<table cellspacing="0" cellpadding="0" border="0" ><tr><td valign="top" style="font: inherit;">
<p><font color="black" size="2" face="Arial"><span style="font-size: 9.5pt; color: black; font-family: Arial;">May 11,
2009</span></font></p>
<p><strong><b><font color="black" size="2" face="Arial"><span style="font-size: 9.5pt; color: black; font-family: Arial;">FDA Approves New
Drug to Treat Cushing’s Disease in Dogs</span></font></b></strong><font color="black" face="Arial"><span style="color: black; font-family: Arial;"></span></font></p>
<p><font color="black" size="2" face="Arial"><span style="font-size: 9.5pt; color: black; font-family: Arial;">The Food and Drug
Administration announced today the approval of Vetoryl (trilostane) Capsules,
a new drug for the treatment of pituitary-dependent and adrenal-dependent
hyperadrenocorticism, commonly known as Cushing’s disease. Vetoryl, a
new molecular entity, is the first drug approved to treat both pituitary- and
adrenal-dependent Cushing’s disease in dogs.
</span></font></p>
<p><font color="black" size="2" face="Arial"><span style="font-size: 9.5pt; color: black; font-family: Arial;">Cushing's disease
is a condition that results when the body produces too much cortisol.
Cortisol is normally released during times of stress. The level of
cortisol produced in dogs with Cushing’s disease is excessive and, if left
untreated, becomes incapacitating. Vetoryl acts to block production of
cortisol, produced by the adrenal glands. The disease is a complicated
and slowly developing one, and the early signs are not always noticed.
Symptoms include increased drinking, increased urination, increased appetite,
reduced activity, excessive panting, thin or fragile skin, hair loss,
recurrent skin infections, and enlargement of the abdomen.
</span></font></p>
<p><font color="black" size="2" face="Arial"><span style="font-size: 9.5pt; color: black; font-family: Arial;">Safety and
effectiveness were supported by two field studies in the United Kingdom (U.K.)
and one multi-center field study in the United States (U.S.). Success
was measured by improvements in both ACTH stimulation test results and
clinical signs (appetite, activity, panting, thirst and urination).
</span></font></p>
<p><font color="black" size="2" face="Arial"><span style="font-size: 9.5pt; color: black; font-family: Arial;">The most comment
adverse reactions were vomiting, lethargy, diarrhea, and
anorexia.</span></font></p>
<p><font color="black" size="2" face="Arial"><span style="font-size: 9.5pt; color: black; font-family: Arial;">Vetoryl is
manufactured by Penn Pharmaceuticals,
Wales and distributed by Dechra Veterinary
Products, Overland Park ,
KS .
</span></font></p>
<p><font color="black" size="2" face="Arial"><span style="font-size: 9.5pt; color: black; font-family: Arial;">For additional
information, please see <a rel="nofollow" target="_blank" href="http://www.fda.gov/cvm/FOI/141-291o120508.pdf">http://www.fda.gov/cvm/FOI/141-291o120508.pdf</a>
and <a rel="nofollow" target="_blank" href="http://www.fda.gov/consumer/updates/cushings051109.html">http://www.fda.gov/consumer/updates/cushings051109.html</a>.</span></font></p></td></tr></table><br>