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 . Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. 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. ANTARES SPECIFICALLY DISCLAIMS ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH ACCESS TO OR USE OF THE WEBSITE, EVEN IF ANTARES HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO RELIANCE BY ANY PARTY ON ANY CONTENT OBTAINED THROUGH THE USE OF THE WEBSITE, OR THAT ARISES IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO OR FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THE WEBSITE OR VIRUSES, WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, WAR, TERRORISM, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION OF, OR UNAUTHORIZED ACCESS TO THE WEBSITE, OR RELATED INFORMATION OR PROGRAMS. 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. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. If you do not agree to the terms of this Privacy Policy, please do not use the Site. Personal Information That You Voluntarily Provide. If you do not agree to be bound, you will not be given access to the page or service. Antares understands the importance of protecting children's privacy in the interactive online world. 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. 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. 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. 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. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. An increase in red blood cell mass may increase the risk of thromboembolic events. Get Dragon Pharma Steroids To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both TLANDO and XYOSTED and support our future growth with an expanded commercial portfolio. Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. 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 use of certain pages or services within this website may be subject to additional terms and conditions. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. 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. The most commonly reported adverse reactions ( 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain. 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. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. Halozyme Therapeutics, Inc. May 24, 2022, 08:30 ET. XYOSTED may harm your unborn baby. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. y7y F6+O#2EtjpT{HZ(4#xnpx6+JxdQ`0FQ[VWA Unless otherwise set forth in a written agreement between you and Antares, you must adhere to Antaress linking policy as follows: (i) any link to an Antares website must be a text only link clearly marked Antares WEBSITE, (ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Antaress names and trademarks, (iii) the link must point to the root domain name of the Antares website and not to other pages within the website, (iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, affiliated with, or associated with Antares, (v) when selected by a user, the link must display the website on full-screen and not within a frame on the linking website, and (vi) Antares reserves the right to revoke its consent to the link at any time and in its sole discretion. 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). To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. 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. 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%. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . Keep your XYOSTED in a safe place to protect it. 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. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . 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. Because of these concerns, the label for Tlando includes a boxed warning regarding possible blood pressure increases, stating that these "can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.". This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. These are not all the possible side effects of XYOSTED. To report side effects to the FDA visitwww.fda.gov/medwatch, or call 1-800-FDA-1088. 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. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. 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. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Antares will not sell your Personal Information or Health-related Personal Information. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. 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. 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. Antares may modify its services at any time. Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. 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 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. Improper use may result in acceleration of bone age and premature closure of epiphyses. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of TLANDO. The Site is not designed for, or intentionally targeted at, children under 13 years of age. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Antares understands the importance of protecting children's privacy in the interactive online world. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. 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. Antares reserves the right to seek all remedies available at law and in equity for violations of these Terms of Use, including the right to block access from a particular Internet address to the website. To perform the contract we are about to enter into or have entered into with you. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. 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. 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. Hypogonadism can be treated with testosterone replacement therapy. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. We may have access to the following categories of Personal Information regarding you and your visit to our website. XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Unauthorized use of any Trademark may be a violation of federal and state trademark laws. 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). XYOSTED can cause serious side effects including: Call your healthcare provider right away if you have any of the serious side effects listed above. Lactation: TLANDO is not indicated for use in females. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action. These studies did not meet current standards for nonclinical development toxicity studies. 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.". T}b j[yj WhvLdK5D:Goai5.w=u_n'jt"XD/PeV *kH12z(^`0 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. X8x_x9>z1-ti pE#!.F? San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . The right to know what personal information we have collected, used, disclosed and sold about you. /Prnewswire/ -- be subject to additional terms and conditions ACT of 1995,... 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