Profile: Acorda Therapeutics Inc (ACOR.O)
30 Nov 2016
Acorda Therapeutics, Inc., incorporated on March 17, 1995, is a biopharmaceutical company. The Company is engaged in the identification, development and commercialization of therapies that restore function and recovers the lives of people with neurological disorders. Its commercial products include Ampyra, Fampyra, Zanaflex Capsules and a generic version of the capsules, Zanaflex tablets and Qutenza. Its research and development programs include CVT-301, Dalfampridine, Plumiaz, Neuregulin Program, Remyelinating Antibodies Program, CVT-427 and Chondroitinase Program. Its Ampyra (dalfampridine) Extended Release Tablets, 10 milligrams, is used as a treatment to improve walking in patients with multiple sclerosis (MS). It also markets Zanaflex Capsules and tablets, which are short-acting drugs for the management of spasticity, and Qutenza, a dermal patch for the management of neuropathic pain associated with post-herpetic neuralgia, also known as post-shingles pain. Its pipeline of neurological therapies addresses a range of disorders, including MS, Parkinson's disease, chronic post-stroke walking deficits (PSWD), epilepsy and migraine.
The Company's Ampyra (dalfampridine) is an oral drug approved by the Food and Drug Administration (FDA) as a treatment to improve walking in patients with MS. Ampyra has demonstrated efficacy in people with four types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). Ampyra can be used alone or with concurrent medications, including immunomodulatory drugs. The majority of patients in its two Phase III clinical trials for Ampyra were taking immunomodulatory drugs (interferons, glatiramer acetate or natalizumab). Ampyra is an extended release tablet formulation of dalfampridine (4-aminopyridine (4-AP)).
The Company's Zanaflex Capsules and Zanaflex tablets contain tizanidine hydrochloride. Tizanidine hydrochloride is approved by the FDA as a short-acting drug for the management of spasticity. There are various generic versions of tizanidine hydrochloride tablets on the market.
The Company's Qutenza is a dermal patch containing approximately 8% prescription strength capsaicin the effects of which can last for over three months. It is approved by the FDA for the management of neuropathic pain associated with post-herpetic neuralgia, also known as post-shingles pain.
CVT-301 and ARCUS Technology
The Company's CVT-301 is an inhaled formulation of levodopa (L-dopa) for the treatment of OFF periods in Parkinson's disease. CVT-301 is based on the ARCUS technology platform. The ARCUS technology is a dry-powder pulmonary delivery system. This platform allows delivery of larger doses of medication. Its CVT-301 development includes this Phase III efficacy trial and safety extension, and over two pharmacokinetic studies in specific sub-populations. It has initiated and completed a Phase I clinical trial of CVT-427 for acute treatment of migraine.
Ampyra/Dalfampridine Development Programs
The Company is studying the use of dalfampridine in patients experiencing chronic post-stroke deficits. The Company has conducted a Phase II proof-of-concept trial of dalfampridine-extended release (ER) in people with post-stroke deficits. In the study, treatment with dalfampridine improved walking, as measured by the Timed 25-Foot Walk test (T25FW). The Company has also commenced a Phase III clinical trial evaluating the use of dalfampridine administered twice daily (BID) to improve walking in people suffering from chronic post-stroke walking deficits after experiencing an ischemic stroke. The Company has been exploring a once-daily (QD) formulation of dalfampridine for use in the chronic post-stroke clinical program.
The Company is developing Plumiaz, a nasal spray formulation of diazepam, for the treatment of people with epilepsy on stable regimens of antiepileptic drugs (AEDs) experiencing bouts of increased seizure activity, also known as seizure clusters or acute repetitive seizures (ARS). Diazepam is also available in other formulations, such as used for intramuscular and intravenous administration, for certain indications. The nasally administered formulation offers patients and caregivers a practical and socially acceptable treatment option. The Company has initiated three trials.
The Company's Cimaglermin alfa is a member of the neuregulin growth factor family, and has been shown to promote recovery after neurological injury, as well as enhance heart function in animal models of heart failure. The Company has completed a Phase I clinical trial of cimaglerminin heart failure patients. This was a dose-escalating trial designed to test the maximum tolerated single dose, with follow-up assessments at one, three, and six months. Data from its Phase I study showed a dose-related improvement in ejection fraction in addition to safety findings. A dose-limiting toxicity was also identified in the highest planned dose cohort, specifically acute liver injury meeting Hy's Law for drug induced hepatotoxicity. The Company is also conducting a Phase Ib single-infusion trial in people with heart failure is assessing tolerability of approximately three dose levels of cimaglermin, and also includes assessment of drug-drug interactions and several exploratory measures of efficacy.
Remyelinating Antibodies Program
The Company's remyelinating antibodies program is based on its research collaboration with Mayo Foundation for Medical Education and Research (Mayo Clinic). Studies have demonstrated the ability of this family of antibodies to stimulate repair of the myelin sheath in three different animal models of MS. These antibodies were found to react with molecules on the surface of the cells that make the myelin sheath and stimulate them, leading to increased remyelination activity. Some antibodies within this portfolio also stimulate the growth of neurons and may have applications beyond demyelinating disorders. First identified in mice, similar remyelinating antibodies were subsequently identified in human blood samples by Mayo Clinic, and the Company has produced a recombinant human antibody (rHIgM22). The Company is developing the lead antibody (rHIgM22) as a potential therapeutic for MS. The Company has initiated a Phase I clinical trial of rHIgM22 to assess the safety and tolerability of rHIgM22 in patients with MS. The study also includes various exploratory clinical, imaging and biomarker measures. The trial, which followed participants for approximately six months after receiving a single dose of rHIgM22, found no dose-limiting toxicities at any of the five dose levels studied.
The Company's Chondroitinase program is focused on developing chondroitinase as a therapeutic to break down the matrix of scar tissue that develops as a result of an injury to the central nervous system (CNS). The Company has tested the ability of the molecule, Chondroitinase ABC-I, to improve function in an animal model of spinal cord injury (SCI). In these studies, rats that sustained an SCI were treated with either chondroitinase or an ineffective enzyme control and evaluated over 10 weeks of recovery. Animals treated with chondroitinase showed improvements both in motor function of the limbs and in bladder function, compared to those treated with the control enzyme. The Company has also produced and tested a recombinant version of naturally occurring Chondroitinase ABC-I in these same animal models. The Company is conducting a research program to develop second generation approaches to overcoming the proteoglycan matrix.
The Company competes with Biogen Inc., Schering AG, Teva Pharmaceutical Industries, Ltd., Merck Serono, Elan, Novartis AG, Sanofi, BioMarin Pharmaceutical Inc., Apotex Inc, Mylan Laboratories Limited, Impax Laboraties, Impax Depomed Inc., NeuroDerm Ltd., Abbvie Inc., Alexza Pharmaceuticals, Inc., MannKind Corporation, Pulmatrix, Inc., Vectura Group plc, Allergan, Inc., GlaxoSmithKline plc, Pfizer, Upsher-Smith and Neurelis, Inc.
Acorda Therapeutics Inc
420 Saw Mill River Rd
ARDSLEY NY 10502-2605
Company Web Links
- BRIEF-Acorda to discontinue development of Dalfampridine for treatment of post-stroke walking difficulties
- BRIEF-Acorda Therapeutics Q3 non-GAAP loss per share $0.04
- BRIEF-Acorda Therapeutics presents data from clinical and preclinical trials of CVT-301
- BRIEF-Arbitral Tribunal confirms Acorda's redemption right regarding Biotie shares
- BRIEF-Acorda presents phase 1 data on Migraine drug at 58th annual meeting of American Headache Society