|SciClone Pharma acquires NovaMed. Vicor gets 510(k) clearence. After the bell: FDA approves Roche and Biogen vasculitis drug|
|By BioMedReports.com Staff|
|Tuesday, 19 April 2011 20:06|
SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) today announced that it has acquired NovaMed Pharmaceuticals Inc., a China-based specialty pharmaceutical company. The acquisition brings additional broad sales and marketing, as well as regulatory and extensive business capabilities and pharmaceutical assets in the regulatory approval stage to its growing and profitable China-focused specialty pharmaceutical business. SciClone believes this acquisition will further position it as a leader in the rapidly expanding pharmaceutical industry in China.
Under terms of the agreement, NovaMed shareholders are entitled to receive up-front payments of approximately $24.7 million in cash, 8,298,110 shares of SciClone common stock valued at approximately $37.1 million (based upon the closing price of $4.47 on the NASDAQ stock market on April 18, 2011) and the right to additional cash consideration of up to $43.0 million, contingent upon the successful achievement of revenue and earnings targets for the 2011 and 2012 fiscal years.
Vicor Technologies, Inc. (OTC.BB:VCRT), today announced the Company's receipt of 510(k) clearance from the U.S. Food and Drug Administration for its PD2i nonlinear algorithm and software to be used as a measure of heart rate variability at rest, and in response to controlled exercise and paced respiration (Ewing Maneuvers) in patients specifically undergoing cardiovascular disease testing. Vicor Technologies is a biotechnology company focused on the commercialization of its PD2i Analyzer, an innovative, non-invasive diagnostic employing its patented, proprietary PD2i nonlinear algorithm. Physician use of the PD2i Analyzer is supported by an expanding body of literature demonstrating the value of the PD2i nonlinear algorithm as a metric for risk stratifying specific target populations for future pathological events, including diabetics for the presence of diabetic autonomic neuropathy (DAN), cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and trauma victims for imminent death absent immediate lifesaving intervention.
This approval enables Vicor to market the PD2i Analyzer directly to cardiologists as a diagnostic specifically targeted for use in cardiovascular disease testing, including the Ewing Maneuvers, which are performed during PD2i Analyzer ECG data collection.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Biogen Idec (Nasdaq:BIIB) announced after the bell today that the FDA approved Rituxan, in combination with corticosteroids, as a new medicine for adults with Wegener’s Granulomatosis (WG) and Microscopic Polyangiitis (MPA).
WG and MPA are two severe forms of vasculitis called ANCA-Associated Vasculitis (AAV), a rare autoimmune disease that largely affects the small blood vessels of the kidneys, lungs, sinuses, and a variety of other organs. Both WG and MPA are considered orphan diseases with an estimated prevalence in the United States of approximately three cases per 100,000 people.
"For the first time, people with Wegener’s Granulomatosis and Microscopic Polyangiitis have a medicine that the FDA has approved for the treatment of these rare and relapsing diseases," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We are committed to following the science and focusing on diseases of high unmet medical need, including orphan conditions. Today’s approval is an important example of how the scientific community can work together to advance science and treatment options for orphan diseases."
Biogen Idec (NASDAQ:BIIB) announced earlier today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of AVONEX PEN for patients with relapsing multiple sclerosis (MS) and patients with a single demyelinating event. The CHMP recommendation provides the basis for a European Commission licensing decision, which is expected within 75 days from the opinion. The company also announced an authorisation for AVONEX PEN from Health Canada.
Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology markets, today announced that it has entered into an agreement to acquire the rights to ifetroban, a new Phase II development product. The Company has initiated clinical development under the brand name Hepatoren Injection and is evaluating the product for the treatment of critically ill hospitalized patients suffering from Hepatorenal Syndrome (HRS). Cumberland also has commenced manufacturing and received clearance from the FDA for its investigational new drug submission associated with the product. "This new product is an excellent strategic fit for our company given our established presence in hospital acute care," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals.
DARA BioSciences, Inc. (Nasdaq:DARA), reported today that SurgiVision, Inc. ("SVI"), a privately held company and a leader in interventional MRI-guided systems of which DARA owns over 500,000 shares and warrants, has received clearance from the Food and Drug Administration (FDA) for their SmartFlow(TM) neuro ventricular cannula.
The SmartFlow cannula is an MRI-compatible injection and aspiration cannula for use in the brain. It is compatible with SVI's ClearPoint system which allows neurosurgeons to select a neurological target, navigate the SmartFlow cannula to the target and observe the delivery of the therapeutic agent. Another feature of the SmartFlow cannula includes a multi-step tip design to help prevent reflux along the cannula shaft.
Furiex Pharmaceuticals, Inc. (Nasdaq:FURX) announced today that it has acquired full exclusive license rights to develop and commercialize the compound JNJ-Q2 under its existing development and license agreement with Janssen Pharmaceutica N.V. (Janssen). Furiex acquired these rights as a result of Janssen’s decision not to exercise its option under the agreement that gave Janssen the opportunity to continue development of JNJ-Q2, a novel broad-spectrum fluoroquinolone antibiotic.
Novavax, Inc. (Nasdaq:NVAX) announced today that Stanley C. Erck, its former Executive Chairman, has been appointed to the position of President and Chief Executive Officer and will remain as a member of the Board of Directors. In addition, current Board member James Young, Ph.D., will assume the position of Chairman of the Board.
Spherix Incorporated (NASDAQ:SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its Board of Directors, pursuant to previously obtained stockholder authorization, approved a reverse split of its common stock at a ratio of 1 for 10, with a planned effective date of May 6, 2011.
Vascular Solutions, Inc. (Nasdaq:VASC) today reported financial results for the first quarter ended March 31, 2011. Net revenue for the first quarter was $21.3 million, at the high end of the guidance previously provided by the company and an increase of 17% from the first quarter of 2010. U.S. net revenue increased by 15% while international net revenue increased by 27% from the first quarter of 2010.
DNA Dynamics, Inc (PINKSHEETS: DNAD) announces today that it has confirmed with the State Authorities in Delaware that the record date for the reduction in the Authorized Share Capital from 950m to 350m was 18th April 2011 and that this is now active.