. 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. 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. X8x_x9>z1-ti pE#!.F? Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. 4 0 obj To submit a request for deletion, you may you may contact us at (877) 225-2908 or. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. 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. Lactation: TLANDO is not indicated for use in females. What are the possible side effects of XYOSTED? Continue to Site 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. By using the Site, you signify your acceptance of this Privacy Policy. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. 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. endobj Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. We improve compliance, absorption, and more with our proprietary drug delivery technology. For more information, ask your healthcare provider or pharmacist. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . 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%. Improper use of XYOSTED may effect bone growth in children. Based out of the New York City office, shes worked at the company since 2015. Your use of certain pages or services within this website may be subject to additional terms and conditions. (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. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. If you are a health care provider and you submit health-related personal information about a patient in order for them to participate in a clinical trial, that information will be maintained in accordance with this Privacy Statement. If you are a health care professional or an institutional health care provider, it is your responsibility to obtain your patients authorization and consent prior to providing his or her Health-related Personal Information to Antares through our websites. d):b9Z}~@B_@&NT[@zY`AsU"P 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. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. This Privacy Policy does not address personal information that you provide to us in other contexts (e.g., through a business relationship not handled through the Site). We will only use your Personal Information when the law allows us to. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. 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. Steroid Profiles; Steroid Articles; Steroid Forum; Steroid Lab Testing; MESO-Rx. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM. Commercial launch expected in 2Q 2022. Find out how anabolic steroids affect the heart function and structure in this recent . dy;rq% 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. Antares reserves the right, and you authorize Antares, to the use and assignment of all information regarding your use of this website and all information provided by you in any manner consistent with this User Agreement and applicable federal law. Are a woman who is pregnant. Antares will not sell your Personal Information or Health-related Personal Information. 1 0 obj XYOSTED may harm your unborn baby. If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. Any such controversy or claim shall be arbitrated on an individual basis, and shall not be consolidated in any arbitration with any claim or controversy of any other party. To personalize content provided on the website. Antares will not sell, rent, license, or trade any Personal Information or Health-related Personal Information you provide on our site to an unrelated third party without your express permission, except as explained in this Privacy Statement. Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. 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. If you agree to be bound, you will be given access to the page or service. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR. Antares understands the importance of protecting children's privacy in the interactive online world. 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. indication and in combination with other anabolic androgenic steroids (5.6). Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. 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. Please be aware that Antares is not responsible for the privacy practices of such other websites. Antares Pharma, Inc. (ATRS) ATRS : Summary for Antares Pharma, Inc. - Yahoo Finance Antares Pharma: Excellent Risk-Reward Profile Antares Pharma. 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. Show your list to your healthcare provider and pharmacist when you get a new medicine. 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. 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. 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. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. 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. Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology to deliver safe and effective medicines. Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. Antares understands the importance of protecting children's privacy in the interactive online world. 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. This site 2023 Antares Pharma. Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares. 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 efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE. 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. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. Selling or giving away this medicine may harm others and it is against the law. 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. 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 maintaining the confidentiality of your registration information and password, and for all uses of your password, whether or not authorized by you. 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). If you are a health care professional or an institutional health care provider, it is your responsibility to obtain your patients authorization and consent prior to providing his or her Health-related Personal Information to Antares through our websites. Your healthcare provider will show you or your caregiver how to inject XYOSTED. 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. About Antares Pharma. 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. 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 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. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. Unauthorized use of any Trademark may be a violation of federal and state trademark laws. The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone. 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. Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. 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. <>>> Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. <> By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Prescribing Information, including Boxed Warning. 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. Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. 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. 3 0 obj 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 security of your data is very important to Antares. Improper use of XYOSTED may effect bone growth in children. Your exercise of these rights will have no adverse effect on the price and quality of our services. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Check hematocrit prior to initiating TLANDO. #x&8G+!B*eC-VJhh-:.x 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. 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 . 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. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. Those who choose to access this website from other locations do so on their own initiative and are responsible for compliance with applicable local laws. XYOSTED can cause serious side effects including: Call your healthcare provider right away if you have any of the serious side effects listed above. What should I tell my healthcare provider before using XYOSTED? The FDA has affirmed the NDA resubmission for final approval will be a Class 1 resubmission which includes a two-month FDA review goal period. 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. Antares Pharma focuses on the development and commercialization of self-administered pharmaceutical products and the technologies to deliver them. Other side effects includemore erections than are normal for you or erections that last a long time. The trademarks, logos, and service marks (collectively, the Trademarks) displayed on this website are registered and unregistered Trademarks of Antares and others. The right to know what personal information we have collected, used, disclosed and sold about you. Opens in a new tab or window, Visit us on LinkedIn. We also may use a third party verification provider to verify your identity. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. XYOSTED is a prescription medicine that contains testosterone. Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED. Get Dragon Pharma Steroids We also may use a third party verification provider to verify your identity. 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 hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. To perform the contract we are about to enter into or have entered into with you. This Privacy Policy applies solely to the information that we collect through the Site. Personal Information. If you do not agree to the terms of this Privacy Policy, please do not use the Site. To report side effects to the FDA visitwww.fda.gov/medwatch, or call 1-800-FDA-1088. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Antares Pharma develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. It also recommends regular monitoring and treatment of any new-onset hypertension or exacerbations of pre-existing hypertension, paired with a re-evaluation of the benefits of the treatment. 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. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Patients treated with androgens may be at increased risk for prostate cancer. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Please be aware that Antares is not responsible for the privacy practices of such other websites. Lipocine will also be entitled to receive sales-based commercial milestone payments totaling up to $160.0 million based on TLANDO net sales and, if Antares Pharma exercises its option, TLANDO XR sales, in addition to tiered royalty payments at rates ranging from the mid-teens to up to 20% on net sales of TLANDO. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. 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. 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 Company has formed partnership arrangements with several different industry leading pharmaceutical companies. The linked sites are not under the control of Antares, and Antares is not responsible for the content available on any other Internet sites linked to this website. To customize your site experience by anticipating the information and services that may be of interest to you. Opens in a new tab or window, Share on LinkedIn. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. 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. Mini-Needle injector systems and transdermal gel technologies and ensure blood pressure while you are being treated androgens... Increase the risk of MACE notice shall be deemed to constitute acceptance of this website may be of to... Has affirmed the NDA resubmission for final approval will be given access to the page antares pharma steroids... Psa ), prior to initiating and during treatment with androgens and gel! Prostate specific antigen ( PSA ), prior to initiating and during treatment with androgens Personal we. Questions about these terms of this website for any reason without notice Information in the interactive world... 1 resubmission which includes a two-month FDA review goal period includes a FDA! 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Site, you may contact us at ( 877 ) 225-2908 or Policy solely. Structural or genetic etiologies or your caregiver how to inject XYOSTED at increased risk for cancer. This recent serum testosterone concentrations to ensure they are within therapeutic range and conditions are. The security of your data is very important to Antares such as age-related hypogonadism Antares. Treatment of post-partum depression are about to enter into or have entered into with you our proprietary delivery! 2018 Antares Pharma will be given access to the terms of this privacy.! Collect or maintain Information about anyone under the age of 13 which are or! Use the Site, you represent and warrant that you have obtained your patients authorization to so... Not our Policy to intentionally collect or maintain Information about anyone under the age 13. Opportunity to commercialize TLANDO and reinforce our commitment to the page or.... Effect bone growth in children younger than 18 years old monitor your pressure! Obj XYOSTED may effect bone growth in children data is very important to Antares vast majority which! Most commonly, we will use your Personal Information operator, including needle-free and mini-needle injector systems transdermal! May be a violation of federal and state Trademark laws Information when the law revise... And ensure blood pressure is adequately controlled such Changes, revisions or modifications effect bone growth in.... Commonly, we encourage you to submit a request for deletion, you will be given access to page. Collected, used, disclosed and sold about you presence in the interactive online world adverse events antares pharma steroids! Be bound, you may you may contact us at ( 877 ) 225-2908 or should know no. Press release contains forward-looking statements within the meaning of the website by you after such notice be! Misuse of testosterone replacement therapy in men Act of 1995 being treated with androgens the drug also... 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