Anorchia

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.

Data from study 014/015, a phase II trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia (TRS) for up to one year Presentation of study design for potentially pivotal phase III trial for TRS patients Information on potentially pivotal study 008A in non-TRS patients presented, with results expected in late April 2024 MILAN--(BUSINESS WIRE)-- Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presented four posters and two oral presentations at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) from 3-7 April in Florence, Italy. The data presented were detailing previously reported scientific results of study 014/015, the future clinical development outlook for evenamide and information on study 008A. Study 014/015 was an international, randomized, open label, rater-blinded study of evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication. As previously announced by Newron, the study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events. Treatment with evenamide was associated with sustained, clinically significant benefit that increased throughout the one-year course of treatment. Gradual and sustained improvement was demonstrated across all efficacy scales used. More than 70% of patients experienced clinically important reduction in disease severity at one-year. Review of the efficacy data indicated that treatment with evenamide resulted in approximately 50% of patients at one-year no longer meeting any of the protocol severity criteria used to diagnose treatment resistance. Importantly, 25% of all patients achieved “remission” (no/minimal symptoms for at least six months), not reported before in TRS patients. Moreover, in contrast to common clinical experience, no patient relapsed during the one-year treatment period. Also previously announced, in their totality, the results from study 014/015 support the initiation of a potentially pivotal phase III, randomized, double-blind, placebo-controlled study of evenamide as an add-on treatment in patients with TRS, which will hopefully confirm the benefit of evenamide observed so far. If approved, the compound would be the first add-on drug that improves the symptoms of TRS, offering a much-needed new therapeutic option for those who are not responding to existing antipsychotics. A poster outlining the design of this potentially pivotal study was presented at SIRS. Newron is also investigating evenamide in a potentially pivotal study (study 008A) in a separate indication: in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who demonstrate an inadequate response to that treatment. Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid). Patient enrollment has completed and results from this study are expected in late April 2024. Additional information on this study was outlined in an oral presentation at SIRS. The posters presented at the SIRS conference were titled: - Pharmaceutical pipeline: Glutamate modulation by evenamide as an add on to TRS patients not responding to current antipsychotics is associated with clinically important improvement across outcome measures: results from 1-year, open-label trial - Treatment with evenamide for 1 year in TRS patients not benefitting to current antipsychotics is associated with sustained, clinically important benefit: Results from a prospective, pilot, 1-year, randomized, open-label trial - Addition of evenamide for 1 year to antipsychotics in TRS patients results in increasing clinically important benefit to an extent that a substantial proportion no longer meet international criteria for treatment resistance - Design of a potentially pivotal, phase 3, international, randomized, double-blind, placebo-controlled clinical trial evaluating evenamide as add-on treatment for treatment-resistant schizophrenia (TRS) patients The presentations made at SIRS were titled: - Glutamate modulation by evenamide as an add-on to TRS patients not responding to current antipsychotics is associated with clinically important improvement across outcome measures; results from a pilot, 1-year, open-label trial in treatment resistant schizophrenia (TRS) - Study 008A: Add-on treatment with evenamide in patients with chronic schizophrenia not responding adequately to their current antipsychotic – Patient disposition and characteristics, challenges/issues in enrolling patients and study conduct All posters and presentations presented are available at Newron’s website. About treatment-resistant schizophrenia (TRS) A significant proportion of patients with schizophrenia show virtually no beneficial response to antipsychotics (APs) despite adequate treatment, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no, or inadequate, symptomatic relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. About 15% of patients develop TRS from illness onset, and about one-third of patients overall. Increasing evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of benefit of most typical and atypical antipsychotics. About Study 014/015 Study 014 was a six-week, randomized, rater-blinded study being conducted at multiple sites in three countries (India, Italy and Sri Lanka). Study 014 enrolled 161 patients with TRS on a stable, therapeutic dose of a single antipsychotic other than clozapine. The primary objective of the study was to evaluate the safety and tolerability of evenamide given orally at three fixed doses (7.5, 15 and 30 mg bid). The assessment of preliminary efficacy was based on changes from baseline in the Positive and Negative Syndrome Scale (PANSS). Changes from baseline in Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S), and Strauss-Carpenter Level of Functioning (LOF) scale, were secondary objectives. Study 015 was the extension study to determine the long-term benefits of glutamate release inhibition, up to 1 year of treatment with evenamide. About evenamide Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of ineffective doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide benefit in patients who are poor responders to current APs, including clozapine. About Newron Pharmaceuticals Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: Important Notices This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever. ​ View source version on businesswire.com: Contacts For more information: Newron Stefan Weber – CEO +39 02 6103 46 26 pr@newron.com UK/Europe Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting +44 20 3727 1000 SCnewron@fticonsulting.com Switzerland Valentin Handschin, IRF +41 43 244 81 54 handschin@irf-reputation.ch Germany/Europe Anne Hennecke / Caroline Bergmann, MC Services +49 211 52925222 newron@mc-services.eu USA Paul Sagan, LaVoieHealthScience +1 617 374 8800, Ext. 112 psagan@lavoiehealthscience.com Source: Newron Pharmaceuticals S.p.A. ​ View this news release online at:

Pictured: Artistic rendition of schizophrenia/iSto At the six-month follow-up, about 40% of patients treated with Newron Pharmaceuticals’ evenamide improved so much that they no longer meet the Phase II study’s original eligibility criteria. Pictured: Artistic rendering of schizophrenia/iStock, golubovy New data from Newron Pharmaceuticals ’ Phase II study 014/015 showed that its investigational drug evenamide elicits sustained and significant symptom improvements in patients with treatment-resistant schizophrenia, the company announced Monday. At the six-month follow-up, approximately 40% of patients treated with evenamide experienced substantial symptomatic improvement—so much so that they no longer satisfied the original entry criteria into the study with their disease no longer meeting the qualification for treatment resistance, according to Newron. In addition, unlike the typical clinical experience, none of the evenamide-treated patients experienced worsening of their psychoses. Newron CMO Ravi Anand called these findings “highly encouraging” in a statement, pointing out that in the study evenamide’s benefits for treatment-resistant schizophrenia (TRS) “continue to accrue over time, and many patients who do not respond early achieve clinically important benefits later.” “The findings show that the addition of [evenamide’s] glutamate modulation to first- and second-generation antipsychotics in patients with TRS potentiates their effects on dopamine dysfunction and can potentially produce a beneficial antipsychotic response,” Anand said. Newron is now preparing to launch a potentially pivotal double-blinded, randomized and placebo-controlled Phase III study of evenamide in this indication. These new data were presented at the 36th European Clinical Neuropsychopharmacology Congress, and they follow the study’s one-year interim readout posted in February 2023. At the time, evenamide treatment induced a significant 50% improvement in scores in the Positive and Negative Syndrome Scale compared with the candidate’s initial six-week benefit . Evenamide is an investigational oral drug that works by inhibiting voltage-gated sodium channels. This helps normalize the secretion of glutamate and ease the otherwise overly repetitive neuronal firing in schizophrenia. Unlike other antipsychotic agents, however, evenamide is highly specific and has no detectable activity on some 130 neurotransmitters, enzymes or transporters commonly affected by these medications. Taking a similar precision approach to neuropsychiatric conditions is Karuna, whose schizophrenia hopeful KarXT is an agonist of the muscarinic acetylcholine 1 receptors M1 and M4. In contrast to all approved schizophrenia treatments, which target the condition’s positive symptoms, KarXT instead addresses negative symptoms such as social withdrawal and apathy toward otherwise normal interests. Karuna has recently submitted a New Drug Application for KarXT and expects the standard 10- to 12-month review period. If approved, KarXT could become the first new therapeutic mechanism greenlit for schizophrenia in over five decades . Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com .