On February 09, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported that the updated American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Clinical Practice Guideline on the appropriate use of breast tumor biomarker assay results recommends the use of the Prosigna Breast Cancer Prognostic Gene Signature Assay (PAM50) to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer with known hormone receptor and HER2 status (Press release, NanoString Technologies, FEB 9, 2016, View Source [SID:1234509010]). The Prosigna assay was one of only two such assays to receive a "high" rating of evidence quality together with a "strong" recommendation.
"Prosigna’s inclusion in the ASCO (Free ASCO Whitepaper) Clinical Practice Guideline, specifically for use in guiding decisions on adjuvant systemic therapy for women with early stage breast cancer, places Prosigna on equal footing with the Oncotype DX test," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "This is the sixth major breast cancer treatment guideline to include Prosigna in the past twelve months, and it further strengthens our case for reimbursement and market adoption."

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The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline provides evidence-based recommendations based on a comprehensive review and analyses of the relevant literature for each recommendation. The Guideline states that if a patient has hormone receptor-positive, HER2-negative (node-negative) breast cancer, the clinician may use the PAM50 (Prosigna) risk of recurrence (ROR) score, known as the Prosigna Score in the United States, in conjunction with other clinicopathologic variables, to guide decisions on adjuvant systemic therapy.

"We applaud the rigorous scientific methodology and transparency that the ASCO (Free ASCO Whitepaper) multidisciplinary expert breast cancer panel applied in reviewing and weighing the available scientific evidence," said Alessandra Cesano, M.D., Ph.D., Chief Medical Officer of NanoString. "By focusing on the clinical utility of sparing women unnecessary chemotherapy, the Committee has helped future breast cancer patients avoid the risk of fatal, life-threatening, or permanently changing toxicities."

The Guideline, together with additional information including details of the methodology and review of the scientific literature, is available at: View Source

About the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.

The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory.

In the United States, the Prosigna Assay is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.

In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
(1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.

For more information, please visit www.prosigna.com.

On February 8, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that it has entered into a long-term loan and security agreement with Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. for up to $40 million in financing (Press release, CytRx, FEB 8, 2016, View Source;p=RssLanding&cat=news&id=2136395 [SID:1234508998]).

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CytRx has received the first $25 million of financing under the loan and security agreement. The proceeds will be used for pre-commercialization and manufacturing activities for aldoxorubicin, clinical development, and general corporate purposes. A second tranche of up to $15 million will be available on or before December 31, 2016 if CytRx announces positive data from its global pivotal Phase 3 clinical trial of aldoxorubicin for the treatment of soft tissue sarcoma and initiates a clinical trial of a second novel drug candidate based on CytRx’s LADR technology platform.

"This financing is an important step for CytRx as we complete our pivotal, global Phase 3 trial with aldoxorubicin and prepare for its commercial launch," said Steven A. Kriegsman, Chairman and CEO.

"We are pleased to team up with CytRx in advance of their results from the pivotal Phase 3 clinical trial. This financing will support CytRx through this key milestone and the future launch of aldoxorubicin," said Anup Arora, Managing Director at Hercules Technology.

The financing is in the form of a 48-month term loan bearing interest at a rate of 9.5% per annum, subject to the variability of the prime interest rate. In the first year of the long-term loan, only interest is payable. If the regulatory milestone relating to data from the aldoxorubicin Phase 3 trial is positive, the interest-only period will be extended for an additional six months. If the second tranche of $15 million is funded to CytRx under the loan and security agreement, the interest-only period will be extended for another six months.

In connection with the loan and security agreement, CytRx paid and issued to the lenders certain fees of approximately $450,000 and warrants to purchase approximately 630,000 shares of common stock of CytRx at an exercise price of $2.05 per share.

Armentum Partners, through Trump Securities, LLC and Reedland Capital Partners, through Merriman Capital, Inc., a registered broker-dealer and member FINRA/SIPC, acted as financial advisors to CytRx in connection with the transaction.

On February 8, 2016 Biota Pharmaceuticals, Inc. (NASDAQ:BOTA), a biopharmaceutical company focused on the discovery and development of direct-acting antivirals that address infections that have limited therapeutic options, reported that the first patient has been dosed in a Phase 2 double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability and efficacy of BTA074 5% gel in male and female patients with condyloma, or anogenital warts, caused by human papillomavirus (HPV) types 6 & 11 (Press release, Nabi Biopharmaceuticals, FEB 8, 2016, View Source [SID:1234508993]).

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"We are excited to progress BTA074 into a well-powered proof-of-concept study. The currently approved topical treatments for condyloma lack consistent efficacy and cause a considerable amount of undesirable local skin reactions, such as erosions and edema, often leading to the need to stop treatment. With this larger Phase 2 study, we hope to further validate the clinical activity of BTA074 seen in its earlier Phase 2 trial, which showed evidence of overall clearance and a benign side effect profile," remarked Joseph M. Patti, PhD, president and chief executive officer at Biota. "We now have three direct-acting antiviral programs in the clinic, each of which has the potential to help patients by attacking the root cause of their viral infections."

BTA074 is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, and is designed to prevent HPV DNA replication. The Phase 2 trial is expected to enroll approximately 210 patients with anogenital warts and will have a 2-to-1 randomization of BTA074 5% gel to placebo gel. The patients will be dosed twice daily for up to 16 weeks. The primary efficacy objective is to determine the complete clearance rate for baseline anogenital warts from the commencement of therapy to the end of the treatment period. Secondary efficacy endpoints include various assessments of clearance and wart area reduction for both baseline warts and post-baseline emergent warts.

On February 8, 2016 Pfizer Inc. (NYSE: PFE) reported the executive leadership team for the combined Pfizer and Allergan plc (NYSE: AGN) business following the close of the proposed transaction (Press release, Pfizer, FEB 8, 2016, View Source [SID:1234509009]).

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As previously announced, following the closing, Brent Saunders will become President and Chief Operating Officer of the combined company with responsibility for the oversight of Pfizer and Allergan’s combined commercial businesses, manufacturing and strategy functions.

Effective immediately and through the closing of the transaction Pfizer’s Global Innovative Pharma (GIP) business and its Vaccines, Oncology and Consumer (VOC) business will operate separately under the leadership of Albert Bourla, currently Group President, VOC. Upon the closing of the transaction, the Vaccines and Oncology businesses will be combined with the GIP business, and Albert Bourla will become Group President, Global Innovative Pharma, leading all of these businesses.

In addition, following the close of the transaction, the combined company will create a new operating segment named Global Specialty and Consumer Brands that will include Pfizer’s Consumer Healthcare unit and Allergan’s ophthalmology and aesthetics businesses, and Botox Therapeutic and Cosmetic. Bill Meury, currently Executive Vice President and President Branded Pharma at Allergan, will become Group President, Global Specialty and Consumer Brands, Pfizer.

After the close of the proposed transaction, Pfizer will continue to manage the combined company’s commercial operations through two distinct businesses: an Innovative Products business and an Established Products business. The Innovative Products business will be composed of two operating segments: the Global Innovative Pharmaceutical and the Global Specialty and Consumer Brands segment. The Established Products business will continue to be led by John Young, and consist of the Global Established Pharmaceutical segment, including all legacy Hospira commercial operations.

Upon the close of the transaction, the following executives will be members of the company’s executive leadership team, reporting to Brent Saunders:

Albert Bourla, Group President, Global Innovative Pharma
Tony Maddaluna, Executive Vice President, President Pfizer Global Supply
Bill Meury, Group President, Global Specialty and Consumer Brands
Laurie Olson, Executive Vice President, Strategy, Portfolio and Commercial Operations
John Young, Group President, Global Established Pharma
The following Pfizer executives are continuing in their roles reporting to Ian Read, Pfizer Chairman and Chief Executive Officer:

Frank D’Amelio – Executive Vice President, Business Operations and Chief Financial Officer
Mikael Dolsten – President, Worldwide Research and Development
Chuck Hill – Executive Vice President, Worldwide Human Resources
Rady Johnson – Executive Vice President, Chief Compliance and Risk Officer
Doug Lankler – Executive Vice President, General Counsel
Freda Lewis-Hall – Executive Vice President, Chief Medical Officer
Sally Susman – Executive Vice President, Corporate Affairs
"We are creating an executive team that has deep industry knowledge, a proven track record of success and an unwavering commitment to the patients we serve. I look forward to working with these outstanding leaders to achieve the full potential of this combination and fulfill our mission of becoming the premier biopharmaceutical company in our industry," said Ian Read, Chairman and Chief Executive Officer of Pfizer. "We are designing the combined company to preserve and enhance our option to potentially separate the innovative and established businesses into separate companies in the future, and continue to expect to make a decision about any potential separation by no later than the end of 2018."

Pfizer also announced that Geno Germano, Group President, Global Innovative Pharma Business, will be leaving the company.

"We thank Geno for his many contributions to Pfizer’s business over the past seven years," continued Read. "Under Geno’s leadership we have laid the foundation for the growth potential of our vaccines and oncology businesses, strengthened our in-line portfolio with products like Enbrel, Xeljanz and Eliquis and improved our innovative late-stage pipeline with programs like bococizumab and tanezumab."

Pfizer and Allergan will continue to operate as two separate companies until the close of the transaction, which is expected in the second half of 2016, and is subject to certain conditions, including: receipt of regulatory approval in certain jurisdictions, including the United States and European Union; the receipt of necessary approvals from both Pfizer and Allergan shareholders; and the completion of Allergan’s pending divestiture of its generics business to Teva Pharmaceuticals Industries Ltd.

On February 5, 2015 Biota Pharmaceuticals, Inc. (NASDAQ: BOTA) reported its financial results for the three month period ended December 31, 2015, which is the second quarter of the Company’s 2016 fiscal year, and also provided an update on recent corporate developments (Filing, 8-K, Nabi Biopharmaceuticals, FEB 5, 2016, View Source [SID:1234508985]).

"I am very pleased today to report that significant progress is being made with our antiviral pipeline for respiratory indications and we remain on track to have Phase 2 data readouts in the second half of the year from both the HRV and RSV programs. Our oral RSV fusion inhibitor, BTA585, successfully completed a robust Phase 1 single ascending dose study showing a favorable safety and pharmacokinetic profile. We are nearing completion of the Phase 1 multiple ascending dose study and plan to initiate the Phase 2 RSV challenge study next quarter. Additionally we are progressing with enrollment in the Phase 2b SPIRITUS trial of vapendavir and anticipate top-line data in the second half of this year. Not only is this our lead program but it is the most advanced direct-acting antiviral in the field targeting HRV and has the potential to treat problematic upper respiratory infections in the almost 11 million moderate-to-severe asthmatics in the U.S.," stated Joseph M. Patti, PhD, president and chief executive officer at Biota Pharmaceuticals.

"I am glad to report that we have begun screening patients for the Phase 2 study of BTA074, our first-in-class direct-acting antiviral for the treatment of condyloma caused by HPV types 6 & 11, which is the most common manifestation of HPV infection and also the most common sexually-transmitted viral disease worldwide. Current topical treatments do not act on the virus directly so there is a need for a therapy with improved efficacy and reduced local skin reactions to address this contagious infection."

Recent Highlights
Announced positive Phase 1 data for BTA585. The top-line results were from a blinded, placebo-controlled single ascending dose study, which tested doses of up to 800 mg of BTA585, an oral fusion inhibitor in development for the treatment and prevention of respiratory syncytial virus (RSV) infections. Findings included:

● No serious or severe adverse events

● Low incidence of adverse events

● Pharmacokinetic (PK) data demonstrated that all doses of 100 mg or greater achieved BTA585 plasma levels that exceeded the mean EC50 of RSV clinical isolates for 24 hours. The EC50 represents the concentration of drug that is required for 50% inhibition of viral replication in vitro

● BTA585 plasma Cmax was rapidly achieved at approximately one hour following oral dosing and the half-life (T1/2) was approximately five to six hours across the dose range

● Dosing of BTA585 with a high fat meal did not adversely affect the PK

Commenced dosing in Phase 1 multiple ascending dose (MAD) study of BTA585. This study will evaluate the safety and PK of BTA585 in healthy volunteers following seven days of oral dosing. Top-line data is anticipated to be available in the first quarter of 2016.

Enrollment on track for Phase 2b SPIRITUS trial for vapendavir. Top-line data are expected in the second half of 2016 from the multi-center, randomized, double-blind, placebo-controlled dose-ranging study in moderate-to-severe adult asthmatics with symptomatic human rhinovirus (HRV) and a history of asthma exacerbation from colds.

Corporate Updates

Appointed Mark P. Colonnese as Executive Vice President and Chief Financial Officer on November 2, 2015. The Company announced the appointment of Mark Colonnese as Executive Vice President and Chief Financial Officer. Mr. Colonnese has held a number of senior executive positions in the pharmaceutical industry and, most recently, was Chief Financial Officer of Stealth BioTherapeutics, Inc.

Financial Results for the Three Month Period Ended December 31, 2015

The Company reported a net loss of $6.5 million for the three month period ended December 31, 2015, as compared to net income of $6.5 million in the same quarter of the prior fiscal year. Basic and diluted net loss per share was $0.17 for the three month period ended December 31, 2015, as compared to a basic and diluted net income per share of $0.19 in the same period of 2014.

Revenue decreased to $1.7 million for the three month period ended December 31, 2015 from $13.9 million in the same period in 2014 due to a $4.8 million decrease in royalty revenues, related to a larger Relenza government stockpile order received in the prior year, as well as lower seasonal sales of Relenza and Inavir reflecting an earlier than normal flu season in 2014, and $7.4 million decrease in revenue from services as a result of the termination of the Company’s contract with BARDA in 2014.

Cost of revenue decreased to zero for the three month period ended December 31, 2015 from $1.6 million in the same period last year due to the termination of the Company’s contract with BARDA in 2014.

Research and development expense increased to $6.3 million for the three month period ended December 31, 2015 from $4.8 million in the same period in 2014. The $1.5 million increase was the result of a $2.8 million increase in clinical costs related to the ongoing Phase 2b SPIRITUS trial for vapendavir; the Phase 1 SAD and MAD trials for BTA585; and startup expenses for the Phase 2 trial for BTA074. These costs were offset in part by a $0.8 million decrease in compensation expenses and a decrease of $0.5 million in depreciation and facility related expenses associated with the closure of the Company’s early-stage research facility in March 2015.

General and administrative expense decreased to $2.1 million for the three month period ended December 31, 2015 from $2.6 million in the same period in 2014, due largely to lower compensation expenses as a result of administrative staff reductions related to the facility closure in March 2015.

The Company held $57.2 million in cash, cash equivalents, and short and long-term investments as of December 31, 2015.

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