LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. For more information, please visit www.lipocine.com. 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. 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. 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. XYOSTED is a prescription medicine that contains testosterone. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. 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 . Evaluate serum prolactin levels prior to initiating treatment with TLANDO. Please be aware that Antares is not responsible for the privacy practices of such other websites. TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The Company has formed partnership arrangements with several different industry leading pharmaceutical companies. We also may use a third party verification provider to verify your identity. 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. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Antares will not sell your Personal Information or Health-related Personal Information. by 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. This Antares website may contain links to websites operated by other parties. Halozyme Therapeutics Agrees to Buy Antares Pharma - WSJ Dow Jones, a News Corp company About WSJ News Corp is a global, diversified media and information services company focused on creating. 3 0 obj #x&8G+!B*eC-VJhh-:.x Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Antares Pharma, Inc. EWING, N.J., Oct. 25, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the "Company"), a specialty pharmaceutical company, today announced that an abstract on . Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). When used on the website, words like anticipates, expects, believes, estimates, seeks, plans, intends and similar expressions are intended to identify forward-looking statements designed to fall within securities law safe harbors for forward looking statements. 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). Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. 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. combination with other anabolic androgenic steroids. It is estimated that approximately 35% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism1. Keep your XYOSTED in a safe place to protect 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 . 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. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Halozyme has completed its acquistion of Antares Pharma, creating a leading drug delivery business. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). Antares is not engaged in rendering medical or similar professional services or advice via this website, and the information provided is not intended to replace medical advice offered by a physician. To personalize content provided on the website. 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. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. Personal Information. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR. 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. indication and in combination with other anabolic androgenic steroids (5.6). Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Interestingly, FDA advisory committees recommended against approval of both Tlando and Jatenzo back in 2018 largely due to cardiovascular concerns. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . The need to back-up our systems to protect information from inadvertent loss means that a copy of information about you or your health-related interests may exist in non-erasable forms that will be difficult or impossible for us to locate. 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. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE. SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --. 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. 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. Selling or giving away this medicine may harm others and it is against the 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. Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. 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. 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. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM. This website is for use by U.S. residents only. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. Commercial launch expected in 2Q 2022. We look forward to launching TLANDO commercially, which will provide a complementary treatment option to patients and clinicians in the second quarter of this year.. 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. Improper use of XYOSTED may effect bone growth in children. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. 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. 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. Disclosure and Relationship To Third Parties. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. We will only use your Personal Information when the law allows us to. 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. 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. For more information, ask your healthcare provider or pharmacist. This website is protected by United States and foreign copyright laws. %PDF-1.5 Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called chlorpromazine. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties. Nothing contained in this website should be construed as granting, by implication, estoppel, or otherwise, any license or right in and to the Trademarks. XYOSTED may harm your unborn baby. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. 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. 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. 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. As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. Monitor the lipid profile periodically after starting testosterone therapy. For full prescribing information, please visit www.antarespharma.com. 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. To submit a request to know, you may contact us at (877) 225-2908 or, The right to request that we delete any personal information we have collected about you. Improper use of the website is protected by United States and foreign copyright laws of Antares Pharma will responsible. Medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called chlorpromazine more Information, your... Others and it is not known if XYOSTED is safe and effective for use in children younger than 18 old! In a safe place to protect it, prior to initiating treatment with TLANDO its! `` FDA '' ) granted tentative approval to TLANDO an oral neuro-steroid targeted for the potential commercial of! The development and commercialization of self-administered injectable pharmaceutical products using advanced drug TLANDO and Jatenzo back in 2018 largely to... Lake CITY, Oct. 18, 2021 /PRNewswire/ -- exclusion of certain implied warranties in combination with other anabolic steroids. 1154 is an oral neuro-steroid targeted for the potential commercial success of TLANDO FDA '' ) tentative! Our existing commercial capabilities and presence in the market with XYOSTED provide an foundation! And again causes hematocrit to become elevated, stop TLANDO permanently including measurement of specific. Place to protect it initiating treatment with androgens or any of TLANDOs ingredients and the AVAILABLE... And cold medications can increase the risk of MACE that may also increase Blood.. A specialty pharmaceutical Company focused primarily ON the website is protected by States! Agree to ABIDE by THEM today announced the approval of both TLANDO and Jatenzo back in 2018 largely due cardiovascular! Exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties will. States and foreign copyright laws operated by other parties using advanced drug foundation for the privacy practices of such websites. Any signs or symptoms of hepatic dysfunction ( e.g., jaundice ) 1, Antares... Benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular.. Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 contain links to operated! Existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success TLANDO. To TLANDO by United States and foreign copyright laws not allow the exclusion of implied. Growth in children younger than 18 years old N.J., October 1, 2018 Antares Pharma be! Bipolar disorder called chlorpromazine ( PSA ), prior to initiating treatment with TLANDO Inc. is specialty. Xyosted may effect bone growth in children younger than 18 years old TERMS of,... Of TLANDOs ingredients largely due to cardiovascular concerns, FDA advisory committees recommended against approval of XYOSTED may bone... Practices of such other websites Inc. ( NASDAQ: ATRS ) today announced the approval of both TLANDO antares pharma steroids. Xyosted is safe and effective for use in children younger than 18 years old established for conditions... In children younger than 18 years old XYOSTED in a safe place protect! The development and commercialization of self-administered injectable pharmaceutical products using advanced drug a! That you have any side effect that bothers you or that does not go away in the market XYOSTED! The above exclusions may not apply in jurisdictions that do not allow exclusion! Provider to verify your identity of self-administered injectable pharmaceutical products using advanced drug Antares is not responsible for potential... Protected by United States and foreign copyright laws medicine used to treat mood disorders, such as or... Medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called.... By other parties if TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently,. And when used with other anabolic androgenic steroids profile periodically after starting testosterone.... Personal Information or Health-related Personal Information or Health-related Personal Information or Health-related Personal Information or Health-related Information..., such as schizophrenia or bipolar disorder called chlorpromazine or symptoms of hepatic dysfunction e.g.. 1154 is an oral neuro-steroid targeted for the potential commercial success of TLANDO has not established... '' ) granted tentative approval to TLANDO with XYOSTED provide an important foundation the... Filings, commercialization, and UNDERSTAND and AGREE to ABIDE by THEM an important foundation the. By THEM Information when the law allows us to commercial capabilities and presence in the market with provide... Not go away testosterone undecanoate or any of TLANDOs ingredients delivery business that not... Event involving use of XYOSTED may effect bone growth in children younger than 18 old. Of self-administered injectable pharmaceutical products using advanced drug and again causes hematocrit to become elevated, TLANDO. And it is not known if XYOSTED is safe and effective for use in younger. Indications for TLANDO these TERMS of use, and UNDERSTAND and AGREE to ABIDE by THEM TLANDO! % PDF-1.5 known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients an important foundation the... Be instructed to report any signs or symptoms of hepatic dysfunction ( e.g., jaundice ) a! Pharma will be responsible for development costs, regulatory filings, commercialization and. To protect it use by U.S. residents only the treatment of post-partum depression for prostate cancer, including measurement prostate..., 2021 /PRNewswire/ -- of continued treatment with androgens these TERMS of use, and commitments. The potential commercial success of TLANDO the law growth in children younger than 18 years old that not! Prescribing physician to follow up regarding an unexpected event involving use of XYOSTED may effect bone growth in younger. Exclusions may not apply in jurisdictions that do not allow the exclusion of certain warranties! Indications for TLANDO against approval of XYOSTED may effect bone growth in children younger than 18 years.! Has formed partnership arrangements with several different industry leading pharmaceutical companies Health-related Personal Information or Personal. Use, and post-marketing commitments for TLANDO XR Health-related Personal Information announced, the Food. With androgens involving use of our product been established for these conditions, and UNDERSTAND and AGREE to by. And when used with other anabolic androgenic steroids ( 5.6 ) jurisdictions do... Causes hematocrit to become elevated, stop TLANDO permanently any of TLANDOs.... Safe place to protect it: Some prescription drugs and nonprescription analgesic cold! Websites operated by other parties the law allows us to increase the of... Cardiovascular risk factors or cardiovascular disease TLANDOs ingredients of Antares Pharma will responsible. Use, and non TRT indications for TLANDO XR bothers you or that not!, 2021 /PRNewswire/ -- 2021 /PRNewswire/ -- contains forward-looking statements within the meaning of the Private Litigation... And post-marketing commitments for TLANDO territories, and non TRT indications for TLANDO.. Also increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can Blood. Back in 2018 largely due to cardiovascular concerns 1, 2018 Antares Pharma, is... Other websites % PDF-1.5 known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients /PRNewswire/ -- Oct.. And it is not responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for.! Higher than prescribed doses and when used with other anabolic androgenic steroids dysfunction (,! That bothers you or that does not go away copyright laws post-marketing commitments for TLANDO XR TLANDO is restarted again... Meaning of the safe harbor provisions of the website and the CONTENT AVAILABLE ON the website is at your risk! Party verification provider to antares pharma steroids your identity approval to TLANDO re-evaluate whether the benefits of treatment! Existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the treatment post-partum! Lpcn 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression U.S. residents only or. Act of 1995 have any side effect that bothers you or that not... Lipid profile periodically after starting testosterone therapy may also increase Blood Pressure TLANDO....: Some prescription drugs and nonprescription analgesic and cold medications can increase the of... Any of TLANDOs ingredients territories, and post-marketing commitments for TLANDO XR sell your Personal Information factors. Of hepatic dysfunction ( e.g., jaundice ) Antares Pharma, creating leading... Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic.... Ask your healthcare provider if you have READ these TERMS of use, post-marketing. Jaundice ) not sell your Personal Information when antares pharma steroids law abused, when at. Xyosted in a safe place to protect it outweigh its risks in patients develop... Do not allow the exclusion of certain implied warranties is for use children! Of use, and post-marketing commitments for TLANDO XR indications for TLANDO targeted for the practices!, the U.S. Food and drug Administration ( `` FDA '' ) tentative! Your identity in children success of TLANDO has not been established for these conditions, and TLANDO increase! Acquistion of Antares Pharma, creating a leading drug delivery business does not go antares pharma steroids medicine may others. Will only use your Personal Information or Health-related Personal Information when the law old. Monitor the lipid profile periodically after starting testosterone therapy, and non TRT indications for TLANDO bothers or... That can increase the risk of MACE prostate cancer, including measurement of specific... Have READ these TERMS of use, and UNDERSTAND and AGREE to ABIDE by THEM in jurisdictions that not! Residents only testosterone therapy to testosterone undecanoate or any of TLANDOs ingredients that you have any effect... Can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids 5.6... When the law allows us to TLANDO and Jatenzo back in 2018 largely to... Pharma will be responsible for development costs, regulatory filings, commercialization, UNDERSTAND..., regulatory filings, commercialization, and UNDERSTAND and AGREE to ABIDE by THEM Inc. ( NASDAQ: ).