|Viking soars on 510k clearence. ImmunoCellular announces positive data. MAP surges on migraine study. After the bell: Santarus in license deal. Questcor reports FDA delay|
|By BioMedReports.com Staff|
|Wednesday, 08 September 2010 18:29|
Santarus, Inc. (NASDAQ: SNTS), S2 Therapeutics, Inc. and VeroScience LLC today announced after the bell that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET (bromocriptine mesylate) tablets in the U.S. CYCLOSET is a prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as mono-therapy and in combination with other oral antidiabetic agents. Santarus expects to commercially launch CYCLOSET in November 2010.
CYCLOSET is the first FDA-approved drug for patients with type 2 diabetes to target the activity of dopamine, a chemical messenger between neurons within the central nervous system. The precise mechanism by which CYCLOSET improves glycemic control is unknown, but basic science research suggests that the active agent in CYCLOSET acts to reset aberrant central neuro-metabolic control of peripheral metabolism towards normal in diabetic patients resulting in a reduction in insulin resistance. In clinical studies, once daily, morning administration of CYCLOSET improved glycemic control, as demonstrated by a significant reduction in mean HbA1c (0.4 – 0.9%, data on file), and improved postprandial glucose levels without increasing plasma insulin concentrations in patients with type 2 diabetes.
Shares of Santarus rallied after the bell, gaining nealy 10% or 22 cents to $2.44.
Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) today announced that the U.S. Food and Drug Administration (FDA) has informed Questcor that the FDA will require additional time beyond the current action date of September 11, 2010 to complete its review of Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS). In conjunction with the FDA's review of this sNDA, Questcor and the FDA have been updating and modernizing the product label for Acthar, which has not been modified since 1978, when multiple sclerosis was added to the label. This step of the review process is now complete. Questcor has been notified that the FDA needs some additional time to finalize the wording on the label, review the proposed medication guide, and define post-approval commitments, if any, for the IS indication.
In extended trading, shares of Quest fell more than 5%.
Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced that it is offering to sell 8.3 million shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering. Barclays Capital Inc. is the sole book-running manager of the offering and Halozyme has granted the underwriter a thirty (30) day option to purchase up to 1,245,000 additional shares. Halozyme intends to use the net proceeds from the offering for general corporate purposes and to support further research and development of its product candidates.
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) announced after the market closed today that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis. Both sanofi-aventis and Regeneron management and staff remain blinded to the interim study results.
"We look forward to the final results of the trial, which are expected in the second half of 2011 with belief that the combination of aflibercept and FOLFIRI has the potential to benefit patients with this difficult-to-treat disease," said Tal Zaks, Head of Development, Global Oncology Division, sanofi-aventis.
Viking Systems, Inc. (OTCBB:VKNG) announced today that it has received clearance of its 510(k) application by the Food and Drug Administration related to its Next Generation 3DHD visualization system. The System is scheduled for market launch in Washington D.C. at this year's American College of Surgeons' Annual Clinical Congress which will be held from October 3-7.
Jed Kennedy, Viking President & CEO said, "We are very pleased to have received timely FDA 510(k) clearance of our Next Gen system for a broad base of minimally invasive procedures including general surgery, urology, gynecology, spinal, bariatric, ENT and thoracic." Kennedy went on to say, "With the 510(k) in place, we will now focus on completing the documentation required to apply the CE mark to the 3DHD system." The CE mark demonstrates compliance with the European community's Medical Device Directive.
Shares of Viking soared 50% or 14 cents to $0.42.
ImmunoCellular Therapeutics (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced long-term data from a Phase I clinical trial of ICT-107, the Company’s lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The data show six out of 16 (37.6%) patients who received ICT-107 were disease-free after more than two years, with three of these patients (18.8%) remaining disease-free for more than three years. One of these patients remains disease-free after almost four years. No treatment-related serious adverse events have been observed to date.
"These data continue to demonstrate the potential of targeting cancer stem cells to significantly delay disease recurrence and thereby increase survival in GBM," said Manish Singh, Ph.D., president and CEO of ImmunoCellular Therapeutics. "Glioblastoma is a devastating disease that is associated with a two-year progression-free survival rate of approximately 11%, and a three-year progression-free survival rate of less than 5%. We are therefore highly encouraged by the substantially extended progression-free survival rates we have seen thus far, which we expect to increase as we continue gathering data from this study. We look forward to further investigating the potential of ICT-107 in a larger Phase II clinical study, which we are on track to commence later this year."
The Phase I clinical study was conducted in 16 newly diagnosed glioblastoma patients, who received three injections of ICT-107 in addition to standard treatment with surgery, radiation and chemotherapy. Earlier this year, the Company reported two-year survival rates of 80% in study patients, which compares favorably to the historic median two-year survival rate of 26.5% with standard of care alone. The study’s median progression-free (PFS) survival of 17.7 months compared especially favorably to the historic median PFS of 6.9 months. Eleven of the 16 patients continue to survive. No serious adverse events have been reported and minor side effects have been limited to fatigue, skin rash and pruritis.
Shares of ImmunoCellular surger more than 15% on the news.
MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) today reported results from a pharmacodynamics (PD) trial comparing the acute effects on pulmonary artery pressure of LEVADEX, dihydroergotamine mesylate (DHE) administered intravenously (IV) and placebo. In the trial, there was no statistically significant difference between the LEVADEX and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.
LEVADEX was well tolerated and there were no drug-related serious adverse events reported. There were no clinically significant changes in any cardiovascular parameters measured in this trial. There were no mean increases in QT interval in the LEVADEX group. All pharmacokinetic results in this trial were consistent with those reported in previous LEVADEX trials.
"Intravenous DHE has been used safely for over 60 years, and we wanted to evaluate whether LEVADEX, with its novel administration through the lung, would have an effect on pulmonary artery pressure. We are pleased to report that LEVADEX did not have an effect on pulmonary artery pressure compared to placebo and was, in fact, less than that seen with IV DHE," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals.
Shares of MAP shot up more than 18% or $2.20 to $13.01.
AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based therapeutics, announced today that the United States Patent and Trademark Office issued AVI a patent granting key claims covering the use of phosphorodiamidate morpholino based oligomers (PMOs) as antibacterial agents. The patent, titled Antisense Antibacterial Method and Compound (No. 7,790,694), contains broad claims for the use of peptide-conjugated phosphorodiamidate morpholino oligomers (PPMOs) to target the acyl carrier protein (AcpP), a gene considered essential for bacterial growth in both gram positive and gram negative bacteria.
DARA BioSciences (Nasdaq:DARA) announced today that it presented study results from its Phase 2 multicenter, placebo controlled, double-blind, randomized dose escalation study for KRN5500.
The study was designed to evaluate the safety and efficacy of KRN5500 for treatment of neuropathic pain in patients with cancer, and primary endpoint results from the study have previously been released.
Prevalence of Chemotherapy-induced Peripheral Neuropathy (CIPN) is reported to be as high as 38% in patients who receive multi-agent chemotherapy. Presently, there is no approved treatment for this indication; thus, exploratory analyses of a subset of study patients with CIPN (17 of 19 total) provides clinically meaningful information regarding KRN5500 as potential treatment for CIPN.
Marshall Edwards, Inc. (Nasdaq:MSHL), an oncology company focused on the clinical development of novel anti-cancer therapeutics, announced today that it has reached an agreement in principle with Novogen Limited (ASX: NRT; Nasdaq: NVGN) to acquire Novogen's entire isoflavone-related intellectual property portfolio in a stock-based transaction. Specific terms of the proposed agreement were not disclosed.
NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, will deliver four poster presentations on its compounds at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The conference will take place September 12-15, 2010 at the Boston Convention and Exhibition Center in Boston, MA.
The presentations will highlight new data developed from studies of NovaBay's Aganocide family of compounds, which have shown to be highly effective against bacteria, including multi-drug resistant strains (e.g. MRSA), viruses and fungi in preclinical testing. Additionally, NovaBay's lead Aganocide, NVC-422, has recently demonstrated efficacy in a 129 patient dose-ranging Phase 2 clinical trial for the treatment of impetigo, a highly contagious skin infection affecting over 1.3 million patients in the U.S. annually.
Shares of NovBay jumped 27 cents or 16% on the news.
Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced that it has entered into an exclusive agreement with Ono Pharmaceutical Co., Ltd. to develop and commercialize two compounds from Onyx's proteasome inhibitor development program, carfilzomib and ONX 0912. Under the terms of the agreement, Ono has exclusive rights to develop and commercialize both compounds for all oncology indications in Japan. Onyx retains commercialization rights in other countries in the Asia Pacific region, as well as in all other regions of the world, including the U.S. and Europe. The potential value of the transaction, which includes rights to all oncology indications for the two molecules, is estimated to exceed $300 million, plus royalties.
Positron Corporation (OTCBB:POSC), a leading molecular imaging company specializing in the field of nuclear cardiology, announced today it has placed orders on its sales of three Attrius(TM) PET scanners. The sales of these systems are for leading cardiology practices and hospitals. The Company also reaffirmed its growth targets as previously disclosed, and is anticipating steady growth acceleration through 2012.
Stereotaxis, Inc. (Nasdaq:STXS) highlighted significant new additions to the body of evidence demonstrating exceptional clinical outcomes achieved with its Niobe® Magnetic Navigation System in ventricular tachycardia (VT) ablation.
At the European Cardiology Society Annual Congress in Stockholm last week, the research team led by Dr. Tamas Szili-Torok from the Erasmus Medical Center in Rotterdam presented the first comparative trial in a prospective study of 64 consecutive VT patients, comparing Stereotaxis VT ablation to conventional, non-magnetic ablation. Acute success was achieved in 97% of the Stereotaxis VT ablation group versus 81% of the manual ablation group. Patients in the Stereotaxis VT group averaged 50% less x-ray exposure, and after a year, only 14% VT recurrence, versus a 50% recurrence rate among manual ablation patients. A remarkable 25% reduction in total procedure time was achieved in the Stereotaxis VT group compared to the manual group.
ULURU Inc. (NYSE Alternext: ULU) announced today that it has signed a worldwide distribution agreement appointing Novartis the exclusive distributor of a veterinary version of Altrazeal® for marketing to the animal health sector.
Under the terms of the agreement ULURU will supply Novartis with finished product for marketing in the global markets. The agreement includes other wound care products that may be developed by ULURU that the parties mutually agree to be covered by this agreement.
Commenting on the agreement, Kerry P. Gray, President and CEO of ULURU, stated, "We are very pleased to be working with Novartis, a leading global animal health care company and one of the top 5 pharmaceutical companies in the world. Initial wound healing testing in animals with Altrazeal® produced positive results. We look forward to working with the Novartis team to establish our wound franchise as a leader in the veterinary market."
Shares of ULURU jumped more than 15% on the news.
Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced that Michael R. Minogue, Chairman, President and Chief Executive Officer, will present at the Morgan Stanley 2010 Global Healthcare Conference on Monday, September 13, 2010 at 3:55 p.m. ET.