|Durata Says Phase 3 Trial of Dalbavancin Met Primary Endpoints; Amicus Announces Positive Results From All Four Cohorts in Phase 2 Chaperone-(ERT)|
|By Staff and Wire Reports|
|Friday, 04 January 2013 19:52|
Durata Therapeutics, Inc. (Nasdaq: DRTX) announced additional preliminary, top-line results for its DISCOVER 1 ("Dalbavancin for Infections of the Skin Compared to Vancomycin at an Early Response") Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus). As reported on December 11, 2012, preliminary top-line data show that dalbavancin achieved its primary endpoint of non-inferiority at 48-72 hours after initiation of therapy, as determined by the cessation of spread of the lesion, as well as the resolution of fever. The subpopulation of patients with MRSA at baseline achieved similar results. The secondary endpoint of clinical success at the end of treatment, the expected primary endpoint for regulatory review in Europe, was also met. Statistical analyses of the results from this secondary endpoint are included below in the updated table of top-line data.
Researchers were comparing two intravenous (IV) doses of dalbavancin given one week apart with twice-daily vancomycin doses for 14 days. Patients randomized to the vancomycin regimen had an option to switch to oral linezolid after three days of vancomycin treatment. The DISCOVER 1 protocol was conducted pursuant to a special protocol agreement (SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA's Draft Guidance for Developing Drugs for Treatment of ABSSSI. The protocol for the trial was also designed based on scientific advice provided by the European Medicines Agency (EMA). DISCOVER 1 was a randomized, double-blind, double-dummy trial conducted in 573 patients at 92 sites in the United States, Canada, and Europe comparing dalbavancin to a regimen of vancomycin and an option for oral linezolid for the treatment of ABSSSI.
Amicus Therapeutics (NASDAQ:FOLD) announced positive preliminary results from all 4 dose cohorts in a Phase 2 study (Study 010) to evaluate the safety and pharmacokinetic (PK) effects of the pharmacological chaperone AT2220 (duvoglustat HCl) co-administered with enzyme replacement therapy (ERT) for Pompe disease (Myozyme® and Lumizyme®). Myozyme and Lumizyme (alglucosidase alfa, or recombinant human GAA enzyme, rhGAA) are the first and only approved treatments for Pompe disease. Based on the Study 010 results, Amicus expects to initiate a repeat-dose clinical study in the third quarter of 2013.
For people with Pompe disease, deficient GAA enzyme leads to the accumulation of glycogen in tissues affected by disease (primarily muscle). Preclinical data 1 demonstrated that AT2220 in combination with ERT enhances rhGAA enzyme activity, reduces glycogen accumulation, and potentially mitigates ERT-related immunogenicity in a mouse model of Pompe disease. In Study 010, co-administration of AT2220 to Pompe patients increased rhGAA enzyme activity and enhanced rhGAA enzyme uptake into muscle tissue compared to ERT alone.
John F. Crowley, Chairman and Chief Executive Officer stated, "Study 010 has established human proof-of-concept that AT2220-ERT co-administration increases GAA enzyme activity in muscle. We look forward to initiating our repeat-dose clinical study to investigate the effect of AT2220-ERT co-administration on ERT stability and activity, ERT-related immunogenicity, and other clinical measures. We believe that co-administration may deliver significant benefits compared to ERT alone and become an important therapy for people with Pompe disease."
Additional details surrounding the development strategy for AT2220 in combination with ERT for Pompe disease will be provided during a live presentation and webcast at the 31st Annual JPMorgan Healthcare Conference on January 9, 2013 at 3:00 p.m. PT.
Actinium Pharmaceuticals, Inc. (OTCBB: CTVN) today announced that Jack Talley, the company's President and Chief Executive Officer, will be presenting at the Biotech Showcase in San Francisco on Monday, January 7, 2013 at 11:45 AM Pacific Time.
Biogen Idec (NASDAQ: BIIB) announced the company recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B.
BioMed Realty Trust, Inc. (NYSE: BMR) today announced the appointment of Daniel M. Bradbury to its board of directors, increasing the board to eight members.
Bristol-Myers Squibb Company (NYSE:BMY) will announce results for the fourth quarter and full year of 2012 on Thursday, January 24, 2013.
Cardium Therapeutics (NYSE MKT: CXM) today announced that Christopher J. Reinhard, the Company's Chairman & CEO, will present at the Biotech Showcase 2013 Conference, being held at the Parc 55 Wyndham San Francisco Union Square Hotel, on Monday, January 7, 2013 at 2:15 p.m. (Pacific).
China Jo-Jo Drugstores, Inc. (NASDAQ:CJJD) (the “Company”), a retail and wholesale distributor of pharmaceutical and other healthcare products in Zhejiang and Shanghai, today announced the appointment of Mr. Taihong Guo to, and the resignations of Ms. Shuizhen Wu and Messrs.
CollabRx, Inc. (NASDAQ: CLRX), a data analytics company focused on genomics, today announced that Chairman and CEO Thomas R. Mika is scheduled to present at Biotech Showcase™ 2013 on Wednesday, January 9, 2013, at 2:45 p.m. Pacific Standard Time.
Cytori Therapeutics, Inc. (NASDAQ: CYTX) will webcast their corporate presentation at the Biotech Showcase™ at 11:30 AM PT (2:30 PM ET) on Tuesday, January 8.
Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced changes to its board of directors and appointed a new Chief Executive Officer (CEO).
Haemonetics Corporation (NYSE: HAE) today announced significant progress on key business initiatives in conjunction with the 31st Annual J.P. Morgan Health Care Conference in San Francisco.
IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it filed two abbreviated new drug applications, or ANDAs, on December 28 and December 31, 2012 in accordance with one of its customer development agreements.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it is commencing shipment of Oxymorphone Hydrochloride Extended-Release Tablets, through Global Pharmaceuticals, Impax’s generics division.
InspireMD, Inc. (OTC: NSPRD) ("InspireMD" or the "Company") appointed Alan W. Milinazzo President, Chief Executive Officer, and a member of the board, effective January 3, 2013.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced the completion of a debt offering of $175 million. Ironwood intends to use the net proceeds from this transaction to fund its research and development efforts and to support the commercial launch of LINZESS™ (linaclotide), in addition to general corporate purposes.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced that David P. King, Chairman and Chief Executive Officer, is scheduled to speak at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco, CA.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Kenneth C. Frazier, Merck's chairman and chief executive officer, is scheduled to present at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco on January 7 at 4:00 p.m. PST (7:00 p.m. EST).
Nektar Therapeutics' (Nasdaq: NKTR) President and Chief Executive Officer, Howard W. Robin, is scheduled to present at the upcoming 31st Annual J.P. Morgan Healthcare Conference in San Francisco at the Westin St. Francis Hotel on Wednesday, January 9, 2013 at 8:30 a.m. Pacific time.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, announced today that it expects revenues in the fourth quarter 2012 in the range of $53 to $54 million.
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that Kenneth A. Berlin, President and CEO, is scheduled to present a corporate overview at Sidoti & Company's 2013 Micro-Cap Conference on Monday, January 7, 2013 at The Grand Hyatt Hotel in New York City.
Senesco Technologies, Inc. (OTCQB: SNTI) announced today that it has entered into a securities purchase agreement to raise approximately $3.0 million in gross proceeds through the sale of 30,000,000 shares of its common stock.
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for OrbeShieldTM (oral beclomethasone 17,21-dipropionate or oral BDP) for the mitigation of morbidity and mortality associated with the gastrointestinal acute radiation syndrome (GI-ARS).
Walgreens (NYSE: WAG) (Nasdaq: WAG) had December sales of $6.71 billion, a decrease of 4.0 percent from $6.99 billion for the same month in fiscal 2012.