On March 13, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of secondary endpoint results from the Phase 3 ENGOT-OV16/NOVA trial of niraparib at the 2017 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, March 12 to 15, 2017 by Dr. Sven Mahner, M.D., Director, Department of Gynecology and Obstetrics, University of Munich (Press release, TESARO, MAR 13, 2017, View Source [SID1234518109]).

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"The results of several secondary endpoints from the ENGOT-OV16/NOVA trial, including chemotherapy-free interval (CFI), time to second subsequent therapy (TSST), and progression-free survival 2 (PFS-2), demonstrate the positive and durable treatment effect of niraparib in a broad population of patients with ovarian cancer, regardless of germline BRCA mutation status," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "An assessment of progression-free survival in patients who have progressed on treatment received after completing the NOVA study treatment (PFS-2) compared to their first progression while on the NOVA study (PFS) indicates that niraparib does not decrease the benefit of subsequent treatment."

Niraparib is the only PARP inhibitor that has shown a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase 3 clinical trial.

Secondary Endpoint Results:
Niraparib Significantly Improved Chemotherapy-free Interval (CFI)
Among patients who were germline BRCA mutation (gBRCAmut) carriers, the niraparib arm successfully achieved statistical significance over the control arm for the secondary endpoint of CFI, with a hazard ratio of 0.26 (95% CI, 0.166-0.409). The median CFI for patients treated with niraparib was 22.8 months, compared to 9.4 months for control (p<0.0001).

Among patients without germline BRCA mutations (non-gBRCAmut), the niraparib arm successfully achieved statistical significance over the control arm for the secondary endpoint of CFI, with a hazard ratio of 0.50 (95% CI, 0.370-0.666). The median CFI for patients treated with niraparib was 12.7 months, compared to 8.6 months for control (p<0.0001).

Niraparib Significantly Improved Time to First Subsequent Treatment (TFST)
Among patients who were germline BRCA mutation carriers, the niraparib arm successfully achieved statistical significance over the control arm for the secondary endpoint of TFST, with a hazard ratio of 0.31 (95% CI, 0.205-0.481). The median TFST for patients treated with niraparib was 21.0 months, compared to 8.4 months for control (p<0.0001).

Among patients without germline BRCA mutations, the niraparib arm successfully achieved statistical significance over the control arm for the secondary endpoint of TFST, with a hazard ratio of 0.55 (95% CI, 0.412-0.721). The median TFST for patients treated with niraparib was 11.8 months, compared to 7.2 months for control (p<0.0001).

Niraparib Had No Impact on the Efficacy of Next-Line Therapy
For a pooled group of patients who have progressed on subsequent therapy (including patients with germline BRCA mutations and without germline BRCA mutations), each patient’s initial progression-free survival interval was subtracted from the progression-free survival 2 interval, which showed no reduction in benefit of niraparib treatment on the effectiveness of subsequent chemotherapy, with a hazard ratio of 1.02 (95% CI, 0.765-1.349). In the NOVA study, a HR of 1.0 demonstrates that the impact of niraparib on efficacy of the subsequent therapy was clinically indistinguishable from the impact of placebo control on the efficacy of the subsequent therapy.

Progression-free Surivival-2 and Overall Survival are Immature, but Favor Niraparib
PFS-2 data were statistically significant and favored niraparib over control for patients in both the gBRCAmut cohort (HR 0.48; 95% CI, 0.242-0.687) and non-gBRCAmut cohort (HR 0.69; 95% CI, 0.494-0.964). Given the relatively long PFS patients experienced on niraparib, PFS-2 was immature, with only 30% of events captured for patients in the gBRCAmut cohort and only 50% of events captured for patients in the non-gBRCAmut cohort. Data for overall survival were also immature (HR 0.73; 95% CI, 0.480 to 1.125; p=0.1545), as fewer than 20% of events had occurred at the time of analysis.

Phase 3 ENGOT-OV16/NOVA Trial Results
The ENGOT-OV16/NOVA trial is an international Phase 3, double-blind, placebo-controlled study that enrolled 553 patients with recurrent ovarian cancer who had achieved either a partial or complete response (PR or CR) to their most recent platinum-based chemotherapy. Niraparib significantly increased PFS in patients with and without germline BRCA mutations as compared to control, and the magnitude of benefit was similar for patients entering the trial with a PR or a CR. Results also showed that treatment with niraparib reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (HR 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). Niraparib is the only PARP inhibitor that has shown a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase 3 clinical trial.

The most common grade 3/4 adverse reactions to niraparib in the NOVA trial included thrombocytopenia (29%), anemia (25%), neutropenia (20%), and hypertension (9%). The majority of hematologic adverse events were managed via dose modification. Discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively.

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three pivotal trials. In pre-clinical studies, niraparib was found to concentrate in the tumor relative to plasma, delivering selective, greater than 90% durable PARP inhibition and a persistent anti-tumor effect.

TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial), a registrational Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial), and a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and niraparib plus bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

The niraparib New Drug Application (NDA) has been accepted for priority review by the U.S. Food and Drug Administration (FDA) and is supported by data from the ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study that enrolled 553 patients, either with or without a germline BRCA mutation, with recurrent ovarian cancer following complete or partial response to their most recent platinum-based chemotherapy. The full results of the ENGOT-OV16/NOVA trial were presented in detail at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress in Copenhagen on October 8, 2016 by Dr. Mansoor Raza Mirza, M.D., Medical Director of the Nordic Society of Gynecologic Oncology (NSGO) and principal investigator. These data were simultaneously published in the New England Journal of Medicine.

Regulatory applications are under review for niraparib in the U.S. and Europe and TESARO expects to launch niraparib in the U.S. in the first half of 2017 and in Europe by year-end 2017, pending regulatory approvals. Niraparib is an investigational agent and, as such, has not been approved by the FDA, European Medicines Agency (EMA), or any other regulatory agencies.

About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. Without an active treatment following chemotherapy, the majority of women who have responded to platinum-based chemotherapy undergo "watchful waiting" — a period without any anti-cancer treatment during which a patient and their healthcare provider will monitor signs of the disease returning. If approved, niraparib may address the difficult "watchful waiting" periods experienced by patients with recurrent ovarian cancer in between cycles of platinum-based chemotherapy.

On March 13, 2017 (GLOBE NEWSWIRE) — Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies, and advancing its proprietary R&D pipeline, reported financial results for the third quarter of fiscal year (FY) 2017 ended January 31, 2017, and provided an update on its contract manufacturing business, preclinical and clinical pipeline, and other corporate developments (Press release, Peregrine Pharmaceuticals, MAR 13, 2017, View Source [SID1234518103]).

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Highlights Since October 31, 2016
"During the third quarter, Avid’s revenue growth continued, which is a strong indicator of the increasing value of this contract development and manufacturing organization (CDMO) business. The steady growth of this business over the past 5 years has been remarkable and we are pleased to see the trend continuing as we move through a number of process validations for clients, which we expect to spur further growth in the future as some or all of those products move to commercialization. We see Avid as a tremendously important asset with solid upside potential that is often overlooked as a value driver for the overall organization. With projected revenue of over $60 million for the current fiscal year, this is already a strong business in an industry that is expecting substantial growth over the next decade and we are excited about the future of the company," stated Steven W. King, president and chief executive officer of Peregrine, and president of Avid Bioservices. "An important component of our Avid growth strategy is capacity expansion within our Myford facility. We are currently on track to install two 2,000-liter bioreactors in the facility within the next few months with a book of business for the reactors already in place. We believe the total capacity potential of the facility, when operating in campaign mode, can exceed more than $75 million annually bringing us to well over $100 million in total potential revenue between our two manufacturing facilities, and giving us adequate capacity to continue Avid revenue growth through FY 2018.

"As we look to the future, based on current operations and projected demand from our existing clients, we have also recently secured additional space within the same building as our Myford facility for which we already have use as part of our existing operations but would also allow us to further expand capacity based on committed business. While we will only begin converting the space into manufacturing capacity once client commitments and other necessary financing is in place, this puts us in an excellent position for continuing to grow the business beyond the coming fiscal year."

Mr. King continued, "During the quarter, we also achieved a number of goals on the development front. These efforts are highlighted by the three clinical trials under our collaboration with the National Comprehensive Cancer Network (NCCN) which are advancing as planned, and we expect at least two of the trials to be initiated by mid-year. Additionally, we and our collaborators will be presenting a number of studies at the upcoming AACR (Free AACR Whitepaper) annual meeting including data from researchers at Memorial Sloan Kettering that support the ability of PS-targeting agents, including bavituximab, to significantly impact the tumor microenvironment, creating a more favorable environment for checkpoint inhibitors. Additionally, our collaborators at the University of Texas Southwestern Medical Center published positive proof-of-concept data for our recently-licensed exosome-based cancer detection platform, which could have broad potential for patients with cancer. Even though we have reduced our R&D expenditures, we are pleased that collaborations such as these are allowing us to continue the advancement of our therapeutic and diagnostic programs as we continue to evaluate the best ways for moving our bavituximab and other PS-targeting programs forward. The combined efforts of growing the Avid biomanufacturing business and these important collaborations are allowing us to make great strides on all fronts."

Avid Bioservices Highlights
"The Avid business continues to build momentum. During the third quarter of FY 2017, contract manufacturing revenue increased 61% to $10.7 million compared to the third quarter of FY 2016. Given this performance, and our expected fourth quarter results, we are increasing our full FY 2017 revenue guidance from $50 to $55 million, to $60 to $65 million," stated Paul Lytle, chief financial officer of Peregrine. "We are also pleased to report that we recently leased 42,000 square feet within the same building as our Myford facility, allowing us to leverage existing oversized utilities and infrastructure that should allow us greater operational efficiency and overall cost savings. While we design the new facility within this new space, it’s important to note that our two existing commercial facilities have sufficient capacity to continue to grow our contract manufacturing revenue in FY 2018."

The company is increasing its manufacturing revenue guidance for the full FY 2017 from $50 – $55 million, to $60 – $65 million.

Avid’s current manufacturing revenue backlog is $70 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog primarily covers revenue to be recognized during the remainder of fiscal year 2017 and fiscal year 2018.

Clinical Development Highlights

— The three clinical trials under the collaboration with the NCCN are advancing as planned.

Moffitt Cancer Center—A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy for Unresectable Hepatitis C Associated Hepatocellular Carcinoma. This protocol is approved and patient screening is expected soon.

Massachusetts General Hospital Cancer Center—Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma. This trial is on track to be initiated by mid-calendar 2017.

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins—Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. This trial is on track to be initiated by mid-calendar 2017.

— The company is continuing its comprehensive biomarker analysis of data collected in the Phase III SUNRISE trial.

Through this analysis, and as reported previously, Peregrine scientists have identified a correlation between overall survival and pre-treatment levels of the biomarker, beta-2 glycoprotein-1 (β2GP1).

The results of an analysis of pre-treatment interferon gamma (IFN-ɣ) will be the subject of a presentation at AACR (Free AACR Whitepaper) entitled:

IFN-ɣ Analysis in Blood and Tissue as a Potential Prognostic and/or Predictive Biomarker

Research Highlights

— Peregrine scientists and collaborators from Memorial Sloan Kettering Cancer Center will present preclinical results from multiple studies at the upcoming AACR (Free AACR Whitepaper) meeting in April. Each study evaluates the use of a bavituximab equivalent in combination with immune stimulating therapies. The following abstracts will be presented:

Memorial Sloan Kettering: Targeting Phosphatidylserine in Combination with Adoptive T Cell Transfer Eliminates Advanced Tumors without Off-Target Toxicities in a Melanoma Preclinical Model

Memorial Sloan Kettering (initial findings presented at SITC (Free SITC Whitepaper)): Phosphatidylserine Targeting Antibody in Combination with Tumor Radiation and Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma

Peregrine (initial findings presented at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting): Combinational Activity of LAG3 and PD-1 Targeted Therapies is Significantly Enhanced by the Addition of Phosphatidylserine Targeting Antibodies and Establishes an Anti-Tumor Memory Response in Murine Triple Negative Breast Cancer

— Collaborators from the University of Texas Southwestern Medical Center at Dallas, recently published positive proof-of-concept findings for Peregrine’s recently licensed exosome-based cancer detection platform in the peer-reviewed journal, Oncotarget. Results demonstrated that those patients with malignant ovarian cancer displayed significantly higher blood PS exosome levels than those with benign tumors, and the malignant and benign groups displayed significantly higher blood PS exosome levels than the healthy subjects.

Financial Highlights and Results

— Peregrine continues to execute its previously-announced strategy to reach sustained profitability by increasing contract manufacturing revenue while decreasing research and development expenses, with the goal of reaching profitability 15 months from now. During the first nine months of FY 2017, the company made significant progress toward this goal with contract manufacturing revenues increasing 55% compared to the first nine months of FY 2016 and research and development expenses decreasing by 50% compared to the first nine months of FY 2016.

Contract manufacturing revenue from Avid’s biomanufacturing services provided to its third-party customers increased to $10,747,000 for the third quarter of FY 2017 compared to $6,672,000 for the third quarter of FY 2016.

Total costs and expenses for the third quarter of FY 2017 were $18,544,000, compared to $23,576,000 for the third quarter of FY 2016. For the third quarter of FY 2017, research and development expenses decreased 60% to $5,989,000, compared to $15,156,000 for the third quarter of FY 2016. Cost of contract manufacturing increased to $7,974,000 in the third quarter of FY 2017 compared to $3,896,000 for the third quarter of FY 2016, primarily due to an increase in the cost of contract manufacturing associated with higher reported revenue. Also contributing to this increase and impacting gross margins for the period is the higher cost of operating the new Myford facility as well as the higher cost associated with performing process validation runs during the quarter. For the third quarter of FY 2017, selling, general and administrative expenses increased slightly to $4,581,000 compared to $4,524,000 for the third quarter of FY 2016 primarily due to the company’s growing manufacturing business.

Peregrine’s consolidated net loss attributable to common stockholders was $9,216,000 or $0.04 per share, for the third quarter of FY 2017, compared to a net loss attributable to common stockholders of $18,227,000, or $0.08 per share, for the same prior year quarter.

Peregrine reported $41,528,000 in cash and cash equivalents as of January 31, 2017, compared to $61,412,000 at fiscal year ended April 30, 2016.

More detailed financial information and analysis may be found in Peregrine’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Conference Call
Peregrine will host a conference call and webcast this afternoon, March 13, 2017, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

On March 13, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has launched the EndoPredict test in the United States for patients with ER+ HER2- early-stage breast cancer(Press release, Myriad Genetics, MAR 13, 2017, View Source [SID1234518101]). EndoPredict is a second-generation test for assessing the 10-year risk of disease recurrence following surgery and for determining which patients can safely forgo adjuvant chemotherapy.

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"Today’s launch strengthens our oncology product portfolio and represents a meaningful advancement in the treatment of patients with breast cancer," said Lloyd Sanders, general manager, Oncology, Myriad Genetic Laboratories. "Along with our best-in-class tests for hereditary cancer and our companion diagnostics, the launch of EndoPredict underscores our commitment to pioneering science, personalized medicine and patient care."

EndoPredict is supported by multiple prospective clinical studies and data from more than 3,500 patients with ER+ HER2- node negative and node positive early-stage breast cancer. The results of the clinical development program show that EndoPredict substantially outperforms the first generation breast cancer recurrence tests. EndoPredict was trained and validated using 10-year outcomes data and includes proliferation-related genes as well as hormone receptor-related genes, providing accurate assessment of early and late risk for recurrence and definitively classifies patients as low or high risk.

"Breast cancer is a complicated disease and there is a critical need for accurate breast cancer recurrence tests that help physicians determine which patients can safely forgo adjuvant chemotherapy," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "The launch of EndoPredict is an important advancement for patients and doctors. By automatically incorporating clinical features and generating an individualized patient test result, EndoPredict identifies a larger subset of true low-risk patients who may safely forgo adjuvant chemotherapy."

EndoPredict already is included in medical guidelines including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and the St. Gallen International Breast Conference. Additionally, the Integrated Oncology Network (ION) named EndoPredict as its preferred breast cancer recurrence test. Myriad is working with payers to making sure EndoPredict is a widely accessible to patients. So far, the test has received positive coverage decisions from 19 payers, bringing total coverage to over 70 million patients in the United States.

Follow Myriad on Twitter via @MyriadGenetics and stay informed about Company news and updates.

Clinical Data Supporting the Launch

Name of Trial # of
Patients Breast Cancer
Sub-Type Nodal Status 10-Year Distant
Metastasis Rate
for Low Risk
Group
Multicenter 964 ER+/HER2- NO, N+ 7.0 %
ABCSG-6 378 ER+/HER2- NO, N+ 4.0 %
ABCSG-8 1,324 ER+/HER2- NO, N+ 4.0 %
ATAC 928 ER+/HER2- NO, N+ 5.8 %
About Breast Cancer
Breast cancer is the second leading cause of mortality among women. A woman living in the United States has a 12.3 percent, or a 1 in 8, lifetime risk of being diagnosed with breast cancer. In 2017, invasive breast cancer will be diagnosed in more than 246,660 women.

On March 13, 2017 Mylan N.V. (NASDAQ, TASE: MYL) reported that Mylan has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product (Press release, Mylan, MAR 13, 2017, View Source [SID1234518100]).

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The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico. In addition to eliminating any legal uncertainty over the launch of Mylan’s trastuzumab, the settlement eliminates further patent litigation expenses associated with Genentech and Roche.
Mylan has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two U.S. Genentech patents (patent numbers 6,407,213 and 6,331,415) as part of the settlement.

Following this settlement and the recent acceptance of Mylan’s application for its proposed biosimilar trastuzumab with the U.S. Food and Drug Administration (FDA), Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin in the U.S.

All other terms and conditions of the settlement and license agreement are confidential.
Mylan CEO Heather Bresch commented, "There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the U.S. and around the world. With 16 biosimilar products in development, we believe Mylan has one of the industry’s broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialize these products on a global basis."

Mylan’s proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

In the U.S., Mylan’s Biologics License Application (BLA) for proposed biosimilar trastuzumab is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
Mylan currently markets its trastuzumab products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the U.S.

On March 13, 2017 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the fourth quarter and year ended December 31, 2016 (Press release, Dynavax Technologies, MAR 13, 2017, View Source [SID1234518096]). The net loss for the year ended December 31, 2016 was $112.4 million, or $2.92 per share, compared to $106.8 million, or $3.25 per share, for the year ended December 31, 2015.

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The Company had $81.4 million in cash, cash equivalents and marketable securities as of December 31, 2016, compared to $196.1 million at December 31, 2015. In addition, in the first quarter of 2017 the Company received proceeds of $23.3 million from sales of common stock under an at-the-market sales agreement.

"We are pleased with the continued progress of our immuno-oncology portfolio during 2016 and the recent promising clinical results from our combination trial in melanoma," said Eddie Gray, chief executive officer for Dynavax. "With the expansion of SD-101 into Phase 2 in both melanoma and head and neck cancer this quarter, our marketing application for HEPLISAV-B under review by the FDA and our strong cash balance, we are in position to deliver key outcomes for several programs during 2017."

Overview

During the last few years, the company has steadily advanced on its objective to evolve into an immuno-oncology company as it prepared for an anticipated launch of HEPLISAV-B. Following receipt of the HEPLISAV-B Complete Response Letter (CRL) from the FDA in November 2016, the company was restructured to focus resources on the immuno-oncology portfolio and to enable HEPLISAV-B to advance through the FDA review process to an approval decision.

Recent Progress

SD-101

In early March, Dynavax presented promising clinical data from the dose escalation phase of an ongoing Phase 1b/2 study investigating SD-101 in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck, known as MSD outside the United States and Canada, in patients with metastatic melanoma. Encouraging overall response rates and complete response rates in patients naïve to anti-PD-1 therapy were observed.

Based on the results of the initial dose escalation phase this trial is being expanded into Phase 2 studies in both melanoma and head and neck cancer. Patients will be enrolled in two cohorts, those naïve to anti-PD-1 treatment and patients who have progressive disease on anti-PD-1 therapy. The trial is designed to build on the encouraging results seen in the anti-PD-1 naïve patient group while allowing for continued dose escalation in patients who have progressive disease on anti-PD-1 therapies.

HEPLISAV-B

In February, Dynavax filed its responses to the November 2016 CRL issued by the FDA for HEPLISAV‐B, the company’s vaccine candidate intended for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established August 10, 2017 as the Prescription Drug User Fee Act (PDUFA) action date.

As part of the January restructuring, the company suspended manufacturing activities, commercial preparations and other longer term investment related to HEPLISAV-B during the regulatory review period and reduced its global workforce by approximately 40%. If the product is approved, Dynavax plans to satisfy anticipated initial demand from existing stockpiled inventory and to scale up commercial activities based on market demand and investment priorities.

Financials

Total revenues were $7.3 million for the fourth quarter of 2016 and $11.0 million for the full year of 2016 compared to $0.7 million and $4.1 million for the same periods in 2015. The increase was primarily due to recognition of $7.2 million under the research collaboration and license agreement with AstraZeneca related to the initiation of a Phase 2a clinical trial by AstraZeneca.

Research and development expenses were $18.4 million for the fourth quarter of 2016 and $84.5 million for the full year of 2016 compared to $20.9 million and $86.9 million for the same periods in 2015. This decrease was primarily due to a reduction in outside services expense associated with the completion of the HBV-23 clinical study in the fourth quarter of 2015, partially offset by an increase in headcount as well as regulatory and manufacturing activities in preparation for the anticipated commercial launch of HEPLISAV-B.

General and administrative expenses were $8.2 million for the fourth quarter of 2016 and $37.3 million for the full year of 2016 compared to $6.7 million and $22.2 million for the same periods in 2015. This increase was primarily due to costs related to preparation for the anticipated commercial launch of HEPLISAV-B including additional headcount, information technology systems and infrastructure to support commercial development as well as costs related to sourcing a debt financing commitment.