On January 8, 2018 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, reported progress in the Company’s pain management and CINV franchises (Press release, Heron Therapeutics, JAN 8, 2018, View Source [SID1234522991]).

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CINV Franchise

SUSTOL Sales. SUSTOL (granisetron) extended-release injection fourth-quarter 2017 net product sales were approximately $10 million, up 16% from third-quarter 2017 net product sales of $8.6 million. SUSTOL full-year 2017 net product sales were approximately $31 million, versus guidance of $25 million to $30 million.
2018 CINV Sales Guidance. Net product sales guidance for full-year 2018 for the CINV franchise is $60 million to $70 million.
Permanent J-Code Now Effective. On January 1, 2018,a product-specific billing code, or permanent J-code, for SUSTOL became available. The new J-code was assigned by the Centers for Medicare and Medicaid Services (CMS) and will help simplify the billing and reimbursement process for prescribers of SUSTOL.
CINVANTI Now Available. In November 2017, the U.S. Food and Drug Administration (FDA) approved the Company’s New Drug Application (NDA) for CINVANTI (aprepitant) injectable emulsion, the first and only polysorbate 80-free intravenous (IV) formulation of a neurokinin-1 (NK1) receptor antagonist indicated for the prevention of acute and delayed CINV. CINVANTI became commercially available in the United States on January 4, 2018.
Pain Management Franchise

Enrollment Complete in Phase 3 Pivotal Trials for HTX-011 in Postoperative Pain. Heron completed enrollment in its two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair. Heron anticipates reporting top-line results in the first half of 2018 and expects to file an NDA with the FDA in the second half of 2018.

"Heron had a strong year in 2017, led by the advancement of the HTX-011 program toward an NDA filing, the success of our commercial team with SUSTOL and the expansion of our CINV franchise with the approval of CINVANTI," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "We expect to build on our momentum in 2018 by reporting top-line pivotal Phase 3 results for HTX-011, filing an NDA for HTX-011 and growing our CINV franchise, which now includes two innovative products."

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. The Phase 2 development program for HTX-011 was designed to target the many patients undergoing a wide range of surgeries who experience significant postoperative pain. Heron completed enrollment in its two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair and anticipates reporting top-line results in the first half of 2018 and expects to file an NDA with the FDA in the second half of 2018.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI is indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce CINV in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI does not contain polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.

Please see Full Prescribing Information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

Please see Full Prescribing Information at www.SUSTOL.com.

About Chemotherapy-Induced Nausea and Vomiting (CINV)

While chemotherapy is one of the most effective and commonly used therapies to help patients fight cancer, it is accompanied by debilitating side effects, including varying degrees of nausea and vomiting, often attributed as a leading cause of premature discontinuation of cancer treatment. The goal of antiemetic therapy is to prevent CINV in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy). The National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) have categorized chemotherapy regimens based on the degree to which they cause nausea and vomiting: low emetogenic chemotherapy (LEC); moderately emetogenic chemotherapy (MEC); and highly emetogenic chemotherapy (HEC).

On January 8, 2018 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported preliminary operational and financial results for the fourth quarter and fiscal year ended December 31, 2017 (Press release, NanoString Technologies, JAN 8, 2018, View Source [SID1234522939]).

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Financial Highlights:

Product and service revenue for fiscal year 2017 is expected to be approximately $72 million, versus prior guidance of $68 to $71 million

Product and service revenue for the fourth quarter of 2017 is expected to be approximately $21 million

Total revenue for fiscal year 2017 is expected to be in the range of $113 to $115 million, including approximately $41 to $43 million of collaboration revenue, versus prior guidance of $109 to $112 million

Cash, cash equivalents and short-term investments of approximately $82 million at December 31, 2017
Operational Highlights:

Approximately 125 nCounter Analysis Systems sold in 2016, including 54 nCounter SPRINT Profilers

Installed base of approximately 605 nCounter Analysis Systems at December 31, 2017, and increase of approximately 25% since year-end 2016

More than 1,820 cumulative peer-reviewed publications of studies based on nCounter technology as of December 31, 2017, an increase of more than 25% over the prior year
"While 2017 was a challenging year, we believe that actions we have taken helped to stabilize the business in the fourth quarter and put us on the path to improved growth over the course of 2018," said NanoString president and chief executive officer, Brad Gray. "The changes that we’ve made to our commercial channel have had a positive impact, and we achieved both solid SPRINT sales and record consumables revenue during the fourth quarter. In addition, we have taken actions to resource key development programs, extend the runway provided by our existing cash, and expand our access to additional capital."

Cost Management and Financial Resources

During the fourth quarter, the company shifted resources to its high-impact platform-development programs, Digital Spatial Profiling and Hyb & Seq, and eliminated approximately 30 positions in lower-priority areas of the business. The company now expects that its existing cash on-hand will be sufficient to fund its operations through mid-2019. Additionally, during the first week of January 2018, the company increased its access to capital by entering into a $15 million revolving credit facility and a $40 million "at-the-market" facility agreement for potential future equity financing.

NanoString president and chief executive officer, Brad Gray, will give a corporate update at the JP Morgan Healthcare conference at 8:00 a.m. PST on Thursday January 11th, 2018. A live webcast of the presentation will be available online from the investor relations page of the company’s corporate website at www.nanostring.com. After the live webcast, the presentation will remain available on the website for approximately 30 days.

These preliminary results are based on management’s initial analysis of operations for the quarter and year ended December 31, 2017 and are subject to further internal review and review/audit by the company’s external auditors.

On January 8, 2018 Foundation Medicine (NASDAQ:FMI) reported preliminary unaudited total revenue of approximately $48.9 million for the fourth quarter of 2017 and approximately $152.9 million for the full year ended December 31, 2017, representing a 70% and 31% increase from the $28.8 million and $116.9 million recorded in the fourth quarter and full year ended December 31, 2016, respectively (Press release, Foundation Medicine, JAN 8, 2018, View Source [SID1234522944]).

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"2017 was a year of significant milestones for Foundation Medicine, including posting record revenue and achieving our largest annual increase in recorded clinical volume," stated Troy Cox, chief executive officer of Foundation Medicine. "Our most notable achievement was the successful completion of the parallel review process during the fourth quarter which culminated with FDA approval and a preliminary National Coverage Determination (NCD) for FoundationOne CDx from CMS. This approval and preliminary NCD are transformational for our company, clinicians, biopharma partners and most importantly, for patients with advanced cancer, as we continue to meaningfully improve access to personalized cancer care."

Revenue from biopharmaceutical companies is expected to be approximately $33.4 million in the fourth quarter of 2017 and approximately $99.7 million for the full year ended December 31, 2017, compared to $19.0 million and $78.8 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 6,206 tests to biopharmaceutical customers in this year’s fourth quarter.

Revenue from clinical testing is expected to be approximately $15.5 million in the fourth quarter of 2017 and approximately $53.1 million for the full year ended December 31, 2017, compared to $9.8 million and $38.1 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 20,044 clinical tests to ordering physicians in the fourth quarter of 2017, compared to a total of 12,788 tests reported during the fourth quarter of 2016, an increase of 57%. A total of 67,375 clinical tests were reported to ordering physicians for the full year ended December 31, 2017, compared to 43,686 clinical tests reported in 2016, an increase of 54%.

Based on the new revenue reporting the company initiated during 2017, Molecular Information Services revenue is expected to be approximately $37.4 million in the fourth quarter of 2017 and approximately $117.1 million for the full year ended December 31, 2017, compared to $20.4 million and $81.8 million in the fourth quarter and full year ended December 31, 2016, respectively. Pharma Research and Development Services revenue is expected to be approximately $11.5 million in the fourth quarter of 2017 and approximately $35.8 million for the full year ended December 31, 2017, compared to $8.4 million and $35.1 million in the fourth quarter and full year ended December 31, 2016, respectively.

Cash and cash equivalents at December 31, 2017 was approximately $71.4 million, including $30 million in new borrowings received during the fourth quarter under the company’s Credit Facility Agreement with Roche Finance.

2017 Enterprise Highlights:

Received approval from the U.S. Food & Drug Administration (FDA) under the parallel review process for FoundationOne CDx, the first broad genomic profiling test incorporating multiple companion diagnostics.

Simultaneously, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary NCD for FoundationOne CDx, which is expected to improve access to molecular information for personalized healthcare. The NCD is expected to be finalized during the first quarter of 2018.

Grew the biopharma business with new and expanded collaborations for molecular information solutions including companion diagnostics, molecular profiling, data insights, and biomarker discovery.

Presented validation data for a novel assay measuring tumor mutational burden in blood (bTMB) providing evidence that response to immunotherapy can be predicted using a blood sample. Based on these findings, Foundation Medicine’s bTMB assay is being integrated as part of Roche/Genentech’s prospective, randomized Phase III Blood First Assay Screening Trial (BFAST) as a companion diagnostic assay investigating the use of bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients.

Received approval from the State of New York Department of Health for FoundationACT, the company’s liquid biopsy assay.

Announced a collaboration with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) to identify patients for its Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Announced a collaboration with the National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group to identify patients for the NCI-Match (Molecular Analysis for Therapy Choice) study.
Increased FoundationCORE, the company’s molecular information database, to nearly 180,000 clinical cases.
Expanded the company’s global footprint and patient access to personalized healthcare by commencing operations at the company’s laboratory in Penzberg, Germany. The Penzberg location is supporting continued growth and expansion in Europe through the company’s commercial collaboration with Roche.

Published 95 peer-reviewed manuscripts in top medical and scientific journals and presented 141 podium talks and posters at scientific and medical meetings.

Complete 2017 fourth quarter and full year financial results will be announced during the company’s fourth quarter and fiscal year 2017 financial results conference call. The company also anticipates providing 2018 financial guidance at that time. This press release contains certain unaudited financial results for the company. These unaudited results could change as a result of further review by the company’s management and its independent auditors.

Mr. Cox is scheduled to present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2017, at 3:30 p.m. PST, in San Francisco. Additionally, Mr. Cox will participate in a panel discussion focused on the FDA and CMS parallel review process on Monday, January 8, 2018 at 5:15 p.m. PST. Live, listen-only webcasts of these presentations and the breakout session may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of these webcasts will be available shortly after the conclusion of the presentations and will be archived on the company’s website for two weeks.

On January 8, 2018 Emergent BioSolutions presented Corporate slide deck, dated January 9, 2018 (Presentation, Emergent BioSolutions, JAN 8, 2018, View Source [SID1234522992]).

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On January 8, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, and Mirati Therapeutics (NASDAQ:MRTX), a clinical-stage targeted oncology company, reported an exclusive license agreement for the development, manufacturing and commercialization of Mirati’s sitravatinib in Asia (excluding Japan), Australia, and New Zealand (Press release, BeiGene, JAN 8, 2018, View Source;p=RssLanding&cat=news&id=2325285 [SID1234523004]). Mirati will retain exclusive rights for the development, manufacturing and commercialization of sitravatinib for the rest of world.

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Sitravatinib is an investigational tyrosine kinase inhibitor that has demonstrated potent inhibition of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET. It is being evaluated by Mirati as a single agent in a Phase 1b expansion trial in patients whose tumors harbor specific genetic alterations in non-small cell lung cancer (NSCLC) and other tumors types. Sitravatinib has shown encouraging interim results in an ongoing Phase 2 trial in combination with nivolumab in NSCLC patients who have progressed after prior treatment with a checkpoint inhibitor.

"We are delighted to enter into this exclusive clinical development and commercialization agreement for sitravantinib and look forward to working with the experienced team at Mirati. Sitravatinib is an exciting compound that has demonstrated a unique tyrosine kinase inhibition profile and promising clinical activity both as a single agent and in combination with a checkpoint inhibitor in non-small cell lung cancer. This collaboration complements our portfolio and will allow us to investigate sitravatinib in combination with tislelizumab, our investigational anti-PD-1 antibody, in China and the rest of the licensed territory," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"We are excited to begin a partnership with BeiGene, which has built a world-class global development organization with a strong presence in Asia-Pacific, as well as an established commercial organization in China. They have demonstrated an ability to enroll patients quickly in a variety of indications which will augment our development capabilities and expand the evaluation of sitravatinib to additional tumor types for patients who are checkpoint inhibitor naïve or who have been previously treated with a checkpoint inhibitor," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati Therapeutics.

Under the agreement Mirati will receive an upfront cash payment of $10 million from BeiGene. Additionally, Mirati is eligible to receive up to $123 million of additional payments based upon the achievement of certain development, regulatory and sales milestones as well as significant royalties on future sales of sitravatinib in the licensed territory.

About Sitravatinib

Sitravatinib (MGCD-0516) is a spectrum-selective kinase inhibitor which potently inhibits receptor tyrosine kinases (RTKs) including RET, TAM family receptors (TYRO3, Axl, MER), and split family receptors (VEGFR2, KIT). Sitravatinib is being evaluated as a single agent in a Phase 1b expansion trial enrolling patients that harbor RET, CHR4Q12, and CBL genetic alterations in NSCLC and other tumors.

As an immuno-oncology agent, sitravatinib is being tested in combination with anti PD-1 checkpoint inhibitor nivolumab in NSCLC patients who have progressed after prior treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family receptors may help overcome resistance to checkpoint inhibitor therapy through enhancement of dendric cell-dependent antigen presentation, targeted depletion of immunosuppressive T regulatory cells and myeloid-derived suppressor cells, and conversion of tumor associated macrophages to an immune-enhancing Type I composition, in the tumor microenvironment.

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).