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. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. 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. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. 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. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. Opens in a new tab or window, Visit us on YouTube. 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. View details here and send questions to info@halozyme.com. Disclosure and Relationship To Third Parties. To personalize content provided on the website. Disclosure and Relationship To Third Parties. The right to know what personal information we have collected, used, disclosed and sold about you. Based out of the New York City office, shes worked at the company since 2015. 4 0 obj % These are not all the possible side effects of XYOSTED. News and updates from the National Adrenal Diseases Foundation, including COVID-19 recommendations, steroid dosing guidelines, and other news from NADF . T}b j[yj WhvLdK5D:Goai5.w=u_n'jt"XD/PeV *kH12z(^`0 Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Information That Is Routinely Collected By Our Site Technology: Whether you are a consumer or a health care professional, we use the information about your use of the services and activities on our website to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. Information about companies other than Antares contained in the news, press releases or otherwise, should not be relied upon as being provided or endorsed by Antares. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. 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. We also may use a third party verification provider to verify your identity. III. The Site is not designed for, or intentionally targeted at, children under 13 years of age. Venous Thromboembolism: There have been post marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as TLANDO. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. 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. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. 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. Never give your XYOSTED to anyone else. March 29, 2022. 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. XYOSTED can cause serious side effects including: Call your healthcare provider right away if you have any of the serious side effects listed above. The right to know what personal information we have collected, used, disclosed and sold about you. 1 0 obj Abuse can cause serious heart and psychological side effects. Improper use of XYOSTED may effect bone growth in children. 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. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. endobj 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 . An increase in red blood cell mass may increase the risk of thromboembolic events. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Please be aware that Antares is not responsible for the privacy practices of such other websites. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Hypogonadism can be treated with testosterone replacement therapy. 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. 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. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). XYOSTED is a prescription medicine used to treat adult men who have low or no testosterone due to certain medical conditions. 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. 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. 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). Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. 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. Keep your XYOSTED in a safe place to protect it. The information you disclose and provide in interactive services may be linked (pursuant to all applicable laws) with the Personal Information you may choose to provide elsewhere on our site and together this may provide us with Personal Information about your health and health care. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). 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. 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. 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. Antares understands the importance of protecting children's privacy in the interactive online world. 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. Improper use of XYOSTED may effect bone growth in children. The website and the information contained herein does not constitute an offer or a solicitation of an offer for sale of any securities. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). 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. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. d):b9Z}~@B_@&NT[@zY`AsU"P All Rights Reserved. The security of your data is very important to Antares. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. 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. 1:{HBRo!#V 3s,i$~sqr,cIp({C/ Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. Antares invites you to view, use and download a single copy of this website for your informational, personal, non-commercial use. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. 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. 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. For example, do not take XYOSTED if you have low testosterone due to age. Antares may modify its services at any time. "Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes. The impact on fertility may be irreversible. 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. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Halozyme has completed its acquistion of Antares Pharma, creating a leading drug delivery business. 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. Know the medicines you take. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. This website is operated by Antares. Male hypogonadism, also known as testosterone deficiency, is an endocrine disorder in which the body fails to produce enough of the hormone. Information That Is Routinely Collected By Our Site Technology: Whether you are a consumer or a health care professional, we use the information about your use of the services and activities on our website to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services. 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. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --. 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. If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both TLANDO and XYOSTED and support our future growth with an expanded commercial portfolio. y7y F6+O#2EtjpT{HZ(4#xnpx6+JxdQ`0FQ[VWA Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. Have low testosterone without certain medical conditions. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. 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. endobj Personal Information. 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. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. Upon exercise of the option, Lipocine to receive: Antares Pharma to be responsible for all clinical development costs, regulatory filings, commercialization, and post-marketing commitments, Lipocine retains all rights for ex-U.S. territories, and non TRT indications for TLANDO and TLANDO XR. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. !=Q|m| heeKk\" &tOI 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. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Kristen Monaco, Staff Writer, MedPage Today 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. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. 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). 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. This website may require you to register or obtain a password prior to permitting access to the website or certain services available on this site. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. This Privacy Policy applies solely to the information that we collect through the Site. 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 . Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. 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. The FDA had previously granted tentative approval to Tlando, but full approval was held off until March 27 when the exclusivity period that was granted to Clarus for Jatenzo under the Hatch-Waxman Act expired. San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . 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.

Sara Miller Contact, Giddy Up And Go Menu, How To Cancel Bizbuysell Subscription, Dog Liver Failure Stages, Articles A