Nervous System—Medicines The company’s CNS portfolio, one of its two core therapeutic areas, includes Copaxone for the treatment of relapsing forms of multiple sclerosis, Azilect for the treatment of the symptoms of Parkinson’s disease and Nuvigil for the treatment of sleep disorders, as well as various therapies for the treatment of pain care, including Fentora, Amrix and Zecuity. Copaxone (glatiramer acetate injection 20 mg/mL and 40 mg/mL) is the multiple sclerosis therapy in the United States and worldwide. Copaxone is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis (RRMS), including in patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. Multiple sclerosis is the most common cause of neurological disability in young adults and affects approximately 2.5 million people worldwide. In the majority of patients, the disease is of the relapsing-remitting form, which is manifested by relapses and slow progression of the disease that can affect the functioning of multiple systems. The company’s multiple sclerosis portfolio consists of Copaxone, as well as laquinimod, a Phase 3 investigational compound under development. In 2015, Copaxone 20 mg/mL was launched in Japan, pursuant to an agreement with Takeda to market this product in Japan. Azilect (rasagiline tablets) is indicated as initial monotherapy and as an adjunct to levodopa for the treatment of the signs and symptoms of Parkinson’s disease, the second most common neurodegenerative disorder. Azilect is a second-generation, irreversible monoamine oxidase type B inhibitor. The company markets Azilect in the United States. Nuvigil (armodafinil), the R-isomer of modafinil, is indicated for the treatment of excessive sleepiness associated with narcolepsy and certain other disorders. Nuvigil is protected by various patents, with a pediatric extension. Fentora/Effentora (fentanyl buccal tablet) is indicated for the treatment of breakthrough pain in opioid-tolerant adult patients with cancer. Fentora/Effentora is protected by patents expiring between 2019 and 2028. Zecuity is a prescription transdermal system approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura in adults. Zecuity is a disposable, single-use, iontophoretic transdermal system that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. The company’s CNS portfolio also includes: Actiq (fentanyl oral transmucosal lozenge) for the treatment of breakthrough pain in opioid-tolerant adult patients with cancer; and Amrix (cyclobenzaprine hydrochloride extended-release capsules) in the United States, for relief of muscle spasm in acute, painful, musculoskeletal conditions. Central Nervous System—Pipeline SD-809 (deutetrabenazine) is a deuterated form of a small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2), that is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain. SD-809 was acquired as part of the Auspex Pharmaceuticals, Inc. acquisition in 2015. SD-809 was granted Orphan Drug Designation by the FDA for the treatment of Huntington disease in 2014. SD-809 is in clinical development for the treatment of Tardive dyskinesia and Tourette syndrome. SD-809 is protected by patents expiring in 2029 in Europe and in 2031 in the United States. Laquinimod is a once-daily, orally administered immunomodulatory compound being developed for treatment of relapsing-remitting and progressive forms of multiple sclerosis. Laquinimod is protected by patents expiring in 2019 worldwide, with potential for extensions in various markets. Pridopidine is an oral small molecule dopamine stabilizer being developed for the symptomatic treatment of motor disorders (including Huntington disease), which the company obtained from Neurosearch A/S in 2012. The company initiated a Phase 2 clinical study to evaluate the safety and efficacy of pridopidine in patients with Huntington disease in February 2014, with results expected in the third quarter o
teva pharmaceutical-sp adr
5 Basel Street
PO Box 3190
Petach Tikva, 49131
Phone: 972 3 926 7267
Fax: 972 3 923 4050www.tevapharm.com
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