FDA Accepts as ``Complete Response'' Oscient Pharmaceuticals' Submission Following FACTIVE Approvable Letter for Five-Day CAP
28 November 2006 - 12:33AM
Business Wire
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.
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