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ONYX Pharmaceuticals, AŞ Message Board

  • ahhaha2 ahhaha2 Nov 2, 2012 11:45 PM Flag

    The CC, status of Kyprolis rollout

    Helen I. Torley - Chief Commercial officer and Executive Vice President

    Beginning with Kyprolis, I'm pleased to report that net sales in the third quarter, following our approval on July 20, were $19 million. This number reflects orders placed and product received by clinics and hospitals. Let me bring some additional color to the market dynamics and product demand we're seeing in this initial launch period. Importantly, there is a clear recognition of the unmet need that exists for the estimated 10,000 to 15,000 patients annually who have receive bortezomib (e.g.,Velcade, from Millenium) and an IMiD and have progressed on or within 60 days of their last therapy, aside the opportunity to spend time in the field with our experienced oncology team in the last several weeks and have seen that this recognition has resulted in good access to health care practitioners through indicatingly strong interest in learning more about using Kyprolis.

    While our promotional efforts are being focused on approximately 2,000 clinics and hospitals where the majority of the Kyprolis-indicated patients are currently managed, our initial priority has been to call in those attendants with the highest volume of potential patients and those centers that participated in the expanded access program. Through the end of September, approximately 50% of the 2,000 target accounts have already placed orders for Kyprolis.

    Centers participating in the expanded access program were among the first to place orders, with 110 patients who remained on the program at approval converting to commercial drug. Further, early orders were driven by centers that have pre-identified patients for immediate use of Kyprolis in the event of Kyprolis approval.

    And in September, we saw adoption continue to broaden to additional clinics and hospitals following visits from our field team. Initial market research and field team feedback suggest that most physicians are using Kyprolis in the third-line plus patients who previously received bortezomib and an IMiD and who are now progressing. Kyprolis penetration of the third-line plus population is estimated to have already reached 10% as of September within 8 weeks of the launch.

    Turning now to reimbursement. The comprehensive program that we rolled out included Onyx 360, extended payment terms and deployment of our field-based reimbursement experts have been well-received. Confirmed coverage has already been received from all 12 of the Medicare Administrative Carriers, or MACs. And in addition, 70% of the 167 million covered lives who are in the top 67 commercial plans have confirmed coverage for Kyprolis. The coverage policies and any prior authorizations that are in place are generally consistent with the label indication and have not been reported to be a barrier to adoption or use.

    Of note, our experience so far is that the majority of commercial plans that have not yet published the coverage policy are also covering Kyprolis on an individual patient basis. The Onyx 360 program staff and our field reimbursement teams are available to help answer questions on Kyprolis.

    In summary, the initial response by physicians to Kyprolis have been quite positive, with the strong early sales driven by the pre-identification of patients for early use following approval, conversion of the expanded access program patients and the continued growth in the number of new accounts adopting and ordering Kyprolis in September.

    Let me now comment on our kinase inhibitor franchise performance and our second product launch for the quarter. Stivarga was approved on September 27, a month ahead of its PDUFA date, and the Bayer and Onyx sales teams were prepared to launch and began promoting Stivarga immediately. An estimated 20,000 to 30,000 patients annually in the United States are indicated under the label. These are previously treated metastatic colorectal cancer patients who have limited treatment options today.

    While it is still too early to provide specifics, initial feedback has been that there is an appreciation of the unmet need that exists for the third-line plus metastatic colorectal cancer patient population and a significant interest on the part of physicians in learning more about Stivarga. We fully expect Stivarga to be reimbursed by most insurance plans and Medicare. And as we await formally reviews, the REACH program, originally set out for next of our patients, will also assist individuals obtaining coverage for Stivarga.

    Looking at other areas outside of the United States, Bayer has regulatory submissions for metastatic CRC pending in Europe and Japan. Bayer has received priority review from metastatic CRC in Japan and priority review for GIST, sNDA in the U.S. Regulatory actions are expected in both of these key regions in 2013.