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Category Archives: Testosterone
Fortress Reports Positive Data And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha
Posted: August 31, 2020 at 6:55 am
Fortress Biotech reports positive data from CUTX-101
Fortress Biotech Inc. (FBIO) reported positive topline clinical efficacy data for CUTX-101. The trial is being conducted by its partner company Cyprium Therapeutics. The data showed the drug candidate brought about statistically significant improvement in overall survival for Menkes disease. CUTX-101 has been given Orphan Drug, Fast Track and Rare Pediatric Disease Designations by the FDA.
The primary efficacy endpoint for the trial is overall survival measured from birth. The primary efficacy analysis compared overall survival in Menkes disease patients who were administered daily dose of CUTX-101 beginning within four weeks of age to a historical control cohort of patients who were not given copper therapy. Primary efficacy analysis included 31 Menkes disease patients who received ET with CUTX-101 and 18 HC Menkes disease patients. The trial met the primary endpoint of overall survival.
The drug candidate brought about nearly 80 percent reduction in the risk of death whereas median survival for the ET cohort was 14.8 years or 177.1 months compared to 1.3 years 15.9 months for the untreated HC cohort. S. Yam, CEO of Cyprium said, These positive topline clinical efficacy data highlight the potential of CUTX-101 as an effective therapy for Menkes disease patients. With no currently approved U.S. Food and Drug Administration (FDA) treatments, Menkes disease is a serious condition with a significant unmet medical need.
The ET cohort participants carried a severe pathogenic mutation of the ATP7A gene and were born within the past 20 years. The treatment with CUTX-101 was initiated within four weeks of age, adjusted for prematurity. The participants survived at least four weeks after birth and were asymptomatic for significant neurological signs and symptoms during the first four weeks.
HC cohort participants carried a severe pathogenic mutation of the ATP7A gene and were also born within the past 20 years. These participants have not received CUTX-101 therapy and have survived at least four weeks after birth. The patients were asymptomatic for significant neurological signs and symptoms during the first four weeks.
CUTX-101 is a subcutaneous injectable formulation of Copper Histidinate. It has been manufactured to offer improved tolerability due to physiological pH and to circumvent the oral absorption of copper, which is diminished in patients suffering from Menkes disease. The drug candidate is being clinically developed for treating Menkes disease. It aims to treat the ailment by reloading Copper Histidinate, repairing copper homeostasis, and retaining serum copper levels in the normal age appropriate range. The enrollment for a Phase 3 trial of CUTX-101 has been completed. Currently, a Cypriot-sponsored expanded access protocol for Menkes disease patients is being carried out.
Cyprium Therapeutics is mainly engaged in developing therapies for treating Menkes disease and related copper metabolism disorders. It has been founded by Fortress Biotech Inc., which is mainly invested in acquiring, developing and commercializing high-potential marketed pharmaceutical products. It also deals in development-stage pharmaceutical product candidates. Fortress Biotech has five marketed prescription pharmaceutical products in its portfolio. It has robust development pipeline with over 25 programs spanning a wide range of market segments including oncology and gene therapy.
Lipocine Inc. (LPCN) provided regulatory update for its lead drug candidate Tlando. The company has been informed by the FDA that it required additional time to complete its review of the New Drug Application. The anticipated Prescription Drug User Food Act goal date was set at August 28, 2020. The FDA has not provided any alternate timeline or a new action date. The regulator has not demanded any additional data.
TLANDO is an oral testosterone replacement therapy product candidate. It comprises Testosterone Undecanoate, which helps in restoring normal testosterone levels in males for conditions associated with a deficiency or absence of endogenous testosterone. Lipocine has faced several roadblocks for Tlando. The company had received its third Complete Response Letter in November 2019. It had previously received CRLs in June 2016 and May 2018 as well.
The company had recently reported its second quarter results. Lipocine suffered a net loss of $6.4 million or $0.13 per diluted shares for the second quarter. The company had reported $3.4 million in net loss for the corresponding quarter of the previous year. Its research and development expenses for the quarter increased from $2 million to $2.3 million on year over year basis. Its General and Administrative expenses also jumped from $1.4 million to $2 million for the second quarter.
Lipocine Inc. has a robust developmental pipeline with various candidates such as TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. LPCN 1144 is a product of bioidentical testosterone. The drug candidate recently completed a proof-of-concept clinical study showing its potential effectiveness in treating non-cirrhotic NASH. TLANDO XR is a novel oral prodrug of testosterone and LPCN 1148 is an oral prodrug of bioidentical testosterone aimed to treat cirrhosis.
Enanta Pharmaceuticals Inc. (ENTA) reported updates for its non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV) development programs. The company is currently working on EDP-305 and EDP-297 for treating NASH. Its EDP-514 is being developed for treating HBV.
Phase 2a ARGON-1 study of EDP-305, its lead Farnesoid Xreceptor (FXR) agonist, showed that the drug candidate met its primary endpoint with statistically significant reduction in alanine transaminase of 28 U/L in comparison to 15 U/L in the placebo cohort at week 12. EDP-305 at the 2.5mg dose also showed statistically significant reduction in liver fat content as measured by MRI-PDFF. The drug candidate also showed robust target engagement as evidenced by decrease in C4 and the increase in FGF-19.
EDP-297 substantially decreased fibrosis progression and enhanced liver function as measured by key biomarkers in a rat model. Rats were randomized to be administered either vehicle control (0.5% methylcellulose), 0.1 mg/kg EDP-297, or 0.3 mg/kg EDP-297 by once-daily oral gavage at the first signs of fibrosis. The data showed that the drug candidate may have a potent anti-fibrotic effect in NASH patients, including those with late-stage F3/4 fibrosis.
The data from first in human, Phase 1 study of EDP-514 showed that it was rapidly absorbed. Its exposure magnified with escalating single and multiple dosing of 600 mg and 400 mg, respectively. The drug candidate was found to be generally safe and well tolerated over a broad spectrum of single and multiple doses for up to 14 days. The trial did not report any discontinuations due to adverse events. EDP-514 demonstrated pharmacokinetics suitable for once daily oral dosing. The geometric mean plasma concentration at 24 hours was found to be significantly higher after multiple dosing with and without a standard meal. The drug candidate is currently being evaluate in two Phase 1b clinical studies.
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That means that when the catalyst comes that will make or break a stock, weve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.
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Fortress Reports Positive Data And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha
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Testosterone Replacement Therapy Market 2020 Size Scope and Comprehensive Analysis, Industry Size, Growth, Trends, Analysis and Forecast 2024 -…
Posted: August 30, 2020 at 2:58 am
The Testosterone Replacement Therapy Market report, added by Global Marketers, descriptively covers the present & future growth trends, in addition to highlighting the global expanse of this industry and elaborating on the regional share and contribution of each region of the Testosterone Replacement Therapy Market. The study evaluates the competitive environment, strategies undertaken by prominent players, supply & demand analysis, and revenue growth statistics.
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AbbVieEndo InternationalEli lillyPfizerActavis (Allergan)BayerNovartisTevaMylanUpsher-SmithFerring PharmaceuticalsKyowa KirinAcerus Pharmaceuticals
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The chapter on regional segmentation details the regional aspects of the global Testosterone Replacement Therapy Market. It highlights the political situation in the market and anticipates its influence on the global Testosterone Replacement Therapy Market.
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Testosterone Replacement Therapy Market Segmentation
Testosterone Replacement Therapy Market, By Type:
GelsInjectionsPatchesOther
Testosterone Replacement Therapy Market, By Applications:
HospitalsClinicsOthers
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Key Highlights of the Testosterone Replacement Therapy Market Report:
Table ofContents
Global Testosterone Replacement Therapy Market Report 2020-2024
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Testosterone Replacement Therapy Market 2020 Size Scope and Comprehensive Analysis, Industry Size, Growth, Trends, Analysis and Forecast 2024 -...
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Global Testosterone Replacement Therapy Market Industry: A Latest Research Report to Share Market Insights and Dynamics – Bulletin Line
Posted: August 30, 2020 at 2:58 am
The recent research report titled 2015-2025 Global Testosterone Replacement Therapy Market Research by Type, End-Use and Region (COVID-19 Version) has been added in the kandjmarketresearch.com database. This market report is a valuable source of insightful data for business strategists. It offers the industry overview with growth analysis and historical & futuristic cost, revenue, demand, and supply data (as applicable). The report explores the current outlook in global and key regions from the perspective of players, countries, product types, and end industries. This Testosterone Replacement Therapy Market study provides comprehensive data that enhances the understanding, scope, and application of this report.
Market Overview
Indispensable insights of the Testosterone Replacement Therapy market are elaborated in the report. The core objective of the report is to deliver reliable and concrete information about the Testosterone Replacement Therapy market that can assist the businessmen to make rational decisions. The expected CAGR and valuation of the Testosterone Replacement Therapy market are mentioned in the report. Proficient analysts have studied the market for the evaluation year of 2020 to 2025. Significant factors that are likely to promote the growth of the Testosterone Replacement Therapy market and possible constraints of the market are elaborated in this market research report. Potential growth scopes are also elaborated in the report. The Testosterone Replacement Therapy market studied in segments to provide information about the same market that encompasses crucial aspects of the Testosterone Replacement Therapy industry or market. The regional progress of the Testosterone Replacement Therapy market is studied under the regional outlook section. A lucid understanding of the transforming competitive landscape of the market can assist investors in several ways. North America, Europe, and APAC are key regions across which is in the studied. For the Rest of the World (RoW), the Testosterone Replacement Therapy market is analyzed across Latin America, South America, and the Middle East Asia and Africa.
The latest report includes Impact of Coronavirus(Covid-19) on the Testosterone Replacement Therapy Industry, it includes on Industry Upstream, Industry Downstream, Industry Channels, Industry Competition, and finally on Industry Employment.
The Final Report Will Include the Impact of COVID 19 Analysis in This Industry. For Sample Report & Graphs & Charts @: https://www.kandjmarketresearch.com/sample-request/460426
Critical questions the report answers:
Key Players overview
Credible sources, such as surveys, financial magazines, and whitepapers are referred for listing key players of the Testosterone Replacement Therapy market. However, interviews with well-known personalities, such as CEOs, COO, and entrepreneurs are accepted as the most effective tool to prepare contribution of key players towards the growth of the Testosterone Replacement Therapy market. Past aspects and current trends of market players in the Testosterone Replacement Therapy market are elaborated in the report. The financial status of market players and their contributions are discussed in the report that offers a clear understanding to the investors and aids them in making rational decisions.
Key Companies:
Key Types:-
Key End-Use:-
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Research Methodology:
Research methodologies utilized in cooking the report are rigorous and fail-safe. The robust scoring process is employed to deliver an objective and accurate overview of the Testosterone Replacement Therapy market. Modern research techniques used to offer vivid qualitative and qualitative findings of the Testosterone Replacement Therapy industry. The powerful research techniques used to study the Testosterone Replacement Therapy market aid in the collection of evidence and data to deliver precise report. The market research firm uses various tools for the collection of information for primary and secondary analysis of the Testosterone Replacement Therapy market to prepare a report that can be an ultimate guide for investors. Top-down and bottom-up approaches maintained for the assessment of the Testosterone Replacement Therapy market for the forecast years ensures high-quality and valuable insights into the Testosterone Replacement Therapy market.
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What Global Testosterone Replacement Therapy Market Report Offers?
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Global Testosterone Replacement Therapy Market Industry: A Latest Research Report to Share Market Insights and Dynamics - Bulletin Line
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Testosterone Replacement Therapy market to Grow at a Whopping 4.4% from 2019 to 2027 – The Daily Chronicle
Posted: August 27, 2020 at 2:56 pm
Transparency Market Research (TMR)has published a new report titled, Testosterone Replacement Therapy Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027.According to the report, the globalTestosterone Replacement Therapy marketwas valued atUS$ 1,613.7 Mnin2018and is projected to expand at a CAGR of4.4%from2019to2027.
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Overview
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Growing Awareness about Testosterone Replacement Therapy to Drive Market
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Competitive Landscape
The global Testosterone Replacement Therapy market is fragmented in terms of number of players. Key players in the global market includeAbbVie, Inc., Allergan plc, Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Mylan N.V., Novartis AG, Pfizer, Inc., Clarus Therapeutics, and Ferring Holding SA, among others
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Transparency Market Research is a global market intelligence company providing global business information reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insight for several decision makers. Our experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.
Our data repository is continuously updated and revised by a team of research experts so that it always reflects latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.
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Testosterone Replacement Therapy Sales Market Still Has Room to Grow With Emerging Players 2027 – The Daily Chronicle
Posted: August 27, 2020 at 2:56 pm
(Augest 2020) SMI published a business research report on Testosterone Replacement Therapy Sales Market: Global Industry Analysis, Size, Share, Growth,Trends, and Forecasts 20202027. Research reportwith 110+ pages on market data Tables, Pie Chat, Graphs & Figures spread through Pages and easy to understand detailed analysis. The information is gathered based on modern floats and requests identified with the administrations and items.
Key players are expected to enhance their marketing capabilities over the forecast period owing to certain market conditions. The report presents certain elements that will reflect whats and hows of such changes in the market. Further, the report studies various aspects of the global market such as upstream raw materials, downstream demand, and production value of leading players subject to market growth.
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Geographical segmentation of the Testosterone Replacement Therapy Sales Market involves the regional outlook which further covers the United States, China, Europe, Japan, Southeast Asia and Middle East & Africa. This report categorizes the market based on manufacturers, regions, type and applications.
Testosterone Replacement Therapy Sales Market: Competitive Landscape
Leading players operating in the global Testosterone Replacement Therapy Sales market include AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals.
Scope of the Report:
The key features of the Testosterone Replacement Therapy Sales Market report 2020-2027 are the organization, extensive amount of analysis and data from previous and current years as well as forecast data for the next five years. Most of the report is made up of tables, charts, and figures that give our clients a clear picture of the Testosterone Replacement Therapy Sales Market. The structure of the Testosterone Replacement Therapy Sales Market by identifying its various segments and sub-segments to help to understand the report.
Testosterone Replacement Therapy Sales Market is growing at a High CAGR during the forecast period 2020-2026. The increasing interest of the individuals in this industry is the major reason for the expansion of this market.
As the report proceeds further, it covers the analysis of key market participants paired with development plans and policies, production techniques, price structure of the market. The report also identifies the other essential elements such as product overview, supply chain relationship, raw material supply and demand statistics, expected developments, profit and consumption ratio.
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Important Data Available In This Report:
An Overview of the Impact of COVID-19 on this Market:
The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms, and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus.
Customer Experience Analysis:
The study offers an in-depth assessment of various customers journeys pertinent to the market and its segments. It offers various customer impressions about products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.
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Testosterone Replacement Therapy Market Size, Analysis, and Forecast Report 2019-2025 – StartupNG
Posted: August 27, 2020 at 2:56 pm
The report is an all-inclusive research study of the global Testosterone Replacement Therapy market taking into account the growth factors, recent trends, developments, opportunities, and competitive landscape. The market analysts and researchers have done extensive analysis of the global Testosterone Replacement Therapy market with the help of research methodologies such as PESTLE and Porters Five Forces analysis. They have provided accurate and reliable market data and useful recommendations with an aim to help the players gain an insight into the overall present and future market scenario. The Testosterone Replacement Therapy report comprises in-depth study of the potential segments including product type, application, and end user and their contribution to the overall market size.
The Testosterone Replacement Therapy Market carries out financial changes that occur year by years in market, with information about upcoming opportunities and risk to keeps you ahead of competitors. The report also describes top company profiles that present in market with trends worldwide. This research guided you for extending business.
The Testosterone Replacement Therapy Market research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data and statistically-supported and industry-validated market data and projections with a suitable set of assumptions and methodology. It provides analysis and information by categories such as market segments, regions, and product type and distribution channels.
For more insights into the Market, request a sample of this report (Including Full TOC, List of Tables & Figures, Chart) @ https://www.researchmoz.com/enquiry.php?type=S&repid=2746283&source=atm
Segment by Type, the Testosterone Replacement Therapy market is segmented intoGelsInjectionsPatchesOther
Segment by Application, the Testosterone Replacement Therapy market is segmented intoHospitalsClinicsOthers
Regional and Country-level Analysis:North AmericaUnited StatesCanadaAsia-PacificChinaJapanSouth KoreaIndiaSoutheast AsiaAustraliaRest of Asia-PacificEuropeGermanyFranceU.K.ItalyRussiaNordic CountriesRest of EuropeLatin AmericaMexicoBrazilRest of Latin AmericaMiddle East & AfricaTurkeySaudi ArabiaUAERest of MEA
Competitive Landscape and Testosterone Replacement Therapy Market Share AnalysisTestosterone Replacement Therapy market competitive landscape provides details and data information by companies. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on sale and revenue by players for the period 2015-2020. Details included are company description, major business, Testosterone Replacement Therapy product introduction, recent developments, Testosterone Replacement Therapy sales by region, type, application and by sales channel.
The major companies include:AbbVieEndo InternationalEli lillyPfizerActavis (Allergan)BayerNovartisTevaMylanUpsher-SmithFerring PharmaceuticalsKyowa KirinAcerus Pharmaceuticals
A proper understanding of the Testosterone Replacement Therapy Market dynamics and their inter-relations helps in gauging the performance of the industry. The growth and revenue patterns can be revised and new strategic decisions taken by companies to avoid obstacles and roadblocks. It could also help in changing the patterns using which the market will generate revenues. The analysis includes an assessment of the production chain, supply chain, end user preferences, associated industries, proper availability of resources, and other indexes to help boost revenues.
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Market Segmentation based On Type, Application and Region:
The global Testosterone Replacement Therapy is analyzed for different segments to arrive at an insightful analysis. Such segmentation has been done based on type, application and Region.
Global Testosterone Replacement Therapy market is presented to the readers as a holistic snapshot of the competitive landscape within the given forecast period. It presents a comparative detailed analysis of the all regional and player segments, offering readers a better knowledge of where areas in which they can place their existing resources and gauging the priority of a particular region in order to boost their standing in the global market.
The Global Testosterone Replacement Therapy Market is gaining pace and businesses have started understanding the benefits of analytics in the present day highly dynamic business environment. The market has witnessed several important developments over the past few years, with mounting volumes of business data and the shift from traditional data analysis platforms to self-service business analytics being some of the most prominent ones.
For the future period, sound forecasts on market value and volume are offered for each type and application. In the same period, the report also provides a detailed analysis of market value and consumption for each region. These insights are helpful in devising strategies for the future and take necessary steps. New project investment feasibility analysis and SWOT analysis are offered along with insights on industry barriers. Research findings and conclusions are mentioned at the end.
Reasons for Buying This Report:
It Provides A Forward-Looking Perspective on Different Factors Driving or Restraining Market Growth.
It Provides A Five-Year Forecast Assessed on The Basis of How the Market Is Predicted to Grow
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It Helps in Making Informed Business Decisions by Having Complete Insights of Market and By Making an In-Depth Analysis of Market Segments.
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Testosterone Replacement Therapy Market Size, Analysis, and Forecast Report 2019-2025 - StartupNG
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LPCN: Tlando: Target Action Date This Friday – Zacks Small Cap Research
Posted: August 27, 2020 at 2:56 pm
By John Vandermosten
NASDAQ:LPCN
READ THE FULL LPCN RESEARCH REPORT
Up and Coming Milestones
Tlando PDUFA date August 28, 2020
Primary endpoint results for LiFT (LPCN 1144) 4Q:20
Patent Infringement trial February 2021
Complete Phase II LiFT (LPCN 1144) 2Q:21
Second Quarter 2020 Operational and Financial Results
On August 6, 2020 Lipocine (NASDAQ:LPCN) filed its second quarter 2020 10-Q and posted its earnings release for the three month period ending June 30, 2020. The company reported zero revenues and a net loss per share of ($0.13) compared to prior year revenues of zero and loss of ($0.14) per share. Activity during the second quarter revolved around several items including presentation at the American Urological Association (AUA) conference, demonstration of treatment potential for LPCN 1144, investigational new drug clearance for LPCN 1148, affirmation of the USPTO decision and the dismissal of a shareholder lawsuit. The companys shares also exceeded $1.00 in June, and have remained above this level, allowing Lipocine to regain compliance with NASDAQ minimum bid requirements. The most important item on the calendar is the FDAs response to Tlandos NDA submission, which is expected on or before August 28th.
We anticipate that upon approval, Lipocine will find a partner to commercialize Tlando and use associated upfront and milestone payments to further develop the existing portfolio, especially LPCN 1144 and LPCN 1148. Potential licensees are waiting until approval is granted before performing their due diligence. This suggests that a deal would be announced in the fourth quarter of 2020 rather than in the weeks following an assumed approval.
Operational expenses for 2Q:20 were $4.2 million, up 26% and net loss totaled ($6.4) million or ($0.13) per share. Research and development expenses totaled $2.5 million. The 16% rise over prior year amounts reflects increased costs related to the LiFT study and higher personnel expenditures offset by a decrease in amounts related to the ABPM study, lower spend on the Tlando XR program and a fall in manufacturing costs for LPCN 1107. General and administrative costs rose 41% over last years second quarter to $2.0 million on an expansion in legal expenditures related to the Clarus dispute and an increase in personnel costs offset by lower marketing expenses, administrative travel and other expenses. A rise in the share price increased the warrant liability and required the recognition of a $2.1 million non-cash loss in other income.
Cash and marketable securities balance was $18.2 million as of June 30, 2020. There is another $5 million of restricted1 cash which will remain on hold until Tlando is approved. Current and non-current debt is carried on the balance sheet at $6.3 million. Cash burn for 2Q:20 was approximately ($4.1) million and net cash provided by financing was $11.7 million representing a stock offering and warrant proceeds partially offset by a small amount of debt repayment.
Tlando
On November 11 of last year, Lipocine announced that it had received a complete response letter (CRL) for Tlando. The CRL identified one deficiency stating that the trial did not meet one of the three secondary endpoints for maximal testosterone concentrations (Cmax). No deficiencies related to chemistry, manufacturing and controls were noted. FDA guidelines call for 85% of subjects to achieve a Cmax below 1500 ng/dL and no more than 5% of subjects presenting a Cmax between 1800 ng/dL and 2500 ng/dL and 0% above 2500 ng/dL. In the most recent dosing validation (DV) study, 85% of subjects were below 1500 ng/dL and 7% were between 1800 ng/dL and 2500 ng/dL. Although there were small variations from the FDA guidelines in the original SOAR study for subjects above 2500 ng/dL, the FDA did not identify these as a deficiency during the original New Drug Application (NDA) submission.
Following the Post Action meeting with the FDA, Lipocine was advised to address the outstanding deficiencies with a reanalysis of existing data. This recommendation relieved Lipocine of the time and cost of an additional trial and also allowed the resubmission of the Tlando NDA in February. A target action date of August 28th was provided. While the resubmission is a positive, Tlando has faced significant hurdles gaining the favor of the FDA. We published a note on February 25th that discussed details regarding the resubmission.
LPCN 1144
Lipocine announced in August 2018 the pursuit of a new indication in nonalcoholic steatohepatitis (NASH). We discuss the indication and Lipocines efforts in an earlier piece that can be accessed here. Full enrollment of 36 subjects was achieved in November 2018.
In January 2019, Lipocine announced meaningful liver fat reduction in patients participating in its Liver Fat Study and informed investors that the company had filed an investigational new drug (IND) application to begin a Phase II study for NASH. Since LPCN 1144 is the same molecule as TLANDO, for which there were numerous safety studies completed, LPCN was allowed to perform a proof of concept (POC) clinical study under the original IND to assess liver fat changes. This 36-person study was conducted in hypogonadal men at risk of developing non-alcoholic steatohepatitis (NASH) and results were measured using the magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique. Topline results were announced in 1Q:19 demonstrating a 4.0% to 8.2% percentage point reduction in liver fat depending on baseline liver fat category. We discussed the results in further detail in our NASH Topline article.
Lipocine launched its Phase II clinical study for LPCN 1144 and dosed its first patient last September. Prior to the start of the trial, Lipocine announced that the FDA would allow the Phase II LiFT trial to enroll eugonadal patients in addition to the NASH patients that were initially targeted. This expansion was based on research that we discussed in a July 29th note. The study is anticipated to last for 18 months and cost approximately $8 million.
LiFT, an acronym of Liver Fat intervention with oral Testosterone, is a paired biopsy Phase II study in NASH subjects. The study design will employ a three-arm, double-blind, placebo-controlled structure and enroll approximately 75 biopsy confirmed male NASH subjects with a NAS2 score of greater or equal to four. The primary endpoint for the study is 12-week MRI-PDFF liver fat reduction and the first patient was enrolled in 3Q:19. As for the anticipated timeline, Lipocine expects top line liver fat reduction data in 4Q:20 as measured by MRI-PDFF at 12 weeks. Biopsy data at 36 weeks is expected to be available in the second quarter of 2021.
Exhibit I LiFT Study Timeline3
NASH Environment
A lot has happened in the NASH space in 2020. Genfit (GNFT) announced that it will halt development of elafibranor after it failed to distinguish itself compared to placebo earlier this year. CymaBay (CBAY) announced that the FDA had lifted the hold on seladelpars Phase II study last month. No evidence was found for liver injury for the drug and the trial is expected to resume. Intercepts (ICPT) OCA received a complete response letter from the FDA in late June noting that the agency remains uncertain that the benefits of the drug outweigh the risks. Viking (VKTX) is conducting the Phase IIb VOYAGE trial for VK2809 which is still ongoing. A bright spot in the space has been results from Akeros (AKRO) Phase IIb trial for efruxifermin in NASH which were announced June 30. The study found that 48% of patients had fibrosis improvement of at least one stage with a 62% response rate. Fibrosis improved by at least two stages for 28% of the group with a 38% response rate and 48% experienced NASH resolution without worsening of fibrosis across all dose groups.
LPCN 1148
Lipocine is preparing to develop its testosterone molecule to treat NASH cirrhosis patients. While the target market is smaller than that of pre-cirrhotic NASH, there are no other FDA approved products available. The inverse relationship between testosterone and sarcopenia and the increased risks of advancing NASH cirrhosis validates this pursuit. Pending funding, Lipocine plans to initiate a proof of concept trial to evaluate the potential of this candidate. The companys Investigational New Drug (IND) application was cleared by the FDA in May 2020. We anticipate Lipocine will launch the Phase II trial after the start of commercialization of Tlando and upon availability of sufficient capital to fund it. Management has guided to a 4Q:20 or 1Q:21 start.
Exhibit II Lipocine Pipeline4
Markman Hearing
On March 26th, Lipocine announced the outcome of the Markman Hearing, also known as a claim construction hearing. This meeting is an important precursor to a patent infringement lawsuit and provides the definitions of terms critical for a jurys determination on whether or not a patent has value. A patent should not be too specific, as it provides insufficient protection to an invention, or too broad, in which case a court may rule it indefinite. In the hearing order5, Judge Bryson did not agree with most of Clarus claims and sided with Lipocine on the majority of definitions and clarifications. While the terms and definitions are subject to an evolving construction, the order is favorable to Lipocines dispute against Clarus. While this order could be appealed again, it is unlikely in the opinion of Lipocines counsel. Lipocine and Clarus are currently engaged in the fact discovery phase of the lawsuit and the jury trial is anticipated to take place in February 2021. Lipocine need only prevail on one claim to merit damages, which places them in a strong position to succeed in the trial or provide incentive for Clarus to settle.
USPTO Decision Affirmed
The US Court of Appeals affirmed the decision of the USPTO in April 2020 to grant Lipocines Priority Motion in the interference case that cancelled Clarus claims to the 428 patent in January 2019. The USPTO, through its Patent Trial and Appeal Board (PTAB), had granted Lipocines priority motion in the related interference case and entered adverse judgment against Clarus. As we have previously shared, this outcome was expected as it is rare for a federal court to overturn a USPTO ruling. As a reminder, in 2Q:19 Lipocinefiled suitagainst Clarus alleging that Jatenzo infringed on six of Lipocines patents. The injunction filing may slow down commercialization of Jatenzo and force Clarus to come to the table to negotiate a settlement. While the cost of pursuing such legal action could be high, we anticipate by the time the case works its way through the courts, cash flow from Tlando could be sufficient to support the legal efforts.
Publications and Abstracts
Results from Lipocines Liver Fat Study were published in Hepatology Communications in an article entitled LPCN 1144 Resolves Non-Alcoholic Fatty Liver Disease In Hypogonadal Males." The study served to identify the prevalence of non-alcoholic fatty liver disease (NAFLD) in hypogonadal males and quantify the beneficial impact of LPCN 1144 on hypogonadism. 36 hypogonadal males were evaluated using MRI-PDFF measurements for liver fat. 81% of those with baseline liver fat equal to or greater than 5% showed improvement in liver fat content and NAFLD resolved in one-third of the group at six weeks and 48% after 16 weeks. The paper concluded that treatment with LPCN 1144 resolved NAFLD in about half of affected patients without any safety signals.
Lipocine submitted several abstracts to the American Urological Association (AUA) Virtual Experience, which took place from May 15 to 17, 2020. Three titles were presented.
Impact of a new oral testosterone undecanoate on blood pressure and cardiovascular risk was presented by Dr. Mohit Khera which investigated the chronic use of testosterone replacement therapy (TRT) on cardiovascular risk. Jatenzo, Xyosted and Tlando were assessed in their impact on blood pressure and cardiovascular risk in hypogonadal men. Marginal increases in blood pressure were observed and no meaningful impact on cardiovascular risk was noted.
A novel oral testosterone therapy restores testosterone to eugonadal levels without dose titration was presented by Dr. Martin Miner and highlights the shortcomings of dose titration when prescribing TRT. The abstract concluded that fixed dose Tlando normalizes testosterone levels in hypogonadal patients while avoiding the potential problems associated with titrated TRT.
Effects of a new oral testosterone undecanoate (TLANDO) therapy on liver was presented by Dr. Irwin Goldstein and compares oral methyltestosterone (MT) with TRT in males deficient in endogenous testosterone. The study results suggested that unlike MT, Tlando has no adverse effects on liver and can be used for an extended period to potentially reduce liver fat.
Milestones
Tlando CRL November 9, 2019
Tlando FDA post action meeting January 2020
Resubmission of Tlando NDA February 2020
Investigational New Drug (IND) clearance for LPCN 1148 May 2020
Wajda v. Patel shareholder suit dismissed July 2020
Tlando PDUFA date August 28, 2020
Primary endpoint results for LiFT (LPCN 1144) 4Q:20
Patent Infringement trial February 2021
Complete Phase II LiFT (LPCN 1144) 2Q:21
Summary
Since our previous update, Lipocine has participated in scientific conferences, published an article in the journal Hepatology Communications and advanced several months towards the upcoming August 28 PDUFA date for Tlando. Assuming a favorable outcome for the application, Lipocine will seek a commercialization partner and should receive upfront and milestone proceeds in conjunction with a deal. The Phase II LiFT trial continues to be a bright spot for the company and is potentially able to address a large unmet need in NASH patients in contrast to other programs which have met with difficulty. Management has guided towards a year-end readout of LiFT trial results. Lipocine is also developing LPCN 1148 for cirrhosis patients which was recently given clearance to begin a Phase II study. While we do not see this program entering the clinic until sufficient capital is available, we do think it will advance if Phase II data for LPCN 1144 are positive.
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1. Tlando was not approved by the FDA by May 31, 2018, and therefore Lipocine is required to maintain $5.0 million of cash collateral at Silicon Valley Bank (the lender) until such time as it is approved by the FDA.
2. NAS: NAFLD (Non-alcoholic fatty liver disease) Activity Score. Discussion of the metric can be found here.
3. Source: Lipocine Corporate Presentation May 2020.
4. Source: Lipocine Corporate Presentation July 2020.
5. A link to the Markman Hearing Order can be found on this page: https://ir.lipocine.com/presentations
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LPCN: Tlando: Target Action Date This Friday - Zacks Small Cap Research
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Doctors find testicles in woman’s stomach that are in early stages of cancer – Mirror Online
Posted: August 27, 2020 at 2:56 pm
A woman was 'devastated' when she found out the reason she'd never had a period is because she's intersex - after doctors discovered she was missing a womb and had testicles inside her stomach.
Content creator and activist, Dani Coyle, 25, from Swindon, grew up suspecting that something made her different. As a young teen, Dani's voice suddenly dropped and whilst her peers began to get their first periods, Dani only developed terrible stomach cramps.
After seeking medical advice, Dani was sent to specialists who at age 14, diagnosed her as being intersex. This means that Dani has a deviation in her gender characteristics that does not match the 'traditional' understanding of the female body.
Dani was told she had a 17 beta-hydroxysteroid dehydrogenase three deficiency. Whilst she'd always appeared to be female, Dani didn't have the female hormones she required once she reached puberty and 'should have' been born as a cisgender male. This is when a person's gender identification matches their birth sex.
The doctors discovered that Dani had XY chromosomes usually found in men and no female reproductive organs such as a womb. A further scan revealed that she has testicles inside her stomach which were in the early stages of cancer.
Doctors told Dani that they could 'normalise' her 'medical defect' through surgery and hormone replacement therapy. In 2009, the suspected cancerous testes were removed and Dani underwent external cosmetic surgery to alter the appearance of her vulva.
Dani thought that the ordeal was over, but she later felt coerced into the surgery after quickly learning that intersex bodies aren't accepted by society.
At school, Dani began to experience transphobic comments as her peers would deem her to be a 'lady boy' and a 'tranny,' due to a lack of understanding on what it means to be intersex. Whilst Dani uses both female and gender-neutral pronouns, she identifies as female.
"When I was told that I'm intersex, in truth, I was devastated although not surprised," Dani said.
"I'd wished for words to explain and understand my differences for a long time. I was relieved but scared to finally have them.
"When I was ten, I noticed things changing in my body that were more typical of what happens in male development. My voice lowered in tone and my period never came. It was an extremely confusing and lonely time.
"At fourteen, I was told I had 'seventeen beta-hydroxysteroid dehydrogenase three' deficiency.
"My body didn't respond 'normally' to the testosterone my testes produced which is why I was born, looked like, and was raised as a girl which is lucky as I've always identified as female.
"I was scared no one was going to love me when I found out. I was angry at the odds why me? I was told and believed it to be a secret that no one needed to know so I quickly underwent the surgery to remove my testes and normalise my external appearance just as the doctors and surgeons recommended.
"I also had hormone replacement therapy which is essentially a menopause oestrogen pill and I thought I'd be back to being a normal girl. Now, I feel like these surgeries were presented as the only viable option like I was robbed by biased doctors who work within a biased system which has caused an immeasurable amount of mental trauma."
Dani is a keen activist and she hopes to raise awareness around intersex surgery particularly surgery performed on young children without their consent. She believes raising awareness in society through extended education in schools could be a part of the solution.
"We are robbed of bodily autonomy in the name of gender binary," said Dani. "For many, the idea there are only two sexes and genders is way more convenient disregarding those of us who don't fit in to 'either' and 'or.' If I had known then what I do know, I wonder if I would have chosen the surgeries or harboured as much and shame and disgust for myself, as I did for so long.
"I used to think being intersex was a curse but now I see that's a blessing. I am free from the confines of gender expectations. I'm a part of the sanctuary of the LGBTQIA+ community and I'm literally one in a million.
"These surgeries are forced upon intersex babies every day, many of whom end up with a gender identity that doesn't align with their body's presentation because it was chosen for them by someone else.
"Even now, I have intimacy issues and body dysmorphia due to the trauma of being poked and prodded so much as a child ` it was incredibly traumatic.
"I want to see representative education in schools that covers the whole spectrum of human biology. I want to see the end of non-consensual, cosmetic intersex genital surgeries on babies and children.
"I want to promote and see the world become more aware, accepting, and inclusive of intersex, trans, and gender non-conforming people and our use of language. Hopefully, I can play a small part in that.
"The differences in our bodies, identities, and cultures are things to celebrate. Let's all be kinder to people who are different from ourselves."
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Doctors find testicles in woman's stomach that are in early stages of cancer - Mirror Online
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Global Testosterone Replacement Therapy Market 2020 Recovering From Covid-19 Outbreak | Know About Brand Players: AbbVie, Endo International, Eli…
Posted: August 19, 2020 at 10:58 pm
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Get in shape during the pandemic – KTAR.com
Posted: August 18, 2020 at 11:56 am
With the stress of a pandemic along with social and political upheaval, its understandable if youve slipped into some unhealthy habits, such as eating more and exercising less than youd like.
Fortunately, its not too late to make a change. No matter if you want to bulk up, slim down, or both, you can get in shape and stay safe, with a few adjustments to your daily activities.
Move your body
Whether you lift weights at home or jog around your neighborhood, its important to move every day. Sedentary living has many health risks, including heart disease, high blood pressure, diabetes, stroke, and an increased chance of depression and anxiety, according to MedlinePlus.
Even though options are limited, as long as you have space to move, any corner of your house or yard or garage, if you have one can be your home gym. Pick a consistent time, play some music, and turn your space into a weight room, cycling studio, boxing club or whatever motivates you. Every day might look a little different, so get creative and break a sweat.
Do what you enjoy
Pandemic or not, you are more likely to consistently exercise if you choose something you enjoy. While running on a treadmill will do in a pinch for some, it may not motivate you, so mix in new activities. Whether youre doing a structured workout or dancing along to music videos, as long as it makes you happy, youll keep at it.
For motivation, online instruction can help. Free classes on the web or in apps make strength training, cycling, yoga and so on accessible. Additionally, many paid subscriptions offer a free trial, so test a few options to see what you like.
Wear a fitness tracker
Fitness trackers count your steps, measure your heart rate, track your water intake, and more. Do some research to find a tracker that will help you meet your goals.
Along with a tracker, you can get personalized help from a trainer. Even if you cant or dont want to visit a gym, you can find a trainer who creates customized workouts, live streams group sessions, or meets online for one-on-one training.
Add healthy foods to your diet
Nutrition is essential to fitness. In fact, if one of your goals has to do with your weight, what you consume is more important than how you work out.
Eating food that meets your daily nutrient needs will not only help you stay in shape but boost your mood. Whole grains, lean proteins and plenty of fresh fruits and vegetables are the building blocks to healthiness.
If you want to take it a step further, ask a dietitian to create a customized eating plan for you.
Check your hormone levels
If you eat healthy and work out but still arent seeing results, your hormones could be to blame. Fatigue, weight gain, loss of muscle, and trouble sleeping are just a few symptoms of low testosterone.
Beginning in our 30s, our bodies start to become fatigued more easily, viTal4men says. You lose muscle mass, mental sharpness and libido (sex drive) begins to decline.
Fortunately, theres an easy way to check and adjust your levels.
At the viTal4men clinic, we treat low testosterone levels with testosterone replacement therapy to get you back to your optimum level, viTal4men says. We are a complete mens wellness center.
Visit Vital4Men.com for more information and to schedule your free consultation.
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