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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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.

Infinity Pharmaceuticals: Non-small cell lung cancer update

By Andrea: http://nursingoncologyjob.com

Infinity Pharmaceuticals, Inc.(INFI) announced that results from its Phase 2 study of IPI-504, a novel IV-administered Hsp90 chaperone inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) were published in the Journal of Clinical Oncology (Sequist et. al., J Clin Oncol. doi: 10.1200/JCO.2010.30.8338, 2010). These data, presented previously at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), documented for the first time the activity of an Hsp90 inhibitor in a molecularly defined cohort of patients with advanced NSCLC. In the study, IPI-504 was generally well tolerated and demonstrated clinical activity, particularly among patients with oncogenic anaplastic lymphoma kinase (ALK) gene rearrangements.

"These results support molecular analysis as a key tool in clinical trials to determine the signature of the best responding patients, and suggest that patients with NSCLC and ALK rearrangements may preferentially respond to Hsp90 chaperone inhibition," stated Lecia Sequist, M.D., MPH, from the Massachusetts General Hospital Cancer Center and an Assistant Professor of Medicine at Harvard Medical School. "We hope the ongoing study of IPI-504 in NSCLC patients with ALK rearrangements will validate these initial findings."

"We are encouraged that IPI-504 was generally well tolerated and demonstrated clinical activity in NSCLC, further supporting the clinical potential of Hsp90 chaperone inhibition as a targeted approach to treating certain cancers," stated Julian Adams, Ph.D., president of research and development, Infinity. "The results of the ongoing Phase 1b study of IPI-504 in combination with Taxotere(R) in patients with solid tumors, as well as data from Dr. Sequist's study assessing IPI-504 in patients with NSCLC and ALK rearrangements, will help inform the path forward for IPI-504."

Trial Design and Results

The Phase 2 study of IPI-504 was designed to evaluate the safety, tolerability and anti-tumor activity of IPI-504 in patients with stage IIIb/IV NSCLC whose tumors had progressed after treatment with an EGFR tyrosine kinase inhibitor. Seventy-six patients were enrolled and stratified by their EGFR mutation status. A subset of patients also underwent EGFR (n = 25), KRAS (n = 30) and BRAF (n = 5) genotyping analysis, as well as a fluorescent in situ hybridization (FISH) assay to detect ALK gene rearrangements.

The results of the Phase 2 study show an objective response rate of seven percent in the overall study population: ten percent in patients who were EGFR wild-type, four percent in those with EGFR mutations, and 12 percent among KRAS wild-type patients. There was a 67 percent response rate among the patients with ALK rearrangements, with two of three patients experiencing partial responses and the third patient experiencing a 24 percent disease reduction. All three patients with ALK rearrangements received IPI-504 for at least six months.

IPI-504 was generally well-tolerated in this study. Most adverse events were Grade 1 or Grade 2. The most commonly reported adverse events (regardless of relationship to drug) were fatigue, nausea, diarrhea, vomiting and cough.

Molecular Insight Pharmaceuticals: Prostate Cancer Update

By Andrea: http://nursingoncologyjob.com

Molecular Insight Pharmaceuticals, Inc.(MIPI) this week presented positive data from Phase 1 clinical studies comparing Trofex(TM) (123I-MIP-1072), its lead molecular imaging candidate for the diagnosis and monitoring of metastatic prostate cancer, and ProstaScint(R) (111In-capromab pendetide), an imaging radiopharmaceutical for the visualization of metastatic prostate cancer. Data presented at the Annual Congress of the European Association of Nuclear Medicine in Vienna demonstrated that Trofex rapidly detected prostate cancer localized in the prostate bed, soft tissues and bone within four hours post injection. In contrast, ProstaScint required five days before imaging and was unable to detect metastatic disease in bone.

Trofex is a radiolabeled, small-molecule that binds prostate specific membrane antigen (PSMA), a protein highly expressed by prostate cancer cells, with high affinity and specificity. The high degree of uptake and retention of Trofex in prostate cancer cells allows for non-invasive molecular imaging of prostate cancer.

Data from two completed Phase 1 studies and preliminary data from one ongoing Phase 1 study were presented in an abstract titled: Detection of Metastatic Prostate Cancer (PCa) in Soft Tissue, Bone, and Prostate with 123I-MIP-1072: A Comparison with 111In-Capromab Pendetide. John W. Babich, Ph.D., Molecular Insight Executive Vice President, Chief Scientific Officer and President of Research and Development, senior author of the study, presented the data from these studies.

Study Methodology The two completed Phase 1 studies enrolled a total of 13 subjects (7 prostate cancer patients and 6 healthy volunteers) while in the ongoing study 12 patients have been enrolled. In the first two studies, patients with confirmed metastatic prostate cancer and normal subjects received Trofex (370 MBq), followed by serial whole-body planar imaging, SPECT/CT scanning, and blood and urine analysis. Image analysis from the Trofex scans was used to estimate organ pharmacokinetics and to calculate radiation dosimetry. In the ongoing study, Trofex and ProstaScint images as well as bone scans were compared in the same patient. All images were compared visually and by quantitative image analysis for assessing relative tumor detectability.

Conclusions Molecular Insight reported that in this limited group of patients Trofex visualized lesions in the prostate, lymph nodes and bone at four hours after injection, confirming that targeting the extracellular domain of PSMA with small molecules is a viable approach for imaging metastatic prostate cancer. In comparison to Trofex, which is rapidly cleared from the blood and can detect tumors within a few hours, ProstaScint requires five days for optimal imaging. In this study, ProstaScint was unable to detect bone metastases and required supplementary blood pool imaging for confirmation of lymph node metastases along the normal vasculature.

In the second presentation at the EANM Annual Congress, Molecular Insight reported new preclinical data from its prostate cancer therapy program. Molecular Insight scientists have developed an analog of Trofex that carries the therapeutic iodine radionuclide, I-131, creating a molecularly targeted radiotherapeutic that specifically binds PSMA on prostate cancer cells and offers the potential for treatment of metastatic prostate cancer. In an abstract titled Inhibition of Human Prostate Cancer Growth by Targeting Prostate Specific Membrane Antigen (PSMA) using an I-131 labeled small molecule inhibitor, researchers reported that a Molecular Insight compound, 131I-MIP-1375, was effective at inhibiting, in a dose-related manner, the growth of human PSMA-expressing prostate tumors in a mouse model. The Company said that these preclinical data provide a basis for advancing the development of 131I-MIP-1375 as a targeted radiotherapeutic option in the treatment of prostate cancer.

About Prostate Cancer According to the American Cancer Society, more than 2.5 million men are currently affected by prostate cancer and approximately 200,000 new cases are diagnosed annually. While early diagnosis has improved overall survival rates, prostate cancer is the second leading cause of cancer death among men in the United States. Most prostate cancer mortalities occur when the disease has spread and therefore staging and monitoring the disease accurately is critically important in improving patient outcomes.