|FDA Approves Navidea’s Lymphoseek® Injection; NeoStem Announces Intellectual Property Expansion|
|By Staff and Wire Reports|
|Wednesday, 13 March 2013 18:49|
Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval of Lymphoseek® (technetium Tc 99m tilmanocept) Injection, a novel product indicated for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek is a receptor targeted radiopharmaceutical designed to identify these lymph nodes which have the highest probability of harboring cancer and thereby assist physicians in the staging of such patients.
Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. Accurate staging of lymph nodes is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 232,000 new cases of breast cancer and 77,000 new cases of melanoma are expected to be diagnosed in the United States in 2013.1
We recommend lymphatic node mapping and sentinel node biopsy for patients with early stage breast cancer and in select cases of ductal carcinoma in situ, said Anne Wallace, M.D., Professor of Surgery, UC San Diego School of Medicine; Director of the Breast Care Unit; UC San Diego Moores Cancer Center; and Principal Investigator for breast cancer in the Lymphoseek Phase 3 clinical trials. The ability to reliably identify multi-node pathology-positive patients is important to optimize their post-surgery management and to spare certain patients from unnecessary surgery and potentially debilitating side effects. Products specifically designed to address reliable lymph node uptake and retention can provide significant clinical utility and help standardize the process of lymph node mapping.
Both the incidence rate and the death rate for melanoma continue to increase, in the United States and in many other parts of the world," said Vernon K. Sondak, M.D., Chair, Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa Fla., and Principal Investigator for melanoma in the Lymphoseek Phase 3 clinical trials. "Most patients present with clinically localized disease, but microscopic metastases to the regional lymph nodes are common and are the major prognostic factor for these patients. Over the past 20 years, surgical staging of the regional nodes with intraoperative lymphatic mapping and sentinel node biopsy has emerged as the worldwide standard of care for patients with clinically node-negative intermediate and thick melanomas, and for selected patients with higher-risk thin primaries as well. New technologies offer the promise of improving intraoperative lymphatic mapping, allowing procedures to be done more quickly and potentially lessening the risk of misclassifying patients as node-negative when in fact their tumor has already spread to the regional nodes.
The approval of Lymphoseek is based on data from more than 540 subjects receiving Lymphoseek. In pivotal Phase 3 studies that were conducted in 332 patients with either breast cancer or melanoma, Lymphoseek, on average, was present in 97% (range 94-100%) of resected, histology-confirmed lymph nodes. To date, no clinically significant drug-related adverse reactions have been reported. Lymphoseek has no contraindications and the most common adverse reactions were injection site irritation and/or pain (<1%).
We believe todays approval of Lymphoseek validates our ability to advance the field of precision diagnostics, said Mark J. Pykett, V.M.D., Ph.D., President and CEO of Navidea. Our vision is to improve diagnostic accuracy, clinical decision-making and patient care. We are gratified that our scientific achievements may benefit thousands of patients diagnosed with breast cancer and melanoma each year. We look forward to continuing the development of Lymphoseek into additional indications and to progressing our oncology and neurology pipeline.
Lymphoseek will be sold and distributed in the U.S. on an exclusive basis by Cardinal Health, Inc. As part of the distribution agreement, Cardinal Healths Nuclear Pharmacy Services business will be responsible for commercializing and dispensing Lymphoseek to health care professionals who are involved in lymphatic mapping. Navidea is also working to identify and partner with distributors in other markets outside of the U.S. Navidea will play an ongoing role in commercial activities through focused deployment of medical science liaison and medical education activities. This is consistent with Navideas overall strategy to remain involved in market-based activities with its products while leveraging the extensive capabilities and infrastructure of partners around the world.
NeoStem, Inc. (NYSE: NBS), a leader in the emerging cellular therapy industry, announced Amorcyte, LLC, its wholly owned subsidiary, received a Notice of Allowance of claims from the U.S. Patent and Trademark office for patent application 13/285,606 covering a method of treating a progressive myocardial injury caused by an ischemic condition and utilizing a multi-dosing regimen. Once granted, this will represent Amorcyte's fourth U.S. patent and sixth patent overall.
"These newly allowed claims further strengthen our broad IP in ischemia-induced cardiovascular disease," said Andrew L. Pecora, M.D., FACP, CPE, Chief Medical Officer of NeoStem (NBS)." One very important condition that these claims cover is use of AMR-001 for treating ischemia-induced congestive heart failure, a major unmet medical need afflicting 5.8 million patients in the United States alone (with an annual incidence of 660,000) and approximately 20 million patients worldwide. Traditionally, the majority of these people are labeled as "ischemic" in etiology, though recent reports from independent research suggest that perhaps all patients have ischemia as a driver of disease, either due to coronary artery disease or microvessel induced ischemia. We expect to file an IND in 2013 to assess the ability of AMR-001 to arrest the progression of CHF and prevent the associated comorbidities of that disease. Moreover, these claims cover cryopreservation of the AMR-001 product, facilitating global distribution if approved by appropriate regulatory agencies."
The cost of cardiovascular disease in the United States continues to rise. As per the Department of Health & Human Services, Agency for Healthcare Research and Quality, the total annual cost of caring for CHF in the United States is over $25 billion. "We believe cell therapy has the potential to improve clinical outcomes and lower overall health care costs. These newly allowed claims significantly bolster our ability to develop AMR-001 for additional indications and through new potential treatment protocols, including a multi-dose regimen," said Robin L. Smith, M.D., MBA, Chairman and CEO of NeoStem.
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 25th Annual ROTH Conference on Tuesday, March 19, 2013, at 10:00 a.m. Pacific Time at The Ritz-Carlton in Laguna Niguel.
Align Technology, Inc. (NASDAQ: ALGN) today announced that Thomas M. Prescott, president and chief executive officer of Align Technology, is scheduled to speak at the 25th Annual ROTH Conference.
ALR Technologies (OTCBB: ALRT) and the Mid-America Coalition on Health Care today announced a partnership in which the MACHC will introduce and offer pilot participation of ALRT's Health-e-Connect Diabetes Management Program to their membership.
Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, has entered into a contractual agreement with FedMed, Inc., one of the largest proprietary Preferred Provider Organization (PPO) networks in the U.S., for diagnostic laboratory testing. FedMed's network is comprised of more than 550,000 providers, including 4,000 hospitals and more than 60,000 ancillary facilities, serving over 40 million Americans.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, will present at the 25th Annual ROTH Conference.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading dental laser manufacturer and distributor, announced today that the Company held its annual distributor meeting on March 12, 2013, the first day of the exhibition at the 35th IDS International Dental Show in Cologne, Germany, recognized as the world's largest dental show.
BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Dr. Michael D. West, Chief Executive Officer, will present a corporate overview of BioTime and its subsidiaries at the 25th Annual ROTH Conference.
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, will be presenting the initial results of its Phase I/II ALS trial at the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego, California, from March 16-23.
China Biologic Products, Inc. (NASDAQ: CBPO), a leading fully integrated plasma-based biopharmaceutical company in China, today announced its financial results for the fourth quarter and fiscal year 2012.
Digirad Corporation (NASDAQ: DRAD) today announced that it has taken additional steps to strengthen its commitment to best corporate governance practices related to its recently announced strategic initiatives.
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a development stage specialty pharmaceutical Company focused on the commercial development of compounded drug formulations, announced today that the underwriter, MDB Capital Group LLC, exercised its over-allotment option to purchase an additional 276,000 shares of the Company's common stock at a price of $5.25 per share, for gross proceeds of approximately $1.45 million.
Islet Sciences, Inc. (OTCBB:ISLT), (ISLT) a clinical stage company engaged in the research, development and commercialization of therapeutics in the field of diabetes, announced today an important study published in Diabetes by the American Diabetes Association titled Immune Therapy and β-Cell Death in Type 1 Diabetes.
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced the appointment of Amit Sharma, M.D. to the newly created position of Vice President, Medical Affairs.
MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, today announced that its Avive® multiple-medication patient adherence solution received the Compliance Package of the Year award from the Healthcare Compliance Packaging Council (HCPC).
Merus Labs International Inc. (TSX:MSL) (NASDAQ:MSLI) today announced that Mr. Elie Farah, the President & CEO of Merus, will present at the upcoming Roth Capital Partners 25th Annual Growth Stock Conference. Mr. Farah's presentation will take place on Wednesday, March 20th, 2013 at 12:30 P.M. (Pacific Time) at the Ritz Carlton hotel, Laguna Niguel, Dana Point, California.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the fourth quarter and year ended December 31, 2012.
PDI, Inc. (Nasdaq: PDII) today announced the signing of a new sales contract which could generate total revenues of up to $17 million over its two-year term. PDI estimates that $5 - $6 million of revenue will be recognized in 2013, beginning in the second quarter.
PharmAthene, Inc. (NYSE MKT: PIP), a biodefense company developing medical countermeasures against biologicaland chemical threats, today reported its financial and operational results for the year ended December 31, 2012.
SK3 Group, Inc. (OTC Pink: SKTO) today announces that it has appointed licensing expert and former Executive of King World Productions, Kevin Allyn, as Chairman of the Board of Directors.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH) today announced the presentation of results from a preclinical study of Keyhole Limpet Hemocyanin (KLH), conducted together with a partner, showing that manufacturing source and molecule form can impact the magnitude and consistency of antibody response to KLH.
Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) today announced that Jon W. Salveson has been appointed to the Company's Board of Directors.
Vycor Medical, Inc. ("Vycor") (OTCBB: VYCO), a provider of innovative and superior surgical and therapeutic solutions, announced that it continues to experience an increase in the number of hospitals where its patented ViewSite™ Brain Access System® ("VBAS") device has been approved for use.