|Spectrum Files IND Application with FDA for SPI-014; Abbott dismisses talk of pharma unit sale|
|By Mary Davila|
|Monday, 05 December 2011 20:05|
Spectrum Pharmaceuticals (NASDAQ:SPPI) announced it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration for SPI-014 (previously referred to as RENAZORB®), a second-generation lanthanum-based nanoparticle phosphate binding agent, that has the potential to treat hyperphosphatemia in patients with Stage 5 chronic kidney disease, or end-stage renal disease (ESRD). Spectrum Pharmaceuticals has the worldwide rights and intellectual property to develop SPI-014 for all human and non-human therapeutic uses.
Hyperphosphatemia (high phosphate levels in blood) negatively affects patients with chronic kidney disease, especially end-stage kidney disease patients on dialysis. It can lead to significant bone disease (including pain and fractures) and cardiovascular disease, and is independently associated with increased mortality. According to the United States Renal Data System, there were more than 571 thousand patients with ESRD in the United States in 2009.
Currently marketed therapies for treating hyperphosphatemia include polymer-based and lanthanum-based phosphate binders, aluminum-based phosphate binders, and calcium-based phosphate binders. Under the National Kidney Foundation K/DOQI guidelines, both calcium-based phosphate binders and non-calcium, non-aluminum, non-magnesium phosphate binders are recommended as first line or long-term therapy for the management of hyperphosphatemia. However, current therapies require the ingestion of a large number of pills, or large size pills that need to be chewed or swallowed along with each meal, leading to problems with patient compliance with the treatment regimen.
After several years of preclinical research and a thoughtful analysis of the market opportunity, we have decided to advance SPI-014 into clinical studies, said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. Because of its potentially higher capacity for binding phosphate on an equal weight basis, SPI-014 is a drug candidate with the potential to reduce the pill dosage burden and enable more effective management for ESRD patients. We will continue to opportunistically advance therapies that have the potential to meaningfully impact patients' lives. We expect to commence Phase I studies as soon as possible after FDA review.
Abbott Laboratories (NYSE:ABT) has no intention of selling its soon-to-be-separated pharmaceuticals business to another drugmaker and any potential bidder would struggle to persuade management otherwise, its chief executive said on Monday.
Miles White told an industry conference in London speculation that Abbott's drugs unit might be touted for sale was "incorrect".
Abbott announced plans in October to split itself in two, in a move designed to increase Wall Street's focus on the remaining diversified medical product business, which has tended to be overshadowed by pharmaceuticals.
The move prompted immediate talk the drugs arm could prove an attractive acquisition target. Analysts at Jefferies, for example, suggested it might be snapped up by the likes of Merck , Roche, AstraZeneca or Bayer in a couple of years.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will host a breakfast meeting with research analysts and institutional investors on Monday, December 12, 2011 at 7:00 a.m. (PST) to discuss the interim data from the pivotal PACE trial of ponatinib, its investigational pan BCR-ABL inhibitor.
Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) announced today an update on the status and progress of its European marketing authorization application ("MAA") for Pixuvri.
Codexis, Inc. (Nasdaq: CDXS) today announced Wesley J. Bolsen has been named Vice President and Chief Marketing Officer.
diaDexus, Inc. (OTC Bulletin Board: DDXS), a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today said that it plans to present at the Canaccord Genuity 6th Annual Cardiovascular, Aesthetics & Metabolic Disorders Conference on Tuesday, December 6, 2010 at 11:00 am Pacific Time (2:00 pm Eastern Time) at the St. Regis Hotel in San Francisco, CA.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that four abstracts on TRU-016 have been accepted for presentation at the 53rd Annual Meeting of the American Society of Hematology (ASH) on December 10-13, 2011 in San Diego, California.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that a Phase 3 clinical trial (Study 114) of its pharmacoenhancing or “boosting” agent cobicistat, which increases blood levels of certain HIV medicines to allow for one pill once-daily dosing, met its 48-week primary objective of non-inferiority to ritonavir.
Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that DUEXIS®(ibuprofen/famotidine), a proprietary single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg), is now available to U.S. physicians for the relief of signs and symptoms of rheumatoid arthritis (RA) and osteoarthritis (OA) and to decrease the risk of developing upper gastrointestinal (GI) ulcers, which in Phase 3 clinical trials were defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications.
INSYS Therapeutics (PINKSHEETS: NEOL) announces the addition of Matthew Napoletano as Vice President of Marketing to their commercial product team.
IsoRay, Inc. (AMEX: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for brain cancer, lung cancer, head and neck cancer and prostate cancer today announced that their December 1st RetailInvestorConferences.com presentation is now available for on-demand viewing.
Metiscan, Inc. (PINKSHEETS: MTIZ) announced today that Metiscan's President, CEO and Acting CFO has released a letter to shareholders discussing Metiscan's name change, reverse split, status and the Company's goals and expectations for 2011.
Micromet, Inc. (NASDAQ: MITI) today announced the appointment of Joseph Lobacki as Senior Vice President and Chief Commercial Officer.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), in a conference call with shareholders last week, discussed its strategy to identify transactions with large privately held companies in healthcare, health IT and revenue cycle management that have expressed interest in becoming publicly traded.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a collaborative agreement with ChanTest Corporation, a leading ion channel screening provider, to perform cardiac safety testing of potential drug compounds using Roche's xCELLigence System RTCA Cardio Instrument and iCell® Cardiomyocytes, human induced pluripotent stem (iPS) cell-derived cardiomyocytes provided by Cellular Dynamics International (CDI).
Senesco Technologies, Inc. (NYSE AMEX: SNT) announced that their December 1st RetailInvestorConferences.com presentation is now available for on-demand viewing.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration for SPI-014 (previously referred to as RENAZORB®), a second-generation lanthanum-based nanoparticle phosphate binding agent, that has the potential to treat hyperphosphatemia in patients with Stage 5 chronic kidney disease, or end-stage renal disease (ESRD).
ViroPharma Incorporated (Nasdaq: VPHM) today announced that Robert Doody, assistant director of investor relations of ViroPharma, will present at the 2011 Deutsche Bank BioFEST Conference at 8:35 A.M. ET on Tuesday, December 6, 2011.
XenoPort, Inc. (Nasdaq:XNPT) announced today preliminary top-line results of a Phase 2, randomized, crossover clinical trial that compared optimized treatment with either Sinemet (immediate-release levodopa/carbidopa) or XP21279 co-formulated with carbidopa (279/CD) in advanced Parkinson’s disease patients with motor fluctuations.
Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced the initiation of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160 (formerly NMED-160), a novel oral N-type calcium channel blocker.