Monday, Feb. 18, 2008

Solvay Pharmaceuticals, Inc. Receives Fast Track Designation From U.S. Food and Drug Administration for Levodopa/Carbidopa Intestinal Gel for Advanced Parkinson's Disease

http://www.centredaily.com/business/story/409559.html

About Duodopa
User Information

MARIETTA, Ga. — Solvay Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program for levodopa/carbidopa intestinal gel for the potential long-term treatment of motor fluctuations associated with advanced Parkinson's disease.

Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. A Priority Review means that the time it takes the FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.

"We are very pleased that the FDA has granted levodopa/carbidopa intestinal gel Fast Track designation and believe that it will be of great assistance in our efforts to expeditiously bring a new treatment option to this important and underserved advanced-stage patient population," said Laurence Downey, M.D., president and CEO, Solvay Pharmaceuticals, Inc.

In 2000, levodopa/carbidopa intestinal gel received Orphan Drug designation from the FDA for the treatment of late-stage Parkinson's disease. Orphan Drug designation provides seven years of marketing exclusivity from the date of a drug's approval. In addition, user fees are waived and the sponsor is eligible for tax credits for clinical testing.

Solvay Pharmaceuticals is currently investigating levodopa/carbidopa intestinal gel in a global Phase III open-label safety study and will enroll patients in pivotal studies in the U.S. and Germany this summer.

For information about clinical trial registration, please visit www.clinicaltrials.gov. [search "duodopa"]

About Advanced Parkinson's disease

Parkinson's disease is a progressive, neurodegenerative disorder that impairs mobility and control of movement. The disorder is caused by loss of dopamine-containing neurons in the substantia nigra area of the brain. Characteristic features include resting tremor, rigidity, bradykinetic (slow) movements and instability of posture. Levodopa is the standard treatment for the management of motor symptoms and has been shown to improve patient mobility and reduce disability. However, patients in the advanced stage of Parkinson's disease who have been treated with oral levodopa for several years may develop severe fluctuations in motor control characterized by unpredictable swings between mobility and immobility ("on-off" phenomenon).

About Levodopa/carbidopa intestinal gel

For long-term administration, the levodopa/carbidopa intestinal gel should be delivered by a portable pump directly into the duodenum through a tube inserted via percutaneous endoscopic gastrostomy (PEG) with an outer transabdominal tube and an inner intestinal tube. The pump used in the Phase III clinical studies is the Smiths Medical CADD-Legacy(R) 1400 ambulatory pump.

Levodopa/carbidopa intestinal gel is currently not approved by the FDA. It is registered in the entire European Economic Area (EEA) under the trade name Duodopa(TM). Marketing authorizations outside the EEA have been granted in Australia, Canada, Croatia and Switzerland. Orphan drug status was obtained in the European Union in 2001 and in Australia in 2006.

About Solvay Pharmaceuticals, Inc.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.

Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, and men's and women's health. Its 2007 sales were EUR 2.6 billion and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.

SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 28,000 people in 50 countries. In 2007, its consolidated sales amounted to EUR 9.6 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at www.solvay.com
Neil Hirsch Manager, U.S. Corporate Communications Solvay Pharmaceuticals, Inc. 770-578-2170 neil.hirsch@solvay.com

All you ever wanted to know about Duodopa.

European Parkinson's Disease Associations

In 2008 it was designated 'fast track' by the FDA. Has that made a difference? how close is it to being FDA approved for use in the US?

jean

Abbot Pharm bought Solvay Pharm last year at this time (Feb 2010). Abbot is a US company based outside of Chicago.

Press Release
Abbott Reports Double-Digit Sales and Ongoing Earnings Growth in Fourth Quarter; Issues Ongoing Earnings Outlook for 2011
Date: January 26, 2011  

* Worldwide Sales Increased 13.4 Percent
* Fourth Quarter Ongoing EPS Growth of 10.2 Percent
* Worldwide Pharmaceutical Sales Increased 22.5 Percent
* Worldwide Vascular Products Sales Increased 13.7 Percent
* U.S. Diagnostics Sales Increased 8.5 Percent

January 26, 2011

Abbott Park, Illinois (NYSE: ABT) — Abbott today announced financial results for the fourth quarter ended Dec. 31, 2010.
.....................

Across its businesses, Abbott has more than 350 clinical trials underway and expects to deliver more than 75 new products or indications over the next five years. In 2010, we added a total of four new molecular entities that are in late-stage development, and expect to have nearly 20 new molecular entities and indications in Phase 2 or 3 development by the end of 2011. We also expect numerous new trial starts and new data presentations throughout the year. Following are select highlights from breakthrough research across both pharmaceuticals and medical products pipelines:
..............

* Neuroscience / Pain
o Abbott is conducting innovative research in neuroscience, where it has developed compounds that target receptors in the brain that help regulate mood, memory and other neurological functions. Abbott has more than a dozen new molecular entities in clinical trials for conditions such as schizophrenia, pain, Alzheimer's disease, Parkinson's disease and multiple sclerosis (MS). This includes three compounds in development for Alzheimer's.
o Abbott's neuroscience pipeline includes a novel, next-generation antibody, daclizumab, which entered Phase 3 development in 2010 for relapsing remitting MS (RRMS), the most common form of the disease.
o Abbott is pursuing compounds that could provide relief across a broad spectrum of pain states, such as chronic back pain, postoperative pain and cancer pain.

That's all I came up with in my research.
Whether they choose to develop the duodopa further or not is now at their discretion.
BTW- a 120 year old megolithic global company whose founder developed and distributed across the planet... wait for it...... SIMILAC!

I once thought the delay in duodopa getting approved in this country was the competition/opposition from DBS...and perhaps there it some of that.

Recently, however, I realized that it must be coming from within: our govt. does NOT want to have to pay $60K a year for folks on medicare to get this, year after year after year....that is the majority of PWP with more everyday.

Additionally, I have no doubt private insurers aren't too happy about the prospect of having to pay for their insureds to get this, again, it's an annual cost, much higher than the initial outlay of DBS and an enormous addition to annual payout costs, certainly much higher than sinemet, mirapex, etc. Those might seem expensive to us, but pale in comparison to the $5K a month duodopa would/could cost.

So what can be done? Duodopa has been languishing for years, now decades in this country. I don't see its approval process any further down the road than years ago. Anyone have any information about this?

LAFC,

I am pretty confident it will be approved and I suspect that the high price tag may drop when it hits our market. I also predicted that it will be approved in 2013 the same year DBS goes generic. If they were only going to use it on people who are nursing home bound, why would they allow clinical trials on YO patients who clearly are not in late stage PD? They would have designed trials for people only at stages 4 or 5 which they did not do.

While I trust Aftermathman, I am curious why there are ambulatory middle aged and younger on Youtube showing on/off differences and reviewing the pump, showing how to use it. Just type in Duodopa at YouTube.

Finally we have word on good authority heard by one of NT most active advocates when consulting with a very prominent researcher and practicing PD doctor. He said it would likely be approved next year; delay is that they are streamlining the pump, and results were "astounding"!

Think of the number of patients now suffering who do not qualify for DBS. This is more than we think...you have to go through weeks of testing including neuropsychological battery. If you have any clinical depression or anxiety; from what I have heard, you do not qualify. There have been DBS affiliated suicides. How would it sound for Abbott to say we have this great new treatment but zap you can't have it because too pricy? It makes much more sense to flood market and sell more drug at a lower cost. They will make so much more profit that way. Incidentally, I know of young women with PD in 20's and 30's who have sought relief from meds with DBS and they have young children! I think there will be a lot of PWP lining up for this thrilled that there is an intermediary option before brain surgery. I don't relish carrying meds around on my body but will take it over the pill megadoses; on/off fluctuations, and lead wires in my cranium. This is what I am banking on; maintaining that high price tag doesn't make much business sense.

BTW, why in the world does it cost that much? The technology is not new and neither is a levodopa suspension. Is the gel made of Unicorn tears or something? Seriously.

Laura

What do you mean "DBS goes generic"? This is an operative procedure. How can they trademark or patent it? Please expound..

Medtronic has had a patent on the hardware used, lead wires, chip set, remote control...a medical device patent not on procedure itself. If you look at Clinicaltrials.gov

http://www.engadget.com/2009/04/02/e...bs-implants-t/

Again, Europeans are first to receive it. We have the best healthcare in the world...so long as you are not sick.

I would love to know we're I can go to get this, even outside the US. Dose anyone know. When do you think it will be here in the US.

Thanks,
Dee

last i heard they were deciding on delivery specifics. it's supposed to be outrageously expensive. has anyone heard updates ? solvay had been jerked around by the FDA for years. you'd think they would be eager to give advanced people relief. their heads are in an entirely different place and that place isn't always real...it must make sense or include logical common sense to be real. i can put you in touch with a close friend of an excellent researcher with duodopa if you like. Private message me of want to give him your contact information.

best,