Janssen Pharmaceuticals, Inc.

iStock, JHVEPhoto With Friday’s ruling by New Jersey District Judge Zahid Quraishi, Novartis joins a growing list of pharmaceutical companies that have failed in their legal challenges to the Inflation Reduction Act. A New Jersey court on Friday threw out Novartis ’ case against the Medicare Drug Price Negotiation Program, handing the Biden administration its latest victory in the legal battle over the Inflation Reduction Act. District Judge Zahid Quraishi wrote in his opinion that Novartis made “nearly identical constitutional challenges” to the negotiation program as other pharma companies, including Bristol Myers Squibb and Johnson & Johnson’s subsidiary Janssen Pharmaceuticals. The companies allege that the drug negotiation program, mandated by the Inflation Reduction Act (IRA), violates both the First and Fifth Amendments of the U.S. Constitution because it forces them to sell their personal property on the government’s terms, while compelling them to “promote the government’s preferred narrative that it is engaged in a negotiation.” However, Quraishi in his ruling on Friday reiterated that the court previously “found that participation in the program is voluntary,” and that it does not constitute a “physical taking of a manufacturer’s drugs.” The judge also ruled that the program does not force the companies’ speech in any way since any “speech” aspects of the program are “merely incidental mechanisms” of the negotiation. BMS and Janssen, which made similar arguments against the drug price negotiation program, lost their lawsuits in April 2024 . Quraishi also handled their cases. In addition to invoking the First and Fifth Amendments, Novartis also alleged that the IRA violates its Eighth Amendment rights because it imposes excessive fines. On this matter, Quraishi concluded that his court “lacks jurisdiction to resolve this claim” under the Anti-Injunction Act, which has a statute that prevents federal courts from prohibiting the Internal Revenue Service from assessing or collecting taxes. With Friday’s ruling, Novartis joins the growing list of pharma companies that have failed to challenge the government’s drug price negotiation under the IRA. In March 2024, Delaware District Judge Colm Connolly denied AstraZeneca’s motion for an injunction against the program, noting that the pharma has “no legitimate claim of entitlement to sell its drugs to the Government at any price other than what the Government is willing to pay.” In July 2024, the District Court of Connecticut ruled against Boehringer Ingelheim , maintaining that the program is voluntary and that companies are free to back out of it should they choose. Judge Michael Shea also recognized that the government “is free to use its economic power as a bulk purchaser of certain goods to negotiation better deals.” Novo Nordisk in August 2024 also lost its IRA case , with Quraishi reiterating his judgement in the BMS and Janssen cases. The drug price negotiation program “is neither a physical taking nor a per se taking of a manufacturer’s drugs,” he wrote at the time. However, the one ray of light for the industry’s legal challenge to the IRA rests on a lawsuit filed by the Pharmaceutical Research and Manufacturers of America. The Fifth Circuit Court of Appeals last month took the side of PhRMA , ruling that the district court has jurisdiction over the case and sending the trade group’s legal complaint back to a lower Texas court.

SAN FRANCISCO, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the appointment of Anil Kapur to its board of directors, effective October 15, 2024. Mr. Kapur has over 25 years of executive experience in pharmaceutical and biotech companies across both U.S. and international markets. “I am delighted to welcome Anil to the Nurix board as we enter this important stage in the company’s development and execute on our plan to advance NX-5948 into pivotal clinical testing in 2025 and prepare for future commercialization,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “Anil has an impressive record of commercial operations excellence and extensive experience launching novel drugs in hematology and oncology with direct relevance to Nurix’s pipeline, including the launch of blockbuster drugs Imbruvica and Darzalex while at Johnson & Johnson. I believe his strategic, marketing, sales and business development insights will be invaluable to Nurix in the years to come.” Mr. Kapur began his pharmaceutical executive career as Vice President, Commercial Leader Hematology Franchise at Janssen Pharmaceuticals, Johnson & Johnson’s global pharmaceutical strategy organization. As the J&J Joint Commercialization Committee Leader in partnership with Pharmacyclics, Mr. Kapur launched Imbruvica, the first BTK inhibitor for chronic lymphocytic leukemia, achieving an estimated $1 billion in sales within 18 months of launch. Mr. Kapur also led the J&J/Genmab joint commercialization committee and the global team that launched the transformational product Darzalex, the first biologic for multiple myeloma. “I am excited to join Nurix’s board of directors at this important time as NX-5948 is poised to enter pivotal trials and as we form the strategy for its commercialization,” said Mr. Kapur. “I believe Nurix’s targeted protein degrader drug pipeline has great potential to change the treatment landscape and help patients living with B cell malignancies and beyond.” As a senior leader in hematology and oncology in both small and large organizations, Mr. Kapur has been responsible for launching significant global brands, building and managing commercial capabilities, driving corporate strategy and managing alliances. Most recently, Mr. Kapur served as Executive Vice President, Corporate Strategy and Chief Commercial Officer at Geron Corporation from December 2019 to August 2024. Prior to Geron, Mr. Kapur served as Chief Commercial Officer at Actinium Pharmaceuticals, Inc., and as Vice President, Head of Early Assets, Biomarkers and External Innovation for Worldwide Oncology Commercialization at Bristol-Myers Squibb. Mr. Kapur is a member of the board of directors of Verastem, Inc., a late-stage development biopharmaceutical company. Mr. Kapur holds a BE in Mechanical Engineering from Birla Institute of Technology in India, an MS in Engineering from Louisiana Tech University, and an MBA from the Fuqua School of Business at Duke University. About Nurix Therapeutics, Inc.Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative small molecules and antibody therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer, inflammatory conditions, and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts, including, but not limited to, statements regarding the expected contributions Mr. Kapur will bring to Nurix, Nurix’s plans to advance NX-5948 into pivotal clinical testing in 2025, and the potential for Nurix’s targeted protein degrader drug pipeline to change the treatment landscape in B cell malignancies, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, the risks described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the period ended August 31, 2024, and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect Nurix’s business and results of operations, which could, in turn, have a significant and adverse impact on Nurix’s stock price. Nurix cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nurix undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events. Contacts: InvestorsJason Kantor, Ph.D.Nurix Therapeutics, Inc.ir@nurixtx.com Elizabeth Wolffe, Ph.D.Wheelhouse Life Science Advisorslwolffe@wheelhouselsa.com MediaAljanae ReynoldsWheelhouse Life Science Advisorsareynolds@wheelhouselsa.com

TREMFYA ® is now U.S. FDA-approved for ulcerative colitis and under review for Crohn’s disease TREMFYA ® is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in the overall population of patients with Crohn’s disease, inclusive of those who are biologic-naïve and biologic-refractory Ninety percent more biologic-naïve patients and three times more biologic-refractory patients with ulcerative colitis achieved endoscopic remission with TREMFYA ® VIENNA, Austria I October 10, 2024 I Johnson & Johnson (NYSE: JNJ ) today announced TREMFYA ® (guselkumab) data in both Crohn’s disease (CD) and ulcerative colitis (UC) showing high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients (including UC patients refractory to JAK inhibitors), indicating a normal appearance of intestinal mucosa. 1,2 These subgroup analyses are from pooled data from the Phase 3 GALAXI 2 & 3 studies of TREMFYA ® in adults with moderately to severely active CD and the Phase 3 QUASAR maintenance study of TREMFYA ® in adults with moderately to severely active UC. These findings are among 19 Johnson & Johnson abstracts being presented at the United European Gastroenterology (UEG) Week 2024. TREMFYA ® is under review for the treatment of adults with moderately to severely active UC and CD by the European Medicines Agency (EMA). “These results show the potential of TREMFYA to offer a differentiated treatment option for patients with CD and UC, including those starting on a biologic for the first time, and those who have failed prior biologics and traditionally have been less likely to respond to other therapies,” stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “TREMFYA builds upon our nearly three decades of leadership in IBD therapy and focused innovation in the IL-23 pathway to address the needs of people living with ulcerative colitis and delivering meaningful improvements in symptoms and the potential for sustained remission.” Endoscopic remission in biologic-naïve patients In the pooled Phase 3 GALAXI 2 & 3 dataset, TREMFYA ® demonstrated greater rates of endoscopic remission compared to ustekinumab at Week 48 in biologic-naïve patients with CD. Endoscopic remission was achieved in 44% of patients treated with TREMFYA ® 100 mg every eight weeks (q8w) subcutaneous (SC) injection and 46.1% of patients treated with TREMFYA ® 200 mg every four weeks (q4w) SC injection, versus 29.8% of patients treated with ustekinumab. 1 In the Phase 3 QUASAR study, TREMFYA ® demonstrated greater rates of endoscopic remission compared to placebo at Week 44 in biologic/JAK inhibitor-naïve patients with UC. Endoscopic remission was achieved in 38.1% of patients treated with TREMFYA ® 100 mg q8w SC injection and 41.7% of patients treated with TREMFYA ® 200 mg q4w SC injection, versus 20.4% of patients treated with placebo. 2 Endoscopic remission in patients with a history of inadequate response or intolerance to biologics/JAK inhibitors In the pooled Phase 3 GALAXI 2 & 3 dataset, TREMFYA ® demonstrated greater rates of endoscopic remission compared to ustekinumab at Week 48 in biologic-refractory patients with CD. Endoscopic remission was achieved in 28.1% of patients treated with TREMFYA ® 100 mg q8w SC injection and 28.6% of patients treated with TREMFYA ® 200 mg q4w SC injection, versus 20.5% of patients treated with ustekinumab. 1 In the Phase 3 QUASAR study, TREMFYA ® demonstrated greater rates of endoscopic remission compared to placebo at Week 44 in biologic/JAK inhibitor-refractory patients with UC. Endoscopic remission was achieved in 31.2% of patients treated with TREMFYA ® 100 mg q8w SC injection and 23.9% of patients treated with TREMFYA ® 200 mg q4w SC injection, versus 8% of patients treated with placebo. 2 Results from these studies reinforce the well-established safety profile of TREMFYA ® including in the treatment of patients with UC and CD. For a full list of abstracts presented please click here. TREMFYA ® received U.S. Food and Drug Administration (FDA) approval in September 2024 for the treatment of adults with moderately to severely active UC and an application for the treatment of moderately to severely active CD is currently under FDA review. Regulatory applications seeking approval of TREMFYA ® for the treatment of adults with moderately to severely active UC and for the treatment of adults with moderately to severely active CD have been submitted in Europe. ABOUT THE GALAXI PROGRAM ( NCT03466411 ) GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab). 3 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3). 1 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years. Patients received guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg subcutaneous maintenance every 4 weeks; or guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg subcutaneous maintenance every 8 weeks; or a biologic active control; or placebo. Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. Of the 873 individuals pooled across the GALAXI 2 & 3 dataset, 456 (52 percent) had prior history of inadequate response to biologics, 365 (41.8 percent) were biologic-naïve and 52 (6 percent) were biologic experienced without documented inadequate response or intolerance. 1 The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in CD. Data from GALAXI 2 & 3 showed guselkumab was superior to ustekinumab in all pooled endoscopic endpoints. ABOUT THE QUASAR STUDY ( NCT04033445 ) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of guselkumab in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). 4 QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the induction study, patients received either guselkumab 200 mg or placebo by intravenous infusion at Week 0, Week 4, and Week 8. In the maintenance study, patients received a subcutaneous maintenance regimen of either TREMFYA 100 mg every 8 weeks, guselkumab 200 mg every 4 weeks, or placebo. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points. Of the 568 individuals included in the QUASAR maintenance study, 240 (42.3 percent) had a history of inadequate response or intolerance to biologics or JAK inhibitors, 309 (54.4 percent) were biologic/JAK inhibitor naïve, and 19 (3.3 percent) were biologic/JAK inhibitor experienced without documented inadequate response or intolerance. 3 ABOUT CROHN’S DISEASE Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe. 5,6 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. 7 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. ABOUT ULCERATIVE COLITIS Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system’s overactive response. 8 Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue. People with UC also have increased rates of depression. 6 ABOUT TREMFYA ® (guselkumab) Developed by Johnson & Johnson, TREMFYA ® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA ® is a prescription medicine approved in the U.S. to treat: TREMFYA ® is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA ® . For more information, visit: www.tremfya.com . Please read the full Prescribing Information , including Medication Guide , for TREMFYA ® and discuss any questions that you have with your doctor. Dosage Forms and Strengths: TREMFYA ® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA ® PEN) for subcutaneous injection, and a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT STELARA ® (ustekinumab) STELARA ® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is a prescription medicine approved in the United States to treat: The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA ® . Please click to read the full Prescribing Information and Medication Guide for STELARA ® and discuss any questions you have with your doctor. 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 https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine . Follow us at @JNJInnovMed . Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen-Cilag International NV are Johnson & Johnson companies. 1 Danese S, et al. Week 48 efficacy of guselkumab and ustekinumab in Crohn’s disease based on prior response/exposure to biologic therapy: Results from the GALAXI 2 & 3 Phase 3 Studies. Poster presentation (Abstract MP672) at United European Gastroenterology Week 2024. October 2024. 2 Allegretti JR, et al. The efficacy of maintenance treatment with guselkumab in patients with moderately to severely active ulcerative colitis: Phase 3 QUASAR maintenance study results at Week 44 by biologic/Janus kinase inhibitor history. Oral presentation (Abstract OP082) at United European Gastroenterology Week 2024. October 2024. 3 National Institutes of Health: Clinicaltrials.gov. A study of the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease (GALAXI). Identifier: NCT03466411. Available at: https://clinicaltrials.gov/study/NCT03466411 . Accessed September 2024. 4 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. https://classic.clinicaltrials.gov/ct2/show/NCT04033445 . Accessed September 2024. 5 Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: www.crohnscolitisfoundation.org/what-is-crohns-disease/overview . Accessed September 2024. 6 Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78. 7 Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes . Accessed September 2024. 8 Crohn’s & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis . Accessed April 2024. 9 TREMFYA ® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed September 2024. 10 STELARA® Prescribing information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf Accessed September 2024. SOURCE: Johnson & Johnson