On October 21, 2015 OPKO Health, Inc. (NYSE:OPK) reported that GeneDx, a business unit of OPKO will be presenting at the National Society of Genetic Counselors (NSGC) 34th Annual Education Conference in Pittsburgh, PA (Press release, Opko Health, OCT 21, 2015, View Source [SID:1234507760]). GeneDx staff and genetic counselors will participate at the conference as individual speakers, poster presenters and exhibitors. GeneDx is also sponsoring a networking reception with partners and colleagues. Details are below:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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GeneDx BOOTH: #115

RSVP here for the Annual GeneDx Happy Hour
When: Thursday, October 22, at 8:00pm
Where: Il Tetto Rooftop Bar at Sienna Mercato

GeneDx Lunch Session and Presentation
Diagnostic Testing, Evolving Phenotypes, and Impact on Patient Care: A GeneDx Update on XomeDxXpress and Inherited Cancer Testing

When: Friday, October 23 at 11:45 pm
Where: Allegheny Grand Ballroom, Westin Hotel
Who: Sara Knapke, MS, CGC; Audra Bettinelli, MS, CGC; Stephanie DeWard, MS, CGC

GeneDx Individual Speaker Presentations
Pre‐Conference Symposium ‐ Diagnostic Exome Sequencing as the Standard of Care
When: Wednesday, October 21 at 9:00 am
Where: Room 315/316
Who: Jane Juusola, PhD, FACMG

Concurrent Paper Session (Clinical Care: Pediatrics & Adult Track) ‐ The Clinical Utility of a Multi‐Gene Panel for Neuromuscular Disorders (#1311)
When: Saturday, October 24 at 3:15 pm
Where: Room 315/316
Who: Meg Bradbury, MS, CGC, MSHS

GeneDx Poster Presentations
NOTE: Odd Numbered Posters: Thursday, October 22, 2015 2:00 pm – 3:00 pm
Even Numbered Posters: Friday, October 23, 2015 1:15 pm – 2:15 pm

Poster# 64
Comparing Yields and Referral Criteria for the Lynch/Colorectal High Risk Panel and the Colorectal Cancer Panel
Anna McGill, MS, LCGC

Poster# 78
Yield of Genetic Testing for Hereditary Cancer Among Male Patients
Kristin Theobald, MS, LCGC

Poster# 153
Genetic Testing Strategies for Patients With Epilepsy and Neurodevelopmental Disorders
Amy Decker, MS, CGC

Poster# 154
Mutations in SPATA5 Are Associated With a Novel Autosomal Recessive Disorder of Microcephaly, Intellectual Disability, Seizures and Hearing Loss
Stephanie DeWard, MS, CGC

Poster# 169
Whole Exome Sequencing Identifies the First PANX1 Germline Mutation in an Individual with Intellectual Disability, Hearing Loss, Endocrine Dysfunction and Skeletal Abnormalities
Kara Levine, MS, CGC

Poster# 192
De Novo Pathogenic Variants in DDX3X Are a Novel Cause of Intellectual Disability in Females
Leah Williams, MS, CGC

Poster# 194
Whole Exome Sequencing Identifies POGZ Mutations as a Cause of Neurodevelopmental Disorders and Microcephaly
Nora Alexander, MS, CGC

Poster# 218
Mutations in ARID2 Are Associated with Syndromic Intellectual Disabilities
Rebecca Willaert, MS, CGC

Poster# 268
Compound Heterozygosity of Two MECP2 Deletions with Paternal Inheritance of a Late-Truncating Mutation in a Female With Atypical Rett Syndrome
Dana Stolar, MS, CGC

On October 20, 2015 Varian Medical Systems reported that increasing access to radiotherapy worldwide through greater investment could save millions of lives, according to The Lancet Oncology Commission’s report presented at the 2015 European Cancer Congress in Vienna, Austria, and published in The Lancet Oncology (Press release, InfiMed, OCT 20, 2015, View Source [SID:1234507742]).1 The Commission’s results were presented here yesterday at the 2015 annual meeting of the American Society for Radiation Oncology (ASTRO).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Patient receives a radiotherapy treatment for cancer.
The Commission found that up to 60% of all cancer patients worldwide will need radiotherapy at some point in their treatment, but a lack of investment in radiotherapy services has severely limited access to radiotherapy treatments worldwide, especially in low-income and middle-income countries (LMIC).

LMIC have 80% of the global cancer burden but only 5% of the resources for cancer control, and in low-income countries, 90% of the population lack access to radiotherapy. Even in high income countries the numbers of radiotherapy facilities, equipment, and trained staff are inadequate.

Radiotherapy is important for managing most cancers, such as breast, lung, prostate, head and neck, and cervical cancers, which account for more than two-fifths of cases worldwide. In their report, the Commission details how a persistent underinvestment in radiotherapy globally has diminished access, and describes the substantial health and economic benefits of investing in radiotherapy.

With the number of new cancer cases expected to rise to 24.6 million by 2035, the Commission claims that increasing access to radiotherapy services in LMIC by scaling up radiotherapy capacity from current levels could lead to a saving of 27 million life years by 2035, over the lifetime of patients who receive this treatment.

In addition to saving human lives, providing full access to radiotherapy through investment could reduce the economic burden of cancer worldwide, which was $2 trillion in 2010. By 2035, full access to radiotherapy for all patients in LMIC could be achieved for as little as $97 billion, with economic benefits ranging from $278 billion to $365 billion over the next 20 years.

The Commission called for a long-term commitment to cancer care and treatment through the following actions:

80% of countries should have cancer plans that include radiotherapy by 2020.
By 2025, radiotherapy treatment capacity should be increased by 25% from 2015 capacity.
Each LMIC should have at least once cancer center by 2020.
LMIC should train 7,500 radiation oncologists; 20,000 radiation technologists; and 6,000 medical physicists by 2025.
LMIC should invest $46 billion by 2025 to establish radiotherapy infrastructure and training.
80% of LMIC should include radiotherapy services as part of their universal health coverage by 2020.
"The Lancet Commission has done an impressive job of demonstrating how increasing access to life-saving radiotherapy treatment makes sense not only for the health and well-being of our world community but economically as well," said Dow R. Wilson, president and CEO of Varian Medical Systems. "Congratulations on this important study, which will, we hope, lead to cancer programs that can help save lives around the world."

On October 20, 2015 Synta Pharmaceuticals Corp. (NASDAQ: SNTA) treported that the Company has decided to terminate the Phase 3 GALAXY-2 trial of ganetespib and docetaxel in the second-line treatment of patients with advanced non-small cell lung adenocarcinoma (Press release, Synta Pharmaceuticals, OCT 20, 2015, View Source;p=RssLanding&cat=news&id=2098806 [SID:1234507747]). Based on the review of a pre-planned interim analysis, the study’s Independent Data Monitoring Committee (IDMC) concluded that the addition of ganetespib to docetaxel is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to docetaxel alone. The IDMC noted that the combination of ganetespib and docetaxel was generally well tolerated in the study, with an adverse event profile consistent with previous studies combining these agents.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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GALAXY-2 is a Phase 3 global, randomized, multi-center trial. Synta continues to support enrollment in four additional large, randomized, multi-center investigator-sponsored studies, including: the GANNET53 trial of ganetespib and paclitaxel in ovarian cancer; the AML LI-1 trial of ganetespib with low dose cytarabine (Ara-C) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS); the AML18 trial of ganetespib with standard DA (daunorubicin and Ara-C) in AML and high-risk MDS; and the I-SPY 2 TRIAL of ganetespib and standard chemotherapy in women with newly diagnosed, locally advanced breast cancer.

"This disappointing outcome underscores the challenges of treating lung cancer in the second-line setting and determining the precise population for whom ganetespib may be most effective," said Chen Schor, President and Chief Executive Officer of Synta. "We thank the patients, caregivers and investigators who participated in GALAXY-2."

Mr. Schor continued: "Despite the outcome of this trial, and pending discussions with the relevant investigators, we will continue to support ongoing investigator-sponsored studies while we determine the appropriate path forward for ganetespib. We also look forward to advancing candidates from our HDC platform into the clinic. With the significant cash reserves we have in hand, our pipeline, our scientific internal leadership and network of advisors, we expect to undertake a comprehensive review of our strategy going forward."

Upon formal acceptance of the IDMC’s recommendation, Synta will communicate with regulatory authorities, and will notify study investigators that treatment with ganetespib should be discontinued in the GALAXY-2 trial.

On October 20, 2015 Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthroughs for serious, underserved diseases, reported an exclusive worldwide license agreement with Genentech, a member of the Roche Group, to discover and develop small molecule inhibitors of interleukin-1 receptor-associated kinase 4 (IRAK4) (Press release, Nimbus Therapeutics, OCT 20, 2015, View Source [SID1234527306]).

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Under the terms of the agreement, Nimbus will receive an undisclosed upfront payment and is eligible to receive milestone payments based on achievement of certain predetermined milestones. In addition, Nimbus is eligible to receive royalties on sales of certain products resulting from the license agreement. Genentech will be responsible for all preclinical and clinical development, manufacturing and commercialization. Financial terms have not been disclosed.

"With its expertise, capabilities and global reach, Genentech is the best partner to rapidly advance these promising candidates to the clinic and, ultimately, bring new treatments to patients," said Don Nicholson, Chief Executive Officer of Nimbus.

"Genentech is dedicated to bringing forth treatments for patients with serious and life-threatening diseases," said James Sabry, Senior Vice President and Global Head of Genentech Partnering. "Nimbus’ unique approach to drug discovery will enhance our research and development programs for immunological disorders."

On October 19, 2015 Valeant Pharmaceuticals reported Third Quarter 2015 Financial results Results (Press release, Valeant, OCT 19, 2015, http://ir.valeant.com/investor-relations/news-releases/news-release-details/2015/Valeant-Pharmaceuticals-Reports-Third-Quarter-2015-Financial-Results/default.aspx [SID:1234507738]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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2015 Third Quarter Results

Total Revenues of $2.8 billion; an increase of 36% over the prior year despite negative foreign exchange impact of $172 million
Same store sales organic growth of 13%; 5th consecutive quarter of > 10% organic growth, driven by:
Continued outperformance of U.S. businesses, particularly dermatology and contact lens
Strong results in China (23%), South Korea (15%) and Mexico (10%)
Total company growth was 8.2% volume and 4.4% price
U.S. branded pharmaceuticals growth was 18.8% volume and 15.2% price
Excluding the impact from genericization of Targretin Capsules during the quarter, same store sales organic growth would have been 14%

Impact from generic Xenazine expected fully in fourth quarter
Salix revenue was $461 million
Strong Xifaxan script uptake following IBS-D approval
Salix wholesaler inventory levels reduced from 3-3.5 months to 2-2.5 months
GAAP EPS $0.14; Cash EPS $2.74, an increase of 30% over prior year despite the negative foreign exchange impact of $0.13 versus the prior year
GAAP Operating Cash Flow $737 million, an increase of 19% over prior year; excluding the impact of foreign exchange, the increase was 26%
Adjusted Operating Cash Flow $865 million, an increase of 12% over prior year; excluding the impact of foreign exchange, the increase was 18%
Deals recently closed include Sprout, brodalumab, Synergetics and Amoun, which is expected to close later today

Fourth Quarter 2015 Guidance

Total Revenue increased to $3.25 – $3.45 billion from $3.2 – $3.4 billion
Cash EPS increased to $4.00 – $4.20 from $3.98 – $4.18

Full Year 2015 Guidance

Total Revenue increased to $11.0 – $11.2 billion from $10.7 – $11.1 billion,
Salix revenue expected to be ~$1.35 billion
Cash EPS increased to $11.67 – $11.87 from $11.50 – $11.80
Adjusted Cash Flow from Operations of greater than $3.35 billion
Same Store Sales Organic Growth of >10% for Q4 and FY 2015