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. All Rights Reserved. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. 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. Because of these concerns, the label for Tlando includes a boxed warning regarding possible blood pressure increases, stating that these "can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.". 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.
Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. 1 0 obj
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It is not our policy to intentionally collect or maintain information about anyone under the age of 13. This website is for use by U.S. residents only. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. YOU ARE RESPONSIBLE FOR TAKING ALL NECESSARY PRECAUTIONS TO ENSURE THAT ANY CONTENT YOU OBTAIN FROM THE WEBSITE IS FREE OF VIRUSES. 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. 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. 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. The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties. To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. If you do not have an account with us, we may ask for your email address, other forms of identification information. "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. . In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. Use XYOSTED exactly as your healthcare provider tells you to take it. 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 . Monitor patients with BPH for worsening signs and symptoms. 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. These studies did not meet current standards for nonclinical development toxicity studies. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. All rights reserved. | Source:
To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. III. Before you use XYOSTED, tell your healthcare provider about all of your medical conditions, including, if you any of the following:high blood pressure or heart problems, high red blood cell count, urinary problems due to an enlarged prostate, kidney or liver problems, a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder, or problems breathing while you sleep (sleep apnea). To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. 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. We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. The website may contain information, news and/or press releases about Antares. Antares invites you to view, use and download a single copy of this website for your informational, personal, non-commercial use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. by The Personal Information and Health-related Personal Information that you provide may be used to create customized offers, information, and services tailored to your interests and preferences. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Unless otherwise set forth in a written agreement between you and Antares, you must adhere to Antaress linking policy as follows: (i) any link to an Antares website must be a text only link clearly marked Antares WEBSITE, (ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Antaress names and trademarks, (iii) the link must point to the root domain name of the Antares website and not to other pages within the website, (iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, affiliated with, or associated with Antares, (v) when selected by a user, the link must display the website on full-screen and not within a frame on the linking website, and (vi) Antares reserves the right to revoke its consent to the link at any time and in its sole discretion. 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. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. We will only use your Personal Information when the law allows us to. 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. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE. Antares Pharma focuses on the development and commercialization of self-administered pharmaceutical products and the technologies to deliver them. 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. To discover new facts that could help us better understand how our products are used in coping with the diseases for which they are marketed. Opens in a new tab or window, Share on Twitter. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Making Medicines Feel Better | About Antares Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with . If you do not agree to the terms of this Privacy Policy, please do not use the Site. 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. If you do not agree to the terms of this Privacy Policy, please do not use the Site. The Site may contain links to other websites. Commercial launch expected in 2Q 2022. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management. 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). <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
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. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. Halozyme has completed its acquistion of Antares Pharma, creating a leading drug delivery business. 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. This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. 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 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. 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. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Opens in a new tab or window, Visit us on TikTok. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. 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. ANTARES SPECIFICALLY DISCLAIMS ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH ACCESS TO OR USE OF THE WEBSITE, EVEN IF ANTARES HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO RELIANCE BY ANY PARTY ON ANY CONTENT OBTAINED THROUGH THE USE OF THE WEBSITE, OR THAT ARISES IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO OR FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THE WEBSITE OR VIRUSES, WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, WAR, TERRORISM, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION OF, OR UNAUTHORIZED ACCESS TO THE WEBSITE, OR RELATED INFORMATION OR PROGRAMS. 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. Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED. Your exercise of these rights will have no adverse effect on the price and quality of our services. 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. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. 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. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. 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. 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. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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. 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. This site 2023 Antares Pharma. For more information, ask your healthcare provider or pharmacist. As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. Show your list to your healthcare provider and pharmacist when you get a new medicine. 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