Sunday, September 12, 2010

Good Vibrations for Parkinson's

One million Americans are living with it, and 60,000 people were diagnosed last year. Parkinson's disease slowly steals a person's control over their body. Now, some doctors are looking into the past to devise treatments for the future.
If Dale Voelker had his way, the golf course would be his office.
"I wish I could golf every day," Voelker told Ivanhoe.

Two years ago, he was diagnosed with Parkinson's and thought his days on the links were over.

"They keep saying there's a cure around the corner, cure around the corner, but I don't know. I can't wait," Voelker said.

His meds made him nauseous and drowsy, so he joined a clinical study for a more tolerable treatment.

"It's very relaxing. It puts me to sleep almost every time," Voelker said.
"It" is a vibration chair. The cushion connects to an amplifier.

"It's almost like there's a big subwoofer in the mattress that vibrates the entire body," Dr. Sachin Kapur, from Rush University Medical Center in Chicago, told Ivanhoe.

"They're sound waves that generate very strong vibrations. This is not a little buzz. This is not a little massage. This is a very strong vibration," Christopher Goetz, M.D., from Rush University Medical Center, explained to Ivanhoe.

It's based off the work of a 19th century French doctor.

"He noticed that patients who went on a carriage ride or train trip, when they descended from the carriage, their Parkinsonism was much less," Dr. Goetz said.
Experts say the vibrations travel through the spinal cord to the brain, which may help with basic motor skills.

A Canadian study showed vibration therapy improved gait, stability and posture. It also decreased tremors and rigidity and helped those who didn't respond to standard meds.

"It goes for about 40 minutes, and by the time I'm done, I've almost stopped shaking," Voelker said.

The chair isn't a cure, but it's how Voelker spells relief.

"It's like I get a little break," he said.

The current study is still enrolling Parkinson's patients at Rush University Medical Center. Patients sit in the chair for 30 minutes a day -- for one month.

PARKINSON'S DISEASE: Parkinson’s disease is a neurological disorder that results from the death of dopamine-producing cells. There are four main symptoms including trembling in the arms, legs, hand, head, jaw, and face, rigidity, bradykinesia, or slowness of movement, and postural instability and loss of balance. As the disease progresses patients have a hard time completing everyday tasks like walking and talking. The disease typically affects people over the age of 50 and symptoms come on subtly and slowly. It is suspected that nearly one million Americans are living with it, and 60,000 were diagnosed last year. The numbers are suspected to increase due to the aging population. The disorder tends to be more common in women.

Parkinson’s is difficult to diagnose however, a neurologist can only look at the symptoms and diagnose the patient. (SOURCE: National Institute of Neurological Disorders and Stroke)

PARKINSON’S TREATMENTS: Currently there is no cure for Parkinson’s disease, but most victims of the disease don’t need treatments for several years after the diagnosis because the symptoms are so mild. When the symptoms progress doctors will often treat the disease with levodopa (L-dopa), which helps replace the brain’s lost dopamine. In extremely severe patients a brain surgery called pallidotomy has been affective in reducing symptoms. Lastly, there is another surgery where healthy dopamine-producing brain tissue is transplanted into the brain. Scientists are currently developing substances that will stop dopamine cells from dying. (SOURCE: National Institute of Neurological Disorders and Stroke)

GOOD VIBRATIONS: Jean-Martin Charcot was a 19th century neurologist who developed the vibrating chair after noticing that Parkinson’s victims seemed more comfortable and had a reduction in symptoms after train and carriage rides. The vibrating chair is a non-traditional therapy method in which the person is subjected to not only body vibrations, but sound vibrations. The chair is equipped with strategically placed speakers that deliver low frequency vibrations throughout the body. The chair has shown to significantly impact the quality of life, and after gait (a way of walking) and posture tests the results showed significant improvement in both. With compared with conventional therapies used to treat Parkinson’s, the vibration therapy was 25 percent more efficient in reversing clinical symptoms. In the trial tests the participants underwent the therapy for 15 minutes five days a week. The vibrations are more effective if done in time frames under 30 minutes. Scientists hope that use of both conventional and vibration therapies will reduce the symptoms greatly.

Good Vibrations for Parkinson's

One million Americans are living with it, and 60,000 people were diagnosed last year. Parkinson's disease slowly steals a person's control over their body. Now, some doctors are looking into the past to devise treatments for the future.
If Dale Voelker had his way, the golf course would be his office.
"I wish I could golf every day," Voelker told Ivanhoe.

Two years ago, he was diagnosed with Parkinson's and thought his days on the links were over.

"They keep saying there's a cure around the corner, cure around the corner, but I don't know. I can't wait," Voelker said.

His meds made him nauseous and drowsy, so he joined a clinical study for a more tolerable treatment.

"It's very relaxing. It puts me to sleep almost every time," Voelker said.
"It" is a vibration chair. The cushion connects to an amplifier.

"It's almost like there's a big subwoofer in the mattress that vibrates the entire body," Dr. Sachin Kapur, from Rush University Medical Center in Chicago, told Ivanhoe.

"They're sound waves that generate very strong vibrations. This is not a little buzz. This is not a little massage. This is a very strong vibration," Christopher Goetz, M.D., from Rush University Medical Center, explained to Ivanhoe.

It's based off the work of a 19th century French doctor.

"He noticed that patients who went on a carriage ride or train trip, when they descended from the carriage, their Parkinsonism was much less," Dr. Goetz said.
Experts say the vibrations travel through the spinal cord to the brain, which may help with basic motor skills.

A Canadian study showed vibration therapy improved gait, stability and posture. It also decreased tremors and rigidity and helped those who didn't respond to standard meds.

"It goes for about 40 minutes, and by the time I'm done, I've almost stopped shaking," Voelker said.

The chair isn't a cure, but it's how Voelker spells relief.

"It's like I get a little break," he said.

The current study is still enrolling Parkinson's patients at Rush University Medical Center. Patients sit in the chair for 30 minutes a day -- for one month.

PARKINSON'S DISEASE: Parkinson’s disease is a neurological disorder that results from the death of dopamine-producing cells. There are four main symptoms including trembling in the arms, legs, hand, head, jaw, and face, rigidity, bradykinesia, or slowness of movement, and postural instability and loss of balance. As the disease progresses patients have a hard time completing everyday tasks like walking and talking. The disease typically affects people over the age of 50 and symptoms come on subtly and slowly. It is suspected that nearly one million Americans are living with it, and 60,000 were diagnosed last year. The numbers are suspected to increase due to the aging population. The disorder tends to be more common in women.

Parkinson’s is difficult to diagnose however, a neurologist can only look at the symptoms and diagnose the patient. (SOURCE: National Institute of Neurological Disorders and Stroke)

PARKINSON’S TREATMENTS: Currently there is no cure for Parkinson’s disease, but most victims of the disease don’t need treatments for several years after the diagnosis because the symptoms are so mild. When the symptoms progress doctors will often treat the disease with levodopa (L-dopa), which helps replace the brain’s lost dopamine. In extremely severe patients a brain surgery called pallidotomy has been affective in reducing symptoms. Lastly, there is another surgery where healthy dopamine-producing brain tissue is transplanted into the brain. Scientists are currently developing substances that will stop dopamine cells from dying. (SOURCE: National Institute of Neurological Disorders and Stroke)

GOOD VIBRATIONS: Jean-Martin Charcot was a 19th century neurologist who developed the vibrating chair after noticing that Parkinson’s victims seemed more comfortable and had a reduction in symptoms after train and carriage rides. The vibrating chair is a non-traditional therapy method in which the person is subjected to not only body vibrations, but sound vibrations. The chair is equipped with strategically placed speakers that deliver low frequency vibrations throughout the body. The chair has shown to significantly impact the quality of life, and after gait (a way of walking) and posture tests the results showed significant improvement in both. With compared with conventional therapies used to treat Parkinson’s, the vibration therapy was 25 percent more efficient in reversing clinical symptoms. In the trial tests the participants underwent the therapy for 15 minutes five days a week. The vibrations are more effective if done in time frames under 30 minutes. Scientists hope that use of both conventional and vibration therapies will reduce the symptoms greatly.

Sunday, September 5, 2010

Santhera and Ipsen Enter into Licensing Agreement for Fipamezole for the Treatment of Dyskinesia in

Santhera Pharmaceuticals (SIX: SANN) and Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today announced a license agreement for the development and commercialization of fipamezole (antagonist of the adrenergic alpha-2 receptor) for territories outside of North America and Japan. This first-in-class compound is currently under investigation for the treatment of levodopa-induced dyskinesia in Parkinson's Disease. Initiation of a first Phase III study by Biovail is scheduled for 2011. Today's agreement stipulates a data sharing, under which Ipsen has the right to use these data for its own purposes.

Klaus Schollmeier, Chief Executive Officer of Santhera, said: "We are pleased to be partnering with Ipsen to advance the potential of fipamezole as a possible first treatment for Dyskinesia in Parkinson's Disease. Dyskinesia is a condition that is functionally disabling to patients and limits effective treatment of the underlying Parkinson's Disease. Ipsen complements perfectly our North American partnership with Biovail. Today's agreement is another strong endorsement for fipamezole and proves that our out-licensing strategy for this innovative drug candidate is working well for the benefit of all parties."

Stephane Thiroloix, Ipsen's Executive Vice-President, Corporate Development said: "L-dopa induced dyskinesia is a serious unmet medical need, and we look forward to providing patients with a positive transformation in the management of their condition. This agreement with Santhera will further enrich Ipsen's pipeline with a new promising first-in-class compound thus complementing our fast-growing neurology franchise, in clear medical and operational synergy with our existing portfolio. We have been impressed with the scientific and development capabilities of both Santhera and Biovail. Ipsen will benefit from the Biovail development and collaborate fully to achieve regulatory filings excluding North America planned for 2015."

About the agreement

Under the agreement, Ipsen acquires the rights to fipamezole outside the United States, Canada and Japan for an upfront payment of EUR 13 million and additional payments contingent to future development, regulatory and sales milestones of up to EUR 128 million. In addition, Santhera is entitled to royalty payments on Ipsen's future net sales.

In a similar transaction in August 2009, Santhera granted Biovail (Canada's largest specialty pharmaceutical company) the development and commercial rights to fipamezole in the United States and Canada. The first Phase III study is scheduled for 2011 in the treatment of levodopa induced dyskinesia. Santhera has the right to use and sublicense data generated by Biovail for development and commercialization purposes outside of the United States and Canada. Today's agreement stipulates that Ipsen has acquired the right to use these data for its own development and commercialization purposes outside the United States, Canada and Japan, whereas the Japanese rights for fipamezole remain with Santhera.

About Fipamezole

Fipamezole is an antagonist of the adrenergic alpha-2 receptor with a novel mode of action in the treatment of dyskinesia in Parkinson's disease. The rationale behind the development is to increase noradrenergic release in certain areas of the brain resulting in the rebalance of the distorted brain network and potentially alleviating symptoms of advanced Parkinson's disease such as dyskinesia, motor fluctuations and other disturbing symptoms without exacerbating the underlying Parkinsonian features of the disease. Encouraging phase 2b data exist in support of this rationale. Loss of motor control and dyskinesia is feature of the majority of Parkinson patients after 5 years of levodopa therapy, and remains a clear unmet medical need.

About Ipsen

Ipsen is a global biopharmaceutical group, with sales exceeding 1 billion euros in 2009. The Group has total worldwide staff of more than 4,400 employees, of which nearly 900 contribute to the discovery and development of innovative drugs for patient care. Ipsen's development strategy is based on fast growing specialty care drugs in oncology, endocrinology, neurology and hematology, and on primary care drugs. This strategy is supported by an active policy of partnerships. Ipsen's research & development (R&D) centers and its peptide & protein engineering platform give the Group a strong competitive edge. In 2009, R&D expenditure totaled close to €200 million, representing nearly 20% of Group sales. Ipsen's shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the "Service de Reglement Differe" ("SRD" ). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit our website at www.ipsen.com.

About Santhera

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of severe neuromuscular diseases, an area of high unmet medical need which includes many orphan indications with no current therapy. Santhera's first product, Catena to treat Friedreich's Ataxia, is marketed in Canada. Following positive clinical results in Leber's Hereditary Optic Neuropathy, the drug is prepared for regulatory filings for marketing approval. Catena is also being investigated in a Phase III study in Duchenne Muscular Dystrophy. Commercial rights in Europe for Friedreich's Ataxia and Duchenne Muscular Dystrophy are licensed to Takeda Pharmaceutical. Santhera's second compound fipamezole has demonstrated efficacy in reducing levodopa-induced Dyskinesia in Parkinson's Disease. Phase III development and commercialization rights in the United States and Canada are partnered with Biovail, and outside North America and Japan with Ipsen. For further information, please visit the Company's web site atwww.santhera.com. Catena is a trademark of Santhera Pharmaceuticals.

Ipsen forward-looking statements

The forward-looking statements, objectives and targets contained herein are based on the Group's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Notably, future currency fluctuations may negatively impact the profitability of the Group and its ability to reach its objectives. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group's activities and financial results. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group's business is subject to the risk factors outlined in its registration documents filed with the French Autorite des Marches Financiers.

Santhera Disclaimer/Forward-looking statements

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
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