secondary testicular failure

Results of survey will be presented by Adrian Dobs, M.D., Professor of Medicine and Oncology, The Johns Hopkins School of Medicine, and Sandeep Dhindsa, M.B.B.S., Director of Division of Endocrinology, Diabetes and Metabolism, St. Louis University School of Medicine, at ENDO 2024 in Boston on June 2. BUFFALO GROVE, Ill., June 2, 2024 /PRNewswire/ -- Tolmar Inc., a fully integrated pharmaceutical company, today announced results from a landmark survey of more than 300 US physicians, revealing barriers to treatment with testosterone-replacement therapy (TRT) among patients and physicians that, if addressed, may improve patient care. Detailed results of the survey will be presented at ENDO 2024, the signature annual meeting in endocrinology, in Boston on Sunday, June 2. The survey was conducted in partnership with the leading online physician community, Sermo. "Men living with a testosterone deficiency have more treatment options than ever, but this expanded range of choices can be confusing. A key finding in the survey is that 66% of men on TRT switched therapy in the last year in order to find a form of therapy that works best for them. Not surprisingly, much of this is driven by insurance, but there is also a lack of awareness of newer and safe treatment options, like oral therapy, that may improve patient care," said Sandeep Dhindsa, M.B.B.S., Director of Division of Endocrinology, Diabetes and Metabolism, St. Louis University School of Medicine. Uncovering Insights Into the Current TRT Landscape Results from the survey showed challenges and potential solutions to effectively treat men with low or no testosterone. More than one-quarter of patients do not take their TRT as prescribed, according to physicians surveyed. For 71% of patients, oral medication is the preferred choice, but only 22% percent are aware of them. Lastly, half of physicians (50%) are unaware of current oral TRT and its proven safety profile. "This reinforces the need for continued education on TRT and the importance of working closely with patients on a treatment plan. With a better understanding of safe and effective TRT options, we can improve adherence, minimize the need to switch treatments and help patients get the care they deserve," said Adrian Dobs, M.D., Professor of Medicine and Oncology, The Johns Hopkins School of Medicine. To explore the data driving these insights, visit to download the presentation of results and findings. About the Survey In February 2024, Sermo conducted a survey of 303 physicians, including endocrinologists, urologists, primary care physicians and others experienced in prescribing testosterone-replacement therapy (TRT). The objectives of the survey were to: 1) understand the TRT patient experience and unmet needs; 2) outline prescribing behaviors and barriers across multiple specialties; and 3) uncover barriers to treatment and opportunities for patient and peer education. About Tolmar Inc. Tolmar is a fully integrated pharmaceutical company focused on the development, manufacturing, and commercialization of specialty pharmaceuticals across multiple therapeutic areas, including Endocrinology. Tolmar's product development and manufacturing facilities are based in Northern Colorado and its executive offices and commercial headquarters are based in Buffalo Grove, Illinois. For more information about the company, please visit . About Sermo Sermo is the largest global healthcare research company and the most trusted physician and provider engagement platform. Sermo engages with more than 1.5 million HCPs across 150 countries and has reach into the U.S. Payer market that now exceeds 230M commercial lives covered. For over 20 years, Sermo has been turning physician experience, expertise, and observations into actionable business insights that benefit pharmaceutical companies, healthcare partners, and the medical community at large. Sermo offers on-demand access to HCPs via a proprietary health-tech ecosystem to gain targeted HCP insights that inform strategic decisioning in real-time. To learn more, visit . About JATENZO® Indication JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitation of use Safety and efficacy of JATENZO in males less than 18 years old have not been established. IMPORTANT SAFETY INFORMATION WARNING: INCREASES IN BLOOD PRESSURE JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled. Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment. Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies. CONTRAINDICATIONS JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm. WARNINGS AND PRECAUTIONS Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently. Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH. Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO. Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Gynecomastia may develop and persist in patients being treated for hypogonadism. Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease. Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy. Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients. Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials. ADVERSE EVENTS The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%). These are not all of the risks associated with JATENZO. For more information, click  here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. Company Contact: Steve Yuan [email protected] 224.880.1616 SOURCE Tolmar Inc.

SALT LAKE CITY, March 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the year ended December 31, 2022 and provided a corporate update. In 2022, Lipocine announced a new strategic direction, focusing on the development of endogenous neuroactive steroids which have broad applicability in treating various CNS conditions. The Company is currently exploring partnering non-core assets including LPCN 1107, for prevention of pre-term birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, for treatment of non-cirrhotic NASH, LPCN 1111, a once-a-day therapy candidate for TRT and LPCN 1021 (TLANDO in the U.S.) outside of the U.S. Clinical Program Highlights Neuroactive Steroids The Company completed an oral PK study and a food effect study with LPCN 1154 demonstrating the first enablement of effective oral delivery of brexanalone, a bioidentical neuroactive steroid. A pilot PK bridge study of LPCN 1154, an oral neuroactive steroid ("NAS") product candidate, in postpartum depression ("PPD") has been initiated. Results are expected in the first half of the year. The FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 via the 505(b)(2) pathway. The proof-of-concept study is a prelude to a pivotal study required for NDA filing. LPCN 1148 in liver cirrhosis Enrollment has been completed in a Phase 2 proof-of-concept ("POC") study evaluating the therapeutic potential of LPCN 1148 for the management of decompensated cirrhosis of various etiologies. Topline results on the primary endpoint (change in skeletal muscle index at Week 24) are expected mid-2023. TLANDO® for hypogonadism TLANDO™ was approved and granted Market Exclusivity by the U.S. Food and Drug Administration ("FDA") for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO™ has been licensed to Antares and was launched commercially in the U.S. in June 2022. Year Ended December 31, 2022 Financial Results Lipocine reported a net loss of $10.8 million, or ($0.13) per diluted share, for the year ended December 31, 2022, compared with a net loss of $634,399, or ($0.01) per diluted share, for the year ended December 31, 2021. Lipocine recognized license revenue of $500,000 during the year ended December 31, 2022, compared to $16.1 million during the year ended December 31, 2021. License revenue in 2022 was related to a non-refundable cash fee of $500,000 received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111. License revenue in 2021 primarily related to the Antares Licensing Agreement for TLANDO which was signed in October 2021 and was comprised of licensing fees, minimum royalties and the sale of finished goods inventory. Research and development expenses were $8.6 million and $7.7 million, respectively, for the years ended December 31, 2022, and 2021. The increase in research and development expenses during the year ended December 31, 2022 was primarily due to an increase in contract research organization expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in manufacturing scale up costs, an increase in personnel expense primarily resulting from additional headcount, and an increase in other R&D expenses. These increases were offset by decreases in costs related to LPCN 1144, LPCN 1107, and LPCN 1154. General and administrative expenses were $4.1 million and $5.3 million, respectively, for the years ended December 31, 2022, and 2021. The decrease in general and administrative expenses during the year ended December 31, 2022 was primarily due to a decrease in legal fees, a decrease in personnel related costs and a decrease in other general and administrative expenses. These decreases were offset by an increase in costs related to the recruitment and compensation for two additional directors, an increase in other various professional fees, an increase in strategic advisory services, an increase related to proxy solicitation services, and an increase in travel related costs. As of December 31, 2022, Lipocine had $32.5 million of unrestricted cash, cash equivalents and marketable investment securities compared to $46.6 million at December 31, 2021. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop products for CNS disorders. Lipocine has candidates in development as well as candidates for which we are exploring partnering. Our candidates represent enablement of patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy and LPCN 1148, an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of pre-term birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, our candidate for treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day therapy candidate for testosterone replacement therapy (TRT). TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, our strategic plans for developing products to treat CNS disorders, our ability to monetize non-core product candidates, including through entering into partnering arrangements, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates to treat CNS disorders, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc.

DUBLIN, Oct. 24, 2022 /PRNewswire/ -- The "Male Hypogonadism Market By Drug Delivery, By Therapy, By Type: Global Opportunity Analysis and Industry Forecast, 2020-2030" report has been added to ResearchAndMarkets.com's offering. The global male hypogonadism market was valued $ 3,072.86 million in 2020 and expected to reach $ 5,085.03 million by 2030, with a CAGR of 5.1% from 2021 to 2030. Hypogonadism is characterized as lack of testosterone level or lack of spermatozoa production, or both. It is caused owing to the disorder related to the testes (primary hypogonadism) or the hypothalamic-pituitary axis (secondary hypogonadism). Both can be inherited or acquired, due to ageing, hormonal disorders or medicines. In addition, various congenital enzyme abnormalities result in various degrees of androgen resistance in target organs. Hormone levels corroborate the diagnosis. The treatment for gonadotropin-releasing hormone, gonadotropin, or testosterone replacement differs depending on the aetiology. The factors that drive the global male hypogonadism market are increase in cases of hypogonadism, surge in awareness of hypogonadism, and rise in number of treatment options. In addition, hypogonadism is prevalent in the geriatric population as well as in patients with diabetes and obesity. As a result, increase in population and rise in the incidence and prevalence of chronic disorders, such as diabetes and obesity drive the growth of the market. According to clinical research, testosterone levels in males aged 60-80 years are 20 percent and 80 percent lower, respectively, than testosterone levels in young men. Hypogonadism is most common in men aged above 60. In countries like Japan, China, and the U.S. there is surge in demand for male hypogonadism treatments, owing to increase in geriatric population and surge in infertility rates. The male hypogonadism market is segmented on the basis of therapy, drug delivery, type, and region. Depending on therapy, it is divided into testosterone replacement therapy and gonadotropin & gonadotropin-releasing hormones therapy. The gonadotropin-releasing hormones therapy segment is segmented into luteinizing hormone (LH), follicle-stimulating hormone (FSH), human chorionic gonadotropin (HCG), and gonadotropin-releasing hormone (GNRH). According to drug delivery, it is fragmented into topical gels, injectable, transdermal patches, and others. As per the type, it is classified into Klinefelter's syndrome, Kallmann syndrome, pituitary disorders, and others. Region wise, it is analyzed across North America, Europe, Asia Pacific, and LAMEA. Major key players operating in the global male hypogonadism market are Allergan PLC., Bayer AG, Eli Lily & Company, Endo Iternational PLC., Ferring Holdings SA, Finox Biotech, Merck & Co. Inc., Pfizer, Perrigo Company PLC., Teva Pharmaceutical Industries Ltd. Key Benefits For Stakeholders This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the male hypogonadism market analysis from 2020 to 2030 to identify the prevailing male hypogonadism market opportunities. The market research is offered along with information related to key drivers, restraints, and opportunities. Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network. In-depth analysis of the male hypogonadism market segmentation assists to determine the prevailing market opportunities. Major countries in each region are mapped according to their revenue contribution to the global market. Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players. The report includes the analysis of the regional as well as global male hypogonadism market trends, key players, market segments, application areas, and market growth strategies. Key Topics Covered: CHAPTER 1: INTRODUCTION CHAPTER 2: EXECUTIVE SUMMARY CHAPTER 3: MARKET OVERVIEW 3.1. Market definition and scope 3.2. Key findings 3.2.1. Top investment pockets 3.3. Porter's five forces analysis 3.4. Top player positioning 3.5. Market dynamics 3.5.1. Drivers 3.5.2. Restraints 3.5.3. Opportunities 3.6. COVID-19 Impact Analysis on the market CHAPTER 4: MALE HYPOGONADISM MARKET, BY DRUG DELIVERY 4.1 Overview 4.1.1 Market size and forecast 4.2 Topical Gels 4.2.1 Key market trends, growth factors and opportunities 4.2.2 Market size and forecast, by region 4.2.3 Market analysis by country 4.3 Injectables 4.3.1 Key market trends, growth factors and opportunities 4.3.2 Market size and forecast, by region 4.3.3 Market analysis by country 4.4 Transdermal Patches 4.4.1 Key market trends, growth factors and opportunities 4.4.2 Market size and forecast, by region 4.4.3 Market analysis by country 4.5 Others 4.5.1 Key market trends, growth factors and opportunities 4.5.2 Market size and forecast, by region 4.5.3 Market analysis by country CHAPTER 5: MALE HYPOGONADISM MARKET, BY THERAPY 5.1 Overview 5.1.1 Market size and forecast 5.2 Testosterone Replacement Therapy 5.2.1 Key market trends, growth factors and opportunities 5.2.2 Market size and forecast, by region 5.2.3 Market analysis by country 5.3 Gonadotropin and Gonadotropin Releasing Hormone Therapy 5.3.1 Key market trends, growth factors and opportunities 5.3.2 Market size and forecast, by region 5.3.3 Market analysis by country CHAPTER 6: MALE HYPOGONADISM MARKET, BY TYPE 6.1 Overview 6.1.1 Market size and forecast 6.2 Klinefelters Syndrome 6.2.1 Key market trends, growth factors and opportunities 6.2.2 Market size and forecast, by region 6.2.3 Market analysis by country 6.3 Kallmann Syndrome 6.3.1 Key market trends, growth factors and opportunities 6.3.2 Market size and forecast, by region 6.3.3 Market analysis by country 6.4 Pituitary Disorders 6.4.1 Key market trends, growth factors and opportunities 6.4.2 Market size and forecast, by region 6.4.3 Market analysis by country 6.5 Others 6.5.1 Key market trends, growth factors and opportunities 6.5.2 Market size and forecast, by region 6.5.3 Market analysis by country CHAPTER 7: MALE HYPOGONADISM MARKET, BY REGION CHAPTER 8: COMPANY LANDSCAPE 8.1. Introduction 8.2. Top winning strategies 8.3. Product Mapping of Top 10 Player 8.4. Competitive Dashboard 8.5. Competitive Heatmap 8.6. Key developments CHAPTER 9: COMPANY PROFILES 9.1 Allergan plc 9.1.1 Company overview 9.1.2 Company snapshot 9.1.3 Operating business segments 9.1.4 Product portfolio 9.1.5 Business performance 9.1.6 Key strategic moves and developments 9.2 Pfizer Inc. 9.2.1 Company overview 9.2.2 Company snapshot 9.2.3 Operating business segments 9.2.4 Product portfolio 9.2.5 Business performance 9.2.6 Key strategic moves and developments 9.3 Bayer AG 9.3.1 Company overview 9.3.2 Company snapshot 9.3.3 Operating business segments 9.3.4 Product portfolio 9.3.5 Business performance 9.3.6 Key strategic moves and developments 9.4 Eli Lilly and Company Ltd. 9.4.1 Company overview 9.4.2 Company snapshot 9.4.3 Operating business segments 9.4.4 Product portfolio 9.4.5 Business performance 9.4.6 Key strategic moves and developments 9.5 Endo International plc. 9.5.1 Company overview 9.5.2 Company snapshot 9.5.3 Operating business segments 9.5.4 Product portfolio 9.5.5 Business performance 9.5.6 Key strategic moves and developments 9.6 Merck & Co., Inc. 9.6.1 Company overview 9.6.2 Company snapshot 9.6.3 Operating business segments 9.6.4 Product portfolio 9.6.5 Business performance 9.6.6 Key strategic moves and developments 9.7 Ferring 9.7.1 Company overview 9.7.2 Company snapshot 9.7.3 Operating business segments 9.7.4 Product portfolio 9.7.5 Business performance 9.7.6 Key strategic moves and developments 9.8 Finox Biotec 9.8.1 Company overview 9.8.2 Company snapshot 9.8.3 Operating business segments 9.8.4 Product portfolio 9.8.5 Business performance 9.8.6 Key strategic moves and developments 9.9 Teva Pharmaceutical Industries Ltd. 9.9.1 Company overview 9.9.2 Company snapshot 9.9.3 Operating business segments 9.9.4 Product portfolio 9.9.5 Business performance 9.9.6 Key strategic moves and developments 9.10 Perrigo Company plc 9.10.1 Company overview 9.10.2 Company snapshot 9.10.3 Operating business segments 9.10.4 Product portfolio 9.10.5 Business performance 9.10.6 Key strategic moves and developments For more information about this report visit Logo - Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets