BioShares Biotechnology Clinical Trials (BBC): $23.53, -$0.17, +27.8% YTD

BioShares Biotechnology Products (BBP): $37.54, -$0.46, +14.6% YTD

 

 

MARKET COMMENTARY

 

Wall Street looked set to start the week on a lower note, after the G20 leaders decided to drop a pledge to avoid trade protectionism. European shares were dragged lower by dipping bank stocks after Deutsche Bank set terms of its 8 billion euro cash call and a slump in oil stocks, while Asian stocks ended mixed. Gold prices advanced while the dollar fell against a basket of currencies. Oil prices fell more than 1 percent as OPEC supplies remained steady despite touted cuts and rising U.S. inventories roused concerns about a supply glut.

 

 

MARKET HIGHLIGHTS

 

Arena Pharmaceuticals announced the appointment of Dr. Preston Klassen, M.D., M.H.S. as Executive Vice President, Research and Development and Chief Medical Officer. Dr. Klassen will report to Amit Munshi, Arena’s President and Chief Executive Officer.  Dr. Klassen has over 20 years of experience in biopharmaceutical product development. Most recently, he was Chief Medical Officer of Laboratoris Sanifit S.L. and prior to that was Executive Vice President, Head of Global Development at Orexigen Therapeutics.

 

Palatin Technologies announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/704,223. The allowed claims are for methods of treating female sexual dysfunction and hypoactive sexual desire disorder (HSDD) with bremelanotide, an investigational product designed for on-demand treatment of HSDD in premenopausal women. Once issued, the patent will have a term to November 2033.

 

BioTime will be presenting at the Oppenheimer 27th Annual Healthcare Conference at the Westin Grand Central in New York City on March 21, at 3:55 p.m. Eastern Time.

 

Nektar Therapeutics announced positive results from the SUMMIT-07 Phase III efficacy study of NKTR-181, a first-in-class opioid analgesic.  NKTR-181 is a new chemical entity (NCE) that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids. The FDA has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.

 

Esperion Therapeutics announced the FDA recently confirmed that Esperion’s LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid.

 

Bristol-Myers Squibb and CytomX Therapeutics announced an expansion of their 2014 strategic collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.

 

Jazz Pharmaceuticals announced positive efficacy results from two global multicenter studies in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA).  JZP-110 demonstrated highly statistically significant differences in the co-primary efficacy endpoints in the TONES 3 study at the 300 mg, 150 mg, 75 mg and 37.5 mg dose arms and in the TONES 4 study in the combined JZP-110 treatment arm (300 mg, 150 mg, and 75 mg doses) compared to placebo. Based on the preliminary safety analysis, the most commonly reported adverse events (AEs) in these studies were consistent with those previously described in the Phase 2 clinical studies evaluating JZP-110 in narcolepsy.

 

Allergan has received approval from the FDA to market JUVÉDERM VOLLURE XC, for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21. In the US pivotal clinical trial, a majority (59%) of subjects saw improvement in moderate to severe nasolabial folds for up to 18 months. Patient satisfaction in the pivotal study was also high: 82% of patients said they were very satisfied at 6 months and 68% at 18 months.

 

Rosetta Genomics announced that the USPTO has granted a patent allowance for patent application No. 15/237,364, relating to “miRNA Expression Signature in the Classification of Thyroid Tumors.” The allowed patent claims a method of classifying a thyroid lesion sample obtained by fine needle aspiration as malignant or benign, through a classifier algorithm that utilizes the expression profile of microRNAs detected by real time polymerase chain reaction (RT-PCR).

 

Cerulean Pharma and Daré Bioscience announced that the two companies, together with the equity holders of Daré Bioscience, have entered into a definitive stock purchase agreement under which the equity holders of Daré Bioscience will become the majority owners of Cerulean.

 

InVivo Therapeutics Holdings announced that a new patient has been enrolled into The INSPIRE Study at the Cooper Neurological Institute (CNI), which is part of Cooper University Hospital, a network providing care to Southern New Jersey and the Delaware Valley. Steven Yocom, DO, Assistant Professor of Neurosurgery, Director of the CNI Spine Program and Principal Investigator at this site, performed the implantation approximately 29 hours after the injury occurred.

 

Interleukin Genetics announced the presentation of clinical data from “The Ioannina Study” at the 66th Annual Scientific Session & Expo of the American College of Cardiology (ACC 2017) in Washington, DC that demonstrates the ability of certain interleukin-1 (IL-1) genetic patterns together with elevated lipoprotein (a) (Lp(a)) to predict recurrent atherosclerotic cardiac events. Dr. Bechlioulis and co-workers reported the new findings from the University Hospital of Ioannina (Greece) along with collaborators from the University of California at San Diego. In the longitudinal study (median time 43 months) of 1,084 patients who underwent diagnostic coronary angiography, non-diabetics with elevated levels of Lp(a) who also tested positive for pro-inflammatory IL-1 genetic patterns had a statistically significant increased risk for secondary cardiac events, including myocardial infarctions, strokes, and death, than patients without the two risk factors. “The Ioannina Study” findings corroborate the results of an earlier study published in 2014 of 499 patients treated at the Mayo Clinic.

 

Corium International reported on positive progress in the pilot bioequivalence (BE) study of its Corplex Donepezil candidate, a once-weekly transdermal patch for delivery of the most commonly prescribed treatment for the symptoms of Alzheimer’s disease.

 

Selexis announced the launch of a novel selection method to screen and pick cells with optimal expression levels. Selexis developed SUREselect to help partners advance difficult-to-express (DTE) proteins to the clinic.

 

Cerenis Therapeutics announced that CARAT Phase II Study data on CER-001 in post-acute coronary syndrome (ACS) patients have been presented at the Annual American College of Cardiology (ACC) Scientific Sessions in Washington DC, USA. The CARAT Phase II Study confirmed the safety profile of CER-001 but did not meet its primary efficacy endpoint of regression of atherosclerotic plaques in post-ACS patients. The negative results encountered with CER-001 were not consistent with the previously reported efficacy profile of CER-001 in the 3mg/kg subgroup of the CHI SQUARE clinical study.

 

Array BioPharma announced that it has withdrawn from the FDA Division of Oncology Products 2 its NDA for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer.

 

Janssen Pharmaceuticals announced new Phase III results from EINSTEIN CHOICE showing patients with venous thromboembolism (VTE) taking XARELTO (rivaroxaban), who received either 10 mg or 20 mg once daily over an extended time period, had significantly fewer recurrent blood clots and similar rates of major bleeding compared to those taking aspirin 100 mg once daily. Specifically, XARELTO 10 mg reduced the risk of recurrent VTE by 74 percent and XARELTO 20 mg by 66 percent.

 

Amgen announced new data from two studies that showed that for appropriate patients (on-label) in the U.S., the majority of prescription claims for PCSK9 inhibitors, such as Repatha (evolocumab), were initially rejected. Additionally, one of the studies showed no major differences in patient characteristics across those approved and denied, suggesting a utilization management process that is not driven by any observable clinical criteria. The studies were presented at the American College of Cardiology 66th Annual Scientific Session (ACC.17).

 

Amgen announced detailed results from the Repatha (evolocumab) cognitive function trial (EBBINGHAUS) evaluating the impact on cognitive function in 1,974 patients enrolled in the Repatha cardiovascular outcomes study (FOURIER). The study demonstrated that the effect of Repatha on the primary endpoint of executive function was non-inferior to placebo. In addition, there was no statistical difference between Repatha and placebo on the other cognitive domains tested: working memory, memory function and psychomotor speed (secondary endpoints). The detailed results from EBBINGHAUS were presented at a Late-Breaking Clinical Trials Session at the American College of Cardiology 66th Annual Scientific Session (ACC.17) in Washington, D.C.

 

AB Science SA announced that the Phase II/III study AB10015 of masitinib in amyotrophic lateral sclerosis (ALS) has met its pre-specified primary endpoint. This is the first successful Phase III trial of a tyrosine kinase inhibitor in the treatment of ALS, signifying masitinib as first-in-class for ALS, with a unique mechanism of action against microglia cells.

 

Eli Lilly announced that its MONARCH 2 trial of abemaciclib met the primary endpoint of progression-free survival (PFS). The Phase III study evaluated abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy. The results demonstrated the addition of abemaciclib to fulvestrant resulted in a statistically significant improvement in PFS, when compared to the control arm of placebo plus fulvestrant. Detailed efficacy and safety results will be presented at an upcoming medical meeting.

 

Boehringer Ingelheim announced important new data from the RE-CIRCUIT study show a better safety profile for Pradaxa (dabigatran etexilate) compared to warfarin in atrial fibrillation (AF) patients undergoing catheter ablation. AF patients who underwent catheter ablation while being treated with uninterrupted Pradaxa experienced less major bleeding and fewer serious adverse events compared to those treated with uninterrupted warfarin. The results were presented in a late-breaking session at the American College of Cardiology 66th Annual Scientific Session in Washington and simultaneously published in the New England Journal of Medicine.

 

Boehringer Ingelheim announced that the first patient has been enrolled in the PF-ILD (progressive fibrosing interstital lung disease) trial. This study investigates the efficacy and safety of nintedanib in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis.

 

Athersys announced that clinical investigators have published results from Athersys’ Phase II trial of MultiStem cell therapy for treating ischemic stroke patients (the “MASTERS” trial) in the peer-reviewed journal, The Lancet Neurology.  The article highlights the feasibility and safety of intravenous MultiStem treatment for patients who have suffered a moderate to severe stroke, the progressive improvements in recovery experienced by these patients through one year, and the increased benefit for those patients receiving MultiStem treatment within 36 hours of their stroke.  In addition, the article describes how patients receiving intravenous MultiStem treatment demonstrated a significant reduction in inflammatory cytokines and immune cells and a decrease in infections associated with immunodepression, compared to patients receiving placebo. These trial findings, together with the article below, provide further clarity about important mechanisms of benefit when treating stroke patients with MultiStem – the modulation of the inflammatory response and preservation of immune system homeostasis – promoting accelerated recovery.

 

VolitionRx announced the creation of a wholly-owned U.S. subsidiary, Volition America, which will be based in Austin, Texas.  Dr. Jason Terrell, Chief Medical Officer of Volition, has been appointed as President and Chief Executive Officer of Volition America. Scott Powell, Executive Vice President of Volition, will serve as Vice President and Chief Financial Officer of Volition America.

 

Loxo Oncology has entered into a collaboration agreement with Ventana Medical Systems a member of the Roche Group, to develop and commercialize a pan-TRK immunohistochemistry (IHC) test as a companion diagnostic to identify patients across tumor types suitable for treatment with larotrectinib.

 

NantKwest announced that the FDA has granted Orphan Drug Designation to the company’s activated natural killer (aNK) cell therapy for treatment of patients with advanced Merkel cell carcinoma.

 

Opiant Pharmaceuticals announced that the Company has initiated a Phase II clinical trial evaluating its novel nasally-delivered opioid antagonist candidate, OPNT001, as a potential treatment for Bulimia Nervosa.

 

Mallinckrodt announced it has closed the sale of its Intrathecal Therapy business to Piramal Enterprises Limited’s subsidiary in the U.K., Piramal Critical Care, for approximately $203 million, including fixed and contingent consideration. The company’s Intrathecal Therapy business markets products for the treatment of spasticity via intrathecal drug delivery, including the key asset Gablofen (baclofen injection).

 

BioLineRx reported partial results data from its open-label Phase II trial for BL-8040 as a novel monotherapy approach for the mobilization and collection of blood forming stem and progenitor cells from the peripheral blood. 

 

CytoSorbents highlighted recent cases using CytoSorb to successfully treat HLH (hemophagocytic lymphohistiocytosis) and their relevance to cytokine release syndrome (CRS) in cancer immunotherapy.

 

Cytokinetics announced that additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase II trial evaluating omecamtiv mecarbil in patients with chronic heart failure, were presented by Tor Biering-Sørensen, MD, PhD, Postdoctoral Research Fellow, Division of Cardiology, Brigham & Women’s Hospital and Harvard Medical School, in a Poster Session at the American College of Cardiology’s 66(th) Annual Scientific Session (ACC.17) in Washington, D.C. The results presented showed that omecamtiv mecarbil improved myocardial deformation, a marker of myocardial function that has been related to outcomes. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.

 

Keryx Biopharmaceuticals announced that the nation’s largest Medicare Part D plan sponsor has added Auryxia (ferric citrate) to its Medicare Part D plan formularies, effective immediately. Auryxia is currently indicated in the U.S. for the control of serum phosphorus levels in people with chronic kidney disease (CKD) on dialysis. Addition to these Part D plan formularies significantly increases unrestricted access to Auryxia for people on dialysis and their caregivers.

 

Imprimis Pharmaceuticals announced the publication of a Dropless Therapy article in the peer-reviewed journal, Current Pharmaceutical Design. Dropless Cataract Surgery is a single-use, injectable combination of antibiotic and steroid formulation administered at the end of cataract surgery to essentially eliminate the need for post-surgery eye drops. The authors provide a retrospective review of data and efficacy of the Dropless approach, examine the transzonular via cannula injection technique, and discuss the benefits of Dropless Therapy to patients, physicians and their staff.

 

Neothetics announced completion of subject enrollment for its Phase II proof of concept trial, LIPO-202-CL-31, for the reduction of submental subcutaneous fat.

 

X-Chem announced the signing of a broad drug discovery collaboration with Astellas Pharma. The collaboration will enable the discovery of novel lead compounds for complex drug targets of interest to Astellas from X-Chem’s growing collection of DNA-encoded DEX(TM) libraries containing over 120 billion compounds. This new partnership is X-Chem’s most expansive first-time alliance with a pharmaceutical company, and is aimed at tackling hard-to-drug targets across multiple therapeutic areas at Astellas.

 

bluebird bio announced that Derek Adams, Ph.D. is joining the company as its Chief Technology and Manufacturing Officer and Joanne Smith-Farrell, Ph.D., is joining as Senior Vice President, Corporate Development and Strategy.

 

Ampio Pharmaceuticals announced an update of corporate activities.

 

 

ANALYST RECOMMENDATIONS

 

SunTrust analyst Sandy Draper downgraded INC Research to “hold” from “buy”, citing limited upside to the $48 price target. The analyst increased his price target of PRA Health Sciences to $72 from $70, citing the partnership with Takeda Pharmaceuticals (International) as well as the recently announced (but not named) second strategic partner supports double-digit revenue growth through at least ‘18.

 

HC Wainwright analyst Shaunak Deepak decreased his price target of Fate Therapeutics to $6 from $8, citing dilution.

 

Leerink analyst Puneet Souda upgraded Illumina to “outperform” from “market perform” and increased his price target to $195 from $138, citing positive NovaSeq survey results.

 

Goldman analyst Terence Flynn decreased his price target of Amgen to $202 from $208, citing lower Repatha estimates.