Hikma Pharmaceuticals USA, Inc.

LONDON, Aug. 20, 2024 /PRNewswire/ -- Hikma Pharmaceuticals in the US joined government officials and non-profit leaders today at a naloxone awareness and training event organized and hosted by Rep. Earl L. "Buddy" Carter of Georgia. This important educational event took place at Groves High School in Savannah, Ga. ahead of National Fentanyl Awareness and Prevention Day. Hikma's participation is part of its ongoing partnership with U.S. government and community leaders and marks a milestone as Hikma celebrates donating more than 600,000 doses of naloxone over the last three years. The U.S. Centers for Disease Control and Prevention (CDC) estimates that more than 107,000 Americans died from drug overdoses in 2023, with most deaths attributed to illicit fentanyl.1 Hikma is working closely with leading government officials like Rep. Carter and the White House Office of National Drug Control Policy (ONDCP) to expand access to life-saving naloxone.2 These actions build on Hikma's long-standing commitment to working with government officials, health care providers, non-profit organizations and the public health community to ensure naloxone is widely accessible to all who can benefit from it. For more than 20 years, Hikma has been working with communities across the U.S. to provide medicines that help people recover overdoses and from opioid use disorder. "Naloxone training events like Congressman Carter's help build understanding of this vital tool that individuals, families, first responders and communities can quickly use to reverse overdoses and save lives, and we are proud to support efforts to expand availability of this essential medicine," said Dr. Hafrun Fridriksdottir, President of Hikma's Generics business. "As a U.S.-based manufacturer of multiple forms of overdose reversal medicines and treatments for opioid use disorder, Hikma is proud to have donated more than 600,000 doses of naloxone over the last three years." Earlier this summer, Rep. Carter introduced a resolution to recognize National Fentanyl Prevention and Awareness Day on Aug. 21. This is one of the many important actions he's taken to expand access to naloxone including legislation to have the life-saving medicine in schools and calling for it to be available in the U.S. House of Representatives buildings. "Naloxone should be in every medicine cabinet in America and as accessible as fire extinguishers. As our nation battles a fentanyl poisoning and opioid overdose epidemic, it is critical that we continue to provide community resources and support to save lives. Thank you to Hikma for participating in this important training and making sure GA-01 has the tools and knowledge necessary to keep our loved ones safe," said Rep. Buddy Carter. Hikma manufactures multiple forms of naloxone including generic injectable vials and prefilled syringes made in New Jersey and KLOXXADO® (naloxone 8mg) intranasal spray produced in Ohio. Ahead of International Overdose Awareness Day on Aug. 31, Hikma is reaffirming its commitment to expanding access to the full range of naloxone available and partnering with diverse groups as part of the "Together We Can," theme. Through its Hikma Community Health initiative, Hikma is partnering with those on the frontlines of the overdose public health emergency across the US to help expand access to naloxone, including by: Donating more than 600,000 doses of KLOXXADO® and injectable naloxone to harm reduction groups, community organizations and others across the US. With the help of more than 40 donation partners, KLOXXADO® has been distributed for free in places it can have the biggest impact, including music festivals, downtowns and schools. Donating 50,000 vials of injectable naloxone in 2021 to members of Remedy Alliance – a leading supplier of naloxone to harm-reduction programs in the US – to help ease a nationwide shortage. Furthering our partnership with Remedy Alliance by providing the first and only private label, discounted naloxone injectable medicine made specifically for the harm-reduction community. As covered in The Washington Post, this partnership ensures supply and price are no longer barriers to this opioid overdose antidote to hundreds of harm reduction groups nationwide. Ensuring widespread access to KLOXXADO® by providing a Co-Pay Assistance Program for eligible individuals, further increasing access and decreasing out-of-pocket costs to this life-saving medication.2 Partnering with State Government and Community Programs to expand access to our naloxone portfolio and continuing to provide generic medications for the treatment of substance use disorder to patients and health care providers. Participating in awareness days and training events with community partners like Facing Fentanyl and This Must Be the Place and meeting with government leaders like ONDCP Director Dr. Rahul Gupta and many members of Congress and state officials. This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. About Hikma (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,100 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc. Hikma Community Health™ is a trademark of Hikma Pharmaceuticals USA Inc. Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg Contraindications Hypersensitivity to naloxone hydrochloride or to any of the other ingredients Warnings and Precautions Use KLOXXADO® right away if you suspect an opioid overdose emergency, even if you are not sure, because an opioid overdose emergency can cause severe injury or death. Signs and symptoms of an opioid overdose emergency may include: Unusual sleepiness; you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum). Breathing problems, including slow or shallow breathing in someone difficult to awaken or who looks like they are not breathing. The black circle in the center of the colored part of the eye (pupil) is very small (sometimes called "pinpoint pupils") in someone difficult to awaken. Family members, caregivers or other people who may have to use KLOXXADO® in an opioid overdose emergency should know where KLOXXADO® is stored and how to give KLOXXADO® before an opioid overdose emergency happens. Get emergency medical help right away after using the first dose of KLOXXADO®. Rescue breathing or CPR (cardiopulmonary resuscitation) may be needed while waiting for emergency medical help. The signs and symptoms of an opioid overdose emergency can return after KLOXXADO® is given. If this happens, give another dose after 2 to 3 minutes, using a new KLOXXADO® device, alternating nostrils, and watch the person closely until emergency medical help arrives. Do not use KLOXXADO® if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO®. KLOXXADO® can cause sudden and severe opioid withdrawal, the symptoms of which may include body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure. In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes. Tell your doctor about all of your medical conditions before using KLOXXADO®, including if you have heart problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, drugs, vitamins and herbal supplements. Side Effects The following serious side effect is discussed in the full Prescribing Information for KLOXXADO®: Sudden and Severe Opioid Withdrawal Symptoms of sudden and severe opioid withdrawal resulting from the use of KLOXXADO® in someone regularly using opioids include: body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure. Infants may have seizures, cry more than normal and have increased reflexes. Some people may become aggressive after abrupt reversal of opioid overdose. In two clinical studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO®, one spray in one nostril. Side effects were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope. These are not all of the possible side effects of KLOXXADO®. Contact your doctor for medical advice about side effects. Pregnancy, Infancy and Breastfeeding, Children Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant and opioid dependent, use of KLOXXADO® may cause withdrawal symptoms in you and your unborn baby. A healthcare provider should monitor you and your unborn baby right away after you use KLOXXADO®. There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production. If the primary concern is an infant at risk of an overdose, consider whether other naloxone containing products may be more appropriate. KLOXXADO® nasal spray is safe and effective in children for known or suspected opioid overdose. Dosage and Administration Do not attempt to prime or test-fire the device. Each KLOXXADO® Nasal Spray contains only 1 dose of medicine and cannot be reused. Read the "instructions for use" at the end of the Prescribing Information and Medication Guide for detailed information about the right way to use KLOXXADO® Nasal Spray. Storage and Handling Store KLOXXADO® at room temperature between 68°F to 77°F (20°C to 25°C). Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C). Do not freeze KLOXXADO®. Keep KLOXXADO® in its box until ready to use. Protect from light. Replace KLOXXADO® before the expiration date on the box. Keep KLOXXADO® and all medicines out of the reach of children. For more information, please see the full Prescribing Information and Medication Guide. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Distributed by: Hikma Specialty USA Inc., Columbus, OH 43228. 1 2 SOURCE Hikma Pharmaceuticals USA Inc.

LONDON, Aug. 15, 2024 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the shelf-life extension of KLOXXADO® (naloxone HCl) nasal spray 8mg from 24 to 36 months. KLOXXADO® packaging has been updated with 36-month dating, starting with product manufactured in March 2024. KLOXXADO® contains twice as much naloxone per spray as Narcan® Nasal Spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important treatment option in addressing the overdose epidemic.1,2 Naloxone has long been recognized as an important, safe and effective treatment in the fight against opioid overdose.3 With the increasing prevalence of illicitly manufactured synthetic opioids, organizations including the CDC,4 the American Medical Association5 and others have noted that a higher dose of naloxone may be required to revive a patient experiencing poisoning from illicit fentanyl or other opioids. As a ready-to-use nasal spray that contains twice as much naloxone per spray than Narcan® Nasal Spray 4mg, KLOXXADO® provides an important lifesaving treatment option.1,2 "The shelf-life extension is good news for frontline responders and the thousands of people who carry KLOXXADO® and who may need to use it at a moment's notice to reverse an overdose," said Dr. Hafrun Fridriksdottir, President, Hikma Generics. "We have a role to play in the fight against illicit fentanyl and as we approach International Overdose Awareness Day on August 31st, it's gratifying that we are supplying an important medicine that can save lives and help address the deadly overdose epidemic." About Naloxone Naloxone hydrochloride is a medicine that rapidly reverses an opioid overdose. It can quickly restore normal breathing in someone experiencing an opioid overdose and should be given to any person who shows signs of an opioid overdose or when an opioid overdose is suspected.6 KLOXXADO® is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.1 KLOXXADO® is not a substitute for emergency medical care.1 KLOXXADO® is intended for immediate administration as emergency therapy in settings where opioids may be present.1 This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. Enquiries Hikma Pharmaceuticals USA Media: Steve Weiss +1 732 788 8279 [email protected] About Hikma Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,100 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc. NARCAN® is a registered trademark of Emergent Operations Ireland Limited. Important Safety Information for KLOXXADO® (naloxone HCl) Nasal Spray 8 mg Contraindications Hypersensitivity to naloxone hydrochloride or to any of the other ingredients Warnings and Precautions Use KLOXXADO® right away if you suspect an opioid overdose emergency, even if you are not sure, because an opioid overdose emergency can cause severe injury or death. Signs and symptoms of an opioid overdose emergency may include: Unusual sleepiness; you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum). Breathing problems, including slow or shallow breathing in someone difficult to awaken or who looks like they are not breathing. The black circle in the center of the colored part of the eye (pupil) is very small (sometimes called "pinpoint pupils") in someone difficult to awaken. Family members, caregivers or other people who may have to use KLOXXADO® in an opioid overdose emergency should know where KLOXXADO® is stored and how to give KLOXXADO® before an opioid overdose emergency happens. Get emergency medical help right away after using the first dose of KLOXXADO®. Rescue breathing or CPR (cardiopulmonary resuscitation) may be needed while waiting for emergency medical help. The signs and symptoms of an opioid overdose emergency can return after KLOXXADO® is given. If this happens, give another dose after 2 to 3 minutes, using a new KLOXXADO® device, alternating nostrils, and watch the person closely until emergency medical help arrives. Do not use KLOXXADO® if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO®. KLOXXADO® can cause sudden and severe opioid withdrawal, the symptoms of which may include body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure. In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes. Tell your doctor about all of your medical conditions before using KLOXXADO®, including if you have heart problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, drugs, vitamins and herbal supplements. Side Effects The following serious side effect is discussed in the full Prescribing Information for KLOXXADO®: Sudden and Severe Opioid Withdrawal Symptoms of sudden and severe opioid withdrawal resulting from the use of KLOXXADO® in someone regularly using opioids include: body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure. Infants may have seizures, cry more than normal and have increased reflexes. Some people may become aggressive after abrupt reversal of opioid overdose. In two clinical studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO®, one spray in one nostril. Side effects were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope. These are not all of the possible side effects of KLOXXADO®. Contact your doctor for medical advice about side effects. Pregnancy, Infancy and Breastfeeding, Children Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant and opioid dependent, use of KLOXXADO® may cause withdrawal symptoms in you and your unborn baby. A healthcare provider should monitor you and your unborn baby right away after you use KLOXXADO®. There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production. If the primary concern is an infant at risk of an overdose, consider whether other naloxone-containing products may be more appropriate. KLOXXADO® nasal spray is safe and effective in children for known or suspected opioid overdose. Dosage and Administration Do not attempt to prime or test-fire the device. Each KLOXXADO® Nasal Spray contains only 1 dose of medicine and cannot be reused. Read the "instructions for use" at the end of the Prescribing Information and Medication Guide for detailed information about the right way to use KLOXXADO® Nasal Spray. Storage and Handling Store KLOXXADO® at room temperature between 68°F to 77°F (20°C to 25°C). Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C). Do not freeze KLOXXADO®. Keep KLOXXADO® in its box until ready to use. Protect from light. Replace KLOXXADO® before the expiration date on the box. Keep KLOXXADO® and all medicines out of the reach of children. For more information, please see the full Prescribing Information and Medication Guide, which you can find on our website at . To report an adverse event or product complaint, please contact us at [email protected] or call 1-877-845-0689 or 1-800-962-8364. Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or . Distributed by: Hikma Specialty USA Inc., Columbus, OH 43228. Document Identification Number: HK-2667-v1 1 2 3 4 5 6 SOURCE Hikma Pharmaceuticals USA Inc.

yuan Bio·News 药 监 资 讯 1、NMPA | 药用辅料GMP和药包材GMP（征求意见稿）发布 2024年7月18日，国家药监局发布公告，公开征求《关于发布〈药用辅料生产质量管理规范〉〈药包材生产质量管理规范〉（征求意见稿）》意见。（相关阅读点击查看） 公告强调： 1、药用辅料、药包材生产企业建立健全质量管理体系 2、药品上市许可持有人加强物料质量管理 （来源：国家药品监督管理局、蒲公英Biopharma） 受 理 情 况 CDE受理情况 2024年7月18日-7月24日期间，中国国家药监局药品审评中心（CDE）共受理药品402个，其中生物制品63个（新药27个和进口7个）。 滑动查看（点击可查看大图） （来源：国家药品监督管理局药品审评中心） 企 业 动 态 1、诺华 | 30亿美元！与Dren Bio合作开发双抗抗癌疗法 2024年7月24日，加利福尼亚州福斯特城，开发癌症、自身免疫和其他严重疾病抗体疗法的临床阶段生物制药公司Dren Bio宣布已与诺华公司的子公司诺华制药（Novartis Pharma AG）达成战略合作。 此次合作将集中于使用Dren Bio专有的靶向髓细胞接合器（Targeted Myeloid Engager）和吞噬（Phagocytosis）平台发现和开发癌症治疗性双特异性抗体。根据协议条款，Dren Bio将从诺华公司获得1.5亿美元的预付款，其中包括2500万美元的股权投资。 Dren Bio还有资格在实现某些临床前、临床、监管和商业里程碑后获得高达28.5亿美元的额外现金支付，以及合作产生的任何商业化产品的未来净销售额的分层特许权使用费。Dren Bio和诺华公司将通过临床候选药物选择合作推进肿瘤学中选定的靶向髓系接合器项目，届时诺华公司将全权负责所有剩余的开发、制造、监管和商业化活动。 （来源：Dren Bio官网、Medaverse） 2、精准生物 |「CD19 CAR-T」1类新药申报上市 2024年7月20日，重庆精准生物自主研发的国家一类生物新药pCAR-19B细胞自体回输制剂（普基仑赛注射液）上市申请（NDA）获国家药品监督管理局（NMPA)正式受理。 该产品是国内首款针对儿童白血病的CAR-T产品，用于治疗3-21岁患有CD19阳性复发/难治性急性淋巴细胞白血病（ALL）的患者。 （来源：精准生物科技官微） 3、信念医药 | 国内首款！AAV基因治疗药物BBM-H901的新药申报上市 2024年7月24日，专注前沿基因治疗领域的创新型企业信念医药集团（Belief BioMed，BBM，下称“信念医药”）宣布：国家药品监督管理局（NMPA）已正式受理BBM-H901注射液用于治疗血友病B成年患者的新药上市申请（NDA）。 BBM-H901注射液是信念医药自主研发和生产的首款重磅产品，也是国内首个递交新药上市申请的针对遗传病的基因治疗药物。此次里程碑式进展，意味着该款产品有望成为中国首个获批上市的适用于血友病B的重组腺相关病毒（AAV）的基因疗法，亦有望重塑全球AAV基因治疗领域新格局。 （来源：信念医药官微） 4、百奥泰 | 乌司奴单抗注射液上市许可申请获FDA和EMA受理 2024年7月19日，百奥泰生物宣布，该公司BAT2206（乌司奴单抗生物类似药）的生物制品上市申请获美国FDA和欧洲EMA受理。BAT2206是百奥泰生物开发的乌司奴单抗注射液。今年5月，该产品在中国的上市申请已经获NMPA受理。 百奥泰已于全球多区域开展了BAT2206（乌司奴单抗）注射液的商业化进程： 与Hikma Pharmaceuticals USA Inc.就BAT2206签署了在美国市场的独家商业化及授权协议，百奥泰负责BAT2206的开发、生产和供应，Hikma负责BAT2206在美国市场的商业化； 与Biomm S.A. 就BAT2206签署了在巴西市场的独家分销权及销售权； 与Pharmapark LLC就BAT2206签署了在俄罗斯和其他独联体国家市场的独家分销权及销售权。 （来源：百奥泰官微） 5、驯鹿生物 | 伊基奥仑赛注射液治疗多发性硬化症新药获FDA临床批准 2024年7月24日，驯鹿生物宣布，其自主研发的全人源靶向BCMA嵌合抗原受体自体T细胞注射液（伊基奥仑赛注射液）的新药临床试验申请（IND）已获得美国食品药品监督管理局（FDA）的默示许可，拟用于治疗多发性硬化症（Multiple Sclerosis, MS）。 这是伊基奥仑赛注射液在2024年继难治性全身型重症肌无力（gMG）之后，成功获得FDA批准的第二个自身免疫疾病适应症IND。 （来源：驯鹿生物官微） END 编辑：芝麻核桃 声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。 近期课程、活动推荐 # 线上：7月24日 降本增效好帮手，PAT技术在生物工艺中的应用 # 线上：7月31日 药企如何确保生产数字化高效合规 # 线下：8月6日 上海张江 | 基因与细胞治疗药物研发交流会 # 线下：8月21-22日 苏州 | 2024中国先进生物工艺论坛 # 线下：4大论坛400位质量经理人9月齐聚南京