Subject to all applicable federal laws, Antares shall be free to use such content, including any ideas, concepts, know-how, or techniques contained in such content, for any reason whatsoever. Blood Pressure Increases XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action. 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. Opens in a new tab or window, Visit us on YouTube. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. If you are a health care provider and you submit health-related personal information about a patient in order for them to participate in a clinical trial, that information will be maintained in accordance with this Privacy Statement. Personal Information That You Voluntarily Provide. III. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology to deliver safe and effective medicines. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. Kristen Monaco, Staff Writer, MedPage Today Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. 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.". dy;rq% Improper use of XYOSTED may effect bone growth in children. Under the terms of Agreement Lipocine to receive: 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. For full prescribing information, please visit www.antarespharma.com. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. 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. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. 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. 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 . The Company has a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. To customize your site experience by anticipating the information and services that may be of interest to you. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Steroid Profiles; Steroid Articles; Steroid Forum; Steroid Lab Testing; MESO-Rx. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Opens in a new tab or window, Visit us on Instagram. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. Use XYOSTED exactly as your healthcare provider tells you to take it. 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. 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 you violate any terms of this Agreement or if you misuse this website, you agree to defend, indemnify and hold harmless Antares, its officers, directors, employees, agents and licensees from any and all liability including, without limitation, costs, expenses and attorneys fees that arise out of or are related to your violation or misuse. 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. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. 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. The right to know what personal information we have collected, used, disclosed and sold about you. The warning label advises clinicians to consider the patient's baseline cardiovascular risk and to ensure adequate blood pressure control prior to initiating Tlando. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . 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. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. If you do not have an account with us, we may ask for your email address, other forms of identification information. <> Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Edema: Androgens, including TLANDO, may promote retention of sodium and water. This website is for use by U.S. residents only. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. If you do not agree to the terms of this Privacy Policy, please do not use the Site. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. Your exercise of these rights will have no adverse effect on the price and quality of our services. Halozyme Therapeutics, Inc. May 24, 2022, 08:30 ET. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. %PDF-1.5 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. Q~wI97S~v # }ZFJ<2gFB\p[ KMSC$U^7D?^Ye^?9CAPG/wv endobj If you do not agree to be bound, you will not be given access to the page or service. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. Lipocine will also be entitled to receive sales-based commercial milestone payments totaling up to $160.0 million based on TLANDO net sales and, if Antares Pharma exercises its option, TLANDO XR sales, in addition to tiered royalty payments at rates ranging from the mid-teens to up to 20% on net sales of TLANDO. If you submit health-related personal information through our website to participate in a clinical trial, we may use that information to assess whether you qualify for enrollment in the trial, to contact you about potential participation in the trial, and to provide you with additional information about the trial. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. In addition, we will use commercially reasonable efforts not to disclose any personal information stored in a non-erasable format after receiving your request for removal, except as required by law. These BP increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease. Antares understands the importance of protecting children's privacy in the interactive online world. 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. Patients with carcinoma of the breast or known or suspected carcinoma of the prostate. 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. Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. Are a woman who is pregnant. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. Improper use may result in acceleration of bone age and premature closure of epiphyses. Dr. Patel further stated, "Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma's capabilities, given its established marketing experience and demonstrated success in the TRT space. Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. 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. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. 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. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management. 1 0 obj Please be aware that Antares is not responsible for the privacy practices of such other websites. 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 . Such links do not imply Antaress endorsement of material on any other site and Antares disclaims all liability with regard to your access to such linked websites. 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. For final approval will be a target for people who abuse prescription medicines safe antares pharma steroids effective.... Not be controlled, XYOSTED may effect bone growth in children undue reliance on the and! 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