News Column

Arena Announces Filing for Marketing Authorization of BELVIQ®; NanoString Announces Study Confirms Ability of Prosigna Assay

February 12, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on February 11, 2014.



{nfg}Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
announced Eisai Laboratorios Ltda., a subsidiary of Eisai Inc., has filed for marketing authorization of BELVIQ® as a treatment for chronic weight management with the Brazilian Health Surveillance Agency (Anvisa). In connection with the filing, Arena will receive a milestone payment of $500,000 from Eisai.



"With over half of adults in Brazil being overweight or obese, there is a significant need for new chronic weight management treatments to help address this medical need," said Jack Lief, Arena's President and Chief Executive Officer. "The filing of this marketing application further illustrates Eisai's commitment to make BELVIQ available to patients and physicians around the world."



BELVIQ is being submitted for marketing authorization in Brazil as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult obese patients (initial body mass index, or BMI, = 30 kg/m2), or overweight patients (initial BMI = 27 kg/m2) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, cardiovascular disease, type 2 diabetes managed with oral hypoglycemic agents, or sleep apnea).



Eisai is responsible for seeking the regulatory approval and the subsequent marketing and distribution of BELVIQ in Brazil. Arena has granted Eisai marketing and distribution rights to BELVIQ for all countries worldwide, except South Korea, Taiwan, Australia, New Zealand and Israel. Arena manufactures BELVIQ at its facility in Switzerland, and sells finished commercial product to Eisai for distribution. Arena is eligible to receive payments based upon Eisai's net sales of BELVIQ, and is also eligible to receive regulatory and development milestone payments.







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NanoString Technologies, Inc., (NASDAQ: NSTG)
a provider of life science tools for translational research and molecular diagnostic products, today announced that a study published online in Clinical Cancer Research showed that the PAM50 assay, on which the company's Prosigna™ Breast Cancer Prognostic Gene Signature Assay is based, accurately assessed the risk of late distant recurrence in postmenopausal women with estrogen receptor-positive (ER+) early-stage breast cancer. The study, titled, “The PAM50 Risk-of-Recurrence Score Predicts Risk for Late Distant Recurrence after Endocrine Therapy in Postmenopausal Women with Endocrine-Responsive Early Breast Cancer” was conducted by researchers from the Austrian Breast & Colorectal Cancer Study Group and can be found online at: http://clincancerres.aacrjournals.org/content/early/2014/02/11/1078-0432.CCR-13-1845.abstract.



“There is an urgent unmet clinical need to accurately differentiate breast cancer patients who remain at high risk of distant recurrence beyond five years after diagnosis,” said senior author Michael Gnant, M.D., Professor at the Medical University of Vienna in Austria. “Prosigna's ability to predict late recurrences may enable identification of patients with endocrine-responsive breast cancer who can be spared extended adjuvant therapy in the future.”



Study authors found that the Prosigna Breast Cancer Assay significantly increased prognostic accuracy with respect to late distant recurrence compared to a score based on clinical factors alone. Between years five and 15 after diagnosis in patients who had not had a recurrence at five years, patients categorized as low risk by the Prosigna Assay demonstrated a risk of distant recurrence of 2.4 percent compared to a risk of 17.5 percent in the high-risk group. The ability to accurately assess risk of late distant recurrence was observed for patients with both node-positive and node-negative disease.



“The ability to stratify patients according to risk of late distant recurrence significantly differentiates the Prosigna Assay from other genomic-based breast cancer assays,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “We believe that this feature provides the potential to expand the clinical utility of the Prosigna Assay, helping to inform treatment decisions that physicians struggle with today.”





Also Wednesday:






Accuray Incorporated (Nasdaq:ARAY)
, announced today that its management is scheduled to participate in three upcoming investor conferences.



Advaxis, Inc. (Nasdaq:ADXS)
, a biotechnology company developing the next generation of cancer immunotherapies, announced that Robert G. Petit, Ph.D., Chief Scientific Officer of Advaxis, will be presenting on an expert panel titled "The Future of Cancer Immunotherapy" during the Bloomberg 2014 State of Healthcare Summit on Friday, February 14, 2014 at 11:15 a.m. ET.



Amicus Therapeutics (Nasdaq:FOLD)
, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today summarized the key highlights from 2 oral platform presentations featuring its Pompe and Fabry programs at the Lysosomal Disease Network WORLD Symposium (LDN WORLD) 2014.



Biodel Inc. (Nasdaq:BIOD)
today announced preliminary results from Study 3-150, a Phase 1 clinical trial comparing Biodel's proprietary insulin formulation, BIOD-531, to the marketed products Humulin® R U-500 (U-500R) and Humalog® Mix 75/25.



CannaVest Corp. (OTC:CANV),
the world's leading industrial hemp company spearheading the development of cannabidiol (CBD)-rich hemp oils and other hemp industry products and services, proudly announces that its wholly-owned subsidiary, PhytoSphere Systems LLC, won its third consecutive High Times Medical Cannabis Cup award for "Highest Cannabidiol (CBD) Concentrate" with the pharmaceutical-grade CBD-rich hemp oil prototype, CBD Simple™.



Chembio Diagnostics, Inc. (Nasdaq:CEMI)
, a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that it has entered into two agreements with RVR Diagnostics SDN BHD ("RVR"), a privately-held company in Malaysia.



Coastal.com (Nasdaq:COA) (TSX:COA)
, the leading global manufacturer and digital retailer of high-quality glasses and contact lenses, has launched a new approach to its revolutionary home trial program that makes it easier for consumers to try and buy eyewear online.



CombiMatrix Corporation (Nasdaq:CBMX)
announced today that it will release its fourth quarter 2013 financial results on Wednesday, February 19, 2014. Results will be released prior to trading on that day.



Due to recent trading activity in CombiMatrix Corporation's (Nasdaq:CBMX)publicly listed warrants, symbol CBMXW, the Company would like to reiterate the terms of said warrants.



Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
announced today the closing of its public offering of 3,450,000 shares of its common stock, which includes 450,000 shares sold upon the full exercise of the underwriters' option to purchase additional shares, resulting in aggregate gross proceeds of $43,125,000, before underwriting discounts, commissions and expenses.



ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in innovative medical devices used in infusion therapy, oncology and critical care applications, announced today the appointment of Vivek Jain as chairman and chief executive officer effective February 13, 2014, concluding a transition process that began when Dr. George Lopez announced his decision to retire as CEO in the fall of 2013.



ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in innovative medical devices used in infusion therapy, oncology and critical care applications, today announced specific financial results for fourth quarter and fiscal year ended December 31, 2013.



IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospitalist physician group practice, today announced that Adam Singer, M.D., chairman and chief executive officer, and Jeff Taylor, president and chief operating officer, are scheduled to present at the following investor conferences: Citi 2014 Global Healthcare Conference at the Hilton New York Hotel in New York City on Monday, Feb. 24 at 9:40 a.m. EST; RBC Capital Markets Healthcare Conference at the New York Palace Hotel in New York City on Tuesday, Feb. 25 at 2:35 p.m. EST.



MacroGenics, Inc. (Nasdaq:MGNX)
, a clinical-stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced the pricing of its underwritten public offering of 3,000,000 shares of its common stock at a price of $36.50 per share, before underwriting discounts.



Medical Marijuana Inc. (OTC Pink:MJNA)
and HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. – are proud to announce that NBC 7 San Diego has conducted an in-depth report on industrial hemp-based cannabidiol (CBD) oil. The report by Candice Nguyen of NBC 7 features Blake Zika, a 22-year-old who has battled seizures since the age of four.



Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced that its radiology solutions have been certified for Meaningful Use (MU), broadening its commitment to radiology customers who participate in the program as well as lead their healthcare environments toward overall imaging interoperability.



Nanophase Technologies Corporation (OTCQB:NANX)
, a technology leader in nanomaterials and advanced nanoengineered products, today announced the Company will disseminate a financial news release for fiscal year 2013 on Wednesday, February 26, 2014, at 3:00 p.m. CST, 4:00 p.m. EST.



OXiGENE, Inc. (Nasdaq:OXGN)
today announced that it has entered into definitive agreements with investors to purchase an aggregate of approximately $12 million of units, in a registered public offering, at a price per unit of $2.05.



Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
announced today that phase I clinical trial data for oral GCD (PRX-112) for the treatment of Gaucher disease will be presented by Professor Ari Zimran at the 10th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2014 being held February 10-13 in San Diego, CA.



StemCells, Inc. (Nasdaq:STEM)
announced today that it has completed enrollment of the first of two planned patient cohorts in the Company's clinical trial of its proprietary HuCNS-SC® product candidate (purified human neural stem cells) for dry age-related macular degeneration (AMD).



Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, today announced the appointment of Ms. Peggy Phillips to its Board of Directors.



Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced data presentations from a single patient treated with recombinant human beta-glucuronidase (rhGUS, UX003), an investigational therapy for the treatment of mucopolysaccharidosis 7 (MPS 7, Sly syndrome).



Ventrus Biosciences, Inc. (Nasdaq:VTUS)
today announced top line efficacy and safety results from the second Phase 3 clinical trial of Diltiazem Hydrochloride 2% Cream (VEN 307) in patients with pain related to anal fissure (AF).



Vical Incorporated (Nasdaq:VICL)
today reported financial results for the year ended December 31, 2013. The net loss for 2013 was $31.2 million, or $0.36 per share, compared with a net loss of $22.9 million, or $0.27 per share, for 2012.






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Source: BioMed Reports


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