On October 27, 2016 Adaptive Biotechnologies, the leader in combining next-generation sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, reported that the National Comprehensive Cancer Network (NCCN) revised their clinical practice guidelines recommending the use of highly sensitive diagnostic tools, including NGS, to assess the presence of measurable residual disease (MRD) in Multiple Myeloma (Press release, Adaptive Biotechnologies, OCT 27, 2016, View Source [SID1234516105]). Results from these new innovative clinical tools can help inform treatment decisions for active symptomatic patients as well as those undergoing maintenance treatment.

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These clinical practice guidelines recommend the use of highly sensitive diagnostic tools with the ability to detect at least 1 cell among 100,000 normal cells and advise that testing should occur after each treatment stage (induction, high-dose therapy/ACST, consolidation, and maintenance) at times of suspected complete response. This unanimous recommendation from 27 of the nation’s leading experts in the field of Multiple Myeloma treatment and research signals a shift in the management of patients and supports regular assessment of MRD by new validated clinical tools. For more information, go to: View Source

"Advanced diagnostic tools are transforming patient management in Multiple Myeloma and other lymphoid malignancies," said C. Ola Landgren, MD, PhD, Chief, Myeloma Service at Memorial Sloan Kettering Cancer Center. "Robust new diagnostic tools along with advanced new treatment options are enabling clinicians to respond with the optimal intervention at the right time, which is changing the natural course of this disease."

"The approval of incredible new treatments for blood cancers continues to elevate the need for robust diagnostic tools, and we are excited that the NCCN recognizes the importance of regular MRD assessment throughout the care and management of Multiple Myeloma patients," said Chad Robins, President, Chief Executive Officer and Co-Founder of Adaptive Biotechnologies. "Adaptive is highly committed to providing a robust validated assay with the ability to assess levels of residual disease down to 1 cell in 1,000,000 cells using our proprietary clonoSEQ Assay. Making this important clinical tool available to patients around the world is a priority for Adaptive and supports our mission to improve patient care."

About Minimal Residual Disease


Minimal/measurable residual disease (MRD) refers to cancer cells that may remain in the body of a person with lymphoid cancer after treatment. These cells can be present at levels undetectable by traditional morphologic, microscopic examination of blood, bone marrow or a lymph node biopsy. Sensitive molecular technologies, such as the next-generation sequencing utilized by the Adaptive Biotechnologies clonoSEQ Assay, are needed for reliable detection of MRD at levels below the limits of traditional assessment.

About the clonoSEQ Assay

Adaptive’s clonoSEQ Assay enables physicians to utilize next-generation sequencing-based measurable residual disease (MRD) detection to inform clinical decision-making for patients with lymphoid malignancies (blood cancers). With its ability to detect and identify cancer cells at a level as low as one per one million cells, the clonoSEQ Assay is ten to one hundred times more sensitive than other methods of MRD detection, allowing physicians to address possible recurrence earlier. The clonoSEQ Assay provides consistent, accurate results which allow physicians to track specific cancer cell clones over time and optimize treatments for better patient management. Adaptive is currently seeking regulatory review and clearance of the clonoSEQ Assay.

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 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.

On October 26, 2016 Varian Medical Systems (NYSE:VAR) reported GAAP net earnings of $1.24 per diluted share and non-GAAP net earnings of $1.38 per diluted share for the fourth quarter of fiscal year 2016 (Press release, Varian Medical Systems, OCT 26, 2016, View Source [SID1234516087]). For the full fiscal year 2016, GAAP net earnings were $4.19 per diluted share, and non-GAAP net earnings were $4.68 per diluted share. Varian’s revenues totaled $912 million for the fourth quarter of fiscal year 2016, up 12 percent in dollars from the year-ago quarter and up 11 percent in constant currency. Varian’s revenues for the full fiscal year were $3.2 billion, up 4 percent in dollars versus fiscal year 2015 and up 5 percent in constant currency. The company ended the fourth quarter with a $3.5 billion backlog, down 1 percent from the end of fiscal year 2015 with a gain in Oncology business offset by declines in the Particle Therapy and Imaging Components backlogs.

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"The company finished the year on a strong note with solid growth in revenues and margins for both of its major businesses," said Dow R. Wilson, CEO of Varian Medical Systems. "For the fourth quarter, total company gross margin increased by nearly four percentage points over the year-ago quarter. Weak oncology orders in EMEA, where we had tough year-ago comparisons, offset gross order growth in the Americas and in Asia."

The company finished the fiscal year with $844 million in cash and cash equivalents and
$667 million of debt. Cash flow from operations was $152 million for the fourth quarter and $356 million for the fiscal year. During the quarter, the company spent $87 million to repurchase about 1 million shares of common stock.

Oncology Systems
Oncology Systems’ fourth quarter revenues totaled $678 million, up 7 percent in dollars from the same quarter of fiscal year 2015 and up 6 percent in constant currency. Annual revenues were $2.5 billion, up 5 percent in dollars from the prior fiscal year and up 6 percent in constant currency.

Fourth-quarter gross orders were $897 million, down 2 percent in dollars from the year-ago quarter and down 4 percent in constant currency. For the full fiscal year 2016, Oncology gross orders were $2.7 billion, up 1 percent in dollars and up 2 percent in constant currency. Oncology gross orders in the Americas rose 4 percent in dollars and increased 3 percent in constant currency for the fourth quarter. For fiscal year 2016, Americas gross orders rose 4 percent both in dollars and constant currency. Gross orders in Asia rose 8 percent in dollars and fell 1 percent in constant currency in the fourth quarter. For the fiscal year 2016, gross orders in Asia rose 5 percent in dollars and 3 percent in constant currency. Gross orders in EMEA fell 17 percent in both dollars and constant currency for the quarter. For the fiscal year, Oncology gross orders in EMEA fell 6 percent in dollars and 4 percent in constant currency.

"Oncology Systems generated healthy revenue growth, and strong gains in both its gross and operating margins with a favorable product mix and a sharp focus on product cost initiatives during the quarter," said Wilson. "We saw respectable gross orders growth in the Americas and in emerging markets during the quarter while facing challenging conditions in Western Europe where we had record-setting growth in the year ago period. Gross orders in North America were down 2 percent in the quarter but up 5 percent for the full fiscal year."

Imaging Components
Imaging Components revenues were $166 million for the fourth quarter, up 7 percent from the year-ago period, and $598 million for the fiscal year, down 2 percent from fiscal year 2015. Gross orders totaled $168 million for the fourth quarter, up 2 percent from the year-ago period, and totaled $571 million for the fiscal year, down 6 percent from fiscal year 2015.

"Our Imaging Components business continued to strengthen in the second half of the fiscal year with ongoing revenue growth driven in part by recent acquisitions and with solid improvements in its gross and operating margins," said Wilson. "This business has successfully weathered some severe challenges in the first half of the year and finished a fiscal year highlighted by two consecutive quarters of strong revenue growth and favorable product mix as well as several key new product introductions."

Varian intends to establish the Imaging Components business as a new, independent publicly-traded company, Varex Imaging Corporation, through a tax-free spin.

Other
The company’s Other category, including the Varian Particle Therapy business and the Ginzton Technology Center, recorded fourth quarter revenues of $68 million, up $38 million from the prior year period. Revenues for fiscal year 2016 were $163 million, up 13 percent from fiscal year 2015. During the quarter, the Particle Therapy business booked its first order for its Compact single room system. However, proton system gross orders were down from the prior year quarter and prior fiscal year when the company booked an unusually high number of orders. "While gross orders remain lumpy and timing is difficult to forecast, the sales funnel remains strong," said Wilson.

Outlook
"We believe that for the first quarter of fiscal year 2017, non-GAAP earnings for the total company, including the Imaging Components business and ramp-up costs for its separation, will be in the range of $1.03 to $1.07 per diluted share and revenues will increase by about 1 to 2 percent," said Wilson. "As we announced earlier, we will not give earnings guidance for the full fiscal year until after we have completed the separation of the Imaging Components business. For the full fiscal year 2017, we expect that Varian revenues, excluding the Imaging Components business, will rise by 3 to 4 percent. We expect that Imaging Components revenues for the full fiscal year 2017 will also rise by 3 to 4 percent."

Please refer to the attached "Discussion of Non-GAAP Financial Measures" for a description of items excluded from expected non-GAAP earnings.