Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts:   Target Concepts:
Query: UMLS:C0040425 (tonsillitis)
 1,594 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The ketolide telithromycin (HMR-3647; Ketek), a derivative of clarithromycin, has been launched by Aventis Pharma (formerly Hoechst Marion Roussel) for the treatment of respiratory tract infections with gram-positive or gram-negative cocci, Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, intracellular pathogens, atypical microorganisms, toxoplasma or anaerobic bacteria. By May 2001, filings in the US and EU had been completed and a filing in Japan was expected to take place in the fourth quarter of 2001. In July 2001, telithromycin was granted marketing authorization by the EC for the treatment of community-acquired respiratory tract infections, including those caused by bacteria resistant to commonly used antibiotics. In October 2001, the product was launched in Germany. In March 2000, telithromycin was submitted to the US FDA and the EMEA, under the EU centralized approval procedure, for approval for the treatment of community-acquired pneumonia (CAP), acute sinusitis, acute exacerbations of chronic bronchitis and tonsillitis/pharyngitis. The company had expected to launch the product in early 2001. The CPMP issued a positive opinion for all four indications on April 23 2001. In September 2001, the company indicated that it expected the product to be launched in Japan in 2002. The FDA's Anti-infectives Advisory Committee was due to review telithromycin for all the submitted indications on January 29 2001; however, this was postponed. This postponement was thought to be at Aventis' request in order to discuss the potential for a resistant pneumococcal infection labeling which would boost product sales. The revised date for the meeting was April 26 2001, at which the Anti-Infective Drugs Advisory Committee of the FDA recommended approval of telithromycin for the treatment of CAP in patients 18 years of age or older. The committee failed to recommend approval for the use of the drug for the remaining three indications for which it was filed, citing concerns over potential cardiovascular risk and liver toxicity; at this time, the company was in active discussions with the FDA regarding approval of the remaining three indications. An approvable letter for CAP, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis was received by the company in June 2001; Aventis also received a non-approvable letter for the treatment of tonsillitis/pharyngitis at this time. In April 1999, ABN Amro predicted annual sales of DM 50 million in 2001, rising to DM 100 million in 2002. In February 1999, Lehman Brothers estimated a 70% probability that this ketolide would come to market. The analysts also estimated a launch date of 2001, with peak sales of US $700 million in 2009. Analysts Merrill Lynch predicted in September 200, that the product would be launched by 2001, with sales of euro 50 million in that year, rising to euro 284 million in 2004. Deutsche Bank predicted in August 2001, that sales of the product would reach euro 5 million in 2001, rising to euro 300 million in 2005. Analysts at Merrill Lynch predicted in November 2001, that the product would be resubmitted in the US in mid-2002, and would make sales of US $5 million in 2001, rising to US $250 million in 2004.
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PMID:Telithromycin. Aventis Pharma. 1189 30

Telithromycin, a recently approved ketolide antibiotic derived from 14-membered macrolides, is active against erythromycin-resistant pneumococci. Telithromycin has enhanced activity in vitro because it binds not only to domain V of ribosomal RNA (like macrolides do) but also to domain II. However, it is not active against streptococci and staphylococci with constitutive macrolide, lincosamide, and streptogramin B resistance. Telithromycin, available in an oral formulation, is approved by the US Food and Drug Administration for use in adults for treatment of (1) community-acquired pneumonia due to Streptococcus pneumoniae (including multidrug-resistant isolates), Haemophilus influenzae, Moraxella catarrhalis, Chlamydia pneumoniae, or Mycoplasma pneumoniae; (2) acute exacerbation of chronic bronchitis due to S. pneumoniae, H. influenzae, or M. catarrhalis; or (3) acute bacterial sinusitis due to S. pneumoniae, H. influenzae, M. catarrhalis, or methicillin- and erythromycin-susceptible Streptococcus aureus. It is not approved for treatment of tonsillitis, pharyngitis, or severe pneumococcal pneumonia. Unique visual adverse effects occurred in 0.27%-2.1% of patients receiving telithromycin therapy. Its enhanced activity against some common respiratory pathogens makes it a valuable addition to the available macrolides.
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PMID:Telithromycin: a ketolide antibiotic for treatment of respiratory tract infections. 1588 65

Replidyne is developing faropenem medoxomil, the ester-type prodrug of faropenem, for the treatment of bacterial infections and respiratory tract infections, including acute exacerbations of chronic bronchitis (AECB), acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP). Faropenem medoxomil is also being developed for the treatment of tonsillitis, pharyngitis and otitis media in children. Faronpenem medoxomil was discovered by scientists at Suntory Institute for Biomedical Research (now Asubio Pharma). The compound has significantly improved oral bioavailability and is dehydropeptidase-I stable. Following absorption, faropenem medoxomil is rapidly hydrolysed to the active drug faropenem. An NDA was filed in the US but was deemed not approvable by the US authorities. Following the termination of the license agreement between Replidyne and Forest Laboratories, Replidyne is now exploring other partnering opportunities for faropenem medoxomil. Daiichi Suntory Pharma (now Asubio Pharma) has granted Replidyne the exclusive rights to faropenem medoxomil for the US and Canada and an exclusive option to develop and commercialize the compound in the rest of the world, excluding Japan. Replidyne has rights to the preclinical and clinical data generated up to the time of the agreement (August 2004) and will complete clinical development of the drug. Replidyne is also developing a paediatric formulation for the treatment of common bacterial infections. In February 2006, Replidyne sublicensed development, commercialization and distribution rights of faropenem medoxomil in the US to Forest Laboratories Holdings (Forest Laboratories). However, the agreement was terminated in February 2007, following the US FDA's non-approvable letter for the product. Replidyne re-acquired all US adult and paediatric rights previously granted to Forest. Bayer AG previously licensed exclusive worldwide rights to develop faropenem medoxomil from Suntory (now Asubio Pharma) and conducted a number of phase III clinical trials. This agreement appears to have been superseded by the agreement with Replidyne in 2004. In April 2007, Daiichi Asubio Pharma was renamed as Asubio Pharma Co., Ltd. Daiichi Asubio Pharma was the name used by Daiichi Suntory Pharma after it became a wholly owned subsidiary of Daiichi Pharmaceutical in September 2005. Daiichi Suntory Pharma was the joint venture company owned by Daiichi Pharmaceutical and Suntory. In April 2006, Daiichi Pharmaceutical merged with Sankyo to form Daiichi Sankyo Inc. The FDA issued a non-approvable letter in October 2006 for faropenem medoxomil in the treatment of ABS, CAP, AECB and uncomplicated skin and skin structure infections. Consequently, drug development has reverted back to phase III in the US. The agency has indicated that four phase III trials in three adult respiratory indications, ABS, CAP and AECB, will be required for a US marketing application. According to this advice, Replidyne may be required to conduct one superiority study (versus placebo) each for the ABS and AECB indications and two non-inferiority, active-controlled studies for the treatment of CAP. The required dose of faropenem medoxomil in future trials will be 600 mg, administered twice daily, and trials will involve approximately 1500 patients to ensure an acceptable database of safety information for review. Replidyne is continuing to work with the FDA on further trial details. Replidyne first filed the NDA seeking approval for faropenem medoxomil in December 2005. This submission marked the first marketing approval application for faropenem medoxomil worldwide. The NDA, which was accepted in February 2006, was primarily based on data from 11 phase III trials in patients with respiratory tract and skin infections; the safety data included information from more than 5000 patients treated with the drug. The proposed commercial name for faropenem medoxomil, Orapemtrade mark, was not approved by the FDA due to its similarity to another commercially approved drug. Replidyne and the FDA are working together to identify a suitable alternative. Two phase III trials have been conducted that demonstrated faropenem medoxomil was non-inferio o azithromycin and clarithromycin in the treatment of AECB. Replidyne's phase II trial evaluating an oral liquid formulation of faropenem medoxomil (7.5-40 mg/kg) in paediatric patients with acute otitis media (AOM), met its primary endpoint. The trial was completed in March 2007 and enrolled approximately 310 patients in Costa Rica and Israel. Replidyne intends to meet with the US authorities to discuss the design of the planned phase III trial in paediatric AOM. In addition to 5 years of Hatch-Waxman exclusivity granted upon approval, faropenem medoxomil is protected by an issued US composition of matter patent, which expires in 2015. Extension of exclusivity under Hatch-Waxman legislation is expected.
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PMID:Faropenem medoxomil: A0026, BAY 56-6854, BAY 566854, faropenem daloxate, SUN 208, SUN A0026. 1829 29