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CCM Biosciences announces launch of 5Prime Sciences business unit

New business unit is focused on DNA Biotechnology and Molecular Diagnostics, leveraging state-of-the-art platforms for enzyme engineering

 

Global annual revenue from company’s intellectual property portfolio is $30-50M

 

 

MOUNT LAUREL, N.J. — (BUSINESS WIRE) — Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime’s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics.

 

5Prime has two focus areas: 1) in vitro diagnostic (IVD) tests: a wide array of companion diagnostics (CDx) tests for targeted cancer, rare disease, and prenatal/preimplantation diagnostics, developed using the droplet digital Polymerase Chain Reaction (ddPCR) and Next-Generation Sequencing (NGS) methodologies, which accompany the personalized medicine therapeutic (Rx) pipeline of CCM Bio; 2) synthetic biology: engineered DNA- and RNA-manipulating enzymes that improve upon the enzymes used in IVD tests, in PCR reagents, and also in enzymatic DNA/RNA synthesis.

 

Proven technology behind market-leading DNA sequencing products and diagnostic tests; including one of the 5 highest revenue-generating technologies invented in the history of Princeton University

 

Focus areas 1 and 2 are based on the company’s patented technology originating in the PhD thesis work of Co-Founder and CEO Dr. Raj Chakrabarti at Princeton University. According to the Princeton University Office of Technology Licensing, patents in this portfolio, which are now controlled by 5Prime, are among the top 5 revenue-generating patents in the history of the university, having been commercialized in collaboration with companies such as Celera Diagnostics, Quest Diagnostics, Abbott, New England Biolabs, and Toyobo Life Sciences. Diagnostic tests and products based on the company’s intellectual property include the XSense test from Quest Diagnostics, which is the leading DNA-based carrier screening test for autism (Fragile X syndrome); and the Q5 polymerase kit marketed by New England Biolabs, which is the leading high-fidelity polymerase kit for DNA sequencing.

 

In the context of molecular diagnostics, NGS is typically applied to diagnose in high-throughput the patterns of DNA mutations in genes. A related method called RNA-Seq, which applies NGS to RNA rather than DNA to measure real-time gene expression levels, has emerged as a foundation for modern personalized medicine. However, a notorious difficulty in both traditional NGS and RNA-Seq is sequence bias, which results in inaccurate estimates of the relative copy numbers of different genes and associated disease-causing mutations, and which has limited the transformative potential of these methods. ddPCR is a sensitive method for diagnosing mutations in specific disease-associated genes that is also limited by problems of sequence bias.

 

5Prime’s technology enables the efficient polymerization and amplification of nearly any DNA or RNA sequence to overcome sequence bias in nucleic acid amplification and associated diagnostic methods like NGS and ddPCR, the global markets for which were valued at $10B and $6B, respectively, in 2022 and expected to surpass $44B and $14B, respectively, by 2032. Its state-of-the-art synthetic biology platform for polymerase enzyme engineering generates proprietary polymerases with optimal properties for NGS or PCR-based diagnostic tests, by applying machine learning algorithms to the big data generated from ultrahigh-throughput, microfluidic experimental screening of enzyme activity. In addition, the company’s technology platform applies proprietary nonaqueous media and computational systems biology methods in conjunction with such enzymes to dramatically improve nucleic acid polymerization and amplification efficiency.

 

About CCM Biosciences

CCM Biosciences, Inc. is a biotechnology company dedicated to discovering and developing novel drugs – including small molecules, gene therapies, biologics, and nanomedicines – as well as associated companion diagnostics. CCM Bio’s patented molecular discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, American Chemical Society journals and Nature Publishing Group journals. CCM Bio is partnered with the global chemical and pharmaceutical services company PMC Group, Inc. for fully integrated discovery, development and manufacturing of drugs and diagnostics.

Contacts

Dr. Anisha Ghosh
email: anisha@ccm-bio.com

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A study estimates that there are 13.3B+ videos on YouTube, with 4B+ posted to its platform in 2023; median YouTube video has 39 views

—  I got interested in this question a few years ago, when I started writing about the “denominator problem.”

 

Ethan Zuckerman:

 

 

— A great deal of social media research focuses on finding unwanted behavior – mis/disinformation, hate speech – on platforms. This isn’t that hard to do: search for “white genocide” or “ivermectin” and count the results. Indeed, a lot of eye-catching research does just this – consider Avaaz’s August 2020 report about COVID misinformation. It reports 3.8 billion views of COVID misinfo in a year, which is a very big number. But it’s a numerator without a denominator – Facebook generates dozens or hundreds of views a day for each of its 3 billion users – 3.8 billion views is actually a very small number, contextualized with a denominator.

 

A few social media platforms have made it possible to calculate denominators. Reddit, for many years, permitted Pushshift to collect all Reddit posts, which means we can calculate what a small fraction of Reddit is focused on meme stocks or crypto, versus conversations about mental health or board gaming. Our Redditmap.social platform – primarily built by Virginia Partridge and Jasmine Mangat – is based around the idea of looking at the platform as a whole and understanding how big or small each community is compared to the whole. Alas, Reddit cut off public access to Pushshift this summer, so Redditmap.social can only use data generated early this year.

 

Twitter was also a good platform for studying denominators, because it created a research API that took a statistical sample of all tweets and gave researchers access to every 10th or 100th one. If you found 2500 tweets about ivermectin a day, and saw 100m tweets through the decahose (which gave researchers 1/10th of tweet volume), you could calculate an accurate denominator (100m x 10) (All these numbers are completely made up.) Twitter has cut off access to these excellent academic APIs and now charges massive amounts of money for much less access, which means that it’s no longer possible for most researchers to do denominator-based work.

 

Interesting as Reddit and Twitter are, they are much less widely used than YouTube, which is used by virtually all internet users. Pew reports that 93% of teens use YouTube – the closest service in terms of usage is Tiktok with 63% and Snapchat with 60%. While YouTube has a good, well-documented API, there’s no good way to get a random, representative sample of YouTube. Instead, most research on YouTube either studies a collection of videos (all videos on the channels of a selected set of users) or videos discovered via recommendation (start with Never Going to Give You Up, objectively the center of the internet, and collect recommended videos.) You can do excellent research with either method, but you won’t get a sample of all YouTube videos and you won’t be able to calculate the size of YouTube.

 

I brought this problem to Jason Baumgartner, creator of PushShift, and prince of the dark arts of data collection. One of Jason’s skills is a deep knowledge of undocumented APIs, ways of collecting data outside of official means. Most platforms have one or more undocumented APIs, widely used by programmers for that platform to build internal tools. In the case of YouTube, that API is called “Inner Tube” and its existence is an open secret in programmer communities. Using InnerTube, Jason suggested we do something that’s both really smart and really stupid: guess at random URLs and see if there are videos there.

 

Here’s how this works: YouTube URLs look like this: https://www.youtube.com/ watch?v=vXPJVwwEmiM

 

That bit after “watch?v=” is an 11 digit string. The first ten digits can be a-z,A-Z,0-9 and _-. The last digit is special, and can only be one of 16 values. Turns out there are 2^64 possible YouTube addresses, an enormous number: 18.4 quintillion. There are lots of YouTube videos, but not that many. Let’s guess for a moment that there are 1 billion YouTube videos – if you picked URLs at random, you’d only get a valid address roughly once every 18.4 billion tries.

 

We refer to this method as “drunk dialing”, as it’s basically as sophisticated as taking swigs from a bottle of bourbon and mashing digits on a telephone, hoping to find a human being to speak to. Jason found a couple of cheats that makes the method roughly 32,000 times as efficient, meaning our “phone call” connects lots more often. Kevin Zheng wrote a whole bunch of scripts to do the dialing, and over the course of several months, we collected more than 10,000 truly random YouTube videos.

 

There’s lots you can do once you’ve got those videos. Ryan McGrady is lead author on our paper in the Journal of Quantitative Description, and he led the process of watching a thousand of these videos and hand-coding them, a massive and fascinating task. Kevin wired together his retrieval scripts with a variety of language detection systems, and we now have a defensible – if far from perfect – estimate of what languages are represented on YouTube. We’re starting some experiments to understand how the videos YouTube recommends differ from the “average” YouTube video – YouTube likes recommending videos with at least ten thousand views, while the median YouTube video has 39 views.

 

I’ll write at some length in the future about what we can learn from a true random sample of YouTube videos. I’ve been doing a lot of thinking about the idea of “the quotidian web”, learning from the bottom half of the long tail of user-generated media so we can understand what most creators are doing with these tools, not just from the most successful influencers. But I’m going to limit myself to the question that started this blog post: how big is YouTube?

 

Consider drunk dialing again. Let’s assume you only dial numbers in the 413 area code: 413-000-0000 through 413-999-9999. That’s 10,000,000 possible numbers. If one in 100 phone calls connect, you can estimate that 100,000 people have numbers in the 413 area code. In our case, our drunk dials tried roughly 32k numbers at the same time, and we got a “hit” every 50,000 times or so. Our current estimate for the size of YouTube is 13.325 billion videos – we are now updating this number every few weeks at tubestats.org.

 

Once you’re collecting these random videos, other statistics are easy to calculate. We can look at how old our random videos are and calculate how fast YouTube is growing: we estimate that over 4 billion videos were posted to YouTube just in 2023. We can calculate the mean and median views per video, and show just how long the “long tail” is – videos with 10,000 or more views are roughly 4% of our data set, though they represent the lion’s share of views of the YouTube platform.

 

Perhaps the most important thing we did with our set of random videos is to demonstrate a vastly better way of studying YouTube than drunk dialing. We know our method is random because it iterates through the entire possible address space. By comparing our results to other ways of generating lists of YouTube videos, we can declare them “plausibly random” if they generate similar results. Fortunately, one method does – it was discovered by Jia Zhou et. al. in 2011, and it’s far more efficient than our naïve method. (You generate a five character string where one character is a dash – YouTube will autocomplete those URLs and spit out a matching video if one exists.) Kevin now polls YouTube using the “dash method” and uses the results to maintain our dashboard at Tubestats.

 

We have lots more research coming out from this data set, both about what we’re discovering and about some complex ethical questions about how to handle this data. (Most of the videos we’re discovering were only seen by a few dozen people. If we publish those URLs, we run the risk of exposing to public scrutiny videos that are “public” but whose authors could reasonably expect obscurity. Thus our paper does not include the list of videos discovered.) Ryan has a great introduction to main takeaways from our hand-coding. He and I are both working on longer writing about the weird world of random videos – what can we learn from spending time deep in the long tail?

 

Perhaps most importantly, we plan to maintain Tubestats so long as we can. It’s possible that YouTube will object to the existence of this resource or the methods we used to create it. Counterpoint: I believe that high level data like this should be published regularly for all large user-generated media platforms. These platforms are some of the most important parts of our digital public sphere, and we need far more information about what’s on them, who creates this content and who it reaches.

 

Many thanks to the Journal for Quantitative Description of publishing such a large and unwieldy paper – it’s 85 pages! Thanks and congratulations to all authors: Ryan McGrady, Kevin Zheng, Rebecca Curran, Jason Baumgartner and myself. And thank you to everyone who’s funded our work: the Knight Foundation has been supporting a wide range of our work on studying extreme speech on social media, and other work in our lab is supported by the Ford Foundation and the MacArthur Foundation.

 

Finally – I’ve got COVID, so if this post is less coherent than normal, that’s to be expected. Feel free to use the comments to tell me what didn’t make sense and I will try to clear it up when my brain is less foggy.

 

 

 

— Techmeme

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Art & Life Education International & World Perspectives Regulations & Security Science Travel & Leisure

More than a century-old, buried documents throw doubt on fate of condemned man

NEW YORK — Patrick O’Donnell survived the seemingly unsurvivable — including the Great Hunger, the aptly nicknamed Coffin Ships and the infamous Typhoid Sheds — on his way to the hangman’s noose in December 1883.

 

Having traveled from Ireland to the United States in search of a better life, Patrick O’Donnell sealed his grim fate when he committed murder, but there is so much more to his life than was ever revealed — until now.

 

In his unforgettable new book, The Execution, Life and Times of Patrick O’Donnell, author Gavin O’Donnell uses an epistolary technique to reconstruct the story of Patrick’s remarkable life using a series of letters purportedly written by Patrick as he awaited the hangman’s noose — letters smuggled from his death cell in his wife Margaret’s petticoats and that have remained undiscovered for 133 years.

 

“There has in my family always been a belief that we are related to a man named Patrick O’Donnell,” Gavin O’Donnell explained in an interview. “There is some evidence to support this but it’s patchy and not strong. … but it is the reason I took an interest in the man.”

 

Gavin O’Donnell blends real world events, biographical information about Patrick and his own imagination to create a compelling narrative that follows Patrick’s path through the Great Hunger to the typhoid sheds of Quebec; from his service in the Confederate army and capture at Chattanooga in 1863 to the grisly O’Donnell massacre at Wiggan’s Patch, Pennsylvania; and ultimately to that fateful day off the coast of Port Elizabeth where Patrick put three bullets into James Carey, and in so doing sealed his own fate and his place in history — but for the wrong reasons.

 

“He was a real person, but how I draw him is how I imagine him to have been as he faced his lifelong challenges and as he sat in his death cell,” Gavin O’Donnell said.

 

Included are accounts of letters of clemency sent to Patrick’s trial and indeed to Queen Victoria herself by Victor Hugo, (the great author but also well-known campaigner against capital punishment), and from U.S. President Chester Arthur. Interventions which hint at an extraordinary life for an Irish peasant.

 

“History tells us that Patrick O’Donnell was hanged in Newgate Prison in December 1883 for the murder of James Carey,” Gavin O’Donnell added. “History, however, tells us almost nothing of his remarkable life. Was he a British agent, hero of Ireland or something else altogether?”

 

About the Author

Gavin O’Donnell grew up in Wales, Ireland, North Africa and England. A selective mute until age 5, he was unable to read properly at age 11 and was classified as “Educationally Sub Normal.” He studied Construction Management in Limerick, obtaining a degree, and later, at age 40, by way of distance learning, he obtained a Bachelor of Laws honors degree at Nottingham.

 

While vacationing in Bordeaux in 1990, he and his wife lost their daughter in a fire, and their son was badly injured. Later diagnosed with bipolar disorder and PTSD partly as a result of the trauma, he retired from his career in Project Management and concentrated on property development.

 

He and his wife, Linda, refurbished several cottages in Southern France and built up a small holiday business before selling up and returning to rural South Wales. They now reside in a self-built stone cottage along with three cats, Jess, Bob and Kpo; a few thousand bees, whom they have not named; and several chickens. Two grown children and one grandchild live nearby.

 

For more information, please visit https://www.patrickodonnell.uk or  https://www.facebook.com/executionpatrickodonnell

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Business Culture Economics Healthcare Lifestyle Local News Perks Science

PureTech founded entity Karuna Therapeutics to be acquired by Bristol Myers Squibb for $14 billion

Transaction Delivers KarXT, a First-in-Class M1 / M4 Muscarinic Receptor Agonist, with Differentiated Efficacy and Safety

KarXT Is a Potential First-in-Class Treatment for Schizophrenia and as an Adjunctive Therapy, and First-in-Disease Treatment for Alzheimer’s Disease Psychosis, with Promise in Additional Neuropsychiatric and Neurodegenerative Indications

KarXT Is Expected to Launch in the U.S. for the Treatment of Schizophrenia in Adults with a Prescription Drug User Fee Act Date of Sept. 26, 2024

Bristol Myers Squibb to host a conference call today at 8 a.m. ET

 

Bristol Myers Squibb strengthens neuroscience portfolio with acquisition of Karuna Therapeutics

 

PRINCETON, N.J. & BOSTON — Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) Friday 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 Sept. 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 no meaningful 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 53.4% premium to Karuna Therapeutic’s closing stock price on Dec. 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.

 

Conference Call Information

Bristol Myers Squibb will host a conference call today, Friday, Dec. 22, 2023, at 8:00 a.m. ET during which company executives will review discuss the transaction and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com.

 

Investors and the public can register for the live conference call here. Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-866-777-2509 or international +1 412-317-5413. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call.

 

A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on December 22, 2023, through 11:30 a.m. ET on Jan. 4, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 3194180.

 

Advisors

Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as exclusive financial advisor to Karuna, and Simpson Thacher & Bartlett LLP is serving as legal counsel.

 

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

 

About Karuna Therapeutics

Karuna Therapeutics is a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by serious mental illness. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com.

 

Additional Information and Where to Find It

In connection with the proposed acquisition of Karuna Therapeutics by Bristol Myers Squibb, Karuna Therapeutics intends to file a preliminary and definitive proxy statement. The definitive proxy statement and proxy card will be delivered to the stockholders of Karuna Therapeutics in advance of the special meeting relating to the proposed acquisition. This press release is not a substitute for the proxy statement or any other document that may be filed by Karuna Therapeutics with the SEC. KARUNA THERAPEUTICS’ STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF BRISTOL MYERS SQUIBB AND KARUNA THERAPEUTICS WITH THE SEC IN CONNECTION WITH THE PROPOSED ACQUISITION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED ACQUISITION AND THE PARTIES TO THE PROPOSED ACQUISITION. Investors and security holders will be able to obtain a free copy of the proxy statement and such other documents containing important information about Bristol Myers Squibb and Karuna Therapeutics, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Bristol Myers Squibb and Karuna Therapeutics make available free of charge at Bristol Myers Squibb’s website at www.bms.com/investors and Karuna Therapeutics’ website at https://karunatx.com/, respectively, copies of materials they file with, or furnish to, the SEC.

 

Participants in the Solicitation

This press release does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities. Bristol Myers Squibb, Karuna Therapeutics and their respective directors, executive officers and certain employees may be deemed to be participants in the solicitation of proxies from the stockholders of Karuna Therapeutics in connection with the proposed acquisition. Information regarding Bristol Myers Squibb’s directors and executive officers is contained in Bristol Myer Squibb’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on February 14, 2023, and its definitive proxy statement for the 2023 annual meeting of stockholders, which was filed with the SEC on March 23, 2023. Information regarding Karuna Therapeutics’ directors and executive officers is contained in Karuna Therapeutics’ definitive proxy statement for the 2023 annual meeting of stockholders, which was filed with the SEC on April 27, 2023. To the extent holdings of Bristol Myers Squibb’s or Karuna Therapeutics’ securities by their respective directors or executive officers have changed since the amounts set forth in such 2023 proxy statements, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be included in the definitive proxy statement relating to the proposed acquisition when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov, Bristol Myers Squibb’s website at www.bms.com and Karuna Therapeutics’ website at https://karunatx.com/.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the proposed acquisition of Karuna Therapeutics by Bristol Myers Squibb, the expected timetable for completing the transaction, future opportunities for the combined businesses, the expected benefits of Bristol Myers Squibb’s acquisition of Karuna Therapeutics and the development and commercialization of Karuna Therapeutics’ product candidates, including the therapeutic and commercial potential of KarXT and Karuna Therapeutics’ other technologies and products in development. These statements may be identified by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. These statements are only predictions, and such forward-looking statements are based on current expectations and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them, that are difficult to predict, may be beyond our control and could cause actual outcomes and results to differ materially from those expressed in, or implied by, the forward-looking statements. Actual results may differ materially because of numerous risks and uncertainties including with respect to (i) the approval of Karuna Therapeutics’ stockholders of the proposed acquisition, which may be delayed or may not be obtained, (ii) the risk that the expected benefits or synergies of the acquisition will not be realized, (iii) the risk that legal proceedings may be instituted related to the merger agreement, (iv) any competing offers or acquisition proposals for Karuna Therapeutics, (v) the possibility that various conditions to the consummation of the acquisition may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the acquisition and (vii) unanticipated difficulties or expenditures relating to the proposed acquisition, including the response of business partners and competitors to the announcement of the proposed acquisition or difficulties in employee retention as a result of the announcement and pendency of the proposed acquisition. The actual financial impact of this transaction may differ from the expected financial impact described in this press release. In addition, the compounds described in this press release are subject to all the risks inherent in the drug development process, and there can be no assurance that the development of these compounds will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, and Karuna Therapeutics’ business, particularly those identified in the risk factors discussion in Karuna Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2022, as well as other documents that may be filed by Bristol Myers Squibb or Karuna Therapeutics from time to time with the SEC. Neither Bristol Myers Squibb nor Karuna Therapeutics undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made and readers are cautioned not to place undue reliance on such statements.

 

Use of Non-GAAP Financial Information and Financial Guidance

In discussing financial guidance, Bristol Myers Squibb refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this communication that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods.

 

Non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because Bristol Myers Squibb believes they neither relate to the ordinary course of Bristol Myers Squibb’s business nor reflect Bristol Myers Squibb’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods.

 

Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to or as a substitute for the related financial measures that are prepared in accordance with GAAP and are not intended to be considered in isolation and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

 

A reconciliation of the forward-looking non-GAAP measures presented in this communication is not provided due to the inherent difficulty in forecasting and quantifying items that are necessary for such reconciliation. Namely, we are not able to reliably predict the impact of specified items such as unwind of inventory purchase price adjustments, accelerated depreciation and impairment of property, plant and equipment and intangible assets and stock compensation resulting from acquisition-related equity awards, or currency exchange rates beyond the next twelve months. As a result, the reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is not available without unreasonable effort. In addition, Bristol Myers Squibb believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on our future GAAP results. In addition, the non-GAAP financial guidance in this communication excludes the impact of any potential additional future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this communication.

 

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases.

Contacts

PureTech
Public Relations

publicrelations@puretechhealth.com
Investor Relations

IR@puretechhealth.com

EU Media
Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

ben.atwell@FTIconsulting.com

U.S. Media
Nichole Sarkis

+1 774 278 8273

nichole@tenbridgecommunications.com

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HealthEC, LLC data event impacts companies nationwide, including Corewell Health

GRAND RAPIDS, Mich. — (BUSINESS WIRE) — Please replace the release with the following corrected version due to multiple revisions.

 

The updated release reads:

HEALTHEC, LLC DATA EVENT IMPACTS COMPANIES NATIONWIDE, INCLUDING COREWELL HEALTH

 

Population health management platform HealthEC, LLC, is notifying people nationwide of a data security event that happened earlier this year. For more information, please see HealthEC’s news release.

 

The company enables value-based health systems to identify high-risk patients, close gaps in care and recognize barriers to optimal care. HealthEC is a vendor for Corewell Health in Southeast Michigan.

 

The information of approximately 1 million patients of Corewell Health in Southeast Michigan could be impacted by the HealthEC data event. HealthEC is sending letters to every person who was impacted.

 

Not all individuals have the same data impacted, but the possible impacted data could include: Name; address; date of birth; Social Security number; medical record number; medical information like diagnosis, diagnosis code, mental/physical condition, prescription information, and provider’s name; health insurance information including beneficiary number, subscriber number, Medicaid and/or Medicare identification; billing and claims information including patient account number, patient identification number, treatment cost information. This event did not impact platforms such as Epic and MyChart and they are safe to use.

 

HealthEC is offering 12 months of credit monitoring and identity protection services through TransUnion. Instructions on how to activate these services is being sent to all impacted people.

 

Those seeking additional information can contact HealthEC toll-free at 1-833-466-9216 or visit the HealthEC website. People can also write to HealthEC at Attn: Compliance Officer, 343 Thornall St., Suite 630, Edison, NJ 08837.

Contacts

Ellen Bristol, Ellen.Bristol@corewellhealth.org

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Patritumab Deruxtecan granted Priority Review in the U.S. for certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer

  • Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients with advanced EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies
  • Application being evaluated under FDA Real-Time Oncology Review
  • If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients

 

 

BASKING RIDGE, N.J. & RAHWAY, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSE: MRK) announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.

The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2021.

 

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The BLA is being reviewed under the Real-Time Oncology Review (RTOR) program, an initiative of the FDA which is designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application.

 

Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and Merck.

 

The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial and data results presented at the IASLC 2023 World Conference on Lung Cancer (#WCLC23), which were simultaneously published in the Journal of Clinical Oncology.

 

In HERTHENA-Lung01, patritumab deruxtecan was studied in 225 patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy, which demonstrated an objective response rate (ORR) of 29.8% (95% CI: 23.9-36.2), including one complete response and 66 partial responses. The median duration of response was 6.4 months (95% CI: 4.9-7.8). The safety profile of patritumab deruxtecan observed in HERTHENA-Lung01 was consistent with previous phase 1 clinical trials in NSCLC with a treatment discontinuation rate of 7.1% due to treatment-emergent adverse events (TEAEs). Grade 3 or higher TEAEs occurred in 64.9% of patients. The most common (≥5%) grade 3 or higher TEAEs were thrombocytopenia (21%), neutropenia (19%), anemia (14%), leukopenia (10%), fatigue (6%), hypokalemia (5%) and asthenia (5%). Twelve patients (5.3%) had confirmed treatment-related interstitial lung disease (ILD) as determined by an independent adjudication committee. One grade 5 ILD event was observed.

 

“The FDA’s prioritization of the BLA submission reflects the strength of the data from HERTHENA-Lung01 and emphasizes the need to provide new options to patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “If approved, patritumab deruxtecan could become the first HER3 directed medicine approved in the US and the second DXd antibody drug conjugate approved from Daiichi Sankyo’s oncology pipeline.”

 

“The acceptance of the BLA submission of patritumab deruxtecan marks an important step in potentially bringing this new medicine to previously treated patients with EGFR-mutated non-small cell lung cancer who often experience recurrence and have few remaining treatment options,” said Marjorie Green, MD, Senior Vice President and Head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories. “Today is the first of many important milestones from our collaboration with Daiichi Sankyo, as we work together to bring new and potentially first-in-class antibody drug conjugates to people living with cancer.”

 

About HERTHENA-Lung01

HERTHENA-Lung01 is a global, multicenter, open-label, two-arm phase 2 trial evaluating the safety and efficacy of patritumab deruxtecan in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy. Patients were randomized 1:1 to receive 5.6 mg/kg (n=225) or an uptitration regimen (n=50). The uptitration arm was discontinued as the dose of 5.6 mg/kg of patritumab deruxtecan was selected following a risk-benefit analysis conducted from the phase 1 trial assessing the doses in a similar patient population.

 

The primary endpoint of HERTHENA-Lung01 was ORR as assessed by blinded independent central review (BICR). Secondary endpoints included duration of response, progression-free survival (PFS), disease control rate, and time to response – all assessed by both BICR and investigator assessment – as well as investigator-assessed ORR, overall survival, safety and tolerability.

 

HERTHENA-Lung01 enrolled patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

 

About EGFR-Mutated Non-Small Cell Lung Cancer

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.1 NSCLC accounts for approximately 85% of all lung cancers – 55% having distant spread at diagnosis – with EGFR mutations occurring in 14% to 38% of all NSCLC tumors worldwide.2,3,4

 

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases.5 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment.6,7 There is currently no HER3 directed therapy approved for the treatment of any cancer.

 

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

 

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02, a phase 3 trial versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on or after treatment with a third-generation EGFR TKI; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with advanced NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been completed.

 

About the Daiichi Sankyo and Merck Collaboration

Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

 

About the DXd ADC Portfolio of Daiichi Sankyo

The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

 

Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

 

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

 

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

References

1 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Accessed September 2023.

2 Economopoulou P, et al. Ann Transl Med. 2018; 6(8):138.

3 Chen R, et al. J Hematol Oncol. 2020; 13(1):58.

4 Zhang Y-L, et al. Oncotarget. 2016; 7(48):78985-78993.

5 Mishra R, et al. Onco Rev. 2018; 12(355):45-62.

6 Scharpenseel H, et al. Scientific Reports. 2019; 9:7406.

7 Yonesaka K, et al. Clin Cancer Res. 2022; 15:28(2):390-403.

Contacts

Daiichi Sankyo
Global/US Media:
Jennifer Brennan

Daiichi Sankyo, Inc.

jbrennan2@dsi.com
+1 908 900 3183 (mobile)

Japan Media:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

Ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Merck
Media:
Robert Josephson

+1 203 914 2372

robert.josephson@merck.com

Investors:
Peter Dannenbaum

+1 732 594 1579

peter.dannenbaum@merck.com

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Organon to present at the 42nd Annual J.P. Morgan Healthcare Conference

JERSEY CITY, N.J. — (BUSINESS WIRE) — Organon (NYSE: OGN), announced on Thursday that Kevin Ali, Chief Exec. Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 9, 2024, at 1:30 p.m. PT.

 

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at: https://jpmorgan.metameetings.net/events/healthcare24/sessions/49500-organon/webcast?gpu_only=true&kiosk=true

 

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

 

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

 

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formally known as Twitter) and Facebook.

Contacts

Media:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investor:

Jennifer Halchak

(201) 275-2711

Alex Arzeno

(646) 430-2028

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Amneal to participate at the 42nd Annual J.P. Morgan Healthcare Conference

BRIDGEWATER, N.J. — (BUSINESS WIRE) — Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced today that Chirag Patel, Co-Chief Exec. Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 42nd Annual J.P. Morgan Healthcare Conference on Jan. 9 to 10, 2024.

 

Chirag will present on Jan. 10 at 11:15 a.m. PST, and a live webcast will be accessible on the Company’s website at https://investors.amneal.com. A replay of the webcast will be available for 30 days following the event.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars.

 

In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

Contacts

Investor
Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

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Merck provides US regulatory update on gefapixant

RAHWAY, N.J. — (BUSINESS WIRE) — $MRK #MRK — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

 

In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the safety of gefapixant. Merck is reviewing the FDA’s feedback to determine next steps.

Chronic cough is defined as a cough lasting longer than 8 weeks. In adults with RCC, the cough persists despite appropriate treatment of underlying conditions such as asthma or gastroesophageal reflux disease, and UCC is a cough where the underlying cause cannot be identified despite a thorough evaluation.

 

“We thank our clinical trial participants and investigators for their important contributions that add to the body of knowledge related to chronic cough and help to raise awareness about the significant unmet medical need and the impact of RCC and UCC on patients,” said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. “Acknowledging the absence of any approved treatments for refractory or unexplained chronic cough, we are disappointed in the FDA’s response to our application for gefapixant.”

 

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Deb Wambold

(215) 779-2234

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

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Universal Display Corporation named to The Wall Street Journal’s list of Best-Managed Companies of 2023

EWING, N.J. — (BUSINESS WIRE) — $OLED #OLED — Universal Display Corporation (Nasdaq: OLED) (UDC), enabling energy-efficient displays and lighting with its UniversalPHOLED® technology and materials, has been named to The Wall Street Journal’s (WSJ) Top 250 ranking of The Best-Managed Companies of 2023.

 

The annual Management Top 250 ranking of America’s best-run companies is based on a holistic measure of corporate effectiveness that was developed by the Drucker Institute and examines five dimensions of corporate performance: customer satisfaction, employee engagement and development, innovation, social responsibility and financial strength.

 

“This recognition is a testament to the dedication, passion and hard work of our incredible UDC team members and is a celebration of our commitment to excellence in every facet of our global company,” said Steven V. Abramson, President and Chief Executive Officer of Universal Display Corporation.

 

“From our broadening portfolio of innovative and energy-efficient products and services to fostering a corporate culture of inventiveness, integrity, inclusion and collaboration, we are building on our robust leadership position in the growing OLED ecosystem. As we approach the 30th anniversary of UDC’s founding, we are excited to reach even greater heights in the future and make a lasting impact in the industry.”

 

About Universal Display Corporation

Universal Display Corporation (Nasdaq: OLED) is a leader in the research, development and commercialization of organic light emitting diode (OLED) technologies and materials for use in display and solid-state lighting applications. Founded in 1994 and with subsidiaries and offices around the world, the Company currently owns, exclusively licenses or has the sole right to sublicense more than 6,000 patents issued and pending worldwide. Universal Display licenses its proprietary technologies, including its breakthrough high-efficiency UniversalPHOLED® phosphorescent OLED technology that can enable the development of energy-efficient and eco-friendly displays and solid-state lighting. The Company also develops and offers high-quality, state-of-the-art UniversalPHOLED materials that are recognized as key ingredients in the fabrication of OLEDs with peak performance. In addition, Universal Display delivers innovative and customized solutions to its clients and partners through technology transfer, collaborative technology development and on-site training. To learn more about Universal Display Corporation, please visit https://oled.com/.

 

Universal Display Corporation and the Universal Display Corporation logo are trademarks or registered trademarks of Universal Display Corporation. All other company, brand or product names may be trademarks or registered trademarks.

 

All statements in this document that are not historical, such as those relating to the projected adoption, development and advancement of the Company’s technologies, and the Company’s expected results and future declaration of dividends, as well as the growth of the OLED market and the Company’s opportunities in that market, are forward-looking financial statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are cautioned not to place undue reliance on any forward-looking statements in this document, as they reflect Universal Display Corporation’s current views with respect to future events and are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated. These risks and uncertainties are discussed in greater detail in Universal Display Corporation’s periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission, including, in particular, the section entitled “Risk Factors” in Universal Display Corporation’s Annual Report on Form 10-K for the year ended December 31, 2022. Universal Display Corporation disclaims any obligation to update any forward-looking statement contained in this document.

 

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Contacts

Universal Display:
Darice Liu

investor@oled.com
media@oled.com
+1 609-964-5123