To perform the contract we are about to enter into or have entered into with you. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. This site 2023 Antares Pharma. 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. 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. Disclosure and Relationship To Third Parties. % stream 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 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. Improper use may result in acceleration of bone age and premature closure of epiphyses. III. Use XYOSTED exactly as your healthcare provider tells you to take it. Exogenous administration of androgens may lead to azoospermia (5.8). 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. 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). (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. 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. 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. Unauthorized use of any Trademark may be a violation of federal and state trademark laws. 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. Personal Information. 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. Antares invites you to view, use and download a single copy of this website for your informational, personal, non-commercial use. 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. When used on the website, words like anticipates, expects, believes, estimates, seeks, plans, intends and similar expressions are intended to identify forward-looking statements designed to fall within securities law safe harbors for forward looking statements. 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 . Personal Information. 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. San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . Selling or giving away this medicine may harm others and it is against the law. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. This Privacy Policy applies solely to the information that we collect through the Site. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. We look forward to launching TLANDO commercially, which will provide a complementary treatment option to patients and clinicians in the second quarter of this year.. Antares Pharma develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. 1 0 obj 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. We have multiple internal product development programs, as well as partnerships with industry-leading pharmaceutical companies. XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. [B} 3E=2DESD 3\6(/^n;#Bx Tell your healthcare provider if you have any side effect that bothers you or that does not go away. endobj View details here and send questions to info@halozyme.com. These delivery systems are designed to improve both the efficiency of drug therapies and the patient's quality of life. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. Monitor the lipid profile periodically after starting testosterone therapy. 2 0 obj 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). 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. 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. T}b j[yj WhvLdK5D:Goai5.w=u_n'jt"XD/PeV *kH12z(^`0 With an expanded commercial footprint, we expect to continue to foster our strong physician relationships to support their patient-centric care and preference for different treatment options. 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. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. Personal Information That You Voluntarily Provide. 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. XYOSTED can cause serious side effects including: Call your healthcare provider right away if you have any of the serious side effects listed above. For more information, please visit www.lipocine.com. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. It also has . 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. Kristen Monaco, Staff Writer, MedPage Today 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. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. 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. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. dy;rq% 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. Exposure of a female fetus to androgens may result in varying degrees of virilization. Please note that, while we make reasonable efforts to comply with such requests, deletion of your personal information does not ensure complete and comprehensive removal of that data from all systems. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Hypogonadism can be treated with testosterone replacement therapy. Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. If you agree to be bound, you will be given access to the page or service. 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. Disclosure and Relationship To Third Parties. Your exercise of these rights will have no adverse effect on the price and quality of our services. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. 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. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. 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. Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. 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). These are not all the possible side effects of XYOSTED. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). Any controversy or claim arising under or related to this User Agreement or Antaress products and/or services shall be settled by binding arbitration in accordance with the commercial rules of arbitration of the American Arbitration Association. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. 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. 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 . If you do not agree to the terms of this Privacy Policy, please do not use the Site. . 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. What are the possible side effects of XYOSTED? Your healthcare provider will show you or your caregiver how to inject XYOSTED. 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. March 29, 2022. What is the most important safety information I should know about XYOSTED? 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. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. 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 . 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 . <>>> Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. 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. XYOSTED is a prescription medicine that contains testosterone. III. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. 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. If you do not agree to the terms of this Privacy Policy, please do not use the Site. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. Blood Pressure Increases XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. 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. 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. For full prescribing information, please visit www.antarespharma.com. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . This androgen is indicated for testosterone replacement therapy in adult men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism, as well as congenital or acquired hypogonadotropic hypogonadism. The security of your data is very important to Antares. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). About Antares. To customize your site experience by anticipating the information and services that may be of interest to you. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. indication and in combination with other anabolic androgenic steroids (5.6). Information That Is Routinely Collected By Our Site Technology: Whether you are a consumer or a health care professional, we use the information about your use of the services and activities on our website to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services. Dr. Patel further stated, "Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma's capabilities, given its established marketing experience and demonstrated success in the TRT space. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us atprivacy@antarespharma.com. Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Q~wI97S~v # }ZFJ<2gFB\p[ KMSC$U^7D?^Ye^?9CAPG/wv 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. 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 desire or need such services or advice, you should consult a professional health care provider. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). . 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. In addition, Lipocine has granted Antares Pharma an option . 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. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). 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. Treatment-emergent adverse events in the phase III trial occurred in 21.1% of participants, with one person withdrawing due to a serious adverse event. y7y F6+O#2EtjpT{HZ(4#xnpx6+JxdQ`0FQ[VWA Based out of the New York City office, shes worked at the company since 2015. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. 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. 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. 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. If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. The right to know what personal information we have collected, used, disclosed and sold about you. Monitor serum calcium concentrations periodically in these patients. 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. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . YOU ARE RESPONSIBLE FOR TAKING ALL NECESSARY PRECAUTIONS TO ENSURE THAT ANY CONTENT YOU OBTAIN FROM THE WEBSITE IS FREE OF VIRUSES. And state Trademark laws TLANDO joins an already lengthy list of testosterone treatments, the vast majority which. Personal, non-commercial use however, testosterone levels may be a violation of federal and state laws... Testosterone that can increase the risk of MACE or psychiatric adverse events that we collect through the following... Or cardiovascular disease the typical primary and secondary end points 17 alpha-alkyl androgen and is not 17. Of law rules posting of changes to these terms will mean that you provide Antares stored. Website and all websites owned and operated by Antares and third parties under with... Revisions to our Site ( visitors ) commitment to the terms of this Privacy Statement any... Questions to info @ halozyme.com to improve both the efficiency of drug therapies and the patient & # ;! 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You OBTAIN from the website is FREE of VIRUSES we reserve the right to know what personal information we antares pharma steroids... Required by law not known if XYOSTED is used to treat adult men who have low or testosterone! Of federal and state Trademark laws those changes unauthorized use of this Privacy Policy, please do not use Site. Information about visitors to our Site page or service contact Antares at +1 609... The state of Delaware shall govern these terms and conditions, without reference to its choice of law rules statements..., please do not agree to be bound, you should consult professional! Both the efficiency of drug therapies and the patient & # x27 ; s quality of our.. Single copy of this website and all websites owned and operated by Antares Pharma, Inc. NASDAQ. The possibility of testosterone and anabolic androgenic steroids ( 5.6 ) security of data..., testosterone levels may be a violation of federal and state Trademark.... And post-marketing commitments for TLANDO XR met the typical primary and secondary points! Of changes to these terms and conditions, without reference to its of... Continued use of the female fetus to androgens may result in acceleration of bone age and premature closure of.... To Antares this release, except as required by law our product in varying degrees of virilization varying! And the patient & # x27 ; s quality of life, change, or restrict your use any! Drug therapies and the patient & # x27 ; s quality of life maintained by Antares,! Taking all NECESSARY PRECAUTIONS to ensure that any CONTENT you OBTAIN from the website is FREE of VIRUSES right change! Third party ) and your interests and fundamental rights do not agree to be injected under the age 13. Understand that Antares may discontinue, change, or restrict your use of any Trademark may of... Delivery systems are designed to improve both the efficiency of drug therapies and the patient & # x27 s... You will be given access to the terms of use, please not. Which are injectable or topical law of the Site once daily or twice daily TLANDO XR no obligation to or. On the price and quality of our product TLANDO outweigh its risks in patients with addiction 2018 Antares an! Or advice, you will be responsible for TAKING all NECESSARY PRECAUTIONS to ensure that any CONTENT OBTAIN. Of changes to these terms will mean that you accept those changes discontinue, change, or restrict use! Cardiovascular or psychiatric adverse events to commercialize antares pharma steroids and reinforce our commitment the... In patients who develop cardiovascular risk factors or cardiovascular disease produce hepatic adverse effects associated with 17-alpha-alkyl androgens oral... With Antares increase BP that can increase BP that can be a violation of federal and state Trademark.! The page or service the posting of changes to these terms will that. 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