McKesson Corp. (MCK) acquires US Oncology for $2.16 Billion

By Andrea: http://nursingoncologyjob.com

McKesson Corporation (MCK), a leading healthcare services and information technology company, and US Oncology, a leading integrated oncology company, recently announced that the two companies have signed a definitive agreement under which McKesson will purchase all outstanding shares of US Oncology for cash. The total transaction, including the assumption of US Oncology's outstanding debt, is valued at approximately $2.16 billion. The combined organization will focus on providing a comprehensive offering of solutions for the oncology industry, one of the fastest-growing segments in healthcare.

The parties are targeting a closing by the end of McKesson's third fiscal quarter, ending December 31, 2010, subject to customary conditions, including all necessary regulatory clearances. Excluding transaction and integration costs, the acquisition is expected to be neutral to McKesson's diluted earnings per share in its current fiscal year, and modestly accretive beginning in McKesson's fiscal year 2012. In connection with the acquisition, it is anticipated that substantially all of US Oncology's debt will be repaid or refinanced, including the Senior Floating Rate PIK Toggle Notes due 2012 issued by US Oncology Holdings, Inc., and the 9.125% Senior Secured Notes due 2017 and 10.75% Senior Subordinated Notes due 2014, both issued by US Oncology, Inc.

The unified organization will bring together the collective capabilities of McKesson and US Oncology to provide oncology customers access to:

• Leading evidence-based medicine offerings that drive continued improvements in clinical outcomes and enable value-based reimbursement;
• Expanded clinical expertise, clinical research and personalized medicine offerings;
• Integrated, efficiency-enabling healthcare information technology, including the iKnowMed(TM) and Lynx^(R) technology platforms, facilitating outcomes measurement, reporting, and advanced product and inventory management;
• Innovative practice-management solutions and consultative capabilities that allow independent community specialists to thrive in a changing healthcare environment; and
• Superior distribution capabilities and supply-chain expertise.

These solutions will help community oncologists improve the care experience for patients and drive business and clinical innovations that address the increasing demand for high-quality, cost-effective, personalized cancer care.

"McKesson is committed to improving the health and vitality of our customers, with the ultimate goal of improving the health of patients," said John H. Hammergren, chairman and chief executive officer, McKesson. "The combination of US Oncology and McKesson will enhance our ability to achieve these goals in one of the most important segments in healthcare. Community oncology practices need strategic support that offers not only technology and distribution solutions, but also value-added clinical and reimbursement management services that enable them to provide the highest-quality, most efficient care to their patients. With this acquisition, McKesson will offer a compelling suite of services and solutions to community oncologists and other partners in the rapidly evolving specialty business."

The combined McKesson Specialty Care Solutions business will be led by Bruce Broussard, chairman and chief executive officer of US Oncology, and will be headquartered in The Woodlands, Texas, with continuing operations in the San Francisco Bay Area and other locations throughout the country. Broussard will report to Paul Julian, executive vice president and group president, McKesson Corporation. McKesson will continue to operate the United Network of US Oncology, including US Oncology's Comprehensive Strategic Alliance offering, US Oncology Research and other services under the US Oncology brand name.

Strategic Acquisition Creates Broader, Deeper Oncology Offering

The unified company will deliver a best-in-class oncology program, clinical tools, guidelines and care pathways that will create a leader in evidence-based medicine backed by a deep team of clinical experts. With approximately 3,000 total physician customers, the new organization's expanded breadth will accelerate investments in integrated systems, process excellence, and clinical programs that will help drive productivity, efficient care delivery, and the best possible care experience for patients.

"With the healthcare marketplace moving rapidly toward reimbursement based on quality and cost-effectiveness, our physician customers need access to deep clinical, operational and information technology capabilities to create integrated networks that continually enhance the quality of care in a cost-efficient manner," said Bruce Broussard. "In joining McKesson, we are building the scale and expertise necessary to empower our customer base to shape the future of healthcare."

"The addition of US Oncology's physician-centric business model and clinical expertise to the McKesson portfolio advances our strategy and significantly strengthens our offering for community oncology and other partners in the specialty segment," said Paul Julian. "McKesson and US Oncology's businesses are highly complementary, providing our collective customers access to more services and solutions that will enhance their ability to deliver advanced cancer care."

Unified Organization Creates More Choices for Community Oncology

Together, McKesson and US Oncology will provide oncology practices with a robust suite of practice-support options and services, which can be tailored to meet each customer's specific needs. US Oncology's existing Comprehensive Strategic Alliance (CSA) practice-management offering and core services will remain intact, while the combined organization will offer a broad array of a la carte technology, practice-management, reimbursement and clinical services to the community oncology segment. US Oncology does not employ the physicians or own the practices affiliated with the company, and all customers will retain the flexibility to select the business-relationship model that best suits their individual needs.

"This strategic acquisition is a logical next step in our commitment to ensure the continued vitality of community oncology, while creating value for our shareholders," concluded Hammergren. "We look forward to welcoming US Oncology's innovative, experienced employees to McKesson and to working together with our customers to create better health for our customers and the patients they serve."

About US Oncology

US Oncology, Inc. is the nation's leading integrated oncology company. By uniting the largest community-based cancer treatment and research network in America, US Oncology expands patient access to high-quality care and advances the science of cancer care. Headquartered in The Woodlands, Texas, US Oncology is affiliated with more than 1,300 community-based oncologists, and works with patients, hospitals, payors and the medical industry across all phases of the cancer research and delivery continuum. By promoting the use of innovative technology, clinical research, evidence-based medicine and shared best practices, US Oncology improves patient outcomes and offers a better patient experience.

About McKesson

McKesson Corporation, currently ranked 14th on the FORTUNE 500, is a healthcare services and information technology company dedicated to helping its customers deliver high-quality healthcare by reducing costs, streamlining processes, and improving the quality and safety of patient care. Over the course of its 177-year history, McKesson has grown by providing pharmaceutical and medical-surgical supply management across the spectrum of care; healthcare information technology for hospitals, physicians, homecare and payors; hospital and retail pharmacy automation; and services for manufacturers and payors designed to improve outcomes for patients.

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Seattle Genetics, Inc. (SGEN): brentuximab vedotin (SGN-35) Hodgkin Lymphoma Drug Update

By Andrea: http://nursingoncologyjob.com

Seattle Genetics, Inc.(SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited , today announced that brentuximab vedotin (SGN-35) will be featured in three poster presentations at the 8th International Symposium on Hodgkin Lymphoma (ISHL) being held October 23-26, 2010 in Cologne, Germany.

The following posters will be presented on Tuesday, October 26, 2010:

Objective responses with SGN-35 retreatment in CD30-positive hematologic malignancies: a case series (Abstract #113) Activity, safety and tolerability of antibody-drug conjugate (ADC) SGN-35 in relapsed/refractory Hodgkin lymphoma and CD30+ hematologic malignancies (Abstract #74) Activity of SGN-35 in preclinical models of combination therapy and relapse prevention (Abstract #49)

"These presentations complement the recent positive results from our pivotal Hodgkin lymphoma and phase II systemic anaplastic large cell lymphoma (ALCL) trials, both in the relapsed or refractory setting, and describe the additional opportunities we are pursuing to meet the needs of patients with CD30-positive malignancies," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "In addition, we are preparing our brentuximab vedotin Biologics License Application (BLA) for submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011."

"The acceptance of these presentations at ISHL underscores the scientific community's continued interest in brentuximab vedotin," said Nancy Simonian, M.D., Chief Medical Officer of Millennium. "We maintain our focus on meeting with regulators in Europe to discuss filing strategies in relapsed or refractory Hodgkin lymphoma and relapsed or refractory ALCL."

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE) utilizing Seattle Genetics' proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.

Seattle Genetics and Millennium recently reported top-line data from a pivotal trial of brentuximab vedotin for relapsed or refractory Hodgkin lymphoma and a phase II trial for relapsed or refractory ALCL. In the pivotal Hodgkin lymphoma trial, 75 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response was greater than six months. In the phase II ALCL trial, 86 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response has not yet been reached at a median follow up on study of approximately six months. The safety profile of brentuximab vedotin in these trials was generally consistent with prior clinical trial experience. More complete data sets from both trials will be presented in oral sessions at the American Society of Hematology (ASH) annual meeting, December 4-7, 2010, in Orlando, FL.

The companies are also conducting a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for the front-line treatment of Hodgkin lymphoma.

About the Seattle Genetics/Millennium Collaboration

Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.

According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2010 and more than 1,300 will die from the disease. Globally, there are more than 30,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond autologous stem cell transplant.

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Neoprobe Corp (NEOP.ob) - RIGScan: Solid Tumor Cancer Technology

By Andrea: http://nursingoncologyjob.com

Neoprobe Corporation (NEOP.ob), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has submitted a response letter to the U.S. Food and Drug Administration (FDA) regarding its RIGScan™ technology Biologic License Application (BLA). The filing of the BLA response letter is the initial step in Neoprobe’s efforts to commercialize the RIGS technology designed to enhance the surgical treatment of solid tumor cancers. The review responsibility for the RIGS BLA was recently transferred from CBER to the Division of Medical Imaging Products in CDER at FDA.

“The submission of the BLA response letter is the first of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology,” said Rodger Brown, Neoprobe’s Vice President of Regulatory Affairs and Quality Assurance. “We intend to file a request for an Investigational New Drug (IND) for the biologic component of the RIGS technology. The IND request will be accompanied by a synopsis of the proposed Phase 3
RIGS technology clinical evaluation. Once FDA has assigned a new IND we will file the complete protocol for FDA evaluation under the provisions of a Special Protocol Assessment (SPA). A SPA review of the prospective protocol will provide a clear development pathway for RIGS in 2011.”

Neoprobe executives will discuss the development activities for both the RIGS and Lymphoseek product initiatives during the third quarter earnings conference call tentatively scheduled for the second week of November.

Ariad Pharmaceuticals Inc. : Myeloid Leukemia and Lymphoblastic Leukemia Update

By Andrea: http://nursingoncologyjob.com

Ariad Pharmaceuticals Inc. (ARIA) recently announced the initiation of the pivotal Phase 2 clinical trial of its investigational pan-BCR-ABL inhibitor, ponatinib (previously known as AP24534), in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL). The PACE (Ponatinib Ph+ ALL and CML Evaluation) trial is designed to provide definitive clinical data for regulatory approval of ponatinib in this setting. Ponatinib has been granted orphan drug status in both the United States and Europe for the treatment of CML and Ph+ ALL.

"The start of the pivotal PACE trial represents an important step in the development of our second molecularly targeted cancer therapy," stated Harvey J. Berger, M.D., chairman and chief executive officer. "With the strong clinical evidence observed to date of hematologic, cytogenetic and molecular anti-leukemia activity of ponatinib in heavily pretreated patients with CML, including those patients with the T315I mutation for whom no current treatments are available, we are highly optimistic about the likelihood of success for ponatinib in this registration trial. We also believe that the time to full patient enrollment in this study and to potential regulatory approval of ponatinib will be swift."

Trial Design

The PACE trial is a global, single-arm clinical study of oral ponatinib in 320 patients with chronic phase, accelerated phase, or blast phase CML, as well as Ph+ ALL. Patients resistant or intolerant to dasatinib (Sprycel(R)) or nilotinib (Tasigna(R)), or with T315I mutation of BCR-ABL, will be enrolled in the trial. Patients will be grouped into one of six separate cohorts based on their phase of CML (i.e., chronic, accelerated or blast) and BCR-ABL mutation status (i.e., with or without the T315I mutation); Ph+ ALL patients will be grouped with blast phase CML. A total of 160 patients with chronic phase CML will be included. The primary endpoints are major cytogenetic response rate for chronic phase patients and major hematologic response rate for accelerated or blast phase CML patients and Ph+ ALL patients. Secondary endpoints in the trial include major molecular response rate, duration of response, progression-free survival, and overall survival.

Patients will receive ponatinib in tablet form once daily at a dose of 45 mg. The PACE trial will be conducted at approximately sixty centers in North America, Europe, Australia and Asia. Full patient enrollment is anticipated by year-end 2011.

"Clinical results from the ongoing Phase 1 trial of ponatinib, taken together with the preclinical data that characterize ponatinib as a potent, pan-BCR-ABL inhibitor, provide a strong rationale for advancing directly to a pivotal trial of ponatinib in a population of patients who have extremely limited, if any, treatment options," stated Jorge Cortes, M.D., professor and deputy chair, Department of Leukemia, The University of Texas MD Anderson Cancer Center and a leading investigator in the PACE trial. "There is great interest in the PACE trial from clinicians and patients, and I look forward to having this investigational option available for patients with this disease."

Regulatory Agency Agreement on Study Design

The PACE trial protocol was developed in consultation with leading CML experts from around the world. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) provided valuable input on the design and analysis of the pivotal trial. Based on these favorable interactions and depending on the actual results of this pivotal trial, ARIAD anticipates that it will be able to submit data from this single-arm trial with six months of follow-up response data.

All patients in the PACE trial will be genotyped in a central laboratory upon enrollment in the study to determine their BCR-ABL mutation status. Direct sequencing for determination of the T315I mutation will be applied rigorously and uniformly throughout the study. In parallel, ARIAD is proceeding with plans to have a companion diagnostic test for the T315I mutation developed and commercialized. The need for a commercialized companion diagnostic test in the United States applies only to the T315I cohorts and not to the larger resistant/intolerant CML patient population.

"We will use the same diagnostic test to determine T315I mutation status in the PACE trial that we used in the Phase 1 clinical trial of ponatinib, performed at a single site and applied uniformly," stated Frank G. Haluska, M.D., Ph.D., vice president and chief medical officer at ARIAD. "We have agreement with the FDA on how to proceed with genotypic evaluation of all patients in the PACE trial and will finalize plans for development and commercialization of the companion diagnostic as the PACE trial moves ahead."

Novel Kinase Inhibitors: Oncology Research Update

By Andrea: http://nursingoncologyjob.com

ArQule, Inc. (ARQL) and Daiichi Sankyo Co. recently announced that they will expand on their current research and development to continue the exploration of novel kinase inhibitors in Oncology:

ArQule, Inc. (ARQL) and Daiichi Sankyo Co., Ltd. today announced the expansion of their research, development and license agreement for the discovery of novel kinase inhibitors in the field of oncology. This expanded agreement establishes a third therapeutic target, with an option for a fourth, in the field of oncology, and it includes a two-year extension based on the application of the proprietary ArQule Kinase Inhibitor Platform (AKIP(TM)) technology.

"This technology has provided us with a unique and innovative approach for discovery in the treatment of cancer," said Dr. Hideyuki Haruyama, the Global Head of Research, Daiichi Sankyo. "We expect that the expansion of this collaboration will produce other drug candidates and lay the foundation for future growth in this field."

Consistent with the existing AKIP(TM) collaboration, the economic terms provided for in the expanded agreement include payments for research support, licensing fees for compounds discovered as a result of this research, milestone payments related to clinical development, regulatory review and sales, and tiered royalty payments on net sales of each product. Daiichi Sankyo will have an option to license compounds directed to the targets defined under the agreement following the completion of certain pre-clinical studies. ArQule retains the option to co-commercialize any resulting licensed products in the U.S.

"Our initial drug discovery collaboration has identified a development candidate for one target, and we are optimizing advanced lead compounds for the other target," said Dr. Thomas C.K. Chan, chief scientific officer of ArQule. "The expansion of this collaboration will continue to deploy AKIP technology to discover inhibitors with novel modes of action for additional oncology targets over the next two years."