Individualized neoantigen therapies: exploring one medicine for one patient
Scientists are researching new ways to help train the immune system to fight cancer
April 13, 2023
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Over the past decade, immunotherapy has transformed our understanding of how the immune system can be used to help fight some types of cancer. However, for the last 50 years, scientists have been researching how we could potentially use vaccines to treat cancer — another investigational approach to harness the immune system to help recognize and destroy cancer cells — with little success.
Now we’re looking at a potential therapy that is building upon the learnings of immunotherapy trials from the past and incorporating that into an individualized cancer approach that’s specific to a patient’s own tumor. Researchers are currently exploring the potential of individualized neoantigen therapies to help fight cancer.
Cancer research is becoming more personalized
Cancer is a result of the body’s own cells undergoing mutations which create abnormal proteins in cancer cells, known as neoantigens, that are not usually seen in normal cells. These mutations are unique to each person’s tumor, so that’s one of the reasons why patients who have been diagnosed with the same type of cancer and who have received the same type of treatment may have different responses.
As the treatment of cancer continues to evolve and advance, researchers are focusing on more individualized approaches. This includes a new area of research into individualized neoantigen therapies that use information from a person’s tumor biopsy sample to help develop a therapy unique to their tumor’s mutations.
“This area of research has really captured our imagination of what’s possible in the development of cancer therapeutics.”
Dr. Jane Healy Vice president and head of oncology early development at MSD Research Laboratories
In collaboration with Moderna, we’re studying this area of research in an effort to advance more individualized approaches to help improve outcomes for people living with cancer.
Learn more about individualized neoantigen therapies
Testing experiments in a lab can be a lot like raising kids. Sometimes your molecules do what you want them to do, and sometimes they don’t. But it’s a challenge Denarra Simmons, a senior scientist at MSD and a mother of two, is always up for.
“You’re constantly trying to find other medicines because all medicines don’t work the same way for all people,” Simmons said.
“You spend the long nights thinking about experiments, how to make things better, how to move things faster to help more people.”
— Denarra Simmons
Simmons has been curious about how and why things work for most of her life. As a young child, she peppered her family with questions, trying to understand the “why” behind anything and everything. But it wasn’t until a man in a lab coat came to her grade school to talk about his career that she realized what her true passion was.
“He wrote an equation on the board and was talking about how people made medicines, and I thought that was fascinating,” Simmons said. “But the thing that really drew my attention was how excited he was when he was explaining what he did. I wanted to do something that I would love that much and over time, I realized that for me, it was science and helping people.”
For 12 years, Simmons has funneled that passion into her research at MSD. Simmons works in drug development to test the efficacy and safety of our biologic medicines used for investigational new drug (IND) enabling studies.
“Working in the lab is my favorite part of my job — and getting good data."
Some days in the lab may be more successful than others, and Simmons uses it all to show her children what it takes to be a scientist. “Good days are celebrated, and the tricky days, we keep working towards improving,” she said.
Simmons also feels strongly about teaching her children that there’s more to life than work.
“I’m always thinking about the experiments, but when I’m home with the children, I really try to give them the attention and time they need,” she said.
But once her daughter and son finish their homework and head to bed, Simmons finds herself thinking about her next set of experiments.
“When you find out a medicine you worked on has helped so many people, you feel really special and you know all the work has been worthwhile,” she said. “And that’s why you’re doing what you do: you’re making a difference in society.”
In Burkina Faso, a personal mission to make a difference in one community
MSD colleagues found non-profit to provide critical resources for a village in one of the poorest countries in the world
November 28, 2022
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Challenging life experiences united two MSD colleagues — Jules Millogo and Cathy Hoath — on a mission to create opportunities and break the cycle of poverty in the small village of Konkourona, in the West African country of Burkina Faso.
Homelessness, hunger and illness in Konkourona
Konkourona is where Millogo, director, medical affairs, global vaccines, grew up with extremely limited access to health care, education, clean water and the bare necessities. It’s also where he witnessed six of his siblings pass away from preventable diseases. Millogo’s father was a strong believer in education and sent him to attend the nearest school in another village, which was hours away from Konkourona on foot.
Despite experiencing much communal trauma growing up, Millogo graduated from medical school and began his career in a Burkina Faso province far from Konkourona, serving as the only doctor for a population of 250,000.
“I somehow managed to overcome bouts of homelessness, hunger and illness from infectious diseases that often come with extreme poverty,” said Millogo. “I grew up knowing that I needed to make a difference in Konkourona and bring opportunities and hope to the people living there.”
Forming Konkourona Alliance Foundation (KAFO) to fight for opportunity and equity
When Millogo joined MSD, he met Cathy Hoath, senior director of regulatory affairs international, vaccines. Hoath was born in Booth Memorial Hospital for Unwed Mothers in Philadelphia, after her teenage birth mother was thrown out of her parents’ home and was unable to find a job or apartment. That experience fuels Hoath’s drive to fight for equity and opportunities — for women, children and all who want to create better lives for themselves and their communities in the U.S. and around the world.
In 2019, during a meeting with the World Health Organization to register our company’s Ebola Zaire vaccine in the countries at highest risk in Africa, Millogo and Hoath began discussing ways they could support development in Konkourona. A few months later, they co-founded the non-profit organization Konkourona Alliance Foundation (KAFO), Inc.
“It was the perfect convergence of my professional and personal worlds, giving me the chance to fight for greater opportunity and equity for some of the world’s most vulnerable people.”
Cathy Hoath
Because remote villages like Konkourona are often referred to in development efforts as “the last mile,” they named their effort “The First Mile Development Program.” The people of Konkourona are KAFO’s highest priorities.
KAFO builds foundation for education
Millogo and Hoath have met many like-minded people — both within our company and beyond — who have become supporters of KAFO since its founding. And they’ve made good progress in Konkourona.
New classroom with desks and textbooks for each child
KAFO has built three new classrooms — reducing class sizes from approximately 90 to 45 students — as well as an office and housing for teachers. It also renovated an existing building for use as a library.
Approximately 400 students are now receiving assistance, from books and tutoring to tuition and bicycles so older students can make the two-hour journey to the closest upper-level school.
Students are making educational progress
Previously, only one or two students per year progressed to middle school. Now, in just a couple of years, over 80 students are continuing their education at middle school and beyond.
“In 2020, we began providing books for each child because there were not nearly enough. We also opened the school at night — the only place in the village with electricity — and offered tutoring services. That year, 20 children passed the middle school entrance exam — which is unheard of in any school in this sub-region,” said Hoath. “In the past two years, 63 additional students have progressed to middle school.”
Eric is a mentor to the younger children and a role model for what can be achieved with an opportunity and hard work.
One of those students is Eric, who couldn’t afford tuition for middle school. His father died, and he had to help his mother, so he got a job on Millogo’s brother’s farm. Now, through KAFO’s sponsorship, he’s going to high school. He’s also helping to sustain the program long term by mentoring younger children and working with the team on the ground to secure books and bicycles.
He’s now thinking about what he may want to study in college — a dream that would not have existed just several years ago.
“We have high hopes for this thoughtful young man,” said Millogo.
Improving access to health care and clean water
The maternal and child mortality rates in Burkina Faso are among the highest in the world. In addition to a lack of health care resources, the villagers also had very little access to clean water.
“One of the biggest problems we face in Konkourona is water-borne diseases,” said Millogo. “People drink water from wherever they can find it — open ponds or other sources contaminated with human and animal waste and other pathogens.”
Clean water is now widely available for drinking and washing
Working closely with the Mami Siara Na Association, a community-led organization created in 2019 to partner with KAFO to lead and sustain development efforts on the ground, the team has now constructed three water towers, three community fountains, a health center for mothers and children, a separate facility for primary care, a pharmacy, latrines, housing for health care workers and an incinerator.
“Providing access to clean water in Konkourona is practically a revolution.”
Jules Millogo
“And the health care facility, where we can provide critical maternal care, immunizations, and primary services for children and community members — like caring for illnesses, wounds, etcetera — will have a significant impact for this community in many ways,” said Millogo.
Providing economic development and hope for a better future
Konkourona’s new — and first — pharmacy
The improvements in education and health care have sparked local economic development as well. There are new jobs in Konkourona to ensure continued access to education, health care, water and sanitation, not to mention those related to construction activities.
Over the next five years, Millogo and Hoath plan to build a middle school, a technical school and a high school, as well as housing for teachers in these schools. They also plan to expand the health center.
“We’re all in on this program and learning every day how to do new things — things we don’t have experience in — to make progress in Konkourona,” said Millogo. “We’re fortunate that we’ve received so much support from so many people to help make these important visions a reality. And, we’re just getting started.”
Millogo plants one of the 1,100 native shade and fruit trees KAFO donated to provide an alternate food source and replenish what has been lost over the past few decades.
Worker sets up almost $500,000 of equipment and supplies in one of the new health center buildings. Green barriers surround two of the 1,100 trees KAFO planted earlier in the year as part of a reforestation effort.
Villagers celebrate the opening of the new — and first — health center.
At a celebration for the new health center, Millogo expresses gratitude to the people all over the world who are helping support KAFO's efforts in Konkourona.
New latrines built around the health center will help keep the environment clean by encouraging people to transition toward better sanitation.
The librarian in Konkourona's first library talks about the variety of books are now available to villagers. Previously, the only type of book available in the village was a small supply of textbooks.
Konkourona consists of roughly 4,000 subsistence farming inhabitants, who use nearly all crops or livestock to maintain the farmer and the farmer's family. This farmer is milling grain for storage.
Walking is the primary form of transportation in the village, but the fortunate families have bikes. Through sponsorships, students now have access to bikes to make the two-hour journey to upper level schools in other villages.
Donations from Care and Share Thrift Shoppes will help hundreds in Konkourona (left to right: Sarah Bergin, executive director of Care and Share Thrift Shoppes, Hoath and Millogo)
Our company is collaborating with a range of partners to enable access for patients around the world
September 8, 2022
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At the outset of our research efforts for COVID-19, our company made clear its commitment to make any vaccine or medicine we develop for this pandemic broadly accessible.
Here’s how we have been working to fulfill that commitment:
Learn how our teams mobilized like never before to ensure we were ready to address a global need
August 24, 2022
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From the earliest stages of the COVID-19 pandemic, we knew we had a responsibility to mobilize and innovate to rise to the challenge of this unique moment.
How vaccines can help prevent certain infectious diseases
By following recommended vaccination schedules, you can help protect yourself and loved ones from vaccine preventable diseases
August 8, 2022
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Managing your health can be tough. In recent years, we’ve been reminded how our health is truly global. Even though we’re worlds apart, what affects one could affect all.
Fortunately, there’s a lot you can do to help keep yourself and your family healthy. By staying up to date on recommended vaccinations, you can help prevent a variety of infectious diseases.
Health care providers are ready to help protect you. Talk to your health care provider about recommended vaccines for you and your family.
Infants and children
Adolescents
Adults
Your health care provider can help
When you’re preparing for an appointment, here are a few suggestions:
Create a list of questions to ask your doctor about your recommended vaccines.
Keep your doctor up to date on any changes to your child’s or your own health since the last visit.
Discuss any concerns about your child’s or your own health.
Proteins in space: taking our research to the final frontier
MSD Research Laboratories scientist Paul Reichert works with the International Space Station to drive innovation
June 29, 2022
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MSD Research Laboratories (MRL) is known for pushing the frontiers of science with its cutting-edge research. And MRL scientist Paul Reichert has taken that concept even further — to space!
Reichert was one of the first scientists in the pharmaceutical industry to propose studying protein crystallization under microgravity conditions, and his work continues today.
“We regularly use crystallization processes for our small molecule and small protein therapeutics. Our goal with these experiments is to identify crystallization processes for biologics for enhanced and simpler drug delivery,” explained Reichert.
Experimental conditions in microgravity are unique because without the force of Earth’s gravity, solutions have reduced convection currents, reduced sedimentation and reduced molecular motion, leading to higher-order crystals with higher purity and more uniform suspensions. Researchers have been able to apply this knowledge ‘on the ground’ by manipulating key variables to mimic those in microgravity, such as using rotational mixers to reduce sedimentation.
Paul Reichert (L) joins April Spinale and Raymond Polniak of the ISS National Laboratory, managed by the Center for the Advancement of Science in Space, Inc. (CASIS), to inspect the experiment
The latest MRL experiment blasted off to the International Space Station in December with astronaut Marc Vande Hei completing the experiment designed to study the effects of purity, mixing, diffusion and temperature on crystallization. Simultaneously, back on Earth, a research team was doing a control experiment in a laboratory for comparison. Reichert is now working alongside other MRL scientists to analyze and compare the results of the experiment run in space against the ground experiment done under the same conditions with gravity.
“I feel so fortunate to have been able to push the frontiers of science with amazing scientists here at MSD and at the ISS National Laboratory. It’s been the highlight of my career.”
Paul Reichert Associate principal scientist, structural chemistry
Here for Good: The human element inspiring our cancer research
Learn how one doctor turned his family connection to cancer into a career driven by scientific innovation
May 27, 2022
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Advances in oncology research require a firm commitment to scientific investigation. Behind every innovation, there are countless researchers, doctors and clinicians who dedicate their lives to helping patients through scientific breakthroughs.
At MSD, Dr. Gregory Lubiniecki, vice president, oncology clinical research, is a senior leader who oversees cancer research. He’s also a practicing clinician, continuing to see patients — adding a human connection to his research.
For Lubiniecki, having a “one-on-one connection” with patients is important both personally and professionally, and helps to keep the patient experience at the forefront when designing clinical studies.
Dr. Lubiniecki’s drive to pursue a career in oncology was motivated by his family’s experience with cancer — watching his mother go through surgery and chemotherapy while he was in high school — and his own scientific curiosity. “The complexity of the molecular biology involved in cancer was very intriguing to me,” he said.
Dr. Lubiniecki and his team play a critical role in advancing MSD’s effort to help save and improve lives around the world through leading-edge science. With an ongoing connection to patients and his research firmly focused on the future, Dr. Lubiniecki is excited about where cancer care may go next.
“I’m very excited about several clinical projects that are going to try and improve the lives of patients who are fighting cancer.”
Dr. Gregory Lubiniecki
Watch the video to learn more about Dr. Lubiniecki
The Mectizan Donation Program is the longest-running, disease-specific drug donation program of its kind
May 25, 2022
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Our commitment: “as much as needed, for as long as needed…"
For centuries, river blindness — also known as onchocerciasis — plagued remote communities in Africa, Latin America and Yemen, and there was no answer to this affliction.
This all began to change in the mid-to-late 1970s when Dr. William Campbell of MSD Research Laboratories suggested the use of ivermectin (later named Mectizan) for river blindness in humans. Following the breakthrough lab work by Dr. Campbell, another MSD researcher, Dr. Mohammed Aziz, championed the clinical development of Mectizan. Dr. Aziz led the collaboration with the World Health Organization (WHO) in the early 1980s to design and implement field studies in West Africa that, ultimately, proved the effectiveness of the drug against river blindness.
In 1987, MSD committed to donate Mectizan – as much as needed, for as long as needed – with the goal to help eliminate river blindness.
MDP partners include: World Health Organization, the Task Force for Global Health, ministries of health, non-governmental development organizations, academic institutions and local communities in endemic communities.
A ground-breaking public-private partnership
In order to reach this goal, MSD leaders recognized that many organizations with unique skills would need to work together as a team. To enable this collaboration, MSD established the Mectizan Donation Program (MDP), a ground-breaking public-private partnership. Operating from the Atlanta-based Task Force for Global Health, the MDP coordinates technical and operational activities between MSD, WHO, endemic countries, and a range of public and private stakeholders.
Building on the successful implementation of the river blindness program, in 1998 MSD expanded its commitment to include donating Mectizan for another neglected tropical disease, lymphatic filariasis, also known as elephantiasis, in African countries and Yemen where it co-exists with river blindness. For lymphatic filariasis, Mectizan is administered with albendazole, a drug donated by GSK.
In November 2017, in support of new WHO guidelines, MSD announced an expansion of the program to reach up to an additional 100 million people per year through 2025 as part of the global effort to eliminate lymphatic filariasis.
More than thirty years later, the results of the MDP speak for themselves. Several countries in Africa are making significant progress towards eliminating both diseases. In Latin America, four countries – Colombia, Ecuador, Mexico and Guatemala – have received WHO verification of river blindness elimination. Lymphatic filariasis has now been eliminated in Togo, Yemen and Malawi. Both river blindness and lymphatic filariasis are on WHO’s list of neglected tropical diseases targeted for elimination globally.
Pioneering a community-directed approach
Today, the MDP is the longest-running, disease-specific drug donation program of its kind and has been influential in the development of a number of other drug donation programs. And, the MDP’s community-directed strategy used to distribute Mectizan has enabled add-on health services to be introduced in remote communities where health services are limited. The program reaches more than 300 million people in the affected areas annually, with more than 4.4 billion treatments donated since 1987.
People in the communities are an integral part of the distribution process in 49 countries where Mectizan has been distributed.
According to Uche Amazigo, former director of the African Programme for Onchocerciasis Control, “by engaging the people, the treatment coverage increased significantly.”
“This pioneering program has changed the face of global health over the past three decades,” said Yao Sodahlon, head of the MDP. “When I visit communities where Mectizan is donated, I can see how the program has helped alleviate suffering and allowed people to live better and healthier lives.”
What are river blindness and lymphatic filariasis?
River blindness (onchocerciasis)
River blindness is one of the leading causes of preventable blindness worldwide. Transmitted through the bite of black flies — which live and breed near fast-flowing streams and rivers — and can cause intense itching, permanent skin and eye lesions and, over time, blindness. It has historically been prevalent in remote rural areas of 36 countries (in Africa, Latin America, and in Yemen.)
Lymphatic filariasis (LF)
Also known as elephantiasis, LF results in disfiguring swelling in the limbs and genitals. Parasitic infection spread by mosquitoes and damages the human lymphatic system. More than 1.3 billion people are at risk, and 30 percent of those infected live in Africa.
35 years later, results of this program speak for themselves
More than 4.4 billion cumulative treatments
Donations to 49 countries
Through the efforts of a variety of partners, more than 4.4 billion treatments have been donated to 49 countries in Africa, Latin America, Eastern Mediterranean, Asia, and South Pacific. River blindness transmission has been interrupted – meaning no new cases have been identified – in four of the six affected countries in Latin America and regions in five African countries. The program reaches more than 300 million people annually.
Today, the MDP is the longest-running, disease-specific drug donation program of its kind.
“We are proud of the positive difference that the Mectizan Donation Program has made in the lives of so many people, their families and communities, and health care systems over the years. Together, with our alliance of partners, we will continue to support endemic countries in their commitment to eliminate these devastating diseases.”
Rob Davis, CEO and President, MSD
Explore our history of helping bring treatment to those afflicted by river blindness and elephantiasis
1978
Dr. William Campbell of MSD Research Laboratories suggests the use of Mectizan (ivermectin) against onchocerciasis (river blindness) in humans.
1981
The first human clinical trials begin in Dakar with the first patient receiving a single dose.
1987
MSD CEO Dr. Roy Vagelos announces the company’s commitment to donate Mectizan to treat river blindness — as much as needed, for as long as needed — the MDP is formed.
1988
The Mectizan Expert Committee meets for the first time to establish the strategy for distribution and the donation review process. Mectizan has been produced at the MSD plant in Haarlem, the Netherlands, since the beginning of the program.
1991
MSD, the MDP Secretariat and WHO establish the Non-Governmental Development Organization (NGDO) Coordination Group for Onchocerciasis Control. NGDOs play a critical role in Mectizan distribution through their work with ministries of health and local communities, expertise in program management, and financial support.
1993
The Onchocerciasis Elimination Program for the Americas (OEPA), formed by the River Blindness Foundation and currently sponsored by The Carter Center, brings together the ministries of health of six countries in Latin America affected by onchocerciasis.
1995
WHO, the World Bank, international NGOs, and 19 African countries partner to create the African Program for Onchocerciasis Control (APOC), providing a structure for financial support and coordination of river blindness control efforts.
1998
MSD begins a partnership with GSK to expand the MDP to include the elimination of LF, commonly referred to as elephantiasis, in African countries and in Yemen.
MSD and the MDP celebrate the 100 millionth treatment in Uganda.
1999
The iconic river blindness statue, “Sightless Among Miracles” by sculptor R. T. Wallen, is dedicated at WHO headquarters in Switzerland. Identical statues are also found at The Carter Center (Georgia, USA), the World Bank (Washington, D.C., USA), the Royal Tropical Institute (Amsterdam, the Netherlands), MSD (New Jersey, USA) and Lions Club International Foundation (Illinois, USA).
2002
In Tanzania, MSD CEO Raymond
Gilmartin celebrates the 250 millionth
treatment distributed.
2008
The Pan American Health Organization passes a resolution calling for the interruption of transmission of river blindness in the Americas by the year 2012.
WHO confirms the potential for elimination of river blindness in some parts of Africa through current treatment strategies.
2010
MSD reaffirms its commitment to the MDP. MSD “will continue to [donate Mectizan] until river blindness becomes a disease of the past,” said MSD CEO Richard T. Clark.
2011
Colombia becomes the first country to apply for WHO certification for the elimination of onchocerciasis transmission after suspending treatment with Mectizan in 2007.
2012
MSD CEO Kenneth C. Frazier commemorates the 25th anniversary of the MDP at a celebratory event in London.
2013
WHO verifies that Colombia has eliminated onchocerciasis, thus becoming the first country in the world to achieve this goal.
2014
WHO verifies the elimination of onchocerciasis in Ecuador. Ecuador worked in partnership with the MDP and a number of other organizations and now becomes the second country in the world to be free of this disease.
2015
WHO verifies the elimination of onchocerciasis in Mexico, the third country in the world to be free of river blindness.
Dr. William C. Campbell, Ph.D., is jointly awarded the Nobel Prize in Physiology or Medicine for the discovery of avermectin, which led to a treatment for river blindness. Dr. Campbell performed his Nobel Prize-winning work at MSD Research Laboratories in Rahway, N.J., where he worked from 1957 until his retirement in 1990.
2016
WHO verifies the elimination of onchocerciasis in Guatemala thanks to a partnership with the MDP and a number of other organizations. With this milestone, four of the six countries in the Americas historically at-risk for river blindness now have verified elimination of the disease.
2017
Togo becomes the first country in Africa recognized by WHO to have eliminated LF as a public health problem.
MSD announces an expansion of the MDP to reach up to an additional 100 million people per year through 2025 as part of the global effort to eliminate LF.
2019
WHO verifies the elimination of LF as a public health problem in Yemen. The Mectizan Expert Committee meets in Togo and presents the Ministry of Health with the Lymphatic Filariasis Elimination Award.
2020
WHO verifies the elimination of LF as a public health problem in Malawi.
2021
MDP and MSD announce a $500,000 donation to strengthen laboratory capacity to support onchocerciasis elimination in Africa in partnership with WHO’s Collaborating Centre for Onchocerciasis Diagnostics at the College of Public Health, University of South Florida.
2022
MSD and MDP mark the 35th anniversary of the program.
How Wilson, N.C., plays a critical role in our commitment to supply
Meet the North Carolina-based manufacturing team that’s producing and packaging our oral antiviral COVID-19 medicine
March 4, 2022
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From the earliest stages of the COVID-19 pandemic, we knew we had a responsibility to rise to the challenge of this unique moment. That’s why our teams mobilized like never before to ensure we were ready to address a global need.
In late 2020, our manufacturing teams began utilizing our global supply network — including sites in nine countries across three continents — to start production of our investigational oral antiviral COVID-19 medicine. This monumental effort made it possible for us to produce 10 million courses of therapy in 2021, with at least another 20 million on track for 2022.
A major part of that effort takes place in Wilson, North Carolina, where our colleagues are working tirelessly to carry out our mission and ensure supply during this crucial time.
“This is a perfect example of the company coming together as one team with a single goal,” said Francisco Toste, associate vice president, plant management at the Wilson site. “I am proud to work for our great company because of the impact that we make for patients around the world in helping them combat serious disease.”
Meet the team in Wilson behind this heroic effort:
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This website 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 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, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
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The information contained in this website was current as of the date presented. The company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date.
