Farmacy

Jan 18 2018

Roivant Sciences, Biopharmaceutical Drug Development, pharmacology companies.#Pharmacology #companies

Revitalizing

Roivant Sciences is a global healthcare company focused on realizing the full value of promising biomedical research to improve the lives of patients and their families.

Who We Are

Roivant is dedicated to transformative innovation in healthcare. Our mission is to systematically reduce the time and cost of the drug development process. We partner with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly delivered to patients. Our goal is to serve our partners, contribute positively to the healthcare system, and improve the lives of patients around the world.

Roivant is the parent of a growing family of companies focused on diverse therapeutic areas including neurology, dermatology, urology, endocrinology, women’s health, and rare diseases.

Vivek Ramaswamy on Roivant and how we’re different

THE ROIVANT FAMILY OF COMPANIES

Axovant

Finding new solutions

THE ROIVANT FAMILY OF COMPANIES

Enzyvant

Developing transformative therapies

for patients with rare diseases.

THE ROIVANT FAMILY OF COMPANIES

Myovant

Dedicated to women’s

health and prostate cancer.

THE ROIVANT FAMILY OF COMPANIES

Urovant

Improving quality of life

through advancements in urology.

THE ROIVANT FAMILY OF COMPANIES

Dermavant

Leading innovation in

THE ROIVANT FAMILY OF COMPANIES

Datavant

through artificial intelligence.

OUR WORK

Pipeline

We have a diverse pipeline of 16 investigational drugs in 7 therapeutic areas being tested in over 40 clinical trials across our family of companies.

THERAPEUTIC AREA

PHASE

Pharmacology companies

Dementia with Lewy Bodies (DLB)

Lewy body dementia, or LBD, is a chronic, progressive neurodegenerative disorder and represents the second most common form of dementia. LBD is characterized by a build-up of abnormal proteins known as Lewy bodies in areas of the brain that control cognition, movement, alertness, and behavior. Lewy body dementia includes two similar conditions – dementia with Lewy bodies, or DLB, and Parkinson’s disease dementia, or PDD. The primary difference between both conditions generally depends on the timing of the onset of cognitive decline relative to the onset of movement-related symptoms. In dementia with Lewy bodies, cognitive decline generally occurs within one year of the onset of movement disorder symptoms.

Along with suffering from impaired cognition and behavioral disturbances, DLB patients often suffer from: visual hallucinations; fluctuations in cognition, attention and alertness; sensitivity to neuroleptic (antipsychotic) medications; REM behavior disorder, or RBD, in which people physically act out their dreams; and Parkinsonism (movement disorder, with symptoms including muscle rigidity and tremors). The Lewy Body Dementia Association estimates that there are 1.4 million patients with Lewy body dementia in the United States.

Our subsidiary, Axovant, is currently developing two drug candidates to treat certain aspects of Lewy body dementia – intepirdine (RVT-101) and nelotanserin. Currently, there are no drugs approved by the FDA for the treatment of DLB. Intepirdine has the potential to be the first drug approved by the FDA for the treatment of DLB.

Gait and Balance Impairments in Dementia

Visual Hallucinations in Lewy Body Dementia

REM Behavior Disorder (RBD) In LBD

Alzheimer’s Disease and Dementia with Lewy Bodies

Axovant plans to develop and, if successful, commercialize RVT-104, a combination of rivastigmine and a peripheral muscarinic receptor antagonist, as a potential treatment for patients with Alzheimer’s Disease and DLB.

Cholinesterase inhibitors are the standard of care in both Alzheimer’s disease and DLB. Despite their widespread use, many patients cannot tolerate the cholinesterase inhibitors because of their cholinergic side effects such as nausea, vomiting and diarrhea. Axovant believes that drugs that can mitigate these cholinergic side effects will allow more patients to receive optimal cholinesterase inhibitor therapy. The company’s pilot RVT-104 study, initially in healthy volunteers in an inpatient setting, is being redesigned to assess the effects in dementia patients in the outpatient setting. Axovant anticipates commencing this study in dementia patients in the first quarter of 2018.

Prostate Cancer

Uterine Fibroids

Endometriosis

Female Infertility

Approximately 25% of infertile women have problems related to ovulation, including the inability to produce fully matured eggs or release an egg from the ovary (i.e., “ovulate”). In the course of treating infertility related to anovulation, fertility specialists use a group of medications to temporarily correct ovulatory problems and increase a woman’s chance for pregnancy. These and related procedures are broadly termed Assisted Reproductive Technology, or ART. According to the CDC, approximately 208,000 cycles of ART were performed in the US in 2014 (the most recent year data is available), with millions more performed worldwide.

Myovant is currently developing MVT-602, an oligopeptide kisspeptin agonist, as a potential treatment for female infertility in women as part of assisted reproduction. Kisspeptin is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. In a Phase 1 study in healthy female volunteers conducted in the second half of 2017, a single injection of MVT-602 was observed to cause a dose-dependent luteinizing hormone surge. Myovant intends to conduct additional Phase 1 evaluation in women to further characterize the pharmacokinetic and pharmacodynamic profile of MVT-602 prior to the initiation of a Phase 2 proof-of-concept clinical trial in 2018.

Farber Disease

Complete DiGeorge Syndrome

Mild-to-Moderate Atopic Dermatitis

Moderate-to-Severe Dermatologic Indications

Inflammatory Skin Diseases

Overactive Bladder

Overactive bladder (OAB) is a condition that affects potentially 46 million American adults. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

Urovant’s lead therapeutic candidate is vibegron, an investigational oral β3-adrenergic agonist being developed for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. β3-adrenergic receptors play an important role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB.

Over 2,700 patients with symptoms of overactive bladder have been enrolled in clinical studies evaluating the safety and efficacy of vibegron, including a completed global randomized, double-blind, placebo- and active comparator-controlled Phase 2b study of over 1,300 subjects that met its primary and key secondary endpoints, and a completed randomized, placebo and active comparator-controlled Phase 3 study of over 1,000 patients conducted outside of the United States that met its primary and key secondary endpoints. Urovant anticipates initiating an international Phase 3 registration program for vibegron by early 2018.





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