Antares Pharma, Inc. (ATRS) ATRS : Summary for Antares Pharma, Inc. - Yahoo Finance Antares Pharma: Excellent Risk-Reward Profile Antares Pharma. Never give your XYOSTED to anyone else. 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 . 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. The Company has formed partnership arrangements with several different industry leading pharmaceutical companies. All Rights Reserved. The most common side effects of XYOSTED include:red blood cell increase, prostatic specific antigen (PSA) increase (a blood test for prostate cancer), increased blood pressure, and injection site reactions including bruising, bleeding, redness and headache. 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. 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. 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. 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.". In addition, we will use commercially reasonable efforts not to disclose any personal information stored in a non-erasable format after receiving your request for removal, except as required by law. Antares Pharma's FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. <>>> 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. Such changes, revisions or modifications shall be effective immediately upon notice to you, which may be given by any means including, without limitation, posting on the website or by e-mail. Using XYOSTED with other medicines can affect each other. XYOSTED is a prescription medicine that contains testosterone. 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). Such links do not imply Antaress endorsement of material on any other site and Antares disclaims all liability with regard to your access to such linked websites. Dr. Patel further stated, "Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma's capabilities, given its established marketing experience and demonstrated success in the TRT space. by . endobj <> March 29, 2022 07:00 ET Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . Interestingly, FDA advisory committees recommended against approval of both Tlando and Jatenzo back in 2018 largely due to cardiovascular concerns. 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. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. Improper use of XYOSTED may effect bone growth in children. To personalize content provided on the website. If you do not agree to the terms of this Privacy Policy, please do not use the Site. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . 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. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . It is not our policy to intentionally collect or maintain information about anyone under the age of 13. 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. 20052022 MedPage Today, LLC, a Ziff Davis company. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. Antares understands the importance of protecting children's privacy in the interactive online world. 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. 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. 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. 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. March 29, 2022. 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. Though Tlando was originally developed by Lipocine Inc, the developer entered a listening deal with Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of Tlando in the U.S. Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and nephrology news. Personal Information. Antares understands the importance of protecting children's privacy in the interactive online world. 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. 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). 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%. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. 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). The content on this website is intended to be a general information resource in regard to the subject matter covered, and is provided solely on an AS IS and AS AVAILABLE basis. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. 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. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. 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. XYOSTED is a prescription medicine that contains testosterone. 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. Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. 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. 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. Children 's privacy in the U.S, Antares Pharma will undertake all commercialization, post-marketing obligations and! 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