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). TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. TLANDO (testosterone undecanoate) capsules, for oral use, CIII. 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. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. y7y F6+O#2EtjpT{HZ(4#xnpx6+JxdQ`0FQ[VWA Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. Abuse and misuse of testosterone are seen in male and female adults and adolescents. If you do not have an account with us, we may ask for your email address, other forms of identification information. Improper use of XYOSTED may effect bone growth in children. We have put in place procedures to deal with any suspected Personal Information breach and will notify you and any applicable regulator of a breach where we are legally required to do so. This privacy statement applies solely to information collected by Antares. 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. 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. We may have access to the following categories of Personal Information regarding you and your visit to our website. 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 . Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. The Site is not designed for, or intentionally targeted at, children under 13 years of age. Personal Information. Antares Pharma's FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. We have put in place procedures to deal with any suspected Personal Information breach and will notify you and any applicable regulator of a breach where we are legally required to do so. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. This privacy statement applies solely to information collected by Antares. 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. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Improper use of XYOSTED may effect bone growth in children. To submit a request to know, you may contact us at (877) 225-2908 or, The right to request that we delete any personal information we have collected about you. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . 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). These studies did not meet current standards for nonclinical development toxicity studies. 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. "We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. 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 . This Privacy Policy applies solely to the information that we collect through the Site. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Some Internet browsers include the ability to transmit Do Not Track signals. What should I tell my healthcare provider before using XYOSTED? Opens in a new tab or window, Visit us on Twitter. SAN DIEGO, May 24, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (" Halozyme ") today announced the successful completion of . 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. You are responsible for maintaining the confidentiality of your registration information and password, and for all uses of your password, whether or not authorized by you. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. Any controversy or claim arising under or related to this User Agreement or Antaress products and/or services shall be settled by binding arbitration in accordance with the commercial rules of arbitration of the American Arbitration Association. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. 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). Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. 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. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. Prescribing Information, including Boxed Warning. 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. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. 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. For more information, ask your healthcare provider or pharmacist. dy;rq% Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. 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 . 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. It also recommends regular monitoring and treatment of any new-onset hypertension or exacerbations of pre-existing hypertension, paired with a re-evaluation of the benefits of the treatment. Please be aware that Antares is not responsible for the privacy practices of such other websites. The Company has a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. Monitor the lipid profile periodically after starting testosterone therapy. <>>> 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 20052022 MedPage Today, LLC, a Ziff Davis company. 3 0 obj 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. Ask your pharmacist for a list of all your medicines if you are not sure. 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. Keep your XYOSTED in a safe place to protect it. XYOSTED may harm your unborn baby. Antares will not sell your Personal Information or Health-related Personal Information. If you desire or need such services or advice, you should consult a professional health care provider. by 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. Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. For more information, please visit www.lipocine.com. If these occur, promptly discontinue TLANDO while the cause is evaluated. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. 1 0 obj To customize your site experience by anticipating the information and services that may be of interest to you. Opens in a new tab or window, Visit us on TikTok. The website and the information contained herein does not constitute an offer or a solicitation of an offer for sale of any securities. SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --. Get Dragon Pharma Steroids 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. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM. We look forward to launching TLANDO commercially, which will provide a complementary treatment option to patients and clinicians in the second quarter of this year.. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. 1:{HBRo!#V 3s,i$~sqr,cIp({C/ As we prepare for the commercial launch, we look forward to our sales representatives detailing a differentiated portfolio of products consisting of XYOSTED, TLANDO and NOCDURNA that will continue to deliver solutions for improved patient care, added Joe Renda, Senior Vice President, Commercial of Antares Pharma. Geriatric Use: There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Are a woman who is pregnant. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . We also may use a third party verification provider to verify your identity. THIS WEBSITE DOES NOT PROVIDE MEDICAL OR PROFESSIONAL SERVICES ADVICE. Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. Lactation: TLANDO is not indicated for use in females. By using this website, you represent that you are at least eighteen (18) years old and a United States resident. 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%. You should not inject XYOSTED until you have been trained on the proper way to use it. Antares Pharma develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. Patients treated with androgens may be at increased risk for prostate cancer. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. 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. 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. The impact on fertility may be irreversible. Opens in a new tab or window, Share on LinkedIn. 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. 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 the receipt of final FDA approval of TLANDO, the timing and amount of sales and development milestone payments and royalties under the License Agreement, the exercise of Antares' option with respect to TLANDO XR, the costs and timing of any post-marketing studies of TLANDO and clinical studies relating to TLANDO XR, our ability to compete in the TRT market, the degree to which TLANDO will gain market share in the TRT market, if at all, Antares Pharma's ability to successfully commercialize TLANDO, the benefits to Lipocine and Antares Pharma under the License Agreement, the potential benefits of TLANDO to patients, Lipocine's product candidates and related clinical trials, the potential uses and benefits of our product candidates, and our product development efforts. It also has . Drug dependence in individuals using approved doses for approved indications have not been documented. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. 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. If you do not agree to be bound, you will not be given access to the page or service. | Source: Have low testosterone without certain medical conditions. Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. Treatment-emergent adverse events in the phase III trial occurred in 21.1% of participants, with one person withdrawing due to a serious adverse event. 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. The most commonly reported adverse reactions ( 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Use XYOSTED exactly as your healthcare provider tells you to take it. Peliosis hepatis can be a life-threatening or fatal complication. Licensing Agreement To Commercialize TLANDO, For further information: Morgan Brown, Executive Vice President & Chief Financial Officer, (801) 994-7383, mb@lipocine.com; or Investors, Hans Vitzthum, (617) 535-7743, hans@lifesciadvisors.com, Commercial sales milestone payments of up to, Tiered royalties on net sales of TLANDO from mid-teens up to 20%. Except as otherwise provided on this page, no part of any content or software on this website may be copied, downloaded or stored in a retrieval system for any other purpose, nor may it be redistributed for any purpose, without the express written permission of Antares. 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. 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 . Only some categories of information identify you directly, but each category offers some information about your interests and activities that could be used to make inferences about you. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. March 29, 2022. 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. 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. This Privacy Policy applies solely to the information that we collect through the Site. "The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients," said Robert F. Apple, president and CEO of Antares Pharma. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). For full prescribing information, please visit www.antarespharma.com. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Other side effects includemore erections than are normal for you or erections that last a long time. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. For all other inquiries, please contact us through the relevant product, support or Antares website. We have implemented appropriate security measures, including encryption practices, to prevent your Personal Information and Health-related Personal Information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. To send you an e-mail confirming your registration with our site and to respond to questions from you. Your use of certain pages or services within this website may be subject to additional terms and conditions. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. 4 0 obj Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. 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. Send you an e-mail confirming your registration with our Site and to respond to questions from.... 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