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Original Source: FD (FAIR DISCLOSURE) WIRE
. John Elicker, Bristol-Myers Squibb, VP of IR . Dr. Elliott Sigal, Bristol-Myers Squibb, Chief Scientific Officer . Dr. Renzo Canetta, Bristol-Myers Squibb, VP of Oncology Clinical Research . David Risinger, Merrill Lynch, Analyst . Dr. Brian Daniels, Bristol-Myers Squibb, Head of GLobal Development . Chris Schott, Banc of America Securities, Analyst . John Boris, Bear Stearns, Analyst . David Moskowitz, Friedman, Billings, Ramsey, Analyst . Seamus Fernandez, Cowen & Co., Analyst . Jim Kelly, Goldman Sachs, Analyst
Management reported that last week, the FDA's Oncologic Drug Advisory Committee unanimously recommended accelerated approval of Dasatinib for the treatment of adults with all phases of Chronic Myeloid Leukemia with resistance or intolerance to prior therapy including Gleevec. BMY believes that the new data presented at ASCO for all of the late-stage compounds are very encouraging and bodes well for future submissions regulatory authorities.
S1. Opening Comments (E.S.) 1. ASCO Meeting Highlights: 1. BMY is particularly pleased with the progress in its oncology pipeline.
2. Last week, the FDA's Oncologic Drug Advisory Committee
unanimously recommended accelerated approval of Dasatinib for
the treatment of adults with all phases of Chronic Myeloid
Leukemia with resistance or intolerance to prior therapy including Gleevec. 1. The committee recommended full approval for patients with Philadelphia positive ALL who have failed prior therapy. 2. The Co. is anticipating an approval decision by the end of June. 3. Over the last few days, BMY presented new data on Dasatinib, as well as other compounds in its pipeline at the American Society of Clinical Oncology meeting in Atlanta, Georgia. 4. Over the last several years, BMY has steadily increased its investment in the discovery and development of new treatments
in oncology. 5. Building from the Co.'s prior success in this field, its goal is to reestablish its oncology leadership.
6. BMY has entered the new arena of targeted therapy first with
ERBITUX along with its partner ImClone, and next with the
potential approval of Dasatinib. 7. BMY has also built its biologics capabilities and expanded its pipeline in both protein therapeutics and small molecule compounds. 8. In R&D, the Co. has established a broad therapeutic platform involving multiple approaches. 1. BMY is pursuing novel approaches to cytotoxic therapy because it believes that these will remain the backbone of
most regiments containing targeted therapies. 9. BMY's near-term pipeline includes potential filings for two novel cytotoxics, Ixabepilone and Vinflunine. 10. In the area of targeted kinase inhibitors, BMY continues to investigate an expanded role with compounds like Dasatinib. 11. BMY is working to expand the indications for ERBITUX with a significant amount of data becoming available over the next 18 months. 12. BMY is exploring immunotherapy, a novel area of cancer therapy focused on boosting the body's own immune system to destroy cancer cells. 1. The compound here was Ipilimumab in Phase III with its partner, Medarex, illustrates that approach. 13. BMY is investigating other novel approaches early in the pipeline. 1. This broad platform of R&D is fundamental to fully meeting the goal of oncology leadership.
2. Dasatinib's success at Friday's FDA Advisory Committee shows
positive momentum for this plan.
S2. Clinical Findings & Near-term Milestones (R.C.) 1. ERBITUX Details:
1. ERBITUX has been further developed with a large program of
registration of clients where the growth of Taxol in Asia and
in Japan, in particular, is supported by new schedules and new
indications. 2. In the near future, BMY hopes to gain approval for four new molecules creating a steady flow of new drug introductions led by Dasatinib, the compound that was discovered at BMS.
3. In the early development pipeline, currently BMY feels that
with internally discovered compounds, the diversification of
the drugs in Phase I and Phase II clinical trials is evident.
4. ERBITUX is the Co.'s monoclonal antibody directed to the EGF
receptor and it has had a large number of important aspects
presented at ASCO covering tumor types such as colorectal and
head and neck cancers for which is already approved, but also
innovative clinical investigations in a number of different
malignancies. 5. As a prelude to the near future additional regulatory submissions, early randomized clinical trials have suggested an incremental efficacy of standard chemotherapy in first-line colorectal and lung cancer by the addition of ERBITUX.
6. ERBITUX was prominently featured in the innovative area of
combination therapy with multiple therapy patients. 1. This is a major theme in the new cancer treatment scenario. 7. ERBITUX continues to combine well with standard chemotherapy and (indiscernible) therapy and its versatility offers new opportunities for combined modality approaches in several tumor types. 8. This year, an impressive number of large Phase III trials have been fully approved with an enrollment of more than 5,200
patients. 1. The results of these trials should become available over the next 18 months thus providing the basis for an unprecedented number of supplemental BLA submissions, as well as for the registration of ERBITUX in Japan. 9. In cooperation with ImClone and [Emerk] continues to produce a coordinated steady flow of clinical data to support the continued development of the compound. 10. As in the case of recently approved head and neck indication, many of these trials listed have an overall survival endpoint and that will establish ERBITUX as a leader in its class. 11. For the first time in its history, the FDA Oncologic Drugs Advisory Committee was held away from the Washington area.
12. The Dasatinib NDA obtained a resounding support from the FDA
advisers, resulting in a recommendation for accelerated
approval in Chronic Myeloid Leukemia and full approval in Philadelphia positive acute lymphatic leukemia. 2. …