Below are some of the newsmakers in the healthcare sector on Tuesday, September 14, 2010.
After the bell Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
"KRYSTEXXA is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy," said Paul Hamelin R.Ph., President of Savient Pharmaceuticals. "The clinical data have demonstrated that many patients treated with KRYSTEXXA 8 mg administered every two weeks can experience within six months of treatment significant positive clinical improvement reversing the course of this severe, crippling and debilitating disease. A statistically significant proportion of patients in our pivotal clinical trials achieved a lowering of their serum uric acid level to a mean of 0.7 mg/dL and achieved a complete response for the resolution of tophi within the first six months of therapy. We believe that the approval of KRYSTEXXA is a significant step towards realizing our mission of transforming the lives of the patients in the U.S. suffering with chronic gout refractory to conventional therapy, as many of them finally have a treatment that gives them hope of reversing this severely debilitating disease."
Savient expects KRYSTEXXA to be available by prescription in the U.S. later this year and believes it is well advanced in its preparations for the U.S. launch of KRYSTEXXA. Specific timing for the launch of KRYSTEXXA will be determined within the context of the Company's commercialization plan and by the progress and status of the Company's efforts to pursue a strategic transaction for the sale of Savient. KRYSTEXXA was granted an Orphan Drug designation by the FDA in 2001 that the Company expects will provide the drug seven years of orphan drug market exclusivity. The composition, manufacture and methods of use and administration of KRYSTEXXA are also the subject of a broad portfolio of patents and patent applications that the Company expects will provide protection into 2026.
After the market closed, on heavy volume, shares of Savient rallied more than 20% or $3.00 to $17.76
After the bell Tuesday, Neurocrine Biosciences, Inc. (Nasdaq:NBIX) announced top-line efficacy and safety results from a Phase II clinical trial utilizing Corticotropin Releasing Factor (CRF1) receptor antagonist GSK561679 in patients currently experiencing a major depressive episode. This double-blind, placebo controlled trial randomized 150 patients into two treatment arms, 350 mg of GSK561679 daily and placebo, and was conducted in the United States by GlaxoSmithKline (GSK) under the GSK/Neurocrine CRF1 collaboration. The primary endpoint was change from baseline in the Bech Melancholia scale at Week 6 and a key secondary endpoint was change from baseline in the HAMD-17 scale at Week 6.
Results of statistical analysis using the intent-to-treat population revealed no benefit of GSK561679 compared with placebo on both the Bech Melancholia and HAMD-17 endpoints. The top-line results are based on the six week placebo-controlled portion of the study for the intent to treat population of 145 patients. From a safety perspective, there were no significant adverse events, and the drug was generally well tolerated.
"It is clear from this study that CRF1 remains a difficult drug target in the drive to improve current pharmaceutical therapies for depression," said Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "We plan to meet with GSK in the coming months after the full clinical data set is complete to determine the next steps for the CRF depression program."
In extended trading, shares fell more than 7% on the news.
Shares of Harbor BioSciences, Inc. (Nasdaq:HRBR) soared after the bell today after the company released new positive data from its ongoing Phase I/IIa clinical trial with Apoptone(R) (HE3235) for castration resistant prostate cancer (CRPC) -- also referred to as hormone resistant prostate cancer.
The most current results from this study include data on the 100 mg and 350 mg cohorts of chemotherapy-naive patients. One patient in the 350 mg group has a confirmed partial overall response of the disease. The median time to progression (TTP) for the 100 mg cohort is 24 weeks. The median TTP has not been reached for the 350 mg dose.
Bruce Montgomery, M.D., Associate Professor, Department of Medicine, Division of Oncology, University of Washington School of Medicine, and lead investigator of the ongoing Phase I/IIa clinical trial remarked: "This is an exciting finding because, at the 350 mg dose, we are seeing a quantitative response by RECIST criteria. This response correlates with the patient having the highest serum levels seen thus far and without any evidence of toxicity. Further dose escalation is justified to explore the promise of activity at higher serum concentrations of the drug."
Dose escalation to 700 mg has been initiated based on both the quantitative response and experience with the 350 mg dose, which demonstrate that the drug is safe and well tolerated.
A novel steroid analog of a testosterone metabolite, Apoptone has been found to induce cell death (apoptosis) in prostate tumors. The dose-response study was designed to determine safety and time to disease progression for both taxane-resistant and chemotherapy-naive patients with CRPC; and the study is being conducted with participating sites including the Prostate Cancer Clinical Trial Consortium (PCCTC).
In the after hours session, shares of Harbor BioSciences shot up as high as 50 cents before pulling back to 40 cents, up more than 70% or 17 cents.
GenVec, Inc. (Nasdaq:GNVC) today announced that it has achieved the first milestone in its collaboration with Novartis (NYSE:NVS), related to the development of treatments for hearing loss and balance disorders. The milestone was triggered by the successful completion of certain preclinical development activities.
"Completion of this milestone signifies progress made in moving the potential product toward clinical development," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "The rapid completion of this initial milestone in our collaboration with Novartis validates our strategy to work with the best collaborators in the industry. We look forward to reaching additional milestones with Novartis as the program progresses."
In January 2010, GenVec entered into a worldwide licensing and collaboration agreement with Novartis to discover and develop novel treatments for hearing loss and balance disorders. Under the terms of the agreement, if certain clinical, regulatory, and sales milestones are met, GenVec is eligible to receive up to $213.6 million, including upfront and milestone payments in addition to royalties on future sales.
Shares of GenVec shot up nearly 10% on the news.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob), a biopharmaceutical company specializing in products for cancer and supportive care, announced today it has received its first commercial order for MuGard from BioScrip (Nasdaq:BIOS), its specialty distribution partner. BioScrip's initial purchase order of MuGard, totaling over $700,000, will provide adequate inventory for its various distribution channels to support the Company's first phase of its product launch for MuGard. Access Pharmaceuticals has inventory on hand and will begin shipping product to BioScrip immediately. MuGard is an FDA-approved, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of radiation and/or chemotherapy.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine, manufactured at the Company's intended commercial manufacturing site. The 12-month stability data are consistent with the stability data collected at 6 and 9 months and will support the Company's submission of a New Drug Application (NDA) for Exelbine, which the Company expects to take place in the fourth quarter of this year.
American Medical Systems Holdings, Inc. (NASDAQ:AMMD), a leading provider of world-class devices and therapies for male and female pelvic health, announced today that the company is pleased with yesterday’s U.S. Court of Appeals for the Federal Circuit’s ruling that reversed a summary judgment and finding for Biolitec, Inc. The Court of Appeals found that a trial judge erred in his interpretation when he ruled last year that Biolitec didn’t infringe the patent.
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it intends to appeal the U.S. Food and Drug Administration's (the "FDA") previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). CTI had requested accelerated approval of its NDA for this patient group for which there are no currently approved drugs. The FDA issued a Complete Response Letter to CTI related to this NDA stating, in part, that CTI should conduct an additional clinical trial prior to approval. CTI is preparing to file an appeal under the FDA's Formal Dispute Resolution process. CTI reached this decision by taking into account that CTI believes there are no approved or effective therapies for patients with relapsed or refractory aggressive NHL beyond second relapse, and that PIX 301 was the first and only randomized trial in this patient group to demonstrate significant improvement in clinically relevant endpoints including complete response rate, overall response rate, and progression free survival while being safe and effective in this indication.
Micro Identification Technologies, Inc. (OTC.BB:MMTC) (MIT) announces that its plans to start production of the MIT 1000 System remain on-track to begin later this year. Critical sub-system electronics were successfully tested and the remaining tasks that include the build and test of the first production System present no additional challenges for MIT and its contract manufacturer, OSI Optoelectronics.
Seattle Genetics, Inc. (Nasdaq:SGEN) and Genmab A/S (OMX:GEN) announced today that the companies have entered into an antibody-drug conjugate (ADC) research collaboration agreement. Under the agreement, Genmab has rights to utilize Seattle Genetics’ ADC technology with its HuMax-TF antibody targeting the Tissue Factor antigen, which is expressed on numerous types of solid tumors. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a co-development option for any resulting ADC products at the end of Phase I clinical development.
A5 Laboratories Inc. (A5 Labs) (OTCBB:AFLB) today announced the CRO team has completed its CRO testing and analytical standard operating procedures (SOPs) ahead of schedule.
Abbott (NYSE:ABT) announced today that it has been named one of the 100 Best Companies by Working Mother magazine.
Assured Pharmacy (Pink Sheets:APHY), a pharmacy service healthcare organization operating a chain of specialty pharmacies providing advanced prescription medication fulfillment solutions to sufferers of chronic pain, is pleased to announce that it has received $500,000 of debt financing from an existing shareholder which can be converted in whole or in part anytime over the 2 year term at the holder's option into a maximum of 500 shares of the Company's Series A Preferred Stock.
AVANIR Pharmaceuticals, Inc. (Nasdaq:AVNR) today announced the electronic publication of the results of the pivotal Phase III STAR trial of its investigational drug AVP-923 (dextromethorphan/quinidine) in the Annals of Neurology.
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, announced today that the company is scheduled to present at the UBS Global Life Sciences Conference, Monday, September 20, 2010, at 10:30 a.m. Eastern Time in New York City.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that Joshua Grass, Vice President, Corporate and Business Development of BioMarin, will present a company update at the UBS Global Life Sciences Conference in New York City on Tuesday, September 21, 2010 at 3:30 p.m. ET.
Bionovo, Inc. (Nasdaq: BNVI, BNVID), a drug discovery and development company focused on unmet needs in women's health and oncology, today announced that Dr. Isaac Cohen, O.M.D, Chairman and Chief Executive Officer and Mr. Tom Chesterman, Chief Financial Officer, will be presenting at a Cambria Capital investor meeting at 4:00 p.m. MST on Thursday, September 16, 2010. The event will be held at Yorgio's Restaurant in Salt Lake City, UT.
Bohai Pharmaceuticals Group, Inc. (OTCBB/OTCQB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, today released an online overview video featuring TCM industry experts and Mr. Hongwei Qu, CEO of Bohai Pharmaceuticals Group, Inc.
Boston Scientific Corporation (NYSE:BSX) today announced the schedule of the Company's major events and press announcements at the Cardiovascular Research Foundation's (CRF) 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, September 21 - 25 in Washington, D.C.
Cannabis Science, Inc. (OTCBB:CBIS), a pioneering U.S. biotech company developing pharmaceutical cannabis products, is hailing the news that the Israeli Health Ministry is greatly expanding its medical marijuana program.
Celera Corporation (NASDAQ:CRA) announced today that it will webcast its presentation at the UBS Global Life Sciences Conference on Tuesday, September 21, 2010.
CytoGenix, Inc. (Pink sheets: CYGX-News) today announced publication of positive results of a study using CytoGenix's novel liner DNA technology.
Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that additional Phase I clinical trial data relating to omecamtiv mecarbil (formerly CK-1827452)was presented as a poster at the 2010 Heart Failure Society of America Annual Meeting being held September 12-15, 2010 at the San Diego Convention Center in San Diego, California.
Derma Sciences, Inc. (Nasdaq:DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that patient screening in its DSC127 Phase 2 trial in diabetic foot ulcer healing will be completed tomorrow, and that enrollment in the trial will conclude on September 30.
ERT (Nasdaq:ERES), announced today that Dr. Michael J. McKelvey, the Company's President and CEO, and Keith Schneck, the Company's Executive Vice President and CFO, are scheduled to present at UBS Global Life Sciences Conference at 11:30 AM EDT on September 20, 2010 in New York City, New York.
Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has entered into an exclusive Product Licensing & Distribution Agreement with PMG S.A. for the registration, marketing, distribution and sale of Generex Oral-lyn, the Company's proprietary buccal insulin spray product, in Chile.
Gentium S.p.A. (Nasdaq:GENT) today announced that two posters and one oral presentation on defibrotide will be presented at the 33rd World Congress of International Society of Hematology to be held at the ICC Jerusalem International Convention Center in Jerusalem, Israel, October 10-13, 2010.
Grupo International Inc. (formally HIV-VAC, Inc.) current stock symbol (PINKSHEETS: HIVV) -- President Ramon Richard announced today that Rafeal Rubio has agreed to take the position to serve on the Board as a Director for the coming year, 2011.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, announced today that President and CEO Bruce Barclay is scheduled to present at the UBS 2010 Global Life Sciences Conference.
Helix BioPharma Corp. (TSX, FSE: "HBP" / OTCQX: "HXBPF") today announced that it has been authorized to list its shares of common stock on the NYSE Amex stock exchange.
HORIZON HEALTH INTERNATIONAL CORP. (PINK SHEETS:HZH) appoints Dr. Max Arella as Chairman to its Board of Directors.
Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that its presentation at the Stifel Nicolaus 2010 Healthcare Conference will be webcast.
Innophos Holdings, Inc. (Nasdaq:IPHS), a leading North American specialty phosphates producer, today announced that Randy Gress, Chief Executive Officer, will address the 2010 Oppenheimer Industrials Conference in New York City on September 30, 2010 at 8:00 a.m. (Eastern Time).
Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced today that Adrian Adams, President and CEO, will present at the UBS Global Life Sciences Conference on Tuesday, September 21, 2010 at 9:00 am ET and at the JMP Securities Healthcare Conference on Monday, September 27, 2010 at 12:00 pm ET in New York City.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced it will host a conference call and webcast today at 6:00 p.m. Eastern Time to discuss the positive top-line results of its Phase 3 clinical trial of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C).
Isis Pharmaceuticals, Inc. (Nasdaq:ISIS), the leader in antisense therapeutics, today announced that management will present a company overview at UBS' Global Life Sciences Conference on Tuesday, September 21, 2010 at 4:00 p.m. ET at the Grand Hyatt New York.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) announced today that Bob Myers, the company's president, will present at the UBS Global Life Sciences Conference in New York on Monday, September 20, 2010 at 1:00 p.m. Eastern Time.
K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has entered into an agreement with U.S. Healthcare I, L.L.C. and U.S. Healthcare II, L.L.C. for a $20 million loan secured by assets of the Company. K-V will utilize the proceeds of the loan for working capital and general operating purposes.
Lannett Company, Inc. (NYSE AMEX: LCI) announced that today it purchased 1,270 shares of its common stock in the open market under the company's stock repurchase program.
Life Technologies Corporation (NASDAQ:LIFE) today announced that it has finalized cell line license agreements with a number of companies to provide rights to Life Technologies' proprietary CHO (Chinese hamster ovary) cell lines for the production of recombinant proteins used as therapeutic agents and vaccines.
Medivation, Inc. (Nasdaq:MDVN) today announced that David Hung, M.D., president and chief executive officer, will present at the UBS Global Life Sciences Conference on Tuesday, September 21, at 8:30 a.m. Eastern Time at the Grand Hyatt in New York.
Mediware Information Systems, Inc. (NASDAQ: MEDW) announced it is expanding the integration between Mediware's HCLL®blood transfusion management software and Epic Systems' Electronic Medical Record (EMR) software for acute care hospitals.
Medizone International, Inc. (OTCBB:MZEI) announced today it has filed a U.S. Provisional patent application covering the use of AsepticSure™ in food processing plants and related facilities for the sterilization of food-borne pathogens such as Listeria, Salmonella and other human harmful, food poisoning-causing bacteria.
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) and Pain, announced today that it has changed the paymentterms to its Cobroxin distribution agreement with XenaCare Holdings.
NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders, today announced financial results for the quarter ended June 30, 2010.
NuVasive, Inc. (NASDAQ:NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, updated guidance for 2010 today in conjunction with a meeting that it will host for analysts and investors this morning beginning at 10 a.m. ET.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) announced that new data from its North American and European fidaxomicin Phase 3 clinical trials in patients with Clostridium difficile infection (CDI) was presented at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.
PharmaGap Inc. (TSX VENTURE:AP)(OTCBB:PHRGF) announced today that it has completed the second tranche of an offering of equity units.
Proteonomix, Inc. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon human cells and their derivatives, announced further developments with its Joint Venture Company, XGEN Medical LLC ("XGen") towards implementing operations in the United Arab Emirates (U.A.E.).
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has completed enrollment in the first of two dose cohorts in its Phase 1 clinical trial of PV-10 for liver cancer, and that the therapy was very well tolerated by all three subjects treated, with substantial evidence of efficacy.
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) today announced that the abstract entitled Treatment of Acute Stroke With Thymosin β4 has been honored with a score in the top 10 percent of all abstracts presented at the American Heart Association’s specialty conferences during the year, and therefore has been selected for re-presentation as a poster at the AHA’s Scientific Sessions on November 15.
Safeway Inc. (NYSE:SWY) announced today that all Safeway pharmacies in the United States can now administer a new high-dose flu vaccine called Fluzone High-Dose which has been approved by the FDA for use in people 65 years of age and older.
Simulated Environment Concepts (PINKSHEETS: SMEV), makers of the high pressurized dry water massage and relaxation station SpaCapsule, announced that its long anticipated plans of making an investment into the production process, both reducing the cost of manufacturing considerably and dramatically strengthening the company's cash flow and profitability, may likely come to fruition within the next few weeks.
Skystar Bio-Pharmaceutical Company (NASDAQ:SKBI) a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, announces that Mr. Weibing Lu, Skystar chairman and chief executive officer, and R. Scott Cramer, Director and U.S. Representative, will preside over the NASDAQ stock market closing bell ceremony today at the NASDAQ MarketSite in Times Square, New York.
SpectraScience, Inc. (OTCBB: SCIE), a San Diego based medical device company, today announced that an independent study performed at the San Diego Veterans Administration Hospital on 383 patients markedly reduced the cost of care when using the Company's WavSTAT Optical Biopsy System in screening for colorectal cancer.
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers, today announced that Daniel Swisher, Chief Executive Officer of Sunesis, will be presenting at the UBS Global Life Sciences Conference on Tuesday, September 21, 2010 at 1:30 P.M. Eastern Time at the Grand Hyatt New York.
Tengion, Inc. (Nasdaq:TNGN), a leader in regenerative medicine, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion, will present at the upcoming UBS Global Life Sciences Conference on Monday, September 20, 2010, at 8:30am EDT.
TrinityCare Senior Living (OTCBB:TCSR) today announced that it has completed the transaction anticipated in a definitive agreement for a business combination via the acquisition of 100% of the outstanding capital stock of SeaBridge Freight, Inc., a Tampa Bay area based company which is the pioneer in creating the U.S. Marine Highway Industry, providing the most environmentally friendly, safe, cost efficient container-on-barge, blue water, intermodal freight service through geographical advantaged routes.
Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced a strategic realignment and the creation of two new highly focused Strategic Business Units - "Unigene Biotechnologies" and" Unigene Therapeutics".
Vicor Technologies, Inc. (OTCBB:VCRT), today announced that the Company has named Christopher Vissman National Sales Manager, a new position.
Waters Corporation (NYSE:WAT) today introduced the new Ostro Sample Preparation Plate, representing a novel approach for the removal of phospholipids from biological samples.
Weikang Bio-Technology Group Co., Inc. (OTC Bulletin Board:WKBT) a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced 2010 and 2011 fiscal year guidance.
Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced that Mark Corrigan, President and CEO is scheduled to preside over the NASDAQ closing bell ceremony on Friday, September 17, 2010 at 4:00 p.m. to celebrate the Company's recent name and ticker symbol change.
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