New Prescription Pain Treatment Completes European Mutual Recognition Procedure

May 16, 2006

New Prescription Pain Treatment Completes European Mutual Recognition

Procedure

JURNISTA prolonged-release tablets (Hydromorphone HCl), a new

prescription treatment for severe pain, has successfully completed

the Mutual Recognition Procedure in Austria, Czech Republic, Estonia,

Finland, Germany, Hungary, Italy, Latvia, Lithuania, Norway,

Portugal, Slovak Republic, Slovenia and Spain. The countries mutually

agreed to recognize the approval of JURNISTA granted by the Reference

Member State, Denmark.

JURNISTA was developed by ALZA Corporation and utilizes the OROS®

Push-Pull delivery system to release the opioid hydromorphone at a

consistent rate. It will be registered and marketed by Janssen-Cilag

companies in Europe. ALZA and Janssen-Cilag are affiliates of

& .

As with all opioid analgesics, hydromorphone exerts its

pharmacological effects by binding to specific opioid receptors

predominantly located in the central nervous system. Following oral

dosing of JURNISTA, data show that hydromorphone hydrochloride is

released continuously for 24 hours. The continuous release of

hydromorphone results in relatively consistent plasma concentrations

for approximately 24 hours post-dose. JURNISTA will be available in

four dosage strengths - 8 mg, 16 mg, 32 mg and 64 mg prolonged-

released tablets.

In clinical trials with JURNISTA, the most commonly reported adverse

reactions were constipation, nausea, and vomiting. These symptoms are

common with opioid analgesics and can usually be managed by

laxatives, antiemetics, or dose reduction, as needed.

ALZA Corporation is leading the next generation of drug delivery,

with the world's broadest array of technology platforms, including

oral, transdermal, implantable, and liposomal technologies. More than

30 products marketed in over 80 countries worldwide now incorporate

ALZA's drug delivery technologies.

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