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IN VIVO: Will New Drugs For Motor Symptoms Of Parkinson's Disease Deliver?

August 15, 2021

Written By: Timothy Tankosic (Contributor)

Issue: IN VIVO Jul. 2011

Industry Segment: Biotechnology; Pharmaceuticals

Therapeutics Categories: Neurology, Nervous System; Neurology, Nervous System/Parkinson's Disease

Companies: Addex Pharmaceuticals Ltd.; Boehringer Ingelheim Ltd. GMBH; Cynapsus Therapeutics Inc.; GlaxoSmithKline PLC; H. Lundbeck AS; Impax LaboratoriesInc.; Johnson & Johnson/Janssen Pharmaceuticals Cos./Janssen Pharmaceuticals Inc./Ortho-McNeil-Janssen Pharmaceuticals Inc.; Merck & Co. Inc.; Merck KGAA; Merck KGAA/Merck Serono SA; Newron Pharmaceuticals SPA; Novartis AG; Santhera Pharmaceuticals AG; UCB Group; Valeant Pharmaceuticals Inc; Vecture Group PLC.

Executive Summary:  Because of the severity of the disease and the unmet medical need, competition to develop more effective treatments for motor complications of Parkinson's disease is fierce. Biopharma companies are employing a variety of strategies including reformulating approved drugs via new delivery systems and developing first-in-class therapies, which although riskier scientifically may command higher prices and greater acceptance from payors.

Market: Major market sales of drugs that treat motor symptoms of PD are projected to grow from about $2.5 billion in 2010 to about $3 billion by 2018. This growth occurs despite recent and looming generic introductions of drugs for motor symptoms and before the first anticipated approval of a disease-modifying drug. Recent deals for drugs to treat PD's motor symtpoms suggest this is a market worth pursuing. (See: "Parkinson's Disease at a Crossroad: Deals and Emerging Therapeutics", The Pink Sheet, June 13, 2022 [A#00110613026] and "Building the New Generation of Drugs in Neurodegeneration, IN VIVO, February 2010 (A#2010800024].)


...Rescue requires fast onset of action, similar to that of the SC drug; and the severity and rate of adverse effects related to the delivery route must be acceptable. Temporary pre-treatment with an anti-emetic is a manageable necessity. Vectura Group PLC's VR040, a formulation for oral inhalation through the lungs, has been tested in 126 subjects in three clinical trials and demonstrated a clinically relevant and statistically significant benefit. Vectura has completed its planned investment in VR040 and is meeting with prospective licensees interested in obtaining worldwide development and commercialization rights.

Cynapsus Therapeutics Inc., meanwhile, is developing APL-130277, a sublingual thin filmstrip formulation that dissolves within 30 seconds (similar to Listerine strips). In animal studies, the absorption rate of APL-130277 and its measured time of onset were almost identical to values obtained with subcutaneous apomorphine. A Phase I trial measuring the compound’s pharmacokinetics should be completed by the end of this year and an abbreviated regulatory route will be pursued.

At present, only relatively few neurologists and patients consider using injectable apomorphine because of the difficulties of self-administration and the pain and the lesion formation associated with regular injections. Cynapsus' survey of 50 neurologists (i.e., movement disorder specialists responsible for the treatment 12,000 patients with PD) found that, in addition to patients with severe PD, neurologists believe that a substantial group of moderately affected patients experience off episodes and would benefit from and use a more convenient formulation of apomorphine. The company believes that a non-injectable apomorphine formulation could transform the current $40 million market to nearly $300 million. Market potential might be twice that estimate if apomorphine uptake in moderate PD were significant. Although patients with moderate PD would use the drug less frequently, perhaps once daily compared to three times daily in patients with severe disease, the market impact would be substantial because the moderate PD group (about 47% of PD patients) is much larger than the severe group (<19%)...

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