Fluoroquinolone antibiotic now available for the treatment of AECB
MONTREAL AND WALTHAM, MASS., March 2 /CNW/ - Abbott Canada, the Canadian
affiliate of Abbott, has launched Oscient Pharmaceuticals Corporation's
(Nasdaq: OSCI) fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate)
tablets in Canada for the five-day treatment of acute bacterial exacerbations
of chronic bronchitis (AECB). Oscient granted the commercialization rights for
FACTIVE to Abbott Canada in August of last year.
"As the most active member of the fluoroquinolone class of antibiotics in
vitro, FACTIVE is an important addition to our anti-infective product
portfolio," stated Marcelo A. Vizio, General Manager, Abbott Canada, Abbott
International. "We are marketing FACTIVE, with its convenient once-daily
dosing and short-course therapy, to physicians across Canada with our primary
care sales force."
"With extensive anti-infective experience, Abbott Canada is
well-positioned to launch FACTIVE to Canadian healthcare providers," stated
Steven M. Rauscher, President and Chief Executive Officer of Oscient
Pharmaceuticals. "In Canada, chronic obstructive pulmonary disease patients
typically have two to three AECB episodes a year, resulting in 1.5 million
physician visits annually."
Abbott Canada plans to pursue additional indications for FACTIVE in the
future and has access to the drug's entire clinical trial dossier. In 2004,
FACTIVE was approved in Canada for the treatment of AECB caused by
Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae,
Moraxella catarrhalis and Staphylococcus aureus. FACTIVE is approved in the
U.S. for the seven-day treatment of community-acquired pneumonia of mild to
moderate severity (CAP) and the five-day treatment of AECB. Oscient received a
modest milestone payment from Abbott Canada related to the launch.
About Abbott Canada
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The company
employs 65,000 people and markets its products in more than 130 countries.
Abbott Canada is headquartered in the borough of Saint-Laurent, Montreal,
Quebec, and employs approximately 2,000 people. Its key businesses include
nutritionals, pharmaceuticals, diabetes care products, diagnostics,
point-of-care products and vascular products.
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) (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 in
the U.S. for the five-day treatment of acute bacterial exacerbations of
chronic bronchitis and the seven-day treatment of 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).
Notice to U.S. Healthcare Providers: For important information regarding
the safety and use of ANTARA, please see the full prescribing information
available at www.antararx.com.
Important Safety Information about FACTIVE for Canadian Prescribers (1)
FACTIVE is contraindicated in patients with a history of hypersensitivity
to gemifloxacin, fluoroquinolone antibiotics, or any of the product
components. FACTIVE may prolong the QT interval in some patients and 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 (e.g., quinidine,
procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents.
FACTIVE should be discontinued immediately at the appearance of any sign
of an immediate hypersensitivity skin rash or any other manifestation of a
hypersensitivity reaction; the need for continued fluoroquinolone therapy
should be evaluated. FACTIVE should be used with caution in patients with CNS
diseases such as epilepsy, or in patients predisposed to convulsions. FACTIVE
should be discontinued if the patient experiences pain, inflammation or
rupture of a tendon.
(1) FACTIVE Product Monograph. Abbott Laboratories, Limited. August 22,
For additional information regarding the safety and use of FACTIVE in
Canada, please see the full product monograph available at www.abbott.ca.
Important Safety Information about FACTIVE for U.S. Prescribers
FACTIVE is indicated in the U.S. for the five-day treatment of AECB
caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus
parainfluenzae or Moraxella catarrhalis and the seven-day treatment of CAP
caused by Streptococcus pneumoniae (including multi-drug resistant strains),
Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae,
Chlamydia pneumoniae or Klebsiella pneumoniae.
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
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
Forward-Looking Statement for Oscient Pharmaceuticals
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 Abbott Canada's plans to pursue
additional indications for FACTIVE in the future. 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) our ability to integrate ANTARA into our business; (c)
whether we will be able to expand the indications for which FACTIVE is
approved;(d) 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; (e) delays by the FDA; (f) the Company's
inability to raise additional capital on favorable terms or at all and (g)
claims against us by third parties, including claims relating to our
intellectual property position. 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.
For further information:
For further information: For Abbott Canada Media Contact: Sylvie Legare,
514-832-7175 or For Oscient Pharmaceuticals Investor Contact Christopher
Taylor, 781-398-2466 or Media Contact Sarah Emond, 781-398-2544