Vermillion Receives Notice of Allowance; Allergan Announces Positive Top-Line Results from Phase III BOTOX® Print E-mail
By Staff and Wire Reports   
Wednesday, 28 March 2012 18:57
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 28, 2012.

Vermillion, Inc. (NASDAQ:VRML)
, a leading molecular diagnostics company, has received a notice of allowance from the United States Patent and Trademark Office for a patent, "Methods for Diagnosing Ovarian Cancer."

This patent further expands the list of biomarkers Vermillion has employed in the diagnosis or status determination of ovarian cancer. In this case, the granted claims cover the use of Protein C Inhibitor (PCI) in ovarian cancer tests using blood and several other sample types.

"Vermillion continues to expand its already extensive portfolio of biomarker-related patents in ovarian cancer and other important disease states," said Donald Munroe, Ph.D., chief science officer and VP of research & development at Vermillion. "The latest patent allowance further strengthens the ovarian cancer franchise behind our lead product, OVA1®, and offers creative new options to detect and manage this silent killer."


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Allergan, Inc. (NYSE: AGN)
announced two Phase III clinical trials of BOTOX® (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials demonstrate that BOTOX® significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment. The summary data are being presented as part of Allergans Research and Development Technology Review, which will be held today at 1 p.m. Eastern Time. The full study results of the North American Phase III study are expected to be presented at an upcoming medical meeting.

Based on the results of the two Phase III clinical trials, Allergan (AGN) has submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) and an application with European Regulatory authorities seeking approval for the use of BOTOX® as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX® is currently approved in the United States and in several European countries for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Allergan is committed to the research and clinical development of novel treatment options for urologists and their patients, and we look forward to potentially expanding the use of BOTOX® as a treatment option following approval by the respective regulatory agencies, said Scott Whitcup, M.D., Allergans Executive Vice President, Research and Development, Chief Scientific Officer. We are pleased with the results of our idiopathic overactive bladder Phase III clinical trials, which demonstrated that BOTOX® treatment provided benefit to these overactive bladder patients with symptoms of urinary incontinence who failed or were intolerant of other therapy.

Both Phase III clinical trials included patients with symptoms of OAB not caused by a neurological condition who were suffering with urinary incontinence for at least six months and who were inadequately treated with an anticholinergic therapy. Patients were randomly assigned to treatment with BOTOX® or placebo injections into the detrusor (bladder) muscle, followed by an injection with BOTOX® after a minimum of 12 weeks if desired. In both studies, there was a highly statistically significant decrease in the number of daily incontinence episodes in patients treated with BOTOX® vs. placebo (p<0.001).

In both Phase III clinical trials, BOTOX® treatments were well tolerated in patients suffering from OAB symptoms with urinary incontinence. Adverse events were primarily limited to the urinary tract, with urinary tract infection rates between 15-20 percent and urinary retention rates between 5-6 percent for patients treated with BOTOX® in both studies. Patients receiving BOTOX® treatments in both studies also reported an improvement in quality of life.



Also Wednesday:




ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD)
, a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will present at the 11th Annual Needham Healthcare Conference on Tuesday, April 3, 2012, at 9:20 a.m. Eastern Time at The New York Palace Hotel in New York City.

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that two abstracts have been selected for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2012 in Chicago, IL, from March 31-April 4.

Allergan, Inc. (NYSE: AGN)
today announced that two Phase III clinical trials of BOTOX® (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials demonstrate that BOTOX® significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment.

Antares Pharma, Inc. (NYSE Amex: AIS)
today announced that Robert F. Apple, Executive Vice President, Chief Financial Officer, and President of the Parenteral Products Division, will present at the 11th Annual Needham Healthcare Conference Wednesday, April 4, 2012 at 1:20 pm ET (Eastern Time).

ArQule, Inc. (Nasdaq: ARQL)
today announced that the Company will present at the 11th Annual Needham Healthcare Conference on April 4, 2012 at 11:20 a.m.

Mark A. Sirgo is the President and CEO of BioDelivery Sciences International, Inc. (NASDAQ: BDSI).

BioLineRx Ltd. (NASDAQ:BLRX) (TASE:BLRX)
, a biopharmaceutical development company, today announced that its Chief Financial and Operating Officer, Philip Serlin, and its Vice President of Research and Development, Leah Klapper, Ph.D., will be presenting at the 2012 Annual Needham Healthcare Conference at the New York Palace Hotel in New York.

Bristol-Myers Squibb Company (NYSE:BMY)
and Meso Scale Discovery today announced they have entered an agreement to develop diagnostic assays that will measure cerebrospinal fluid biomarkers for use in Alzheimer’s disease research.

Clovis Oncology, Inc. (Nasdaq: CLVS)
announced today that the first clinical study of CO-1686 has commenced with the dosing of the first patient at a U.S. study site.

Compugen Ltd. (NASDAQ: CGEN)
announced today the establishment of operations in South San Francisco, California for the development of oncology and immunology monoclonal antibody (mAb) drug candidates against Compugen-discovered targets.

EP Global Communications, Inc., (PINKSHEETS: EPGL)
, is pleased to announce that it has reached a restructuring agreement with the liquidator of AJW funds to convert 100% of the Company's debt into equity and restructure the Company into a medical device manufacturer, subject to shareholder approval.

Galectin Therapeutics Inc. (NASDAQ: GALT, GALTU, GALTW)
today announced it has closed its underwritten public offering of 1,333,361 units (including 173,916 units that were offered and sold by Galectin pursuant to the exercise in-full of the underwriter’s over-allotment option) at a price to the public of $9.00 per unit, with each unit consisting of two common voting shares, par value $0.001 per share (the “Common Stock”) and one warrant to purchase one share of Common Stock.

Helix BioMedix, Inc. (OTCQB: HXBM)
, a developer of bioactive peptides, today announced financial results for the year ended December 31, 2011.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
will be presenting at the Needham 11th Annual Health Care Conference on Wednesday, April 4, 2012, in New York.

Mentor Capital, Inc. (PINKSHEETS: MNTR)
will hold its annual shareholders' meeting at the company offices outside of San Diego, April 29, 2012 at 10:00AM.

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, today announced the appointment of Michael J. Holston as chief ethics and compliance officer effective June 25, 2012.

Metabolix, Inc. (NASDAQ: MBLX)
, a bioscience company focused on developing clean, sustainable solutions for plastics, chemicals and energy, today announced that it has appointed Stephen J. Large to its board of directors.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB)
, a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Phase 3 clinical study investigating 99m-Tc-Tilmanocept (Lymphoseek®) in oral and squamous cell cancers (SCC) were presented as a poster presentation at the 65th Annual Cancer Symposium of the Society of Surgical Oncology (SSO) meeting held in Orlando, Florida, March 21-24, 2012.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX)
, a specialty pharmaceutical company, today announced financial results for the quarter and year ended December 31, 2011.

Proteonomix, Inc. (OTCBB: PROT)
updated the progress of its cosmeceutical business operated by its Proteoderm, Inc, subsidiary under the guidance of recently appointed CEO Jaci Mandil.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has commenced commercial launch of Quetiapine Fumarate Tablets, the Company’s generic version of AstraZeneca’s schizophrenia treatment, Seroquel® Tablets.



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