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. d):b9Z}~@B_@&NT[@zY`AsU"P Abuse and misuse of testosterone are seen in male and female adults and adolescents. Are a woman who is pregnant. These are not all the possible side effects of XYOSTED. @wiaimh;;phJ; 0 Pa0/~REluQ%RF UMA%@uE}{[OD$Hvx Cv\5zg#}K8m)o|yHk8jG\'Q06AIT^x"$*#IB="T*Jysa-%-'MY6{HSExH" TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. 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. The website may contain information, news and/or press releases about Antares. Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Those who choose to access this website from other locations do so on their own initiative and are responsible for compliance with applicable local laws. 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. Antares Pharma develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. 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. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). Abuse can cause serious heart and psychological side effects. PLEASE READ THESE TERMS OF USE CAREFULLY! 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 . 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. Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. If you do not agree to be bound, you will not be given access to the page or service. As of May 24, 2022 Halozyme completed its acquisition of Antares Pharma, Inc., creating a leading drug delivery business with broadly licensable opportunities across the ENHANZE and Antares' auto injector technologies. Q~wI97S~v # }ZFJ<2gFB\p[ KMSC$U^7D?^Ye^?9CAPG/wv Halozyme Therapeutics, Inc. May 24, 2022, 08:30 ET. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. SAN DIEGO, May 24, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (" Halozyme ") today announced the successful completion of . Kristen Monaco, Staff Writer, MedPage Today Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED. Antares may modify its services at any time. 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. March 29, 2022. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Please be aware that Antares may not comply with a consumers request to amend or remove information that was provided to Antares by a health care professional or a consumer regarding an adverse drug event. Your healthcare provider will show you or your caregiver how to inject XYOSTED. Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Exposure of a female fetus to androgens may result in varying degrees of virilization. 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. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). 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. 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. 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. About Antares Pharma. TLANDO can cause BP increases that can increase the risk of MACE. When used on the website, words like anticipates, expects, believes, estimates, seeks, plans, intends and similar expressions are intended to identify forward-looking statements designed to fall within securities law safe harbors for forward looking statements. This Privacy Policy applies solely to the information that we collect through the Site. 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). For more information, ask your healthcare provider or pharmacist. SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --. Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. Upon exercise of the TLANDO XR option, Lipocine is entitled to receive an additional $4.0 million in license fees, clinical and regulatory milestone payments of up to an aggregate of $35.0 million, and tiered royalties on net sales at rates ranging from the mid-teens to up to 20%. 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 . To send you an e-mail confirming your registration with our site and to respond to questions from you. Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S. Lipocine grants Antares Pharma an option to license TLANDO XR for development and commercialization in the U.S. Personal Information. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Your exercise of these rights will have no adverse effect on the price and quality of our services. For more information, please visit www.lipocine.com. 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 Pharma Drug Portfolio. Improper use of XYOSTED may effect bone growth in children. 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. Antares Pharma, Inc. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, The FDA approval of TLANDO brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. 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. Increase in Blood Pressure: In Study 18-001, TLANDO increased systolic BP after 4 months of treatment by an average of 4.3 mmHg based on ambulatory blood pressure monitoring (ABPM) and 4.8 mmHg from baseline based on blood pressure cuff measurements. The approval was based on a phase III trial in which about 80% of participants achieved 24-hour average serum testosterone concentrations within the normal range between 300 to 1,080 ng/dL with Tlando, meeting the primary efficacy endpoint. Prescribing Information, including Boxed Warning. Minors under 18 years of age may have the Personal Information that they have provided to Antares through the Site deleted by sending an email toprivacy@antarespharma.comrequesting deletion. Opens in a new tab or window, Visit us on TikTok. . Before being given access to these pages or services, you will be asked to indicate whether you agree to be bound by the additional terms and conditions. Decreased Thyroxine-binding Globulin: Androgens, including TLANDO, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of triiodothyronine (T3) and thyroxine (T4). By using the Site, you signify your acceptance of this Privacy Policy. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. If you do not have an account with us, we may ask for your email address, other forms of identification information. If we allow a third party contractor to have access to your Personal Information or health-related personal information, we will not authorize them to take it or use it for any purpose that is not consistent with this Privacy Statement. Such changes, revisions or modifications shall be effective immediately upon notice to you, which may be given by any means including, without limitation, posting on the website or by e-mail. Opens in a new tab or window, Visit us on Instagram. We also may use a third party verification provider to verify your identity. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. Contact:Tram BuiVice President, Corporate Communications and Investor Relations609-359-3016tbui@antarespharma.com, Primary hypogonadism (congenital or acquired), Hypogonadotropic hypogonadism (congenital or acquired), Safety and efficacy of TLANDO in males less than 18 years old have not been established. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Using XYOSTED with other medicines can affect each other. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. Patients treated with androgens may be at increased risk for prostate cancer. Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of TLANDO. Not for Use in Women: Due to lack of controlled studies in women and the potential for virilizing effects, TLANDO is not indicated for use in women. by If you do not agree to the terms of this Privacy Policy, please do not use the Site. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. Show your list to your healthcare provider and pharmacist when you get a new medicine. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that 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 www.sec.gov. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. Continue to Site indication and in combination with other anabolic androgenic steroids (5.6). If serum prolactin remains elevated, discontinue TLANDO. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. Halozyme has completed its acquistion of Antares Pharma, creating a leading drug delivery business. [B} 3E=2DESD 3\6(/^n;#Bx Commercial launch expected in 2Q 2022. The right to know what personal information we have collected, used, disclosed and sold about you. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. This website is operated by 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. Pediatric Use: The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. About Antares Pharma. The arbitration shall be conducted in the State of Delaware, and judgment on the arbitration award may be entered by any court of competent jurisdiction. Check hematocrit prior to initiating TLANDO. We improve compliance, absorption, and more with our proprietary drug delivery technology. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both TLANDO and XYOSTED and support our future growth with an expanded commercial portfolio. Hypogonadism can be treated with testosterone replacement therapy. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. All rights reserved. Get Dragon Pharma Steroids LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. Our proprietary drug delivery business involving use of the website by you after such notice shall deemed! Are being treated with androgens the website by you after such notice shall be deemed to constitute acceptance of Changes! 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