An internal news brief for KISQALI® (ribociclib) global associates             Go To Launch Meeting Update             Are you ready to Go To Launch (GTL)? Preparations are set, strategies are in place, and tools and materials have been developed. Now it's on to Barcelona to bring it all together and create the Winning Formula for global launch success. More than 300 cross-functional Novartis associates from 58 countries will gather for 1.5 days to acquire the knowledge and resources needed to successfully launch KISQALI in their countries. It takes a lot to succeed in this competitive marketplace. The Winning Formula includes a great product, powerful data, and so much more: your energy, motivation, and expertise, which are critical to driving success!             We'll work as a team to gain a deeper understanding of the medical, commercial, and market-access strategies, as well as the M2 (MONALEESA-2) pivotal trial. We'll also have a chance to practice how we're going to execute our strategy, function by function. This will be accomplished not as individuals, but as a group. We'll learn from each other and teach one another, as only Novartians can!             US Label Receives FDA Approval!                 KISQALI Now Approved announcement on display on the Thomson Reuters digital screens in Times Square, New York City.       The US Launch meeting took place in Las Vegas, Nevada, the week of March 13. As luck would have it, the FDA chose that Monday afternoon to announce that KISQALI was approved in the US. The well-prepared team never missed a beat as the Launch meeting became Launch Day, with materials and website ready to go live. The marketers, sales representatives, and other team members on hand were exuberant after hearing the breaking news. "KISQALI is emblematic of the innovation that Novartis continues to bring forward for people with HR+/HER2– metastatic breast cancer," said Bruno Strigini, CEO, Novartis Oncology. "We at Novartis are proud of the comprehensive clinical program for KISQALI that has led to today's approval and the new hope this medicine represents for patients and their families." "This is a significant result for women with this serious form of breast cancer," said Gabriel N. Hortobagyi, MD, Professor of Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, and MONALEESA-2 Principal Investigator. "These results affirm that combination therapy with a CDK4/6 inhibitor like ribociclib and an aromatase inhibitor should be a new standard of care for initial treatment of HR+ advanced breast cancer." This approval means that, as Novartis team members, we can proudly add another important chapter to our heritage and our 30+ years of commitment to the treatment of patients with breast cancer. To view the final US package insert, click here.             They're Talking About Us       We all know KISQALI is something special and it's nice to know we aren't alone. In truth, the word is out, and of course our top-notch public relations team has played a key role in getting people talking about KISQALI. Check out some of the headlines that we've been making:     From FirstWord Pharma, M‍arch 15, 2‍017       Physician Views Poll Results: Ibrance to remain in pole position, but Novartis' Kisqali looks primed for oncologist adoption       "FirstWord snap-polled 30 US-based oncologists to gauge sentiment towards Novartis' Kisqali..."     From ENDPOINTS NEWS, M‍arch 14, 2‍017       UPDATED: Watch out Pfizer, Novartis' LEE011 bags quick OK for frontline use against breast cancer       "The drug, also known as ribociclib, hits the market as KISQALI, with peak sales estimates of around $2.5 billion a year, giving the pharma giant a clear shot at a new blockbuster franchise."     From FiercePharma, M‍arch 13, 2‍017       Novartis rolls out flex pricing scheme for newly approved Ibrance rival Kisqali       "...EP Vantage has pegged Novartis' entrant as the seventh biggest that'll roll out this year, with an estimated $1.6 billion in 2022 sales."             Next Launch Countries: Ready to Go       The FDA approved KISQALI in the US on March 13, setting the tone for a very exciting year, with more regulatory milestones expected globally. Here's a partial list of when and where we expect KISQALI to be available next.                   The Amazing Journey of Our KISQALI Tablets             When you consider the supply chain for KISQALI, we think you'll agree that it's a good thing that medicine doesn't get jet-lagged. This is because each and every KISQALI tablet followed a complex path, criss-crossing the globe, before finally landing on a pharmacy shelf and then finding its way into the hands of a patient with advanced or metastatic HR+/HER2– breast cancer.         • KISQALI began its journey in the UK at the Novartis Grimsby site, where the active ingredient was formulated     • From there it was shipped to Singapore, where the tablets were produced     • Next, the tablets jetted back to Europe, to the Novartis plant in Wehr, Germany, where they were placed in blister packs     • After a quick hop over the Alps, our blister packs landed in the final distribution center in Switzerland, where they awaited their final destination     • Tablets destined for the US were packed by hand into dose packs before being shipped to our distribution hub in the state of Pennsylvania, ready to be sent to pharmacies and patients across the US     • And, on M‍arch 15, the first US order was fulfilled!       Phew. Wouldn't it be great to have all those frequent-flyer miles?       KISQALI—Truly a Global Treatment!       The Wehr, Germany, team with some finished blister packs ready to go to the US. M‍arch 15: First US KISQALI order fulfilled.             CompLEEment-1 Trial Going Strong             UPDATE       CompLEEment-1 is full speed ahead. This is a phase IIIb study evaluating the safety and tolerability of ribociclib + letrozole in a broader HR+/HER2– advanced breast cancer patient population. The trial is intended to generate additional real-world safety and efficacy data in a global community setting. With 7 countries, 101 sites, and 98 patients already enrolled as of A‍pril 3, we are well on our way to establishing a new standard of excellence with this important study.     Total number enrolled as of A‍pril 3: 98 patients                   Did You Know? An update from our ongoing KISQALI market research       Did you know:       96% of physicians in Germany, 78% of physicians in France, and 68% of physicians in the UK reported that they routinely perform ECGs with their metastatic breast cancer patients at or prior to initiation of therapy.       ECG monitoring is not uncommon in metastatic breast cancer, and many physicians are already routinely conducting the test. However, given that Ibrance® (palbociclib) does not have this requirement in its label, it will be important to evaluate whether offering a local solution to reduce any perceived patient burden is appropriate for your market. Contact Maria MacTaggart to access the full global market research report for additional insights on how physicians perceive ECG monitoring and the potential impact for KISQALI. As more news comes in, we'll keep you posted on what's going on! —Your Global KISQALI Launch Team This newsletter is for internal use only and is not to be shared or disseminated outside of Novartis. Please consult with your local regulatory and legal teams before incorporating any data or information contained in this newsletter. All trademarks are the property of their respective owners.               Novartis Pharma AG CH-4002 Basel S‍witzerland ©2017 Novartis 3‍/17 G-RIB-1160117