|AMAG Announces Preliminary Results from its Phase III Study; Solta Provides Update on Liposonix Launch|
|By Staff and Wire Reports|
|Wednesday, 07 March 2012 20:14|
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported preliminary results from the first of two Phase III studies that comprise its global registrational program for Feraheme® (ferumoxytol) in patients with iron-deficiency anemia (IDA) regardless of the underlying cause. The study being reported today compared treatment with Feraheme to treatment with intravenous (IV) iron sucrose, and enrolled 605 patients at 74 sites in Europe, Asia Pacific and Australia. The patients enrolled in the study had a history of unsatisfactory oral iron therapy, and had IDA associated with various conditions including abnormal uterine bleeding, cancer, gastrointestinal disorders or other causes.
The study was an open-label, active-controlled trial that randomized patients 2:1 to receive a one gram IV course of either Feraheme (n=406) or iron sucrose (n=199), and it was powered to demonstrate non-inferiority on efficacy. The demographics and all baseline parameters were well balanced between the two treatment groups. The primary efficacy endpoint of the study was the mean change in hemoglobin from baseline to week five or the proportion of subjects who achieved a ≥ 2.0 g/dL increase in hemoglobin at any time from baseline to week five, depending on the regulatory authority.
In this study, Feraheme achieved the predefined criteria for non-inferiority on both primary efficacy endpoints. Patients treated with Feraheme achieved a mean increase in hemoglobin at week five of 2.7 g/dL, compared to a mean increase of 2.4 g/dL in patients treated with IV iron sucrose. A ≥ 2.0 g/dL increase in hemoglobin at any time from baseline to week five was achieved in 84% of patients treated with Feraheme, compared with 81% of patients treated with IV iron sucrose.
No new safety signals were observed with Feraheme and the types of reported adverse events were consistent with those seen in previous studies and those contained in the U.S. package insert for Feraheme. Overall adverse events (AEs) were comparable between the treatment arms, with AEs reported in 41.4% of Feraheme-treated patients, compared to 44.2% of patients treated with IV iron sucrose.
Patients in both treatment groups experienced protocol-defined adverse events of special interest, which included moderate to severe hypotension or hypersensitivity reactions, ranging from fever alone to an anaphylactoid reaction. Cardiovascular AEs were comparable between the two treatment groups. Serious adverse events (SAEs) were reported in 4.2% of Feraheme-treated patients, compared to 2.5% of patients treated with IV iron sucrose; the SAEs reported in two Feraheme treated patients (0.5%) were reported as related by the investigators.
“We are pleased that Feraheme met the primary efficacy endpoint in each of the planned analyses of this study, and that no new safety signals were identified with Feraheme. Importantly, Feraheme treatment resulted in robust, clinically relevant increases in hemoglobin in this broad patient population with a high unmet medical need,” said Lee F. Allen, MD, Ph.D., chief medical officer of AMAG. “The global registrational program for Feraheme consists of two phase III studies, the second of which will read out in the coming months. We are currently starting to prepare for the submission of a supplemental new drug application to the U.S. Food and Drug Administration seeking approval for Feraheme to treat this broader population of patients with iron deficiency anemia and a history of unsatisfactory oral iron therapy.”
The other study in the registrational program, being conducted in the US, Canada, Europe and India, is evaluating Feraheme compared to placebo in 800 patients. This study is now fully enrolled with results expected in mid-2012. AMAG plans to submit an sNDA for the broader U.S. iron deficiency anemia label for Feraheme to the U.S. Food and Drug Administration in the second half of 2012.
Solta Medical, Inc. (NASDAQ: SLTM), a global leader in the medical aesthetics market, today provided an update on the launch of the second generation Liposonix non-invasive fat reduction system recently approved by the FDA.
A majority of the Company's approximately twenty key opinion leaders (KOLs), comprised of leading plastic surgeons and dermatologists, who received Liposonix systems in mid-December as part of the pre-launch trial, have successfully evaluated and purchased the product. The company expects that virtually all the remaining KOL's evaluating the system will purchase the device this month. Liposonix was officially introduced in early January of 2012.
"For the full year 2012, we provided guidance that we would generate approximately $17 million in Liposonix revenue," said Stephen J. Fanning, Chairman, President and CEO of Solta Medical. "Through the first two months of the year, we are on track to meet or exceed this guidance. Systems have been sold, on average, at list price."
The Liposonix system uses non-invasive, high-intensity focused ultrasound (or HIFU) to permanently get rid of targeted fat around the waistline, love handles and abdomen, without surgery. The average waistline reduction after just one, 1-hour treatment is about one inch – which typically means one dress or pant size. Results are usually seen in 8 to 12 weeks (which is the time needed for the body to naturally remove the treated fat).
Since its introduction, Liposonix has been featured in many high profile media outlets, including national broadcast programs such as Dr. Oz, The Doctors, and 20/20 with Barbara Walters. Thus far the Liposonix treatment has received very positive reviews from patients as reflected in on-line aesthetic procedure forums.
"The Gen 2 system is proving to provide several distinct advantages compared with the first generation, including a larger treatment tip, which enables clinicians to deliver comparable energy over multiple passes while maintaining a treatment time of about an hour," continued Mr. Fanning. "This has improved the treatment experience for both patients and physicians."
"In addition, most physicians using Liposonix do not find it necessary to medicate patients for the treatment, and those that do, are using non-narcotic medication, resulting in little to no post-treatment downtime. The acceptance and feedback from physicians about our Gen 2 system has been extremely positive and Liposonix is delivering on its promise of one treatment, one hour, one inch or pant size smaller," Mr. Fanning concluded.
Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in RNA therapeutics and obesity, announced today that it has released a white paper describing the health problem posed by the hepatitis B virus (HBV), the substantial unmet need for chronic HBV infected patients, and how Arrowhead’s Dynamic Polyconjugate (DPC) enabled RNAi therapeutic in development could potentially address deficiencies of current treatment options.
BioLineRx (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that a European patent has been granted claiming BL-1020's composition and its use for the treatment of schizophrenia.
BioLineRx Ltd. (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, today announced that its Chief Executive Officer, Kinneret Savitsky, and its Vice President of Business Development, David Malek, will be presenting at the 2012 Annual Roth Growth Conference in Orange County, California.
Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, communicates to its shareholder base.
Catalyst Health Solutions, Inc. (NASDAQ: CHSI) announced today that David T. Blair, Chairman and Chief Executive Officer, is scheduled to present at the Barclays Capital Global Healthcare Conference on Wednesday, March 14, 2012, at approximately 10:45 a.m. ET in Miami, Florida.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the fourth quarter and the year ended December 31, 2011.
CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, announced that it is sponsoring a research forum on the role of cytokine reduction in the treatment of sepsis at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels, Belgium on Wednesday, March 21, 2012.
GE Healthcare, a unit of GE (NYSE:GE) announced today it has reached an agreement to acquire Xcellerex, Inc. a supplier of innovative manufacturing technologies for the fast-growing biopharmaceutical industry.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced full Phase 3 clinical trial results from pivotal Study 102 demonstrating that the Quad, a once-daily single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection, is non-inferior to Atripla® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) after 48 weeks of therapy in treatment-naïve adults.
Illumina (NASDAQ:ILMN) today introduced the TruSeq Amplicon - Cancer Panel, a highly multiplexed panel that will allow researchers to accurately sequence hundreds of the most relevant cancer loci, even in difficult samples such as formalin-fixed, paraffin embedded (FFPE) tumor samples.
International Stem Cell Corporation (OTCBB:ISCO) today announced that Co-Chairman Kenneth Aldrich and President and Chief Operating Officer Kurt May will be presenting at the 24th Annual Roth Conference on Wednesday, March 14, 2012 at 1:00 p.m. Pacific time.
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that CEO Frank Reynolds is scheduled to appear on KTVI-TV’s Fox 2 News in the Morning at 7:40 am CDT on Monday, March 12th in St. Louis, MO.
Medtronic, Inc. (NYSE: MDT), the world’s leading medical technology company, today announced it will participate in the Barclays Capital Global Healthcare Conference on Wednesday, March 14, 2012, in Miami, FL.
MELA Sciences, Inc. (NASDAQ: MELA), the medical device company that has developed MelaFind®, today announced that the company has commenced commercialization of MelaFind as part of a controlled and deliberate launch in the U.S. and in Germany.
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced that David Stack, president and chief executive officer of Pacira Pharmaceuticals, is scheduled to present at the Barclays Capital Global Healthcare Conference on Wednesday, March 14, 2012, at 4:45 p.m. ET at the Loews Hotel in Miami Beach.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today provided a business update and certain preliminary, unaudited financial results in the fourth quarter and full year 2011 at the Cowen and Company 32nd Annual Health Care Conference.
TheDirectory.com, Inc. (PINKSHEETS: SEEK) today announced its preliminary top-line sales results for its fiscal first quarter ending February 29th.
Transgenomic, Inc. (OTCBB: TBIO) today reported financial results for the year ended December 31, 2011 and provided a business update.
Viral Genetics (Pinksheets: VRAL) announced today that it has submitted a pre-IND briefing document to the US Food and Drug Administration (FDA) for its Lyme Disease drug candidate, VGV-L, marking important milestones for both the Company and its supporters in the Lyme community.