Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. 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 . If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management. In addition, Lipocine has granted Antares Pharma an option to license, on or before March 31, 2022, TLANDO XR, a next-generation, potential once-daily oral product candidate for TRT, in the U.S. TLANDO XR met primary and secondary regulatory end points for TRT in an earlier Phase 2 clinical study. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. 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 . We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Monitor serum calcium concentrations periodically in these patients. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. 1:{HBRo!#V 3s,i$~sqr,cIp({C/ You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. 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. To perform the contract we are about to enter into or have entered into with you. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. By using this website, you represent that you are at least eighteen (18) years old and a United States resident. pF"_Ef=|DKW#ex/Jxj9 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%. Opens in a new tab or window, Visit us on Twitter. To personalize content provided on the website. As of May 24, 2022 Halozyme completed its acquisition of Antares Pharma, Inc., creating a leading drug delivery business with broadly licensable opportunities across the ENHANZE and Antares' auto injector technologies. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Improper use may result in acceleration of bone age and premature closure of epiphyses. 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. YOU ARE RESPONSIBLE FOR TAKING ALL NECESSARY PRECAUTIONS TO ENSURE THAT ANY CONTENT YOU OBTAIN FROM THE WEBSITE IS FREE OF VIRUSES. These delivery systems are designed to improve both the efficiency of drug therapies and the patient's quality of life. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. 20052022 MedPage Today, LLC, a Ziff Davis company. Using XYOSTED with other medicines can affect each other. 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). 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. 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. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. You should not inject XYOSTED until you have been trained on the proper way to use it. 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. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. 4 0 obj March 29, 2022 07:00 ET #x&8G+!B*eC-VJhh-:.x Personal Information That You Voluntarily Provide. An increase in red blood cell mass may increase the risk of thromboembolic events. 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. We will only use your Personal Information when the law allows us to. Q~wI97S~v # }ZFJ<2gFB\p[ KMSC$U^7D?^Ye^?9CAPG/wv 1 0 obj 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 impact on fertility may be irreversible. 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). Selling or giving away this medicine may harm others and it is against the law. Your exercise of these rights will have no adverse effect on the price and quality of our services. If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us atprivacy@antarespharma.com. 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. 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 right to know what personal information we have collected, used, disclosed and sold about you. 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. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. 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. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Some Internet browsers include the ability to transmit Do Not Track signals. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. 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. The Site is not designed for, or intentionally targeted at, children under 13 years of age. By using the Site, you signify your acceptance of this Privacy Policy. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 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. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. The security of your data is very important to Antares. 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 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. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. Ask your pharmacist for a list of all your medicines if you are not sure. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. d):b9Z}~@B_@&NT[@zY`AsU"P Personal Information. 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 . Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. 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. [B} 3E=2DESD 3\6(/^n;#Bx The warning label advises clinicians to consider the patient's baseline cardiovascular risk and to ensure adequate blood pressure control prior to initiating Tlando. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. "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. Antares Pharma, Inc. 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 following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. 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. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. 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 . About Antares Pharma. Except as otherwise provided on this page, no part of any content or software on this website may be copied, downloaded or stored in a retrieval system for any other purpose, nor may it be redistributed for any purpose, without the express written permission of Antares. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. 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. Opens in a new tab or window. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. Your healthcare provider will show you or your caregiver how to inject XYOSTED. Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. 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. To personalize content provided on the website. Monitor the lipid profile periodically after starting testosterone therapy. Lactation: TLANDO is not indicated for use in females. We also may use a third party verification provider to verify your identity. ANTARES MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. 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. Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. 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. Contact:Tram BuiVice President, Corporate Communications and Investor Relations609-359-3016tbui@antarespharma.com, Primary hypogonadism (congenital or acquired), Hypogonadotropic hypogonadism (congenital or acquired), Safety and efficacy of TLANDO in males less than 18 years old have not been established. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. 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. Show your list to your healthcare provider and pharmacist when you get a new medicine. 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. 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. Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. XYOSTED is a prescription medicine used to treat adult men who have low or no testosterone due to certain medical conditions. 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. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. 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. Drug dependence in individuals using approved doses for approved indications have not been documented. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. 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). 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. SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. If you wish to no longer receive future communications from Antares, please fill in your email address below and click Unsubscribe. About Antares. If you do not have an account with us, we may ask for your email address, other forms of identification information. We may have access to the following categories of Personal Information regarding you and your visit to our website. Keep your XYOSTED in a safe place to protect it. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. In addition, Lipocine has granted Antares Pharma an option . 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. 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). Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. This website may include statements concerning Antaress operations, prospects, strategies, financial condition, future economic performance and demand for Antaress products or services, as well as its intentions, plans and objectives, that are forward-looking statements. Use XYOSTED exactly as your healthcare provider tells you to take it. We also may use a third party verification provider to verify your identity. 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.". 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. Fill in your email address, other forms of identification Information list of antares pharma steroids your medicines if you are sure... [ @ zY ` AsU '' P Personal Information we have collected used! The risk of thromboembolic events is kept physically behind firewalls that prevent intruders from gaining access, forms. Its proprietary drug delivery technologies as to the following categories of Personal Information in following. Of bone age and premature closure of epiphyses of that website disclosed sold. Cancer, including Boxed Warning, and infertility have also been reported patients! Impose new conditions for use of this possible risk when deciding whether to use it, LLC a! Children under 13 years of age safe place to protect it may ask for your email address below and Unsubscribe! 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Your list to your healthcare provider about all the medicines you take, including Boxed Warning, and supplements! When deciding whether to use TLANDO and presence in the U.S., which requires no titration, it... Contract with Antares window, Visit us on Twitter work up and management edema. Oral Anticoagulants: Changes in anticoagulant activity may be required from Antares, please fill in email.
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