PRINCETON, NJ & BOSTON, MA - Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired. The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.

Karuna is a biopharmaceutical company driven to discover, develop and deliver transformative medicines for people living with psychiatric and neurological conditions. Karuna’s lead asset, KarXT (xanomeline-trospium), is an antipsychotic with a novel mechanism of action (MoA) and differentiated efficacy and safety. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults was accepted for review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease. Bristol Myers Squibb believes KarXT represents a significant revenue contribution opportunity. Bristol Myers Squibb also sees potential from Karuna’s early-stage and pre-clinical pipeline.

“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space. We expect KarXT to enhance our growth through the late 2020s and into the next decade,” said Christopher Boerner, Ph.D., Chief Executive Officer of Bristol Myers Squibb. “This transaction fits squarely within our business development priorities of pursuing assets that are strategically aligned, scientifically sound, financially attractive, and have the potential to address areas of significant unmet medical need. We look forward to welcoming the talented Karuna team to Bristol Myers Squibb.”

“Schizophrenia and Alzheimer’s disease psychosis affect millions of people worldwide, with limited to no treatment options. KarXT’s novel mechanism has resulted in a transformational profile in schizophrenia, with compelling efficacy and a differentiated safety profile,” said Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Drug Development of Bristol Myers Squibb. “KarXT also has the potential to deliver meaningful benefits to patients as an adjunctive treatment for patients with schizophrenia and as a first treatment for Alzheimer’s disease psychosis.”

Bill Meury, President and Chief Executive Officer of Karuna Therapeutics, said, “Karuna’s portfolio offers advancements in treatment not seen in many years. With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale and legacy in neuroscience, KarXT and the other assets in our pipeline will be well-positioned to reach those living with schizophrenia and Alzheimer’s disease psychosis. This announcement is a testament to the Karuna team’s talent, hard work, and innovation.”

Delivering Meaningful Benefits to Patients with KarXT

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. KarXT has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments, including weight gain, extrapyramidal symptoms, increased prolactin levels, akathisia and/or sedation.

Given this differentiated profile, KarXT has meaningful and expanding revenue potential in schizophrenia and with upside in additional indications and geographies:

• Schizophrenia: KarXT is expected to launch in late 2024 in the U.S. as a treatment for schizophrenia in adults. There are approximately 1.6 million¹ people treated for schizophrenia in the U.S., a significant portion of whom do not respond to currently available therapies and experience unacceptable side effects.
• Adjunctive schizophrenia: A registrational clinical trial is currently underway evaluating KarXT as adjunctive treatment with current standard of care agents for the treatment of schizophrenia, with data expected in 2025.
• Alzheimer’s disease psychosis: Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026. There are more than 6 million² people living with Alzheimer’s disease in the U.S. There are currently no approved treatments for Alzheimer’s disease psychosis.
• Additional indications: Bristol Myers Squibb believes KarXT also has potential in additional indications, including Bipolar I disorder, which impacts approximately 1.4 million¹ people in the U.S., and Alzheimer’s disease agitation.

The transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.30 in 2024 from the financing cost of the transaction, as Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued resource allocation, cost efficiencies and portfolio prioritization. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction. Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance. Bristol Myers Squibb’s cash flows and strong financial profile enable continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases.

Transaction Terms and Financing

Under the terms of the merger agreement, Bristol Myers Squibb will acquire all outstanding shares of Karuna common stock for $330.00 per share in cash representing an approximately 53% premium to Karuna Therapeutic’s closing stock price on December 21, 2023, for a total equity value of approximately $14.0 billion, or $12.7 billion net of estimated cash acquired.

The transaction is expected to close in the first half of 2024, subject to customary closing conditions, including approval of Karuna stockholders and receipt of required regulatory approvals.

DUBLIN - Theravance Biopharma, Inc. ("Theravance" or the "Company") (NASDAQ: TBPH) today announced the appointment to its Board of Directors of Jeremy Grant, who serves as a Special Advisor to Irenic Capital Management LP ("Irenic"). With the addition of Mr. Grant, Theravance has appointed four new directors to the Board since 2020. 

"We are pleased to welcome Jeremy to the Theravance Board as a new independent director," said Rick E Winningham, Chairman and CEO of Theravance. "Jeremy's appointment underscores that Theravance values the perspectives of its investors and that the Board and management team are focused on our shared goal of maximizing value for shareholders. We look forward to benefitting from Jeremy's financial background and perspectives as a seasoned investor." 

"I am excited to join the Theravance Board at this time," said Mr. Grant. "Theravance is operating from a position of strength, and I look forward to working with my fellow directors to deliver value to shareholders." 

With the appointment of Mr. Grant, the Theravance Board will temporarily increase to 10 directors. As previously announced, Dr. Burton Malkiel has informed the Company that he does not intend to stand for re-election at the 2024 Annual General Meeting of Shareholders (the "2024 AGSM"), which is scheduled for May 8, 2024. Following the 2024 AGSM, the Board will comprise nine directors, eight of whom are independent. 

In connection with today's announcement, Theravance has entered into a cooperation agreement (the "Agreement") with Irenic. Pursuant to the agreement, Irenic has agreed to customary standstill and voting commitments, among other provisions. The Agreement will be filed on a Current Report on Form 8-K with the U.S. Securities and Exchange Commission (the "SEC"). 

"We appreciate the productive discussions we've had with Irenic and are pleased to have reached this agreement," Mr. Winningham continued. "Since mid-2022, we have returned over $300 million to shareholders, reduced shares outstanding by approximately 35%, eliminated debt, enhanced governance, progressed ampreloxetine into Phase 3 and grown YUPELRI sales while streamlining our expense base. Theravance is committed to maximizing shareholder value and plans to maintain our disciplined approach to expense management and implement cost-cutting initiatives within G&A. As we did earlier this year in increasing our capital return program from $250 million to $325 million, our Board is pleased to reaffirm our commitment to return all excess capital to shareholders through repurchases or dividends." 

"Irenic invested in Theravance because we believe Rick and the team are well-positioned to complete the Phase 3 trial of ampreloxetine successfully and deliver value to shareholders from its market-leading respiratory portfolio," said Adam Katz, Co-founder and Chief Investment Officer of Irenic. "We believe Theravance is committed to operating in a disciplined manner and delivering enhanced value to shareholders." 

About Jeremy Grant 

Mr. Grant is the Founder and Managing Partner of Harbor Ridge LP, an investment firm, and a Special Advisor to Irenic Capital Management LP. He was previously an Associate Portfolio Manager at Elliott Management Corporation. Prior to Elliott, he worked as an investment professional at Oak Hill Advisors and as an analyst at Credit Suisse. Mr. Grant currently serves on the board of directors of Acosta Inc. and as an observer of the board of directors of Arconic Corporation. He is a CFA charterholder and graduated from the Wharton School at the University of Pennsylvania with a B.S. in Economics. 

About Theravance Biopharma 

Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension, has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in multiple system atrophy patients. The Company is committed to creating/driving shareholder value. 

For more information, please visit www.theravance.com. 

TAMPA, FL - Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that its Board of Directors (the “Board”) has appointed Frank D. Lee as Chief Executive Officer and a member of the Board, effective January 2, 2024. As previously announced in September 2023, David Stack will retire from his roles as Chief Executive Officer and Chairman of the Board, effective January 1, 2024, and will remain with the company through August 2025 in an advisory capacity to help ensure a smooth transition. In connection with Mr. Stack’s retirement, the Board has elected Paul Hastings, Lead Independent Director, as Chair of the Board, also effective January 2, 2024.

Mr. Lee brings more than three decades of global experience and a strong track record of product development and commercial leadership success across a wide range of therapeutic areas within the biotech and pharmaceutical industry. Most recently he served as Chief Executive Officer and member of the board of directors of Forma Therapeutics from March 2019 through its acquisition by Novo Nordisk in October 2022. During his tenure at Forma, Mr. Lee transformed the company from an early-stage drug discovery company into one focused on the clinical development of lead assets in rare hematologic disorders and cancer.

“Following a comprehensive executive search process, we are delighted to welcome Frank as our new CEO and are confident he is the ideal leader for our next phase of growth and value creation,” said Paul Hastings, Chair elect of Pacira BioSciences, Inc. “Frank is a proven leader who has distinguished himself over the course of his career as a disciplined executive with a focus on revenue growth and cost management, having built successful patient-focused organizations driving product growth to blockbuster and multi-blockbuster status across a wide range of therapeutics areas and treatment settings. He has a proven ability to forge partnerships with key stakeholders and to deliver creative solutions that provide value and improve patients’ lives. We believe he has the relevant skills and experience to continue the execution of our strategy to maximize shareholder return and unlock the significant untapped potential within our best-in-class opioid-sparing commercial portfolio.”

“I am excited to join Pacira to continue advancing the company’s important mission to expand patient access to non-opioid pain management,” said Mr. Lee. “The efforts that Dave and his team have made establishing Pacira as a leader in opioid-sparing innovation are exceptional and I am eager to work with the team to capitalize on the significant opportunities ahead. I look forward to working closely with Dave to ensure a smooth transition, and to partnering with the entire Board and leadership team to build upon our strong foundation and deliver value for all Pacira stakeholders.”

Mr. Hastings concluded, “On behalf of the entire Board, I want to thank Dave for his visionary leadership and numerous contributions to Pacira. As CEO for the last 16 years, Dave has transformed Pacira into a leader in non-opioid pain management and positioned the company for future success. We wish him the best in his well-deserved retirement.”

Prior to Forma, Mr. Lee most recently served as Senior Vice President, Global Product Strategy and Therapeutic Area Head for Immunology, Ophthalmology and Infectious Diseases at Genentech, a member of the Roche Group. At Genentech, he was responsible for driving development and commercial strategy for a broad portfolio of molecules in development and for global in-line product sales of more than $11 billion. His 13-year career path at Genentech included leadership positions of increasing scope and responsibility for delivering transformative medicines to patients.

Prior to joining Genentech, Mr. Lee spent approximately 13 years across Novartis, Janssen and Eli Lilly in engineering, manufacturing, sales/marketing and business development. Mr. Lee received a bachelor’s degree in chemical engineering from Vanderbilt University and an MBA in marketing and finance from the Wharton Graduate School of Business. He currently serves as executive chairman of the board of directors of privately held Therini Bio, Inc. and chairman of the board of privately held Catamaran Bio, Inc. He is also a member of the board of directors of Bolt Biotherapeutics, Inc. (Nasdaq: BOLT).

On December 20, 2023, in connection with Mr. Lee’s appointment as Chief Executive Officer, the Board approved the grant of inducement awards to Mr. Lee. The awards were made pursuant to the Pacira BioSciences, Inc. Amended and Restated 2014 Inducement Plan, which was approved by the Board without stockholder approval pursuant to, and in compliance with, Rule 5635(c)(4) of the Nasdaq Listing Rules.

Mr. Lee’s inducement awards included (i) a non-qualified stock option to purchase an aggregate of 692,512 shares of Pacira’s common stock with an exercise price per share equal to the closing price of Pacira’s common stock as reported on the Nasdaq Global Select Market on January 3, 2024, and, subject to continued service with Pacira as of each vesting date, such option will vest and become exercisable as to 25% of the option shares on January 3, 2025, and vest as to the remaining shares in successive equal quarterly installments over the subsequent three years, and (ii) a restricted stock unit award for 99,520 shares of Pacira’s common stock, subject to continued service with Pacira as of each vesting date, to vest in four equal annual installments beginning on January 2, 2025, in each case, pursuant to the terms and provisions of the Inducement Plan.

RAHWAY, NJ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.

“Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease. We look forward to discussing the data that support our filing with the FDA and are working with urgency to bring this potential new preventative measure to adult patients.”

The BLA for V116 is based, in part, on data from STRIDE-3, a pivotal Phase 3 trial which evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine. Results from the STRIDE-3 trial were presented at the World Vaccine Congress West Coast in November 2023. The BLA for V116 is supported by results from multiple Phase 3 clinical studies evaluating V116 in both vaccine-naïve and vaccine-experienced adult patient populations, including STRIDE-3, STRIDE-4, STRIDE-5 and STRIDE-6. Results from additional trials will be shared with the scientific community at future congresses. An overview of the V116 late-stage development program is available here.

According to CDC data from 2018-2021, the serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older. V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines, which were responsible for approximately 30% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data.

DEERFIELD, IL - Baxter International Inc. (NYSE:BAX), an innovative leader in infusion therapies and technologies, announced the completion of the first phase of its intravenous (IV) bag recycling program pilot. Launched in conjunction with Northwestern Medicine, a premier integrated academic health system in Chicago, more than six tons (or 12,000 pounds) of polyvinyl chloride (PVC) IV bag waste — enough to cross the city of Chicago if bags were laid end-to-end — has been successfully diverted from landfill to be recycled for a useful second life. This program is the first of its kind to launch in the U.S.

“Across the country, hundreds of thousands of IV bags are used every day. Baxter is a proud manufacturer and supplier of these bags, which are ubiquitous in hospital care—particularly single-use plastic containers that provide patients clinically essential solutions including fluids, nutrition and medicines,” said Cecilia Soriano, president of Baxter’s Infusion Therapies and Technologies division. “In line with Baxter’s commitments as a responsible corporate citizen, we believe this pilot helps pave the way for meaningful, long-term waste reduction.”

Unlike other medical equipment products such as syringes and needles, which have established post-use collection methods, standard practice for non-hazardous IV bag removal includes draining of residual fluid and disposing as waste that ultimately ends up in a landfill. Through this pilot program, stakeholders from several Northwestern Memorial Hospital departments — including nursing, supply chain and environmental services — were engaged to help develop a new process that enables the incorporation of material separation for recycling into nursing workflow while also managing space constraints common to hospital settings. With dedicated third-party logistics and recycling partners, collected IV bags are transported and inspected to ultimately be recycled into products such as industrial floor mats and protective edging for docks and landscaping. All IV bags involved in this pilot were made of PVC, one of the most widely used plastic materials in medical products.

“We are proud to pilot this program with Baxter to be the first health system in the nation to begin recycling PVC IV bags,” said Jeff Good, Northwestern Medicine’s first chief sustainability executive and vice president of operations. “What started as a single-unit pilot is now standard practice across several of our inpatient units within Northwestern Memorial Hospital and has resulted in the recycling of more than 170,000 IV bags. Our health system understands the environmental importance of this pilot program and we are dedicated to creating initiatives that support our overarching sustainability goals to reduce our carbon footprint and eliminate unnecessary waste.”

As a company focused on waste reduction, Baxter’s objective for the pilot’s first phase was to establish proof of concept for a program that assists hospitals in recycling plastic IV bags manufactured by Baxter. Following the successful conclusion of the pilot phase, Northwestern Medicine will continue to implement the program and will explore expanding the program throughout the health system. Baxter is now actively seeking to engage additional health system participants in the Chicago area to further validate the process and economic feasibility. Doing so will support long-term, large-scale implementation with potential roll out to other health systems across the country.

This program builds on Baxter’s innovative experiences partnering with hospitals and waste collection companies outside of the U.S. to recycle valuable materials at the end of product life. In recent years, Baxter has introduced several programs to facilitate recycling for patients and hospitals in Australia, New Zealand, Guatemala and Colombia.
 

CHICAGO, IL - Long Grove Pharmaceuticals, LLC, a manufacturer of differentiated pharmaceuticals, is filling a critical supply shortage of Fluorescein Injection, USP. In June 2023, Long Grove Pharmaceuticals acquired the New Drug Application (NDA) for AK-FLUOR. The company has reached a distribution agreement with the Food and Drug Administration (FDA) Office of Drug Shortages to make available existing inventory of AK-FLUOR, Fluorescein Injection, USP manufactured by Akorn Pharmaceuticals. 

AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. It is currently available in the following presentations:

• 10% (100mg/mL 5mL vials) 12 pack
• 25% (250mg/mL 2mL vials) 12 pack

Fluorescein Injection, USP is currently impacted by a supply shortage resulting from Akorn Pharmaceuticals’ exit from the U.S. market. To ensure the consistent availability of Fluorescein Injection, USP prior to its relaunch as a Long Grove Pharmaceuticals product, Long Grove Pharmaceuticals will make available the existing AK-FLUOR inventory manufactured by Akorn Pharmaceuticals in both 10% and 25% solutions.

“Our goal is to provide the market a consistent supply of this essential medication now and after its relaunch as a Long Grove-labeled product,” said Peter Karas, Chief Commercial Officer at Long Grove Pharmaceuticals. “Until we can fill the gap in supply through our own manufacturing, the existing Akorn-manufactured product will assist in easing procurement burdens for ophthalmic providers and health systems.”

For more information about Long Grove Pharmaceuticals and AK-FLUOR, visit www.longgrovepharma.com.

CHICAGO, IL - Long Grove Pharmaceuticals, LLC, a manufacturer of differentiated pharmaceuticals, is expanding its product offerings through a strategic in-licensing of Cyclophosphamide for Injection, USP from Sunny Pharmtech, Inc. Cyclophosphamide for Injection, USP will be manufactured by Sunny Pharmtech, Inc. in Taiwan. The product is an APrated generic product and Trade Agreement Act (TAA) compliant. 

Cyclophosphamide for Injection, USP is an antineoplastic chemotherapy medication that slows the growth of cancer cells. It is used to treat multiple malignant diseases, including blood cancers and solid tumors. Sunny Pharmtech, Inc. received Food and Drug Administration (FDA) approval for the drug through an Abbreviated New Drug Application (ANDA) in October 2023. It is currently available in 500 milligram, 1 gram and 2 gram dry powder vials. 

“Our team at Long Grove Pharmaceuticals has a long history of collaboration with Sunny Pharmtech, Inc,” said Peter Karas, Chief Commercial Officer at Long Grove Pharmaceuticals. “This current opportunity to jointly offer cyclophosphamide continues our commitment to improving customer choice by increasing access to generics.” 

“Our partnership with Long Grove Pharmaceuticals helps ensure we can successfully bring cyclophosphamide to market in the U.S.,” said Yon-Lian Wu, Ph.D., Founder, Chairman and Chief Executive Officer at Sunny Pharmtech, Inc. “We’re excited about the launch of cyclophosphamide, but also by the continued opportunity to collaborate on pharmaceutical products that save and improve lives.” 

For more information about Long Grove Pharmaceuticals and Cyclophosphamide for Injection, USP, visit www.longgrovepharma.com.

SAN MATEO, Calif.SAN MATEO, CA -  (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication of a quantitative market research study evaluating current U.S. physician anticoagulation use during continuous renal replacement therapy (CRRT) in patients with acute kidney injury in the intensive care unit.  The only FDA-approved anticoagulant for dialysis circuits is heparin, which has a half-life of 1-3 hours. Heparin is therefore classified as a "systemic" anticoagulant, as it circulates back into the patient from the dialysis circuit, resulting in anticoagulation of the patient, which is often dangerous. The FDA has given an Emergency Use Authorization (EUA) to citrate, which is classified as a "regional" anticoagulant, as its effect is reversed with a calcium infusion that is administered to the patient, therefore limiting its anticoagulant effect to the circuit.

The publication, entitled "Anticoagulation Practices for Continuous Renal Replacement Therapy: A Survey of Physicians from the United Statesthe United States," is lead authored by Dr. David BoldtDavid Boldt, and published in the journal Renal Failure.  Dr. Boldt is an Associate Professor at the University of California, Los Angeles School of Medicine,University of California Critical Care Intensivist and Division Chief of Trauma and Adult Multi-Specialty Anesthesiology. In the study, a total of 150 U.S. board-certified physicians consisting of critical care medicine specialists (n=80) and nephrologists (n=70) who specialize in CRRT were surveyed by MedSurvey from November to December 2022 regarding their current CRRT anticoagulation practices.

This study resulted in a number of key findings:

• CRRT machine use increased by approximately 30% from pre-pandemic era to late 2022.
• On average, physicians use heparin in the CRRT circuit for 43% of patients, with citrate being used in 28% of patients and no anticoagulation used in 29% of patients.
• The top reason for use of heparin is that it is readily available, but concerns with heparin included systemic bleeding and heparin-induced thrombocytopenia, which were ranked 3.5 and 3.4 respectively, on a 1-5 scale of "not challenging" to "very challenging".
• Hypocalcemia (52% of physicians) and citrate safety (42% of physicians) were ranked as the top two reasons for not using citrate in heparin-intolerant patients. Physicians who do use citrate reported that hypocalcemia occurs in 37% of patients.
• When no anticoagulation is used in the CRRT circuit, 84% of physicians stated filter clogging was a problem and almost a quarter of the physicians stated an increase in transfusions was required as a result.

Study limitations include that the study was an online survey; however, physicians had to pass eight screening questions to ensure they were board-certified in critical care medicine or nephrology, worked in an ICU, and were familiar with the protocols and logistics of CRRT use in their hospital.

"It is clear from this study that physicians in charge of CRRT at their institutions are not completely satisfied with the currently available anticoagulants, heparin and citrate, for use in the dialysis circuit," stated Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. "Niyad as a potentially new regional anticoagulant for patients who cannot tolerate heparin could provide a meaningful improvement to the current standard of care in this field. Allowing physicians to avoid the complexities associated with citrate and reducing the number of patients who receive no anticoagulation by offering a new alternative can hopefully improve the quality of CRRT for these very fragile patients."

Dr. Boldt states, "We really don't have any great choices as it relates to CRRT anticoagulation, which is why I am excited about the potential approval of Niyad as a new anticoagulant option. Nafamostat's ultra short half-life of 8 minutes and its limited systemic effect could really change how we approach anticoagulation of CRRT circuits. Heparin is fraught with potentially significant, and often life-threatening, complications such as systemic bleeding and heparin-induced thrombocytopenia, as well as heparin resistance, all of which make using heparin challenging in many patients." Dr. BoldtDr. Boldt continues, "While citrate avoids the risk of systemic bleeding, its complicated administration protocol, requirement for a calcium infusion, frequent testing of calcium levels, and citrate toxicity risks can lead many clinicians to avoid its use altogether."

AcelRx provided funding to conduct the study. Some of the authors, including Dr. BoldtDr. Boldt, are consultants for AcelRx but were not paid for their contributions to this manuscript.

NEW YORK, NY - Pfizer Inc. (NYSE: PFE) today announces that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, expired December 11, 2023, with respect to Pfizer’s pending acquisition of Seagen Inc. (NASDAQ: SGEN). Pfizer and Seagen have now received all required regulatory approvals to complete the acquisition. Pfizer expects to close the acquisition of Seagen on December 14, 2023, subject to the satisfaction of other customary closing conditions.

To address U.S. Federal Trade Commission concerns, Pfizer has chosen to irrevocably donate the rights of royalties from sales of Bavencio® (avelumab) in the U.S. to the American Association for Cancer Research (AACR). This unrestricted donation will support AACR in its mission to prevent and cure cancer through research, education, communication, collaboration, science policy, and funding for cancer research.

Changes in Commercial Organization
Pfizer also announces changes in its commercial organization to incorporate Seagen and improve focus, speed and quality of execution. Specifically, Pfizer will create an end-to-end business organization called the Pfizer Oncology Division, which will integrate certain oncology commercial and R&D operations from both companies and will be led by Dr. Chris Boshoff, who will become Chief Oncology Officer, Executive Vice President, and continue reporting to Dr. Albert Bourla, Chairman and Chief Executive Officer. Pfizer will split its non-oncology commercial organization into two more focused business divisions: the Pfizer U.S. Commercial Division, which will be led by Aamir Malik, who will become Chief U.S. Commercial Officer, Executive Vice President, and continue reporting to Dr. Bourla; and the Pfizer International Commercial Division, which will be led by Alexandre de Germay, who will join Pfizer as Chief International Commercial Officer, Executive Vice President, and will report to Dr. Bourla. Biographical information for Alexandre de Germay can be found here.

While these three leaders will begin transitioning to their new roles immediately after the completion of the Seagen acquisition, the new organization structure will go into effect January 1, 2024.

After a stellar nearly 27-year career at Pfizer, Angela Hwang, Chief Commercial Officer, and President, Global Biopharmaceuticals Business will be leaving Pfizer. Angela has agreed to stay on as an advisor to help transition the organization into the new model. Under Angela’s leadership, Pfizer introduced an unprecedented number of new medicines and vaccines to patients across the globe.

“The completion of all regulatory reviews in association with the Seagen acquisition supports our belief that this transaction is good for patients in the battle against cancer,” said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. “With the anticipated Seagen closing in the coming days, Pfizer has announced changes to the company’s commercial structure designed to maximize the impact of this transaction and enhance our commercial execution across all the company’s therapeutic areas. I also want to thank Angela Hwang and celebrate her vast achievements and the unforgettable legacy she leaves behind. Angela is a purpose-driven leader, and her focus has consistently been on working to bring more breakthroughs to patients around the world.”

Invitation to Public Webcast to Discuss Seagen Acquisition and Provide Full-Year 2024 Financial Guidance
Separately, Pfizer invites investors and the general public to view and listen to a webcast of a live conference call with investment analysts at 8:30 a.m. EST on Wednesday, December 13, 2023. During the call Pfizer will discuss the Seagen acquisition, new commercial organization, and provide full-year 2024 financial guidance.

To view and listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance of the conference call.

You can also listen to the conference call by dialing either (800) 456-4352 in the United States and Canada or (785) 424-1086 outside of the United States and Canada. The passcode is 70115.

The transcript and webcast replay of the call will be made available on our web site at www.pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.

PARIS - Sanofi is disappointed with the Federal Trade Commission’s announcement that it is seeking a preliminary injunction against a proposed licensing agreement between Sanofi and Maze Therapeutics. The agreement, announced on May 1, 2023, is for MZE001, a glycogen synthase 1 (GYS1) inhibitor program that has completed Phase 1 and is in development for Pompe Disease, a rare, inherited and often fatal disorder that disables the heart and skeletal muscles. 

"We respectfully disagree with the action by the FTC which also delays potential advancements that could impact the lives of patients. The Maze partnership was designed to apply Sanofi’s resources, knowledge, and expertise to accelerate the development of MZE001, with the hope of addressing unmet medical needs for this devastating condition. The delay associated with a long litigation has led Sanofi to conclude that it would not be in the best interests of patients to contest this litigation and Sanofi will therefore be terminating the agreement with Maze in accordance with its terms. Sanofi remains committed to address the Pompe patient community’s unmet needs."