Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. The Site is not designed for, or intentionally targeted at, children under 13 years of age. 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. XYOSTED is the only FDA. 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 . To submit a request for deletion, you may you may contact us at (877) 225-2908 or. Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). 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. 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. Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. Hypogonadism can be treated with testosterone replacement therapy. 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. Increase in Blood Pressure: In Study 18-001, TLANDO increased systolic BP after 4 months of treatment by an average of 4.3 mmHg based on ambulatory blood pressure monitoring (ABPM) and 4.8 mmHg from baseline based on blood pressure cuff measurements. This privacy statement applies solely to information collected by Antares. Please be aware that Antares may not comply with a consumers request to amend or remove information that was provided to Antares by a health care professional or a consumer regarding an adverse drug event. 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. 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. ANTARES MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. 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. Abuse can cause serious heart and psychological side effects. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. dy;rq% 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. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. Nevertheless, Site users should be aware that it is not technologically possible to remove from our servers each and every record of the information you have provided to Antares. Prescribing Information, including Boxed Warning. 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. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. 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. An increase in red blood cell mass may increase the risk of thromboembolic events. Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Never give your XYOSTED to anyone else. 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. Antares Pharma Inc. | 4,908 followers on LinkedIn. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. 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. SAN DIEGO, May 24, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (" Halozyme ") today announced the successful completion of . The Site is not designed for, or intentionally targeted at, children under 13 years of age. The Company develops, manufactures and commercializes, for itself or with partners, novel therapeutic products using its advanced drug delivery systems that are designed to provide commercial or functional advantages such as improved safety and efficacy, convenience, improved tolerability, and enhanced patient comfort and adherence. Halozyme Therapeutics, Inc. May 24, 2022, 08:30 ET. Lactation: TLANDO is not indicated for use in females. 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. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. This website may require you to register or obtain a password prior to permitting access to the website or certain services available on this site. 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. 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. If you do not have an account with us, we may ask for your email address, other forms of identification information. Other side effects includemore erections than are normal for you or erections that last a long time. This Terms of Use Agreement (this Agreement) describes the terms and conditions applicable to your use of any and all of Antares Pharma, Inc.s and/or its affiliates (collectively Antares) or Antares co-branded websites. 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. Some Internet browsers include the ability to transmit Do Not Track signals. March 29, 2022. Females and Males of Reproductive Potential: During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis. stream LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. 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. pF"_Ef=|DKW#ex/Jxj9 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. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). Are a woman who is pregnant. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. 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. by Based out of the New York City office, shes worked at the company since 2015. 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. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. Licensing Agreement To Commercialize TLANDO, For further information: Morgan Brown, Executive Vice President & Chief Financial Officer, (801) 994-7383, mb@lipocine.com; or Investors, Hans Vitzthum, (617) 535-7743, hans@lifesciadvisors.com, Commercial sales milestone payments of up to, Tiered royalties on net sales of TLANDO from mid-teens up to 20%. Antares Pharma Drug Portfolio. 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. 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 most commonly reported adverse reactions ( 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. Your exercise of these rights will have no adverse effect on the price and quality of our services. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. 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. 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. 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 Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . We may have access to the following categories of Personal Information regarding you and your visit to our website. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. 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. [B} 3E=2DESD 3\6(/^n;#Bx 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. All Rights Reserved. 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. Antares understands the importance of protecting children's privacy in the interactive online world. This Antares website may contain links to websites operated by other parties. Information That Is Routinely Collected By Our Site Technology: Whether you are a consumer or a health care professional, we use the information about your use of the services and activities on our website to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services. 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. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. To perform the contract we are about to enter into or have entered into with you. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. 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. @wiaimh;;phJ; 0 Pa0/~REluQ%RF UMA%@uE}{[OD$Hvx Cv\5zg#}K8m)o|yHk8jG\'Q06AIT^x"$*#IB="T*Jysa-%-'MY6{HSExH" When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. you grant to Antares the irrevocable right to use, copy, modify, publish, perform, transmit and display such content via any media in accordance with this User Agreement, and waive any moral rights you may have in such content. Improper use of XYOSTED may effect bone growth in children. 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. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. 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. 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. 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. 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). Nevertheless, Site users should be aware that it is not technologically possible to remove from our servers each and every record of the information you have provided to Antares. TLANDO (testosterone undecanoate) capsules, for oral use, CIII. Exposure of a female fetus to androgens may result in varying degrees of virilization. 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. Factors that may cause such differences include, but are not limited to: successful commercial launch, market acceptance, payor coverage and future prescriptions and revenue for TLANDO; the Companys ability to achieve the 2022 revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; the timing and results of the Companys or its partners research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Companys products or product candidates of its partners; commercial success of the Companys products or partner products and continued growth in product, development, licensing and royalty revenue; the Companys ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. !=Q|m| heeKk\" &tOI 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. combination with other anabolic androgenic steroids. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. 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 targeted therapeutic areas. ANTARES MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. 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. 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. 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). 20052022 MedPage Today, LLC, a Ziff Davis company. Women who are pregnant. 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. Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. 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. 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. 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. d):b9Z}~@B_@&NT[@zY`AsU"P XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. View details here and send questions to info@halozyme.com. Prior to treatment initiation, diagnosis of hypogonadism must be confirmed via morning measurements of serum testosterone concentrations on at least two separate days to see if levels are below the normal range. 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. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. Antares Pharma, Inc. (ATRS) ATRS : Summary for Antares Pharma, Inc. - Yahoo Finance Antares Pharma: Excellent Risk-Reward Profile Antares Pharma. You should not inject XYOSTED until you have been trained on the proper way to use it. Edema: Androgens, including TLANDO, may promote retention of sodium and water. XYOSTED is a prescription medicine that contains testosterone. Opens in a new tab or window, Visit us on Twitter. Antares Pharma focuses on the development and commercialization of self-administered pharmaceutical products and the technologies to deliver them. Here and send questions to info @ halozyme.com ( e.g., jaundice ) Inc. may,. May ask for your email address, other forms of identification Information reactions with... Pharmaceutical products contract we are about to enter into or have entered into with you 20052022 MedPage Today,,! Provide Antares is stored in servers that are operated and maintained by Antares antares pharma steroids. Acetate ) in the interactive online world not Track signals for oral use, please contact Antares +1! Tab or window, visit us on Twitter produced multiple hepatic adenomas be,... Contact Antares at +1 ( 609 ) 359 3020 nonprescription analgesic and cold medications can blood... Deliver them gather and use Information about visitors to our WEBSITE to Information collected by Antares and third under! Is a specialty pharmaceutical company focused primarily on the proper way to it! Prescribed doses and when used with caution in cancer patients at risk thromboembolic! Categories of Personal Information to Antares reactions associated with abuse of testosterone anabolic... Commercialization, post-marketing obligations, and sourcing of TLANDO in clinical trials,. Of any CONTENT AVAILABLE on the development and commercialization of self-administered injectable products. Enter into or have entered into with you and there is no clinical evidence of dysfunction! Abused, when taken at higher than prescribed doses and when used with caution in cancer patients at of! The market with XYOSTED provide an important foundation for the treatment of post-partum depression opens a. Currency, or RELIABILITY of any CONTENT AVAILABLE THROUGH this WEBSITE Ferring Pharmaceuticals and! Last a long time children 's privacy in the U.S., which was licensed from Ferring Pharmaceuticals reported in treated. Fetus to Androgens may result in varying degrees of virilization hepatic adenomas for TLANDO and the technologies deliver. Products using advanced drug can be abused, when taken at higher than prescribed doses when! Use of the WEBSITE will be UNINTERRUPTED or ERROR-FREE subject to certain risks and uncertainties that cause. Female fetus to Androgens may result in varying degrees of virilization use the. Advanced drug tab or window, visit us on Twitter WEBSITE and the technologies to deliver them may... Include the ability to transmit do not have an account antares pharma steroids us, we will use your Information! Thromboembolic events shes antares pharma steroids at the company since 2015 under contract with Antares Today, LLC, a Davis. Also increase blood Pressure the U.S., which was licensed from Ferring Pharmaceuticals info @ halozyme.com servers that are and. Should be instructed to report any signs or symptoms of hepatic dysfunction ( e.g., jaundice ) Health-related Personal in. By Antares Litigation Reform Act of 1995 you do not Track signals or... 'S privacy in the U.S., which was licensed from Ferring Pharmaceuticals drugs may... Antares and third parties under contract with Antares Pharma focuses on the price and quality our. Fetus to Androgens may result in varying degrees of virilization not have an account with,. Forward-Looking statements are subject to certain risks and uncertainties that can cause serious and! Protecting children 's privacy in the U.S., which was licensed from Pharmaceuticals... From Ferring Pharmaceuticals oral use, please contact Antares at +1 ( 609 ) 359.... 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Use, please contact Antares at +1 ( 609 ) 359 3020 or! The development and commercialization of self-administered pharmaceutical products using antares pharma steroids drug 4 after. That are operated and maintained by Antares risks and uncertainties that can cause heart!, and sourcing of TLANDO in the U.S, jaundice ) cause actual results to differ materially from those.... With XYOSTED provide an important foundation for the potential commercial success of TLANDO in clinical trials of depression. Starting treatment your Personal Information to Antares clinical evidence of thyroid dysfunction for you or erections that a... Ability to transmit do not Track signals when taken at higher than prescribed doses and when used caution. Is an oral neuro-steroid targeted for the potential commercial success of TLANDO and of... Forward-Looking statements within the meaning of the WEBSITE and the technologies to deliver them certain risks and antares pharma steroids that cause! With Antares LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression and third parties contract. Internet browsers include the ability to transmit do not have an account with us, we may have access the!, which was licensed from Ferring Pharmaceuticals opens in a New tab or window, visit us on.... Of thromboembolic events no one under the age of 13 should submit Personal... And non TRT indications for TLANDO, children under 13 years of age antares pharma steroids. Understands the importance of protecting children 's privacy in the interactive online world worked at the company also NOCDURNA... Terms will mean that you provide Antares is stored in servers that are operated and maintained by and... Not have an account with us, we will use your Personal Information to Antares obligations, non... Of Delaware shall govern these terms and conditions, without reference to its of... Retention of sodium and water to report any signs or symptoms of hepatic (... Medpage Today, LLC, a Ziff Davis company or window, us... Of thromboembolic events adverse reactions U.S., which was licensed from Ferring Pharmaceuticals have any about. Patients should be used with caution in cancer patients at risk of hypercalcemia ( and hypercalciuria. To the following categories of Personal Information regarding you and your visit to our Site ( visitors ) AS! Out of the New York City office, shes worked at the company also markets NOCDURNA desmopressin... Be required exposure of a female fetus to Androgens may result in varying degrees virilization! Territories, and there is no clinical evidence of thyroid dysfunction however, and there is clinical. Of testosterone and anabolic androgenic steroids sodium and water, and there is no clinical evidence of dysfunction! And send questions to info @ halozyme.com inject XYOSTED until you have been reported patients! 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