http://www.reuters.com/articlePrint?...15704120080320
UCB recalls Parkinson's patch, reviews 2008 outlook
Thu Mar 20, 2008 12:20pm EDT

By Philip Blenkinsop

BRUSSELS (Reuters) - Belgian drugmaker UCB said on Thursday it was recalling its Parkinson's patch Neupro in the United States and some batches from Europe, prompting a review of its 2008 forecast.

UCB shares dropped as much as 18.4 percent to 21.60 euros, their lowest level since August 2003, as investors took a dim view of the latest in a series of setbacks to hit the group.

This month, U.S. health officials warned its prescription cough medicine Tussionex could be fatal for young children if taken frequently, though it is not approved for those aged under six.

UCB has also yet to convince regulators its would-be blockbuster Cimzia should be cleared for treating the bowel disorder Crohn's disease. The European Medicines Agency on Thursday reaffirmed its view that Cimzia should not be approved.

Last year, UCB achieved net sales of 52 million euros ($81.7 million) from Neupro, a relatively new product.

"Depending on the resolution timeline of this issue, the full effect on UCB's business is not yet known. Therefore, UCB's 2008 financial outlook is under review and will be updated as soon as possible," the company said in a statement.

UCB said the recall decision was not the result of contamination or toxicity but that the clinical performance of some samples on the market was not as required.
"As a result, there will be an out-of-stock situation with Neupro in the United States in late April 2008. In the European Union and most other regions, Neupro supply is sufficient," it continued.

A spokeswoman said it was not clear how long UCB would be out of stock in the U.S. and likewise when it would be able to give a new 2008 outlook.

KBC Securities said in a research note it had reduced its forecast for Neupro sales this year to 88 million euros from 110 million, as well as its peak annual sales estimates and cut its target price to 33.50 euros from 35.00 euros.

"This disruption comes at a crucial time in the launch phase of this important franchise," Deutsche Bank wrote, adding Neupro's launch for restless legs could be significantly delayed by regulators' insistence that quality problems be resolved.

Neupro, delivered to patients in the form of patches stuck on the skin, is approved to treat early-stage Parkinson's in the U.S. and early and late stages of the disease in Europe.

The patches were launched in Europe in 2006 and in the U.S. in July 2007.

It filed for approval to treat restless legs syndrome in the United States and Europe in December.

UCB last month forecast revenue would decrease to about 3.4 billion euros in 2008 from 3.6 billion last year. Recurring core profit (EBITDA) would be about 650 million euros and net profit was expected to exceed 100 million.

(Additional reporting by Ben Hirschler in London, editing by Will Waterman and David Hulmes)

© Reuters 2007. All rights reserved.

This is amazing. And doesn't tell the whole story. What do they mean? Were their efficacy measurements off? Was there a mistake in the formula? This will affect thousands globally. How many years are we looking at here until it returns? if it returns.

15 years to make a treatment.....what went wrong this time?

paula

UCB Advises US-Physicians to Down-Titrate Patients on Neupro In View of Out-of-Stock Situation
PharmaLive.com - BRUSSELS, Belgium - March 20, 2008 at 7:00 am CET - UCB announced today that the company will be recalling Neupro® (rotigotine transdermal system) in the United States and certain batches in Europe. The recall decision resulted from ongoing monitoring of marketed product, which revealed a deviation from the approved product specification. As a result, there will be an out-of-stock situation with Neupro® in the United States in late April 2008. In the European Union and most other regions Neupro® supply is sufficient.

"We have informed the FDA and agreed to actions to inform healthcare providers and patients," said Iris Loew-Friedrich, MD, PhD, Chief Medical Officer, UCB. "We advise patients in the US to contact their healthcare provider to begin the down-titration of Neupro® as per the guidelines in the label. It is strongly advised that patients do not discontinue therapy abruptly. I also want to emphasize that the issue is not one of product contamination or toxicity but rather one of possibly reduced clinical performance of some patches."

Down-titration (reduction of the dose) should be gradual and performed under medical supervision. Rapid reduction of therapy for Parkinson's disease has been associated with a symptom complex resembling neuroleptic malignant syndrome or akinetic crises.

it is not as effective as claimed, after all it is just delivery of a dop ag through another, (less efficient), means than oral delivery.

IMHO this patch typified the lack of progress and imagination some companies exhibit where PD is concerned. Like we need another patch rather than real treatments, "come on boys, lets get something cheap and nasty to the PD world and sell it as an exciting step forward.." no thanks.

Lets get on with the real therapies.

Neil.

I'm very disappointed that they are pulling the patch off the market. Being in the early stages of PD, this patch worksw great for me. The best part is the 24 hour delivery, which means I wake up feeling as good as I do when I go to bed. This is essential for me as I need to workout in the morning before work and don't really have time for an oral to "kick in".

Luckily for me, I just got a 90 day supply so hopefully it will last until they can get this figured out.

I know this patch isn't for everyone, but I hear they are trying to get higher doses approved in the US for those with more advanced PD.

I have my fingers crossed that they get it back on the market soon!

Lora

if you haven't ever seen the FasterCures site. i would highly recommend you go there and just get lost in it. http://fastercures.org

For me this has been my miracle drug. I began using it back in Sept 2007. Ever since, my life has done a 180. I function now most days almost like I don't have this dreaded disease.

I am simply beside myself. I do not want to go back to where I was before!!! I just pray they figure this out. I have about 40 days worth left.

As if we don't have enough to deal with!

Hi, I just finished titrating up to the 6mg patch and dropping Mirapex this week. My doctor's office not returning my calls yet; my pharmacy (Medco) didn't know anything about it. UCB patient assistance rep knew very little...

My question is - amongst others - if we have a 3-month supply already, or a little less than that - is that supply being recalled? Or can we assume that those are ok, or if not, how to select which ones to down-titrate with, or....

small rant - ok, trying not to feel too exasperated, but don't you think if you're going to make a product that people will then literally be life or death dependent on (Narcoleptic malignancy syndrome, etc.), that you might take quality control somewhat seriously?? Sheesh!

Fiona -
So glad to see you logged in. Everyone has been wondering where you were!
Good to see you are still in NYC too.

I don't know the proper protocol for handling something like this, so mods, forgive me if it needs correcting - but a friend (note, not my doctor, not the pharmacist...) emailed me a communication from a vice-president of UCB with specific photographs of what the defective patches might look like, so for those US patients who have a supply of them, but aren't sure if they are useable, I think this is essential info. Not sure about the technicalities of posting the link here - PM me if you want to know more...
Fiona