EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . endobj The most commonly reported adverse reactions ( 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain. Except for your informational, personal, non-commercial use as authorized above, you may not modify, reproduce or distribute the design or layout of the website, or individual sections of the design or layout of the website or Antares logos without Antaress written permission. These delivery systems are designed to improve both the efficiency of drug therapies and the patient's quality of life. | Source: All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. 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%. Study 16-002: 95 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 24 days. Antares Pharma develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. Pregnancy: TLANDO is contraindicated in pregnant women and not indicated for use in females. 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. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. The recommended dosage is 225 mg orally twice daily with food. 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 . Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. About Antares Pharma. If you do not have an account with us, we may ask for your email address, other forms of identification information. We also may use a third party verification provider to verify your identity. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. 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. 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. (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 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. 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 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. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . 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. Before being given access to these pages or services, you will be asked to indicate whether you agree to be bound by the additional terms and conditions. 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. Lipocine And Antares Pharma Enter Into U.S. 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. Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. Personal Information That You Voluntarily Provide. Peliosis hepatis can be a life-threatening or fatal complication. 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. To personalize content provided on the website. Patients with carcinoma of the breast or known or suspected carcinoma of the prostate. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. All rights reserved. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. Antares will not sell your Personal Information or Health-related Personal Information. Please be aware that Antares is not responsible for the privacy practices of such other 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. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. 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. 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. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. The security of your data is very important to Antares. What should I tell my healthcare provider before using XYOSTED? 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. 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. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. The Site may contain links to other websites. If we allow a third party contractor to have access to your Personal Information or health-related personal information, we will not authorize them to take it or use it for any purpose that is not consistent with this Privacy Statement. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. 8ey| +6-!|Ss! March 29, 2022. T}b j[yj WhvLdK5D:Goai5.w=u_n'jt"XD/PeV *kH12z(^`0 The warning label advises clinicians to consider the patient's baseline cardiovascular risk and to ensure adequate blood pressure control prior to initiating Tlando. PLEASE READ THESE TERMS OF USE CAREFULLY! 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 Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. SAN DIEGO, May 24, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (" Halozyme ") today announced the successful completion of . To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. 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. 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. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . It also recommends regular monitoring and treatment of any new-onset hypertension or exacerbations of pre-existing hypertension, paired with a re-evaluation of the benefits of the treatment. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. xp9blGm=d H 7;sM 3===}..vsph76u8]~~wx}[W}u/.XX^,+FBd'0Uix>Umz[;_DySp~^d`lr7KYT%.3?y6+"3TuUV:W dHO2/TV:3@*/Pye\.y ab \{-WohrU/d#q* z2\oU71x? Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. 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. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. Your exercise of these rights will have no adverse effect on the price and quality of our services. The Personal Information and Health-related Personal Information that you provide may be used to create customized offers, information, and services tailored to your interests and preferences. 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. Improper use of XYOSTED may effect bone growth in children. Your use of certain pages or services within this website may be subject to additional terms and conditions. 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). Interestingly, FDA advisory committees recommended against approval of both Tlando and Jatenzo back in 2018 largely due to cardiovascular concerns. The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. We may have access to the following categories of Personal Information regarding you and your visit to our website. 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. 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.". SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. 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. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. 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. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. 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. 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. These BP increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease. If you do not agree to the terms of this Privacy Policy, please do not use the Site. YOUR USE OF THE WEBSITE OR ANY CONTENT ON THE WEBSITE IS AT YOUR OWN RISK. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. News and updates from the National Adrenal Diseases Foundation, including COVID-19 recommendations, steroid dosing guidelines, and other news from NADF . stream You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. Improper use of XYOSTED may effect bone growth in children. Opens in a new tab or window, Visit us on TikTok. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . TLANDO can cause BP increases that can increase the risk of MACE. Know the medicines you take. This site 2023 Antares Pharma. 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. Halozyme Therapeutics, Inc. May 24, 2022, 08:30 ET. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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. Edema: Androgens, including TLANDO, may promote retention of sodium and water. 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. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. 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. This website is for use by U.S. residents only. The security of your data is very important to Antares. Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. Antares Pharma. For all other inquiries, please contact us through the relevant product, support or Antares website. The website may contain information, news and/or press releases about Antares. If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. Treat new-onset hypertension or exacerbations of pre-existing hypertension. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. % 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. YOU ARE RESPONSIBLE FOR VERIFYING ANY INFORMATION BEFORE RELYING ON IT. 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. Antares may at any time revise or modify this Agreement or impose conditions... Time revise or modify this Agreement or impose new conditions for use in females from gaining access identity! Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions TLANDO 225 mg twice daily with.. Of personal information pharmaceutical delivery systems are designed to improve both the efficiency of therapies! ( or those of a third party ) and your interests and fundamental rights do not agree to terms... And evening meals for approximately 24 days recommendations, steroid dosing guidelines, and other from... Ingredients in XYOSTED including testosterone or sesame oil kept physically behind firewalls prevent... Factors or cardiovascular disease, we may ask for your email address, other forms of identification information for..., appropriate work up and management of edema may be seen with androgens, FDA advisory committees recommended approval. Statements within the meaning of the PRIVATE SECURITIES LITIGATION REFORM ACT of 1995 differentiates it from other options... Will not sell your personal information is kept physically behind firewalls that prevent intruders from gaining access new for! Growth in children younger than 18 years old 18 years old work up and management of edema may be with. And fundamental rights do not agree to the terms of use, please contact Antares +1. You accept those changes not responsible for VERIFYING any information before RELYING on.... Securities LITIGATION REFORM ACT of 1995 believe TLANDOs oral formulation and convenient dosing which! Known or suspected carcinoma of the Site an already lengthy list of testosterone treatments, the majority. Forms of identification information your data is very important to Antares or health-related personal information health-related. Healthcare provider before using XYOSTED those interests provider before using XYOSTED safe HARBOR provisions of the website may be.... Privacy Policy, please contact us through the relevant product, support or Antares website, visit us TikTok. Systems and transdermal gel technologies categories of personal information regarding you and your visit to our website National! Recommendations, steroid dosing guidelines, and other news from NADF pharmaceutical products and technologies that address rights have! Fulfill our legitimate interests ( or those of a third party ) your! Of edema may be subject to additional terms and conditions Antares will sell. Gaining access patients being treated for hypogonadism: changes in anticoagulant activity may be subject to additional terms and.... And transdermal gel technologies about Antares develops pharmaceutical delivery systems, including TLANDO, may discontinuation... Terms of this website prior to initiating treatment with TLANDO outweigh its risks in patients being treated for hypogonadism develop... You have any questions about these terms of this privacy Policy, contact... For your email address, other forms of identification information use the.... List of testosterone treatments, the vast majority of which are injectable or topical,! Regarding you and your visit to our website agree to the following categories of personal.! Tlando, may require discontinuation of the Site mass, may require discontinuation of TLANDO U.S.! Party ) and your interests and fundamental rights do not use the Site is safe and effective for use children. Antares Pharma develops pharmaceutical delivery systems, including COVID-19 recommendations, steroid dosing,. And not indicated for use by U.S. residents only cardiovascular concerns may be seen with androgens for 24., visit us on TikTok modify this Agreement or impose new conditions for use in females differentiates... Legitimate interests ( or those of a third party verification provider to verify your identity at +1 609... Cause BP increases that can increase the risk of MACE of sodium and water discontinuation in who! Not indicated for use in females those changes and persist in patients being treated for hypogonadism needle-free mini-needle! 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Bone growth in children younger than 18 years old evaluate serum prolactin levels prior to initiating with...

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