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Parkinson's Space in Focus as Acorda Stops Tozadenant Trial
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Acorda Therapeutics, Inc. recently announced that it is scrapping development of one of its lead Parkinson’s disease (“PD”) candidates, tozadenant. The decision was taken after some serious safety issues were observed in the phase III study, which was reported last week.
The company reported death of several patients from the study including some diagnosed with sepsis, an infection caused by lower white blood cell count.
It has been a tough time for Acorda this year. In August, the company informed that the FDA had issued a refusal to file letter in connection with the new drug application (“NDA”) for its key PD candidate, Inbrija. The FDA’s refusal to Inbrija’s NDA will delay its commercial launch, previously expected in the first half of 2018.
With the discontinuation of tozadenant, investors’ focus has once again shifted to the Parkinson’s space.
Parkinson’s disease (PD) is a progressive, degenerative neurological movement disorder resulting from the loss of dopamine-producing brain cells. The disease mainly progresses with age.
It is the second most common neurodegenerative disorder after Alzheimer’s. An estimated seven to 10 million people worldwide are living with Parkinson’s disease. Around 60,000 people in the United States are diagnosed with this disease annually, which is expected to more than double by 2040. The combined direct and indirect cost of Parkinson’s, including treatment, social security payments and lost income from inability to work, is estimated to be nearly $25 billion per year in the United States alone.
The research for innovative therapies in Parkinson’s space has increased in the last 10 years.Incidence of the disease is on the rise globally, given a rapid increase in greying populace. Per GBI Research, the Parkinson’s disease market is expected to touch $3.2 billion by 2021 at a CAGR of 5.7%.
Presently Marketed Drugs for PD
It has been observed that PD patients, treated with traditional medications like levodopa often suffer from side effects. However, despite this drawback, PD is predominantly treated with levodopa and dopamine agonists. Key medicines that dominate the PD market include Israeli Teva Pharmaceuticals' (TEVA - Free Report) Azilect, Belgium-based UCB SA’s Neupro and Swiss giant Novartis' (NVS - Free Report) Stalevo most of which, are levodopa-based. However, all these products’ loss of patent exclusivity is hurting the drugs' sales.
In August, Adamas Pharmaceuticals’ Gocovri received an FDA approval for treating dyskinesia in PD patients, who are on levodopa-based therapy. With no drug approved for treating dyskinesia, Gocovri’s approval holds huge potential. The company expects the drug to be made available by the year-end and a formal launch is planned for January 2018.
Candidates in Pipeline
Prothena is evaluating PRX002 in collaboration with Roche (RHHBY - Free Report) for treatment of Parkinson’s disease and other related synucleinopathies. In July, the companies initiated a phase II study, PASADENA, on PRX002 in patients suffering the same.
AstraZeneca (AZN - Free Report) and Takeda Pharmaceuticals, a Japanese pharma company, are also jointly developing preclinical candidate, MEDI1341, for potential treatment of PD. The candidate is due to enter phase I studies, later this year.
Other companies trying to bring Parkinson’s disease treatments to the market include Edison Pharma’s Vatiquinone, Prexton Therapeutics’ Foliglurax and Prana Biotechnology’s PBT434.
Apart from inducing a costly treatment, the disease substantially degrades one’s quality of life and the capacity to carry on daily activities. The severity of Parkinson’s stretches to such an extent that 37% of the patients with this malady are forced to retire earlier than those unaffected. Moreover, lack of curative therapy in this particular area is increasing the need for a better treatment option. Thus, the market opportunity to bring innovative products in this space is immense, thereby attracting more players to come up with a better treatment option to cater to the hugely unmet need.
Conclusion
With biopharmaceutical companies implementing the latest knowhow and technologies to improve treatment options for Parkinson’s, we expect a lot of updates from this space in the near term.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
Parkinson's Space in Focus as Acorda Stops Tozadenant Trial
Acorda Therapeutics, Inc. recently announced that it is scrapping development of one of its lead Parkinson’s disease (“PD”) candidates, tozadenant. The decision was taken after some serious safety issues were observed in the phase III study, which was reported last week.
The company reported death of several patients from the study including some diagnosed with sepsis, an infection caused by lower white blood cell count.
It has been a tough time for Acorda this year. In August, the company informed that the FDA had issued a refusal to file letter in connection with the new drug application (“NDA”) for its key PD candidate, Inbrija. The FDA’s refusal to Inbrija’s NDA will delay its commercial launch, previously expected in the first half of 2018.
With the discontinuation of tozadenant, investors’ focus has once again shifted to the Parkinson’s space.
Parkinson’s disease (PD) is a progressive, degenerative neurological movement disorder resulting from the loss of dopamine-producing brain cells. The disease mainly progresses with age.
It is the second most common neurodegenerative disorder after Alzheimer’s. An estimated seven to 10 million people worldwide are living with Parkinson’s disease. Around 60,000 people in the United States are diagnosed with this disease annually, which is expected to more than double by 2040. The combined direct and indirect cost of Parkinson’s, including treatment, social security payments and lost income from inability to work, is estimated to be nearly $25 billion per year in the United States alone.
The research for innovative therapies in Parkinson’s space has increased in the last 10 years. Incidence of the disease is on the rise globally, given a rapid increase in greying populace. Per GBI Research, the Parkinson’s disease market is expected to touch $3.2 billion by 2021 at a CAGR of 5.7%.
Presently Marketed Drugs for PD
It has been observed that PD patients, treated with traditional medications like levodopa often suffer from side effects. However, despite this drawback, PD is predominantly treated with levodopa and dopamine agonists. Key medicines that dominate the PD market include Israeli Teva Pharmaceuticals' (TEVA - Free Report) Azilect, Belgium-based UCB SA’s Neupro and Swiss giant Novartis' (NVS - Free Report) Stalevo most of which, are levodopa-based. However, all these products’ loss of patent exclusivity is hurting the drugs' sales.
In August, Adamas Pharmaceuticals’ Gocovri received an FDA approval for treating dyskinesia in PD patients, who are on levodopa-based therapy. With no drug approved for treating dyskinesia, Gocovri’s approval holds huge potential. The company expects the drug to be made available by the year-end and a formal launch is planned for January 2018.
Candidates in Pipeline
Prothena is evaluating PRX002 in collaboration with Roche (RHHBY - Free Report) for treatment of Parkinson’s disease and other related synucleinopathies. In July, the companies initiated a phase II study, PASADENA, on PRX002 in patients suffering the same.
AstraZeneca (AZN - Free Report) and Takeda Pharmaceuticals, a Japanese pharma company, are also jointly developing preclinical candidate, MEDI1341, for potential treatment of PD. The candidate is due to enter phase I studies, later this year.
Other companies trying to bring Parkinson’s disease treatments to the market include Edison Pharma’s Vatiquinone, Prexton Therapeutics’ Foliglurax and Prana Biotechnology’s PBT434.
Apart from inducing a costly treatment, the disease substantially degrades one’s quality of life and the capacity to carry on daily activities. The severity of Parkinson’s stretches to such an extent that 37% of the patients with this malady are forced to retire earlier than those unaffected. Moreover, lack of curative therapy in this particular area is increasing the need for a better treatment option. Thus, the market opportunity to bring innovative products in this space is immense, thereby attracting more players to come up with a better treatment option to cater to the hugely unmet need.
Conclusion
With biopharmaceutical companies implementing the latest knowhow and technologies to improve treatment options for Parkinson’s, we expect a lot of updates from this space in the near term.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>