In the news and demonstrating the need for a PD pipeline fast track through the FDA
As of 12/09/2009 Phytopharm has raised the money needed to bring Cogane to Phase II trial in the first half of 2010. The results for the Phase II trial of Cogane, the neurotropic factor which uses both GDNF and BDNF to cross the blood brain barrier, are expected in 2012.
Another announcement is that Cogane will be tested for Huntington's Disease.
Phytopharm stock is doing well.
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For all awaiting the return of the Neupro Transdermal Patch, here's the latest news from UCB, the global biopharma. After the crystalization recall and subsequent removal from both the European and the US market, many patients who had found relief from this unique molecule which helped patients improve against a broad range of day-night symptoms by maintaining a constant plasma level to relieve motor symptoms, sleep problems and morning akinesia (limited motion) were with only enough supply to titrate down.
The patch was approved by the EMEA (the European Medicines Agency) for approval to return to the European market by the summer of 2009 and there are 33,000 PD and RLS patients who are using it in Europe; however, the Neupro rotigotine patch is still not available in the US.
A year ago in December 2008, UCB submitted their response letter to the FDA.
In June of 2009 am extensive update on the cold chain data was submitted to the FDA.
The dialogue continues and it is expected that Neupro will be made available to US patients in 2010 according to UCB.
We've supplied a link to one online pharmacy which will fill a prescription request and other readers have supplied links to others in the comments sections of previous posts. If you're looking for the Neupro patch, check these posts and their comments sections.
June 2010 Neupro Patch Update:
With the blessing of the FDA, UCB has gone back to the drawing board with the Neupro patch to eliminate the need for cold storage. The implication of this announcement suggests that it could be as long as 3 years before the patch can be returned to the USA market.
June 2010 Neupro Patch Update:
With the blessing of the FDA, UCB has gone back to the drawing board with the Neupro patch to eliminate the need for cold storage. The implication of this announcement suggests that it could be as long as 3 years before the patch can be returned to the USA market.
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In the research and the pipeline are other GDNF delivery options. One approach is biodegradable microspheres still in research. Another is an intranasal delivery in research now studying nasal toxicity and the quantity of the GDNF which reaches the brain. Ths latter study is still in lab rat mode before moving on to human trials.
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The mixed bag news is that there is motivation to develop new therapies which work better than older, existing therapies. That's good. In Europe alone, PD accounted for a $1 billion market which is expected to grow to about $2.25 billion by 2015. Even if a cure is found, there is a growing number of people developing Parkinson's disease as the world population continues to expand and as diagnoses become more accurate (another market in itself) and are done at an earlier stage of the disease...
We'd love to be able to tell you more about a unique dopaminergic agonist being developed but Lu 02-750 is very hush-hush.
In October of 2009 Lundbeck announced the beginning of Phase I clinical trials for Lu 02-750 in a Press release. They anticipate regulatory filing probably after 2011.
Lundbeck is a global pharmaceutical company specializing in brain disorders. Although headquartered in Copenhagen, Denmark H Lundback A/S has employees worldwide through company acquisitions and development partners.
Lundbeck is also developing treatments for AD, Schizophrenia, Freidreich's Ataxia, Major depressive disorder. They also market medications for insomnia.
On an interesting note, Lundbeck is one of the few pharmaceutical companies listing non-medication treatments for Parkinson's disease.
The development of Lu 02-750 was apparently conducted under the direction of Professor Håkan Wikström who describes himself as a bio-professional geek. Professor Wilkstorm, is on the faculty of Groningen University in the Netherlands and is a co-founder Axon Biochemicals B.V.
About Lu 20-750 it has been reported that "In animal studies, (it is) the drug candidate shown to have a stronger effect on the disease than current drugs."
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News from Parkinsons Action Network about Health Care legislation affecting Parkinson's disease
First, on Saturday, December 19, the Senate gave final approval to the Department of Defense Appropriations bill, sending to President Obama a piece of legislation including $25 million for the innovative Neurotoxin Exposure Treatment Parkinson's Research (NETPR) program.
The NETPR program is the only Parkinson's-specific research program funded by the Federal government. Advocates must work to secure funding for this program every year, and the Parkinson's community rallied through a tough economy to ensure that the NETPR program did not receive a budget cut.
The second piece of legislation also took place on Saturday when the Cures Acceleration Network (CAN) Act of 2009, introduced by Senator Arlen Specter (D-PA), was included in the final Senate version of health care reform legislation. The CAN Act seeks to cut the time between discovery and development of new drugs and therapies. For some time PAN has focused on this troubling trend. Thanks to Sen. Specter's leadership and PAN advocates who contacted their Senators, a focus has been placed on accelerating tomorrow's therapies and drugs through the development pipeline.
The Senate expects to vote for final approval of the bill before Christmas, and PAN will work to sustain the CAN amendment during the Conference between the House and Senate.
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As of December 14, 2009 Azilect no longer carries the cheese effect warning.
You can read about in the Teva Pharmaceutical Industries Ltd press release
If you haven't read Dr Karl Kieburts comments about the ADAGIO study and the inconclusive results of the 2mg dosage as opposed to the positive results at 1mg, please take a look:
There will probably be another differently drawn Azilect (rasagiline) study of the 2mg dose.
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June 2010 COGANE Update
Phytopharm PLC received a USA regulatory approval by the FDA to begin the Phase II Clinical Trial.
Patient enrollment should begin in late 2010
You can read the Phytopharm press release here
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Droxidopa from Chelsea Therapeutics International (Nasdaq: CHTP) Droxidopa is described as a pro-drug to treat neurogenic orthostatic hypotension (NOH)
"Droxidopa provided statistical significance in the treatment of Neurogenic Orthostatic Hypotension (NOH) improving the motility of these patients and reduced their risk of falls with a benign safety profile. These improvements were measured through an orthostatic hypotension questionnaire and corresponding clinical indications"
- NOH is a drop in blood pressure resulting from deficient release of norepinephrine and is characterized by dizziness, weakness, blurred vision and fatigue.
- NOH occurs in patients suffering from autonomic dysfunction and movement disorders such as Parkinson's disease, multiple system atrophy and pure autonomic failure.
- Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.
"Study 302 evaluated the efficacy and safety of Droxidopa, a pro-drug that results in increased body stores of norepinephrine, in 101 patients with symptomatic NOH. All patients in Study 302 were evaluated for functional and symptomatic improvement through multiple endpoints including the orthostatic hypotension questionnaire (OHQ)."
Although Droxidopa is currently on the market in Japan, it is not on the general market in the US. In 2007 Droxidopa was awarded orphan drug status specifically to treat NOH in the US and in Europe. "for the treatment of symptomatic NOH in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy, and pure autonomic failure), dopamine-ß-hydroxylase deficiency, or nondiabetic autonomic neuropathy"
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