My ipx066 trial has two weeks left. The drug has significantly improved the quality of my life with Parkinson’s. It has a compounding effect in that I am able to exercise more which has provided further relief. I am not looking forward to being forced to stop taking ipx066.
In April, I received the following reassurance from Impax.

Dear Doug,



An additional study to allow continued use of IPX066 beyond study PX066-B09-03 is in the advanced planning stage. Please stay in contact with your current trial site for details.



Best regards,

Jeff



Jeff Mulchahey, PhD

Senior Director, Regulatory Affairs

IMPAX Pharmaceuticals,

A Division of IMPAX Laboratories, Inc.

31047 Genstar Road

Hayward, California 94544

USA





In May, the following was announced by Impax.



Our internal work on the new open label extension study was put on hold while our Senior Management reviewed our projects, resources and budgets.

Today we learned that we will not be moving forward with this study.

We will, however, be working diligently to submit our NDA [Impax’s request for FDA approval of the study drug so it can be made available to the public] this year so that IPX066 will be available to patients once it is approved.

We appreciate all of your efforts on our studies and know that this will be disappointing to your study staff and the patients.”

In July, MJFF announced the following.

Michael J. Fox Foundation awards Impax $400,000 grant for research of IPX066 for Parkinson’s disease
Published on July 14, 2011 at 9:25 AM · No Comments




Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), has been awarded funding of up to $400,000 by The Michael J. Fox Foundation for ongoing clinical research of the Company's investigational carbidopa-levodopa extended release (CD-LD ER) product IPX066, which is intended to treat the motor symptoms of Parkinson's disease (PD).

“One of our priorities is to improve symptomatic treatments for patients today”

The funding will support a planned dosing conversion study of CD-LD ER to IPX066, to be followed by an open-label extension safety study of IPX066 in subjects with advanced PD.

"One of our priorities is to improve symptomatic treatments for patients today," said Brian Fiske, Ph.D., director of research programs at the Michael J. Fox Foundation. "IPX066 holds promise as a potentially useful future treatment option for PD. By collaborating with Impax Pharmaceuticals to develop additional clinical data about IPX066, we hope to gather important information for physicians treating PD and their patients."

"We appreciate the support and recognition of The Michael J. Fox Foundation as we further advance the development of IPX066 for Parkinson's disease," said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc.



This August, I called Dr. Mulchahey at Impax. He did not return my call. I emailed - no response.

Please forward this email to Brian Fiske, Ph.D., director of research programs at the Michael J. Fox Foundation.

I wish to ask him if he knew that his stated priority,
“One of our priorities is to improve symptomatic treatments for patients today”
does not appear to be a priority of Impax to whom he awarded $400,000.

Thank you for your time. Please forward to someone who can help.
As Davis Phinney states “Every victory counts”
Thank you for helping turn this defeat into a victory!

Sincerely,
Doug Manuel
253-858-8741