Washington Editor

Genentech Inc. and partners Tanox Inc. and Novartis Pharma AG said late Friday the FDA approved Xolair, a first-in-class monoclonal antibody for moderate to severe persistent asthma in adults and adolescents.

The drug is expected to be available in July, and also is expected to be one of the highlights of a press conference Genentech has scheduled this morning at the Biotechnology Industry Organization annual convention in Washington.

Xolair, which targets the IgE antibody, is indicated for adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

"Genentech has a long history of innovating first-in-class biologics and pioneering unique approaches to disease management," said Arthur D. Levinson, Genentech's chairman and CEO. "Xolair is a significant advance in the evolution of asthma therapy and its approval is a milestone event in bringing biologic therapies to new markets and meeting an unmet need for patients with asthma mediated by IgE."

For Genentech, the news continues a hot streak, as last month the South San Francisco-based company reported that its anti-angiogenesis product Avastin provided benefit that "far exceeded" what the study was designed to demonstrate in a Phase III metastatic colorectal cancer trial. (See BioWorld Today, May 20, 2003.)

On release of the Avastin news, Genentech's stock (NYSE:DNA) soared 44.7 percent, or $16.95, to close at $54.85. The company's stock has been climbing ever since, closing Friday at $74.32, up 25 cents.

The decision on Xolair came a little more than a month after the FDA's Pulmonary-Allergy Drugs Advisory Committee voted unanimously in favor of the drug, saying Genentech's data demonstrated a favorable risk-benefit for the use of Xolair as a means of reducing asthma exacerbation rates and controlling symptoms of the illness. (See BioWorld Today, May 16, 2003.)

Xolair will be the first IgE blocker and the first biologic therapy for the treatment of moderate to severe asthma, and according to Genentech, the first asthma product to be administered every two or four weeks.

The product was developed with Novartis, of Basel, Switzerland, and Tanox, of Houston. Officials at Genentech would not discuss the price of Xolair. However, analysts speculate the cost will be $7,500 to $10,000 per year per patient, generating about $600 million at peak (year 2008) in allergic asthma.

Regarding its partners, Genentech and Novartis have kept mum about financial details of their agreement, except to say the companies will share development costs. The relationship with Tanox actually rose from a dispute over breach of contract and patent infringement dating back to 1993. The companies settled by combining resources and entering a three-way deal. (See BioWorld Today, Oct. 18, 2002; July 11, 2001; and July 10, 1996.)

Tanox will receive a 10 percent royalty on U.S. and European sales. It's also been reported that Protein Design Labs Inc., of Fremont, Calif., will receive about a 3 percent royalty. Novartis and Genentech will co-promote Xolair in the U.S., where each will have a sales force. Novartis will market it outside the U.S. Novartis received approval of Xolair in Australia, but withdrew its European application in favor of submitting more data. The application is expected to be resubmitted in the first half of 2004.

The biologics license application for Xolair included efficacy data from two pivotal Phase III trials that enrolled in excess of 500 patients each, ages 12 to 75. The smaller of the two, Study 008, evaluated moderate to severe allergic asthma that was uncontrolled despite treatment with inhaled corticosteroids and frequent use of beta-agonist rescue medication. Study 009 evaluated moderate to severe persistent allergic asthma that was uncontrolled despite treatment with inhaled corticosteroids and frequent use of beta-agonist rescue medication.

In clinical trials alone, Xolair has been tested in about 6,000 people. Adverse events associated with the trials included viral infections, sinusitis, upper respiratory infection and headache. Also, in advance of the panel meeting, several reporters and analysts made an issue of an increased malignancy rate found in an FDA review of the trials. Panel members said there was no evidence that cancer was related to Xolair.

The companies filed the BLA in June 2000 requesting approval in asthma and seasonal allergic rhinitis. After a 12-month review process, the FDA requested additional safety data, which the companies provided. On submitting the additional information, the companies dropped seasonal allergic rhinitis as an indication. (See BioWorld Today, Dec. 20, 2002; July 11, 2001; and June 6, 2000.)