Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. Disclosure and Relationship To Third Parties. "We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. 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. 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 will not sell your Personal Information or Health-related Personal Information. Disclosure and Relationship To Third Parties. 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. 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. Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. 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. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. We will only use your Personal Information when the law allows us to. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. 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. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. If your blood pressure increases while you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. We also may use a third party verification provider to verify your identity. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. Upon the expiration of the exclusivity period granted to Clarus Therapeutics, Inc., with respect to its drug, JATENZO, under the Hatch-Waxman Act, which expires on March 27, 2022, TLANDO will be eligible for final approval. Your exercise of these rights will have no adverse effect on the price and quality of our services. For all other inquiries, please contact us through the relevant product, support or Antares website. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. 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 website may contain information, news and/or press releases about Antares. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. III. Antares Pharma develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. Improper use may result in acceleration of bone age and premature closure of epiphyses. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). To perform the contract we are about to enter into or have entered into with you. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. 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. Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). These are not all the possible side effects of XYOSTED. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. 8ey| +6-!|Ss! To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) and Antares Pharma, Inc. (NASDAQ:ATRS) today announced the launch of the generic equivalent to Imitrex 1 (sumatriptan succinate) injection, 4 mg and 6 mg single-dose, prefilled syringe autoinjectors, in the U.S. Sumatriptan injection is used to treat acute migraine with or without aura, and acute cluster headaches in adults. 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. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. It also has . The transaction is expected to be immediately accretive to Halozyme's 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple . 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. About Antares Pharma. 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. Monitor patients with BPH for worsening signs and symptoms. Antares may modify its services at any time. 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. by XYOSTED is the only FDA. If you do not agree to the terms of this Privacy Policy, please do not use the Site. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. The Site may contain links to other websites. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. 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. We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. If these occur, promptly discontinue TLANDO while the cause is evaluated. Pediatric Use: The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. Ask your pharmacist for a list of all your medicines if you are not sure. 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. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. We also may use a third party verification provider to verify your identity. All Rights Reserved. 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 . 1 0 obj endobj 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 report side effects to the FDA visitwww.fda.gov/medwatch, or call 1-800-FDA-1088. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). For full prescribing information, please visit www.antarespharma.com. 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. Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares. 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. Opens in a new tab or window. March 29, 2022 07:00 ET When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. 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. 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. Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. T}b j[yj WhvLdK5D:Goai5.w=u_n'jt"XD/PeV *kH12z(^`0 . 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. In addition, Lipocine has granted Antares Pharma an option . pF"_Ef=|DKW#ex/Jxj9 Personal Information. 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. Male hypogonadism, also known as testosterone deficiency, is an endocrine disorder in which the body fails to produce enough of the hormone. None of the information contained herein is intended to be, and shall not be deemed to be, incorporated into any of Antaress securities-related filings or documents. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. 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 . 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%. 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 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. 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. We have multiple internal product development programs, as well as partnerships with industry-leading pharmaceutical companies. Never give your XYOSTED to anyone else. Women who are pregnant. 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. 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. 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. 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. If you wish to no longer receive future communications from Antares, please fill in your email address below and click Unsubscribe. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. 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. The Site may contain links to other websites. III. Opens in a new tab or window, Visit us on Twitter. 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. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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.. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. An increase in red blood cell mass may increase the risk of thromboembolic events. 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. Reduced fertility is observed in some men taking testosterone replacement therapy. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. 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. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. All rights reserved. Under the terms of Agreement Lipocine to receive: 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. Peliosis hepatis can be a life-threatening or fatal complication. Making Medicines Feel Better | About Antares Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with . The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Monitor serum calcium concentrations periodically in these patients. Share on Facebook. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. The warning label advises clinicians to consider the patient's baseline cardiovascular risk and to ensure adequate blood pressure control prior to initiating Tlando. Treat new-onset hypertension or exacerbations of pre-existing hypertension. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Patients treated with androgens may be at increased risk for prostate cancer. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management. If you do not agree to the terms of this Privacy Policy, please do not use the Site. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. To perform the contract we are about to enter into or have entered into with you. Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. 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. (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. 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. 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. Patients with carcinoma of the breast or known or suspected carcinoma of the prostate. As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. <> For example, do not take XYOSTED if you have low testosterone due to age. To customize your site experience by anticipating the information and services that may be of interest to you. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Use XYOSTED exactly as your healthcare provider tells you to take it. 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.". Antares Pharma Inc. | 4,908 followers on LinkedIn. Have low testosterone without certain medical conditions. Lipocine And Antares Pharma Enter Into U.S. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. 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. 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 . Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. Continue to Site Abuse and misuse of testosterone are seen in male and female adults and adolescents. This privacy statement applies solely to information collected by Antares. Monitor the lipid profile periodically after starting testosterone therapy. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . 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 Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in . Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. 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. This website is for use by U.S. residents only. The security of your data is very important to Antares. stream You should not inject XYOSTED until you have been trained on the proper way to use it. 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