FDA Alert: TNOX, DNA, NVN, CRDM

Tanox
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, Genentech
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, and Novartis
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When the FDA speaks, the investment community and companies listen.
It soon will be time for the FDA to meet, speak, and decide the fate of
several new products. The first
opportunity arrives next week.

On May 15, the FDA’s
Pulmonary-Allergy Drugs Advisory Committee (PADAC) will review the Biologics
License Application (BLA) for the new asthma drug Xolair.
Xolair is being developed and marketed by Tanox
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, Genentech
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, and the
pharmaceutical giant Novartis
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.
Xolair is a new approach to treat asthma in adolescents and adults.
It is a monoclonal antibody (anti-IgE) to the naturally occurring
antibody IgE. IgE normally is involved in
promoting the acute inflammatory response that often mitigates an allergic,
asthma attack. By blocking this antibody
in the body, Xolair mutes the inflammatory response and minimizes (or prevents)
an acute asthma attack. The clinical data
already made public does show that Xolair can prevent asthma attacks and
minimize the acute hospitalizations that result from asthma attacks.
In addition, Xolair has also shown to reduce the complications of asthma
and reduce the steroid use in many asthma patients.
The drug does work and potentially can lead to the long-term savings of
millions of healthcare dollars. 

Xolair has been in the news in the past and does have a history.The
initial BLA was filed with the FDA back in 2000.
In July 2001, the FDA sent back a complete response letter asking for
additional efficacy and safety data. At
the time, Xolair was submitted for the treatment of children as well as adults.
This broad application spooked the FDA and they balked at the children
population. This was a setback for all
three companies. However, they wised up
and dropped the children from their application and are now aiming at the
adolescent/adult population.

An additional clinical data
amendment was submitted last December and now the FDA Advisory Panel is ready to
make a decision. This decision has all
the earmarking of short-term volatility. We
have a novel drug aimed at a very large target disease, asthma (over 17 million
patients in US). This drug could generate
substantial revenue over time because it is expensive and has to be chronically
administered in order to maintain its efficacy.

Of all the three companies
involved, Tanox will probably bear the brunt
of the volatility on decision day. The
company has had a nice run since mid-February in anticipation of this decision
and I suspect it has more to go once the decision is made.
Overall, Xolair has a good chance of getting a positive recommendation
from the FDA Advisory Panel because the presenting companies have learned their
lesson. In addition to the day of the
decision, trading may also be halted the day before.

Cardima
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This small medical-device company is in the heart catheter business and about to
go in front of the FDA. On May 29, the
agency’s Circulatory System Devices Panel will decide whether to approve
Cardima’s new catheter technology. The
company has developed a minimally invasive catheter system (Revelation) designed
to treat a specific arrhythmia of the heart called atrial fibrillation (afib). 

Atrial fibrillation is a common
disease of the elderly and involves an asynchronous beating of the two chambers
of the heart. The top chamber, called the
atrium, is unable to beat normally in this condition.
The disease can lead to heart attacks, congestive heart failure,
hypotension, blood clots, and stoke. It
is usually treated initially with medication, often blood thinners.
Unfortunately, some of the side effects of the medication can be
troublesome (abnormal bleeding) and in the long run, drugs may not even work.

There is an invasive operation
preformed by cardiac surgeons (the Maze Procedure) that is effective in patients
not responding to medication. However,
the operation itself is risky and can be associated with morbidity and
mortality. The surgery involves splitting
the sternum (breastbone), opening up the atrium of the heart, and destroying the
abnormal electrical pathways causing the atrial fibrillation. 
Yes, this sounds very invasive, risky, and it is.
Cardiologists do shy away from sending patients for this operation
because it is such a stress on the human body. The
traditional Maze Procedure is a last resort. 

On the other hand, Cardima has developed a microcatheter system that will
allow invasive cardiologists to potentially mimic the effectiveness of the Maze
Procedure but minimize the risk to the patient. There
is no spitting of the sternum, no putting the patient on an open-heart bypass
machine. Once inside the atrium,
cardiologists potentially will be able to map out, identify, and destroy the
abnormal heart tissue responsible for the atrial fibrillation.
It is a minimally invasive approach to treat a growing disease market.
The hope is to minimize the risk to patients, treat their atrial
fibrillation, and get them off the potentially complicating blood thinner
medication.

It all sounds great and
cardiologists would love to have this option available to their patients.
The studies made public so far do show that the micocatheter system is
safe and can lead to successful treatment in a certain percentage of patients
(47% of patients had no afib after six months). Despite
this, I do like the company’s chances of getting their technology approved.
From what I have seen, the technology is safe and there is a niche need
for a minimally invasive approach to treat atrial fibrillation.
Despite the not so convincing data, a group of heat patients can benefit
from this technology because an actual open-heart operation carries too much
risk. The stock is currently selling
under $2/share and will spike, once the decision comes down

Good Luck,

Paul Ruggieri, MD