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. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Personal Information That You Voluntarily Provide. March 29, 2022. For more information, please visit www.lipocine.com. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. ANTARES MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. 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. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. 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. 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%. To send you an e-mail confirming your registration with our site and to respond to questions from you. We also may use a third party verification provider to verify your identity. To customize your site experience by anticipating the information and services that may be of interest to you. Antares Pharma, Inc. 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 of endogenous testosterone, or hypogonadism in adult males. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. 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. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. 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 at any point, we decide to use personally identifiable information or health-related personal information in a manner different from that stated at the time it was collected, you will be given a choice to allow or disallow any additional uses or disclosures of your personally identifiable information or health-related personal information. 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. 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. Monitor the lipid profile periodically after starting testosterone therapy. If you do not agree to be bound, you will not be given access to the page or service. that, if you are a health care professional, you will not submit any information that would directly identify a patient or any information for which you do not have all necessary consents or authorizations to disclose; you will only submit content that complies with applicable law, and will not submit content that is abusive, defamatory, obscene, infringing, threatening, repetitive, or otherwise inappropriate, or that contains any viruses or other software that may adversely affect the operation of anothers computer; you understand and agree that such content that is submitted to a feedback page, will be deemed non-confidential; and. 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. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. If your blood pressure increases while you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . y7y F6+O#2EtjpT{HZ(4#xnpx6+JxdQ`0FQ[VWA 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. You have been unsubscribed from receiving future communications from us. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. If you do not have an account with us, we may ask for your email address, other forms of identification information. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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. If we determine that your patient is eligible for the trial, we will use the information you submit to contact you about your patients potential participation in the trial and to provide you with additional information. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. 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. 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. endobj Potential for Adverse Effects on Spermatogenesis: With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. 4 0 obj Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. 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. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. 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. Halozyme Therapeutics, Inc. May 24, 2022, 08:30 ET. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Personal Information. 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. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. 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). Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. 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. Opens in a new tab or window, Visit us on TikTok. The trademarks, logos, and service marks (collectively, the Trademarks) displayed on this website are registered and unregistered Trademarks of Antares and others. Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). 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. 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. Opens in a new tab or window, Visit us on LinkedIn. Based out of the New York City office, shes worked at the company since 2015. If you desire or need such services or advice, you should consult a professional health care provider. Improper use may result in acceleration of bone age and premature closure of epiphyses. Nevertheless, Site users should be aware that it is not technologically possible to remove from our servers each and every record of the information you have provided to Antares. Ask your pharmacist for a list of all your medicines if you are not sure. If we determine that your patient is eligible for the trial, we will use the information you submit to contact you about your patients potential participation in the trial and to provide you with additional information. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. In addition, Lipocine has granted Antares Pharma an option . 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. Though Tlando was originally developed by Lipocine Inc, the developer entered a listening deal with Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of Tlando in the U.S. Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and nephrology news. 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. 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. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. You should not construe Antaress publication of this content as an endorsement by Antares of the views expressed herein, or any warranty or guarantee of any strategy, recommendation, treatment, action, or application of medication or preparation made by the author of the content. xp9blGm=d H 7;sM 3===}..vsph76u8]~~wx}[W}u/.XX^,+FBd'0Uix>Umz[;_DySp~^d`lr7KYT%.3?y6+"3TuUV:W dHO2/TV:3@*/Pye\.y ab \{-WohrU/d#q* z2\oU71x? The safety of TLANDO was evaluated in 2 clinical studies in a total of 233 men. 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. Opens in a new tab or window, Visit us on Instagram. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. Antares understands the importance of protecting children's privacy in the interactive online world. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). Antares Pharma Inc. | 4,908 followers on LinkedIn. 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. Sleep apnea may occur in those with risk factors (5.12). 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. 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. Patients with carcinoma of the breast or known or suspected carcinoma of the prostate. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. The Site may contain links to other websites. "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. 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