**Statement by Steven Ainbinder, MD**

**1476 Romanesca Drive**

**Henderson, NV 89052-5532**

**(702) 914-8108**

s@ainbinderinc.com

**To the Food and Drug Administration Pulmonary-Allergy Drugs Advisory
Committee**

**Re: BLA 103976, XOLAIR Omalizumab (Humanized Monoclonal Antibody to
Human IgE) for the treatment of allergic asthma**

**May 15, 2003**

**Holiday Inn**

**The Ballrooms**

**Two Montgomery Village Avenue**

**Gaithersburg, MD**

Good afternoon. My name is Dr. Steven Ainbinder. I am here today from
Henderson, Nevada. Thank you for allowing me to testify on my experience
with the benefits of Xolair. My comments are on my own behalf, though
the Asthma and Allergy Foundation of America has helped make my presence
here today possible. I would like to also introduce you to my wife,
Ivana, who has been beside me during the worst of my asthma attacks---I
frankly don't think I would be here today without her love and support.

I am 32 years old and was diagnosed as a steroid-resistant severe
asthmatic a little over three years ago. This came very much as a
surprise since my childhood asthma had resolved itself to mild
intermittent asthma by age 14. I thought my condition was well under
control.

At the time of my new diagnosis, I was working to complete my
postdoctoral training at the UCLA Medical Center in Los Angeles, CA, and
looking forward to a fellowship in surgical gynecology. I was working
about 100 hours each week, and to burn off some steam, I used to try to
run about 5 miles in the evenings.

In August 1999, after one such run, I began wheezing uncontrollably and
ended up in the emergency room. I was diagnosed with severe asthma. Two
weeks later, I experienced a pneumothorax (I blew out a part of my lung)
and ended up back in the hospital. Although now I was certain to believe
more in the severity of my condition, I still tried to not let it slow
me down. I continued in my medical residency for about another year. My
colleagues in the operating room had to help me use my inhaler from time
to time under my mask while I was performing surgery. In November of
2000, after a few run-ins with near death, the Chairman of my Department
at UCLA and my wife convinced me that the smartest thing was to take a
brief sabbatical.

Well, 1 month turned in to 3 months turned in to half-a-year and all of
a sudden it became clear I could not go back to work anytime soon. Here
I was in the prime of my life, with a job I loved dearly...and I had to
quit. It was a very difficult thing to do. I'm a trained physician. My
father is a physician. I was seen by the best and the brightest doctors
available---by allergists, immunologists, endocrinologists, and
rheumatologists. Nothing helped. I had all the access anyone might need
to good medicine, yet no product existed that would help me with my
steroid-resistant asthma.

That doesn't mean, of course, that I wasn't on a variety of medicines
every day. My daily regimen included Medrol, Desloratadine, Formoterol
Fumerate, Levolalbuterol, Ipratopium Bromide, two nebulizations, and
KCL. My asthmatic attacks were precipitated by pruritic macular and
target-shaped lesions that started on my hands and feet. I was
hospitalized for my condition about once a month. Without work (I was
considered legally disabled) and having to deal with the physical side
effects of these serious medications, my psychosocial existence and well
being was crumbling.

In August 2001, my physician recommended the randomized clinical trial
for Xolair. Being a physician myself and having published some articles
in immunology, I did my due diligence prior to joining the trial and was
intrigued by the drug's mechanistic approach.

The results were incredible. Within one month of joining the trial, my
Medrol medication was reduced from between 40-60 mg daily to about 6 mg.
My symptoms dramatically improved, my spirometry significantly improved;
I was never hospitalized during the six-month trial, and my rash
disappeared. My quality of life was also greatly enhanced. Within a
month, I was thinking better, reacting better and increasing my level of
activity.

Unfortunately, after the clinical trial ended in April 2002, my symptoms
returned and I was again extremely limited in my functionality and
ability to control my disease. Then, in September 2002, I was fortunate
to again have access to Xolair as part of a clinical trial extension.
This time around, my daily steroid dose of Medrol was reduced to 4 mg
per day and again, my symptoms, spirometry, and atopy all improved
dramatically and I didn't have to be hospitalized. After the extension
trial ended, though---about six weeks after my last injection with
Xolair in February 2003---I ended up in the hospital emergency room with
an epinephrine drip. My symptoms returned and my daily steroid dose was
back up to its previous level. Finally, about two weeks ago, I was
approved to receive the drug through the company's compassionate care
program and am once again feeling much, much better.

As a patient with severe asthma, as a medical doctor, as a scientist and
as a husband, I urge the FDA to approve Xolair. As a physician and
scientist, my main message here today is that asthma is truly a
heterogeneous disease. In fact, before I was diagnosed with
steroid-resistant asthma, I had never even heard of it. I am extremely
curious as to how many of the approximately 5,000 deaths in asthma each
year are due to steroid resistance? We are learning more and more each
day about Beta-2 receptor resistance and how bronchial inflammation
comes into play with asthma. The role of an immunoglobulin in the
treatment of this disease is a remarkable scientific achievement and
medical advancement.

As a patient and a caring husband, I ask that FDA approve Xolair because
it is the only drug that helps me---my life depends on it. Its approval
will help me and others like me get back to the business of living
productively and doing the things they love to do.

Thank you for your time.