Oscient Pharmaceuticals (MM) (NASDAQ:OSCID)
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The U.S. Food and Drug Administration (FDA) has accepted as complete
Oscient Pharmaceuticals Corporation’s (Nasdaq:
OSCI) response to the FACTIVE®
(gemifloxacin mesylate) tablets approvable letter for the
application seeking approval for the five-day treatment of
community-acquired pneumonia of mild to moderate severity (CAP). FACTIVE
is currently approved by the FDA for the five-day treatment of acute
exacerbations of chronic bronchitis (AECB) and the seven-day treatment
of CAP.
The approvable letter, received on September 21, 2006, asked for
clarification and additional interpretation regarding certain data
included in the application to assist the FDA in its evaluation. Oscient
submitted its response to the approvable letter last month. The FDA has
classified the complete response as a Class II resubmission with a user
fee deadline of May 1, 2007.
“We are looking forward to working with the
FDA through this final phase of review of our five-day CAP application,”
stated Steven M. Rauscher, President and CEO.
The NDA 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.
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a commercial-stage
biopharmaceutical company marketing two FDA-approved products with its
national primary care sales force. ANTARA®
130 mg (fenofibrate) capsules is indicated for the adjunct treatment of
hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia
(high triglycerides) in combination with diet. FACTIVE®
(gemifloxacin mesylate) tablets is an antibiotic approved for the
treatment of acute bacterial exacerbations of chronic bronchitis and
community-acquired pneumonia of mild to moderate severity. Oscient also
has a novel, late-stage antibiotic candidate, Ramoplanin, under
investigation for the treatment of Clostridium difficile-associated
disease (CDAD).
For important information regarding the safety and use of ANTARA and
FACTIVE, please see the full prescribing information available at www.antararx.com
and www.factive.com.
Important Safety Information about
FACTIVE Tablets
The most common (more than 2% incidence) drug-related side effects
reported in FACTIVE clinical trials were diarrhea (3.6%), rash (2.8%)
and nausea (2.7%). In clinical trials, drug-related rash was reported in
2.8% of patients receiving gemifloxacin and was more commonly observed
in patients less than 40 years of age, especially females. The incidence
of rash increases with treatment longer than the maximum-labeled
duration of 7 days. In clinical trials, the discontinuation rate due to
drug-related adverse events was similar for FACTIVE tablets and
comparators (2.2% versus 2.1%, respectively).
Gemifloxacin is contraindicated in patients with a history of
hypersensitivity to gemifloxacin, fluoroquinolone antibiotic agents, or
any of the product components. Patients receiving marketed
fluoroquinolones have reported serious and occasionally fatal
hypersensitivity and/or anaphylactic reactions, peripheral neuropathy,
antibiotic-associated colitis and tendon ruptures. Gemifloxacin should
be discontinued immediately at the first sign of any of these events.
Fluoroquinolones may prolong the QT interval in some patients.
Gemifloxacin should be avoided in patients with a history of
prolongation of the QTc interval, patients with uncorrected electrolyte
disorders (hypokalemia or hypomagnesemia), and patients receiving Class
IA or Class III antiarrhythmic agents. In clinical studies with
gemifloxacin, CNS effects have been reported infrequently. As with other
fluoroquinolones, gemifloxacin should be used with caution in patients
with known or suspected CNS diseases. If CNS reactions occur,
gemifloxacin should be discontinued and appropriate measures instituted.
No significant drug-drug interactions were seen with theophylline,
digoxin, oral contraceptives, cimetidine, omeprazole, and warfarin,
although patients receiving a fluoroquinolone concomitantly with
warfarin should be monitored closely. Drug-drug interactions include
probenicid, sucralfate, antacids containing aluminum or magnesium, iron,
multivitamins containing metal cations, and didanosine. The safety and
effectiveness of gemifloxacin in children, adolescents (less than 18
years of age), pregnant women, and lactating women have not been
established. For complete safety and efficacy information, please see
the full prescribing information available at www.factive.com.
Forward-Looking Statement
This news release may contain forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements regarding the timing
of FDA’s response to our resubmission of our
sNDA seeking approval for the five-day treatment of CAP. Forward-looking
statements represent our management’s
judgment regarding future events. Forward-looking statements typically
are identified by use of terms such as “may,”
“will,” “should,”
“plan,” “expect,”
“intend,” “anticipate,”
“estimate,” and
similar words, although some forward-looking statements are expressed
differently. We do not plan to update these forward-looking statements.
You should be aware that our actual results could differ materially from
those contained in the forward-looking statements due to a number of
risks affecting our business. These risks include, but are not limited
to (i) our ability to successfully commercialize and market ANTARA or
FACTIVE due to: the limitations on our resources and experience in the
commercialization of products; lack of acceptance by physicians,
patients and third party payors; unanticipated safety, product
liability, efficacy, or other regulatory issues; delays in recruiting
and training sales personnel; problems relating to manufacturing or
supply; inadequate distribution of the products by wholesalers,
pharmacies, hospitals and other customers; and competition from other
products; (ii) our ability to integrate ANTARA into our business;
(iii) whether we will be able to expand the indications for which
FACTIVE is approved; (iv) the delay or inability to find sublicensing
partners for FACTIVE or to negotiate favorable licensing terms; (v) the
delay in or inability to obtain additional regulatory approvals of our
products and product candidates due to negative, inconclusive or
insufficient results in ongoing or future clinical trials, the FDA
requiring additional information or data, delays in the progress of
ongoing clinical trials, safety concerns arising with respect to our
products or product candidates and disputes with the third parties from
whom we license our products or product candidate; and (vi) delays by
the FDA. Additional factors that could cause actual results to differ
materially from those projected or suggested in any forward-looking
statements are described under the heading “Risk
Factors” in the Company’s
Quarterly Report on Form 10-Q for the quarter ending September 30, 2006
and in other filings that we may make with the Securities and Exchange
Commission from time to time.
The U.S. Food and Drug Administration (FDA) has accepted as
complete Oscient Pharmaceuticals Corporation's (Nasdaq: OSCI) response
to the FACTIVE(R) (gemifloxacin mesylate) tablets approvable letter
for the application seeking approval for the five-day treatment of
community-acquired pneumonia of mild to moderate severity (CAP).
FACTIVE is currently approved by the FDA for the five-day treatment of
acute exacerbations of chronic bronchitis (AECB) and the seven-day
treatment of CAP.
The approvable letter, received on September 21, 2006, asked for
clarification and additional interpretation regarding certain data
included in the application to assist the FDA in its evaluation.
Oscient submitted its response to the approvable letter last month.
The FDA has classified the complete response as a Class II
resubmission with a user fee deadline of May 1, 2007.
"We are looking forward to working with the FDA through this final
phase of review of our five-day CAP application," stated Steven M.
Rauscher, President and CEO.
The NDA 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.
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a commercial-stage
biopharmaceutical company marketing two FDA-approved products with its
national primary care sales force. ANTARA(R) 130 mg (fenofibrate)
capsules is indicated for the adjunct treatment of
hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia
(high triglycerides) in combination with diet. FACTIVE(R)
(gemifloxacin mesylate) tablets is an antibiotic approved for the
treatment of acute bacterial exacerbations of chronic bronchitis and
community-acquired pneumonia of mild to moderate severity. Oscient
also has a novel, late-stage antibiotic candidate, Ramoplanin, under
investigation for the treatment of Clostridium difficile-associated
disease (CDAD).
For important information regarding the safety and use of ANTARA
and FACTIVE, please see the full prescribing information available at
www.antararx.com and www.factive.com.
Important Safety Information about FACTIVE Tablets
The most common (more than 2% incidence) drug-related side effects
reported in FACTIVE clinical trials were diarrhea (3.6%), rash (2.8%)
and nausea (2.7%). In clinical trials, drug-related rash was reported
in 2.8% of patients receiving gemifloxacin and was more commonly
observed in patients less than 40 years of age, especially females.
The incidence of rash increases with treatment longer than the
maximum-labeled duration of 7 days. In clinical trials, the
discontinuation rate due to drug-related adverse events was similar
for FACTIVE tablets and comparators (2.2% versus 2.1%, respectively).
Gemifloxacin is contraindicated in patients with a history of
hypersensitivity to gemifloxacin, fluoroquinolone antibiotic agents,
or any of the product components. Patients receiving marketed
fluoroquinolones have reported serious and occasionally fatal
hypersensitivity and/or anaphylactic reactions, peripheral neuropathy,
antibiotic-associated colitis and tendon ruptures. Gemifloxacin should
be discontinued immediately at the first sign of any of these events.
Fluoroquinolones may prolong the QT interval in some patients.
Gemifloxacin should be avoided in patients with a history of
prolongation of the QTc interval, patients with uncorrected
electrolyte disorders (hypokalemia or hypomagnesemia), and patients
receiving Class IA or Class III antiarrhythmic agents. In clinical
studies with gemifloxacin, CNS effects have been reported
infrequently. As with other fluoroquinolones, gemifloxacin should be
used with caution in patients with known or suspected CNS diseases. If
CNS reactions occur, gemifloxacin should be discontinued and
appropriate measures instituted.
No significant drug-drug interactions were seen with theophylline,
digoxin, oral contraceptives, cimetidine, omeprazole, and warfarin,
although patients receiving a fluoroquinolone concomitantly with
warfarin should be monitored closely. Drug-drug interactions include
probenicid, sucralfate, antacids containing aluminum or magnesium,
iron, multivitamins containing metal cations, and didanosine. The
safety and effectiveness of gemifloxacin in children, adolescents
(less than 18 years of age), pregnant women, and lactating women have
not been established. For complete safety and efficacy information,
please see the full prescribing information available at
www.factive.com.
Forward-Looking Statement
This news release may contain forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements regarding the
timing of FDA's response to our resubmission of our sNDA seeking
approval for the five-day treatment of CAP. Forward-looking statements
represent our management's judgment regarding future events.
Forward-looking statements typically are identified by use of terms
such as "may," "will," "should," "plan," "expect," "intend,"
"anticipate," "estimate," and similar words, although some
forward-looking statements are expressed differently. We do not plan
to update these forward-looking statements. You should be aware that
our actual results could differ materially from those contained in the
forward-looking statements due to a number of risks affecting our
business. These risks include, but are not limited to (i) our ability
to successfully commercialize and market ANTARA or FACTIVE due to: the
limitations on our resources and experience in the commercialization
of products; lack of acceptance by physicians, patients and third
party payors; unanticipated safety, product liability, efficacy, or
other regulatory issues; delays in recruiting and training sales
personnel; problems relating to manufacturing or supply; inadequate
distribution of the products by wholesalers, pharmacies, hospitals and
other customers; and competition from other products; (ii) our ability
to integrate ANTARA into our business; (iii) whether we will be able
to expand the indications for which FACTIVE is approved; (iv) the
delay or inability to find sublicensing partners for FACTIVE or to
negotiate favorable licensing terms; (v) the delay in or inability to
obtain additional regulatory approvals of our products and product
candidates due to negative, inconclusive or insufficient results in
ongoing or future clinical trials, the FDA requiring additional
information or data, delays in the progress of ongoing clinical
trials, safety concerns arising with respect to our products or
product candidates and disputes with the third parties from whom we
license our products or product candidate; and (vi) delays by the FDA.
Additional factors that could cause actual results to differ
materially from those projected or suggested in any forward-looking
statements are described under the heading "Risk Factors" in the
Company's Quarterly Report on Form 10-Q for the quarter ending
September 30, 2006 and in other filings that we may make with the
Securities and Exchange Commission from time to time.