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. Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. . 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. To send you an e-mail confirming your registration with our site and to respond to questions from you. Are a woman who is pregnant. 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. Q~wI97S~v # }ZFJ<2gFB\p[ KMSC$U^7D?^Ye^?9CAPG/wv No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. 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. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. 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. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). Use XYOSTED exactly as your healthcare provider tells you to take it. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. This site 2023 Antares Pharma. 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. 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. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. What is the most important safety information I should know about XYOSTED? Under the terms of Agreement Lipocine to receive: 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. If serum prolactin remains elevated, discontinue TLANDO. We have multiple internal product development programs, as well as partnerships with industry-leading pharmaceutical companies. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. @wiaimh;;phJ; 0 Pa0/~REluQ%RF UMA%@uE}{[OD$Hvx Cv\5zg#}K8m)o|yHk8jG\'Q06AIT^x"$*#IB="T*Jysa-%-'MY6{HSExH" We also may use a third party verification provider to verify your identity. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. 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. Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. The Site may contain links to other websites. Opens in a new tab or window, Visit us on Instagram. 20052022 MedPage Today, LLC, a Ziff Davis company. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. 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 Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. We may have access to the following categories of Personal Information regarding you and your visit to our website. 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 you do not have an account with us, we may ask for your email address, other forms of identification information. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . Some Internet browsers include the ability to transmit Do Not Track signals. 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. 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. Halozyme has completed its acquistion of Antares Pharma, creating a leading drug delivery business. Antares will not sell your Personal Information or Health-related Personal Information. Antares may modify its services at any time. 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. 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 . endobj 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. 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. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. 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. For all other inquiries, please contact us through the relevant product, support or Antares website. 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. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). 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 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. Opens in a new tab or window. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. The website and the information contained herein does not constitute an offer or a solicitation of an offer for sale of any securities. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. The transaction is expected to be immediately accretive to Halozyme's 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple . Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. We also may use a third party verification provider to verify your identity. Monitor serum calcium concentrations periodically in these patients. If you violate any terms of this Agreement or if you misuse this website, you agree to defend, indemnify and hold harmless Antares, its officers, directors, employees, agents and licensees from any and all liability including, without limitation, costs, expenses and attorneys fees that arise out of or are related to your violation or misuse. The Site may contain links to other websites. Based out of the New York City office, shes worked at the company since 2015. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of TLANDO. Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. #x&8G+!B*eC-VJhh-:.x 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. Antares reserves the right to seek all remedies available at law and in equity for violations of these Terms of Use, including the right to block access from a particular Internet address to the website. pF"_Ef=|DKW#ex/Jxj9 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. 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. The website may contain information, news and/or press releases about Antares. It does not require dose titration. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. 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 . Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. TLANDO is an oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Share on Facebook. Some Internet browsers include the ability to transmit Do Not Track signals. Medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called chlorpromazine. Continue to Site 8ey| +6-!|Ss! Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). 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. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Your use of certain pages or services within this website may be subject to additional terms and conditions. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. If you do not agree to the terms and conditions of this Agreement, please do not use this website. Selling or giving away this medicine may harm others and it is against the law. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. 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. 1:{HBRo!#V 3s,i$~sqr,cIp({C/ Patients treated with androgens may be at increased risk for prostate cancer. It also has . By using the Site, you signify your acceptance of this Privacy Policy. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. 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. Nothing contained in this website should be construed as granting, by implication, estoppel, or otherwise, any license or right in and to the Trademarks. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. "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. 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. If these occur, promptly discontinue TLANDO while the cause is evaluated. Disclosure and Relationship To Third Parties. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. Male hypogonadism, also known as testosterone deficiency, is an endocrine disorder in which the body fails to produce enough of the hormone. 1 0 obj Blood Pressure Increases XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Opens in a new tab or window, Visit us on Twitter. YOU ARE RESPONSIBLE FOR TAKING ALL NECESSARY PRECAUTIONS TO ENSURE THAT ANY CONTENT YOU OBTAIN FROM THE WEBSITE IS FREE OF VIRUSES. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. 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). 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. Women who are pregnant. 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. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. Personal Information That You Voluntarily Provide. SAN DIEGO, May 24, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (" Halozyme ") today announced the successful completion of . Keep your XYOSTED in a safe place to protect it. By using this website, you represent that you are at least eighteen (18) years old and a United States resident. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Medicine used to treat depression called a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI). The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. Pediatric Use: The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. 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). This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo. To personalize content provided on the website. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) and Antares Pharma, Inc. (NASDAQ:ATRS) today announced the launch of the generic equivalent to Imitrex 1 (sumatriptan succinate) injection, 4 mg and 6 mg single-dose, prefilled syringe autoinjectors, in the U.S. Sumatriptan injection is used to treat acute migraine with or without aura, and acute cluster headaches in adults. Antares Pharma, Inc. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders. EWING, N.J., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced the availability of XYOSTED (testosterone enanthate) injection. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Know the medicines you take. 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. To perform the contract we are about to enter into or have entered into with you. The safety of TLANDO was evaluated in 2 clinical studies in a total of 233 men. This website is for use by U.S. residents only. % This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). Upon exercise of the TLANDO XR option, Lipocine is entitled to receive an additional $4.0 million in license fees, clinical and regulatory milestone payments of up to an aggregate of $35.0 million, and tiered royalties on net sales at rates ranging from the mid-teens to up to 20%. About Antares Pharma. Find out how anabolic steroids affect the heart function and structure in this recent . 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. 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