>> Xolair Is the Better Drug for Peanut Allergy Therapy
May 19, 2005
We are writing to express our disappointment and strong exception to your page-one article "Silent Treatment: How Genentech, Novartis Stifled a Promising Drug" (April 5). The article included an incomplete discussion of the scientific facts regarding the development of a potential therapy for peanut allergies. Because science is at the center of our efforts to develop a treatment for peanut allergy, the article's neglect of some important facts had the potential to be misleading to your readers.
Genentech, Novartis and Tanox together strived to identify the most promising medicine that could be brought to patients with peanut allergies most rapidly. The fundamental question was simply, what was the best way to develop an effective treatment for patients suffering from peanut allergy quickly and safely?
Two similar compounds with an identical mechanism of action -- Xolair, which was on the market, and TNX-901, in early development -- were considered as potential drug candidates to treat peanut allergy reactions. Because Xolair was already on the market and TNX-901 would require many years of development activities, Xolair was chosen as the most promising project.
It is imperative that we conduct the right trials to determine safety and efficacy. Xolair already has a record of safety and efficacy based on trials involving more than 6,000 patients as well as physician prescriptions for more than 40,000 patients. TNX-901 did not have a similar patient database. Secondly, Xolair already had a well-developed, FDA-approved manufacturing process and was on the market for a different indication. Therefore, the best way to move forward as quickly as possible for treating peanut allergies was to focus the trial program on Xolair.
Genentech, Novartis and Tanox have always focused on bringing innovative medicines to patients as quickly as possible, and we have kept this mission at the center of our efforts in developing a treatment for peanut allergies.
Susan Desmond-Hellmann, M.D. President, Product Development Genentech South San Francisco, Calif.
James Shannon, M.D. Global Head, Clinical Development & Medical Affairs Novartis Pharma AG Basel, Switzerland
>> By DAVID P. HAMILTON Staff Reporter of THE WALL STREET JOURNAL January 16, 2006
Genentech Inc. stopped a clinical trial of a drug it hopes can be used to prevent peanut-allergy reactions, citing safety concerns not with the drug itself but with an allergy test.
The South San Francisco, Calif., biotechnology company said two children in the 150-person trial experienced "severe hypersensitivity reactions" when given a trace amount of peanut protein, an initial step designed to gauge the severity of a patient's allergies. Neither child had received the drug, called Xolair, the company said. Xolair is on the market, approved as a treatment for allergic asthma.
"We had always been very nervous about that study," said Susan Desmond-Hellmann, head of product development for Genentech. "We are not going to do that anymore."
Cancellation of the Xolair trial means that an approved treatment for peanut allergy remains years away at the earliest. Dr. Desmond-Hellmann said Genentech may explore the possibility of moving straight to a large-scale trial that wouldn't involve a peanut "challenge," as the allergic-reaction test is called. Instead, such a trial might track volunteers over an extended period of time, to determine if those receiving Xolair experienced fewer accidental peanut reactions than those taking a placebo.
"It's going to take a long time, and it's going to be hard work, but it's better than exposing someone we know to be allergic" to peanuts, Dr. Desmond-Hellmann said.
The setback is the latest delay in a long and fitful effort to find a drug that can blunt the serious consequences of peanut allergy. The condition, which affects an estimated 1.5 million Americans, can lead to life-threatening anaphylactic shock if allergic individuals ingest even a trace amount of peanut flour or oil. In November, a 15-year-old Canadian girl with the allergy died reportedly after a kiss from her boyfriend, who had earlier eaten a peanut-butter snack.
Several years ago, a drug called TNX-901 from a Houston biotechnology company called Tanox Inc. appeared to reduce peanut sensitivity in a similar clinical trial of allergic individuals. But Tanox's corporate partners, Genentech and Novartis AG, objected to continued development of the drug, wanting to focus on Xolair instead. After years of legal tussles, Tanox agreed to shelve TNX-901 in early 2004. The decision to shelve Tanox was the subject of a page-one article last year in The Wall Street Journal.
The three companies next agreed to test Xolair as a possible peanut-allergy treatment. The clinical trial was similar to the earlier test of TNX-901, and some researchers had anticipated that it might produce results later this year. Volunteers, however, were slow to sign up, Genentech officials said. <<
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