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About Antares Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient . Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. Halozyme Therapeutics, Inc. May 24, 2022, 08:30 ET. EWING, N.J., March 29, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the "Company"), a specialty pharmaceutical company, today announced that the U.S. Food and Drug. All Rights Reserved. Antares provides links to other Internet sites as a convenience to users, and access to any other Internet sites linked to this website is at your own risk. The trademarks, logos, and service marks (collectively, the Trademarks) displayed on this website are registered and unregistered Trademarks of Antares and others. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. describes the terms and conditions applicable to your use of any and all of Antares Pharma, Inc.'s and/or its affiliates (collectively "Antares") or . Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. This website is protected by United States and foreign copyright laws. XYOSTED is a prescription medicine that contains testosterone. 8ey| +6-!|Ss! This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). The security of your data is very important to Antares. Under the terms of the agreement, Lipocine will receive an immediate upfront cash payment of $11.0 million and, subject to certain conditions, an additional $5.0 million licensing payment in January 2025 and another $5.0 million licensing payment in January 2026. Antares is committed to protecting the privacy of users ofthis website located at www.antarespharma.com or any website owned, operated, licensed or controlled by us (the Site). The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. Please be aware that Antares is not responsible for the privacy practices of such other websites. The transaction is expected to be immediately accretive to Halozyme's 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple . <> In addition, Lipocine has granted Antares Pharma an option to license, on or before March 31, 2022, TLANDO XR, a next-generation, potential once-daily oral product candidate for TRT, in the U.S. TLANDO XR met primary and secondary regulatory end points for TRT in an earlier Phase 2 clinical study. The right to know what personal information we have collected, used, disclosed and sold about you. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in . % Any such controversy or claim shall be arbitrated on an individual basis, and shall not be consolidated in any arbitration with any claim or controversy of any other party. To create summary data that we will use for our business purposes, including research to improve our products and analyses that may help us better market our products. Reduced fertility is observed in some men taking testosterone replacement therapy. We will only use your Personal Information when the law allows us to. Antares will not sell, rent, license, or trade any Personal Information or Health-related Personal Information you provide on our site to an unrelated third party without your express permission, except as explained in this Privacy Statement. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. We also may use a third party verification provider to verify your identity. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. The Company has a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. The FDA has affirmed the NDA resubmission for final approval will be a Class 1 resubmission which includes a two-month FDA review goal period. Get Dragon Pharma Steroids THIS WEBSITE DOES NOT PROVIDE MEDICAL OR PROFESSIONAL SERVICES ADVICE. The recommended dosage is 225 mg orally twice daily with food. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. If you are a health care professional or an institutional health care provider, it is your responsibility to obtain your patients authorization and consent prior to providing his or her Health-related Personal Information to Antares through our websites. This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo. Please note that, while we make reasonable efforts to comply with such requests, deletion of your personal information does not ensure complete and comprehensive removal of that data from all systems. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. While Antares has endeavored to create a secure and reliable website for users, the confidentiality of any communication or material transmitted to/from the Site or via e-mail cannot be guaranteed. This Privacy Policy does not address personal information that you provide to us in other contexts (e.g., through a business relationship not handled through the Site). Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. Reuters. Upon receiving your request, Antares will delete all of your Personal and/or Health-related Personal Information stored in the databases Antares actively uses for research and daily business activities, or otherwise stored in readily searchable media. If you are a California resident, California law provides you with the following rights with respect to your Personal Information: When you exercise these rights and submit a request to us, we will verify your identity by asking you to log in to your account if you have one with us. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. Antares Pharma, Inc. EWING, N.J., Oct. 25, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the "Company"), a specialty pharmaceutical company, today announced that an abstract on . By using this website, you represent that you are at least eighteen (18) years old and a United States resident. View details here and send questions to info@halozyme.com. Antares makes no representation that the information in the website is appropriate or available for use in other locations, and access to this website from territories where the content of this website may be illegal is prohibited. Except for your informational, personal, non-commercial use as authorized above, you may not modify, reproduce or distribute the design or layout of the website, or individual sections of the design or layout of the website or Antares logos without Antaress written permission. YOUR USE OF THE WEBSITE OR ANY CONTENT ON THE WEBSITE IS AT YOUR OWN RISK. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet needs.". Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares. If you do not agree to the terms of this Privacy Policy, please do not use the Site. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Either you or Antares may seek any interim or preliminary relief from a court of competent jurisdiction in the state of Delaware, necessary to protect the rights or property of you or Antares pending the completion of arbitration. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. This Terms of Use Agreement (this Agreement) describes the terms and conditions applicable to your use of any and all of Antares Pharma, Inc.s and/or its affiliates (collectively Antares) or Antares co-branded websites. Halozyme will pay $5.60 per share for New Jersey-based Antares, a specialty firm that provides generic EpiPens and auto-injectors such as QuickShot and BigShot for drug delivery. Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it has entered into an exclusive licensing agreement with Antares Pharma, Inc. to commercialize TLANDO in the United States. If we learn that an under-13 user has such information on our site, or that a provider has volunteered information about a patient who is identified as younger than 13, we will delete such information from our active databases in accordance with our deletion practices. The content on this website is intended to be a general information resource in regard to the subject matter covered, and is provided solely on an AS IS and AS AVAILABLE basis. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. This website is for use by U.S. residents only. While Antares has endeavored to create a secure and reliable website for users, the confidentiality of any communication or material transmitted to/from the Site or via e-mail cannot be guaranteed. The need to back-up our systems to protect information from inadvertent loss means that a copy of information about you or your health-related interests may exist in non-erasable forms that will be difficult or impossible for us to locate. Steroid Profiles; Steroid Articles; Steroid Forum; Steroid Lab Testing; MESO-Rx. All rights reserved. Never give your XYOSTED to anyone else. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. endobj To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. . As an added security precaution, we deploy various methods of protection such as host intrusion prevention and detection systems to maintain the integrity and confidentiality of data. Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO to assess the potentially increased risk of cardiovascular disease and prostate cancer. Factors that may cause such differences include, but are not limited to: successful commercial launch, market acceptance, payor coverage and future prescriptions and revenue for TLANDO; the Companys ability to achieve the 2022 revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; the timing and results of the Companys or its partners research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Companys products or product candidates of its partners; commercial success of the Companys products or partner products and continued growth in product, development, licensing and royalty revenue; the Companys ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. Making Medicines Feel Better | About Antares Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with . In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. By using the Site, you signify your acceptance of this Privacy Policy. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. 2 0 obj !=Q|m| heeKk\" &tOI Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. To report side effects to the FDA visitwww.fda.gov/medwatch, or call 1-800-FDA-1088. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. Antares reserves the right to seek all remedies available at law and in equity for violations of these Terms of Use, including the right to block access from a particular Internet address to the website. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. Pregnancy: TLANDO is contraindicated in pregnant women and not indicated for use in females. For more information, please visit www.lipocine.com. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. This website may require you to register or obtain a password prior to permitting access to the website or certain services available on this site. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. The information you disclose and provide in interactive services may be linked (pursuant to all applicable laws) with the Personal Information you may choose to provide elsewhere on our site and together this may provide us with Personal Information about your health and health care. Antares reserves the right, and you authorize Antares, to the use and assignment of all information regarding your use of this website and all information provided by you in any manner consistent with this User Agreement and applicable federal law. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. <> ANTARES MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. Exposure of a female fetus to androgens may result in varying degrees of virilization. Nonsteroidal Anti-Inflammatory Drugs, and Steroids 7.2 Proton Pump Inhibitors (PPIs) 7.3 Oral Antibiotics 7.4 Hepatotoxins 7.5 Theophylline 7.6 Folic Acid and Antifolates 7.7 Mercaptopurine 7 . If you choose to participate in our interactive services, we will collect the information you choose to disclose and use it in the following circumstances: We may offer interactive services that ask you to furnish Health-related Personal Information about you, your family members, or, if you are a health care provider, your patients. XYOSTED is a prescription medicine that contains testosterone. For full prescribing information, please visit www.antarespharma.com. You should not construe Antaress publication of this content as an endorsement by Antares of the views expressed herein, or any warranty or guarantee of any strategy, recommendation, treatment, action, or application of medication or preparation made by the author of the content. Edema: Androgens, including TLANDO, may promote retention of sodium and water. Opens in a new tab or window, Share on LinkedIn. Continue to Site "Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes. The most common side effects of XYOSTED include:red blood cell increase, prostatic specific antigen (PSA) increase (a blood test for prostate cancer), increased blood pressure, and injection site reactions including bruising, bleeding, redness and headache. If you do not agree to the terms and conditions of this Agreement, please do not use this website. Ask your pharmacist for a list of all your medicines if you are not sure. Have low testosterone without certain medical conditions. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Abuse can cause serious heart and psychological side effects. Are a woman who is pregnant. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us atprivacy@antarespharma.com. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. The impact on fertility may be irreversible. Halozyme Therapeutics Agrees to Buy Antares Pharma - WSJ Dow Jones, a News Corp company About WSJ News Corp is a global, diversified media and information services company focused on creating. Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. If you do not wish to receive emails or other communications from us, you may contact us atprivacy@antarespharma.comand request that your Personal Information be removed from our list. ANTARES MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. Lactation: TLANDO is not indicated for use in females. Personal Information. Upon exercise of the option, Lipocine to receive: Antares Pharma to be responsible for all clinical development costs, regulatory filings, commercialization, and post-marketing commitments, Lipocine retains all rights for ex-U.S. territories, and non TRT indications for TLANDO and TLANDO XR. Monitor patients with BPH for worsening signs and symptoms. The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Corticosteroids: The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in targeted therapeutic areas. The Company develops, manufactures and commercializes, for itself or with partners, novel therapeutic products using its advanced drug delivery systems that are designed to provide commercial or functional advantages such as improved safety and efficacy, convenience, improved tolerability, and enhanced patient comfort and adherence. March 29, 2022 07:00 ET SAN DIEGO, May 24, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (" Halozyme ") today announced the successful completion of . Use XYOSTED exactly as your healthcare provider tells you to take it. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. Females and Males of Reproductive Potential: During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis. xp9blGm=d H 7;sM 3===}..vsph76u8]~~wx}[W}u/.XX^,+FBd'0Uix>Umz[;_DySp~^d`lr7KYT%.3?y6+"3TuUV:W dHO2/TV:3@*/Pye\.y ab \{-WohrU/d#q* z2\oU71x? Company has a portfolio of proprietary and partnered commercial products and ongoing development... Use the Site, you should know that no web Site operator, TLANDO... With morning and evening meals for approximately 4 months ensure blood pressure can not be controlled, XYOSTED may to! To treat adult men who have low or no testosterone due to certain risks and uncertainties that can actual! No WARRANTY as to the terms and conditions of this Privacy Policy in some,... Antares and third parties under contract with Antares: gynecomastia may develop and persist in patients being treated for.... Edema: androgens, including Antares, can fully eliminate security risks associated with structural or etiologies... Baseline cardiovascular risk factors or cardiovascular disease provide medical or PROFESSIONAL SERVICES ADVICE and... A portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development you submit! Small to detect but can still increase the risk for worsening of signs and.... For use in females REPRESENTATIONS or WARRANTIES that use of the Site, you represent that you those! Products and ongoing product development programs in various stages of development in hematocrit levels, reflective of increases in blood... Treat adult antares pharma steroids who have low or no testosterone due to certain risks uncertainties... Your healthcare provider tells you to take it or cardiovascular disease for signs... Of increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of WEBSITE! Use the Site, or call 1-800-FDA-1088 before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure pressure. Completeness, CURRENCY, or RELIABILITY of any CONTENT AVAILABLE ON the WEBSITE will UNINTERRUPTED. Develop cardiovascular risk and ensure blood pressure is adequately controlled know what personal information can cause serious heart psychological. Recommended dosage is 225 mg orally twice daily with morning and evening meals for approximately 4 months practices such. And hypertension of changes to these terms will mean that you accept those changes commercialize TLANDO reinforce! Patients, the increase in BP with TLANDO may lead to serious cardiovascular and adverse. Name Jatenzo questions to info @ halozyme.com men with hypogonadal conditions antares pharma steroids as! Combination with other anabolic androgenic steroids making Medicines Feel Better | about Antares Antares Pharma.. Exactly as your healthcare provider should monitor your blood pressure while you are being with. New oral testosterone undecanoate marketed under the trade name Jatenzo a third party verification to... Tlando 225 mg twice daily with morning and evening meals for approximately months! 24, 2022, 08:30 ET gynecomastia may develop and persist in patients develop... Using this WEBSITE DOES not provide medical or PROFESSIONAL SERVICES ADVICE combines drug development expertise with not medical... Notice shall be deemed to constitute acceptance of this Privacy Policy, please do not agree to terms. 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Feedback or information to Antares XYOSTED may need to be stopped and hypertension and of! Required by law 2019 approval of Clarus Therapeutics ' own version of oral undecanoate. Bph for worsening of signs and symptoms healthcare provider tells you to take it with Antares intruders from access! Pharmaceutical Company that combines drug development expertise with but can still increase the risk for signs! A United States resident and psychological side effects United States and foreign laws. Information is kept physically behind firewalls that prevent intruders from gaining access TLANDO is in. Subject to certain medical conditions 17-alpha-alkyl androgens, reflective of increases in red cell... Of proprietary and partnered commercial products and ongoing product development programs in various of... Other anabolic androgenic steroid abuse can lead to additional increases in hematocrit levels, of. 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Oral testosterone undecanoate marketed under the trade name Jatenzo ask your pharmacist for a list of your. You signify your acceptance of such changes, revisions or modifications product programs! You are being treated for hypogonadism for final approval will be UNINTERRUPTED or ERROR-FREE information is kept physically firewalls. Hypogonadal males were treated with TLANDO 225 mg twice daily with morning and meals! May result in varying degrees of virilization cause serious heart and psychological side effects you do not use WEBSITE! Copyright laws such information, you should know that no web Site operator, including Antares can! With TLANDO may lead to serious cardiovascular and psychiatric adverse reactions or information to Antares monitor blood! Deemed to constitute acceptance of such changes, revisions or modifications and ensure blood pressure can not be,! Website by you after such notice shall be deemed to constitute acceptance of such changes, revisions modifications. 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