April 16, 2007 05:00 PM Eastern Daylight Time
FDA Approves Fast Track Designation for Naryx Pharma’s Product for
Chronic Sinusitis

SANTA BARBARA, Calif.--(BUSINESS WIRE)--Naryx Pharma, Inc. announced
today that the FDA has granted a request for Fast Track Designation of
SPRC-AB01, an antibiotic product being developed for the treatment of
chronic sinusitis in patients who have undergone previous sinus surgical
procedures.

Under the FDA Modernization Act of 1997, a new drug may be designated
“Fast Track” if the agency feels that the drug candidate has the
potential to address an unmet medical need by treating a serious or
life-threatening condition. Naryx is now eligible to submit a New Drug
Application (NDA) on a rolling basis and may apply for expedited review
of its NDA.

In its response to Naryx’s application, The Division of Anti-Infective
and Ophthalmology Products acknowledged that chronic sinusitis that
persists after sinus surgery has an enduring adverse impact on the
day-to-day functioning of patients who suffer from the condition.
Moreover, there are no currently approved medical therapies for the
treatment of chronic sinusitis in post-surgical patients, and
information from clinical trials suggests that SPRC-AB01 relieves the
symptoms of chronic sinusitis in these patients.

Robin Campbell, Ph.D., President and CEO of Naryx Pharma, stated, ”Over
30 million people in the U.S. are diagnosed with chronic sinusitis and a
substantial proportion continue to have problems even after attempts at
surgical correction. We are pleased that the FDA has recognized that
chronic sinusitis that persists after sinus surgery is a serious
disease, and that SPRC-AB01 has the potential to address an unmet
medical need.”

Naryx Pharma is currently conducting a Phase 2b study comparing
SPRC-AB01 to placebo in this population of patients. More information
about the study, including clinical study sites, can be obtained at
www.naryxpharma.com/ft.

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[
From their website
http://www.naryxpharma.com/about/overview.html

it appears that this new antibiotic is administered via nasal inhaler
rather than orally.
]