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Amgen Announces 10 Percent Increase In 2019 First Quarter Dividend

On December 7, 2018 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.45 per share dividend for the first quarter of 2019 (Press release, Amgen, DEC 7, 2018, View Source;p=RssLanding&cat=news&id=2379993 [SID1234531966]). The dividend will be paid on March 8, 2019, to all stockholders of record as of the close of business on Feb. 15, 2019. This represents a 10 percent increase from that paid in each of the previous four quarters.

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MacroGenics Announces Partial Clinical Hold on MGD009 Phase 1 Studies

On December 7, 2018 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that on December 6, it received a letter from the U.S. Food and Drug Administration (FDA) indicating that a partial clinical hold has been placed on its Phase 1 monotherapy study of MGD009, a B7-H3 × CD3 bispecific DART molecule, as well as on a combination study of MGD009 and MGA012 (anti-PD-1) (Press release, MacroGenics, DEC 7, 2018, View Source [SID1234531963]). Under the partial clinical hold, no new patients will be enrolled in either study until the partial hold is lifted by the FDA. Current study participants may continue to receive drug at their pre-assigned dose.

The partial clinical hold was initiated following MacroGenics’ reporting of hepatic adverse events on the MGD009 monotherapy trial to the FDA, including reversible elevations of transaminases with or without concurrent elevations of bilirubin. Although these events have been otherwise uncomplicated and short-lived in duration, MacroGenics also communicated to the FDA the company’s plans to amend the existing MGD009 studies with additional supportive care to mitigate these events. The FDA has placed the trials on partial clinical hold, pending review of additional details regarding these events, and satisfactory review of the planned amendments to the monotherapy and combination study protocols and related documents. MacroGenics will be working closely with the FDA to review these events and seek to resolve this clinical hold.

"MacroGenics’ top concern in conducting clinical trials is the safety of study participants," said Scott Koenig, M.D., Ph.D. "As we’ve identified to the FDA, we believe that transaminitis observed in patients administered MGD009 was likely a cytokine-mediated event. We are working with the FDA and will provide an update when we have additional information. This partial clinical hold does not impact ongoing clinical studies for enoblituzumab and MGC018, our other B7-H3-targeted molecules."
About MGD009
MGD009 is a humanized, bispecific DART molecule that recognizes both B7-H3 and CD3 and has a prolonged serum half-life. B7-H3 is a member of the B7 family of molecules involved in immune regulation and is over-expressed on a wide variety of cancer cells, including cancer stem cells, as well as on the supporting tumor vasculature and underlying tissues, or stroma. The intended mechanism of action of MGD009 is its ability to redirect T cells, via their CD3 component, to kill B7-H3-expressing cells.

In addition to MGD009, MacroGenics’ comprehensive B7-H3 franchise includes enoblituzumab, an Fc-optimized monoclonal antibody, as well as MGC018, an antibody-drug conjugate (ADC). These clinical molecules target B7-H3. MacroGenics retains worldwide rights to its franchise of three B7-H3-based molecules.

Entry into a Material Definitive Agreement

On December 7, 2018 Sophiris Bio Inc. (the "Company") reported that entered into an Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co., as sales agent ("Cantor Fitzgerald"), pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, common shares of the Company having an aggregate offering price of up to $20.0 million (Press release, Sophiris Bio, DEC 7, 2018, View Source [SID1234531962]). The shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-219887).

The Company is not obligated to sell any shares under the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald will use commercially reasonable efforts, consistent with its normal sales and trading practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Capital Market, to sell shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. Under the Sales Agreement, Cantor Fitzgerald may sell shares in privately negotiated transactions or by any other method or payment permitted by law deemed to be an "at-the-market" offering as defined in Rule 415 under the Securities Act of 1933, as amended. The Company will pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from each sale of shares, reimburse certain legal fees and disbursements and provide Cantor Fitzgerald with customary indemnification and contribution rights. The Sales Agreement may be terminated by Cantor Fitzgerald or the Company at any time upon notice to the other party, or by Cantor Fitzgerald at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the shares.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K. The legal opinion of Fasken Martineau DuMoulin LLP relating to the common shares being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any shares under the Sales Agreement, nor shall there be any sale of such shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

New Studies Show MammaPrint® and BluePrint® Tests Provide Greater Clarity Regarding Risk of Breast Cancer Recurrence and Classifications for Treatment

On December 7, 2018 Agendia, Inc., a world leader in precision oncology, reported findings from two key studies presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) this week, reinforcing the utility and benefits of its MammaPrint 70-Gene Breast Cancer Risk-of-Recurrence and BluePrint Breast Cancer Molecular Subtyping tests (Press release, Agendia, DEC 7, 2018, View Source [SID1234531959]). Both studies underscore the growing importance of genomic testing in helping physicians to personalize breast cancer treatment management.

BluePrint reclassifies 85 percent of HER2-positive, and clarifies HER2-equivocal breast cancers in a real-world diagnostic setting1

The first study addressed challenges acknowledged within the Aphinity and ExteNET trials regarding the potential benefits of added HER2-targeted treatment in breast cancer as well as the uncertainty regarding the nature of tumors classified as HER2 "equivocal" by traditional immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). A previous trial showed that BluePrint reclassified almost half of HER2-postive/ER-positive patients identified as HER2-positive using IHC/FISH to the Luminal subtype with differential neoadjuvant treatment response.2,3

In this study, Agendia scientists analyzed HER2-positive and HER2-equivocal cancers (as defined by the 2013 CAP Guidelines), comparing IHC/FISH status from pathology results to BluePrint molecular subtype in a real-world diagnostic setting. In IHC/FISH HER2-amplified tumors, BluePrint reclassified 85 percent to non-HER2 molecular subtypes, mostly Luminal-type for ER-positive tumors and Basal-type for ER-negative tumors. BluePrint also classified all HER2-equivocal tumors to non-HER2 subtypes, Luminal and Basal, which could not be derived from IHC/FISH. No HER2 "equivocal" cancers by IHC/FISH displayed a HER2-driven genotype.

Dr. William Audeh, chief medical officer at Agendia, said: "The findings from this real-world study indicate that additional therapeutic options should be considered for some women with clinically HER2-positive cancers with genomic profiles of Luminal or Basal subtypes. These data also provide further precision to clarify the clinical uncertainty regarding the HER2 "equivocal" subtype. This study further reinforces the critical role BluePrint plays in helping to inform more personalized treatment decisions by adding to a growing body of evidence demonstrating the importance of tumor molecular subtyping in breast cancer."

MammaPrint identifies 46 percent of patients under 50 years of age with an intermediate recurrence score as Low Risk4

The second study reevaluated data from the PROMIS (PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score) trial using the same subgroup analyses that was used in the TAILORx trial. It aimed to establish greater certainty regarding the benefits of chemotherapy among female breast cancer patients under 50 with an intermediate recurrence score from the 21-gene assay (RS 18-30). The new analyses found 46 percent of these women had a low genomic risk of recurrence as assessed by MammaPrint and were unlikely to benefit from chemotherapy. Researchers also found that in the MINDACT trial, MammaPrint patients younger than age 45 and between the ages of 45-55 who also have a Low Risk result had a favorable 5-year distant metastasis-free survival of 95-98 percent in both clinically low and high risk groups.

Dr. Hatem Soliman, medical director of clinical trials at the Moffitt Cancer Center and lead study author, said: "The TAILORx trial raised important questions about the benefits of chemotherapy in women under 50, so we were pleased to see that our new subgroup analysis of the PROMIS data, using the same approach as seen in TAILORx, showed that MammaPrint provides greater certainty regarding which women are unlikely to benefit from chemotherapy. Patient quality of life, in the short-term and longer-term, is paramount, so the role of MammaPrint in signaling where physicians can safely de-escalate their patients’ treatments, and thus side effects, is important."

A full list of abstracts featuring MammaPrint and BluePrint presented during SABCS can be viewed here: View Source(2018NOV)%20-%20SABCS%202018%20Abstract%20Summary%20interactive.pdf

1. BluePrint molecular subtyping versus HER2 assessment by immunohistochemistry and FISH in the real-world diagnostic setting. Poster presented at SABCS. December 2018; San Antonio, Texas.

2. Whitworth P, et al., Chemosensitivity Predicted by BluePrint 80-Gene Functional Subtype and MammaPrint in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST). Ann Surg Oncol. 2014; 21(10): 3261–3267.

3. Pathological complete response in basal subtype tumors predicts improved distant metastasis free survival in the NBRST trial. Poster presented at ASCO (Free ASCO Whitepaper) 2018; Chicago, Illinois.

4. MammaPrint identifies 46% of patients, age ≤50 years with oncotype RS 18-30, as low risk and safe to forgo chemotherapy. Poster presented at SABCS. December 2018; San Antonio, Texas.

About MammaPrint

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines.

XOSPATA® (gilteritinib) Available at Biologics by McKesson

On December 7, 2018 Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, reported that it has been selected by Astellas Pharma US, Inc. to be in the limited distribution network for XOSPATA (gilteritinib) (Press release, McKesson, DEC 7, 2018, View Source [SID1234531958]).

XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. XOSPATA was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018, based on an interim analysis of data from the ongoing phase III ADMIRAL trial. In May 2018, the FDA accepted, with Priority Review, the company’s New Drug Application (NDA) for gilteritinib. Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the FDA.

Acute Myeloid Leukemia (AML) is a cancer that impacts the blood and bone marrow, and its incidence increases with age. The American Cancer Society estimates that in 2018, approximately 19,000 new patients will be diagnosed with AML in the U.S. XOSPATA is the first and only FLT3-targeting agent approved by the FDA for the treatment of adult patients with relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.

"Patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia have had limited treatment options," said Brandon Tom, PharmD, vice president, Commercial Services, Biologics by McKesson. "We are pleased to be able to offer this much needed new drug to this patient population, who accounts for approximately 30 percent of all AML patients."

Biologics by McKesson is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of oncology therapies, an experienced oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help cancer patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics by McKesson team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics by McKesson via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.