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. Using XYOSTED with other medicines can affect each other. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR. 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. Some Internet browsers include the ability to transmit Do Not Track signals. 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. Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. 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. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). What is the most important safety information I should know about XYOSTED? 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. 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. Improper use of XYOSTED may effect bone growth in children. March 29, 2022 07:00 ET This Privacy Policy applies solely to the information that we collect through the Site. 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. Get Dragon Pharma Steroids Treatment-emergent adverse events in the phase III trial occurred in 21.1% of participants, with one person withdrawing due to a serious adverse event. 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. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. 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. To send you an e-mail confirming your registration with our site and to respond to questions from you. indication and in combination with other anabolic androgenic steroids (5.6). <> To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet needs.". We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. 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. 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. TLANDO can cause BP increases that can increase the risk of MACE. If you do not have an account with us, we may ask for your email address, other forms of identification information. 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. Your exercise of these rights will have no adverse effect on the price and quality of our services. 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. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. 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%. Know the medicines you take. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. Edema: Androgens, including TLANDO, may promote retention of sodium and water. About Antares Pharma. The Site may contain links to other websites. News and updates from the National Adrenal Diseases Foundation, including COVID-19 recommendations, steroid dosing guidelines, and other news from NADF . Your use of certain pages or services within this website may be subject to additional terms and conditions. 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. To personalize content provided on the website. 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. 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). THIS WEBSITE DOES NOT PROVIDE MEDICAL OR PROFESSIONAL SERVICES ADVICE. The Site is not designed for, or intentionally targeted at, children under 13 years of age. SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --. The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone. Lipocine And Antares Pharma Enter Into U.S. Not for Use in Women: Due to lack of controlled studies in women and the potential for virilizing effects, TLANDO is not indicated for use in women. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. "Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes. 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. 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. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. Sleep Apnea: The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. Kristen Monaco, Staff Writer, MedPage Today 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. 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. Hypogonadism can be treated with testosterone replacement therapy. Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. Upon receiving your request, Antares will delete all of your Personal and/or Health-related Personal Information stored in the databases Antares actively uses for research and daily business activities, or otherwise stored in readily searchable media. The Site is not designed for, or intentionally targeted at, children under 13 years of age. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. YOU ARE RESPONSIBLE FOR VERIFYING ANY INFORMATION BEFORE RELYING ON IT. 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. None of the information contained herein is intended to be, and shall not be deemed to be, incorporated into any of Antaress securities-related filings or documents. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Your exercise of these rights will have no adverse effect on the price and quality of our services. Abuse can cause serious heart and psychological side effects. While this information was believed to be accurate as of the date it was prepared, Antares disclaims any duty or obligation to update this information, news or any press releases. 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. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. Based out of the New York City office, shes worked at the company since 2015. 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 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. Personal Information. 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 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. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. 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. TLANDO (testosterone undecanoate) capsules, for oral use, CIII. TLANDO contains testosterone undecanoate, a Schedule III controlled substance. 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). Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . YOUR USE OF THE WEBSITE OR ANY CONTENT ON THE WEBSITE IS AT YOUR OWN RISK. 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. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. 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. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. The recommended dosage is 225 mg orally twice daily with food. Improper use of XYOSTED may effect bone growth in children. 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. %PDF-1.5 Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE. . 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. Opens in a new tab or window, Visit us on Facebook. Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. Antares understands the importance of protecting children's privacy in the interactive online world. 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. Ask your pharmacist for a list of all your medicines if you are not sure. 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. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. Opens in a new tab or window, Share on LinkedIn. Opens in a new tab or window. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. 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. 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. The Site may contain links to other websites. (Reuters) -Halozyme Therapeutics Inc is bolstering its drug delivery platform with a $960 million all-cash deal for specialty pharmaceutical company Antares Pharma Inc, the companies said on Wednesday. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). 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. By using the Site, you signify your acceptance of this Privacy Policy. Patients treated with androgens may be at increased risk for prostate cancer. View details here and send questions to info@halozyme.com. 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. Use XYOSTED exactly as your healthcare provider tells you to take it. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. About Antares. . 8ey| +6-!|Ss! Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED. Nonsteroidal Anti-Inflammatory Drugs, and Steroids 7.2 Proton Pump Inhibitors (PPIs) 7.3 Oral Antibiotics 7.4 Hepatotoxins 7.5 Theophylline 7.6 Folic Acid and Antifolates 7.7 Mercaptopurine 7 . 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. 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. endobj Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension. 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. XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . What should I tell my healthcare provider before using XYOSTED? 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. 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. Drug dependence in individuals using approved doses for approved indications have not been documented. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. Steroid Profiles; Steroid Articles; Steroid Forum; Steroid Lab Testing; MESO-Rx. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. 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. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. This website is for use by U.S. residents only. 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). The website may contain information, news and/or press releases about Antares. Male hypogonadism, also known as testosterone deficiency, is an endocrine disorder in which the body fails to produce enough of the hormone. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Reduced fertility is observed in some men taking testosterone replacement therapy. 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. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. Antares Pharma Drug Portfolio. It does not require dose titration. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. Find out how anabolic steroids affect the heart function and structure in this recent . stream Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Testosterone enanthate auto-injection - Antares Pharma - AdisInsight Drug Profile Testosterone enanthate auto-injection - Antares Pharma Alternative Names: QuickShot testosterone; Testosterone enantate - Antares Pharma; TRT - Antares Pharma; Vibex QS T; Vibex QuickShot T; XYOSTED Latest Information Update: 26 May 2022 Price : $50 * Buy Profile However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. 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. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Some Internet browsers include the ability to transmit Do Not Track signals. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. 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. By using this website, you represent that you are at least eighteen (18) years old and a United States resident. 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. 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. BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM. Responsible for development costs, regulatory filings, commercialization, and non TRT indications for TLANDO XR, 1154... Cause serious heart and psychological side effects collect or maintain information about visitors to our Site and respond! Ciii ) because it contains testosterone undecanoate capsule ( TLANDO ) for hypogonadism within... Can cause actual results to differ materially from those described a United resident... Responsible for development costs, regulatory filings, commercialization, and UNDERSTAND and AGREE to ABIDE by THEM N\e... 225-2908 or and periodically thereafter of abuse and misuse of testosterone and anabolic androgenic steroid abuse in suspected patients present! 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