Factive: profile and news
Oscient Pharma narrows loss on Factive sales 06 Mar 2006
Revenue growth from the launch of its bronchitis treatment drug Factive helped Oscient Pharmaceuticals Corp. narrow its net loss ... - Boston Business Journal,
Oscient Pharmaceuticals and Pfizer Enter Agreement for FACTIVE ... Feb 7, 2006
7, 2006 - Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) has sublicensed the commercialization rights to FACTIVE(R) (gemifloxacin mesylate) tablets in ... - PharmaLive.com (press release),
Oscient Pharmaceuticals y Pfizer celebran acuerdo por las tabletas ... Feb 7, 2006
2006 -- Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) concedió una sublicencia de los derechos de comercialización de las tabletas FACTIVE(R) (mesilato ... - Business Wire (press release),
Oscient Pharmaceuticals to Present at Fifth Annual JMP Securities ... Mar 2, 2006
Company's President and CEO, Steven Rauscher, will provide an overview of the Company including details on the recent sublicense of FACTIVE(R) (gemifloxacin ... - Genetic Engineering News,
Pfizer acquires rights to Oscient antibiotic in Mexico Feb 9, 2006
By Staff Writer. Biopharma company Oscient Pharmaceuticals has given Pfizer rights to commercialize its antibiotic pneumonia treatment Factive in Mexico. ... - Pharmaceutical Business Review
Oscient, Pfizer sign marketing deal Feb 7, 2006
...said Tuesday it sublicensed the Mexican marketing rights for its Factive antibiotic tablets, used to treat community-acquired pneumonia and chronic bronchitis ... - BusinessWeek
Webcast Alert: Oscient Pharmaceuticals Announces Date for Release ... Feb 22, 2006
The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the five-day treatment of acute bacterial exacerbations of chronic ... - Business Wire (press release),
Oscient, Pfizer sign marketing deal Feb 7, 2006
WALTHAM, Mass. Oscient Pharmaceuticals says it sublicensed the Mexican marketing rights for its Factive antibiotic tablets to Pfizer's Mexican arm. ... - Eyewitness News,
Oscient Pharmaceuticals Acquires Expanded Worldwide Rights to Lead ... Feb 8, 2006
The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic ... - Genetic Engineering News,
Robust Viral Load Reduction Successfully Achieved in Phase II ... Feb 14, 2006
LGLS seeks to continue developing global brand products, such as Factive(R) (gemifloxacin), and expanding its market presence in the world with focus in Asia. ... - PharmaLive.com (press release),
Webcast Alert: Oscient Pharmaceuticals to Present at BIO CEO & ... 09 Feb 2006
Company's President and CEO, Steven Rauscher, will provide an overview of the Company including details on the recent sublicense of FACTIVE(R) (gemifloxacin ... - Genetic Engineering News,
Oscient Factive application accepted Jan 20, 2006
WALTHAM, Mass. Oscient Pharmaceuticals says the FDA has accepted a marketing application for Factive as a five-day treatment for mild to moderate pneumonia. ... - Eyewitness News,
FDA Accepts for Filing Oscient Pharmaceuticals' Supplemental New ... Jan 20, 2006
...for filing Oscient Pharmaceuticals' (Nasdaq: OSCI) supplemental New Drug Application (sNDA) seeking marketing approval for the use of FACTIVE(R) (gemifloxacin ... - Genetic Engineering News,
Oscient Pharmaceuticals Provides Preliminary Revenues for Fourth ... Jan 9, 2006
...to record total fourth quarter revenues of approximately $9.2 million, with approximately $8 million in revenue from its lead product, FACTIVE(R) (gemifloxacin ... - Genetic Engineering News,
Oscient gets good news, bad news from FDA Jan 20, 2006
The US Food and Drud Administration has agreed to consider allowing Oscient Pharmaceuticals' drug Factive to be used as a five-day treatment for mild to ... - Boston Business Journal,
Oscient Sees Strong Fourth-Quarter Sales Jan 9, 2006
...$22.3 million. Boosting Oscient's performance during the period was $8 million in sales of its lead drug, Factive. The medication ... - Schaeffers Research,
Oscient sees strong 4Q sales Jan 9, 2006
...selling drug. Boosting Oscient's performance during the period was eight (m) million dollars in sales of its lead drug, Factive. The ... - Providence Eyewitness News,
Highlights of rising and falling US stocks Jan 20, 2006
Oscient Pharmaceuticals Corp. (OSCI) said its filing of a supplemental new drug application for the use of its Factive tablets as a five-day treatment for ... - Investor's Business Daily (subscription)
Oscient chooses Priority Solutions Jan 31, 2006
In September 2004, Oscient launched FACTIVE fluoroquinolone antibiotic tablets for the treatment of acute bacterial exacerbations of chronic bronchitis and ... - PharmaLive.com (press release),
New Data on FACTIVE(R) Tablets and Ramoplanin Presented at the ... Dec 9, 2005
Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets, and lead product candidate ... - Genetic Engineering News,
Oscient Pharmaceuticals to Present at First Albany Capital Annual ... Nov 29, 2005
President and CEO, Steven Rauscher, will provide an overview of the Company as well as an update on the market performance of FACTIVE(R) (gemifloxacin mesylate ... - Business Wire (press release),
Oscient Files Drug Application With FDA Nov 21, 2005
...said Monday it submitted a supplemental application to the Food and Drug Administration seeking approval for the use of Factive tablets for the five-day ... - Forbes
Clinical Data on FACTIVE(R) Tablets for ABS and AECB Presented at ... Oct 7, 2005
Society of America (IDSA) features clinical data on Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin ... - Genetic Engineering News,
Clinical Data on FACTIVE(R) Tablets to be Presented at the 43rd ... Sep 30, 2005
Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets, is the subject of two poster ... - Genetic Engineering News,
Clinical Data on FACTIVE Tablets to be Presented at the 43rd ... Sep 30, 2005
WALTHAM, Mass.--(BUSINESS WIRE)--Sep 30, 2005 - Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin ... - PharmaLive.com (press release),
Oscient Pharmaceuticals Completes Sales Force Expansion; Company ... Oct 3, 2005
The national sales force is focused on promoting Oscient's fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets and Auxilium Pharmaceuticals ... - Business Wire (press release),
Oscient Pharmaceuticals downgraded to "neutral weight" - update Oct 4, 2005
In a research note published this morning, the analyst mentions that the company announced on Tuesday that it would promote FACTIVE itself, indicating its ... - New Ratings
Full Results Released From Phase III Trial Comparing Five-Day and ... Sep 18, 2005
Data from the study of Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets, for the ... - RedNova.com,
Oscient Pharmaceuticals Files Shelf Registration Statement Sep 30, 2005
The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic ... - Genetic Engineering News,
Full Results Released from Phase III Trial Comparing Five-Day and ... Sep 18, 2005
...(PressMethod) - Data from the study of Oscient Pharmaceuticals' (Nasdaq: OSCI - News) FDA-approved fluoroquinolone antibiotic, FACTIVE® (gemifloxacin mesylate ... - Press Method (press release),
Oscient Pharma bolsters sales force Oct 3, 2005
The sales force will be focused on promoting Oscient's antibiotic Factive and Auxilium Pharmaceuticals' Testim testosterone gel, a testosterone replacement ... - Boston Business Journal,
Full Results Released from Phase III Trial Comparing Five-Day and ... Sep 19, 2005
BUSINESS WIRE)--Sep 18, 2005 - Data from the study of Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin ... - PharmaLive.com (press release),
Business in Asia -- Sept. 29, 2005 Sep 29, 2005
Under the deal, the Japanese company will have an exclusive right to sell the antibiotic drug Factive after winning approval from Japanese authorities. ... - Yahoo! News (press release)
Metabasis Advancing Internal Programs With $41M Funding Oct 3, 2005
...its products. The national sales force is focused on promoting the antibiotic Factive, as well as Testim testosterone gel. Tessera ... - BioWorld Online (subscription),
Many meds don't mix with the sun Sep 21, 2005
...de-meclocycline (Declomycin), doxycycline (Vibramycin) ethio-namide (Trecator-SC), flucytosine (Ancobon), gemifloxacin (Factive), griseofulvin (Fulvicin, Gris ... - Pioneer Press,
Oscient Pharmaceuticals to Present at Thomas Weisel Healthcare ... Sep 2, 2005
President and CEO, Steven Rauscher, will provide an overview of the Company as well as an update on the market performance of FACTIVE(R) (gemifloxacin mesylate ... - Genetic Engineering News,
Morality as a Mental State Aug 29, 2005
Morality is not a factive attitude. ... Since knowing is a factive attitude, the truth it relates to is the contingently true nature of moral propositions. ... - Global Politician,
Can Aspen continue it’s sterling performance? - Monique Vanek Aug 22, 2005
Aspen’s CEO Stephen Saad attributed the growth to the launch of significant number of new products such as Factive, used for respiratory tract infections ... - Moneyweb,
Aspen - Reviewed Preliminary Group Financial Results For The Year ... Aug 22, 2005
The product launches included the new chemical entity Gemifloxacillin Mesylate, specific for respiratory tract infections, marketed under the trademark Factive ... - Finance24,
Oscient Pharmaceuticals Reports Financial Results for Second ... Aug 2, 2005
During this period, the Company recorded $4.2 million in total revenue, with $3.8 million from sales of the Company's lead product, FACTIVE (R) (gemifloxacin ... - Business Wire (press release)
Pharma Oscient sees higher revenue, wider losses in Q2 Aug 2, 2005
...reported higher revenue but also larger net losses for its 2005 second quarter, driven by expenses relating to its bronchitis/pneumonia treatment Factive. ... - Boston Business Journal
Developing a life sciences hub Jul 28, 2005
He started work on the project's 304th candidate antibiotic which proved a potent and well tolerated medicine, which LGLS called ``Factive''. ... - Bangkok Post
Oscient Pharmaceuticals Announces Transition of Chairman of Board ... Jul 20, 2005
...assets of our companies, recruited additional highly regarded members to our Board and put in place an experienced management team that launched FACTIVE(R) and ... - Genetic Engineering News
Webcast Alert: Oscient Pharmaceuticals Announces Date for Release ... Jul 19, 2005
The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic ... - Business Wire (press release)
Hobbes in the Himalayas Jul 26, 2005
...fusion of the psychopathic with the apocalyptic—surely the essence of "terror" in our time—is transferred to America by another "factive" passage, this one ... - Atlantic Online
Factiva Added To Yahoo! Search Subscriptions Jul 19, 2005
...a query. Once a user clicks through a Yahoo result derived from the Factive database, they will be taken to a Factiva page. Full ... - WebProNews
Other information
Indication
For the treatment of Bacterial infection caused by susceptible strains such as S.pneumoniae, H.influenzae, H.parainfluenzae, or M.catarrhalis, S.pneumoniae (including multi-drug resistant strains [MDRSP]), M.pneumoniae, C.pneumoniae, or K.pneumoniae.
Pharmacology
Gemifloxacin is a quinolone/fluoroquinolone antibiotic. Gemifloxacin is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. Gemifloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.
Mechanism Of Action
The bactericidal action of Gemifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.
Drug Category
Anti-bacterial Agents; ATC:J01MA15
Brand Names/Synonyms
Factive; Gemifloxacin; Gemifloxacin Mesilate; Gemifloxacin [Inn]
Dosage Forms
TABLET
Absorption
Gemifloxacin is rapidly absorbed from the gastrointestinal tract. The absolute bioavailability of the 320 mg tablet averaged approximately 71% (95% CI 60%-84%).
Interactions
-->Interactions for Gemifloxacin:
Administration of repeat doses of FACTIVE had no effect on the repeat dose pharmacokinetics of
theophylline, digoxin or an ethinylestradiol/levonorgestrol oral contraceptive product in healthy subjects.
Concomitant administration of FACTIVE and calcium carbonate, cimetidine, omeprazole, or an
estrogen/progesterone oral contraceptive produced minor changes in the pharmacokinetics of gemifloxacin, which were
considered to be without clinical significance.
Concomitant administration of FACTIVE with probenecid resulted in a 45% increase in systemic exposure
to gemifloxacin.
FACTIVE had no significant effect on the anticoagulant effect of warfarin in healthy subjects on
stable warfarin therapy. However, because some quinolones have been reported to enhance the anticoagulant effects of
warfarin or its derivatives in patients, the prothrombin time or other suitable coagulation test should be closely
monitored if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives.
Quinolones form chelates with alkaline earth and transition metals. The absorption of oral
gemifloxacin is significantly reduced by the concomitant administration of an antacid containing aluminum and
magnesium. Magnesium- and/or aluminum-containing antacids, products containing ferrous sulfate (iron), multivitamin
preparations containing zinc or other metal cations, or Videx (didanosine) chewable/buffered tablets or the pediatric
powder for oral solution should not be taken within 3 hours before or 2 hours after FACTIVE. Sucralfate should not be
taken within 2 hours of FACTIVE.
Chemical IUPAC Name
1-acetyloxycyclohexane-1-carboxylicacid
Chemical Formula
C18H20FN5O4
Half Life
7 (+/- 2) hours
Drug Type
Approved Drug
# Accession No
APRD00053
CAS Registry Number
175463-14-6