|Navidea Announces EMA Continues Review for Lymphoseek; Vertex Says Phase 3 Study Did Not Meet Primary Endpoint|
|By Staff and Wire Reports|
|Thursday, 19 December 2013 20:39|
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced the European Medicines Agency (EMA) has provided updated Day 180 feedback and has elected to continue the assessment of the Marketing Authorization Application (MAA) for Lymphoseek® (technetium 99m tilmanocept) Injection. The updated Day 180 feedback was limited to supplemental product specification data and the NEO3-06 Phase 3 study in Head and Neck Cancer, which was submitted later in the MAA review process at Day 120, leaving less time for evaluation of these new data. The MAA review clock will continue to be stopped at Day 180 to await Navidea's responses to the updated EMA feedback. During this time, the MAA remains active and Navidea will continue its ongoing process of interacting with the EMA.
"With the Lymphoseek MAA remaining in the EMA's assessment process, we will continue to work with the EMA to support a positive opinion as early as possible in 2014," stated Mark Pykett, VMD, PhD, Navidea CEO. “We view potentially gaining a positive opinion that would also include Head and Neck Cancer as advantageous. While we prepare our responses to the EMA's updated Day 180 feedback, we will continue to implement our plans for European market development during 2014 which we believe will support material revenue generation from Europe beginning in 2015, as we have previously disclosed."
Expanding Global Efforts - Navidea's activities in Europe are part of its expanding global strategy for Lymphoseek commercialization. The Company recently announced it has entered into a partnership agreement for Lymphoseek distribution in Canada; partnerships are in process for additional markets. Navidea has also commenced shipment of Lymphoseek to select medical centers in the Middle East. These market expansion activities build on the growth of Lymphoseek sales being seen in the United States, which continue the positive trends recently reported at the Company's Analyst Science Day on December 5, 2013.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced data from a Phase 3 study of ivacaftor in 69 people 6 years of age and older with cystic fibrosis (CF) who have the R117H mutation. In the study, the mean absolute treatment difference in the change from baseline in percent predicted FEV between treatment with ivacaftor and placebo was 2.1 percentage points (p=0.20) and the mean relative treatment difference in percent predicted FEV was 5.0 percent (p = 0.06) through the 24-week treatment period among all patients (intent-to-treat analysis).
The study did not meet its primary endpoint of the absolute change from baseline in FEV (percent predicted forced expiratory volume in one second, FEV) throughout the treatment period for ivacaftor compared to placebo across all patients. A pre-specified subset analysis in patients 18 years of age and older (n=50) showed statistically significant improvements in lung function and other key secondary endpoints.
In these patients, the mean absolute treatment difference in percent predicted FEV between treatment with ivacaftor and placebo was 5.0 percentage points (p=0.01) and the mean relative treatment difference in percent predicted FEV was 9.1 percent (p=0.008) through the 24-week treatment period. Vertex believes that the results show a clinical benefit for patients age 18 and older with the R117H mutation. The company plans to meet with the U.S. Food and Drug Administration (FDA) in early 2014 to discuss these data and the potential submission of a supplemental New Drug Application (sNDA) for people with the R117H mutation.
R117H is the most common residual function mutation. In North America, Europe and Australia, approximately 1,100 people with CF ages 6 and older have at least one copy of an R117H mutation. In the United States, approximately 300 people have the R117H mutation and are 18 years of age or older.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that it has been granted a key composition-of-matter patent from the Australian Patent Office for ixmyelocel-T, Aastrom's cell therapy product candidate.
Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces the appointment of Jerald J. Wenker as a special advisor to its Board of Directors.
Apricus Biosciences, Inc. (Nasdaq:APRI), today announced that France's National Agency for Medicines and Health Products Safety (ANSM) has granted national phase approval to Vitaros®, indicated for the treatment of patients with erectile dysfunction ("ED").
Athersys, Inc. (Nasdaq:ATHX) today announced that Pfizer Inc. has completed patient enrollment of a Phase II clinical study involving administration of Athersys' MultiStem® cell therapy to ulcerative colitis patients as part of a 2009 collaboration agreement between Athersys and Pfizer.
Bio-Reference Laboratories, Inc. (Nasdaq:BRLI) announces best-ever quarterly results for revenues despite significant reimbursement changes noted in the Company's earlier announcement regarding quarterly headwinds.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, announces the addition of Christopher Mitton as Director of National Account Development and Sales Operations.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that Kenneth I. Moch, President and CEO of Chimerix, will present at the 32nd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2014 at 12:30pm PST (3:30pm EST) at the Westin St. Francis Hotel in San Francisco.
CNS Response, Inc. (OTCQB:CNSO) announced today that Decision Calculus Associates has released a new study today showing that just 5% of patients treated for depression with medication receive an objective test prior to receiving a prescription.
The Cooper Companies, Inc. (NYSE:COO) today announced that it will hold its next annual meeting of stockholders on Monday, March 17, 2014. Stockholders of record as of the close of business on January 21, 2014 will be eligible to vote on matters presented in the Company's proxy statement, including electing its slate of directors.
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, today announced further enhancements to its sales and marketing organization.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that new preclinical data show its leading galectin-inhibiting drugs – GR-MD-02 and GM-CT-01 – demonstrate positive therapeutic effects on nonalcoholic steatohepatitis (NASH, or fatty liver disease) with fibrosis.
GreeneStone Healthcare Corporation (OTCBB:GRST), a provider of healthcare services including Addiction and Mental Health has agreed to terms with several investors for a private placement of shares for Gross proceeds of $425,000.00.
IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospitalist physician group practice company, announced today that it has acquired two Michigan-based practice groups: Bruce G. Johnson, D.O., PC, based in Roseville; and Allen Trager, D.O., PC, located in Flint.
Jazz Pharmaceuticals plc (Nasdaq:JAZZ) and Gentium S.p.A. (Nasdaq:GENT) today announced that they have entered into a definitive agreement pursuant to which a subsidiary of Jazz Pharmaceuticals will make a cash tender offer of $57.00 per share for all outstanding Gentium ordinary shares and American Depositary Shares, in a transaction that is valued at approximately $1 billion.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq:NBI), which will become effective prior to market open on Monday, December 23, 2013.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) announces the appointment of Jerald J. Wenker as a special advisor to its Board of Directors.
NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY), a clinical-stage biopharmaceutical company developing non-antibiotic antimicrobial products, today announced that it expects to reinitiate a Phase 2b clinical trial of auriclosene for impetigo in 2014.
Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, provided an update today on the progress made by its contractor, Inno Biologics, regarding the cloning of the cancer-prodrug ifosfamide-activating cells that form the basis for the cancer treatment and will be encapsulated as part of the development of the treatment for Nuvilex's future clinical trials in advanced pancreatic cancer.
Orion Corporation (Nasdaq OMX Helsinki: ORNAV and ORNBV) announced today that it has entered into a license agreement with Janssen Pharmaceuticals, Inc. for the development and commercialization of Orion's novel, investigational alpha-2c adrenoceptor antagonists for the symptoms of Alzheimer's disease, including a clinical phase compound ORM-12741.
RedChip Companies, Inc., today announced it has issued a research profile on Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics that personalizes the clinical management of difficult-to-diagnose cancers.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced it has added Michael Suesserman to the Company's Board of Directors.
In a transaction on October 30, 2012, Oculus Innovative Sciences (Nasdaq:OCLS) agreed to issue $3.5 million dollars of restricted common stock to its primary lender, Venture Lending and Leasing (VLL), which agreed to reduce the company's debt liability with the sale of these common shares.
Prosensa Holding N.V. (NASDAQ: RNA), the Dutch biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, commented on a recent update by GlaxoSmithKline (GSK) to patient groups and investigators regarding the ongoing analyses for drisapersen, an investigational antisense oligonucleotide, for the treatment of Duchenne Muscular Dystrophy (DMD) patients with an amenable mutation, which is exclusively licensed to GSK.
ScripsAmerica Inc. (OTCBB:SCRC), today announced that the Company has received and processed a record high $51,920 in orders during the week ending December 13, 2013 and $84,821 in orders for the first two weeks of the month from its recent pharmaceutical distribution joint venture.