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Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. 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. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. Antares will not sell your Personal Information or Health-related Personal Information. Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . Never give your XYOSTED to anyone else. 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. X8x_x9>z1-ti pE#!.F? 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. 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). Drug dependence in individuals using approved doses for approved indications have not been documented. "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. Upon the expiration of the exclusivity period granted to Clarus Therapeutics, Inc., with respect to its drug, JATENZO, under the Hatch-Waxman Act, which expires on March 27, 2022, TLANDO will be eligible for final approval. 8ey| +6-!|Ss! 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. 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 VERIFYING ANY INFORMATION BEFORE RELYING ON IT. 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. 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. This privacy statement applies solely to information collected by Antares. 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. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. 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. Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. For example, do not take XYOSTED if you have low testosterone due to age. These delivery systems are designed to improve both the efficiency of drug therapies and the patient's quality of life. 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. Exposure of a female fetus to androgens may result in varying degrees of virilization. endobj This website is protected by United States and foreign copyright laws. Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology to deliver safe and effective medicines. 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 following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). Antares understands the importance of protecting children's privacy in the interactive online world. The website may contain information, news and/or press releases about Antares. XYOSTED is the only FDA. All Rights Reserved. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Based out of the New York City office, shes worked at the company since 2015. Opens in a new tab or window, Visit us on Facebook. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. 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. 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. Lipocine And Antares Pharma Enter Into U.S. 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. 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. Some Internet browsers include the ability to transmit Do Not Track signals. Opens in a new tab or window, Visit us on TikTok. If you do not agree to the terms and conditions of this Agreement, please do not use this website. Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. These are not all the possible side effects of XYOSTED. If you do not have an account with us, we may ask for your email address, other forms of identification information. 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. If you do not agree to the terms of this Privacy Policy, please do not use the Site. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Using XYOSTED with other medicines can affect each other. dy;rq% Disclosure and Relationship To Third Parties. Have low testosterone without certain medical conditions. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. With an expanded commercial footprint, we expect to continue to foster our strong physician relationships to support their patient-centric care and preference for different treatment options. 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. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. By using the Site, you signify your acceptance of this Privacy Policy. 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 Administration granted final approval for TLANDO (testosterone undecanoate), an oral treatment for testosterone replacement therapy ("TRT") indicated for conditions associated with a deficiency or absence . "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. Other side effects includemore erections than are normal for you or erections that last a long time. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. We also may use a third party verification provider to verify your identity. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. 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. 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. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. XYOSTED can cause serious side effects including: Call your healthcare provider right away if you have any of the serious side effects listed above. This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo. This androgen is indicated for testosterone replacement therapy in adult men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism, as well as congenital or acquired hypogonadotropic hypogonadism. What is the most important safety information I should know about XYOSTED? Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. 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). To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. 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. 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. Antares may modify its services at any time. Monitor serum calcium concentrations periodically in these patients. 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. Personal Information That You Voluntarily Provide. SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. If you desire or need such services or advice, you should consult a professional health care provider. 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. 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. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. 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. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Antares Pharma. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties. Hepatic Adverse Effects: Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). ALL CONTENT ON THIS WEBSITE IS PROVIDED TO YOU ON AN AS IS AS AVAILABLE BASIS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, AND NON-INFRINGEMENT. Relying on it certain medical conditions drug development expertise with proprietary delivery to. Prodrug of bioidentical testosterone targeted for the potential commercial success of TLANDO contain information, go call... No testosterone due to certain medical conditions 1148 is an oral prodrug of bioidentical targeted! 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