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 disease, 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.
Key Marketed Drugs for Parkinson’s Disease
It has been observed that PD patients, treated with traditional medications like levodopa often suffer from its side effects. However, despite this drawback, PD, at present, is predominantly treated with levodopa and dopamine agonists. Key medicines that are presently dominating the PD market include Israeli based 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, most of these products have lost patent exclusivity, which is hurting sales of the drugs.
What’s in the Pipeline?
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 an accelerated increase in aging population. According to GBI Research, the Parkinson’s disease market is expected to touch $3.2 billion by 2021 at a CAGR of 5.7%.
Apart from requiring 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 disorder 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. Therefore, the market opportunity to bring innovative products in this space is huge, attracting more players to come up with a better treatment option to cater to the huge unmet need.
Many companies are trying to bring Parkinson’s disease treatments to the market. These include Acorda Therapeutics, Inc.’s Inbrija, Prothena Corporation plc’s PRX002, AstraZeneca’s MEDI1341, Edison Pharma’s Vatiquinone, Prexton Therapeutics’ Foliglurax and Prana Biotechnology’s PBT434.
A lot has been happening in the space lately. Let's discuss them here:
This week, Adamas Pharmaceuticals announced FDA approval of Gocovri for treating dyskinesia in patients with Parkinson's disease who are on levodopa-based therapy. With no drug approved for treating dyskinesia, the approval of Gocovri holds huge potential. The company expects to make the drug available in the fourth quarter of 2017 and a formal launch is planned for January 2018.
Acorda is seeking approval for Inbrija in the U.S. as a treatment for symptoms of OFF periods in people with Parkinson’s. However, this week, the company received a refusal to file (RTF) letter from the FDA in connection with the new drug application (NDA) for Inbrija. The FDA has deemed the application incomplete after a preliminary review and as a result, the regulatory body now requires additional supporting information to review the application.
Acorda mentioned that it will request the FDA for a Type A meeting in a bid to resolve the issues. The FDA’s refusal for Inbrija’s NDA will delay its commercial launch, previously expected in the first half of 2018. The company intends to file for approval in Europe by year end.
Prothena is also evaluating PRX002, in collaboration with Roche (RHHBY - Free Report) , for the treatment of Parkinson’s disease and other related synucleinopathies. In July 2017, the companies initiated a phase II study, PASADENA, on PRX002 in patients suffering from Parkinson’s disease.
Nonetheless, this week, AstraZeneca (AZN - Free Report) and Takeda Pharmaceutical, a Japanese pharma company, announced an agreement to jointly develop and commercialize preclinical candidate MEDI1341 for the potential treatment of PD. The candidate is due to enter phase I studies later this year.
With biopharmaceutical companies implementing the latest knowhow and technologies to improve treatment options for Parkinson’s, we expect a lot of updates from the space in the near term.
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