On October 26, 2016 Genomic Health, Inc. (NASDAQ: GHDX) reported publication in Reviews in Urology of a comprehensive economic analysis of the use of the Oncotype DX Genomic Prostate ScoreTM (GPS) in low-risk prostate cancer patients (Press release, Genomic Health, OCT 26, 2016, View Source [SID1234516026]). Results showed that use of the GPS results in a net savings of $2,286 per patient – including the cost of the test – by decreasing unnecessary immediate invasive treatment.

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"Not all low-risk prostate cancers are aggressive, but it is critical to know exactly which patient can forego immediate surgery safely," said study principal investigator David M. Albala, M.D., chief of urology, Crouse Hospital, Syracuse, New York. "Better treatment decisions can be made when patients have genomic information about their prostate tumors. Our study reconfirms that the GPS provides physicians and patients with additional risk assessment that resolves uncertainty in prognosis and informs individuals’ treatment decisions based on tumor biology."

Led by Associated Medical Professionals (AMP) of New York, the study demonstrated that incorporation of the GPS as part of the treatment decision algorithm for prostate cancer patients with NCCN very low and low-risk disease (64 percent of the study population) led to a 21 percent net increase in the use of active surveillance. The study specifically included prostate cancer patients covered by Excellus BlueCross BlueShield insurance in New York. Of these, treatment patterns and cost for 80 men tested with Oncotype DX were compared to 100 patients in the same practice without genomic testing.

Based on a real-world practice setting with a contemporary patient population and using current treatment cost averages, these published results demonstrated that the use of Oncotype DX represented a more than 50 percent return on investment over six months by reducing the cost of unnecessary immediate interventions. Additional savings can also be expected by removing the cost of management of associated side effects of treatment such as impotence and incontinence.

"The cost of caring for prostate cancer patients in the United States is estimated to be approximately $18 billion by 2020," said Phil Febbo, M.D., chief medical officer, Genomic Health. "The study provides additional important evidence to support broader adoption of Oncotype DX as we continue to fulfill Genomic Health’s vision to bring precision medicine to cancer patients, to empower physicians with actionable molecular information and to provide value and cost savings to our healthcare systems."

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The Oncotype DX prostate cancer test identifies which clinically low-risk patients are eligible for active surveillance, as well as those who may benefit from immediate treatment by predicting disease aggressiveness. With more than 600,000 patients tested in more than 90 countries, Oncotype DX testing has redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX prostate cancer test, visit www.OncotypeDX.com or www.MyProstateCancerTreatment.org.

On October 26, 2016 X-Rx, Inc, a biotechnology company focused on the creation of small molecule drug candidates, and Mercachem BV, a leading chemistry CRO with expertise in medicinal and process chemistry, reported progress with two discovery-stage oncology programs from the portfolio of X-Rx (Press release, X-Rx, OCT 26, 2016, View Source [SID1234527704]). The programs target Mcl1, an anti-apoptotic target that is over-expressed in many liquid and solid tumor types, and TAK1, a member of the mitogen-activated protein kinase family.

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Under the service agreement with X-Rx, Mercachem is responsible for hit-to-lead and lead optimization campaigns targeting Mcl1 and TAK1. Mcl1-targeting agents could lead to inducing tumor cell death via apoptosis and via modulation of the tumor micro-environment, drive sensitivity to chemotherapy and other immunotherapy approaches. Blocking TAK1, a kinase that when over-expressed in many cell types can drive tumor onset and progression, fibrosis and autoimmune diseases, will have numerous clinical applications.

"In 2015, we successfully partnered two of our therapeutic programs with leading pharma organizations in major markets. We are committed to building on this initial success and bringing additional candidates towards a stage where significant value has been generated to partner them on favorable terms," said Dr. Lee Babiss, CEO of X-Rx. "With today’s news we are taking the next step in the discovery and development of our Mcl1 and TAK1 programs together with Mercachem."

"We are pleased that X-Rx has chosen Mercachem as their collaboration partner as they further explore the therapeutic potential of their two promising oncology targets using our competence and expertise with kinases and PPI targets," commented Dr. Gerhard Müller, SVP Medicinal Chemistry of Mercachem.

On October 26, 2016 Dong-A ST Co., Ltd. (170900: Korea SE), the Korean pharmaceutical company, and Beactica AB, the Swedish fragment-based drug discovery company, reported a new multi-year research and drug discovery collaboration and licensing agreement (Press release, Dong-A ST, OCT 26, 2016, View Source [SID1234535725]). Beactica and Dong-A ST will jointly develop novel anti-cancer drugs against certain disease-related oncology targets.

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Under the terms of the agreement, Dong-A ST will gain exclusive global rights for the further development and commercialization of Beactica’s small molecule inhibitors against multiple members of a family of epigenetic enzymes. The partnership will pool existing compound series from both companies and combine Beactica’s unique early-stage lead generation capabilities with DONG-A ST’s strengths in downstream pre-clinical and clinical development of new therapeutic agents.

Beactica will receive an undisclosed upfront payment and is eligible to receive research funding as well as potential milestone payments for certain research, preclinical, clinical and regulatory milestones. In addition, Beactica is eligible to receive royalties on commercial sales of the products resulting from the partnership. Beactica is also entitled to a revenue share from any related future licensing activities by Dong-A. Full financial details remain undisclosed.

"This global research collaboration between Dong-A ST and Beactica which specializes in developing novel drug targets marks a big step forward in development of next generation anti-cancer therapeutics" said Dr Soo-Hyoung Kang, President and CEO of Dong-A ST. "This collaboration and licensing of Beactica’s small molecule inhibitors will greatly strengthen Dong-A ST’s current oncology pipeline and will further enhance Dong-A ST’s global competitiveness in the pharmaceutical industry."

"We’ve been impressed by Dong-A’s commitment to benefiting cancer patients through therapeutics that modulate epigenetic pathways and are excited to initiate this collaboration." said Dr Per Källblad, CEO of Beactica. "This is a ground-breaking partnership in terms of structure, scope and the potential clinical impact of therapeutics created through our complementary capabilities."

Epigenetics is the study of physiological changes caused by altered gene expressions originating from inherited changes other than the DNA sequence itself. Cancer epigenetics is a rapidly emerging research area with potential to provide new treatments for patients by modifying DNA and chromatin, both of which play important roles in tumour development.

On October 26, 2016 Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, reported its third quarter 2016 financial results and provided an update on recent events and development timelines for its therapeutic programs (Press release, Sangamo BioSciences, OCT 26, 2016, View Source [SID1234516044]).

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Sangamo BioSciences, Inc. (PRNewsFoto/Sangamo BioSciences, Inc.)
"The third quarter of 2016 has been a pivotal time for Sangamo, as we worked to focus our efforts and execute on our prioritized therapeutic programs in hemophilia B, hemophilia A, MPS I and MPS II," said Sandy Macrae, M.B., Ch.B., Ph.D., Sangamo’s president and chief executive officer. "I am pleased to announce that the Phase 1/2 clinical trial for SB-FIX, our in vivo genome editing program for hemophilia B, is open. We are also on track to file an IND application for our AAV cDNA Factor 8 gene therapy program for hemophilia A by the end of this year. In addition, we submitted the additional data package for our MPS I and MPS II programs to the FDA in September, and I am pleased to report that the FDA has cleared these programs for clinical development. Preparations are now underway to initiate Phase 1/2 clinical trials for these indications in early 2017."

Dr. Macrae continued, "We also made a number of organizational changes, including several key hires in our clinical and technical operations teams and instituted new procedures in order to position the company for clinical success. I am very encouraged by the commitment of our entire team and the progress we have made in the third quarter to drive these activities forward. I remain confident that we can demonstrate the value and therapeutic potential of our genome editing and gene therapy platforms and with reliable steps, make sensible progress and realize our vision of transforming Sangamo into a patient-focused therapeutics company."

Recent Highlights

Initiation of FIXtendz (SB-FIX-1501) Phase 1/2 clinical trial designed to assess safety, tolerability and potential efficacy of SB-FIX in adults with hemophilia B. In October, Sangamo opened the first clinical study of an in vivo genome editing therapeutic, its Phase 1/2 clinical trial (FIXtendz, SB-FIX-1501). SB-FIX-1501 is an open-label, dose-escalation study in male subjects over eighteen years of age, with severe hemophilia B, who do not have inhibitors or hypersensitivity to recombinant Factor IX protein (rFIX). The study will enroll up to nine subjects in three dosing cohorts of two subjects per cohort, with additional subjects to be enrolled at the optimal therapeutic dose, and will evaluate the safety and potential efficacy of a single administration of SB-FIX.

U.S. Food and Drug Administration (FDA) grants orphan drug designation to SB-FIX, the first in vivo genome editing therapeutic in development. In September, Sangamo announced that the FDA granted Orphan Drug Designation (ODD) to SB-FIX, the company’s zinc finger nuclease (ZFN)-mediated in vivo genome editing therapeutic candidate for hemophilia B. Orphan drug designation is granted to investigational drugs and biologics that are intended to treat rare diseases that affect fewer than 200,000 people in the U.S. This designation helps facilitate drug development by providing several benefits to drug developers, including assistance with clinical study design and drug development, tax credits for qualified clinical trial costs, exemption from certain FDA application fees and seven years of market exclusivity upon regulatory product approval.

FDA clearance to initiate Phase 1/2 clinical trials for SB-318 (MPS I) and SB-913 (MPS II) therapeutic programs. Sangamo submitted the additional in vitro studies requested by the FDA in September and recently received clearance to initiate Phase 1/2 clinical trials for the Mucopolysaccharidosis Type I (MPS I, Hurler syndrome) and Mucopolysaccharidosis Type II (MPS II, Hunter syndrome) programs based on its ZFN-mediated in vivo genome editing therapeutic platform. The company expects to initiate the clinical studies in early 2017.

Appointment of new head of technical operations. In August, Sangamo appointed Mohammad El-Kalay, Ph.D., as Vice President, Technical Operations. Dr. El-Kalay brings over 25 years of operational management experience in the life sciences field, including expertise in process development and cGMP manufacturing operations at clinical scale with hematopoietic stem cells, T-cells and various other cell types. Dr. El-Kalay is responsible for process development and manufacturing of all biotherapeutics for Sangamo.

Third Quarter 2016 Results
For the third quarter ended September 30, 2016, Sangamo reported a consolidated net loss of $19.0 million, or $0.27 per share, compared to a net loss of $9.2 million, or $0.13 per share, for the same period in 2015. As of September 30, 2016, the Company had cash, cash equivalents, marketable securities and interest receivable of $155.4 million.

Revenues for the third quarter of 2016 were $2.8 million, compared to $8.6 million for the same period in 2015. Third quarter 2016 revenues were generated from the Company’s collaboration agreements with Biogen and Shire International GmbH (Shire), enabling technology agreements and research grants. The revenues recognized for the third quarter of 2016 consisted of $2.7 million from collaboration agreements and $0.1 million from research grants, compared to $8.4 million and $0.2 million, respectively, for the same period in 2015. The decrease in collaboration agreement revenues was a result of an amendment to the Company’s collaboration and license agreement with Shire in the third quarter of 2015, which returned the rights to the hemophilia programs to Sangamo, as well as a decrease in revenues from the Biogen agreement as the initial research phase of these programs has matured and activities during this quarter were largely internal.

In the third quarter of 2016, Sangamo recognized $1.2 million of revenues related to research services performed under the collaboration agreement with Biogen, and $0.2 million of revenues related to research services performed under the collaboration agreement with Shire. In addition, Sangamo received upfront payments of $13.0 million and $20.0 million pursuant to the agreements entered into with Shire in 2012 and Biogen in 2014, respectively. The Shire payment is being recognized as revenue on a straight-line basis over the initial six-year research term. Beginning in January 2016, the Biogen payment is being recognized over approximately 42 months which reflects the revised service period related to Sangamo’s deliverables under the Biogen agreement. The Company recognized $0.5 million of the Shire upfront payment and $0.6 million of the Biogen upfront payment as revenue for the third quarter of 2016.

Research and development expenses were $17.0 million for the third quarter of 2016, compared to $16.7 million for the same period in 2015. General and administrative expenses were $5.0 million for the third quarter of 2016, compared to $4.6 million for the same period in 2015.

Total operating expenses for the third quarter of 2016 were $22.0 million, compared to $21.3 million for the same period in 2015.

Nine Months Results
For the nine months ended September 30, 2016, the consolidated net loss was $62.0 million, or $0.88 per share, compared to a consolidated net loss of $26.7 million, or $0.38 per share, for the nine months ended September 30, 2015. Revenues were $10.5 million for the nine months ended September 30, 2016, compared to $30.4 million for the same period in 2015. The decrease in revenues was primarily related to the amendment of our collaboration and license agreement with Shire, as well as a decrease in revenues related to our agreements with Sigma and Biogen. Total operating expenses were $73.2 million for the nine months ended September 30, 2016, compared to $61.6 million for the same period in 2015 and reflect increased expenses related to salaries and benefits, including stock-based compensation expense, as well as professional fees, consulting services and other corporate costs.

Financial Guidance for 2016
The Company reiterates guidance as follows:

Cash and Investments: Sangamo expects that its cash, cash equivalents and marketable securities will be at least $140 million at the end of 2016, inclusive of research funding from existing collaborators but exclusive of funds arising from any additional new collaborations or partnerships, equity financings or other new sources.

Revenues: Sangamo expects that revenues will be in the range of $12 million to $17 million in 2016, inclusive of research funding from existing collaborations.

Operating Expenses: Sangamo expects that operating expenses will be in the range of $85 million to $95 million for 2016.

On October 26, 2016 The Medicines Company (NASDAQ:MDCO) reported its financial results for the third quarter ended September 30, 2016 (Press release, Medicines Company, OCT 26, 2016, View Source;p=RssLanding&cat=news&id=2215909 [SID1234516084]).

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Third-Quarter 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $37.6 million in the third quarter of 2016 compared to $57.2 million in the third quarter of 2015. Included in total net revenue for the third quarter of 2016 and 2015 were $18.8 million and $24.5 million, respectively, of royalty revenues derived from the gross profit on authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Worldwide Angiomax/Angiox (bivalirudin) net product sales were $10.2 million in the third quarter of 2016, compared to $22.5 million in the third quarter of 2015, with net product sales in the United States decreasing to $8.2 million in the third quarter of 2016 from $18.8 million in the third quarter of 2015. Other products, including Ionsys(fentanyl iontophoretic transdermal system), Minocin (minocycline) for Injection, and Orbactiv(oritavancin), along with the recently-divested non-core cardiovascular products, recorded sales of $8.7 million in the third quarter of 2016 compared to $10.2 million in the third quarter of 2015.

Net loss from continuing operations in the third quarter of 2016 was $86.4 million, or $1.23 per share, compared to $90.6 million, or $1.35 per share, in the third quarter of 2015. Adjusted net loss(1) from continuing operations in the third quarter of 2016 was $44.9 million, or $0.64(1) per share, compared to $56.0 million, or $0.83(1) per share, in the third quarter of 2015.

Third-Quarter 2016 Financial Summary from Discontinued Operations

In the first quarter of 2016, the Company completed the sale of its hemostasis products. Net income from discontinued operations in the third quarter of 2016 was $0.1 million, compared to net loss from discontinued operations of $14.5 million, or $0.22 per share, in the third quarter of 2015.

First Nine Months 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $142.6 million in the first nine months of 2016 compared to $241.8 million in the first nine months of 2015. Included in total net revenue in the first nine months of 2016 and 2015 was $62.1 million and $24.5 million, respectively, of royalty revenues derived from the gross profit on authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Worldwide Angiomax/Angiox (bivalirudin) net product sales were $42.8 million in the first nine months of 2016 compared to $188.8 million in the first nine months of 2015, with net product sales in the United States decreasing to $34.2 million in the first nine months of 2016 from $174.5 million in the first nine months of 2015, driven by the loss of Angiomax exclusivity in July 2015. Other products, including Ionsys, Minocin for Injection, and Orbactiv, along with the recently-divested non-core cardiovascular products, recorded sales of $37.7 million in the first nine months of 2016 compared to $28.6 million in the first nine months of 2015.

The sale of the Company’s non-core cardiovascular products resulted in a gain of $288.3 million, which was recorded in the second quarter of 2016.

Net income from continuing operations in the first nine months of 2016 was $5.1 million, or $0.07 per share, compared to net loss from continuing operations of $153.7 million, or $2.33 per share, in the first nine months of 2016. Adjusted net loss(1) from continuing operations in the first nine months of 2016 was $163.9 million, or $2.35(1) per share, compared to $94.5 million, or $1.43(1) per share in the first nine months of 2015.

First Nine Months 2016 Financial Summary from Discontinued Operations

Net loss from discontinued operations in the first nine months of 2016 was $1.4 million, or $0.02 per share, compared to net income from discontinued operations of $7.0 million, or $0.11 per share, in the first nine months of 2015.

(1)Adjusted net loss and adjusted loss per share from continuing operations are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the Non-GAAP Financial Performance Measures and Reconciliations of GAAP to Adjusted Net Loss and Adjusted Loss per Share sections of this release.

At September 30, 2016, the Company had $600 million in cash and investments compared to $373 million at the end of 2015.

"We are pleased with our execution and operational progress during the third quarter," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. "We delivered meaningful advancements around our pipeline of potential blockbuster programs and we continued to strengthen our financial and operating flexibility by delivering strong execution against the strategic goals we laid out last November."

Third-Quarter 2016 Conference Call and Webcast Information

The Company will host a conference call and webcast at 8:30 a.m., Eastern Time, on October 26, 2016, to discuss its financial results. The dial-in information to access the call is:

U.S./Canada: (877) 359-9508

International: (224) 357-2393

Conference ID: 98417278

A taped replay of the conference call will be available from 11:30 a.m., Eastern Time, following the conference call until 11:30 a.m., Eastern Time, on November 2, 2016. The replay may be accessed as follows:

U.S./Canada: (855) 859-2056

International: (404) 537-3406

Conference ID: 98417278

The webcast can be accessed in the Investors section of The Medicines Company website. A replay of the webcast will also be available.