Aventis' promotional message for Ketek will center on the antibiotic's ability to specifically target all pathogens commonly associated with respiratory tract infections without affecting other bacterial strains.

FDA approved Ketek April 1 for use in patients ages 18 and older for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and mild-to-moderate community acquired pneumonia, including infection caused by multi-drug resistant Streptococcus pneumoniae.

Ketek (telithromycin) is the first approved agent in the ketolide class of antibiotics, which specifically target mild-to-moderate community-acquired respiratory tract infections.

Aventis said it plans to highlight in physician detailing that Ketek covers the complete spectrum of pathogens that cause infection in the respiratory tract, including resistant strains, and targets only pathogens in that tract.

Ketek's targeted activity means that the antibiotic has a lower propensity to promote resistant bacterial strains, Aventis added.

Ketek will primarily compete against Pfizer's Zithromax (azithromycin), which is the market leader, GlaxoSmithKline's Augmentin (amoxicillin) and Abbott's Biaxin (clarithromycin).

Aventis said its sales rep counter-detailing efforts will highlight that macrolide antibiotics, such as Zithromax, Augmentin and Biaxin, do not adequately target multi-drug resistant strains of Streptococcus pneumoniae, while quinolones, such as Bayer's Cipro (ciprofloxacin), cause resistance due to their non-specific activity.

The company has also designed Ketek's packaging to directly compete with Zithromax'. Like the Pfizer product, which is packaged in "Z-Paks," Aventis will supply telithromycin 400 mg tablets in blister packs that carry the trade name "Ketek Pak."

Each blister will contain a full Ketek dose of two 400 mg tablets. Aventis will also supply 400 mg tablets of Ketek in 60-count bottles.

Aventis plans to have Ketek on pharmacy shelves by the end of July. The slightly delayed launch is designed to coincide with the start of the fall respiratory season (¹ Also see "Aventis Plans To Launch Genasense, Ketek and Apidra In 2004" - Pink Sheet, 19 January, 2004., p. 24).

A late summer launch may also allow sales reps to begin detailing Ketek with an FDA-approved promotional aid.

Aventis said it expects Ketek to be the most successful antibiotic launch in U.S. history.

The company believes telithromycin will generate peak global sales of $1.5 bil. Worldwide sales of Ketek totaled 115 mil. euro in 2003. Aventis said the agent's U.S. pricing will be "competitive" with other oral solid-dose antibiotics.

Aventis has pointed to Ketek's sales potential in defending itself from Sanofi-Synthelabo's hostile takeover bid. The company has maintained that Sanofi's $60 bil. bid overlooks the value of such products as Ketek, the oncologic Genasense and the inhaled insulin product Exubera (² Also see "Aventis Defense Against Sanofi: Strong Pipeline Or Irrational “Exubera-nce”?" - Pink Sheet, 9 February, 2004., p. 22).

Aventis said it has agreed to three postmarketing commitments: pediatric use studies in acute bacterial sinusitis and CAP, and a report on postmarketing vision-related adverse events globally.

Ketek has had a long history at FDA. Aventis submitted the NDA in March 2000; in April 2001, FDA's Anti-Infective Drugs Advisory Committee concluded efficacy had been established in CAP but called for more safety data (³ Also see "Aventis Ketek CAP Resistance Claim Needs Larger Trials, Advisory Cmte. Says" - Pink Sheet, 30 April, 2001., p. 4).

FDA issued an "approvable" letter in June 2001. In response, Aventis submitted data from a 24,000-patient "usual care" study on the drug's safety (⁴ [A#00640250023], p. 33).

In January 2003, FDA's advisory committee recommended approval of Ketek for all three indications (⁵ Also see "Aventis Ketek Recommended For Pneumonia, Sinusitis, And Bronchitis" - Pink Sheet, 13 January, 2003., p. 13). FDA subsequently issued a second "approvable" letter requesting additional analyses of clinical data and postmarketing surveillance. Aventis responded Oct. 17, 2003 (⁶ 'The Pink Sheet' Oct. 27, 2003, In Brief).

Aventis Ketek July Launch Will Highlight Targeted Antibacterial Activity

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