Hyperbilirubinemia, Neonatal

Breakthrough Therapy Designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for HDFN Phase 3 clinical trial enrollment underway, representing the only therapy reported to be under clinical development for this serious, life-threatening and rare condition SPRING HOUSE, Pa., Feb. 9, 2024 /PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizeda pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN). Nipocalimab is currently the only therapy reported to be in clinical development for the treatment of alloimmunized pregnant individuals at risk of severe HDFN, a serious and rare condition that occurs when the blood types of a pregnant individual and the fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.1 "Nipocalimab represents a novel approach for the treatment of patients at risk of severe HDFN who need proven, safe, non-surgical solutions to help address the serious health consequences of this condition," said Katie Abouzahr, M.D., Vice President, Autoantibody and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson. "We are committed to addressing the substantial unmet need in this devastating disease." The data from the proof-of-concept Phase 2 open-label UNITY clinical trial provided support for the BTD.2 The trial met the primary endpoint, with the majority of pregnant patients who received nipocalimab achieving a live birth at or after the gestational age of 32 weeks, without the need for an intrauterine transfusion (IUT) throughout their entire pregnancy.3 Severe or serious adverse events were generally low and consistent with events associated with pregnancy, HDFN, and gestational age at birth.3 Nipocalimab was granted Fast Track designation in July 2019, orphan drug status in June 2020 by the FDA, and orphan medicinal product designation by the European Medicines Agency in October 2019 for the HDFN indication. The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement in at least one clinically significant endpoint over available therapies. The AZALEA Phase 3 pivotal trial is currently enrolling pregnant individuals who are at risk for severe HDFN who have a history of severe HDFN in a prior pregnancy(ies).2 Editor's Notes: a. Alloimmunized: an immune response to foreign antigens upon exposure to genetically different cells or tissues.4 About the UNITY trial UNITY (NCT03842189) is a global, multicenter, non-blinded Phase 2 clinical trial designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab for the treatment of pregnant individuals at high risk for EOS HDFN.5 The trial enrolled RhD (D) or Kell (K) alloimmunized pregnant individuals with singleton pregnancies at high risk for EOS HDFN due to an obstetric history of severe fetal anemia, fetal hydrops, or a stillbirth at ≤24 weeks gestation.3 The primary endpoint was live birth at or after gestational age of 32 weeks, without a need for an IUT throughout the entire pregnancy.3 Safety was monitored for 24 weeks post-delivery for the 13 maternal individuals enrolled, and up to 96 weeks post-birth for infants.3 Participants received once-weekly intravenous infusions.3 The trial met the primary endpoint, with 54% of pregnant patients who received nipocalimab achieving a live birth at or after the gestational age (GA) of 32 weeks, without the need for an intrauterine transfusion throughout their entire pregnancy. About HDFN Hemolytic disease of the fetus and newborn (HDFN) is a rare disease (and in its severe form, even rarer) that arises in pregnancies with maternal-fetal incompatibility in certain red blood cell types. Alloantibodies produced by the maternal immune system against fetal red blood cells cross the placenta during pregnancy and attack fetal red blood cells causing fetal anemia or persist after birth in the neonate to cause neonatal hyperbilirubinemia and anemia.1 The symptoms of HDFN can range from mild jaundice, to neurotoxic hyperbilirubinema in the neonate, to life-threatening fetal anemia requiring invasive intervention.6 The potential for in utero onset at increasingly earlier gestational age with increasing risk of severe outcomes may occur with each incompatible pregnancy due to pregnancy-related alloimmunization.7 Currently no non-surgical interventions are approved for pregnancies at high risk of early-onset severe (EOS) HDFN in the U.S. Pregnancies affected by severe HDFN may necessitate repeated intrauterine transfusions (IUTs).8 IUTs are invasive, technically complex surgical procedures performed by specialists at specialized medical centers, and these procedures may be associated with an increased rate of fetal mortality and premature birth.9,10 The most difficult to treat cases of HDFN are those that develop before 24 weeks gestational age, defined here as EOS, due to high rates of IUT-related complications associated with mortality.11 According to the American Journal of Obstetrics and Gynecology, in the U.S., it is estimated that up to 80 of every 100,000 pregnancies are affected by HDFN each year.12 About Nipocalimab Nipocalimab is an investigational, high-affinity, fully human, aglycosylated, effectorless, monoclonal antibody that aims to selectively block FcRn to reduce levels of circulating immunoglobulin G (IgG) antibodies, including autoantibodies and alloantibodies that underlie multiple conditions.13 Nipocalimab is the only anti-FcRn being studied across three key segments in the autoantibody space: Rare Autoantibody diseases (e.g., generalized myasthenia gravis in adults and children, chronic inflammatory demyelinating polyneuropathy, warm autoimmune hemolytic anemia, and idiopathic inflammatory myopathies); Maternal Fetal diseases mediated by maternal alloantibodies (e.g., HDFN); and Prevalent Rheumatology (e.g., rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus).5,14,15,16,17,18,19,20,21 Blockade of FcRn has the potential to reduce overall autoantibody levels while preserving immune function without causing broad immunosuppression. Blockade of IgG binding to FcRn in the placenta is also believed to prevent transplacental transfer of maternal alloantibodies to the fetus.5,22 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson 2024. All rights reserved. Media contact: Bridget Kimmel Mobile: (215) 688-6033 [email protected] Investor contact: Raychel Kruper [email protected] SOURCE Johnson & Johnson

Strategic effort aims to bring stable, quality supply to providers and enhanced pricing predictability for critical labor and delivery drug CHARLOTTE, N.C. and DUBLIN, July 17, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) and Premier, Inc. (NASDAQ: PINC) announced today that Endo's Par Sterile Products business will supply Pitocin® (oxytocin injection, USP) vials through Premier's ProvideGx® and PremierProRx® programs. Pitocin® is used to induce labor in pregnant women. The product is on the World Health Organization's essential medications list and has a history of supply disruptions, which can result in potential health risks to mothers and babies, as well as costly delays in hospital labor and delivery wards. The partnership involves a multifaceted approach seeking to provide stable product supply through adequate safety stock on a long-term basis. "We're pleased to offer Pitocin® injection through the robust and highly reliable ProvideGx® and PremierProRx® supply channels," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "As a long-standing collaborator with Premier, we're proud to join the organization in helping to address drug shortages and serving as a reliable supplier of this labor and delivery product." "This initiative with Endo is yet another step forward to help eliminate drug shortages for our healthcare provider members, create increased market competition and promote more predictable, long-term prices," said Michael J. Alkire, President and CEO of Premier. "Both ProvideGx® and the PremierProRx® private label program are building a more diversified pharmaceutical market designed to create sustainable supply of a drug vital for maternal care and health in the U.S." Guided by health systems with more than 1,600 hospitals across the nation, Premier's ProvideGx® and PremierProRx® programs create long-term committed buying contracts with participating manufacturers—creating a steady demand signal and guaranteed buyer base in exchange for increasing production of generics in shortage, maintaining safety stocks or diversifying supply sources. These programs offer members access to more than 150 drugs that are or have been recently designated as shortage drugs, and have successfully helped resolve 14 drug shortages, resulting in their official delisting from the U.S. Food & Drug Administration's shortage list. With a stable supply of Pitocin®, Premier can continue efforts aimed at addressing factors that impact maternal and infant health outcomes, including the PINC AI™ Perinatal Improvement Collaborative that brings together more than 220 health systems in all 50 states using performance improvement tools and standardized data to measure outcomes and help identify the drivers of maternal mortality and morbidity. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Antepartum use of Pitocin is contraindicated in any of the following circumstances: Where there is significant cephalopelvic disproportion; In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery; In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; In fetal distress where delivery is not imminent; Where adequate uterine activity fails to achieve satisfactory progress; Where the uterus is already hyperactive or hypertonic; In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord; In patients with hypersensitivity to the drug. WARNINGS Pitocin, when given for induction of labor or augmentation of uterine activity, should be administered only by the intravenous route and with adequate medical supervision in a hospital. PRECAUTIONS All patients receiving intravenous oxytocin must be under continuous observation by trained personnel who have a thorough knowledge of the drug and are qualified to identify complications. Electronic fetal monitoring provides the best means for early detection of overdosage. When properly administered, oxytocin should stimulate uterine contractions comparable to those seen in normal labor. Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin. This fact must be considered by the physician in exercising his judgment regarding patient selection. Oxytocin should not be administered in the following conditions: fetal distress, hydramnios, partial placenta previa, prematurity, borderline cephalopelvic disproportion, and any condition in which there is a predisposition for uterine rupture, such as previous major surgery on the cervix or uterus including cesarean section, overdistention of the uterus, grand multiparity, or past history of uterine sepsis or of traumatic delivery. The decision can be made only by carefully weighing the potential benefits which oxytocin can provide in a given case against rare but definite potential for the drug to produce hypertonicity or tetanic spasm. Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths due to various causes have been reported associated with the use of parenteral oxytocic drugs for induction of labor or for augmentation in the first and second stages of labor. Oxytocin has been shown to have an intrinsic antidiuretic effect, acting to increase water reabsorption from the glomerular filtrate. Consideration should, therefore, be given to the possibility of water intoxication, particularly when oxytocin is administered continuously by infusion and the patient is receiving fluids by mouth. When oxytocin is used for induction or reinforcement of already existent labor, patients should be carefully selected. Pelvic adequacy must be considered and maternal and fetal conditions evaluated before use of the drug. ADVERSE REACTIONS The following adverse reactions have been reported in the mother: Anaphylactic reaction, postpartum hemorrhage, cardiac arrhythmia, fatal afibrinogenemia, nausea, vomiting, premature ventricular contractions, pelvic hematoma, subarachnoid hemorrhage, hypertensive episodes, and rupture of the uterus. The following adverse reactions have been reported in the fetus or neonate: Due to induced uterine motility: Bradycardia, premature ventricular contractions and other arrhythmias, permanent CNS or brain damage, fetal death, and neonatal seizures have been reported with the use of Pitocin. Due to use of oxytocin in the mother: Low Apgar scores at five minutes, neonatal jaundice, and neonatal retinal hemorrhage. DRUG INTERACTIONS Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia. Cyclopropane anesthesia may modify oxytocin's cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia. INDICATIONS AND USAGE Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. Postpartum: Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage. Please click for full Prescribing Information. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. About Premier, Inc. Premier, Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of more than 4,400 U.S. hospitals and health systems and approximately 250,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, N.C., Premier is passionate about transforming American healthcare. Please visit Premier's news and investor sites on ; as well as Twitter, Facebook, LinkedIn, YouTube, Instagram and Premier's blog for more information about the company. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Messrs. Sims and Alkire, any statements relating to product supply, reliability, availability or pricing, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect Endo's (the "Company's") current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. View original content to download multimedia: SOURCE Endo International plc Company Codes: NASDAQ-NMS:PINC, OTC-BB:ENDPQ, OTC-PINK:ENDPQ

92 percent of pregnancies treated with nipocalimab resulted in a live birth, with 54 percent delivering at or after 32 weeks without intrauterine transfusions1 SPRING HOUSE, Pa., June 26, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) hemolytic disease of the fetus and newborn (HDFN).1 A statistically significant (54 percent [n=7/13]) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs)1,a compared to the historic reference point of 10 percent, which was derived from published and unpublished data.2-5,b Among the seven participants who achieved the primary endpoint, the median gestational age at delivery was 37 and 1/7 weeks.6 This study demonstrates the potential for nipocalimab to help address the underlying disease mechanism of EOS HDFN.1 If approved, nipocalimab would be the first anti-neonatal Fc receptor (FcRn) treatment and the first approved non-surgical intervention for pregnancies at high risk of HDFN in the U.S.7 These data will be presented for the first time at the Fetal Medicine Foundation World Congress in Valencia, Spain on June 26, 2023.1 Janssen is planning a pivotal Phase 3 trial for nipocalimab in pregnancies at risk for severe HDFN. Nipocalimab is currently the only therapy reported in clinical development for the treatment of alloimmunizedc pregnant individuals at high risk of severe HDFN,7 a serious and rare condition which occurs when the blood types of a pregnant individual and the fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.8 "Pregnancies affected by HDFN currently experience a high treatment burden, such as repeated, invasive IUTs that require access to specialty care and put the life of the fetus at risk," said Kenneth J. Moise Jr., M.D., Professor, Department of Women's Health and Director, Comprehensive Fetal Care Center, at Dell Medical School of the University of Texas at Austin and lead study investigator.d "I find these data encouraging, as they suggest the possibility of providing families with an effective, non-surgical HDFN treatment option if approved." In the UNITY clinical trial, 12 of 13 participants experienced a live birth.1 Additional results show: In pregnancies that met the primary endpoint of a live birth at gestational age of or after 32 weeks without IUTs (54 percent; n=7/13), one infant required a simple (blood) transfusion.6,e In pregnancies requiring an IUT (n=6/13), all live-born infants (n=5/5) required a simple transfusion.1 Among the 12 live-born infants, one infant required an exchange (blood) transfusion.1,f The median gestational age at the first IUT was 28 and 3/7 weeks (range: 24 1/7 – 31 5/7 weeks) for those with live births.1 There were no reports of fetal hydrops.1,g Nipocalimab was generally well tolerated across all the dose groups studied in pregnant individuals at high risk for EOS HDFN: One pregnancy resulted in fetal demise due to complications following an IUT performed at gestational age 22 and 5/7 weeks.1 These complications were considered unrelated to nipocalimab.1 There were no maternal or infant deaths.1 The most frequently reported adverse events (AEs) were events that are not uncommonly reported in pregnancy or underlying HDFN.1 In the majority of participants, serious adverse events (SAEs [n=4]) were primarily related to HDFN or to various pregnancy-associated conditions and occurred with no discernible pattern or relationship to treatment with nipocalimab. Two participants who experienced live births demonstrated SAEs possibly related to nipocalimab.1 One participant experienced a subchorionic hematoma,h fetal growth restriction and fetal heart rate deceleration.1 The other participant experienced premature separation of the placenta.1 Neonatal and infant serum immunoglobulin G (IgG) approximated normal physiological nadirs at 24 weeks of age.1 Overall, in neonates/infants with maternal nipocalimab exposure, there were no unusual/unexpected childhood illnesses and infections reported in neonates/infants are generally those that are commonly seen during the neonatal period through infancy.1 Nipocalimab was shown to demonstrate an acceptable benefit-risk profile given the favorable efficacy results in the study, the significant unmet medical need with a potential for fetal/neonatal morbidity or mortality, and was overall well tolerated, supporting further clinical development for the treatment of HDFN.1 "I have both experienced and heard from others the profound and devastating impact of HDFN," said Katie Shanahan, Executive Director, Allo Hope Foundation.i "An approved treatment option for HDFN could offer hope to pregnant individuals and may provide an important alternative to an invasive medical procedure for overwhelmed families struggling to find the right care and treatment plan following an HDFN diagnosis." "There is a significant unmet need to help address the serious and life-threatening health consequences of HDFN. Our aspiration is to transform the existing paradigm for families who endure the consequences of HDFN by seeking approval of a targeted and effective therapy," said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Disease Area Leader, Janssen Research & Development, LLC. "These Phase 2 UNITY data in high-risk pregnancies demonstrated the important role that nipocalimab, an FcRn blocking antibody, may play in preventing the transfer of maternal alloantibodies through the placenta, thereby offering a potential treatment option for this devastating disease." Nipocalimab was granted Fast Track designation in July 2019 and orphan drug status in June 2020 by the U.S. Food and Drug Administration (FDA), and orphan medicinal product designation by the European Medicines Agency (EMA) in October 2019 for the prevention of HDFN.7,9,10 Editor's Notes a. Intrauterine transfusion: an invasive, technically complex surgical procedure performed by specialists to inject blood (red blood cells) from a donor to the fetus, usually through the umbilical cord, that may be associated with complications that could lead to morbidity, fetal mortality and premature birth.11,12 b. Historical reference point used in this study is based on data from published literature (n=51); and academic research centers with expertise in managing EOS HDFN, including the Fetal Center at Children's Memorial Hermann Hospital in Houston, Texas, U.S. (n=2); The Department of Maternal Fetal Medicine at Ohio State University in Columbus, Ohio, U.S. (n=4); and The University of Toronto Fetal Medicine program at Mount Sinai Hospital in Toronto, Canada (n=12).2-5 Across these 69 cases, all patients with prior EOS HDFN pregnancies required an IUT in subsequent at-risk pregnancies. A conservative benchmark of 10 percent of patients not requiring an IUT was chosen to account for uncertainties in the accuracy and representation of the underlying data.2 c. Alloimmunized: an immune response to foreign antigens upon exposure to genetically different cells or tissues.13 d. Dr. Kenneth Moise is a paid consultant for Janssen. He has not been compensated for any media work. e. Simple transfusion: a procedure wherein a patient receives blood from another blood donor.14 Neonates impacted by HDFN receive transfusions to treat severe anemia.10 f. Exchange transfusion: a procedure that removes most of the patient's blood (which contains the antigen-positive red blood cells) and replaces it with fresh donor blood or plasma that has a normal bilirubin level.15 Exchange transfusions are used in HDFN for neonates whose bilirubin levels continue to rise to treatable levels.15 Exchange transfusions are an invasive procedure with potentially severe side effects and risk of mortality.15 g. Fetal hydrops: a condition in which large amounts of fluid buildup in a baby's tissues and organs, causing extensive swelling (edema), and can be life-threatening.16 About half of unborn babies with hydrops do not survive.16 Fetal hydrops is a complication of HDFN, occurring when the mother's immune system causes a baby's red blood cells to break down.16 h. Subchorionic hematoma: bleeding that occurs beneath the placental chorion membranes which enclose the embryo in the uterus.17 It is believed to happen when the chorion membranes partially detach from the uterine wall.17 i. Katie Shanahan has not been compensated for any media work. About UNITY UNITY (NCT03842189) is a global, multicenter, open-label, non-blinded Phase 2 clinical trial designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab for the treatment of pregnant individuals at high risk for EOS HDFN.18 The trial enrolled RhD (D) or Kell (K) alloimmunized pregnant individuals with singleton pregnancies at high risk for EOS HDFN with an obstetric history of severe fetal anemia, fetal hydrops, or a stillbirth at ≤24 weeks gestation.1 In the trial, 13 participants with 14 pregnancies were enrolled.1 One pregnancy was included in the safety analysis but was not included in the efficacy analysis due to early elective abortion for a genetic disorder unrelated to HDFN at gestational age 17 weeks.1 Due to complications following an IUT that was performed at gestational age 22 and 5/7 weeks, one pregnancy resulted in fetal demise considered by the trial investigator to be unrelated to nipocalimab.1 Participants received once-weekly intravenous infusions.1 The primary endpoint was live birth at or after gestational age of 32 weeks, without a need for an IUT throughout the entire pregnancy.1 Safety was monitored for 24 weeks post-delivery for the 13 maternal individuals enrolled, and up to 96 weeks post-birth for infants.1 About HDFN Hemolytic disease of the fetus and newborn (HDFN) is a rare disease where maternal alloantibodies produced in a pregnant person's immune system cross the placenta and attack fetal red blood cells — causing fetal red blood cell hemolysis, leading to anemia.8 The symptoms of HDFN can range from mild to life threatening; some cases can involve neonatal jaundice or hyperbilirubinemia, and severe cases can result in life-threatening fetal anemia requiring intervention to prevent development of fetal hydrops.19 With every pregnancy with an antigen-positive fetus, disease severity increases with an earlier gestational age of HDFN onset due to repeated alloimmunization.20 There are currently no approved non-surgical interventions for pregnancies at high risk of EOS HDFN in the U.S., and pregnancies affected by severe HDFN may necessitate repeated IUTs.21 IUTs are invasive, technically complex surgical procedures performed by specialists at specialized medical centers, and these procedures may be associated with an increased rate of fetal mortality and premature birth.11,12 The most difficult to treat cases of HDFN are those that develop before 24 weeks gestational age, defined here as early-onset, due to the IUT-related higher procedural complication rate and related mortality.22 HDFN is categorized as a rare disease and the severe form is even rarer.8,10 According to the American Journal of Obstetrics and Gynecology, in the U.S., it is estimated that up to 80 out of every 100,000 pregnancies are affected by HDFN each year.23 About nipocalimab Nipocalimab is an investigational, high-affinity, fully human, aglycosylated, effectorless, monoclonal antibody that is believed to selectively block the FcRn to reduce levels of circulating IgG antibodies, including autoantibodies and alloantibodies that underlie multiple conditions.24 Nipocalimab is the only anti-FcRn being studied across three key segments in the autoantibody space: maternal-fetal diseases mediated by maternal alloantibodies (e.g., HDFN); rare autoantibody diseases (e.g., generalized myasthenia gravis in adults and children, chronic inflammatory demyelinating polyneuropathy, warm autoimmune hemolytic anemia, and idiopathic inflammatory myopathies); and prevalent rheumatological diseases (e.g., rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus).18,25-32 Blockade of FcRn by nipocalimab has the potential to reduce overall autoantibody levels while maintaining immune function. FcRn blockade is also believed to prevent placental transfer of maternal alloantibodies to the fetus.18,33 About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension. Learn more at . Follow us at . Janssen Research & Development, LLC is a part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. References Moise, K, et al. Safety and Efficacy of Nipocalimab in Pregnant Individuals at High Risk for Early-Onset Severe Hemolytic Disease of the Fetus and Newborn: Results from the Phase 2 UNITY Study. Oral Presentation at The Fetal Medicine Foundation World Congress, June 25-29. 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