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TAIPEI, Taiwan, Oct. 25, 2024 /PRNewswire/ -- Bora Pharmaceuticals Co., Ltd. ("Bora" or "the Company", TWSE: 6472), today announced that its Board of Directors has approved the acquisition of US-based Pyros Pharmaceuticals, Inc. ("Pyros"), a specialty pharmaceutical company developing treatments for rare diseases. Continue Reading VIGAFYDE™ (vigabatrin) Oral Solution Founded in 2017 by Michael Smith and Edwin Urrutia, Pyros recently launched VIGAFYDE™ (vigabatrin) oral solution, which is indicated as monotherapy for the treatment of infantile spasms (IS) in pediatric patients 1 month to 2 years, where the potential benefits outweigh the potential risk of vision loss. Infantile spasms, a rare but severe form of epilepsy, pose significant challenges for patients and their families. VIGAFYDE™ is the first and only ready-to-use vigabatrin oral solution and represents a significant advancement in the treatment of infantile spasms as the first new product approved for this condition in 15 years. As the only premixed, ready-to-use vigabatrin formulation, VIGAFYDE™ offers patients and caregivers a simpler dosing process and enhances the likelihood of accurate dosing. VIGAFYDE™ was approved by the U.S. Food and Drug Administration (FDA) on June 17, 2024 and became available to patients in September 2024. This acquisition follows Bora's recent purchase of Upsher-Smith Laboratories, LLC earlier this year and TWi Pharmaceuticals in 2022. These moves mark Bora's rapid growth into a global competitor in both the contract development and manufacturing (CDMO) and commercial prescription (Rx) sectors. "We see incredible synergies between Upsher-Smith and Pyros," stated Bobby Sheng, Chairman and CEO of Bora Group. "Pyros' innovative R&D and deep understanding of the unmet needs of the market, combined with Upsher-Smith's reputation in the pediatric CNS space, create a powerful alliance that will enhance treatment satisfaction and patient outcomes with vigabatrin." Michael Smith, co-founder and CEO of Pyros commented, "We are excited to reach this agreement with Bora, a company that shares our commitment to supporting families navigating the unique challenges of rare diseases and aligns with our mission of elevating the standard of care for these often overlooked and under-supported patient communities." Sheng added, "Our combined team is committed to educating healthcare providers on the unparalleled value of VIGAFYDE™ and its unique benefits for both caregivers and patients alike." For Bora, Stifel is acting as exclusive financial advisor and Gibson, Dunn & Crutcher LLP is acting as legal advisor in this transaction. For Pyros, Piper Sandler is acting as exclusive financial advisor and Cooley LLP is acting as legal advisor. Vigabatrin REMS All vigabatrin products including VIGAFYDE™, are governed by a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA. The Vigabatrin REMS ensures that patients and healthcare providers make informed risk-benefit decisions about its use. Healthcare providers must be enrolled in the Vigabatrin REMS to prescribe these products, and patients must be enrolled to receive them. IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin) What is the most important information I should know about VIGAFYDE? VIGAFYDE can cause serious side effects, including: Permanent vision loss: VIGAFYDE can damage the vision of anyone who takes it. Some babies can have severe loss, particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, your baby may only be able to see things straight in front of them (sometimes called "tunnel vision"). Your baby also may have blurry vision. If this happens, it will not get better. Tell your healthcare provider right away if your baby might not be seeing as well as before starting VIGAFYDE or is acting differently than normal. Vision loss in babies: Because of the risk of vision loss, VIGAFYDE is used in babies 1 month to 2 years of age with infantile spasms only when you and your healthcare provider decide that the possible benefits of VIGAFYDE are more important than the risks. Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe. It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting VIGAFYDE or within 4 weeks after starting VIGAFYDE, and every 3 months after that until VIGAFYDE is stopped. Your baby also should have a vision test about 3 to 6 months after VIGAFYDE is stopped. Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing VIGAFYDE, but they will not be able to watch for any vision loss. Even if your baby's vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby's vision before it is severe and permanent. All babies who take VIGAFYDE: Are at risk for permanent vision loss with any amount of VIGAFYDE. The risk of vision loss may increase with higher doses of VIGAFYDE, and the longer it is taken. It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGAFYDE or any time during treatment. It may even happen after treatment has stopped. Because VIGAFYDE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called Vigabatrin Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will explain the details of the Vigabatrin REMS to you. For more information, go to or call 1-866-244-8175. Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS): brain pictures taken by MRI show changes in some babies after they are given VIGAFYDE. It is not known if these changes are harmful. What are the possible side effects of VIGAFYDE? VIGAFYDE can cause serious side effects, including sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable) and weight gain without swelling. Serious side effects that happen in adults who take vigabatrin and are not known if they will happen in babies are low red blood cell counts, nerve problems, and swelling. Tell your baby's healthcare provider right away if your baby's seizures get worse. The most common side effects of VIGAFYDE in babies include sleepiness, ear infection, swelling of the bronchial tubes, and irritability. Tell your healthcare provider if your baby has any side effect that bothers them or that does not go away. These are not all the possible side effects of VIGAFYDE. Do not stop taking VIGAFYDE suddenly. This can cause serious problems. Talk to your healthcare provider for directions on how to stop treatment. What should I tell my healthcare provider before starting VIGAFYDE? Before giving VIGAFYDE to your baby for IS, inform your healthcare provider about all your baby's medical conditions. This includes whether your baby has ever had an allergic reaction to vigabatrin, such as hives, itching, or trouble breathing, as well as any history of vision problems, or kidney issues. Tell your healthcare provider about all the medicines your baby takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Interactions between VIGAFYDE and other medicines could lead to side effects. You may report side effects to the FDA at or call 1-800-FDA-1088 or Pyros at 1-855-406-1010. Please see full Prescribing Information, including BOXED WARNING, Medication Guide, and Instructions for Use for additional Important Safety Information. About Bora Founded in 2007, Bora Pharmaceutical Co., Ltd. ("Bora" or "the Company", 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Bora is dedicated to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability. For more information, visit . About Pyros Pyros Pharmaceuticals is dedicated to developing enhanced specialty pharmaceuticals for rare diseases. Pyros's mission is to elevate the standard of care for infantile spasms, providing treatment options that significantly improve the lives of affected children. Through innovative therapies and comprehensive support, Pyros helps providers and caregivers navigate the complex patient journey. For more information, visit . Forward-Looking Statements The Company has made statements throughout this press release which constitute forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause its actual results, levels of activity, performance or achievements to be materially different from any results, levels of activity, performance or achievements expressed or implied by any such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "expect," "hopes," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "likely," "potential," or "continue" or the negative of these terms and similar words. Although management believe that the expectations reflected in these forward-looking statements are reasonable, management cannot guarantee future results, levels of activity, performance or achievements. Furthermore, management undertakes no obligation to update any forward-looking statements for any reason unless required to do so by law. Contacts Bora Pharmaceuticals Co., Ltd. Elizabeth Likly Kovak-Likly Communications, LLC [email protected] 203-762-8833 Jim Maahs Head of Commercial Upsher-Smith Laboratories, LLC 763-315-2000 Pyros Pharmaceuticals, Inc. Edwin Urrutia Chief Operating Officer [email protected] 201-743-9468 SOURCE Bora Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

New Partnership Will Provide TytoCare Devices to Thousands of Frontier Members across the U.S., Enabling In-Home Diagnostics and Extending Convenient Access to Relationship-Based Primary CareNEW YORK, Oct. 14, 2024 (GLOBE NEWSWIRE) -- TytoCare is partnering with Frontier Health to offer a virtual extension of Frontier Health’s Direct Primary Care offering. Frontier Health is a Texas-based direct primary care organization with nine brick-and-mortar locations and 30,000+ contracted members across the United States. Through this collaboration, members of Frontier’s virtual care extensions will receive a TytoCare Home Smart Clinic device, at no additional cost, to visit their primary care provider virtually with the ability to provide care consistent to its in-person clinic visits. "TytoCare shares a vision with Frontier that primary care should be affordable, convenient, and easy to access,” said Dedi Gilad, TytoCare CEO. "We believe that, in many cases, virtual primary care should be available as a first line of defense for people who need to access medical care, and in order for that to work, virtual care must be able to simulate the in-office experience and quality. That’s why we created the Home Smart Clinic, and we’re making it available today through our partnership with Frontier.” Through the new program, Frontier Direct Care members can use the TytoCare Home Smart Clinic to visit their providers from the convenience of home. The Home Smart Clinic enables members to securely share vital signs, body temperature, and high-resolution images of the heart, lungs, skin, ears, and throat with Frontier Direct Care providers during live video consultations. Frontier Direct Care provides its members, which include individuals and employer groups, in the private and public sectors, with subscription-based, relationship-focused primary care with no wait times, co-pays, or deductibles, as well as direct cash pay options and Rx savings. Offering TytoCare’s Home Smart Clinic to these members facilitates efficient, cost-effective, in-home diagnosis of common primary care conditions. "At Frontier Direct Care, we are committed to delivering accessible, high quality, and affordable healthcare to our members," said Brad Springer, Frontier Direct Care Chief Revenue Officer. "By partnering with TytoCare, we are enhancing our virtual capabilities with advanced telemedicine capabilities right at home. This seamless integration of TytoCare's technology into our high-engagement model enables our dedicated providers to make more informed clinical decisions remotely, enhancing the quality of care and outcomes for our patients."For example, Jessica is a current Frontier Direct Care member and TytoCare device user and fan, sharing that, “Last month, my daughter woke up with a painful ear infection, and I was worried about how we’d get her the care she needed without waiting for an appointment. Thanks to Frontier Direct Care and the TytoCare device, I was able to check her ears at home and connect with a Frontier provider immediately. The provider reviewed the results and prescribed the necessary medication, all without us leaving the house. It made such a difference to have this kind of accessible and immediate care when we needed it most.” By integrating TytoCare’s cutting-edge technology into their care model, Frontier Direct Care aims to enhance patient satisfaction, improve health outcomes, and reduce the overall cost of care for members and their employers. Frontier Direct Care operates and is licensed in all 50 U.S. states. About Frontier HealthFrontier Health is a direct primary care and cash-centric primary care program. Frontier Health offers direct primary care services for employees of primarily self-insured companies to receive medical care. Members have access to essential healthcare services, including healthcare provider visits and preventive care, without wait times, copays, or deductibles. Frontier prioritizes the patient-provider relationship by eliminating tasks that, in the traditional healthcare model, consume the provider’s time, leading to provider burnout, abbreviated, disjointed visits for the patient, and added costs and hassle for all parties. Putting the relationship first (NPS score of 94), Frontier Direct Care providers have the autonomy to care for the whole person, considering the body as well as the checkbook. About TytoCareTytoCare is a virtual healthcare company that enables leading health plans and providers to deliver remote healthcare to the whole family through its Home Smart Clinic. Combining a cutting-edge, easy-to-use, FDA-cleared device, the Home Smart Clinic enables the whole family to conduct remote physical exams with a doctor, replicating in-clinic exams for immediate answers from home. TytoCare drives utilization rates that are five times higher than traditional telehealth services; reduces the total cost of care by an average of five percent; diverts ER visits by an average of 10.8 percent; and has a high average NPS of 83. The Home Smart Clinic includes Tyto Engagement Labs™, a proven framework of engagement journeys designed for the successful deployment and adoption of the solution. To complete its offering, TytoCare also provides the Pro Smart Clinic, for professional settings outside the home to serve rural clinics, schools, workplaces, and more. TytoCare serves over 220 major health systems and health plans in the U.S., Europe, Asia, Latin America, and the Middle East.

Board-certified dermatologist, Dr. Sandra Lee , widely known as Dr. Pimple Popper , among others, details her journey with mild-moderate atopic dermatitis, the most common form of eczema, and her experience on Opzelura® (ruxolitinib) cream 1.5% WILMINGTON, Del. --(BUSINESS WIRE)--Oct. 10, 2024-- Incyte (Nasdaq:INCY) announced today the expansion of its Moments of Clarity program, an educational initiative highlighting stories of people living with mild to moderate atopic dermatitis (AD) and their paths to finding relief. Building on last year’s program launch in partnership with Mandy Moore , the Moments of Clarity program will now feature several additional real-life patient perspectives, including that of Dr. Sandra Lee and Emily, a mom of three, who share their emotional experiences and the impact AD has had on their lives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241009443934/en/ In the new program content, each patient shares defining moments throughout their journeys including how they finally found relief with Opzelura® (ruxolitinib) cream 1.5%. Opzelura is a nonsteroidal, twice-daily cream that is indicated for the short-term and non-continuous treatment of mild to moderate eczema in certain people 12 and older whose disease is not well-controlled with topical prescription therapies or when those therapies are not recommended. Use of Opzelura in combination with biologics, other JAK inhibitors or potent immunosuppressants is not recommended. “While many people know me as a dermatologist from my TV show, most probably don’t know that I live with eczema and have struggled with symptoms like persistent itch and skin inflammation throughout my life,” said Dr. Lee . “I started using Opzelura, a non-steroidal topical option, to treat my eczema flares, which helped alleviate some of my worst symptoms like itch. In the pivotal clinical trial for mild to moderate AD, 54% of patients had clear to almost clear skin at 8 weeks and 52% of patients had a significant reduction in their itch, compared to 15% of patients who used a cream that did not contain medication. I partnered with Incyte on their Moments of Clarity program to share my story and to empower others to seek out a treatment that is right for them.” AD – the most common type of eczema – is a chronic condition characterized by inflammation of the skin, which can manifest as persistent itch, dry and scaly patches or red lesions on the body1. AD affects more than 21 million people aged 12 years and older in the U.S. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. “We understand the impact eczema can have on daily life, which furthers the need for patients to find a treatment to address their individual symptoms,” said Matteo Trotta , Executive Vice President, General Manager, U.S. Dermatology, Incyte . “We are proud to elevate the patient voice and share the real, lived experience with Opzelura as part of our commitment to patients and to providing a treatment that can help address some of the most burdensome symptoms of AD. Our hope is that the Moments of Clarity program helps those living with eczema connect with others and inspires them to have conversations with their doctor.” OPZELURA is not for everyone. See below for IMPORTANT SAFETY INFORMATION including boxed Warning for Serious Infections, Increased Risk of Death, Lymphoma and other Cancers, Major Cardiovascular Events and Blood Clots. To hear more visit MyMomentsofClarity.com. All individuals were compensated for their participation. About Opzelura® (ruxolitinib) Cream Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States . Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. In April 2022 , Incyte entered into a strategic alliance agreement with Maruho Co., Ltd. for the development, manufacturing and exclusive commercialization of ruxolitinib cream for treatment of autoimmune and inflammatory dermatology indications in Japan . Opzelura is a registered trademark of Incyte . IMPORTANT SAFETY INFORMATION OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. OPZELURA may cause serious side effects, including: Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA. OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA. Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth. Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen. Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers. Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth. Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen. Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides. Before starting OPZELURA, tell your healthcare provider if you: After starting OPZELURA: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever. These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463. INDICATIONS AND USAGE OPZELURA is a prescription medicine used on the skin (topical) for: The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo. Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. About Incyte Dermatology Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need. We strive to identify and develop therapies to modulate immune pathways driving uncontrolled inflammation to help restore normal immune function and bring the body closer to homeostasis. Specifically, our efforts in dermatology are focused on a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus and prurigo nodularis To learn more, visit the Dermatology section of Incyte.com. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware , Incyte has operations in North America , Europe and Asia . For additional information on Incyte , please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the partnership between Incyte and Dr. Sandra Lee Incyte’s goal of improving the lives of patients, whether and when Opzelura might provide a successful treatment option for patients with atopic dermatitis, and Incyte’s dermatology program generally, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other regulatory authorities outside of the United States ; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission , including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2024 . Incyte disclaims any intent or obligation to update these forward-looking statements. 1 National Eczema Association . What is atopic dermatitis? https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ View source version on businesswire.com: https://www.businesswire.com/news/home/20241009443934/en/ Media media@incyte.com Investors ir@incyte.com Source: Incyte