NORTH CHICAGO, Ill., and WALTHAM, Mass. - AbbVie Inc. (NYSE: ABBV) and ImmunoGen, Inc. (NASDAQ: IMGN) today announced a definitive agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy ELAHERE^® (mirvetuximab soravtansine-gynx), a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC). The acquisition accelerates AbbVie's commercial and clinical presence in the solid tumor space. Additionally, ImmunoGen's follow-on pipeline of promising next-generation ADCs further complements AbbVie's ADC platform and existing programs.

Under the terms of the transaction, AbbVie will acquire all outstanding shares of ImmunoGen for $31.26 per share in cash. The transaction values ImmunoGen at a total equity value of approximately $10.1 billion. The boards of directors of both companies have approved the transaction. This transaction is expected to close in the middle of 2024, subject to ImmunoGen shareholder approval, regulatory approvals, and other customary closing conditions.  

"The acquisition of ImmunoGen demonstrates our commitment to deliver on our long-term growth strategy and enables AbbVie to further diversify our oncology pipeline across solid tumors and hematologic malignancies," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Together, AbbVie and ImmunoGen have the potential to transform the standard of care for people living with cancer."

ImmunoGen's oncology portfolio has the potential to help drive long-term revenue growth for AbbVie's oncology franchise. Ovarian cancer is the leading cause of death from gynecological cancers in the U.S. ELAHERE is the first targeted medicine to show meaningful survival benefit in PROC. As a fast-growing solid tumor therapy, ELAHERE provides AbbVie with a potential multi-billion-dollar on-market medicine with expansion opportunities in earlier lines of therapy and larger segments of the ovarian cancer market.

"With global commercial infrastructure and deep clinical and regulatory expertise, AbbVie is the right company to accelerate geographic and label expansion, and realize the full potential of ELAHERE as the first and only ADC approved in ovarian cancer," said Mark Enyedy, president and chief executive officer, ImmunoGen. "The addition of ImmunoGen's pipeline, platform, and expertise to AbbVie's oncology portfolio is an exciting opportunity for the combined companies to advance innovation in ADCs. This transaction is the culmination of our 40-year commitment to develop and deliver the next-generation of ADCs and more good days for people living with cancer."

ELAHERE is a first-in-class ADC targeting folate receptor alpha (FRα) with a maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE received U.S. Food and Drug Administration (FDA) accelerated approval in 2022 for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The positive Phase 3 results from the MIRASOL confirmatory trial will support a Marketing Authorization Application (MAA) to the European Union and a supplemental Biologic License Application (sBLA) submission to the U.S. FDA in order to gain full approval. Ongoing clinical development programs are underway to expand into earlier lines of therapy and enter other large patient segments of the ovarian market over the next 5-10 years.

ImmunoGen's follow-on pipeline of promising next-generation ADCs expands AbbVie's growing oncology pipeline of potentially transformative programs across multiple different solid tumors and hematologic malignancies. ImmunoGen's Phase 1 asset, IMGN-151, is a next-generation anti-FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications. Pivekimab sunirine, currently in Phase 2, is an anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN.

Transaction Terms

AbbVie will acquire all outstanding ImmunoGen common stock for $31.26 per share in cash. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals and approval by ImmunoGen stockholders. The proposed transaction is expected to be accretive to diluted earnings per share (EPS) beginning in 2027.

Conference Call Details

AbbVie will host an investor conference call today at 8:00 a.m. CT to discuss this transaction. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 9:00 a.m. CT. Presentation materials for the investor conference call are available here.

Advisors

AbbVie's lead financial advisor is J.P. Morgan Securities LLC, which has delivered a fairness opinion for the transaction and Wachtell, Lipton, Rosen & Katz is serving as legal advisor. Morgan Stanley & Co. LLC is also serving as a financial advisor to AbbVie.

ImmunoGen's financial advisors are Goldman Sachs & Co. LLC and Lazard, and Ropes & Gray LLP is serving as legal advisor.

About AbbVie in Oncology

At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of tumor types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit www.abbvie.com/oncology.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

About ImmunoGen

ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™.

Learn more about who we are, what we do, and how we do it at www.immunogen.com.

Forward-Looking Statements

Some statements in this news release, including those relating to the proposed acquisition of ImmunoGen by AbbVie, are, or may be considered, forward-looking statements. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie and ImmunoGen caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals and failure to obtain the requisite vote by ImmunoGen stockholders) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close, the possibility that competing offers may be made, risks related to the ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period, the risk that the businesses will not be integrated successfully, disruption from the transaction making it more difficult to maintain business and operational relationships, negative effects of this announcement or the consummation of the proposed acquisition on the market price of AbbVie's common stock and/or operating results, significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the proposed acquisition or ImmunoGen's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's and ImmunoGen's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (the "SEC"), as updated by its subsequent Quarterly Reports on Form 10-Q and in Item 1A, "Risk Factors," of ImmunoGen's 2022 Annual Report on Form 10-K, which has been filed with the SEC, as updated by its subsequent Quarterly Reports on Form 10-Q, respectively. Neither AbbVie nor ImmunoGen undertakes any obligation, and each specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

About ELAHERE (mirvetuximab soravtansine-gynx)

ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The prescribing information includes a boxed warning. ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue ELAHERE for Grade 4 ocular toxicities.

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

Please see full Prescribing Information, including Boxed Warning for ELAHERE.

Additional Information and Where to Find It

In connection with the proposed transaction, ImmunoGen plans to file with the SEC and mail or otherwise provide to its shareholders a proxy statement regarding the proposed transaction. The Company may also file other documents with the SEC regarding the proposed transaction. This communication is not a substitute for the proxy statement or any other document that may be filed by ImmunoGen with the SEC. BEFORE MAKING ANY VOTING DECISION, IMMUNOGEN'S SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY IMMUNOGEN WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTION BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Any vote in respect of resolutions to be proposed at ImmunoGen's stockholder meeting to approve the proposed transaction or related matters, or other responses in relation to the proposed transaction should be made only on the basis of the information contained in ImmunoGen's proxy statement. Shareholders may obtain a free copy of the proxy statement and other documents the Company files with the SEC (when they are available) through the website maintained by the SEC at www.sec.gov. The Company makes available free of charge on its investor relations website at investor.immunogen.com copies of materials it files with, or furnishes to, the SEC.

The proposed transaction will be implemented solely pursuant to the merger agreement, which contains the full terms and conditions of the proposed transaction.

No Offer or Solicitation

This communication is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

Participants in the Solicitation

ImmunoGen and its directors, executive officers and certain employees and other persons may be deemed to be "participants" in the solicitation of proxies from shareholders of ImmunoGen in favor of the proposed transaction. Information about ImmunoGen's directors and executive officers is set forth in ImmunoGen's proxy statement on Schedule 14A for its 2023 Annual Meeting of Stockholders, which was filed with the SEC on April 26, 2023 and in ImmunoGen's Current Report on Form 8-K filed with the SEC on September 18, 2023. Additional information concerning the interests of ImmunoGen's participants in the solicitation, which may, in some cases, be different than those of ImmunoGen's stockholders generally, will be set forth in ImmunoGen's proxy statement relating to the proposed transaction when it becomes available. These documents are available free of charge at the SEC's website at www.sec.gov and at investor.immunogen.com.

WEST READING, PA - Reading Hospital announced plans on Wednesday to open a third full-service pharmacy in Wyomissing. Among its services, the new pharmacy will offer free home delivery to residents within a 25-mile radius.

“Having simple, easy, and affordable access to care is essential and our community deserves it,” said Michael Kleinschmidt, vice president of Acute Retail and Pharmacy. “We are grateful that we can provide our patients exceptional clinical services at our new community-based pharmacy location.”

Reading Hospital Wyomissing Pharmacy, located at 1001 Reed Avenue Suite 400, will offer automatic refills, text notifications, medication counseling, prescription transfers, and house complex medications that require special storage and handling.

Wyomissing Pharmacy hours are Monday through Friday from 8 a.m. to 5 p.m. with a closure for lunch between 12:30 and 1 p.m.

The addition of the new pharmacy means that Reading Hospital will now offer the community three full-service pharmacies to make picking up prescriptions easy and convenient.

Reading Hospital Ambulatory Pharmacy is located at 420 S. Fifth Avenue and Reading Hospital 7th Avenue Pharmacy is located at 301 S. Seventh Avenue in Suite 145. Both locations also offer a prescription drop-off box to dispose of unused or expired medications.

“This was a collective effort, and I am thankful to all the teams for their hard work and unwavering commitment to the health and wellness of our community,” Kleinschmidt said.

GAITHERSBURG, MD - Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services has awarded a $75 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of newly licensed anthrax vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted). Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024. 

Previously known as AV7909, CYFENDUS™ vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact. 

“CYFENDUS™ vaccine is a critical component of Emergent’s anthrax medical countermeasures franchise, and supports the U.S. government's anthrax preparedness strategy,” said Paul Williams, senior vice president, products head at Emergent. “This procurement helps ensure the nation has sufficient anthrax vaccine and aligns with Emergent’s longstanding commitment to strengthen public health preparedness.” 

In 2016, BARDA and Emergent extended their partnership to support clinical development and manufacturing efforts for the AV7909 vaccine, including a Phase 3 trial to demonstrate safety and efficacy, working toward the goal of eventual FDA licensure. A pre-Emergency Use Authorization (EUA) package was submitted in December 2018, and the first pre-EUA doses of AV7909 were delivered to the U.S. government in 2019. In April 2022, Emergent submitted the Biologics License Application to the FDA for review, leading to approval and licensure in July 2023. This latest contract option supplements previous contract procurements and supports the U.S. biodefense preparedness efforts. 

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under contract HHSO100201600030C.

SAN DIEGO, CA - Asteres Inc., the industry’s leading provider of ScriptCenter® automated lockers and kiosks for prescriptions and personal care products in retail, hospital, and Veteran’s Affairs/Department of Defense (VA/DoD) pharmacies announced today a new group purchasing contract agreement with AllSpire Health GPO to create new savings opportunities for their member hospitals.

ScriptCenter^®, Asteres’ innovative technology, provides a quick and convenient prescription pickup destination for hospital employees, especially those who work when the pharmacy is closed. ScriptCenter® also offers employees the ability to purchase popular retail items such as over-the-counter (OTCs) and personal care products anytime. By offering 24/7 pharmacy services to hospital employees, healthcare systems are able to keep prescriptions ‘in-house’ and substantially reduce pharmacy benefit management (PBM) costs.

"We are committed to working with AllSpire member hospitals in their efforts to improve patient care, reduce PBM costs, and increase pharmacy revenues through employee prescription capture," said David J. Lenny, Asteres President & CEO. “ScriptCenter® has achieved significant savings at multiple AllSpire member locations with impressive paybacks of less than a year and we look forward to helping other AllSpire members recognize similar results while improving patient care."

“We look forward to leveraging ScriptCenter® to improve operational efficiency, reduce costs, and ultimately, deliver enhanced healthcare experiences for our member hospitals,” said Robert Waite, Director of Pharmacy at AllSpire Health GPO.

Texas A&M University’s Irma Lerma Rangel School of Pharmacy is responding to the increasing demand for pharmacy technicians in Texas by adding the Aggie Pharmacy Technician Program (PTP) to its educational offerings.

Pharmacy technicians play a crucial role alongside pharmacists in various health care settings, including hospitals, clinics and pharmacies to prepare and dispense medications, manage inventory, administer vaccines and facilitate communication with patients and health care providers.

“Pharmacy technicians are vital members of the health care team and contribute to delivering effective and timely patient care,” said Andrea Mora, Aggie PTP program director, clinical associate professor and associate department head of pharmacy practice. “A shortage of pharmacy technicians can result in reduced pharmacy business hours, backlogs of unfilled prescriptions, delays in patients receiving their medications and suboptimal health outcomes. Texas is experiencing a shortage and is in dire need of pharmacy technicians,”

The Aggie PTP curriculum, spanning 17 weeks, is shorter than many other programs, and is based on the apprenticeship model where students practice in retail or hospital pharmacies what they learn in the classroom and lab.

“We are working with various pharmacy partners to create paid apprenticeship opportunities for our Aggie PTP trainees. This will mean that during the last five weeks of the curriculum, our trainees will be able to earn while they learn,” said Asim Abu-Baker, clinical professor and associate dean for clinical and professional affairs.

The program also provides American Pharmacists Association Immunization Delivery training for technicians. Upon completion of the program, students will be certified to administer certain immunizations.

The cost of tuition is half as much as the average cost of other technician programs in Texas. The WoodNext Foundation has generously gifted the Rangel School of Pharmacy $1 million to create the Aggie Pharmacy Technician Program and support incoming students in various ways, including scholarships.

The program is seeking American Society of Health System Pharmacists (ASHP) and American Council on Pharmaceutical Education (ACPE) accreditation, ensuring quality and compliance with their standards, as well as the principled Texas A&M standards. Unique to Aggie PTP, courses are taught by Rangel School of Pharmacy Pharm.D. and Ph.D. faculty, and academic support is provided to participants through Pharm.D. peer mentors and other supplemental instructors.

“The Aggie PTP is looking for applicants who are hard-working, motivated, conscientious with high morals, and eager to make a positive impact on patients’ lives,” Mora said.

The program is accepting applicants, with an application deadline set for Jan. 1. The first cohort of students will begin in Spring 2024.

To learn more about eligibility or to apply, visit Aggie PTP.

Kenneth L. Davis, MD, a transformative leader who has been Chief Executive Officer of the Health System and its predecessor since 2003, will become Executive Vice Chairman of the Mount Sinai Boards of Trustees. Both appointments are effective early next year.

“Dr. Carr is a visionary leader and physician who will chart an exciting course for the Health System,” said Richard A. Friedman and James S. Tisch, Co-Chairmen of the Boards of Trustees of the Mount Sinai Health System. “We are certain that he will propel Mount Sinai to further success in our mission to provide compassionate patient care through unrivaled education, research, and outreach in the many diverse communities we serve.”

Mr. Friedman and Mr. Tisch added: “We want to once again thank Dr. Davis for his remarkable and transformative tenure leading Mount Sinai for more than 20 years, and are delighted that we will continue to benefit from his wisdom in his new role. We are extremely fortunate and grateful for Ken’s service and equally excited and honored to have a physician-executive as qualified and accomplished as Dr. Carr as the system’s next leader.”

As Chief Executive Officer, Dr. Carr will report to the Boards of Trustees. In partnership with them, he will chart a strategy for Mount Sinai’s next chapter, and will oversee all critical strategic, operational, and business-building areas of the Health System, including its eight hospitals, the Icahn School of Medicine at Mount Sinai, and more than 400 ambulatory locations and physician practices.

"I am honored and deeply grateful for the opportunity to lead this preeminent institution and dynamic team of people who care deeply about advancing health for the patients and communities we serve,” Dr. Carr said. “Together, we will continue to innovate in order to provide the safe, high-quality, and equitable care that our patients deserve and expect. I would also like to recognize Dr. Davis for his tremendous accomplishments and thank Jim and Rich for their support and partnership.”

Dr. Davis became President and Chief Executive Officer of The Mount Sinai Medical Center in 2003 and of the Mount Sinai Health System upon its formation in 2013. He has led Mount Sinai through an era of unprecedented growth and change, including the creation of the Health System, the transformation of care delivery, the COVID-19 pandemic, and sustained academic and research growth.

“I look forward to working with Brendan in the next few years,” Dr. Davis said. “With Brendan and our existing leadership team, I know the system is in the right hands as we continue to serve New York with the exacting precision and immense passion that are the hallmarks of Mount Sinai.”

Dr. Carr is currently Mount Sinai Professor in Emergency Medicine at Icahn Mount Sinai and Chair of Emergency Medicine for the Mount Sinai Health System. As a renowned emergency physician and health policy researcher, he has focused on building regional systems of emergency care, especially for trauma, stroke, cardiac arrest, and sepsis, and developing innovative delivery system solutions to create a more distributed and accessible acute-care delivery system. He has served in an advisory role to domestic and international organizations and is a member of the National Academy of Medicine.

Dr. Carr previously served on the faculty at the Perelman School of Medicine at the University of Pennsylvania and as an Associate Dean of the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia. In addition to his academic accomplishments, Dr. Carr also served the U.S. Department of Health and Human Services in a variety of roles focused on improving trauma and emergency care delivery for the nation. His portfolio focused on aligning the public sector and private sector response during disasters and public health emergencies.

Dr. Carr earned his medical degree from Temple University School of Medicine, and completed both his residency in emergency medicine and his fellowship in trauma and surgical critical care at the University of Pennsylvania. He is an alumnus of the Robert Wood Johnson Foundation’s Clinical Scholars Program and holds master’s degrees in both clinical psychology and health policy research. He is an accomplished researcher, has authored more than 175 manuscripts, and has received funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and multiple foundations.

RAHWAY, NJ & CAMBRIDGE, MA - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Caraway Therapeutics, Inc. announced today that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Caraway Therapeutics for a total potential consideration of up to $610 million, including an undisclosed upfront payment as well as contingent milestone payments. The upfront payment will be expensed by Merck in the fourth quarter of 2023 and included in non-GAAP results.

“Caraway’s multidisciplinary approach has yielded important progress in evaluating novel mechanisms of modulation of lysosomal function with potential for the treatment of progressive neurodegenerative diseases,” said George Addona, senior vice president, discovery, preclinical development and translational medicine, Merck Research Laboratories. “We look forward to applying our expertise to build upon this work with the goal of developing much needed disease-modifying therapies for these conditions.”

Caraway is a preclinical biopharmaceutical company pursuing innovative approaches for the treatment of genetically defined neurodegenerative and rare diseases. The company has built a pipeline of novel, small-molecule therapeutics for the treatment of genetically defined neurodegenerative and rare diseases.

“This important milestone is a testament to the hard work and dedication of the Caraway team and our mission to develop therapeutics with the potential to alter the progression of devasting neurodegenerative diseases and help patients,” said Martin D. Williams, chief executive officer, Caraway Therapeutics. “This acquisition leverages Merck’s industry-leading research and development capabilities to help further advance our discovery and preclinical programs. We thank and appreciate our investors, including SV Health Investors and its Dementia Discovery Fund, AbbVie Ventures, Amgen Ventures, Eisai Innovation and MRL Ventures Fund for their support.”

Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Caraway with earnout milestones associated with the development of certain pipeline candidates. The Board of Directors of Caraway Therapeutics has approved the transaction. Merck, through its MRL Ventures Fund, has been a shareholder of Caraway Therapeutics since 2018.

PRINCETON, NJ & CAMBRIDGE, MA - Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase 3 KarMMa-3 study. The date of the ODAC meeting has not yet been confirmed by the FDA. The FDA also informed the companies that a decision on the application will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.

The companies anticipate that the committee will review data related to the secondary endpoint of overall survival (OS). The companies look forward to continuing discussions with the FDA and participating in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed RRMM in earlier lines of treatment. The ODAC meeting has no impact on the currently approved indication for Abecma for adult patients with triple-class exposed RRMM after four or more prior lines of therapy.

The KarMMa-3 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard regimens, significantly reducing the risk of disease progression or death versus standard regimens in patients with triple-class exposed RRMM. Safety results were consistent with the well-established and generally predictable safety profile of Abecma. Final PFS data and interim OS data from the KarMMa-3 study will be presented on December 11 at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition.

Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed RRMM based on the KarMMa-3 study results are also currently under review by Japan’s Ministry of Health, Labour and Welfare, European Medicines Agency and Swissmedic.

Researchers at the University of São Paulo (USP) in Brazil, partnering with Foresee Pharmaceuticals, a Taiwan and US-based biopharmaceutical company, have tested a synthetic molecule for the treatment of heart failure. The study, funded by FAPESP, was published in the European Heart Journal. The theme was also highlighted in the magazine's editorial.

Heart failure is a condition in which the heart muscle cannot pump enough blood to meet the body's needs for blood and oxygen. It causes more deaths worldwide than any other disease, in the sense that other cardiovascular disorders tend to lead to heart failure, which affects over 2 million people in Brazil. A number of drugs can slow its progression but currently no treatment exists that can reverse it even partially. A heart transplant is considered if the condition becomes severe.

In the translational study conducted at USP, several experiments were conducted to demonstrate the effect of the molecule, named AD-9308, to restore the activity of the enzyme aldehyde dehydrogenase 2 (ALDH2), which is present in mitochondria (the organelles that generate energy to power cells’ biochemical reactions) and plays a key role in heart failure.

“The study lasted more than ten years and included both laboratory experiments and samples from heart failure patients with the aim of understanding a novel mechanism involved in heart failure progression. In parallel with our experiments, the biopharmaceutical company worked on improving the efficacy of a molecule described back in 2014, which has potential to treat cardiac diseases,” said Julio Cesar Batista Ferreira, corresponding author of the article and a professor at the Institute of Biomedical Sciences (ICB-USP).

The molecule prototype compound first described was named Alda-1. At the time, the researchers found that the drug compound increased heart function by 40% in rats with heart failure and that this effect was due to activation of ALDH2 in cardiac cells (more at: https://agencia.fapesp.br/19463).

Structural modifications were made to the original molecule to boost its pharmacological properties and qualify it as a potential development compound. After many versions iterations and tests, the scientists at Foresee Pharmaceuticals developed the AD-9308. “This new version activates the enzyme ALDH2 three times more than the original molecule,” Ferreira said.

The biopharmaceutical firm has completed clinical trials of another molecule similar to AD-9308, assuring its safety. “The results show that the synthetic molecule is well tolerated by healthy subjects. These are the required steps to apply to the FDA for permission to test the drug in heart failure patients. However, it requires more volunteers and more time, but it’s the only way to find out which kind of heart failure it could treat and at what stage of the disease,” he explained. The FDA is the United States Food and Drug Administration, responsible for protecting public health by assuring the safety and efficacy of human and veterinary drugs, among other duties.

Mitochondrial malfunction

Several studies conducted at ICB-USP in the past ten years have shown that heart failure is associated with mitochondrial malfunction. Like a car engine, mitochondria convert chemical energy into mechanical energy, which the heart needs to pump blood. “When a car engine isn’t running properly, energy conversion is impaired, efficiency drops, and pollution increases,” Ferreira said.

The “pollutant” produced by mitochondria in people with heart failure is 4-hydroxynonenal, a compound belonging to the class of aldehydes. “Every cell has hundreds or sometimes thousands of mitochondria, which produce enough aldehyde to poison the entire cell when they aren’t running properly. We discovered in this latest study that too much of 4-hydroxynonenal switches off a vital event for the cell: processing of microRNAs [small non-coding RNAs that regulate the activity of other genes],” he said.

Using mass spectrometry, the researchers observed that 4-hydroxynonenal [the aldehyde produced by mitochondria] binds irreversibly to Dicer [a protein essential to microRNA formation] and inactivates it. “In addition, we showed that AD-9308 improves mitochondrial filtration enough to eliminate this cellular pollutant,” he said.

Animals genetically engineered to lack Dicer are known to develop heart failure. “In this study, we identified the chemical alterations that inactivate Dicer in rodents and humans owing to the accumulation of aldehyde caused by heart failure. This was a hitherto unknown mechanism. The point is that Dicer is a limiting enzyme for formation and maturation of the microRNAs responsible for overall control of cellular biology,” he said. Interruption of microRNA formation and maturation is associated with several health problems, including cancer, metabolic syndrome, neurodegenerative disorders, and cardiovascular disease.

In experiments involving animals, cell cultures and heart tissue samples from the Heart Institute (Incor) at Hospital das Clínicas, the hospital complex run by the university’s Medical School (FM-USP), the researchers found that aldehyde binding makes Dicer stop working and reduces the amount of microRNAs available to the heart.

In addition to their discovery of this novel mechanism associated with heart failure, the researchers showed in samples of human heart tissue that the disorder can be reversed, and Dicer activity restored using the drug AD-9308.

“In summary, AD-9308 stimulates the removal of aldehyde from sick cells, reducing the likelihood that it will ‘switch off’ Dicer and hence protecting the heart cells. This tends to keep the microRNA profile closer to that of a healthy heart. I consider our partnership with Foresee Pharmaceuticals a success. It's been essential to our multidisciplinary multicenter research and development, producing highly promising results that can now be trialed in patients,” Ferreira said. 

BETHESDA, MD - Today, The Pharmacy Technician Society℠(TPTS), a national membership organization exclusively dedicated to further elevating pharmacy technician roles in patient care and recognizing their significant contributions to healthcare, launched its operations.

Created by ASHP (American Society of Health-System Pharmacists), TPTS is a new organization led by and comprised of pharmacy technicians to provide critical advocacy and advancement opportunities for the pharmacy technician workforce in all patient care settings. The new organization offers a range of services, including comprehensive continuing education, career development, networking, publications and resources, and standards for the professional practice of pharmacy technicians. TPTS will also advocate for federal and state policies and regulations that promote safe and effective medication use and advanced technician roles.

"Pharmacy technicians are critical members of the pharmacy workforce who provide valuable patient care services across the continuum of care and are instrumental in achieving optimal medication outcomes," said ASHP CEO Paul W. Abramowitz, PharmD, ScD (Hon), FASHP. "We believe TPTS will make significant inroads in elevating the role of pharmacy technicians as part of the healthcare team and are proud to lend our extensive experience to create a new organization dedicated to providing education, resources, and needed advocacy to empower current and aspiring pharmacy technicians."

The ASHP Pharmacy Technician Forum, launched in 2018, created the foundation for the formation of TPTS. With the launch of the new organization, ASHP will gradually transition the activities of the Pharmacy Technician Forum to TPTS, with all existing ASHP technician members automatically receiving dual membership to both organizations.

TPTS is offering pharmacy technicians a free trial membership through June 30, 2024, with all members receiving:

• Access to continuing education, webinars, podcasts, and practice resources such as a monthly newsletter, a comprehensive website, and career development services.
• Opportunities to connect with other pharmacy technician professionals across the country through live and virtual networking forums.
• National and state advocacy on behalf of pharmacy technicians.
• Venues to create and advocate for policies and regulations that promote safe medication use and create advanced practice positions for technicians.
• Toolkits, guidelines, publications, and other resources that support the daily work and advancement of pharmacy technicians.

"TPTS will devote substantial attention to addressing the significant workforce opportunities and challenges faced by pharmacy technicians building on ASHP's longstanding commitment to these vital members of the pharmacy workforce," said Hannah K. Vanderpool, PharmD, MA, executive director of TPTS and vice president of ASHP's office of member relations. "We need to ensure technicians across all practice settings have the support they need to thrive and are pleased to provide a new professional home solely dedicated to empowering pharmacy technicians as we support advancements in technicians' careers, expansion of technician knowledge and skills, and advocacy and leadership for the technician workforce."

The U.S. Bureau of Labor and Statistics projects that employment of pharmacy technicians will grow 6% from 2022 to 2032, with more opportunities expected for technicians to expand their roles as increased demand for healthcare services continues. Despite a positive job outlook, recent surveys have highlighted technician workforce challenges. Nearly three-quarters (74%) of hospitals reported shortages of entry-level pharmacy technicians, and 96% experienced shortages of experienced pharmacy technicians, according to the 2022 ASHP National Survey of Pharmacy Practice in Hospital Settings.

TPTS will appoint members to its inaugural Board of Directors in 2024, and technicians will vote for TPTS Board members going forward. Technicians interested in serving in the inaugural TPTS Board of Directors can submit an application by January 31, 2024.

For more information about TPTS, visit pharmtechsociety.org.