[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of fesoterodine fumarate extended-release tablets in patients with overactive bladder

评价富马酸非索罗定缓释片用于膀胱过度活动症患者的有效性和安全性

[Translation]

To evaluate the efficacy and safety of fesoterodine fumarate extended-release tablets in patients with overactive bladder

Start Date25 Aug 2023

Sponsor / Collaborator

Cisen Pharmaceutical Ltd.

[+1]

CTR20220830

/ RecruitingNot Applicable

评估受试制剂富马酸非索罗定缓释片（规格：8 mg）与参比制剂（Toviaz®）（规格：8 mg）在中国健康受试者中空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、双交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study to evaluate the bioequivalence of the test formulation, fesoterodine fumarate extended-release tablets (strength: 8 mg), and the reference formulation (Toviaz®) (strength: 8 mg) in healthy Chinese subjects under fasting and fed conditions

主要研究目的以江苏万邦生化医药集团有限责任公司研制的富马酸非索罗定缓释片（规格：8mg）为受试制剂，按生物等效性研究的有关规定，与Pfizer Europe MA EEIG持证、Pfizer Manufacturing Deutschland GmbH生产的富马酸非索罗定缓释片（参比制剂，商品名：Toviaz®，规格：8 mg）对比在健康人体内的药代动力学特征，考察两制剂的人体生物等效性。次要研究目的考察富马酸非索罗定缓释片受试制剂（规格：8 mg）和参比制剂（商品名：Toviaz®，规格：8 mg）在健康受试者中的安全性。

[Translation]

Main research purpose Using fesoterodine fumarate sustained-release tablets (specification: 8 mg) developed by Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the pharmacokinetic characteristics in healthy humans were compared with fesoterodine fumarate sustained-release tablets (reference preparation, trade name: Toviaz®, specification: 8 mg) certified by Pfizer Europe MA EEIG and produced by Pfizer Manufacturing Deutschland GmbH, to investigate the bioequivalence of the two preparations in humans. Secondary research purpose Investigate the safety of fesoterodine fumarate sustained-release tablets (specification: 8 mg) and reference preparations (trade name: Toviaz®, specification: 8 mg) in healthy subjects.

Start Date20 Feb 2022

Sponsor / Collaborator

Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.

CTR20211953

/ CompletedNot Applicable

评估富马酸非索罗定缓释片（规格：8 mg）受试制剂与参比制剂（Toviaz®）在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of fesoterodine fumarate extended-release tablets (strength: 8 mg) and the reference formulation (Toviaz®) in healthy adult subjects under fasting and fed conditions

主要试验目的：研究空腹和餐后状态下单次口服受试制剂富马酸非索罗定缓释片（规格：8 mg，广州玻思韬控释药业有限公司生产）与参比制剂富马酸非索罗定缓释片（Toviaz®，规格：8 mg；Pfizer Europe MA EEIG持证、Pfizer Manufacturing Deutschland GmbH生产）在健康受试者体内的药代动力学特征，评价空腹和餐后状态单次口服两种制剂的生物等效性。次要试验目的：研究单次口服富马酸非索罗定缓释片（规格：8 mg）受试制剂和参比制剂（Toviaz®）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation fesoterodine fumarate extended-release tablets (specification: 8 mg, produced by Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd.) and the reference preparation fesoterodine fumarate extended-release tablets (Toviaz®, specification: 8 mg; certified by Pfizer Europe MA EEIG, produced by Pfizer Manufacturing Deutschland GmbH) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after a single oral administration in the fasting and fed state. Secondary purpose of the study is to study the safety of the test preparation fesoterodine fumarate extended-release tablets (specification: 8 mg) and the reference preparation (Toviaz®) in healthy subjects after a single oral administration.

Start Date11 Sep 2021

Sponsor / Collaborator

Cisen Pharmaceutical Ltd.

100 Clinical Results associated with Fesoterodine Fumarate

100 Translational Medicine associated with Fesoterodine Fumarate

100 Patents (Medical) associated with Fesoterodine Fumarate

458

Literatures (Medical) associated with Fesoterodine Fumarate

01 Apr 2025·Urogynecology (Philadelphia, Pa.)

Trends in Medicare Coverage of Overactive Bladder Medications in the United States

Article

Author: Wallace, Megan B. ; Gaddam, Neha G. ; Dieter, Alexis A.

Importance:

Strong evidence demonstrates long-term cognitive decline associated with anticholinergics. While prevalent among older populations, medical management of overactive bladder (OAB) is dictated by insurance coverage rather than medical provider and patient preferences.

Objective:

The aim of this study was to assess Medicare insurance plan coverage for select OAB medications and evaluate coverage of preferred medications to medications with a greater risk of cognitive dysfunction.

Study Design:

This cross-sectional study analyzed formularies and coverage tiers across 6 U.S. insurers for the following OAB medications: oxybutynin instant-release (IR) 5 mg, oxybutynin extended-release (ER) 5 mg, tolterodine IR 1 mg, tolterodine ER 2 mg, fesoterodine ER 4 mg, darifenacin 7.5 mg, solifenacin 5 mg, trospium IR 20 mg, trospium ER 60 mg, mirabegron 25 mg, and vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, tolterodine, fesoterodine, darifenacin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, a weighted distribution based on coverage tier frequency relative to the number of plans investigated, were generated with a lower score indicating better coverage (range, 0.2–1.0).

Results:

One thousand six hundred nineteen insurance plans representing an estimated 47% of the market share were evaluated. Oxybutynin IR had the best coverage score across insurers (0.4), whereas trospium ER had the worst (0.89). Preferred medications had worse coverage versus nonpreferred medications (P < 0.001). Centene had the best overall coverage and lowest initiation cost, whereas Aetna/CVS had the best coverage and initiation cost for preferred medications.

Conclusions:

Beta-3 agonists had worse coverage across insurers nationwide. Current trends in Medicare coverage reveal a need for improved coverage of preferred OAB medications for an aging population already at risk of cognitive dysfunction.

01 Feb 2025·JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Brain distribution and muscarinic receptor occupancy of an active metabolite of fesoterodine in rats

Article

Author: Kubo, Yoshiyuki ; Kurosawa, Toshiki ; Tanaka, Shimako ; Okura, Takashi ; Nakatani, Eriko ; Shiho, Mizuki ; Deguchi, Yoshiharu

Several large-scale clinical trials have shown that long-term use of antimuscarinic agents for overactive bladder treatment increases the risk of dementia and that this risk varies between agents. Fesoterodine, an overactive bladder antimuscarinic, reportedly has no significant effect on cognitive function. Differences in the brain distribution of antimuscarinic agents and blockade of muscarinic receptors could be the reasons for the differences in central side effects among antimuscarinics. In this study, we assessed the brain distribution of antimuscarinic agents and muscarinic receptor occupancy using brain microdialysis and in vivo receptor-binding analysis in rats. The test drugs were 5-hydroxymethyl tolterodine (5-HMT), an active metabolite of fesoterodine, oxybutynin, and trihexyphenidyl, a central antimuscarinic agent. The brain/plasma unbound concentration ratio at steady state (K_puu) of 5-HMT was much lower than that of oxybutynin and trihexyphenidyl, indicating very low 5-HMT distribution in the brain. The muscarinic receptor occupancy in the rat brain at clinical plasma concentrations of 5-HMT was rarely observed, whereas the occupancy by oxybutynin and trihexyphenidyl was 20% and 67%, respectively. The brain muscarinic receptor occupancy, reconstituted using K_puu values and muscarinic receptor affinity retrieved from literature, revealed a significant correlation between the calculated and measured values. These results indicate that 5-HMT has low brain distribution and muscarinic receptor occupancy, which might be the reasons for the insignificant effect of fesoterodine on cognitive function. SIGNIFICANCE STATEMENT: This study reports that 5-hydroxymethyl tolterodine, the active metabolite of fesoterodine, has much lower brain distribution and muscarinic receptor occupancy compared with oxybutynin and trihexyphenidyl based on brain microdialysis and in vivo receptor-binding analysis with unlabeled muscarinic tracer in rats. The low brain distribution and muscarinic receptor occupancy of 5-hydroxymethyl tolterodine might be the reasons for the insignificant effect of fesoterodine on cognitive function.

01 Feb 2025·BMJ medicine

Bladder drugs and risk of dementia: Danish nationwide active comparator study

Article

Author: Janbek, Janet ; Waldemar, Gunhild ; Gasse, Christiane ; Meaidi, Amani ; Pourhadi, Nelsan ; Jensen-Dahm, Christina ; Laursen, Thomas Munk

Objective:

To assess the association between cumulative use of anticholinergic bladder drugs and risk of all cause dementia compared with non-use and use of the β3 agonist bladder drug, mirabegron.

Design:

Danish nationwide active comparator study.

Setting:

National Danish registries, 1 January 2000 to 31 December 2022.

Participants:

1 29 254 individuals with dementia were matched by age and sex to 646 270 controls without dementia, identified from a cohort of 2.26 million individuals aged 60-75 years between 2000 and 2022 with no previous dementia. Two separate nested case-control populations were studied: the general population and an active comparator population of 58 242 new users of bladder drugs (2198 developed dementia and were matched to 10 990 controls). Information on medication use was based on filled prescriptions and defined daily doses.

Main outcome measures:

Conditional logistic regression provided incidence rate ratios for associations between anticholinergic bladder drugs and dementia compared with non-use and mirabegron use adjusted for educational level, cardiovascular disease, diabetes, hypertension, dyslipidaemia, and Charlson Comorbidity Index.

Results:

Compared with non-use, ever use of anticholinergic bladder drugs was associated with an increased risk of dementia, with an incidence rate ratio of 1.44 (95% confidence interval (CI) 1.40 to 1.48). The incidence rate ratio increased with increasing cumulative drug use, from 1.31 (95% CI 1.27 to 1.36) for 1-90 defined daily doses to 1.68 (1.59 to 1.76) for >365 defined daily doses. Compared with non-use, all types of anticholinergic bladder drugs were associated with increased incidence rate ratios for dementia: tolterodine 1.43 (95% CI 1.38 to 1.49), solifenacin 1.37 (1.29 to 1.46), trospium 1.52 (1.37 to 1.67), and fesoterodine 1.48 (1.26 to 1.74). The increased risk of dementia with use of anticholinergic bladder drugs was not seen when compared directly with the use of the β3 agonist mirabegron (incidence rate ratio 0.82, 95% CI 0.74 to 0.92), irrespective of the type of anticholinergic drug.

Conclusions:

In this study, all types of anticholinergic bladder drugs were associated with an increased risk of dementia compared with non-use, but not when applying the active comparator of the β3 agonist bladder drug mirabegron. These findings highlight the relevance of using an active comparator. Future research should evaluate the risk of cognitive impairment and dementia for both types of bladder drugs.

News (Medical) associated with Fesoterodine Fumarate

08 Jul 2022

·www.biospace.com

Dr. Reddy's Laboratories Announces the Launch of Fesoterodine Fumarate Extended-Release Tablets in the U.S. Market

HYDERABAD, India &PRINCETON, N.J.--(BUSINESS WIRE)-- Dr. Reddy's Laboratories, Inc. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) announces the launch of Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets in the U.S. market following the approval by the U.S. Food and Drug Administration (USFDA). The Toviaz® brand had U.S. sales of approximately $211 million MAT for the most recent twelve months ending in May 2022 according to IQVIA. Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30. Please click here to see the full prescribing information: . Toviaz is a trademark of Pfizer Inc. RDY-0622-424 About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2022. The company assumes no obligation to update any information contained herein.

Generic DrugBiosimilarAcquisition

29 Jun 2022

·www.prnewswire.com

Interstitial Cystitis Drugs Market Recorded 4.81% Y-O-Y Growth Rate in 2021| Evolving Opportunities with Perrigo Co. Plc & Pfizer Inc | Technavio

NEW YORK, June 29, 2022 /PRNewswire/ -- The Interstitial Cystitis Drugs Market report provides a detailed analysis of the competitive scenario, the pre-and post-COVID-19 impact on businesses, and the market growth across various regions. The interstitial cystitis drugs market size is expected to increase by USD 283.95 million, at a CAGR of 5.06% from 2020 to 2025. Technavio categorizes the interstitial cystitis drugs market as a part of the global pharmaceuticals market within the overall healthcare industry. Our research report has extensively covered external factors influencing the parent market growth potential in the coming years, which will determine the levels of growth of the interstitial cystitis drugs market during the forecast period. Technavio has announced its latest market research report titled Interstitial Cystitis Drugs Market by Type and Geography - Forecast and Analysis 2021-2025 For more highlights on the parent market analysis - Request a sample now! Market Dynamics Drivers: The high prevalence of interstitial cystitis is notably driving the interstitial cystitis drugs market growth Trends: Increasing awareness of interstitial cystitis is the key market trend driving the interstitial cystitis drugs market growth. Challenges: The major challenge impeding the interstitial cystitis drugs market growth is the lack of approved drugs. For detailed highlights on the market dynamics - Click Now! Segmentation Analysis By Type, the market is classified into oral therapy and intravesical therapy. The interstitial cystitis drugs market share growth by the oral therapy segment will be significant for revenue generation. Pentosan polysulfate sodium (ELMIRON) is the only approved oral medication to repair the lining of the bladder in people with interstitial cystitis (IC). ELMIRON builds and restores the protective coating of the bladder tissue. There are many off-label oral drugs in the interstitial cystitis drugs market that can reduce the signs and symptoms of the disease facilitating the growth of the segment during the forecast period. By Geography, the market is classified as North America, Europe, Asia, and ROW. 36% of the market's growth will originate from North America during the forecast period. The US is a key market for interstitial cystitis drugs in North America. However, the market growth rate in this region will be slower than the growth of the market in Asia and Europe. The increasing cases of interstitial cystitis and a rise in research funding will facilitate the interstitial cystitis drugs market growth in North America over the forecast period. Company Profiles The interstitial cystitis drugs market is fragmented and the vendors are deploying various organic and inorganic growth strategies to compete in the market. The interstitial cystitis drugs market report provides complete insights on key vendors including Astellas Pharma Inc., Bayer AG, Johnson and Johnson Inc., Novartis AG, Perrigo Co. Plc, Pfizer Inc., Seikagaku Corp., Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Viatris Inc. Key Offerings: Perrigo Co. Plc - The company offers pain and sleep aids such as Ibuprofen. Pfizer Inc. - The company offers an interstitial cystitis drug named Toviaz. Seikagaku Corp. - The company is developing the interstitial cystitis and bladder pain syndrome drug SI-722. Sun Pharmaceutical Industries Ltd. - The company offers interstitial cystitis drugs such as Cystopen capsules Teva Pharmaceutical Industries Ltd. The company offers interstitial cystitis drugs such as VESIcare (solifenacin succinate) Tablets. To know about all major vendor offerings - Grab a sample now! Get ready to achieve excellent business outcomes from this exclusive Interstitial Cystitis Drugs Market report by Technavio. The report will include highlights of the overall market which includes frequently asked questions such as - What are historical revenue figures and estimated revenue figures as well as CAGR during the forecast timeframe? What is the current trend taking place in the market space? Which are business tactics that will influence competitive scenarios along with defining the growth potential of the market? What are market drivers, restraints, and challenges impacting demand & growth of the market? Which regions & segments will garner massive revenue and emerge as market leaders in upcoming years? The competitive scenario provided in the Interstitial Cystitis Drugs Market report analyzes, evaluates, and positions companies based on various performance indicators. Some of the factors considered for this analysis include the financial performance of companies over the past few years, growth strategies, product innovations, new product launches, investments, growth in market share, etc. Don't wait, Make a strategic approach & boost your business goals with our Interstitial Cystitis Drugs Market Forecast Report - Buy Now! Related Reports: The uveitis drugs market share is expected to increase to USD 269.65 million from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 5.9%. The vitiligo therapeutics market share is expected to increase to USD 341.35 million from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 4.5%. Table of Content 1 Executive Summary 2 Market Landscape 2.1 Market ecosystem Exhibit 01: Parent market Exhibit 02: Market characteristics 2.2 Value chain analysis Exhibit 03: Value chain analysis: Pharmaceuticals 3 Market Sizing 3.1 Market definition Exhibit 04: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 05: Market segments 3.3 Market size 2020 3.4 Market outlook: Forecast for 2020 - 2025 Exhibit 06: Global - Market size and forecast 2020 - 2025 ($ million) Exhibit 07: Global market: Year-over-year growth 2020 - 2025 (%) 4 Five Forces Analysis 4.1 Five forces summary Exhibit 08: Five forces analysis 2020 & 2025 4.2 Bargaining power of buyers Exhibit 09: Bargaining power of buyers 4.3 Bargaining power of suppliers Exhibit 10: Bargaining power of suppliers 4.4 Threat of new entrants Exhibit 11: Threat of new entrants 4.5 Threat of substitutes Exhibit 12: Threat of substitutes 4.6 Threat of rivalry Exhibit 13: Threat of rivalry 4.7 Market condition Exhibit 14: Market condition - Five forces 2020 5 Market Segmentation by Type 5.1 Market segments Exhibit 15: Type - Market share 2020-2025 (%) 5.2 Comparison by Type Exhibit 16: Comparison by Type 5.3 Oral therapy - Market size and forecast 2020-2025 Exhibit 17: Oral therapy - Market size and forecast 2020-2025 ($ million) Exhibit 18: Oral therapy - Year-over-year growth 2020-2025 (%) 5.4 Intravesical therapy - Market size and forecast 2020-2025 Exhibit 19: Intravesical therapy - Market size and forecast 2020-2025 ($ million) Exhibit 20: Intravesical therapy - Year-over-year growth 2020-2025 (%) 5.5 Market opportunity by Type Exhibit 21: Market opportunity by Type 6 Customer landscape 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 23: Market share by geography 2020-2025 (%) 7.2 Geographic comparison Exhibit 24: Geographic comparison 7.3 North America - Market size and forecast 2020-2025 Exhibit 25: North America - Market size and forecast 2020-2025 ($ million) Exhibit 26: North America - Year-over-year growth 2020-2025 (%) 7.4 Europe - Market size and forecast 2020-2025 Exhibit 27: Europe - Market size and forecast 2020-2025 ($ million) Exhibit 28: Europe - Year-over-year growth 2020-2025 (%) 7.5 Asia - Market size and forecast 2020-2025 Exhibit 29: Asia - Market size and forecast 2020-2025 ($ million) Exhibit 30: Asia - Year-over-year growth 2020-2025 (%) 7.6 ROW - Market size and forecast 2020-2025 Exhibit 31: ROW - Market size and forecast 2020-2025 ($ million) Exhibit 32: ROW - Year-over-year growth 2020-2025 (%) 7.7 Key leading countries Exhibit 33: Key leading countries 7.8 Market opportunity by geography Exhibit 34: Market opportunity by geography ($ million) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges Exhibit 35: Impact of drivers and challenges 8.3 Market trends 9 Vendor Landscape 9.1 Overview 9.2 Vendor landscape Exhibit 36: Vendor landscape 9.3 Landscape disruption Exhibit 37: Landscape disruption Exhibit 38: Industry risks 10 Vendor Analysis 10.1 Vendors covered Exhibit 39: Vendors covered 10.2 Market positioning of vendors Exhibit 40: Market positioning of vendors 10.3 Astellas Pharma Inc. Exhibit 41: Astellas Pharma Inc. - Overview Exhibit 42: Astellas Pharma Inc. - Product and service Exhibit 43: Astellas Pharma Inc. - Key news Exhibit 44: Astellas Pharma Inc. - Key offerings 10.4 Bayer AG Exhibit 45: Bayer AG - Overview Exhibit 46: Bayer AG - Business segments Exhibit 47: Bayer AG - Key news Exhibit 48: Bayer AG - Key offerings Exhibit 49: Bayer AG - Segment focus 10.5 Johnson and Johnson Inc. Exhibit 50: Johnson and Johnson Inc. - Overview Exhibit 51: Johnson and Johnson Inc. - Business segments Exhibit 52: Johnson and Johnson Inc. - Key news Exhibit 53: Johnson and Johnson Inc. - Key offerings Exhibit 54: Johnson and Johnson Inc. - Segment focus 10.6 Novartis AG Exhibit 55: Novartis AG - Overview Exhibit 56: Novartis AG - Business segments Exhibit 57: Novartis AG - Key news Exhibit 58: Novartis AG - Key offerings Exhibit 59: Novartis AG - Segment focus 10.7 Perrigo Co. Plc Exhibit 60: Perrigo Co. Plc - Overview Exhibit 61: Perrigo Co. Plc - Business segments Exhibit 62: Perrigo Co. Plc - Key news Exhibit 63: Perrigo Co. Plc - Key offerings Exhibit 64: Perrigo Co. Plc - Segment focus 10.8 Pfizer Inc. 10.9 Seikagaku Corp. Exhibit 69: Seikagaku Corp. - Overview Exhibit 70: Seikagaku Corp. - Business segments Exhibit 71: Seikagaku Corp. - Key offerings Exhibit 72: Seikagaku Corp. - Segment focus 10.10 Sun Pharmaceutical Industries Ltd. Exhibit 73: Sun Pharmaceutical Industries Ltd. - Overview Exhibit 74: Sun Pharmaceutical Industries Ltd. - Product and service Exhibit 75: Sun Pharmaceutical Industries Ltd. - Key news Exhibit 76: Sun Pharmaceutical Industries Ltd. - Key offerings 10.11 Teva Pharmaceutical Industries Ltd. Exhibit 77: Teva Pharmaceutical Industries Ltd. - Overview Exhibit 78: Teva Pharmaceutical Industries Ltd. - Business segments Exhibit 79: Teva Pharmaceutical Industries Ltd. - Key offerings Exhibit 80: Teva Pharmaceutical Industries Ltd. - Segment focus 10.12 Viatris Inc. Exhibit 81: Viatris Inc. - Overview Exhibit 82: Viatris Inc. - Business segments Exhibit 83: Viatris Inc. - Key offerings Exhibit 84: Viatris Inc. - Segment focus 11 Appendix 11.1 Scope of the report 11.2 Currency conversion rates for US$ Exhibit 85: Currency conversion rates for US$ 11.3 Research methodology Exhibit 86: Research Methodology Exhibit 87: Validation techniques employed for market sizing Exhibit 88: Information sources 11.4 List of abbreviations Exhibit 89: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

08 Jun 2021

·www.globenewswire.com

Overactive Bladder Pipeline Shows Rapid Advancements in the

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.

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100 Deals associated with Fesoterodine Fumarate

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KEGG	Wiki	ATC	Drug Bank
D08923	Fesoterodine Fumarate	G04BD11	DB06702

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Urinary Bladder, Neurogenic	Japan	Pfizer Japan, Inc.	26 Sep 2022
Neurogenic detrusor overactivity	United States	Pfizer Inc.	17 Jun 2021
Urinary Incontinence, Urge	Japan	Pfizer Japan, Inc.	25 Dec 2012
Urinary Bladder, Overactive	United States	Pfizer Inc.	31 Oct 2008
Overactive bladder syndrome	European Union	Pfizer Europe MA EEIG	20 Apr 2007
Overactive bladder syndrome	Iceland	Pfizer Europe MA EEIG	20 Apr 2007
Overactive bladder syndrome	Liechtenstein	Pfizer Europe MA EEIG	20 Apr 2007
Overactive bladder syndrome	Norway	Pfizer Europe MA EEIG	20 Apr 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pollakisuria	Phase 3	China	Guangzhou Bosto Controlled-Release Pharmaceutical Co Ltd.	25 Aug 2023
Pollakisuria	Phase 3	China	Cisen Pharmaceutical Ltd.	25 Aug 2023
Urinary urgency	Phase 3	China	Guangzhou Bosto Controlled-Release Pharmaceutical Co Ltd.	25 Aug 2023
Urinary urgency	Phase 3	China	Cisen Pharmaceutical Ltd.	25 Aug 2023
Brain Diseases	Phase 3	United States	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	Japan	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	Belgium	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	Canada	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	Estonia	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	Finland	Pfizer Inc.	02 Jul 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04090190 (CTgov)	Phase 4	Urinary Incontinence \| Urinary urgency \| Inflammation	20	Oxybutynin+Tolterodine+Trospium+Solifenacin+Fesoterodine	eagipdaftu(juffzlnbhv) = bmgmvdtzil pmlffqfveo (lawxqduvgl, iavztvsxlx - bheqmnvfkk) View more	-	03 Oct 2022
NCT03946124 (Pubmed \| Female Pelvic Med Reconstr Surg)	Phase 4	Urinary Bladder, Overactive	75	Fesoterodine	kjhxtojonz(jgqsnedwax) = afmgvolhyq tcubyjgcdt (dnetdgvzyh )	-	01 Dec 2021
NCT02501928 (CTgov)	Phase 3	Urinary Bladder, Neurogenic \| Neurogenic detrusor overactivity \| Urinary Bladder, Overactive	12	fesoterodine (Cohort 1)	olupuolhqo = vjztqxlxmp mdvajjgqvd (wiwamuhkkt, ggmjdgvuxa - xpsszrlsjf) View more	-	26 Oct 2020
NCT02501928 (CTgov)	Phase 3		12	fesoterodine (Cohort 2)	olupuolhqo = inerbcfoge mdvajjgqvd (wiwamuhkkt, cqziecysno - aqtvrfmxis) View more	-	26 Oct 2020
NCT03946124 (CTgov)	Phase 4	Urinary Bladder, Overactive	74	Fesoterodine	qpdwnlrgod(rkasgdvnfa) = fnbqhmfvyz lddnctalgf (juwfgnwcep, dsirwgrekt - ndsjryzepj) View more	-	11 Dec 2019
AUA2019	Phase 2	Neurogenic detrusor overactivity	10	Fesoterodine	oixepvvkkj(sjwdowjjfi) = mjfgdqcuui ylbkjjbuyd (oajbqvpxej ) View more	-	01 Apr 2019
NCT00605319 (Toviaz, CTgov)	Phase 4	Prostatic Hyperplasia \| Urinary Bladder Neck Obstruction \| Urinary Bladder, Overactive	17	Toviaz	vxrfprmzdf(mcxinkzhmd) = xalkdjmgec stqoshkqwd (reklcuorad, aulspymbzq - rvesaakwis) View more	-	10 Apr 2018
AUA2016	Not Applicable	Urinary Bladder, Overactive	33	EARLY MUSCARINIC BLOCKADE (SCT control)	fzuaodegyh(vvlbylvptb) = kphlfhfuno yklwnulcte (anfpgxgbqa ) View more	-	01 Apr 2016
NCT01367886 (CTgov)	Not Applicable	Urinary Bladder, Overactive	21	fesoterodine	tbpeovozdz(damxzchzyb) = dleljudbdv jxokswoymw (kcaysbwuli, 4.88) View more	-	12 Jan 2015
PD23-02 (AUA2014)	Not Applicable	Lower Urinary Tract Symptoms	67	Fesoterodine 4-8mg	avjbhjjmbs(bohpjqpcfx) = clshcxfctg cmiqhbiput (yqppburnqb )	Positive	01 Apr 2014
NCT00928070 (Pubmed \| J Urol)	Phase 4	Urinary Incontinence	562	Fesoterodine	fwmbxvlyih(pntzcqvygr) = aemdwwzpow kzikqungcy (jzbfsbvcsf )	Positive	01 Feb 2014
NCT00928070 (Pubmed \| J Urol)	Phase 4	Urinary Incontinence	562	Placebo	fwmbxvlyih(pntzcqvygr) = pijkntrjih kzikqungcy (jzbfsbvcsf )	Positive	01 Feb 2014

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