A randomized, double-blind, placebo-controlled, dual-center clinical study to evaluate the efficacy and safety of pitavastatin calcium dispersible tablets in the treatment of active systemic lupus erythematosus

Start Date01 Aug 2024

Sponsor / Collaborator-

CTR20241053 / CompletedNot Applicable

匹伐他汀钙口崩片生物等效性试验

[Translation] Bioequivalence study of pitavastatin calcium orally disintegrating tablets

主要研究目的研究空腹和餐后状态下单次口服受试制剂匹伐他汀钙口崩片（规格：4mg，广东万泰科创药业有限公司提供）与参比制剂匹伐他汀钙口崩片（Livalo OD，规格：4mg，持证商：興和株式会社），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂匹伐他汀钙口崩片和参比制剂匹伐他汀钙口崩片（Livalo OD）后的安全性。

[Translation]

Main research purpose Study the single oral administration of the test preparation pitavastatin calcium orally disintegrating tablets (specification: 4 mg, provided by Guangdong Wantai Kechuang Pharmaceutical Co., Ltd.) and the reference preparation pitavastatin calcium orally disintegrating tablets (Livalo OD) in the fasting and postprandial states. , Specification: 4mg, Licensee: Kowa Co., Ltd.), pharmacokinetics in healthy adult subjects, and evaluate the bioequivalence of the two preparations taken orally on an empty stomach and after a meal. Secondary research purpose To evaluate the safety of Chinese healthy subjects after a single oral administration of the test preparation pitavastatin calcium orally disintegrating tablets and the reference preparation pitavastatin calcium orally disintegrating tablets (Livalo OD) in fasting and postprandial states.

Start Date03 May 2024

Sponsor / Collaborator

Guang Dong Wan Tai Ke Chuang Yao Ye You Xian Gong Si

NCT05977738 / CompletedEarly Phase 1IIT

Phase 0 lead-in Trial of Pitavastatin in Primary and Recurrent Glioblastoma Patients

The goal of this Phase 0 trial is to study if pre-operative oral pitavastatin administration reaches the tumour in patients with primary or a recurrent glioblastoma. The main question[s] it aims to answer are:
* Does pitavastatin reach a cytotoxic concentration in gadolinium-enhanced tumour tissue after oral administration?
* Does pitavastatin achieve a concentration that can synergize with temozolomide in the gadolinium non-enhanced area of the tumour?
Participants will receive pitavastatin in differing dosages a week before their elective surgery and blood and tumour samples will be collected.

Start Date18 Jan 2024

Sponsor / Collaborator

Erasmus MC

100 Clinical Results associated with Pitavastatin Calcium

100 Translational Medicine associated with Pitavastatin Calcium

100 Patents (Medical) associated with Pitavastatin Calcium

Literatures (Medical) associated with Pitavastatin Calcium

16 Sep 2024·AIDS (London, England)

Proteinuria and albuminuria among a global primary CVD prevention cohort of PWH: prevalence and associated factors.

Article

Author: Zanni, Markella ; Malvestutto, Carlos ; Fitch, Kathleen V ; Fichtenbaum, Carl J ; Bernardino, Jose ; Grinspoon, Steven K ; Mosepele, Mosepele ; McComsey, Grace A ; Overton, Edgar T ; Lu, Michael T ; Ribaudo, Heather ; Wyatt, Christina ; Aberg, Judith A ; Kantor, Amy ; Douglas, Pamela S ; Hickman, Aubri B ; Negredo, Eugenia

OBJECTIVESTo determine baseline prevalence of proteinuria and albuminuria among REPRIEVE participants and evaluate associated risk factors.DESIGNCross sectional analysis of a baseline sample of participants from the REPRIEVE Trial.METHODSREPRIEVE is an international primary cardiovascular prevention RCT of pitavastatin calcium vs. placebo among PWH on antiretroviral therapy. A representative subset (2791 participants) had urine collected at study entry. Urine protein to creatinine ratios (uPCR) and albumin to creatinine ratios (uACR) were classified as normal, moderately increased and severely increased. These were dichotomized to Normal or Abnormal for log-binomial regression analysis. Demographic, cardiometabolic, and HIV-specific data were compared among those with normal versus abnormal results.RESULTSOverall, median age 49 years, 41% female sex, 47% black or African American race, 36% had eGFR <90 mL/min/1.73 mm2. For uPCR, 27% had moderately or severely increased values. For uACR, 9% had moderately or severely increased values. In the fully adjusted model for proteinuria, female sex, older age, residence in sub-Saharan Africa or East Asia, lower BMI, lower CD4 cell count, and use of TDF were associated with abnormal values. In the fully adjusted model for albuminuria, a diagnosis of HTN was associated with abnormal values.CONCLUSIONSAbnormal proteinuria and albuminuria remain common (27% and 9%) despite controlled HIV. Lower current CD4 count and TDF use were strongly associated with proteinuria. Certain modifiable comorbidities, including HTN and smoking, were associated with abnormal values. In PWH with preserved eGFR, urine measures identify subclinical kidney disease and afford the opportunity for intervention.

01 Apr 2024·JAMA Cardiology

Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers in HIV

Article

Author: Arduino, Roberto ; Fletcher, Carl ; Looby, Sara ; Lira, Rita ; Ribaudo, Heather J. ; Duffy, Annie ; Eckard, Allison ; Meyersohn, Nandini M. ; Alli, Oladapo ; Martinez, Esteban ; Daar, Eric S. ; Bone, Fred ; Nohynek, Dana ; Goldkind, Sara ; Lama, Javier ; Hoffman, Udo ; Haas, David W. ; Murphy, Jacqueline ; Hedgire, Sandeep ; Udelson, James ; Sponseller, Craig ; DeFilippi, Christopher ; Grzejka, Ewelinka ; Swaminathan, Shobha ; Cordoso, Sandra W. ; Zanni, Markella ; Klingman, Karin ; Currier, Judith ; Klein, David ; Taron, Jana ; Manson, JoAnn ; Clement, Meredith ; Sopko, George ; Johnson, Keisha ; Giguel, Francoise ; Castillo, Blanca ; Santana-Bagur, Jorge L. ; Alston-Smith, Beverly ; Vlieg, David ; Siminski, Sue ; Karady, Julia ; Melbourne, Kathy ; Norton, Emilia ; Leaver, Tim ; Smeaton, Laura ; Leone, Jaclyn ; Desvigne-Nickens, Patrice ; Hedgire, Sandeep S. ; Bender Ignacio, Rachel ; Flexner, Charles W. ; Stein, James ; Tracy, Russel ; Baum, Jane ; Cheng, Ben ; Hammer, Scott ; Sleeper, Lynn ; Foldyna, Borek ; Diggs, Marissa ; Manne, Jennifer ; Wilkin, Aimee ; Moran, Laura ; Mishkin, Mark ; Tebas, Pablo ; Kohrs, Sharon ; Livnat, Daniella ; Selvage, Shirley ; Costanza, Christie Lyn ; Dube, Michael P. ; Chew, Kara W. ; Presti, Rachel M. ; Fulda, Evelynne ; Falutz, Julian ; Tucker, Jenese ; Overton, Edgar T ; Burdo, Tricia H. ; Sanchez Grande, Maria ; Borloglou, Kate ; Green, Madison ; Robinson, Jennifer ; Paczuski, Pawel ; Saleh, Nada ; Nowak, Jennifer ; Kim, Peter ; Jacobson, Jeffrey M. ; Upadhyay, Namrata ; Hirsch, Martin ; Dragavon, Joan ; Liao, Yuji ; Adedeji, Bola ; Benjamin, Claire ; Tashima, Karen T. ; Volberding, Paul ; Roa, Jhoanna ; Malvestutto, Carlos ; Sturniolo, Audra ; Reese, Karen ; Glesby, Marshall ; Bloomfield, Gerald S. ; Gandhi, Rajesh ; Heath, Sonya L. ; Byroads, Mark ; Moser, Carlee ; Wiviott, Stephen ; Brummel, Sean ; Meyersohn, Nina M. ; Lawal, Folake ; Leon-Cruz, Jorge ; Wilson, Tomeka ; Starr, Kate ; Landis, Jessica ; Luetkemeyer, Annie ; Campbell, Thomas B. ; Walker, Eloise ; Taiwo, Babafemi ; Paradis, Kayla ; Cherban, Erin ; Lowe, Cheryl ; Easley, Keisha ; Pate, Mary ; Douglas, Pamela S. ; Novak, Richard ; Rooney, James ; Sobieszczyk, Magdalena E. ; Bastow, Barbara ; Henn, Sarah ; Ribaudo, Heather ; Davila, Sylvia ; Gutzman, Howard ; LeBlanc, Rebecca ; Robbins, Gregory ; Umbleja, Triin ; Barnett, Ronald ; Overton, Edgar T. ; Van Dam, Cornelius ; Cadet, Tanisha ; Moy, Eva ; Hoffmann, Udo ; Koletar, Susan L. ; Marks, Kristen ; Coates, Cindy ; Fichtenbaum, Carl J. ; Lloyd-Jones, Donald ; Diggs, Alicia ; Zanni, Markella V. ; Lu, Michael T. ; Greenfield, Teri ; Sha, Beverly E. ; Ojumu, Akin ; Pozniak, Anton ; Martinez, Maria ; Aberg, Judith A. ; Grunfeld, Carl ; Hernandez, Angel ; Budoff, Matthew ; Harden, Regina ; Louis, Rochelle ; Riddler, Sharon A. ; Kantor, Amy ; Shaw, Karl ; Jain, Mamta ; Munsiff, Sonal S. ; Humphries, MJ ; Wohl, David A. ; Holguin, Anthony ; Hoffman, Erin ; Jayaweera, Dushyantha ; Malvestutto, Carlos D. ; Harrington, Robert ; Williams, Kenneth ; Fitch, Kathleen V. ; Santos, Breno ; Triant, Virginia ; Bannoo, Selina ; Bloomfield, Gerald ; Manne-Goehler, Jennifer M. ; Mayrhofer, Thomas ; Anthony, Oladapo ; Gershman, Elaine ; Jarrells, Janice ; Sierto, Alba ; Grinspoon, Steven K. ; Currier, Judith S. ; Granche, Janeway ; Ettinger, Robert ; McCallum, Sara ; Bandettini, Patricia ; Klop-Packel, Nory ; Pavlov, Gregory ; Ridker, Paul ; Shahkolahi, Akbar ; Wood, Kenneth ; Sprenger, Heather ; Ketema, Fassil ; Little, Susan J. ; Burdo, Tricia ; Troendle, James ; Barve, Radhika ; Rosenberg, Yves ; Ward, John

ImportanceCardiovascular disease (CVD) is increased in people with HIV (PWH) and is characterized by premature noncalcified coronary plaque. In the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE), pitavastatin reduced major adverse cardiovascular events (MACE) by 35% over a median of 5.1 years.ObjectiveTo investigate the effects of pitavastatin on noncalcified coronary artery plaque by coronary computed tomography angiography (CTA) and on inflammatory biomarkers as potential mechanisms for MACE prevention.Design, Setting, and ParticipantsThis double-blind, placebo-controlled randomized clinical trial enrolled participants from April 2015 to February 2018 at 31 US clinical research sites.PWH without known CVD who were taking antiretroviral therapy and had low to moderate 10-year CVD risk were included. Data were analyzed from April to November 2023.InterventionOral pitavastatin calcium, 4 mg per day.Main Outcomes and MeasuresCoronary CTA and inflammatory biomarkers at baseline and 24 months. The primary outcomes were change in noncalcified coronary plaque volume and progression of noncalcified plaque.ResultsOf 804 enrolled persons, 774 had at least 1 evaluable CTA. Plaque changes were assessed in 611 who completed both CT scans. Of 611 analyzed participants, 513 (84.0%) were male, the mean (SD) age was 51 (6) years, and the median (IQR) 10-year CVD risk was 4.5% (2.6-7.0). A total of 302 were included in the pitavastatin arm and 309 in the placebo arm. The mean noncalcified plaque volume decreased with pitavastatin compared with placebo (mean [SD] change, −1.7 [25.2] mm3 vs 2.6 [27.1] mm3; baseline adjusted difference, −4.3 mm3; 95% CI, −8.6 to −0.1; P = .04; 7% [95% CI, 1-12] greater reduction relative to placebo). A larger effect size was seen among the subgroup with plaque at baseline (−8.8 mm3 [95% CI, −17.9 to 0.4]). Progression of noncalcified plaque was 33% less likely with pitavastatin compared with placebo (relative risk, 0.67; 95% CI, 0.52-0.88; P = .003). Compared with placebo, the mean low-density lipoprotein cholesterol decreased with pitavastatin (mean change: pitavastatin, −28.5 mg/dL; 95% CI, −31.9 to −25.1; placebo, −0.8; 95% CI, −3.8 to 2.2). The pitavastatin arm had a reduction in both oxidized low-density lipoprotein (−29% [95% CI, −32 to −26] vs −13% [95% CI, −17 to −9]; P &lt; .001) and lipoprotein-associated phospholipase A2 (−7% [95% CI, −11 to −4] vs 14% [95% CI, 10-18]; P &lt; .001) compared with placebo at 24 months.Conclusions and RelevanceIn PWH at low to moderate CVD risk, 24 months of pitavastatin reduced noncalcified plaque volume and progression as well as markers of lipid oxidation and arterial inflammation. These changes may contribute to the observed MACE reduction in REPRIEVE.Trial RegistrationClinicalTrials.gov Identifier: NCT02344290

01 Feb 2024·Journal of Lipid Research

Pitavastatin treatment remodels the HDL subclass lipidome and proteome in hypertriglyceridemia

Article

Author: Orsoni, Alexina ; Davidson, W Sean ; Nguyen, Anh ; Swertfeger, Debi ; Chapman, M John ; Robillard, Paul ; Thérond, Patrice ; Shaw, Jonathan E ; Giral, Philippe ; Meikle, Peter J ; Mellett, Natalie A

HDL particles vary in lipidome and proteome, which dictate their individual physicochemical properties, metabolism, and biological activities. HDL dysmetabolism in nondiabetic hypertriglyceridemia (HTG) involves subnormal HDL-cholesterol and apoAI levels. Metabolic anomalies may impact the qualitative features of both the HDL lipidome and proteome. Whether particle content of bioactive lipids and proteins may differentiate HDL subclasses (HDL2b, 2a, 3a, 3b, and 3c) in HTG is unknown. Moreover, little is known of the effect of statin treatment on the proteolipidome of hypertriglyceridemic HDL and its subclasses. Nondiabetic, obese, HTG males (n = 12) received pitavastatin calcium (4 mg/day) for 180 days in a single-phase, unblinded study. ApoB-containing lipoproteins were normalized poststatin. Individual proteolipidomes of density-defined HDL subclasses were characterized prestatin and poststatin. At baseline, dense HDL3c was distinguished by marked protein diversity and peak abundance of surface lysophospholipids, amphipathic diacylglycerol and dihydroceramide, and core cholesteryl ester and triacylglycerol, (normalized to mol phosphatidylcholine), whereas light HDL2b showed peak abundance of free cholesterol, sphingomyelin, glycosphingolipids (monohexosylceramide, dihexosylceramide, trihexosylceramide, and anionic GM3), thereby arguing for differential lipid transport and metabolism between subclasses. Poststatin, bioactive lysophospholipid (lysophosphatidylcholine, lysoalkylphosphatidylcholine, lysophosphatidylethanolamine, and lysophosphatidylinositol) cargo was preferentially depleted in HDL3c. By contrast, baseline lipidomic profiles of ceramide, dihydroceramide and related glycosphingolipids, and GM3/phosphatidylcholine were maintained across particle subclasses. All subclasses were depleted in triacylglycerol and diacylglycerol/phosphatidylcholine. The abundance of apolipoproteins CI, CII, CIV, and M diminished in the HDL proteome. Statin treatment principally impacts metabolic remodeling of the abnormal lipidome of HDL particle subclasses in nondiabetic HTG, with lesser effects on the proteome.

News (Medical) associated with Pitavastatin Calcium

23 Jul 2024

·www.globenewswire.com

ACTG Presents Data Analysis at AIDS 2024 Showing Association between Elevated Risk of Cardiovascular Events and Abacavir Use Among People Living with HIV

Additional ACTG Presentations Address Muscle Density and Area among People Living with HIV and COVID-19 TreatmentLOS ANGELES, July 23, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, will present an exploratory analysis from the REPRIEVE trial demonstrating that former and current use of abacavir was associated with a higher incidence of major adverse cardiovascular events at AIDS 2024 in Munich, Germany. The oral presentation will take place on July 26, 2024, as part of the session Comorbidities: The Heart of the Matter, from 10:30-11:30 am CEST at Hall B0b/Channel 5 and virtually. “This carefully constructed analysis adds to the body of evidence that abacavir use is associated with a higher risk of cardiovascular events like heart attacks and strokes,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles. “These data align with prior studies that had been considered somewhat controversial because no exact mechanism was clearly demonstrated and should be taken into account by clinicians when they evaluate treatment options for people living with HIV.” These are the latest findings from REPRIEVE, the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of major adverse cardiovascular events by 36 percent compared with those receiving a placebo over a median duration of five years of follow up. The analysis being presented at AIDS 2024 evaluated the role of prior and current use of select antiretroviral treatments (including abacavir, tenofovir, thymidine analogs, and protease inhibitors) on the development of major cardiovascular events. These antiretrovirals were selected based upon prior association with cardiovascular risk and kidney impairment (future analyses are planned to examine the role of other antiretrovirals). Among 7,769 participants, 31.3 percent were born female and 65.2 percent were not white. The median age was 50, LDL (low-density lipoprotein, a kind of cholesterol) was 108 mg/dL, CD4 count was 621 cell/mm3, and 88 percent had a viral load under 400 copies/mL. Participants had been taking HIV treatment for a median of 9.5 years. Researchers found that current or past use of abacavir increased the risk of major adverse cardiovascular events by 42 and 50 percent, respectively, while current or past use of other antiretroviral treatments caused no such increase. “This analysis is important as we seek to tease out the various factors that may help reduce cardiovascular risk in people living with HIV,” said lead study author Carl Fichtenbaum, M.D., University of Cincinnati. “While the association between abacavir and cardiovascular risk is disappointing, it is not a surprise. It is, however, reassuring that the other HIV therapies included in the analysis like tenofovir were not associated with a higher risk.” REPRIEVE had a number of unique aspects: study participants had no known prior history of cardiovascular disease, the global cohort from 12 countries had low-to-moderate risk for cardiovascular disease, and all study endpoints were independently vetted by the national study Thrombolysis in Myocardial Infarction (TIMI). REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes. It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare. The trial is led by Steven Grinspoon, M.D. (Chair) and Pamela S. Douglas, M.D. (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D. (Lead Statistician) and Michael Lu, M.D., M.P.H. (Protocol Chair, Mechanistic Substudy of REPRIEVE), who led the Data Coordinating Center. To learn more, please visit www.reprievetrial.org. In addition to these data from REPRIEVE, ACTG will also make the following presentations at AIDS 2024: No Evidence of Pitavastatin Effect on Muscle Density or Area Among People with HIV (REPRIEVE; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kristine Erlandson, et al. This analysis from the REPRIEVE mechanistic substudy found that statins did not reduce muscle density or area. This two-year study of middle-aged people living with HIV at low-to-moderate risk of cardiovascular disease, confirmed through imaging that statins were safe and did not cause significant muscle damage. This is reassuring to people who want to use statins to lower their risk of cardiovascular events like heart attacks and strokes. Efficacy and Safety of Ensitrelvir in Non-Hospitalized Adults at Standard or High-Risk of Progression to Severe COVID-19: the SCORPIO-HR Phase 3, Randomized, Double-Blind Placebo-Controlled Trial (ACTG 5407; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kara Chew, et al. While the oral protease inhibitor ensitrelvir demonstrated anti-viral activity, safety, and a trend toward shorter time to symptom resolution compared to placebo, SCORPIO-HR (ACTG 5407) did not meet its primary endpoint of time to two or more days sustained resolution of 15 COVID-19 symptoms in outpatient participants at standard and higher risk for severe disease. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net

Clinical ResultPhase 3AHAClinical Study

21 Nov 2023

·www.biospace.com

Medicure Reports Financial Results for Quarter Ended September 30, 2023

WINNIPEG, MB / ACCESSWIRE / November 21, 2023 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH)(OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today reported its results from operations for the quarter ended September 30, 2023. Quarter Ended September 30, 2023 Highlights: Recorded total net revenue of $5.0 million during the quarter ended September 30, 2023 compared to $5.3 million for the quarter ended September 30, 2022 and; Recorded total net revenue from the sale of AGGRASTAT® of $2.4 million during the quarter ended September 30, 2023 compared to $3.0 million for the quarter ended September 30, 2022 and; Recorded total net revenue from the Marley Drug business of $2.2 million ($670,000 from sales of ZYPITAMAG® , and $1.53 million from other pharmacy revenue) during the quarter ended September 30, 2023 compared to $1.8 million ($430,000 from sales of ZYPITAMAG® and $1.37 million from other pharmacy revenue) for the quarter ended September 30, 2022 and; Recorded net revenue through insured business from the sale of ZYPITAMAG®of $398,000 during the quarter ended September 30, 2023 compared to $434,000 through insured business for the quarter ended September 30, 2022. Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended September 30, 2023 was $429,000 compared to adjusted EBITDA of $1.4 million for the quarter ended September 30, 2022 and; Net income for the quarter ended September 30, 2023 was $84,000 or $0.01 per share compared to net income of $1.1 million or $0.11 per share for the quarter ended September 30, 2022. R&D expenses for the quarter ended September 30, 2023 were $508,000, and the company remains committed to the completion of the PNPO deficiency Phase 3 clinical trial. The Company remains cash flow positive and carries no debt on its balance sheet. Financial Results Net AGGRASTAT® product sales for the three month period ended September 30, 2023, were $2.4 million compared to $3.0 million during the three month period ended September 30, 2022. The decrease in AGGRASTAT® revenues from the prior year when compared to the previous year is the result of a decrease in the volume of AGGRASTAT® sold, and competition from generic tirofiban. ZYPITAMAG® contributed $398,000 of revenue for the quarter ended September 30, 2023 compared to $434,000 for the quarter ended September 30, 2022. The decrease in revenue through insured channels is primarily as a result of wholesaler returns and higher coverage gap payments to pharmacy benefit managers. This amount does not include sales of ZYPITAMAG® through the Marley Drug business. The Marley Drug business contributed $2.2 million of revenue for the quarter ended September 30, 2023 compared to $1.8 million for the quarter ended September 30, 2022. Marley Drug is a US pharmacy licensed to ship medications to all 50 states, Washington D.C. and Puerto Rico. It serves thousands of customers and provides another channel for direct-to-consumer marketing, distribution and improved profit margin for ZYPITAMAG®. The increase in revenue is a result of increased sales through its e-commerce platform, including increased sales of ZYPITAMAG®. Adjusted EBITDA for the quarter ended September 30, 2023 was $429,000 compared to $1.4 million for the quarter ended September 30, 2022. Decreased adjusted EBITDA for the quarter ended September 30, 2023 resulted from lower net revenue, higher selling and R&D expenses, partially offset by lower cost of goods sold during the current quarter. Net income for the quarter ended September 30, 2023 was $84,000 or $0.01 per share compared to net income of $1.1 million or $0.11 per share for the quarter ended September 30, 2022. The main factor contributing to the decrease in net income recorded for the quarter ended September 30, 2023 was lower net revenue, higher selling and R&D expenses, partially offset by lower cost of goods sold during the current period. At September 30, 2023, the Company had unrestricted cash totaling $5.6 million, an increase from $4.9 million of unrestricted cash held as of December 31, 2022. Cash flows from operating activities for the nine months ended September 30, 2023 was $1.2 million compared to cash flows from operating activities of $1.3 million for the nine months ended September 30, 2022. All amounts referenced herein are in Canadian dollars unless otherwise noted. The full financial statements are available at and on the Company's website at . Notes The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non‑cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and nine month periods ended September 30, 2023 and 2022 results prepared using IFRS, do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies. Conference Call Info: Topic: Medicure's Q3 2023 Results Call date: Wednesday, November 22, 2023 Time: 7:30 AM Central Time (8:30 AM Eastern Time) Toll Free: 1 (888) 506-0062 International: 1 (973) 528-0011 Participant Access Code: 599508 Webcast: This conference call will be webcast live over the internet at the following link: You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company's website. About Medicure Inc. Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the U.S. cardiovascular market. The present focus of the Company is the marketing and distribution of AGGRASTAT® (tirofiban hydrochloride) injection and ZYPITAMAG® (pitavastatin) tablets in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also operates Marley Drug, Inc. ("Marley Drug"), a pharmacy located in North Carolina that offers an Extended Supply drug program serving all 50 states, Washington D.C. and Puerto Rico. Marley Drug® is committed to improving the health status of its patients and the communities they serve while reducing overall health care costs for employers and other health care consumers. For more information visit . To learn more about The Extended Supply Generic Drug Program call 800.286.6781 or email info@marleydrug.com.For more information on Medicure please visit . For additional information about AGGRASTAT®, please visit or refer to the full Prescribing Information. For additional information about ZYPITAMAG®, please visit or refer to the full Prescribing Information. To receive investor and business updates from Medicure, please fill out this form click here to be added to Medicure's e-mail list. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward Looking Information: Statements contained in this press release that are not statements of historical fact, including, without limitation, statements containing the words "believes", "may", "plans", "will", "estimates", "continues", "anticipates", "intends", "expects" and similar expressions, may constitute "forward-looking information" within the meaning of applicable Canadian and U.S. federal securities laws (such forward-looking information and forward-looking statements are hereinafter collectively referred to as "forward-looking statements"). Forward-looking statements, include estimates, analysis and opinions of management of the Company made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors which the Company believes to be relevant and reasonable in the circumstances. Inherent in forward-looking statements are known and unknown risks, uncertainties and other factors beyond the Company's ability to predict or control that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements, and as such, readers are cautioned not to place undue reliance on forward-looking statements. Such risk factors include, among others, the Company's future product revenues, expected results, including future revenue from P5P, the likelihood of receiving a priority review voucher from the United State Food and Drug Administration, expected future growth in revenues, stage of development, additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence upon collaborative partners, changes in government regulation or regulatory approval processes, and rapid technological change in the industry. Such statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions about: general business and economic conditions; the impact of changes in Canadian-US dollar and other foreign exchange rates on the Company's revenues, costs and results; the timing of the receipt of regulatory and governmental approvals for the Company's research and development projects; the availability of financing for the Company's commercial operations and/or research and development projects, or the availability of financing on reasonable terms; results of current and future clinical trials; the uncertainties associated with the acceptance and demand for new products and market competition. The foregoing list of important factors and assumptions is not exhaustive. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements or the foregoing list of factors, other than as may be required by applicable legislation. Additional discussion regarding the risks and uncertainties relating to the Company and its business can be found in the Company's other filings with the applicable Canadian securities regulatory authorities or the US Securities and Exchange Commission, and in the "Risk Factors" section of its current Form 20F. AGGRASTAT® (tirofiban hydrochloride) injection, ZYPITAMAG® (pitavastatin) tablets, and Marley Drug® are registered trademarks. For more information, please contact: Dr. Albert D. Friesen Chief Executive Officer Tel. 888-435-2220 Fax 204-488-9823 E-mail: info@medicure.com Condensed Consolidated Interim Statements of Financial Position (expressed in thousands of Canadian dollars, except per share amounts) September 30, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 5,642 $ 4,857 Accounts receivable 5,531 5,635 Inventories 3,377 3,221 Prepaid expenses 761 1,134 Total current assets 15,311 14,847 Non-current assets: Property and equipment 856 1,187 Intangible assets 9,444 10,624 Goodwill 3,171 3,177 Other assets 63 63 Total non-current assets 13,534 15,051 Total assets $ 28,845 $ 29,898 Liabilities and Equity Current liabilities: Accounts payable and accrued liabilities $ 5,671 $ 7,128 Current portion of royalty obligation - 179 Current portion of acquisition payable 676 677 Current income taxes payable 6 60 Current portion of lease obligation 351 346 Total current liabilities 6,704 8,390 Non-current liabilities Lease obligation 275 503 Total non-current liabilities 275 503 Total liabilities 6,979 8,893 Equity: Share capital 81,014 80,917 Contributed surplus 10,647 10,476 Accumulated other comprehensive income (5,491 ) (5,458 ) Deficit (64,304 ) (64,930 ) Total Equity 21,866 21,005 Total liabilities and equity $ 28,845 $ 29,898 Condensed Consolidated Interim Statements of Net Income and Comprehensive Income (expressed in thousands of Canadian dollars, except per share amounts) Three months ended September 30, 2023 Three months ended September 30, 2022 Nine months ended September 30, 2023 Nine months ended September 30, 2022 Revenue, net $ 5,002 $ 5,287 $ 16,623 $ 16,750 Cost of goods sold 1,362 1,391 4,999 5,034 Gross profit 3,640 3,896 11,624 11,716 Expenses Selling 2,017 1,694 6,123 5,060 General and administrative 1,024 1,036 3,055 3,909 Research and development 508 314 1,703 1,984 3,549 3,044 10,881 10,953 Other Income Change in fair value of contingent consideration - (302 ) - (302 ) Finance (income) costs: Finance (income) expense, net (3 ) 33 (20 ) 90 Foreign exchange (gain) loss, net 17 (10 ) 71 25 14 (279 ) 51 (187 ) Net income (loss) before income taxes $ 77 $ 1,131 $ 692 $ 950 Income tax (recovery) expense Current (7 ) 18 66 39 Net income $ 84 $ 1,113 $ 626 $ 911 Other comprehensive income: Item that may be reclassified to profit or loss Exchange differences on translation of foreign subsidiaries 455 1,257 (33 ) 1,587 Other comprehensive income, net of tax 455 1,257 (33 ) 1,587 Comprehensive income $ 539 $ 2,370 $ 593 $ 2,498 Earnings per share Basic $ 0.01 $ 0.11 $ 0.06 $ 0.09 Diluted $ 0.01 $ 0.11 $ 0.05 $ 0.09 Condensed Consolidated Interim Statements of Cash Flows (expressed in thousands of Canadian dollars, except per share amounts) For the nine months ended September 30 2023 2022 Cash (used in) provided by: Operating activities: Net income for the period $ 626 $ 911 Adjustments for: Change in fair value of contingent consideration (302 ) Recovery of royalties (234 ) - Amortization of property, plant and equipment 319 343 Amortization of intangible assets 1,298 1,171 Share-based compensation 212 50 Finance (income) expense, net 11 90 Unrealized foreign exchange (gain) loss 71 812 Income tax expense 66 39 Change in the following: Accounts receivable 86 (285 ) Inventories (178 ) (61 ) Prepaid expenses 334 203 Accounts payable and accrued liabilities (1,108 ) (865 ) Other assets - 27 Interest received (paid), net 31 10 Income taxes paid (78 ) (42 ) Royalties paid (304 ) (772 ) Cash flows from operating activities 1,152 1,329 Investing activities: Acquisition of intangible assets (142 ) (269 ) Cash flows used in investing activities (142 ) (269 ) Financing activities: Repayment of lease liability (225 ) (219 ) Cash flows used in financing activities (225 ) (219 ) Increase in cash and cash equivalents 785 841 Cash and cash equivalents, beginning of period 4,857 3,694 Cash and cash equivalents, end of period $ 5,642 $ 4,535 SOURCE: Medicure, Inc. View source version on accesswire.com:

Financial StatementPhase 3

06 Nov 2023

·www.prnewswire.com

UPSHER-SMITH LAUNCHES PITAVASTATIN TABLETS

MAPLE GROVE, Minn. , Nov. 6, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Pitavastatin Tablets in 1 mg, 2 mg, and 4 mg strengths. The Pitavastatin Tablet market had U.S. sales of approximately $302 million for the 12 months ending August 2023 according to IQVIA. Pitavastatin Tablets are an AB-rated, generic equivalent to the brand product, LIVALO® (pitavastatin) tablets.* Continue Reading Pitavastatin Tablets in 1 mg, 2 mg, and 4 mg strengths. Upsher-Smith Laboratories, LLC Sawai Group Holdings Co., Ltd.'s (Sawai) company, Sawai USA, Inc. holds the ANDA for Pitavastatin tablets. This marks Sawai's first Paragraph IV product to be launched in the United States market. Upsher-Smith will distribute the product in the U.S. Product Information For questions about ordering, please call Upsher-Smith at 1-800-654-2299. Please refer to the full Prescribing Information for Pitavastatin Tablets here . You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information . You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting . About Upsher-Smith Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. The company brings generics and brands to a wide array of customers, always backed by its attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit . *LIVALO is a registered trademark of the Kowa group of companies. SOURCE Upsher-Smith Laboratories, LLC

Drug Approval

100 Deals associated with Pitavastatin Calcium

External Link

KEGG	Wiki	ATC	Drug Bank
D01862	Pitavastatin Calcium	C10AA08	DB08860

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heterozygous familial hypercholesterolemia	US	Kowa Co., Ltd.	16 May 2019
Hyperlipidemia, Familial Combined	US	Kowa Co., Ltd.	16 May 2019
Hyperlipidemias	IN	Zydus Lifesciences Ltd.	21 Feb 2005
Hypercholesterolemia	JP	Kowa Co., Ltd.	17 Jul 2003
Hyperlipoproteinemia Type II	JP	Kowa Co., Ltd.	17 Jul 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Primary Hyperlipidemia	Phase 1	US	Kowa Research Institute, Inc.	01 Jan 2016
Dyslipidemias	Phase 1	CN	Shanxi BaoTai Pharmaceutical Co. Ltd.	06 Mar 2014
Hypercholesterolemia	Phase 1	CN	-	14 Nov 2013
Hyperlipoproteinemia Type II	Phase 1	CN	-	14 Nov 2013
Hyperlipoproteinemia Type II	Preclinical	CN	Nanjing Chenxiang Medicine Research Co., Ltd.	14 Nov 2013
Hypertension	Preclinical	KR	JW PHARMACEUTICAL Corp.	01 Aug 2011
Hyperlipidemias	Preclinical	US	Sankyo Co., Ltd. (Tokyo)	01 Feb 2005

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01710007 (CTgov)	Phase 3	Hypercholesterolemia	202	Lipitor (Lipitor)	iydwqjhknt(udgxcdvcst) = nazpouhukv qtewtbprps (ckwrxpqikx, cjqacldway - vbehadfxjq) View more	-	17 Jul 2023
				1PC002 (1PC002)	iydwqjhknt(udgxcdvcst) = rzwhixrlni qtewtbprps (ckwrxpqikx, qzejozuyvv - kvhqojzcnd) View more
NCT01660191 (SPARQ, CTgov)	Phase 4	Hypercholesterolemia	134	Pitavastin 4mg+Rosuvastatin 5mg (Atorvastatin 20mg)	oxijqcvscb(hhqgodwbio) = shyqdljnib tmyljpeuxa (ojgdkirgqz, cdazcgnehg - nqlhiecjgv) View more	-	18 Jan 2017
				Rosuvastatin 5mg+Atorvastatin 20mg (Pitavastatin 4mg)	oxijqcvscb(hhqgodwbio) = kiajarvyhu tmyljpeuxa (ojgdkirgqz, nvipfvrmrc - zkkrwtydfp) View more

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