Viatris Inc

VTRS

Held by 2 specialist biotech funds

2 funds opened new positions. Next phase2 readout (latanoprost 75 ug): Mar 2003. Short interest: 3.2% of float.

Drug Manufacturers - Specialty & GenericCEO: Scott Andrew SmithIPO: 1980Website ↗

Viatris Inc. operates as a healthcare company worldwide. The company operates in four segments: Developed Markets, Greater China, JANZ, and Emerging Markets. It offers prescription brand drugs, generic drugs, complex generic drugs, biosimilars, and active pharmaceutical ingredients (APIs). The company offers drugs in various therapeutic areas, including noncommunicable and infectious diseases; biosimilars in the areas of oncology, immunology, endocrinology, ophthalmology, and dermatology; and APIs for antibacterial, central nervous system agents, antihistamines/antiasthmatics, cardiovascular, antivirals, antidiabetics, antifungals, and proton pump inhibitor areas, as well as support services, such as diagnostic clinics, educational seminars, and digital tools to help patients better manage their health. It provides its medicines in the form of oral solid doses, injectables, complex dosage forms, and APIs to retail and pharmacy establishments, wholesalers and distributors, payers, insurers and governments, and institutions. The company distributes its products through pharmaceutical wholesalers/distributors, pharmaceutical retailers, institutional pharmacies, mail-order and e-commerce pharmacies, and specialty pharmacies. It sells its products under the Lyrica, Lipitor, Creon, Influvac, Wixela Inhub, EpiPen auto-injector, Fraxiparine, and Yupelri; Norvasc and Viagra; AMITIZA, Lipacreon, and Effexor; and Celebrex and ARV names, as well as offers biosimilars franchises, including Fulphila, Ogivri, Hulio, and SEMGLEE. The company has collaboration and licensing agreements with Revance Therapeutics, Inc.; Momenta Pharmaceuticals, Inc.; Theravance Biopharma, Inc.; Biocon Ltd.; and Fujifilm Kyowa Kirin Biologics Co. Ltd. Viatris Inc. was founded in 1961 and is headquartered in Canonsburg, Pennsylvania.

Catalysts

Phase 3Q4 1993timololOpen Angle Glaucoma, Ocular HypertensionNCT00751062

Primary: to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment. (6 mos)Enrollment:267/267Sites: 13RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q1 1998PlaceboMigraine With or Without AuraNCT01986270

Primary: Headache response at 1 hour after the first dose for the first attack. (1 hour)Enrollment:1,141/1,141RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q2 1999i. Fixed combination of latanoprost 0.005% and timolol 0.5%Ocular Hypertension, Glaucoma, Open-angle GlaucomaNCT00856622

Primary: To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. (6 months)Enrollment:436/436Sites: 37RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q1 2002PlaceboMigraine Without Aura, Migraine With AuraNCT01859481

Primary: Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. (24 weeks)Enrollment:971/971Sites: 148RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q1 2003latanoprost 75 ugPrimary Open Angle Glaucoma, Ocular HypertensionNCT01379144

Primary: The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28). (Baseline and Day 28)Enrollment:282/282Sites: 25RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q3 2003placeboBenign Prostatic HyperplasiaNCT00645034

Primary: Pharmacodynamic parameters of blood pressure and pulse rate (immediately predose, 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose)Enrollment:20/20Sites: 2RANDOMIZED, DOUBLE, BASIC_SCIENCE

Phase 3Q3 2004ziprasidone versus olanzapine , risperidone or quetiapineSchizophrenia, Schizoaffective Disorder, Psychotic DisordersNCT00159770

Primary: PANSS (The Positive And Negative Syndrome Scale) in a 12 week periodEnrollment:Target 290Sites: 43RANDOMIZED, TREATMENT

Phase 3Q4 2004GabapentinTransient InsomniaNCT00666770

Primary: Latency to persistent sleep as measured by polysomnography (Hour +8)Enrollment:309/309Sites: 5RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q1 2005GabapentinTransient InsomniaNCT00666939

Primary: Subjective sleep latency (Hour +8)Enrollment:773/773Sites: 10RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q2 2005GabapentinTransient InsomniaNCT00666575

Primary: Adverse Events (Day 45)Enrollment:Target 2,105Sites: 23RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q2 2005RisperidoneSchizophreniaNCT00645372

Primary: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score (Week 6)Enrollment:242/242Sites: 5RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ2 2005PregabalinFibromyalgiaNCT00645398

Primary: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint)Enrollment:751/751Sites: 102RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ3 2005Amlodipine/atorvastatin single pillHypertension, HyperlipidemiaNCT00143234

Primary: To evaluate the efficacy of amlodipine/atorvastatin therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III)Enrollment:Target 1,825Sites: 118NON_RANDOMIZED, TREATMENT

Phase 3Q2 2006EplerenoneHypertensionNCT00147615

Primary: Safety of eplerenone in hypertensive childrenEnrollment:Target 140Sites: 21NON_RANDOMIZED, TREATMENT

Phase 3Q4 2006tolterodine extended release capsuleUrinary IncontinenceNCT00139724

Primary: To evaluate the efficacy of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladderEnrollment:260/260Sites: 7RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q4 2006PregabalinAnxietyNCT00151450

Primary: Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.Enrollment:Target 390Sites: 45RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q1 2007GabapentinTransient InsomniaNCT00659100

Primary: Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications) (Throughout Day 90)Enrollment:1,254/1,254Sites: 35NON_RANDOMIZED, TREATMENT

Phase 3Q1 2007Sildenafil citratePulmonary HypertensionNCT00159887

Primary: SafetyEnrollment:260/260Sites: 65NON_RANDOMIZED, TREATMENT

Phase 3Q2 2007pregabalinRadiculopathyNCT00159705

Primary: Pain measurementEnrollment:276/276Sites: 52RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q3 2007AtorvastatinAlzheimer's DiseaseNCT00151502

Primary: If the results of this study demonstrate efficacy and lead to the approval by the FDA of atorvastatin for use in humans for the treatment of Alzheimer's disease, this would be available as an additional treatment option for patients.Enrollment:Target 600Sites: 99RANDOMIZED, DOUBLE, TREATMENT

Phase 3NegativeQ3 2007AtorvastatinCardiovascular DiseasesNCT00343655

Primary: Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.Enrollment:Target 160Sites: 1RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q3 2007PregabalinSeizuresNCT00143130

Primary: Reduction in seizure frequency. (18 months)Enrollment:227/227Sites: 47NON_RANDOMIZED, TREATMENT

Phase 3Q4 2007XalatanGlaucoma, Ocular HypertensionNCT00383019

Primary: Change of Intraocular Pressure (IOP) From Baseline to Week 8 (Baseline to Week 8)Enrollment:300/300Sites: 54RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q4 2007AmlodipineHypertensionNCT00415623

Primary: Change in Systolic Blood Pressure (SBP) From Baseline to Week 8 (Baseline to Week 8)Enrollment:305/305Sites: 14RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ4 2007pregabalinHIV Infections, Peripheral NeuropathyNCT00232141

Primary: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline (Baseline, Week 14)Enrollment:302/302Sites: 44RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q1 2008pregabalinPeripheral Neuropathy, HIV InfectionsNCT00264875

Primary: Mean Visual Analogue Scale (VAS) Pain Scores (Baseline, Week 4, Week 8, Week 12, and Endpoint)Enrollment:220/220Sites: 37NON_RANDOMIZED, TREATMENT

Phase 3PositiveQ1 2008pregabalinGeneralized Anxiety DisorderNCT00413010

Primary: Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores (Baseline, 8 weeks)Enrollment:356/356Sites: 68RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ1 2008PregabalinFibromyalgiaNCT00346034

Primary: Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score (Week 4)Enrollment:357/357Sites: 51NON_RANDOMIZED, TREATMENT

Phase 3PositiveQ1 2008Geodon (Ziprasidone)Bipolar DisorderNCT00141271

Primary: Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score (Baseline to 6 weeks)Enrollment:536/536Sites: 72RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ2 2008Amlodipine 2.5mg/Atorvastatin 5mgHypertension, HypercholesterolemiaNCT00530946

Primary: Change in Systolic Blood Pressure (8 weeks)Enrollment:165/165Sites: 17RANDOMIZED, TREATMENT

Phase 3Q2 2008Sildenafil citratePulmonary Arterial Hypertension, ChildrenNCT00159913

Primary: Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population (Baseline, Week 16)Enrollment:235/235Sites: 41RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q3 2008pregabalinNeuralgia, PostherpeticNCT00424372

Primary: Summary of Adverse Events (52 weeks)Enrollment:126/126Sites: 33NON_RANDOMIZED, TREATMENT

Phase 3Q4 2008pregabalinOsteoarthritis, Postoperative PainNCT00442546

Primary: Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) (48 hours after surgery)Enrollment:307/307Sites: 27RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q1 2009placeboDiabetic Neuropathy, PainfulNCT00553475

Primary: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint))Enrollment:314/314Sites: 49RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q2 2009PregabalinPain, Postoperative, Hernia, InguinalNCT00551135

Primary: Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery (24 hours post surgery)Enrollment:425/425Sites: 42RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q2 2009ZiprasidoneSchizophreniaNCT00139737

Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 72 months)Enrollment:344/344Sites: 87NON_RANDOMIZED, TREATMENT

Phase 3Q4 2009gabapentinEpilepsies, PartialNCT00603473

Primary: Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures (12 weeks)Enrollment:92/92Sites: 26NON_RANDOMIZED, TREATMENT

Phase 3PositiveQ2 2010pregabalin (Lyrica)Pain, PostoperativeNCT00468845

Primary: Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) (Day 2 (24 hours post surgery [PS]))Enrollment:501/501Sites: 42RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q3 2010CelecoxibPainNCT01062113

Primary: Efficacy Rate (Percentage) of Patient's Impression (2 hours post-additional dose)Enrollment:255/255Sites: 22RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q2 2011PlaceboBipolar DisorderNCT01117220

Primary: Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score. (4 weeks)0RANDOMIZED, TRIPLE, TREATMENT

Phase 3PositiveQ2 2011PlaceboFibromyalgiaNCT00830167

Primary: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline (Baseline, Week 15 or study discontinuation)Enrollment:498/498Sites: 35RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q2 2011pregabalinRestless Legs SyndromeNCT00991276

Primary: Wake After Sleep Onset (WASO) (Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET))Enrollment:85/85Sites: 41RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q4 2011ziprasidone oral capsulesBipolar DisorderNCT01124877

Primary: Change from Baseline in blood pressure and pulse Change from baseline in electrocardiogram (QTc) Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) (weeks 1, 2, 6, 10, 14, 18, 22, and 26)0NON_RANDOMIZED, TREATMENT

Phase 3NegativeQ3 2012PlaceboPain, PerioperativeNCT00905437

Primary: Mean Pain on Movement Score (Every 12 hours from Day 1 to Day 5 post-surgery)Enrollment:72/72Sites: 7RANDOMIZED, QUADRUPLE, SUPPORTIVE_CARE

Phase 3Q3 2012pregabalinFibromyalgiaNCT01271933

Primary: Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) (Randomization to Week 19)Enrollment:441/441Sites: 52RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2013PregabalinFibromyalgiaNCT01432236

Primary: Mean NRS Pain Score at End of Period. (End of each period, at Weeks 6 and 14)Enrollment:197/197Sites: 37RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2013atorvastatinFamilial HypercholesterolemiaNCT00827606

Primary: Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study (Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET]))Enrollment:272/272Sites: 40NA, TREATMENT

Phase 3Q1 2014Venlafaxine ERMajor Depressive DisorderNCT01485887

Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months)Enrollment:50/50Sites: 25NON_RANDOMIZED, TREATMENT

Phase 3Q3 2014PregabalinPost Herpetic NeuralgiaNCT01270828

Phase 3Q3 2016Pregabalin add-on therapyEpilepsy, Partial SeizuresNCT01389596

Primary: Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase (Baseline phase (up to 8 weeks prior to treatment phase [Day 1]))Enrollment:295/295Sites: 86RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q1 2018Pregabalin Dose Level 1Partial Onset SeizuresNCT02072824

Primary: Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase (Day 1 up to Day 14)Enrollment:175/175Sites: 72RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q1 2019Pregabalin Dose Level 1Generalized Tonic Clonic SeizuresNCT01747915

Primary: Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase (Day 1 up to Week 12)Enrollment:219/219Sites: 127RANDOMIZED, TRIPLE, TREATMENT

Phase 3NegativeQ2 2020placebo oral capsulesBipolar DisorderNCT02075047

Phase 3NegativeQ3 2020ZiprasidoneBipolar DisorderNCT03768726

Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks))Enrollment:23/23Sites: 9NA, TREATMENT

Phase 3Q3 2024MR-107A-02Acute Pain, Post Operative Pain, PainNCT06215820

Phase 3NegativeQ3 2025Pimecrolimus 0.3% Ophthalmic OintmentBlepharitisNCT06400511

Phase 3Q4 2026CenerimodLupus Erythematosus, SystemicNCT05648500

Phase 3Q4 2026CenerimodLupus Erythematosus, SystemicNCT05672576

Phase 3Q3 2027Acute Myocardial InfarctionNCT04957719

Phase 2Q4 2027cenerimod 4 mgSLE - Systemic Lupus ErythematosusNCT07266090

Primary: Number of participants with treatment-emergent adverse events (AEs) (From first dose of study treatment up to 180 days after the last dose)Enrollment:Target 15Sites: 7NA, TREATMENT

Phase 3Q2 2028CenerimodLupus Erythematosus, SystemicNCT06475742

Phase 3Q3 2029CenerimodNephritis, Lupus, Lupus Erythematosus, SystemicNCT07201129

Primary: Complete renal response (CRR) (At Week 76)Enrollment:Target 300Sites: 9RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2TBDXalatanGlaucoma, Open-Angle, Ocular HypertensionNCT00143429

Primary: IOP level in the study eye0RANDOMIZED, SINGLE, TREATMENT

Phase 3TBDCelecoxibLow Back PainNCT00141154

Primary: Patient's pain assessment (VAS: Visual Analogue Scale)Enrollment:1,234/1,234Sites: 38RANDOMIZED, DOUBLE, TREATMENT

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