Biogen'sTECFIDERA™ Confirms US Approval; Navidea Announces Enrollment of First Subject in Phase 2b Trial of NAV4694 Print E-mail
By Staff and Wire Reports   
Wednesday, 27 March 2013 19:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 27, 2013.

Biogen Idec (NASDAQ: BIIB) announced that the U.S. FDA has approved TECFIDERA™ (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.

Image of Biogen Idec's TECFIDERA™ (dimethyl fumarate) which was approved by the U.S. FDA on March 27, 2013 for relapsing multiple sclerosis. (Photo: Business Wire) TECFIDERA has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.

“With the FDA approval of TECFIDERA™, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA™ will raise expectations for what people living with MS can achieve with their therapy.”

The FDA approval of TECFIDERA™ is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving TECFIDERA have been followed for more than four years.

In DEFINE, TECFIDERA™, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA™ significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p=0.0020) compared to placebo at two years. While not statistically significant, TECFIDERA™ showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. Both studies also showed that TECFIDERA significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging (MRI).

“In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease,” said Robert Fox, M.D., medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, lead investigator of the CONFIRM study, and a paid advisor for Biogen Idec for projects not related to TECFIDERA™ clinical development. “With the efficacy, safety and tolerability measures seen in CONFIRM, this drug provides physicians with an important additional treatment option for their patients across the MS spectrum.”

The most common side effects associated with TECFIDERA™ are flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea and abdominal pain). In clinical studies, flushing symptoms usually began soon after initiating treatment, were mostly mild to moderate, and usually improved or resolved over time. The incidence of GI events was higher early in the course of treatment (primarily in the first month) and decreased over time. Overall, clinical trial discontinuations due to flushing and GI events were low.

TECFIDERA™ may decrease lymphocyte counts in some patients. In clinical studies, mean lymphocyte counts decreased during the first year of treatment and then remained stable. The incidence of infections and serious infections was similar in TECFIDERA-treated patients and those on placebo. There were no opportunistic infections in TECFIDERA™-treated patients. In patients with low lymphocyte counts, there was no increased incidence in serious infections. Patients taking TECFIDERA™ should have a complete blood count (CBC) before starting treatment to measure lymphocyte counts. A follow up CBC is recommended annually and at the discretion of the treating physician.

“We are pleased to see a new, needed treatment option available to people living with MS,” said Dr. Timothy Coetzee, chief research officer at the National MS Society. “With the collaborative focus on MS research around the world, it is an exceptionally encouraging time for those who have been diagnosed with relapsing forms of MS.”

TECFIDERA™ marks the fourth therapy Biogen Idec offers worldwide to people living with MS.


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Navidea Biopharmaceuticals (NYSE: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced enrollment has commenced in its Phase 2b, open-label, safety and efficacy positron emission tomography (PET) imaging study of [18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with Mild Cognitive Impairment (MCI). The study is designed to investigate whether NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with MCI who progress to Alzheimer's disease (AD) from those who do not. Enrollment is currently planned at approximately five sites throughout the U.S. The first patient has been enrolled by the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA.

“We are pleased to participate in this important clinical study of NAV4694 aimed at evaluating a patient population in whom dementia is just emerging and for whom it is believed the best prospects for therapeutic intervention will exist,” said Dr. Anil K. Nair, MD, Chief of Neurology and Head of the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA. “Clinical trial results to date indicate that NAV4694 shows favorable sensitivity and specificity in detecting β-amyloid while exhibiting low white-matter uptake for clearer images that may assist in differential diagnoses associated with MCI. If AD could be diagnosed at an earlier stage, before clinical dementia has fully developed, the potential for successful intervention with current and future treatments could be improved considerably.”

“As the dementia field moves to earlier evaluation and treatment of cognitive impairment, it is of increasing importance to have diagnostic agents that can accurately detect the underlying cause. To our knowledge this is the first prospective, multi-center study to evaluate a radiopharmaceutical β-amyloid agent solely in subjects with MCI, an area of extreme importance as Alzheimer's disease is expected to impact as many as 14 million Americans by 2050,” commented Cornelia Reininger, MD, PhD, Navidea's Senior Vice President and Chief Medical Officer. “The outcome of this trial may enable accurate differentiation of MCI subjects who are at risk of developing Alzheimer's disease from those who are not before the disease has reached more advanced stages that can impair activities of daily living. Our ultimate goal is to provide an improved diagnostic tool with outstanding performance characteristics for physicians to aid in the diagnosis of Alzheimer's disease and other forms of neurodegenerative dementia.”



Also Wednesday:




Amarantus BioScience, Inc. (OTCQB: AMBS)
, a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today reported positive preclinical data for its lead therapeutic MANF in neuroprotection 6-hydroxydopamine (6-OHDA) rat models of Parkinson’s disease.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH)
, a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced it has initiated the CHABLIS-SC1 Phase 3 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of systemic lupus erythematosus (lupus).

InSite Vision Incorporated (OTCBB: INSV)
today announced that Dr. Gholam A. Peyman has joined its Scientific Advisory Board (SAB) which helps to guide and shape the InSite Vision research programs in the development of novel ophthalmic medicines.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious lung diseases in orphan indications that are often life-threatening, today announced Will Lewis, President and Chief Executive Officer of Insmed, will be presenting a corporate overview at the Future Leaders in the Biotech Industry Conference taking place at the Millennium Broadway Hotel & Conference Center in New York City on Friday, April 5, 2013.

Life Technologies Corporation (NASDAQ: LIFE)
today announced that its Applied Biosystems 3500xL Dx Genetic Analyzer has been approved by China's State Food and Drug Administration (SFDA) for clinical diagnostic use in China and the launch of 10 Assays from its joint venture with Daan Gene.  

Lightlake Therapeutics Inc. (OTCBB: LLTP)
(the “Company” or “Lightlake”), an early stage biopharmaceutical company developing addiction treatments, announced today that a scientific abstract based on results of the Company’s Phase II clinical trial of its opioid antagonist nasal spray treatment for patients with Binge Eating Disorder (BED) has been accepted for presentation at the American Psychiatric Association Annual Meeting taking place in San Francisco, California, May 18-22, 2013.

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA).

MusclePharm Corporation (OTCQB: MSLP)
("MusclePharm"), a nutritional supplement company focused on active lifestyles, announced today it has closed a $6 Million common stock offering.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that enrollment has commenced in its Phase 2b, open-label, safety and efficacy positron emission tomography (PET) imaging study of [18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with Mild Cognitive Impairment (MCI).

Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
today announced that a Phase IIb clinical trial to evaluate elagolix for the treatment of uterine fibroids has been initiated.

NovaDel Pharma Inc. (NVDL.PK)
reported unaudited financial results for the twelve months ended December 31, 2012.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce their participation at the 2013 International Society for the Advancement of Spine Surgery (ISASS) Conference from Tuesday, April 2nd, to Saturday, April 6th, 2013, at the Vancouver Convention Centre in Vancouver, Canada, booth #212.

POZEN Inc. (NASDAQ: POZN)
, a pharmaceutical company committed to transforming medicine that transforms lives, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of PA32540/PA8140.

Quantum Materials Corporation (OTCQB:QTMM)
has recently developed and delivered customized tetrapod QD samples for applications being developed by Department of Energy National Lab researchers.

Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for SGX942 for the treatment of oral mucositis resulting from radiation and/or chemotherapy treatment in head and neck cancer patients.

Trovagene, Inc. (NASDAQ:  TROV), today announced the commercial availability of its urine-based HPV-HR (high-risk) assay, a molecular human papillomavirus (HPV) test.

Verastem, Inc., (NASDAQ: VSTM), a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, reported financial results for the year ended December 31, 2012, and also commented on corporate accomplishments and plans.

Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today reported operating highlights and financial results for the fourth quarter and year ended December 31, 2012.



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