Wednesday, October 27, 2004

FDA ISSUES APPROVABLE LETTER FOR ASTHMA DRUG ALVESCO

Altana AG and the Sanofi-Aventis Group received an approvable letter from the Food and Drug Administration for the pharmaceutical brand name drug, Alvesco (ciclesonide), which is a inhaled corticosteroid drug.

The firms are seeking approval of Alvesco for the treatment of persistent asthma, regardless of severity, in patients aged 4 years or older.

A pharmaceutical industry source cited by Reuters said the FDA requested more data on Alvesco. The firms did not release details of the FDA request.

If Alvesco gains FDA approval, it could attain peak annual sales of $1.27 billion, according to Reuters. Altana and Sanofi-Aventis would jointly market the drug in the United States, with Altana supplying Sanofi-Aventis with the drug.

The firms submitted the New Drug Application for Alvesco in December of last year. Also in December, Aventis initiated a 12-month, Phase IIIb trial to further evaluate the safety and tolerability of high-dose Alvesco in adults with moderate to severe asthma.

Tuesday, March 23, 2004

AVENTIS' ALVESCO, PLACEBO PRODUCE SIMILAR SIDE EFFECTS IN ASTHMA PATIENTS, DATA INDICATE

Aventis SA's pharmaceutical brand name drug, Alvesco (ciclesonide), is well tolerated and produces similar mouth-and-throat-related side effects as placebo among patients with mild to moderate asthma, according to data presented in San Francisco at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

Researchers conducted two identical Phase III trials, in which patients with mild to moderate asthma were randomized to receive Alvesco 80 micrograms, Alvesco 160 mcg, Alvesco 320 mcg or placebo daily for 12 weeks.

Composite results from the two studies showed that 85.2 percent of patients who received Alvesco completed the 12-week trial compared with 66.7 percent of placebo-treated patients.

Additionally, oral candidiasis was detected in 1.2 percent of patients treated with Alvesco 80 mcg, no patients receiving Alvesco 160 mcg patients and 1.6 percent of patients who received Alvesco 320 mcg compared with 0.4 percent of placebo recipients. Pharyngitis, or sore throat, was experienced by 5.4 percent of Alvesco 80 mcg-treated patients, 4.0 percent of Alvesco 160 mcg-treated patients and 5.1 percent of patients who took Alvesco 320 mcg compared with 5.2 percent of placebo-treated patients.

"Inhaled corticosteroids are first-line therapy for all severities of persistent asthma, but patient tolerability and side effects like oral and throat infections can limit their use," noted Dr. William Berger, clinical professor in the allergy and immunology division of the University of California's College of Medicine.

Aventis has submitted a New Drug Application to the Food and Drug Administration for Alvesco to be used as a treatment for persistent asthma, regardless of severity, in adolescents and children aged 4 years or older.

In 2001, Altana Inc. entered into an agreement with Aventis to co-market Alvesco in the United States.