Kite Conf Call - My notes
It’s really very impressive. They have prepared for launch in a very, very professional manner and they sound ready to go. They have a large pipeline of other indications and other products. Very worth reading.
Saul
David Chang - We’re extremely encouraged by the recent advisory committee meeting and it’s unanimous support for the risk-benefit of Novartis’ CAR-T therapy. We believe it was a major milestone for the field of cell therapy and provided clarity on how the FDA will view this innovative therapy as it enters the commercial space. We have just past the midpoint of FDA review of our BLA.
To date, the FDA has completed:
its mid-cycle review,
the inspection of our commercial manufacturing facility, and
the inspections of our clinical sites.
The FDA has informed us that they will not need to schedule an advisory committee meeting for axi-cel. We continue to work closely with them as their review moves towards the final phase.
There are also some important updates to the axi-cel program as we look beyond our first potential indications. In July, we submitted of our Marketing Authorization Application in Europe. As you may recall, axi-cel is being developed in Europe under Priority Medicines with Prime Designation. Our Marketing Authorization Application has been granted an accelerated assessment which shortens the review cycle time by 60 days. As we recently announced, we have also initiated the axi-cel clinical program in the EU having successfully treated the first patient. In the next few months, we expect to open additional clinical sites across the EU in order to expand our ongoing clinical studies. We believe this growing, firsthand experience with axi-cel in key European lymphoma and transplant institutions will be critical for the future of axi-cel in this market.
Clinical supply of axi-cel in Europe currently comes from frozen peripheral mononuclear cells at our central facility in El Segundo. We’re evaluating manufacturing options in Europe.
Throughout the remainder of this year and into 2018, we look to expand potential indications of axi-cel with the ZUMA-5 clinical trials in non-Hodgkin’s lymphoma as well as to plan ZUMA-7 clinical study in second line DLBCL. Last week we dosed the first patient in ZUMA-5. This study will involve patients with follicular lymphoma. We plan to enroll approximately 50 patients in this Phase II study.
We’re also moving KTE-C19 forward with ZUMA-3 in adult ALL, ZUMA-4 in pediatric ALL and ZUMA-8 in chronic lymphocytic leukemia. As well as our ongoing efforts in the U.S. and EU, our joint venture in China and our partnership in Japan, are aimed at ensuring that axi-cel will be available for patients globally.
Looking beyond axi-cel, KITE-585 our anti-BCMA CAR program for multiple myeloma has the potential to become the next significant product candidate for Kite. As we announced this morning, we have filed our investigational new drug application or IND with FDA for KITE-585. This underscores our commitment to accelerate development of KITE-585 and we’ll continue to leverage the experience we have gained from the axi-cel program both in clinical study design and execution and product manufacturing to advance KITE-585. Now I’d like to turn the call over to Shawn.
Shawn Tomasello - I’d like to cover the buildout and launch readiness preparations for Europe and the U.S. launch strategy and full operational readiness. The headline, yes, we’re ready.
So let’s start with Europe, with the announcement of our recent MAA filing and potential product approval, launch is now officially on the radar. Many of the critical components needed to unlock the value of axi-cel in Europe are in place. In 2016, Kite made the decision to commercialize axi-cel on our own in Europe and capitalizing on the footprint of our brilliant group of researchers at Kite EU in Amsterdam, we’re aggressively building out our operational infrastructure in Europe.
Our head of Europe, Chris Nowers, is leading the buildout of a stellar team of commercial, medical affairs and other cross functional teams in London. He has hired a General Manager in Germany and expects to announce soon the hiring of General Managers in additional key EU markets. We’re fully engaged with healthcare authorities and opinion leaders in the EU and are executing early marketing preparation and commercialization activities. Our clinical teams are working closely with EU investigators to ensure they understand Kite’s CAR-T technology as well as adverse event medical management.
Lastly, we also have the not-so-secret weapons of two highly experienced and deeply engaged board members: Ian Clark, most recently CEO of Genentech, and Franz Humer, previously Chairman and CEO of Roche. A year ago, the question we heard in Europe was, Kite who? Today, we hear, how can we work with Kite?
Coming soon is a potential approval of axi-cel in the U.S.
Yes, we will be launch-ready by September, to ensure that we’re prepared for an approval at any time. Our commercial headquarters and field-based teams are fully staffed, trained and ready for launch. Awareness of CAR-T therapy which is critical component for adoption, more than doubled from a year ago. We know from research that those health care providers who are aware of CAR-T therapy are more likely to refer or prescribe CAR-T therapy. Speed, service, reliability and ease-of-use will drive success.
We anticipate that our market-leading average manufacturing turnaround time of 17 days, combined with our Kite Connect service model will result in a positive, prescriber and patient experience. The controlled launch strategy is about maximizing the health care practitioner experience, while focusing on patient safety. Following FDA approval we expect to have at least 10 of the top centers in the US ready for final site activation. Beyond these initial centers, we’re actively working with over 30 additional sites, bringing them to our site readiness process. A process that will continue until we reach our ultimate target of 70 to 90 academic centers. The sites are fact accredited and many are creating dedicated cell therapy units within their respective institutions. As a result, they are prepared to treat patients, setting the stage for success with cell therapy in the months and years to come.
Kite Connect is a combination of people, systems and processes that holistically support a positive health care provider and patient caregiver experience with axi-cel. To prepare for execution at launch, we’re conducting end-to-end rehearsal dry runs at each site. These activities enable us and our centers to be confident in the logistics of our workflow processes surrounding axi-cel therapy. Reimbursement support for patients will be a component of Kite connect. Our market access teams have been laying the foundation for coverage and reimbursement, meeting multiple times with all of the national payers and the majority of regional payers. The teams have also held multiple meetings with CMS, centers for Medicare and Medicaid services and have also met with all 12 MACs or Medicare Administrative Contractors.
Our meetings with all payers have been consistently positive and productive and we’re confident in payer coverage of axi-cel. So let’s think about what happens following the day of approval. On day one, we will notify the centers so they can bring their teams together for final trainings on specifics around axi-cel by Kite commercial and medical teams. We expect centers will reach out to patients they’ve identified as candidate for axi-cel and we will be fully prepared to process and deliver the cell orders. In summary, our teams are excited and fully prepared to bring axi-cel to patients that have been waiting.