9 Common Men's Health Myths Debunked by Integrative Men's Health Expert

As the Chief Medical Officer of Vault Health– the first men’s telehealth startup offering direct-to-consumer prescription treatments testosterone replacement therapy to optimize their physical, sexual, and cognitive health– Dr. Myles Spar is an expert in integrative men’s healthcare and recognizes that accessible information is a good thing, but also knows that there’s a lot of inaccurate information out there.

"Whether it’s a well-meaning but misinformed blogger or a private company trying to dupe you into buying their supposed miracle cure, much of what you read online is just plain wrong. Don't be fooled by common health myths," says Dr. Spar.

Here are 5 “facts” that are completely false, as explained by Dr. Spar. 

Myth #1: Low testosterone only affects older men and my doctor has never recommended I get my T levels tested, so they must be fine.
Fact: In most men, testosterone begins to decline after age 30. Common symptoms of low testosterone include fatigue, increased risk of cardiovascular disease, erectile dysfunction, moodiness, inability to focus, lower energy levels, and the inability to lose belly fat. When getting T levels tested, Dr. Spar recommends men make sure they get a complete hormone panel (not just the total T levels), which is just like what his practice offers at Vault Health. “Based on the complete hormone panel, we're able to come up with a personalized testosterone replacement treatment plan available to help men reach their maximum cognitive, sexual, and physical performance,” he says.

Myth #2: Sleeping late on weekends helps you catch up.
Fact: Many of us have a tendency to push ourselves too hard and spread ourselves too thin. But if you think you can drive yourself into the ground during the week and then make up for it by sleeping in on the weekend, think again. In one recent study, researchers set out to determine if extra sleep on weekends could counteract the metabolic problems (like weight gain and reduced insulin sensitivity) often linked to insufficient sleep during the week. They found that not only did “catch-up” sleep not work to counter these issues, muscle- and liver-specific insulin sensitivity was worse in study subjects who had weekend recovery sleep. Dr. Spar says: "The main takeaway is that rather than depriving your body of sleep during the week and trying to make up for it on the weekends, it's best to try to stick to a schedule that allows you to get adequate rest every night."

Myth #3: Men hit their sexual peak at 18.
Fact: Contrary to popular belief, men are not at their sexual best when they’re teenagers. While it’s true that testosterone levels begin to spike around age 18, they continue to rise through the 20s and peak around age 30. This may explain why, according to one survey of over 12,000 people, men said they had the best sex of their lives at age 33. And testosterone isn’t the only factor when it comes to good sex. Dr. Spar says: "An older, more experienced man can have the kind of sex life he could only dream about at 18 (perhaps some of you who remember your early experiences with sex will not be surprised by this revelation). Of course, men of all ages can experience issues with sexual dysfunction."

Myth #4: More protein means more muscle.
Fact: Many people consume more protein than they need, believing it will lead to increased muscle mass. But research indicates that high protein intake doesn’t lead to bigger muscles. A 2018 study looking at the effect of extra protein on the bodies of older men found that eating a high-protein diet had no significant impact on lean body mass, muscle performance, or physical function.

Myth #5: A slowing brain, lower energy levels, decreasing libido, and drops in concentration are all normal parts of getting older that cannot be prevented. 
Fact: Men under the age of 65 shouldn’t feel their age at all, according to Dr. Spar. “If you’re feeling tired or have noticed a drop in your libido or concentration, there’s probably something going on with your health. It could be a change in diet, activity, increased stress, or something to do with hormones. Either way, it’s a big deal and should be addressed.” he says. There's actually a lot men can do to increase libido and energy levels and ensure men are operating at their optimal cognitive, physical, and sexual performance levels. If you experience any of these symptoms, it's best to set up a telehealth doctor's appointment to check your T levels and learn about the different treatment plans and supplements available. After a quick telemedicine visit, a personalized treatment plan can be shipped overnight to your door.

Myth #6: ED only affects older men, so I don’t have to worry.
Fact: Actually, mild and moderate cases of ED affect approximately 52% of men between the ages of 40 and 70. These can be caused not only by age, but also by stress, tension between your partner, alcohol use, depression, opioid use, smoking, heart disease, obesity, diabetes, and many other conditions that can occur in young men, too. Dr. Spar says: "There are many testosterone replacement therapy options and personalized treatment plans available, though, including Vault’s 'Sex Kit' which consists of two innovative treatments that work to help you get and maintain satisfying erections—regardless of age."

Myth #7: Your genes decide your fate.
Fact: If you think genetic predisposition means certain conditions are inevitable, think again. Far from being at their mercy, you can up and down-regulate your genes through lifestyle choices like diet, exercise, and stress management. As Dr. Spar explains, the ever-expanding field of epigenetics (the study of how chemical and environmental factors impact our genetic health) has revealed many ways in which we can influence our genes. For example, one study found people who ate more fruits and vegetables were less likely to develop a cardiovascular disease even if they carried copies of the gene that increases the risk of heart problems, effectively “turning off” the gene.

Myth #8: There’s no such thing as too much exercise.
Fact: As an IRONMAN triathlete, it probably goes without saying that Dr. Spar is a proponent of pushing yourself to the edge of your limits. But he also knows that overtraining, a topic he explores here can lead to injury and may even be detrimental to your mental health. Dr. Spar is all for setting goals in order to drive meaningful growth and stimulate true authentic expression of what matters to you, but not at the expense of your health.

Myth #9: Fat is bad.
Fact: There’s no doubt that consuming trans fats has negative consequences, especially when it comes to your heart. Harvard Health reports that the risk of heart disease rises by 23% for every 2% of calories from trans fats consumed daily. However, as Dr. Spar explains, “good” fats like those found in olive oil have actually been shown to improve heart health. Many studies indicate consuming olive oil can improve cholesterol and keep blood vessels healthy. And, much like fish oil, olive oil seems to be of special help to people at risk of developing heart problems. One randomized clinical trial found a link between olive oil consumption and reduced risks of cardiovascular disease and mortality in individuals at high cardiovascular risk.
 

According to Dr. Spar, it can be hard to cut through all the false information out there and resistance to taking care of ourselves is nothing new in the world of men’s health. "We know that men are more likely to repress whatever might be going on in our lives rather than address it with our medical providers. As a result, men are more likely to die from preventable causes than women. But it doesn’t have to be that way," he says.

For more information about men's health and wellness tips, facts, and myths debunked, visit www.vaulthealth.com.

Worried About Your Bones and Joints? Workouts to Try for Healthy Aging

There are a plethora of reasons why you tend to slow your activity rate as you grow old. It may be weight gain, poor health, pain issues, weakening muscles, or perhaps worries of failing. Or maybe you are worried about breaking your joints and bones. Whichever the reason, you are missing out on the healthy benefits of an active lifestyle at an old age.

Some studies indicate that physical activities play an important role in adding years to your life (even when you start exercising at an advanced age). Other benefits of exercises include boosting your energy levels, improving your general health, weight management, and maintaining your independence.

Having seen the benefits of exercising at an old age, it’s vital you add exercises into your health regimen. But what physical activities can the seniors take part in given their vulnerabilities? Stick on to find out.

Walking

Even though your health doesn’t permit you to carry out a structured workout, simply walk. Walking, even though it’s free, benefits your body by strengthening your bones, improving cardiovascular fitness, boosting muscle power and enhancing endurance.

Yoga

Yoga provides a holistic approach to fitness, which helps build muscle strength, increases mental health, and improves aerobic fitness, critical for seniors. Even though yoga has a low impact on your bones and joints, it’s still weight-bearing, which means you need to support your body with every posture. This is essential in strengthening both your muscles and bones.

Water Sports

Whether you are swimming, undertaking water aerobics, or playing Marco Polo, water exercises are essential for your heart and strengthening your muscles. And the good thing is that water exercises help you achieve these incredible benefits with minimal stress to your bones and joints.

What if you are not a swimmer? Worry not. You can undertake water aerobics classes on the shallow end of the pool.

Cycling

If you can’t run or engage in high-impact activities, cycling is an ideal exercise to increase your legs strength. Additionally, cycling helps improve cardiovascular health and bolsters cognitive performance in older persons.

If you are worried about bad weather or inaccessibility to cycling trails, don’t be. Indoor cycling is a worthwhile option to consider. And the good thing with a stationary bike is that you don’t need to worry about falls or wearing a helmet.

You can’t stop the clock, but you can slow its tick. By considering the above mentioned age-friendly exercises, you will be destined for a healthier life in your golden years. And while at it, you can also consider biodensity, which is a safe and effective exercise-based therapy in increasing bone density and bone strength among other health benefits.

Join the Fight Against Mental Illness: View Life Through Gratitude Lenses

San Diego, CA, January 12, 2021 — The lens through which we view our experiences in life can have a profound impact on how we react to the world around us. Following his father’s death by suicide, Daniel Hack had a decision to make. He could choose to be defined by the tragedy or use it as fuel to elevate his purpose and lift millions of others with him. He chose the latter. 

Daniel embarked upon a period of self-reflection, looking inward to uncover his authentic self and to cultivate a gratitude mindset — not just for himself but also for everyone he could reach. His vision materialized, resulting in Gratitude Lenses, a movement brand that includes not only quality sunglasses, but also a purpose-driven community that encourages life-seekers to live life through a lens of gratitude each and every day. 

Gratitude Lenses offers high quality, polarized sunglasses crafted from acetate material in two popular styles. Inside the arms of each pair are empowering quotes: “Live life through a lens of Gratitude” and “Make it a great day!” For every pair of sunglasses sold, the company gifts a pair of sunglasses, along with other resources, to a family impacted by suicide.

The sunglasses serve as everyday reminders that, in any situation, our reality is determined by the lens through which we view life and that, just like the sunglasses, each of us is made by design and put here for a purpose.

“We have a quality product with a message of gratitude that people resonate with,” Daniel said. “Our sunglasses spark real conversations and serve as reminders to live life through a lens of gratitude.”

Additionally, those who join the Gratitude Community get exclusive access to a Daily Gratitude Affirmation app and an online community of positive-conscious people who provide encouragement and reminders to slow down and be grateful. 

Founded by Daniel Hack in 2020, Gratitude Lenses is a movement brand for life-seekers who desire daily reminders to be in a place of joy, to live healthier and to live a life of purpose. The company’s vision is to transform communities by inspiring people throughout the world to live joy-filled lives while practicing gratitude and being fully present.

To learn more, please visit https://gratitudemovement.co or follow the company on Instagram at www.instagram.com/gratitudelenses/.

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Health Canada approves Lundbeck's (Pr)VYEPTI® (eptinezumab)—the first and only intravenous preventive treatment for migraine

MONTREAL, Jan. 12, 2021 /CNW Telbec/ - Lundbeck is pleased to announce that VYEPTI^® (eptinezumab) has been approved by Health Canada for the preventive treatment of migraine in adults who have at least 4 migraine days per month.

Michal Juul Sørensen, Vice President and General Manager of Lundbeck Canada, comments, "This is an important moment in migraine prevention. VYEPTI^® is an exciting addition to Lundbeck's biopharmaceutical portfolio—one that brings an additional option to Canadians living with migraine and the physicians who support them."

VYEPTI^® is the first Health Canada-approved intravenous (IV) treatment for migraine prevention. Its unique administration delivers prevention of migraine, with effects seen as soon as day one post-infusion through to 3 months.¹ Canadian healthcare professionals and people living with migraine will soon have access to this new treatment option that has demonstrated effective therapeutic results in clinical trials. As a 30-minute IV infusion administered every 12 weeks, VYEPTI^® offers patients with migraine a preventive therapy through 4 treatments per year.

With a novel route of administration in migraine prevention, VYEPTI^® will be complemented by a patient support program to facilitate and support the administration of this IV treatment in people with migraine.

Chair of Migraine Canada and President of the Canadian Headache Society, neurologist Dr. Elizabeth Leroux comments, "With the approval of VYEPTI^®, a new IV option has been added to our therapeutic arsenal—a preventive option that has demonstrated 50% and 75% responder rates and good tolerability. This could mean rapid and sustained relief for many people with frequent migraine."

"We are pleased to learn that a new medication to prevent migraine has been approved by Health Canada. Timely and equitable access to new treatment options is necessary for Canadians living with this painful and disabling condition. This is a hopeful time for patients." said Wendy Gerhart, Executive Director at Migraine Canada. 

About VYEPTI^®
VYEPTI^® is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of VYEPTI^® was demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraineand PROMISE-2 in chronic migraine, which also included patients with a dual diagnosis of chronic migraine and medication overuse headache)^2,3. In both studies, VYEPTI^® met its primary endpoint of decrease in mean monthly migraine days (MMD) over Weeks 1-12.

Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of VYEPTI^® as early as Day 1 post-infusion. The safety of VYEPTI^® was evaluated in 2,076 adult patients with migraine who received at least one dose of VYEPTI^®. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.

The full VYEPTI^® Product Monograph is available on Lundbeck Canada Inc. website.

About migraine
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches, typically accompanied by an array of symptoms including nausea, vomiting, and sensitivity to light or sound. It is estimated to affect 2-3 million Canadians and more than 1.3 billion worldwide, and impacts three times as many women than men.⁴

Migraine is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among patients aged 15 to 49 years, according to the Global Burden of Disease study.⁵  Migraine has a profound impact on people's lives, their relationships, as well as their ability to carry out activities of daily living. It has been estimated that migraine accounts for 7 million lost working days annually in Canada.⁴

Lundbeck contact
Lundbeck is dedicated to keeping physicians informed about the status and availability of VYEPTI^® in Canada. In addition to requested communications including emails from head office and representatives, physicians can also contact Lundbeck Canada General Inquiries at 1-800-586-2325 Ext. 5.

About Lundbeck
Lundbeck is a global biopharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centres in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (CAD 3.5 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com/ca/en.

SOURCE Lundbeck Canada Inc.

For further information:

Media Relations Contact, Caroline Desautels, Public Relations and Communication Consultant, 514-772-0704, cdesautels@toctoccommunications.com

Caught in the Grip of COVID Stress? 
Nine Quick and Easy Ways to Stop Stress in the Moment 
Even when stress levels skyrocket, you can reclaim a sense of calm and control. 
Mark Goulston, MD, and Diana Hendel, PharmD, share simple ways 
frontline healthcare employees can lower their stress anytime, anyplace. 

          Nashville, TN (January 2021)—After a year of fighting COVID-19, no one doubts the toughness, drive, or dedication of healthcare workers. But the pandemic has still taken a crushing toll on our frontline heroes. Though many put on a brave face, their stress levels are at an all-time high, say Diana Hendel, PharmD, and Mark Goulston, MD. And if you’re caught in the grip of COVID-related stress, it’s better to take decisive action in the moment than to ignore it until it escalates into something more serious.

          “No matter how much you pride yourself on staying calm under pressure, it’s important to mitigate stress, especially when you are in the middle of your shift and can’t leave,” says Diana Hendel, PharmD, coauthor along with Mark Goulston, MD, of Why Cope When You Can Heal?: How Healthcare Heroes of COVID-19 Can Recover from PTSD(Harper Horizon, December 2020, ISBN: 978-0-7852-4462-2, $17.99). 

          “No one thrives while they are in perpetual survival mode,” adds Dr. Goulston. “Constantly feeling afraid, exhausted, and overwhelmed is dangerous and puts you at risk for burnout—something neither you nor our community can afford right now.”

          The authors say every healthcare worker should have a tool kit of “stress stoppers” at their fingertips. For example: 

Do frequent self “check-ins” to recognize when your stress levels are rising. When you’re busy and under pressure to perform, it’s easy to go on “autopilot.” Therefore, periodically pause and do a quick self-assessment throughout the day. Consider your emotional state (Do I feel friendly and engaged, or edgy and aggressive?) as well as your physical state (Is my body calm and at ease, or is it holding onto tension?). 

“Take 20 or 30 seconds to scan your body and identify areas that may be holding onto tension or stress,” says Dr. Hendel. “For example, you might be carrying tension in your jaw or shoulders. When you notice an area that is tense, gently release the tension. Over time it should become easier to recognize when stress begins to take hold—and to do something about it.” 

Ground yourself when you start feeling overwhelmed. Grounding is a great way to reduce anxiety and arrive in the here and now. Use it anytime you feel carried away by anxious thoughts or feelings, or triggered by upsetting memories and flashbacks. 

• Find a comfortable place to sit (or stand). If sitting, rest your hands on your legs. Feel the fabric of your clothing. Notice its color and texture. 
• Next, bring your awareness to your body. Stretch your neck from side to side. Relax your shoulders. Tense and relax your calves. Stomp your feet. 
• Look around and notice the sights, sounds, and scents around you for a few moments. 
• Name 15-20 things you can see. For example, the floor, a light, a desk, a sink. 
• As you keep looking around, remind yourself that “The flashback or emotion I felt is in the past. Right now, in this moment, I’m safe.” 

Pause and take a few deep breaths. We tend to hold our breath whenever we are stressed, but this only exacerbates feelings of anxiety and panic. Instead, use “box breathing” to calm yourself and heighten your concentration. Box breathing is the technique of taking slow, deep, full breaths. Here’s a tutorial for when you’re feeling triggered. 

Slowly exhale your breath through your mouth. Consciously focus on clearing all the oxygen from your lungs. Inhale slowly and deeply through your nose for four slow counts. Hold your breath for four more slow counts. On the next four counts, exhale again through your mouth until your lungs are empty. Hold your breath again for a final slow count of four beats. 

Reach for something that anchors you in the present moment. Carry a small reminder of what you love about your life and focus on it if you feel triggered and need to center yourself. It might be a photo of your kids or pet, a small rock you picked up on a scenic nature hike, or a special necklace. Think of the gratitude you feel for your life whenever you look at this token. 

Keep something that makes you laugh nearby. Humor is a great way to alleviate stress. Tape a clip of a funny cartoon to your work area or carry a small notebook with jokes that make you laugh every time you read them. 

Use calming affirmations to give you strength and peace. Written positive statements can give you a lift when you feel yourself sinking. If self-talk is not for you, imagine a supportive other saying these to you in your mind’s eye. A few examples: 

• I am great at my job, and my training and skills are empowering. 
• I feel energized and ready for anything the day has in store for me. 
• I accept myself as I am. I am enough. 
• I am safe in this moment. 

Let your feelings out (when possible). At times you may find you need to step away from your duties for a few minutes and give those intense emotions some “breathing room.” Try to move to a different room so you can cry or discreetly express your feelings. Sometimes you need to release the stress that’s built up in your body, and finding a private place to let the tears fall or vent for a few minutes can lighten your stress and enable you to get back to work. 

Play a mind game. “If there is no way to speak to someone else and you need comfort in the moment, imagine talking to someone who loves you,” says Dr. Goulston. “Imagine that they are listening and lovingly holding and encouraging you. As you hear them talking and walking you through it, you will feel their love and belief in you. This kind of mental pep talk can be a bridge until you are able to speak your feelings to somebody in person.” 

Head outdoors for a few minutes. If at all possible, try to get outside for a few minutes of fresh air. Take deep breaths, stretch your arms and legs, and take in the gifts of nature around you. And if possible, find someone else who is on a break and invite them for a 10-minute walk so the two of you can blow off steam. 

          Don’t just turn to these strategies when you feel stress or anxiety rising in your mind or body. Intentionally practice them daily—even if you are feeling calm and in control. Stress management is a skill you must work at until it becomes a natural part of your life. 

          “Managing stress is a key to resilience and a valuable life skill,” concludes Dr. Hendel. “If you can learn to control your stress levels during a pandemic, you will be more than prepared to meet and conquer other challenges further down the road.”

# # #

About the Authors: 
Mark Goulston, MD, FAPA 
Dr. Mark Goulston is the coauthor of Why Cope When You Can Heal?: How Healthcare Heroes of COVID-19 Can Recover from PTSD (Harper Horizon, December 2020) and Trauma to Triumph: A Roadmap for Leading Through Disruption and Thriving on the Other Side (HarperCollins Leadership, Spring 2021). He is a board-certified psychiatrist, fellow of the American Psychiatric Association, former assistant clinical professor of psychiatry at UCLA NPI, and a former FBI and police hostage negotiation trainer. He is the creator of Theory Y Executive Coaching—which he provides to CEOs, presidents, founders, and entrepreneurs—and is a TEDx and international keynote speaker. 

He is the creator and developer of Surgical Empathy, a process to help people recover and heal from PTSD, prevent suicide in teenagers and young adults, and help organizations overcome implicit bias. 

Dr. Goulston is the author or principal author of seven prior books, including PTSD for Dummies, Get Out of Your Own Way: Overcoming Self-Defeating Behavior, Just Listen: Discover the Secret to Getting Through to Absolutely Anyone, Real Influence: Persuade Without Pushing and Gain Without Giving In, and Talking to Crazy: How to Deal with the Irrational and Impossible People in Your Life. He hosts the My Wakeup Call podcast, where he speaks with influencers about their purpose in life and the wakeup calls that led them there. He also is the co-creator and moderator of the multi-honored documentary Stay Alive: An Intimate Conversation About Suicide Prevention. 

He appears frequently as a human psychology and behavior subject-area expert across all media, including news outlets ABC, NBC, CBS, and BBC News, as well as CNN, Today, Oprah, the New York Times, the Wall Street Journal, Forbes, Fortune,Harvard Business Review, Business Insider, Fast Company, Huffington Post, and Westwood One. He was also featured in the PBS special “Just Listen.” 

Diana Hendel, PharmD 
Dr. Diana Hendel is the coauthor of Why Cope When You Can Heal?: How Healthcare Heroes of COVID-19 Can Recover from PTSD (Harper Horizon, December 2020) and Trauma to Triumph: A Roadmap for Leading Through Disruption and Thriving on the Other Side (HarperCollins Leadership, Spring 2021). She is an executive coach and leadership consultant, former hospital CEO, and author of Responsible: A Memoir, a riveting and deeply personal account of leading during and through the aftermath of a deadly workplace trauma. 

As the CEO of Long Beach Memorial Medical Center and Miller Children’s and Women’s Hospital, Hendel led one of the largest acute care, trauma, and teaching hospital complexes on the West Coast. She has served in leadership roles in numerous community organizations and professional associations, including chair of the California Children’s Hospital Association, executive committee member of the Hospital Association of Southern California, vice chair of the Southern California Leadership Council, chair of the Greater Long Beach Chamber of Commerce, board member of the California Society of Health-System Pharmacists, and leader-in-residence of the Ukleja Center for Ethical Leadership at California State University Long Beach. 

She earned a BS in biological sciences from UC Irvine and a Doctor of Pharmacy degree from UC San Francisco. She has spoken about healthcare and leadership at regional and national conferences and at TEDx SoCal on the topic of “Childhood Obesity: Small Steps, Big Change.”

About the Book:  
Why Cope When You Can Heal?: How Healthcare Heroes of COVID-19 Can Recover from PTSD (Harper Horizon, December 2020, ISBN: 978-0-7852-4462-2, $17.99) is available in bookstores nationwide and from major online booksellers. 

To learn more, please visit https://whycopewhenyoucanheal.com/.

Incyte and MorphoSys Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab

MONTREAL and PLANEGG/MUNICH, Germany, Jan. 12, 2021 /CNW/ - Incyte (NASDAQ: INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT). 

"With the acceptance of the NDS by Health Canada, review of the data can begin, an important step on the path to making tafasitamab available in Canada for use in combination with lenalidomide in eligible patients with relapsed or refractory DLBCL," said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. "We intend to work closely with Health Canada as we seek to bring this innovative targeted therapeutic option to the clinical community and to appropriate patients for whom few treatment options exist." 

"This important milestone moves tafasitamab in combination with lenalidomide into the regulatory review process in Canada, with the potential to significantly advance patient care in the treatment of relapsed or refractory DLBCL," said Nuwan Kurukulasuriya, Ph.D., Senior Vice President Global Medical Affairs, MorphoSys. 

The NDS, submitted by Incyte, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL not eligible for autologous stem cell transplant, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. 

Incyte has exclusive commercialization rights for tafasitamab outside of the United States and, if approved, Incyte will hold the marketing authorization for tafasitamab in Canada. This NDS marks the second marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide¹, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter²,  leading to a high medical need for new, effective therapies³, especially for patients who are not eligible for an autologous stem cell transplant in this setting.

About L-MIND
The L-MIND trial is a single arm, open-label, multicentre Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant The study's primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085

About RE-MIND
RE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.

For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb^® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Following approval by the U.S. Food and Drug Administration in July 2020, tafasitamab is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

XmAb^® is a registered trademark of Xencor, Inc.

The safety and efficacy of tafasitamab is under review and the market authorization in Canada has not yet been obtained.

About Incyte 
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. 

About MorphoSys
MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya^®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi^® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. 

Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.

Monjuvi^® is a registered trademark of MorphoSys AG.

Tremfya^® is a registered trademark of Janssen Biotech, Inc.

Incyte Forward-looking Statements 
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when tafasitamab might be approved in Canada for the treatment of, and whether or when tafasitamab might provide a successful treatment option for, in combination with lenalidomide, certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and the L-MIND and RE-MIND clinical trial programs. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by Canadian regulatory authorities or other regulatory authorities, including the U.S. FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements. 

MorphoSys Forward-looking Statements 
This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

SOURCE Incyte Biosciences Canada

For further information:

Incyte: Media Contacts: Catalina Loveman, Executive Director, Public Affairs, Tel: +1 302 498 6171, cloveman@incyte.com; Jenifer Antonacci, Senior Director, Public Affairs, Tel: +1 302 498 7036, jantonacci@incyte.com; Investor Contacts: Dr. Michael Booth, Division VP, IR & Global Responsibility, Tel: +1 302 498 5914, mbooth@incyte.com; Christine Chiou, Senior Director, Investor Relations, Tel: +1 302 274 4773, cchiou@incyte.com; MorphoSys: Media Contacts: Thomas Biegi, Vice President, Tel.: +49 (0)89 / 89927 26079, thomas.biegi@morphosys.com; Jeanette Bressi, Director, US Communications, Tel: +1 617 404 7816, jeanette.bressi@morphosys.com; Investor Contact: Dr. Julia Neugebauer, Senior Director, Investor Relations, Tel: +49 (0)89 / 899 27 179, julia.neugebauer@morphosys.com; Myles Clouston, Senior Director, Investor Relations, Tel: +1 857 302 7575, miles.clouston@morphosys.com

Multi-Cultural Channel for Youth on YouTube collaborates with world’s leading ebook app to offer youth both an audience and the opportunity to learn modern literacy skills for a changing world.

NEW YORK (PRWEB) JANUARY 12, 2021

Questions around shrinking attention spans have been a popular area of research, but is it about quantity or is it about quality?

Over 100 million ebooks have been created using Book Creator’s worldwide app, making it one of the essential apps for schools everywhere using iPads. Now Book Creator (No. 1 on the iTunes App Store in 90+ countries) is launching its first Write a Story in One Page which the Planet Classroom Network will feature on its YouTube Channel to build more awareness for original stories authored by youth.

“We have the privilege of presenting Book Creator as a curator on our platform,” says co-founder and author C.M. Rubin (Cathy). In an age when the average human attention span is rapidly decreasing, we loved the concept of a youth story-telling challenge in just one page. Learning the skills to make story-telling more innovative, entertaining, engaging and relevant to a changing world will help youth build confidence and sharpen their communication and critical-thinking skills.”

“We are very excited to be associated with Planet Classroom in this brilliant initiative. Literacy is such an important skill, but we know that a lot of kids today are not motivated to write. We believe that's because they don't have an audience for their writing,” noted Dan Kemp, Marketing and Community Manager Book Creator.

Learn More

For more information on Planet Classroom

Visit the Planet Classroom Network YouTube channel

Contact Information:

David Wine

David(at)cmrubinworld(dot)com

About The Planet Classroom Network

The Planet Classroom Network, organized by CMRubinWorld, brings together musicians, dancers, video game creators, filmmakers, learning innovators and emerging technologists from all over the world to entertain, educate and engage youth, and to provide a rich cultural experience at a time when art and learning institutions everywhere are not accessible. Curators and content contributors include Global Nomads, Global Oneness, the Martha Graham Dance Company, Commffest, KIDS FIRST!, Dream a Dream Foundation, OddWorld Inhabitants, Psyon Games, Challenge 59, LXL Ideas, Alliance for Young Artists & Writers/Scholastic Art & Writing Awards, Creative Visions Foundation, Battery Dance, SIMA Classroom, Young Voices for the Planet, Bard Conservatory, Taking It Global, Materials for the Arts, Book Creator, XTalks, NFFTY, Young People’s Chorus of New York City, The International Forum for the Literature and Culture of Peace, Ryan Wong Classroom, The Global Search for Education, Voice America, Rocketium and Brandartica. Young people from around the world played a significant role in conceptualizing, creating, and producing the network’s vision and programming.

The Fertility Partners Welcomes Another IVF Centre to its Growing Network, The Toronto Institute For Reproductive Medicine, and Acquires Sperm Bank ReproMed

The rapidly growing partnership of leading fertility clinics expands its Ontario presence

TORONTO, Jan. 13, 2021 /CNW/ - The Fertility Partners ("TFP"), Canada's leading platform of fertility practices, announced today the acquisition of The Toronto Institute For Reproductive Medicine (TTIRM) and ReproMed. With the west-end Greater Toronto Area (GTA) fertility treatment providers joining its network of partner clinics, TFP has expanded its presence in the GTA to 5 locations and expands its high-quality Canadian donor sperm services. 

The Fertility Partners launched in 2019 and continues to solidify its commitment to being the business partner of choice with Clinicians and Researchers, making it the fastest-growing network offering comprehensive fertility treatment and associated services in the country. The network delivers all aspects of reproductive medicine, a wide range of laboratory diagnostics, and is supported by world-renowned Physicians, Research Scientists, Embryologists and Andrologists. Since July 2020, the combined group of companies has grown to 9 clinics with full IVF laboratories, across 21 locations in 5 provinces.

As a world-class business partner of choice for leading fertility centres across North America, The Fertility Partners aims to support its partner clinics by collaborating on medical, strategic and operational best practices, investing in new technologies, promoting research and development, and offering synergistic back-office support. The TFP partner model empowers physicians and their teams to focus on what they do best – provide the highest quality medicine and patient-focused fertility care.

"Dr. Alfonso Del Valle and his team are highly dedicated to providing optimal clinical outcomes and compassionate patient care," says Dr. Andrew Meikle, TFP Founder, CEO & Executive Chairman. "With values well-aligned with TFP, TTIRM and ReproMed will undoubtedly have a positive impact on our collective goals to foster global best clinical outcomes, achieve an international reputation for excellence, and deliver exceptional patient and employee experiences."

Since 1990, the TTIRM team has been committed to continuous innovation and research into the most effective new procedures and technologies available in infertility treatment, which has helped thousands of couples fulfill their dream of having a family.

"The Toronto Institute for Reproductive Medicine and ReproMed teams are excited for the opportunity to build on our decades-long success in delivering excellent patient care, and to partner with other leading fertility care providers and centers" says Dr. Alfonso P. Del Valle, MD FRCS(C), TTIRM and ReproMed founder and Medical Director. "By joining the TFP network, we look forward to furthering our ability to provide patients both local and international with world-class services and experiences." 

"With the strong leadership of Dr. Del Valle, the TTIRM and ReproMed teams have built an admired practice known for its high pregnancy success rates and internationally-recognized research achievements.," says Dr. Al Yuzpe, Chief Medical Officer at TFP. "We're proud to welcome them to the TFP network where they will be a valued contributor to our collective goal of expanding services and elevating the experience of fertility care for patients."

About The Fertility Partners

The Fertility Partners ("TFP") is a new venture creating a network of fertility clinics across North America. The combined group of companies includes 9 clinics and 21 locations across 5 Canadian provinces, with further growth to include additional IVF clinic acquisitions, de novo clinics and the development of adjacent services. The company aims to be a world-class business partner of choice for leading IVF and prenatal practitioners with the goal of achieving best clinical outcomes, operational excellence and exceptional patient experiences. TFP provides partner clinics with back-office support and a collaborative, synergistic medical-scientific, professional and business environment. www.thefertilitypartners.com

About The Toronto Institute For Reproductive Medicine and ReproMed

The collective mission of The Toronto Institute For Reproductive Medicine (TTIRM) and ReproMed is to provide the highest quality of compassionate and comprehensive health care services for the treatment of male and female infertility. Since 1990, the physicians and professional staff at TTIRM and ReproMed have been committed to providing cutting-edge reproductive technology and surgical techniques, and have helped thousands of couples fulfill their dreams of becoming parents. TTIRM and ReproMed are at the forefront of reproductive sciences, with high pregnancy success rates and internationally-renowned research achievements. The TTIRM and ReproMed facility is located in the west-end of the Greater Toronto Area (GTA). www.repromed.ca 

SOURCE The Fertility Partners

Health Canada Approves IMBRUVICA®* (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients treated with FCR, a chemoimmunotherapy regimen

TORONTO, Jan. 13, 2021 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved IMBRUVICA^® (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).ⁱ Today's milestone marks the tenth Health Canada approval for IMBRUVICA^® across five disease areas and is the fifth approval for IMBRUVICA^® in CLL.ⁱⁱ

This latest approval is based on the Phase 3 ECOG1912 study (also referred to as E1912) that demonstrated newly diagnosed patients age 70 or younger (median age of 58) treated with IMBRUVICA^® plus rituximab had significantly improved progression-free survival (PFS) compared to patients treated with fludarabine, cyclophosphamide and rituximab (FCR). ⁱⁱⁱ  The risk of disease progression or death was reduced by 66 per cent in the IMBRUVICA^® arm compared with FCR, with a median follow-up time of 37 months.^iv

"For younger patients, chemoimmunotherapy is a common first-line treatment," says Dr. Matthew Kang*, Hematologist, Joseph Brant Hospital Oncology Clinic, Assistant Clinical Professor, McMaster University. "With this new indication for IMBRUVICA^®, we have entered a new treatment era, one that is targeted, chemotherapy-free, and shown to help patients live longer without disease progression."

This approval was granted under a modified version of the newly established Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for submission and review of oncology medicine applications among international regulatory agencies.^v This initiative gives international regulators the ability to provide patients with cancer earlier access to important medicines.^vi 

"We commend the ECOG-ACRIN Cancer Research Group and the National Cancer Institute for conducting a robust study that has generated insightful and landmark results in the treatment of CLL," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "We are committed to the continued study of IMBRUVICA-based regimens and building upon the efficacy and safety of the most comprehensively studied Bruton's tyrosine kinase (BTK) inhibitor in our efforts to improve the lives of patients facing a blood cancer diagnosis."

About the ECOG1912 Study
The randomized, multi-centre, open-label, controlled Phase 3 E1912 study was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health in the United States.^vii

The study evaluated 529 previously untreated CLL patients ages 70 years or younger (median age of 58) who were randomly assigned to receive IMBRUVICA^® plus rituximab (n=354) or the chemoimmunotherapy FCR (n=175) and the primary endpoint was PFS as assessed by an independent review committee, according to the International Workshop on CLL.^viiiWith a median follow-up time on study of 37 months, a PFS benefit was observed for the IMBRUVICA^® plus rituximab arm as compared to the FCR treatment arm (hazard ratio [HR], 0.34; 95 per cent confidence interval [CI], 0.22-0.52; p<0.0001).^ix With a median follow-up time of 49 months, median overall survival was not reached with a total of 23 deaths: 11 (3 per cent) in the IMBRUVICA^® plus rituximab arm and 12 (7 per cent) in the FCR treatment arm.^x

The most commonly occurring adverse reactions in studies of CLL patients treated with IMBRUVICA^® (≥20%) were neutropenia, diarrhea, fatigue, musculoskeletal pain, rash, thrombocytopenia, anemia, bruising, nausea, hemorrhage, cough, pyrexia, arthralgia, headache, upper respiratory tract infection and hypertension.^xi

About Chronic Lymphocytic Leukemia (CLL)
CLL is a cancer that begins in blood stem cells, starting in abnormal lymphoid stem cells. It usually develops slowly over the course of months or years.^xii In 95 per cent of cases, the abnormal lymphoid stem cells develop into cancerous, or malignant, B lymphocytes. CLL is one of the most common types of leukemia in adults.^xiii Over 2,200 people in Canada are diagnosed with CLL each year.^xiv

About IMBRUVICA^®
IMBRUVICA^® contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK), and it is the only once-daily BTK inhibitor in Canada. Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread.^xv

IMBRUVICA^® was first approved in Canada in 2014. It is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL),^xvi including those with 17p deletion; or adult patients with CLL who have received at least one prior therapy, including those with 17p deletion.^xvii It is indicated in combination with bendamustine and rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and in combination with obinutuzumab for treatment-naïve adult patients with CLL.^xviii It is now also indicated in combination with rituximab for the treatment of adult patients with previously untreated CLL.^xix

For adult patients with Waldenström's macroglobulinemia (WM), IMBRUVICA^® is indicated as a single agent or in combination with rituximab.^xx Other indications are for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL); patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy; and for patients with steroid dependent or refractory chronic graft-versus-host disease (cGVHD).^xxi

IMBRUVICA^® is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. commercializes IMBRUVICA^® in Canada.

About the Janssen Pharmaceutical Companies of Johnson & Johnson 
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. 

Learn more at www.janssen.com/canada. Follow us at @JanssenCanada. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. 

*All trademark rights used under license. 

**Dr. Kang was not compensated for any media work. He has been compensated as a consultant.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding IMBRUVICA^® (ibrutinib). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

SOURCE Janssen Inc.