co's Factive and innovative financing for the acquisition preserves the balance sheet. |
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| From: sjemmeri | 8/1/2006 9:39:43 AM | | | | | | Oscient, Pfizer Get OK To Market Antibiotic In Mexico>OSCI
Dow Jones Newswires - August 01, 2006 9:03 AM ET
Related Quotes
Symbol Last Chg
OSCI Trade 0.96 +0.079
PFE Trade 26.14 +0.15
Real time quote.
DOW JONES NEWSWIRES
Oscient Pharmaceuticals Corp. (OSCI) said its antibiotic Factive received approval from the Ministry of Health in Mexico to be marketed as Factive-5 for the five-day treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis.
The Waltham, Mass., pharmaceutical company said Pfizer Inc.'s (PFE) Mexico-based Pfizer S.A. de C.V. sub-licensed the rights to develop and market Factive in Mexico in February.
The regulatory approval resulted in an undisclosed milestone payment to Oscient from Pfizer. Oscient also will receive royalties on future sales of the drug in Mexico.
Pfizer prepared the regulatory filing based on the drug's clinical trial dossier and expects to launch Factive-5 in the coming weeks.
-Adam Kuczynski; 201-938-5400; AskNewswires@dowjones.com |
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| From: Doc Bones | 9/12/2006 5:37:50 AM | | | | | | Antibiotic Suffers a Setback [WSJ]
By JENNIFER CORBETT DOOREN
September 12, 2006; Page D4
WASHINGTON -- The risk of skin rashes and other serious skin reactions seen with an Oscient Pharmaceuticals Corp. antibiotic outweighs possible benefits of using the drug to treat sinus infections, the Food and Drug Administration said.
The Waltham, Mass., company is seeking FDA permission to expand use of its antibiotic, Factive, to treat acute bacterial sinusitis. The drug was first approved by the FDA in 2003 to treat mild-to-moderate community-acquired pneumonia and a severe form of bronchitis.
The agency has asked an outside panel of medical experts to make recommendations today about whether the drug should be approved. The FDA typically follows its panel recommendations but isn't required to do so. The FDA presented its views of Factive in documents posted to its Web site yesterday.
Factive was developed by SmithKline Beecham, which later became GlaxoSmithKline PLC. In 2000, the FDA rejected an application for the proposed drug to treat a variety of infections, including sinusitis and bronchitis, because of a higher rate of rash seen among Factive users in certain clinical studies. There were also concerns about possible liver injury.
The FDA requested more studies of Factive in order to approve the drug, which were conducted by Glaxo and other firms that later acquired the drug.
The FDA eventually approved use of a seven-day course of Factive in treating pneumonia and a five-day course of the drug to treat bronchitis after studies suggested the risk of skin rashes was reduced with a seven- or five-day treatment course. The agency said the benefits of treating those infections outweighed the risks of the drug.
While the FDA conceded that the risk of skin rashes and more-severe reactions does seem to be reduced with a shorter course of antibiotic use, the FDA said, "there is still the concern that the incidence of skin reactions is greater" than with other, approved products.
Oscient said the safety profile of Factive is similar to other drugs in its class and has proved to be effective against strains of bacteria that are resistant to other antibiotics.
Oscient said Factive, known generically as gemifloxacin, "represents an important additional therapeutic option for treatment of ABS [sinusitis], particularly those cases where the risk of infection by resistant organisms is of concern."
In 4 p.m. composite trading on the Nasdaq Stock Market, Oscient was at $1.14, up five cents, or 4.6%.
online.wsj.com |
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| From: Ian@SI | 9/22/2006 8:45:57 AM | | | | | | Oscient Pharmaceuticals Receives Approvable Letter from FDA for FACTIVE(R) Tablets for Five-Day Treatment of Community-Acquired Pneumonia
bwire
WALTHAM, Mass. (Business Wire) -- Oscient Pharmaceuticals (Nasdaq: OSCI) has received an
approvable letter from the U.S. Food and Drug Administration (FDA) for
the supplemental New Drug Application (sNDA) seeking approval for the
five-day treatment of community-acquired pneumonia (CAP) of mild to
moderate severity with FACTIVE(R) (gemifloxacin mesylate) tablets.
FACTIVE is currently approved for the five-day treatment of acute
bacterial exacerbations of chronic bronchitis (AECB) and the seven-day
treatment of CAP.
According to the letter, the Company is required to provide
clarification and additional interpretation regarding certain data
included in the application to assist the FDA in its evaluation. The
Company intends to provide this information to the FDA in the coming
weeks; the FDA typically responds to resubmissions within two months.
The Company believes no additional clinical trials are required.
"We look forward to working closely with the FDA to meet the
requirements of the letter," stated Steven M. Rauscher, President and
Chief Executive Officer. "As FACTIVE enters its third respiratory
tract infection season, the drug continues to be an important option
for physicians treating lower respiratory tract infections."
The submission for the five-day treatment of CAP contained data
from a successful Phase III trial completed in 2005 comparing a
five-day and seven-day treatment with FACTIVE 320 mg once-daily for
CAP in 510 patients. That study demonstrated strong clinical response
rates at follow up (the primary endpoint) in both arms. Currently, no
fluoroquinolone is approved for the five-day treatment of both AECB
and CAP. Community-acquired pneumonia is a common and serious illness
in the United States with three to four million cases per year,
resulting in approximately one million hospitalizations and 40,000
deaths annually. Pneumonia is the most common cause of death due to an
infectious disease. |
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