Darifenacin Hydrobromide

Los Angeles, USA, June 07, 2021 (GLOBE NEWSWIRE) -- Overactive Bladder Pipeline Shows Rapid Advancements in the Clinical Trials: A Review by DelveInsight Overactive Bladder therapies with different mechanisms of action are currently being studied with excellent market potential. Ongoing scientific research has provided with greater sophistication and a clearer understanding of the mechanisms of therapeutic interventions, combined with improved outcome measures to assess the efficacy and patient satisfaction, as well as high-quality Overactive Bladder clinical trials with proper design, which would translate into more refined and directed therapies in future years. DelveInsight’s “Overactive Bladder Pipeline Insight” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the Overactive Bladder pipeline landscapes. It comprises Overactive Bladder pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Overactive Bladder therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Overactive Bladder pipeline products. Some of the key takeaways from the Overactive Bladder Pipeline Report Get an overview of pipeline landscape @ Overactive Bladder Clinical Trials Analysis Overactive Bladder (OAB) causes a frequent and sudden urge to urinate that may be difficult to control. One may need to pass urine many times during the day and night and may also experience unintentional loss of urine. There are six antimuscarinic agents available for the OAB treatment worldwide- oxybutynin, tolterodine, fesoterodine, trospium, darifenacin, and solifenacin. Overactive Bladder Emerging Drugs Neuronox, an acetylcholine inhibitor is being developed by Medy-Tox for the treatment of the Overactive Bladder. The active ingredients involve Clostridium botulinum toxin type A. It is currently in the phase III stage of development. In September 2020, US drugmaker Allergan entered into a license agreement with South Korea’s Medytox under the terms of which, on closing, Allergan would pay Medytox an upfront of USD 65 million and Medytox would grant Allergan exclusive rights, worldwide outside of Korea, to develop and, if approved, commercialise certain neurotoxin product candidates currently in development, including a potential liquid-injectable product. In May 2020, AbbVie announced that it had finished its acquisition of Allergan plc. following receipt of regulatory approval from all government authorities needed by the transaction agreement and approval by the Irish High Court. Research and DevelopmentPhase III NCT04113941: In August 2019, Medy-Tox initiated a phase III trial, a randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy and safety of Meditoxin in subject with Idiopathic Overactive Bladder. This study is for patients who have idiopathic overactive bladder symptoms. This study will assess the efficacy and safety of Neuronox against placebo. The trial is currently in the active not recruiting stage with an estimated enrollment of 216 participants and anticipated to be completed in August 2021. Urovant Sciences is developing URO-902 for the treatment of the Overactive Bladder. URO-902 has the potential to be the first gene therapy for OAB patients. This innovative treatment has the capability to tackle an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions pertinent to existing third-line OAB treatments. It is currently in the phase II stage of development. Research and DevelopmentPhase II NCT04211831: In December 2019, Urovant Sciences GmbH initiated a phase II trial titled “An exploratory phase IIa study evaluating the efficacy and safety of URO-902 in subjects with Overactive Bladder and Urge Urinary Incontinence”. This study will investigate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose. The trial is currently in recruiting stage with an estimated enrollment of 78 participants and expected to be completed in September 2022. Solabegron is a highly potent and selective beta-3 adrenoceptor agonist that is being developed for Overactive Bladder treatment. Solabegron has been tested in over 800 study subjects in a twice-a-day formulation and demonstrated efficacy in treating OAB and Irritable bowel syndrome (IBS). A once-daily formulation designed to optimise patient convenience and effectiveness has been developed and is currently being evaluated in phase 2b dose-ranging clinical trials. Research and DevelopmentPhase II NCT03594058: In July 2018, Velicept Therapeutics initiated a phase IIb, multicenter, randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of oral solabegron modified-release tablets in the treatment of Overactive Bladder in adult female subjects. The trial enrolled 1413 participants and was completed in May 2019. Results Velicept Therapeutics announced that its next-generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a phase IIb study in Overactive Bladder patients. In the study, twice-daily administration of solabegron showed a statistically major improvement compared to placebo at week 12, as measured by the mean change in the number of micturitions per day, the study’s primary endpoint. Solabegron also showed statistical significance across various secondary endpoints, comprising a percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes. For further information, refer to the detailed report @ Overactive Bladder Pipeline Therapeutics Scope of Overactive Bladder Pipeline Drug Insight Key Questions regarding Current Overactive Bladder Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customised pipeline report @ Overactive Bladder Drugs Pipeline Report Related Reports DelveInsight’s Overactive Bladder Market Insights, Epidemiology and Market Forecast report provides a detailed overview of the disease and a depth understanding of historical data. DelveInsight's Overactive Bladder - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Overactive Bladder in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. DelveInsight's "Interstitial Lung Disease - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Interstitial Lung Disease, historical and forecasted epidemiology. DelveInsight's Interstitial Cystitis - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease. DelveInsight's Bronchiolitis Obliterans Syndrome - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. Checkpoint Kinase Inhibitor Pipeline Insights, 2021 report by DelveInsight offers comprehensive insights of the pipeline (under development) therapeutics scenario and growth prospects across Checkpoint Kinase Inhibitor development. Browse ASCO 2021 Abstracts here:- About DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

Net revenues of $12.7 million, an increase of 90% over Q2/14 Adjusted EBITDA of $9.4 million, an increase of 188% over Q2/14 Net income of $2.2 million, first full quarter of positive earnings TORONTO, May 13, 2015 /CNW/ - Merus Labs International Inc. ("Merus" or the "Company") [TSX: MSL, NASDAQ: MSLI] is pleased to announce financial results for its second quarter of fiscal year 2015. "I am pleased to announce record financial results for the second quarter of 2015. The positive momentum of our existing products, our strong cash position and enhanced pipeline of opportunities are expected to drive continued positive results," stated Barry Fishman, Chief Executive Officer. For the three months ended March 31, 2015, the Company earned net income of $2,164,733 compared to a net loss of $1,455,185 for the three months ended March 31, 2014. Revenues for the first quarter of fiscal 2015 were $12,680,486, earnings before interest, taxes, depreciation and amortization ("EBITDA") was $9,417,277 and adjusted EBITDA which adds back non-cash share based compensation expense, foreign exchange, investment expenses and acquisition costs was $9,389,152. For the same period last year, revenues, EBITDA, and adjusted EBITDA were $6,690,464, $2,527,010 and $3,264,453, respectively. "As Merus continues to build its product line and deliver profitable growth, we will focus on four core competencies; business development, financial discipline, deal execution and commercial optimization," commented Mr. Fishman. Revenues from Sintrom, recorded on a net basis during the three months ended March 31, 2015, were $2,855,705.  During the current period, the Company recorded Sintrom revenues in the statements of operations entirely on a net basis, whereby revenues were recorded net of cost of goods and selling expenses, subject to a transition arrangement whereby Novartis continues to provide certain sales and distribution functions while the parties work through the process of transferring the necessary marketing authorizations.  As a result of this arrangement the Company is considered to be acting as an agent rather than principal and revenues are recorded on a net basis. Had the Company recorded Sintrom on a gross basis, product revenues would have been $7,074,063 and cost of goods for the product would have been $4,218,358. Revenues attributable to Enablex for the three months ended March 31, 2015 were $9,152,365.  Revenues from Enablex for the prior year comparative period were $5,474,198.  Merus is now benefiting from the expiry of a legacy promotion agreement in the German market, which previously resulted in sharing of revenue with a promotion partner.  In addition, there was some replenishing of inventories as a few shipments originally scheduled for prior quarters were pushed out in the current quarter. In-market sales of Enablex during the period continued to track as planned. Revenues attributable to Vancocin were $672,416 for the three months ended March 31, 2015, compared to $1,216,266 for the three months ended March 31, 2014. The decrease in revenue from this product in the current fiscal year was primarily due to the entry of a second generic Vancomycin which began to impact the market during the third quarter of fiscal 2014. Merus also recently entered into a co-promotion agreement for Enablex® (darifenacin), Merus Labs' overactive bladder medication and Ferring Canada's newly launched product for nocturia, Nocdurna® (desmopressin). The partnership will increase promotional efforts and is expected to generate double-digit sales increases for Enablex in Canada. Management's discussion and analysis, containing a full analysis of financial results, is available on EDGAR ( ) and on SEDAR ( ). The Company will hold a conference call tomorrow, Thursday, May 14th at 8:30am ET to discuss the first quarter fiscal 2015 results.  The conference call can be accessed by dialing (888) 241-0551 and entering conference ID 45537949.  International participants may dial (647) 427-3415.  A replay of the call will be available at this number for those not able to attend live.  The live call and archive may also be accessed via webcast at About Merus Labs International Inc. Merus Labs is a specialty pharmaceutical company focused on acquiring established products. The Company leverages its expertise in European and North American markets to optimize the value of underdeveloped pharmaceutical assets. Non-IFRS Financial Measures The terms "EBITDA" and "adjusted EBITDA" are non-IFRS measures that do not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other companies. The Company believes EBITDA and adjusted EBITDA are important measurements that allow it to assess the operating performance of its ongoing business on a consistent basis without the impact of amortization and impairment expenses, debt service obligations and other non-operating items. The Company excludes amortization and impairment expenses because their level depends substantially on non-operating factors such as the historical cost of intangible assets. The Company's method for calculating EBITDA and adjusted EBITDA may differ from that used by other issuers and, accordingly, this measure may not be comparable to EBITDA and adjusted EBITDA used by other issuers. See the Company's First Quarter 2015 MD&A for a reconciliation of these measures to loss from continuing operations (the nearest IFRS measure). Forward-Looking Statements Certain statements contained in this press release may constitute "forward-looking statements" within the meaning of the United Sates Private Securities Litigation Reform Act of 1995 and applicable Canadian securities legislation. Forward-looking statements include statements relating to the Company's future business and operating plans, the future pricing of the Company's products, the Company's ability to acquire future products, the Company's ability to secure financing to complete acquisitions, and the Company's future results of operations.  Such statements involve assumptions relating to the Company's business, including government regulation of the pricing of the Company's products, the competitive environment of the Company's products, the stability of foreign exchange rates and the availability of prospective acquisition targets.  Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results expressed or implied by these statements. Such factors include the following: general economic and business conditions, changes in demand for Merus' products, changes in competition, the ability of Merus to integrate acquisitions or complete future acquisitions, Merus' ability to complete any financing, interest rate fluctuations, currency exchange rate fluctuations, dependence upon and availability of qualified personnel and changes in government regulation. Investors should refer to the 2014 MD&A and the Company's annual reports for a more comprehensive discussion of the risks that are material to the Company and its business. In light of these and other uncertainties, the forward-looking statements included in this press release should not be regarded as a representation by Merus that Merus' plans and objectives will be achieved.  These forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements. SOURCE Merus Labs International Inc. 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