From the TMS Board > Board News > 2004 Board News > The Zyflo Situation

The Zyflo Situation

May 1, 2004

- Valerie Slee, Co-Chair, Board of Directors
- Rita Barlow, Chair, Board of Directors

We were greatly distressed to find out that Abbott Pharmaceuticals discontinued production of Zileutin™ last summer. We were only made aware of it in January 2004 as the available supply had run out and our prescriptions could be filled.

Many of us are very dependant on Zileutin (Zyflo)™ for quality of life. The other leukotriene inhibitors, Singulair™ and Accolate™, do not inhibit the production of 5-lipooxygenase, which Zileutin™ does. That seems to be critical for many of us with Systemic Mastocytosis and Mast Cell Activation Disorder, with and without Urticaria Pigmentosa, although we do not know why.

We are aware that Zileutin™ is not a cure or single drug therapy for Mast Cell Disease, but rather a very useful form of adjunct therapy that has dramatically improved quality of life for some of our members. Many of us are on multiple doses of many drugs daily just to maintain life, and Zyflo™ was one that greatly stabilized some of us. Many Mast Cell Disease patients are all extraordinarily ill and day-to-day life can be a constant challenge for us.

We believe that Zyflo™ has the potential to help many more of us, but it was not marketed for Mast Cell Disease, and many physicians were reluctant to prescribe it. We were told by Abbott that a small biotech company in Cambridge, Massachusetts, called Critical Therapeutics, purchased some forms of Zileutin™ and plan to develop the drug to take it to market. Subsequently, we met with Rick Finnegan, VP of Sales and Marketing for Critical Therapeutics, who has been enormously helpful to us. They hope to have Zileutin™ in clinical trials by September, and hope to submit the drug to the FDA for approval by late 2004, so the drug potentially could be available to us again in 2005. We have also been in contact with the FDA, various mast cell physicians and researchers, and Hillary Clinton about this matter.

We will continue to keep you informed of progress with the Zyflo™ situation.