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MARKET COMMENTARY

 

U.S. stock index futures were marginally higher, steadying after last week’s wild gyrations as the weekend brought more clarity about possible appointments by U.S. President-elect Donald Trump. European shares started the week on a positive note. Most Asian shares closed lower though Japanese shares bucked the trend to close up. The dollar hit a 11-month peak on expectations of faster domestic inflation. Gold traded lower and a prospect of another year of oversupply, pushed oil prices down.

 

 

MARKET HIGHLIGHTS

 

VBI Vaccines reported interim results from an ongoing Phase IV postmarketing study to evaluate Sci-B-Vac™, VBI’s licensed third-generation hepatitis B vaccine, in healthy adults.  In its interim analysis, Sci-B-Vac™ was found to be well-tolerated and demonstrated rapid onset of protection against the hepatitis B virus ("HBV"). Seroprotection rates, the percent of patients who produced an antibody response capable of preventing an infection, were as follows:  91.9% of study participants were seroprotected at Month 2, one month after receiving a second dose of Sci-B-Vac™.  98.8% of participants were seroprotected at Month 3, two months after receiving a second dose of Sci-B-Vac™, and prior to receiving a third dose.

 

DelMar Pharmaceuticals announced its financial results for the quarter ending September 30, 2016, the first quarter of the Company’s 2017 fiscal year.  For the three months ended September 30, 2016 the Company reported a net loss of $2,290,339, or a net loss per share of $0.23, compared to a net loss of $1,621,388, or a net loss per share of $0.15 for the three months ended September 30, 2015.

 

Eiger BioPharmaceuticals announced an update on presentations of data from its LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program presented as of today at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston, Massachusetts. LOWR HDV is a multi-center, international Phase 2 program designed to identify optimal dosing of lonafarnib (LNF) with ritonavir (RTV) ± pegylated interferon (PEG IFN) for development in the treatment of hepatitis delta infection (HDV). Key Findings:  LNF + RTV (all-oral) regimens achieve HDV-RNA PCR-negativity on treatment.  Low dose LNF + RTV with PEG IFN achieves the most rapid and profound viral load decline, with the highest rate of HDV-RNA PCR-negativity on treatment.  LNF + RTV based regimens lead to normal ALT.  Gastrointestinal adverse events were predominantly mild or moderate.  LNF based regimens can induce a reactivation of the immune response to HDV leading to post-treatment viral clearance of HDV-RNA and reversal of fibrosis.

 

Catalyst Biosciences announced positive results from a preclinical study of CB 2679d/ISU304 in well-validated models of hemophilia B. The study highlighted the attractive pharmacokinetic profile of CB 2679d/ISU304 based on bioavailability, potency, time to maximal concentration, and half-life, which resulted in the ability to dose CB 2679d/ISU304 subcutaneously while also achieving steady-state levels of procoagulant activity that moved hemophilia B mice from the severe range to the mild range.

 

CoLucid Pharmaceuticals announced that over 50% of the 2,968 migraine patients expected to enroll in the Company’s SPARTAN trial, the second of two pivotal Phase 3 clinical trials, have now been randomized. The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint.

 

Onconova Therapeutics reported financial results for the third quarter ended September 30, 2016.  The company reported a third quarter net loss of $1.6 million, or ($0.29) per share.  Cash, cash equivalents and marketable securities as of September 30, 2016, totaled $25.8 million, compared to $19.8 million as of December 31, 2015. 

 

Ignyta announced six data presentations at the 2016 EORTC-NCI-AACR (ENA) Molecular Targets and Cancer Therapeutics Symposium in Munich, Germany. 

 

MediciNova will present a corporate overview at the Piper Jaffray Healthcare Conference on November 29.

 

TRACON Pharmaceuticals presented data at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting, taking place November 11-15 in Boston, MA.  Preclinical data were presented from two separate liver fibrosis models in a poster presentation entitled, “Endoglin Antibody Reduces the NAFLD Activity Score in the STAM Model of NASH and Reduces Liver Fibrosis Following Carbon Tetrachloride Treatment.

 

Bristol-Myers Squibb Company and Innate Pharma SA announced an interim efficacy analysis from a Phase 1/2 study of the combination of lirilumab and Opdivo (nivolumab) in the cohort of advanced platinum refractory squamous cell carcinoma of the head and neck (SCCHN), including exploratory biomarker analyses of patient response by level of PD-L1 expression. Among 29 evaluable patients with SCCHN, the objective response rate (ORR), a secondary endpoint measured by Response Evaluation Criteria In Solid Tumors (RECIST), was 24% (n=7). Seventeen percent (n=5) of these evaluable patients had deep responses, with reductions in tumor burden greater than 80%. Early signals of enhanced clinical benefit were observed in PD-L1 positive tumors, with an ORR of 41% (7/17) in patients with ≥1% PD-L1 expression.

 

OncoSec Medical Incorporated presented new clinical data from a Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF).  The data was presented at an oral poster presentation (#466) by Dr. Alain Algazi at the Society for Immunotherapy of Cancer ("SITC") Annual Meeting in National Harbor, MD.  This single-arm, open-label trial assessed the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse® IL-12, and Merck’s KEYTRUDA® (pembrolizumab) in patients with unresectable metastatic melanoma. A predictive biomarker was used to enroll patients that have a low likelihood of response to an anti-PD1 agent alone, and the purpose of the trial is to assess whether the addition of ImmunoPulse® IL-12 can increase response rates in these patients.

 

Mateon Therapeutics reported financial results for the third quarter of 2016.  For the third quarter of 2016, Mateon reported a net loss of $3.2 million compared to a net loss of $3.6 million for the third quarter of 2015.  At September 30, 2016, Mateon had cash, cash equivalents and short-term investments of $16.3 million, which the Company currently believes is sufficient to fund operations through the availability of key clinical data from the FOCUS Study, which is expected in the second half of 2017.

 

Vermillion will present a corporate overview at the Canaccord Genuity Medical Technology and Diagnostics Forum Conference on Thursday, November 17.

 

Corbus Pharmaceuticals announced positive topline results from its Phase II study evaluating Resunab ("JBT-101") for the treatment of diffuse cutaneous systemic sclerosis ("systemic sclerosis"). JBT-101 out-performed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, reaching 33% at week 16, versus 0% for placebo. The higher the CRISS score the greater the improvement; a CRISS score ≥ 20% (CRISS20) can be considered a medically meaningful improvement. The difference in CRISS scores between JBT-101 and placebo groups over the trial period was significant (p = 0.044). Differences in categorical levels of CRISS responses and changes from baseline in the five individual domains of the CRISS score also supported clinical benefit of JBT-101.

 

Ocular Therapeutix announced positive topline results from its Phase III clinical trial of DEXTENZA (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.

 

Dynavax Technologies announced that it has received a CRL from the FDA regarding its BLA for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection. The FDA issues CRLs to communicate that the Agency has completed a review cycle of an application and to request additional information for review and approval. Dynavax expects a Class 2 designation for a resubmission of the BLA, which would result in a target review period of six months.

 

Inovio Pharmaceuticals announced an interim data analysis showing that its INO-3112 cancer immunotherapy product generated antigen-specific CD8+ killer T cell responses measured both in tumor tissue and in peripheral blood from subjects with head and neck cancer associated with human papillomavirus (HPV). The immunology results show that INO-3112 treatment generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood in four of five subjects who also showed increased T cell activation in resected tumor tissue samples. These four subjects remained disease free in continuing follow-up that ranged from nine to 24 months at the time of analysis. One subject with only minimal increases in T cell immune responses developed progressive disease at 11 months post start of the study. These results were presented November 12(th) at the 2016 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Maryland.

 

Anavex Life Sciences reported encouraging preclinical efficacy for the treatment of neuropathic pain and visceral pain with their novel compound, ANAVEX 1066. The poster titled "Mixed sigma-1 / sigma-2 ligands as analgesics: studies with ANAVEX 1066 in animal models of neuropathic pain and visceral pain" was presented at the annual meeting of the Society for Neuroscience taking place from November 12-16 in San Diego, California.

 

Horizon Pharma announced that a retrospective analysis of data from previous pivotal, randomized KRYSTEXXA (pegloticase) clinical trials demonstrate that refractory chronic gout patients defined as "non-responders" based on serum uric acid levels in the trials still achieved significant clinical benefit despite a loss of response in uric acid levels. These data (abstract 212) were presented during the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington D.C. on Sunday, November 13, 2016.

 

Aralez Pharmaceuticals announced new data for YOSPRALA, a recently FDA-approved prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), demonstrated significantly lower rates of gastric and duodenal ulcers compared to aspirin alone among patients with a history of myocardial infarction at risk for secondary cardiovascular events and gastrointestinal problems related to aspirin therapy at the annual American Heart Association Scientific Sessions.

 

Mallinckrodt confirmed enrollment of the first patient in the company’s Phase IV clinical study assessing the efficacy and safety of H.P. Acthar Gel (repository corticotropin injection) in rheumatoid arthritis (RA) patients with persistently active disease.

 

Eli Lilly and Incyte announced that in two Phase III trials, RA-BEAM and RA-BUILD, patients with rheumatoid arthritis (RA) treated with baricitinib experienced significant improvements in patient-reported outcomes, including joint pain, severity of morning joint stiffness and tiredness, compared to placebo and adalimumab (Humira). These findings were presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington DC, November 11-16, 2016.

 

Eli Lilly and Incyte announced new data analyses of two Phase III trials, RA-BUILD and RA-BEAM, showing that baricitinib treatment resulted in improvements in rheumatoid arthritis (RA) symptoms across a diverse population of patients with RA regardless of age, body mass index (BMI) and previous treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Findings were presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington DC, November 11-16, 2016.

 

Amgen announced that the EC has granted marketing authorization for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session.

 

Nabriva Therapeutics announced that it plans to raise additional capital through a rights offering. The record date of the rights offering will be November 22, 2016. Holders of common shares on the record date will be entitled to exercise non-transferable statutory pre-emptive rights to subscribe for new common shares to maintain their proportionate ownership interest in Nabriva in accordance with the relevant provisions of the Austrian Stock Corporation Act. In addition, holders of ADSs as of 5:00 pm (New York City time) on the record date will also receive non-transferable subscription rights to purchase new common shares, in the form of new ADSs, to maintain their proportionate ownership interest.  Each ADS represents one tenth (1/10) of a common share. Nabriva expects to announce additional details about the planned rights offering in the near future.  Nabriva reserves the right to cancel or terminate the rights offering at any time.

 

Merck announced results from multiple analyses at The Liver Meeting 2016, which provide additional evidence supporting the use of ZEPATIER (elbasvir and grazoprevir) 50mg/100mg tablets in chronic hepatitis C virus (HCV) genotype (GT) 1- or GT4-infected patient populations, including those who receive opioid agonist therapy (OAT), are infected with chronic HCV GT1b, use proton pump inhibitors (PPIs) or have moderate kidney disease.

 

Bristol-Myers Squibb announced safety and efficacy data from a Phase I/II study of urelumab in combination with Opdivo (nivolumab) in patients with hematologic and solid tumors, including biomarker analyses by level of PD-L1 expression. The combination of urelumab and Opdivo showed encouraging efficacy among 46 evaluable melanoma patients with an objective response rate (ORR) of 50% (23/46 with 18 confirmed and 5 unconfirmed). ORR was a secondary endpoint as measured by Response Evaluation Criteria In Solid Tumors (RECIST). Similar response was seen in both PD-L1 positive and PD-L1 negative melanoma patients, with ORR of 50% (10/20) and 47% (8/17) in those with ≥1% and <1% PD-L1 expression, respectively. Among the other cohorts (n=78), one non-small cell lung cancer (NSCLC) patient and one squamous cell carcinoma of the head and neck (SCCHN) patient had an objective response. In the full patient population (n=138), no significant added toxicity was observed with urelumab in combination with Opdivo over Opdivo monotherapy.

 

Merck announced results from the pivotal KEYNOTE-045 study investigating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced bladder (urothelial) cancer previously treated with platinum-containing chemotherapy. As previously announced, KEYTRUDA was superior to investigator-choice chemotherapy for the primary endpoint of overall survival (OS) in this Phase III study, and was stopped early. Specifically, there was a 27 percent reduction in the risk of death in patients treated with KEYTRUDA compared to chemotherapy (OS, HR = 0.73, p-value: 0.0022).

 

Aduro Biotech announced highlights from a poster presentation at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held in National Harbor, Maryland on the preliminary safety and efficacy of its novel immunotherapy, CRS-207, being evaluated in unresectable malignant pleural mesothelioma. These data were from the second cohort of patients in an ongoing Phase Ib clinical trial of CRS-207 in combination with standard of care chemotherapy and immune-modulating doses of cyclophosphamide (Cy) as a first-line treatment.

 

Merck announced the presentation of results from three Phase II clinical trials evaluating MK-3682B (MK-3682/grazoprevir/ruzasvir(1)), the company’s investigational all-oral, triple-combination regimen for the treatment of chronic hepatitis C (HCV) infection (informally referred to as MK3). Results from Part B of C-CREST 1 & 2 demonstrated high rates of sustained virologic response (SVR) 12 weeks after the completion of therapy (SVR12, considered virologic cure) in patients with chronic HCV genotype (GT) 1 or GT3 infection who received eight weeks of treatment with MK-3682B. Findings from C-CREST 1 & 2 Part B also demonstrated high rates of SVR12 in GT1, GT2 and GT3-infected patients who received MK3 for 12 or 16 weeks. Findings from Part C of C-CREST 1 & 2 and interim results from the ongoing C-SURGE study showed high rates of SVR12 and SVR8, respectively, in chronic HCV patients who had failed prior treatment with investigational or approved direct-acting antiviral regimens.

 

Xencor announced preliminary data from XmAb5871-03, an ongoing, open-label, pilot Phase II study of XmAb5871 in patients with active IgG4- RD. Data show that 82% of patients achieved an initial response to therapy within two weeks of their first dose.

 

Alnylam Pharmaceuticals and The Medicines Company announced that results from the Phase I study of inclisiran (in-CLEE-si-ran), the recommended International Nonproprietary Name (INN) for ALN-PCSsc, were published in The New England Journal of Medicine (NEJM). Inclisiran is an investigational RNAi therapeutic targeting PCSK9 – a genetically validated protein regulator of LDL receptor metabolism – being developed for the treatment of hypercholesterolemia.

 

Novartis announced new data showing Cosentyx (secukinumab) delivers sustained improvements in the signs and symptoms of psoriatic arthritis (PsA) over three years – including patient-reported pain. These findings were presented at the 2016 Annual Meeting of the American College of Rheumatology (ACR) in Washington DC, United States,

 

Novartis announced that the FDA granted Priority Review to the PKC412 (midostaurin) NDA for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, as well as for the treatment of advanced systemic mastocytosis (SM). The premarket approval application (PMA) for the PKC412 (midostaurin) FLT3 companion diagnostic, developed in collaboration with Invivoscribe Technologies has also been accepted for review by the FDA. Outside the US, the MAA for PKC412 (midostaurin) in these indications has already been accepted by the EMA.

 

MabVax Therapeutics Holdings reported on progress from its two HuMab-5B1 antibody Phase I programs evaluating the use of MVT-5873 as a therapeutic antibody and MVT-2163 as an immuno-PET imaging agent in patients with locally advanced and metastatic pancreatic cancer or other CA19-9 positive malignancies.

 

CEL-SCI announced new preclinical data that demonstrate its investigational new drug candidate CEL-4000 has the potential for use as a therapeutic vaccine to treat rheumatoid arthritis. CEL-4000 has been developed using CEL-SCI’s patented LEAPS (Ligand Epitope Antigen Presentation System) technology. Data were presented by Daniel Zimmerman, Ph.D., CEL-SCI’s Senior Vice President of Research, Cellular Immunology, at the American College of Rheumatology’s Annual Meeting in Washington DC. The poster presentation titled, "A Therapeutic Peptide Vaccine Reduces Pro-inflammatory Responses and Suppresses Arthritis in the Cartilage Proteoglycan G1 Domain-induced Mouse Model of Rheumatoid Arthritis," was presented on November 14, 2016.

 

Heat Biologics announced that preclinical data from its ComPACT platform, a single product that combines Heat’s ImPACT therapeutic vaccine with an immune co-stimulatory molecule, was presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. In the poster, "Gp96-Ig/Costimulator (OX40L, ICOSL, or 4-IBBL) Combination Vaccine Improves T-cell Priming and Enhances Immunity, Memory and Tumor Elimination," researchers assessed ComPACT/OX40L in a third preclinical mouse tumor model: colorectal cancer (MC38). ComPACT/OX40L amplified antigen-specific CD8+ T cells and memory precursor effector cells (MPECs). It also blocked tumor growth, and increased both tumor rejection and animal survival, generating better results than an OX40 antibody, and without the broad systemic inflammation typically seen with OX40 antibody therapy. Furthermore, ComPACT/OX40L, combined with either PD1 or PD-L1 blocking antibodies, produced even greater antitumor immunity than either compound alone.

 

OpGen announced it has entered into a research collaboration with Merck, known as MSD outside the United States and Canada, to develop new rapid diagnostics and information technology products to help combat the threat of antimicrobial resistance. The companies will collaborate to support OpGen’s development of rapid DNA tests and a genomic knowledgebase of antibiotic-resistant pathogens for predicting antibiotic susceptibility based on test results.

 

Actinium Pharmaceuticals announced that the Company received a notice of allowance from the USPTO for a patent claiming the purification of actinium-225 (Ac-225), the alpha-emitting radioisotope used in Actimab-A. Actimab-A is currently in a Phase II clinical trial in patients newly diagnosed with Acute Myeloid Leukemia (AML) who are over the age of 60.

 

ContraFect announced that it has entered into a three year collaborative research agreement with The Rockefeller University (Rockefeller) to identify new lysin therapeutic candidates targeting Gram-negative bacteria. This agreement renews and expands the existing collaboration between ContraFect and Rockefeller.

 

Arrowhead Pharmaceuticals delivered a poster presentation with Phase I clinical data and an oral presentation with preclinical data on ARC-AAT, its investigational medicine for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD), at The Liver Meeting 2016, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD), in Boston. The data indicate that in a first-in-human clinical study, ARC-AAT was well tolerated and induced deep and durable reduction of the target AAT protein. The preclinical data suggest that treatment with ARC-AAT over time may improve liver health and prevent further damage.

 

Galena Biopharma announced that data from Galena’s GALE-301/GALE-302 clinical program was presented at the Society for Immunotherapy of Cancer Conference 2016 in National Harbor, Maryland. GALE-301 (E39) and GALE-302 (E39′ — variant of E39) are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. The Phase Ib is a single-center, randomized, single-blinded, three-arm study in patients with breast or ovarian cancer diagnosis who were treated with standard of care and showed no evidence of disease at enrollment. This trial augments the Phase I/IIa trial with single-agent GALE-301 in ovarian and endometrial cancers.

 

Celgene announced findings from the ACTIVE Phase IIIb clinical trial of OTEZLA(R) (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), at the 2016 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Washington, D.C. The trial met its primary endpoint of significant improvement in the proportion of patients achieving an ACR20 response at week 16 with OTEZLA versus placebo in patients with active psoriatic arthritis who have not previously been treated with a biologic therapy.

 

Novartis announced that the FDA granted Priority Review to the PKC412 (midostaurin) NDA for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, as well as for the treatment of advanced systemic mastocytosis (SM). The premarket approval application (PMA) for the PKC412 (midostaurin) FLT3 companion diagnostic, developed in collaboration with Invivoscribe Technologies has also been accepted for review by the FDA. Outside the US, the marketing authorization application for PKC412 (midostaurin) in these indications has already been accepted by the EMA.

 

Alnylam Pharmaceuticals announced that, pursuant to the companies’ global alliance signed in January 2014, Sanofi Genzyme elected to opt in to co-develop (through Sanofi R& D) and co-commercialize fitusiran, an investigational RNAi therapeutic for the treatment of hemophilia and rare bleeding disorders (RBD), in the United States, Canada and Western Europe. This expanded right is in addition to their previously exercised opt-in decision to develop and commercialize fitusiran in their rest of world territories. The opt in decision was based on recent promising interim clinical results from a Phase I study of fitusiran presented at the World Federation of Hemophilia (WFH) in late July and additional data that will be presented at the American Society of Hematology (ASH) meeting in December. Alnylam is on track to initiate the fitusiran Phase III program in early 2017.

 

Pfizer announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). As part of the CRADA, Pfizer will collaborate with NCI’s Center for Cancer Research (CCR) to arrange and conduct preclinical and clinical trials to evaluate three investigational immunotherapy agents. These include Pfizer’s proprietary immunotherapy agonistic monoclonal antibodies targeting OX40 (CD134), (also known as PF-04518600); and utomilumab, targeting 4-1BB (CD137), (also known as PF-05082566); as well as avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody (also known as PF-06834635 and MSB0010718C), which is being developed through an alliance between Merck KGaA, Darmstadt, Germany, and Pfizer.

 

Janssen Research & Development announced new findings from a pivotal Phase III study showing the efficacy and safety profile of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI ARIA (golimumab) in the treatment of active ankylosing spondylitis (AS). Data from the GO-ALIVE study showed that 73.3 percent of patients with active ankylosing spondylitis receiving SIMPONI ARIA 2 mg/kg achieved the study’s primary endpoint of at least a 20 percent improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20) at week 16, compared with 26.2 percent of patients receiving placebo (P ≤ 0.001). Data from GO-ALIVE, which will be part of an upcoming submission to the FDA seeking approval of SIMPONI ARIA for the treatment of active ankylosing spondylitis, are being presented for the first time at the 2016 ACR/ARHP Annual Meeting. In July 2013, SIMPONI ARIA received U.S. FDA approval as a 30-minute infusion for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.

 

Janssen Biotech announced findings from two claims database studies examining treatment patterns in patients with rheumatoid arthritis (RA). The first study compared treatment patterns in patients newly beginning therapy with REMICADE (infliximab) and patients newly beginning therapy with an infliximab biosimilar (CT-P13). A second study examined treatment patterns in stable patients who maintained treatment with REMICADE, compared to stable patients who switched from REMICADE to CT-P13. In both studies, higher rates of treatment discontinuation were observed in patients treated with CT-P13 compared to patients treated with REMICADE.

 

Merck KGaA announced the results of the ADDRESS II Phase IIb, multicenter study on atacicept in patients with systemic lupus erythematosus (SLE). Patients on standard-of-care therapy (n=306) were randomized to weekly subcutaneous injections of atacicept (75 or 150 mg) or placebo for 24 weeks. The primary endpoint was the proportion of patients achieving a clinical response as defined by a composite SLE Responder Index (SRI)-4 at week 24. Secondary endpoints included SRI-6 response rate and time to severe flare, assessed by SLEDAI flare index (SFI) or BILAG. Although the primary endpoint was not met in the overall study population, there was a trend favoring atacicept with statistical significance achieved in a pre-specified sensitivity analysis of the primary endpoint using treatment Day 1 as baseline (rather than screening visit); atacicept 75 mg (55.9%, adjusted odds ratio/OR 1.88, p=0.029) and 150 mg (55.8%, adjusted OR 1.96, p=0.020) compared with placebo (41.0%). BILAG A flare was significantly reduced compared to placebo with atacicept 75 mg (p=0.019), and severe SFI flare reduced with 150 mg (p=0.002). Additionally, analyses of a predefined subpopulation of patients with high disease activity (HDA; SLEDAI-2K≥10, n=158) demonstrated statistically significant treatment effects of atacicept when compared to placebo. SRI-6 response at week 24 was significantly greater with atacicept 150 mg (54.9%, adjusted OR 3.30, p=0.005) compared with placebo (28.8%). Both atacicept doses led to significant reductions in the incidence of severe flare versus placebo, BILAG A flare (150 mg, hazard ratio/HR 0.32, p=0.038; 75 mg, HR 0.08, p=0.002) and SFI flare (150 mg, HR 0.19, p=0.004; 75 mg, HR 0.33, p=0.029).

 

Celldex Therapeutics presented data on new product candidate CDX-1140, a fully human antibody targeted to CD40 that has demonstrated potent agonist activity. Found on antigen presenting cells, such as dendritic cells, macrophages and B cells, CD40 is a key activator of the immune response. The data were presented at the Society for Immunotherapy of Cancer Annual Meeting (SITC) on Saturday, November 12 in a poster titled "Functional characterization of CDX-1140, a novel CD40 antibody agonist for cancer immunotherapy." CDX-1140 is expected to be ready to enter clinical studies in 2017.

 

Peregrine Pharmaceuticals announced the presentation of positive data from multiple new preclinical studies of the company’s phosphatidylserine (PS)-targeting antibodies. Study results highlight that PS-targeting antibodies similar to bavituximab synergize with checkpoint inhibitors and radiation to improve anti-tumor activity in various animal tumor models. Importantly, the improved anti-tumor activity seen in these studies was even greater when PS-targeting therapy was a part of triple combination treatment including anti-PD-1 and another therapy. Data were presented by Peregrine scientists, as well as researchers from Memorial Sloan Kettering Cancer Center (MSK), at the Society for Immunotherapy of Cancer (SITC) 2016 Annual Meeting, which was held November 9-13, 2016 in National Harbor, MD.

 

Pharming Group N.V. announced that the results of its "Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human C1 Inhibitor for Prophylaxis of Hereditary Angioedema Attacks", were presented by Marco Cicardi, Professor of Internal Medicine University of Milan, Hospital L. Sacco Milan and co-prinicipal investigator for the study. The presentation was held during the American College of Allergy, Asthma and Immunology 2016 Scientific Meeting ("ACAAI") meeting in San Francisco yesterday afternoon.

 

AmpliPhi Biosciences announced the settlement of its pending lawsuit with NRM VII Holdings I, LLC. The lawsuit relates to a complaint filed by NRM against AmpliPhi and the members of its board of directors following the automatic conversion of NRM’s Series B convertible preferred stock into common stock of AmpliPhi in April 2016. The complaint sought unspecified money damages and other relief. Under the terms of a settlement agreement, NRM has agreed to dismiss with prejudice the lawsuit and AmpliPhi’s insurance carrier will make a cash payment of $2.0 million to NRM. A portion of the settlement payment (approximately $914,000) is attributable to accrued dividends that became payable to NRM upon the automatic conversion of its Series B convertible preferred stock into common stock, which amount is recorded in AmpliPhi’s balance sheet at September 30, 2016. AmpliPhi has agreed to pay its insurance carrier for the accrued dividends amount on an installment basis. AmpliPhi and NRM have agreed to release all claims against each other and all related parties. NRM and its affiliates continue to be significant shareholders in AmpliPhi.

 

Reata Pharmaceuticals announced a potential path to approval for bardoxolone methyl in a new indication, the treatment of chronic kidney disease ("CKD") caused by Alport syndrome. In a Type B meeting on October 5(th) , 2016, the FDA provided guidance that a single, pivotal trial utilizing a retained estimated glomerular filtration rate ("eGFR") endpoint could serve as the basis for approval in this life-threatening, orphan disease.

 

Braeburn Pharmaceuticals and Camurus  announce positive top-line results from a pivotal Phase III randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) for treatment of moderate-to-severe opioid use disorder. In addition to achieving the primary endpoint of non-inferiority versus daily sublingual buprenorphine/naloxone (current Standard of Care, SL BPN/NX), CAM2038 also demonstrated superiority for the key secondary endpoint.

 

AbbVie announced that the CHMP of the EMA has granted a positive opinion for HUMIRA (adalimumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. If approved, HUMIRA will become the first and only biologic treatment option for patients 12 years of age and older. HUMIRA was approved for adults with moderate to severe HS by the European Commission in July 2015. 

 

New data presented at the American Heart Association Scientific Sessions 2016 showed that Jardiance (empagliflozin) consistently reduced the risk for cardiovascular death, regardless of the type of cardiovascular disease at baseline, compared with placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease. The findings are part of the landmark EMPA-REG OUTCOME trial, which is the first trial of a diabetes medication to show a reduction in cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. This study is supported by Boehringer Ingelheim and Eli Lilly.

 

Braeburn Pharmaceuticals and Camurus  announce positive top-line results from a pivotal Phase III randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) for treatment of moderate-to-severe opioid use disorder. In addition to achieving the primary endpoint of non-inferiority versus daily sublingual buprenorphine/naloxone (current Standard of Care, SL BPN/NX), CAM2038 also demonstrated superiority for the key secondary endpoint.

 

Celltrion presented new data presented at the 2016 American College of Rheumatology  Annual Meeting demonstrate that the efficacy and safety profile of CT-P10 (biosimilar rituximab) in rheumatoid arthritis (RA) patients is comparable to patients treated with originator rituximab over 24 weeks. A total of 372 RA patients (161 patients on CT-P10 and 211 patients on originator rituximab) were enrolled in a trial looking at efficacy and pharmacokinetic (PK) equivalence as well as comparing pharmacodynamics (PD) and safety. Results from the Phase III, randomised, controlled study showed that overall efficacy, PD and safety profiles were highly similar between CT-P10 and the originator rituximabs (U.S. sourced originator rituximab and EU sourced originator rituximab).

 

MiNA Therapeutics announced the presentation of pre-clinical data on its MTL-CEBPA program in which the compound was shown to improve survival in a rat model of liver failure. MTL-CEBPA is the first development candidate to emerge from MiNA’s RNA activation platform and is currently being evaluated in a Phase I clinical study in patients with liver cancer.

 

Hutchison China MediTech announced that data from a recent Phase I, first-in-human, dose escalating study of the safety, tolerability and pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of single and multiple doses of HMPL-523, will be presented at the Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (the “ACR/ARHP Annual Meeting”), being held in Washington DC, USA from November 11 to November 16, 2016. The presentation will include additional data on HMPL-523, a highly selective, potent and orally available inhibitor of Spleen Tyrosine Kinase (“Syk”).

 

ProMetic Life Sciences presented new results at the American Heart Association’s (AHA) Annual Meeting in New Orleans from preclinical studies performed at the Montreal Heart Institute, as well as new results on the positive effects of PBI-4050 on cardiovascular biomarkers in patients with Metabolic Syndrome and Type 2 Diabetes.

 

Bristol-Myers Squibb unveiled rheumatoid arthritis (RA) and autoimmune disease data being presented at the 2016 Annual Meeting of the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP) in Washington, D.C. The Company will present 23 abstracts that exemplify Bristol-Myers Squibb’s leadership in autoimmune disease. This includes real-world data analyses examining the role of poor prognostic factors, with a focus on anti-cyclic citrullinated protein antibodies (anti-CCP, also known as ACPA), in patients with moderate to severe RA. Bristol-Myers Squibb’s ACPA-related research has helped further the understanding of ACPA as a key prognostic factor related to rapidly progressive RA.

 

Lannett Company announced that it received approval from the FDA of its ANDA for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, the therapeutic equivalent to the reference listed drug, Namenda Tablets, 5 mg and 10 mg, of Forest Laboratories. According to IMS, total U.S. sales in 2015 of Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, at Average Wholesale Price (AWP) were approximately $50 million.

 

Pfizer announced the commencement of a tender offer to purchase for cash any and all of its outstanding 6.200% Senior Notes due March 15, 2019.

 

 

ANALYST RECOMMENDATIONS

 

Ladenburg Thalmann analyst Kevin DeGeeter reiterated his “buy” rating and $7 target on VBI Vaccines, citing Heplisav-B PDUFA and CMV Immunogenicity Data offer near term upside.

 

Citi analyst Yigal Nochomovitz revised his target price and rating of the following stocks: Ultragenyx downgraded to “sell” from “neutral” and decreased his target price to $64 from $66; Mirati Therapeutics decreased to $11 from $23.

 

Credit Suisse analyst Robert Willoughby decreased his price target of PharMerica to $30 from $31, citing the onboarding of recently acquired Regency Pharmacy.

 

Barclays analyst Douglas Tsao reinstated Teva Pharmaceuticals with an “equal-weight” rating and $46 price target, citing TEVA’s pipeline strength, especially on first to files, offers much improved competitive positioning compared to MYL or ENDP.

 

Wedbush analyst Liana Moussatos downgraded Xoma to “neutral” from “outperform” decreased her price target to $14 from $17, citing anticipated share dilution.

 

The following analysts initiated coverage of Crispr Therapeutics: Guggenheim analyst Tony Butler with a “buy” rating and $30 price target; Piper Jaffray analyst Joshua Schimmer with an “overweight” rating and $21 price target; Barclays analyst Geoff Meacham with an “overweight” rating and $22 price target.

 

Mizuho analyst Irina Koffler increased her price target of Sucampo to $16 from $13, citing strong 3Q:16 set off a strong rally with little momentum from here.

 

Stifel analyst Katherine Breedis initiated coverage of the following companies: Sage Therapeutics with a “buy” rating and $90 price target; Gilead with a “buy” rating and $100 price target; Avexis with a “hold” rating and $65 price target.

 

Jefferies analyst Biren Amin increased his price target of Avexis to $79 from $71, citing positive insights on potential EU trial design.

 

Jefferies analyst Eun Yang increased her price target of Wave Life Sciences to $42 from $28, citing progress in its pipeline candidates, visibility from two recent KOL events on its core programs, benefit from Exondys 51 approval, and biotech rally post-election.

 

BMO analyst Gary Nachman decreased his price target of Valeant to $21 from $29, citing significant pressures remain in several key areas and the numbers are coming down more meaningfully than anticipated.