OSCI...volume has been crazy last few days and increasing daily. Thinking to increase my position tomorrow. Could this be the reason for volume to increase, found in other board:
It takes about 12 months to receive approval in Europe?
Look at the filing date...HMMMMMM.....
Regulatory Filing for FACTIVE Tablets Submitted in Europe
Wed May 7, 2008 7:40am EDT Email | Print | Share| Reprints | Single Page[-] Text [+]
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Oscient Pharmaceuticals' partner, Menarini Group, seeks marketing
approval for fluoroquinolone antibiotic
WALTHAM, Mass.--(Business Wire)--
Oscient Pharmaceuticals Corporation's (Nasdaq: OSCI)
commercialization partner for FACTIVE(R) (gemifloxacin mesylate)
tablets, Menarini Group, a leading European pharmaceutical company
based in Italy, has submitted a regulatory filing seeking approval of
FACTIVE in Europe. Menarini, with broad sales and marketing coverage
throughout Europe and expertise in research and clinical development,
has the fourth largest pharmaceutical sales force in Europe and is
second largest in terms of calls to primary care physicians.
"Menarini's pursuit of marketing approval for FACTIVE in Europe is
an important step in our commercialization plan for FACTIVE in our
licensed territories," stated Steven M. Rauscher, President and Chief
Executive Officer of Oscient Pharmaceuticals. "Menarini is a strong,
experienced partner, and we look forward to working together to build
the FACTIVE brand in Europe."
Menarini is seeking approval of FACTIVE for the treatment of
community-acquired pneumonia, acute bacterial exacerbations of chronic
bronchitis and acute bacterial sinusitis. The regulatory review time
in Europe is approximately 12 months.
Oscient granted commercialization rights to Menarini for FACTIVE
in Europe last year. The oral antibiotic market in Europe is estimated
at $5 billion, with France, Germany, Italy and Spain representing the
largest markets. Oscient licenses the rights to commercialize FACTIVE
in North America and Europe from LG Life Sciences. In 2006, Oscient
forged partnerships for the commercialization of the drug in Mexico
and Canada.
About Menarini
The Menarini Group is a privately owned pharmaceutical company
headquartered in Florence, Italy. Menarini employs approximately
13,000 people, with a strong presence in Western and Eastern Europe,
Asia and Central America. In addition to advancing products through
internal research and development, Menarini has strong experience in
seeking regulatory approval and marketing in-licensed products from a
large number of pharmaceutical companies. In 2007, the Menarini Group
generated revenue of 2.5 billion euros.
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a commercial-stage
pharmaceutical company marketing two FDA-approved products in the
United States: ANTARA(R) (fenofibrate) capsules, a cardiovascular
product and FACTIVE(R) (gemifloxacin mesylate) tablets, a
fluoroquinolone antibiotic. ANTARA is indicated for the adjunct
treatment of hypercholesterolemia (high blood cholesterol) and
hypertriglyceridemia (high triglycerides) in combination with diet.
FACTIVE is approved for the treatment of acute bacterial exacerbations
of chronic bronchitis and community-acquired pneumonia of mild to
moderate severity. Oscient promotes ANTARA and FACTIVE through a
national sales force calling on primary care physicians,
cardiologists, endocrinologists and pulmonologists. The Company also
has a novel, late-stage antibiotic candidate, Ramoplanin, 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 for U.S.
Prescribers
In clinical trials, the most common (more than 2% incidence) side
effects reported in patients receiving FACTIVE versus comparators were
diarrhea (5.0% vs. 6.2%), rash (3.5% vs. 1.1%), nausea (3.7% vs.
4.5%), headache (4.2% vs. 5.2%), abdominal pain (2.2% vs. 2.2%),
vomiting (1.6% vs. 2.0%), and dizziness (1.7% vs. 2.6%). In clinical
trials, drug-related rash was reported in 2.7% 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).
FACTIVE 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. FACTIVE should be
discontinued immediately at the first sign of any of these events.
Fluoroquinolones may prolong the QT interval in some patients.
FACTIVE 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, FACTIVE should be used with caution in
patients with known or suspected CNS diseases. If CNS reactions occur,
FACTIVE 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 FACTIVE 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 contains forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements with regard to the
Company's strategy to build the FACTIVE global brand by
commercializing FACTIVE in its licensed territories. 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 (a) 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; delays in the
supply of products by the third party manufacturers and suppliers on
which we rely; inadequate distribution of the products by wholesalers,
pharmacies, hospitals and other customers; and competition from other
products; (b) 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 or EMEA 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 candidates; (c) delays by the FDA or EMEA; and (d) claims
against us by third parties, including claims relating to our
intellectual property position. Factors that could cause actual
results to differ materially from those projected or suggested in any
forward-looking statement are described under the heading "Risk
Factors" in the Company's Annual Report on Form 10-K for the year
ending December 31, 2007 and in other filings that we may make with
the Securities and Exchange Commission from time to time.
For Oscient Pharmaceuticals
Christopher Taylor, 781-398-2466
or
Sandra Schmidt, 781-398-2310
Copyright Business Wire 2008
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