Latest EPG Online News

Postive results from Phase III analysis of Amitiza (Sucampo) for IBS-C

Sun, 20 May 2012 23:00:00 GMT

A post-hoc analyses of two pivotal Phase III studies of Amitiza (lubiprostone), from Sucampo, for the treatment of Irritable Bowel Syndrome with constipation (IBS-C) demonstrates that the drug provides a statistically significantly higher proportion of patients with consistent relief from IBS-C symptoms compared to placebo treatment. Patients with documented IBS-C, as defined per Rome II criteria, were randomized in a 2:1 ratio to receive Amitiza 8-mcg, or placebo, twice daily (BID), for a 12-week treatment period in either of two pivotal Phase III controlled studies. Results show that patients taking Amitiza showed greater than 30% improvement from baseline in abdominal pain ratings and normalization of bowel frequency for 9 of the 12 treatment weeks. Amitiza was well-tolerated in this group of patients as well, with the most common adverse events (greater than 4%) being nausea (9.8% vs. 5.7%), diarrhea (6.7% vs. 4.3%) and upper respiratory infection (4.9% vs. 2.9%) for lubiprostone vs. placebo, respectively. The drug was approved for the treatment of IBS-C in women 18 yrs of age and older by the FDA in 2008. Results were presented at Digestive Disease Week 2012 in San Diego.

GSK to co pomote Testim (Auxilium Pharma) in USA

Sun, 20 May 2012 23:00:00 GMT

Auxilium Pharmaceuticals, and Glaxo Smith Kline have entered into an agreement to co-promote Testim (testosterone gel) testosterone replacement therapy product used in adult males. Under the terms of the agreement, Auxilium has granted GSK the exclusive right to co-promote Testim in the United States through Sept.30, 2015. GSK will promote Testim using a sizeable established field sales force which has relationships with current Testosterone Replacement Therapy prescribers, particularly primary care physicians, in the U.S.A.

Lancet study shows raising HDL may not affect Heart Disease risk

Sat, 19 May 2012 23:00:00 GMT

A new study published in The Lancet has found that raising HDL levels may not make a difference to heart disease risk. People with genes that result in higher HDL levels have no less heart disease (myocardial infarction) than those who inherit genes that give slightly lower levels. If HDL were protective those with genes causing higher levels should have less heart disease. Higher HDL levels are associated with lower heart disease risk but the relationship may not be causative. see The Lancet, Early Online Publication, 17 May 2012 -doi:10.1016/S0140-6736(12) 60312-2 Cite or Link Using DOI "Plasma HDL cholesterol and risk of myocardial infarction: a mendelian randomisation study"-Benjamin F Voight PhD et al. The findings have implications for new drugs, anacetrapib from Merck Inc. and evacetrapid from Eli Lilly as well as currently marketed Niaspan (niacin) from Abbott Labs.

Votrient (Glaxo Smith Kline) prolongs progression-free survival in advanced Soft Tissue Sarcoma

Fri, 18 May 2012 23:00:00 GMT

For patients with metastatic Soft Tissue Sarcoma (STS) whose disease has progressed following standard chemotherapy, treatment with Votrient (pazopanib), from Glaxo Smith Kline, nearly tripled progression-free survival compared with placebo, according to results of the PALETTE trial. This is the first time a randomised Phase III trial in metastatic STS has shown improvement in PFS. Of 369 patients enrolled, they were randomly assigned to oral Votrient (246 patients) or placebo (123). Results showed that the time it took for a patient's disease to progress was improved by 3 months for those receiving Votrient (4.6 months) compared with those given placebo (1.6 months) at a median follow-up of 15 months. However, there was no significant gain in overall survival (12.5 months vs 10.7 months) in patients receiving Votrient. Common side effects of Votrient included fatigue, diarrhoea, hypertension, nausea, and weight loss. Newly reported side effects were venous thromboembolic events, pneumothorax, and cardiotoxicity, according to lead researcher Professor Winette van der Graaf, Radboud University Nijmegen Medical Centre, Netherlands.

Health Canada approves Prochymal (Osiris Therapeutics) for Graft-v-Host Disease in children

Fri, 18 May 2012 23:00:00 GMT

Canadian health regulators have approved Prochymal, from Osiris Therapeutics, for acute Graft-v-Host Disease in children who are not responding to steroid therapy, making it the first stem cell drug to be approved for a systemic disease anywhere in the world. Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.

Positive two-year results in study of Promus Element Cardiac Stent (Boston Scientific)

Fri, 18 May 2012 23:00:00 GMT

Two-year results from the PLATINUM Small Vessel study demonstrate that the 2.25 mm Promus Element (Everolimus-Eluting) Platinum Chromium Cardiac Stent System, from Boston Scientific, shows positive safety and effectiveness outcomes in treating de novo coronary lesions in small coronary vessels. The PLATINUM study met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4 percent for the Promus Element Stent compared to a pre-specified goal of 21.1 percent based on outcomes for the 2.25 mm Taxus Express Paclitaxel-Eluting Stent. The TLF rate at two years is 4.7 percent with the Promus Element while the rate of target lesion revascularization (TLR) was 2.5 percent. According to lead investigator Ian Meredith, Director of MonashHeart at Monash Medical Centre in Melbourne, Australia, rates of other major adverse events remained low at two years, including cardiac death (2.3 percent) and myocardial infarction (0.0 percent). Data was presented today at the annual EuroPCR Scientific Program. The Promus Element stent received a CE Mark in October 2009 and the company plans to file in the US in 2012.

FDA approves generic Plavix

Thu, 17 May 2012 23:00:00 GMT

The FDA has approved on 17 My 2012 generic versions of Plavix (clopidogrel) for Dr Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals for 300 milligram (mg) clopidogrel. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.

FDA approves Epic Nitinol Stent (Boston Scientific) for Iliac Artery Disease

Thu, 17 May 2012 23:00:00 GMT

oston Scientific announced FDA approval and market launch of the Epic Vascular Self-Expanding Stent System. The Epic Stent is designed to open blocked arteries in patients with iliac artery stenosis, a form of peripheral vascular disease associated with severe leg pain caused by insufficient blood flow. The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. It employs an innovative Tandem Architecture, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics and fracture resistance. The Epic Vascular Self-Expanding Stent System received CE Mark approval and was launched in Europe and other international markets in 2009.

Positive data from Phase III study of Dificid/Dificlir (Optimer Pharma) for patients with CDAD

Thu, 17 May 2012 23:00:00 GMT

The results of a retrospective subpopulation analysis of 183 patients with cancer from two large Phase III trials of Dificid/Dificlir (fidaxomicin), from Optimer Pharma, which showed the cancer patients with Clostridium difficile-associated diarrhea (CDAD) who were treated with Dificid/Dificlir tablets experienced resolution of their diarrheal symptoms approximately two days faster than those treated with oral vancomycin. Results showed that overall, cancer patients with CDAD had slower time to resolution of diarrhea (TTROD) than non-cancer patients (100 hours vs. 55 hours). However, when treatment outcomes were compared between cancer patients receiving Dificid/Dificlir or oral vancomcyin, patients treated with Dificid/Dificlir experienced resolution of diarrhea two days faster than those treated with vancomycin (74 hours vs. 123 hours). The overall safety profile was similar between the Dificid/Dificlir and vancomycin treatment groups. Results will be presented at the 2012 American Society of Clinical Oncology Meeting. Previous results showed that Dificid/Dificlir was five times more likely than vancomycin to produce a clinical response and three times more likely to lead to a sustained response, while patients treated with vancomycin had a 2.6 fold greater risk of experiencing recurrence.

Seebri Breezhaler(Novartis) success in GLOW 2 study for COPD

Thu, 17 May 2012 23:00:00 GMT

Novartis and Vectura reported one-year data from the pivotal, Phase III GLOW 2 study, confirming that the inhaled long acting muscarinic receptor antagonist, NVA237 (glycopyrronium bromide), is superior to placebo and has similar efficacy to open-label tiotropium in the treatment of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Revlimid (Celgene) prolongs disease control for Multiple Myeloma patients

Thu, 17 May 2012 23:00:00 GMT

Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with Revlimid (lenalidomide), from Celgene, following a stem cell transplant. A Phase III study, co-authored by Richard Maziarz, M.D., of the OHSU Knight Cancer Institute, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy. It was conducted at 47 medical centers and involved 568 patients and the data were supported by similar Phase III studies reported from France and Italy reported in the same issue of the New England Journal of Medicine. See: "Lenalidomide after Stem-Cell Transplantation for Multiple Myeloma." Philip L. McCarthy et al. N Engl J Med 2012; 366:1770-1781May 10, 2012

Nucynta (J&J Janssen) provides pain management for Patients with Diabetic Peripheral Neuropathy

Thu, 17 May 2012 23:00:00 GMT

A Phase III study suggests Nucynta ER (tapentadol) tablets, from J&J Janssen, were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful Diabetic Peripheral Neuropathy (DPN). This trial had three phases: an open-label phase, in which the individually optimized tapentadol ER dose (100-250 mg two times per day) was determined for each patient; a 12-week, double-blind maintenance phase, during which patients with a one-point or greater reduction in pain intensity from beginning to end of titration were randomized either to continue taking tapentadol ER (at their optimal dose) or to receive placebo; and a follow-up period. Among patients who had at least a one-point reduction in pain intensity during three weeks of treatment with tapentadol ER, the study showed those who continued on an optimized dose (100-250 mg twice daily) for an additional 12 weeks experienced significantly better pain control compared to those who switched to placebo. Treatment-emergent adverse events reported in 10 percent or more of tapentadol ER-treated patients during the double-blind maintenance period included nausea (21.1 percent) and vomiting (12.7 percent). Lead author was Aaron I. Vinik, Director of Research and Neuroendocrine Unit at Strelitz Diabetes Center for Endocrine and Metabolic Disorders at Eastern Virginia Medical School. The findings of this study are consistent with those of another study published last year, which found tapentadol ER to be effective versus placebo.

Omega 3 fatty acids cellular processes are mapped.

Thu, 17 May 2012 23:00:00 GMT

US based scientists have mapped the cellular processes that power the heath effects of Omega 3 fatty acids by studying living mouse cells and finding that the beneficial fatty acids block an enzyme known as cyclooxygenase (COX) which produces the prostaglandin hormones that spark inflammation. This is the first comprehensive study of what fish oils actually do inside a cell. see Proceedings of the National Academy of Sciences; published online ahead of print; doi:1073 /pnas 1200 189109 "Omega 3 fatty acids cause dramatic changes in TLR 4 and purinergic eicosanoid signalling." Paul C. Norris , Edward A. Dennis

Menarini acquires rights to Priligy for Premature Ejaculation treatment

Wed, 16 May 2012 23:00:00 GMT

Janssen Pharmaceutica and ALZA have returned the rights to the premature ejaculation treatment Priligy (dapoxetine) to Furiex Pharmaceuticals. FuriexPharmaceuticals has licensed to Menarini rights to commercialise Priligy in Europe, most of Asia, Africa, Latin America and the Middle East. Furiex will retain development and commercialisation rights in the US, Japan and Canada. Priligy is marketed for on-demand treatment of premature ejaculation in 15 countries in Europe and elsewhere, and is approved for that indication in 43 countries. In January 2012, the CHMP, recommended the approval of Priligy in the remaining 20 EU countries, Norway and Iceland where the drug is not yet approved.

Seebri Breezhaler (Novartis) success in GLOW-3 trial for COPD

Wed, 16 May 2012 23:00:00 GMT

The GLOW 3 study investigated the effects of Seebri Breezhaler (NVA237), (glycopyrronium bromide) 50 mcg once-daily from Novartis on exercise endurance in moderate-to-severe COPD patients. The study met its primary endpoint by showing a significant 21% improvement in exercise endurance versus placebo at the end of the study (i.e. day 21), with a significant 10% increase from day one (both p<0.001)

VEN 307 success Iin Phase III trial for Anal Fissure Pain

Tue, 15 May 2012 23:00:00 GMT

VEN 307(diltiazem crean) from S.L.A.Pharma met the primary endpoint in a pivitol Phase III study, showing a statistically significant reduction in Anal Pain on defecation after four weeks compared to placebo. Both 4% and 2% diltiazem cream arms demonstrated statistically significant improvement over placebo for change in week four NRS for worst anal pain. Reduction in pain score was 0.44 (p=0.0108) and 0.42 (p=0.0134), for 4% and 2% diltiazem, respectively. Ventrus Bioscience holds the US rights to the drug and plans to meet with FDA officials to discuss the next steps toward filing an NDA. A further Phase III trial is planned for the autumn of 2012.

NICE draft guidance now approves Zytiga (J&J Janssen Cilag) for Prostate Cancer

Tue, 15 May 2012 23:00:00 GMT

NICE has issued new draft guidance recommending the use by the NHS of Zytiga (abiraterone acetate), from J&J Janssen Cilag, in patients with Prostate Cancer. After additional information about the drug was submitted to NICE by the company, the treatment will now be made routinely available for patients on the NHS. NICE had previously rejected the drug because it did not offer value for money however this update included a revised patient access scheme which involves providing the drug to the NHS at a discounted price. The draft guidance has been passed on to consultees, who have the opportunity to appeal against it. NHS bodies will make funding decisions locally until NICE issues its final guidance on the drug.

FDA discusses Phase III studies of Arimenda (Adamas Pharmaceuticals) for Alzheimers treatment

Tue, 15 May 2012 23:00:00 GMT

Adamas Pharmaceuticals has held an end-of-Phase II meeting with the FDA to discuss the proposed safety and efficacy studies to be conducted for the registration of Arimenda (memantine HCl extended release and donepezil HCl) capsules, for treatment of Alzheimers Disease. At the meeting, the FDA agreed to Adamas' Phase III clinical safety studies and confirmed that, if successful, those studies should be sufficient to support a future NDA submission. Arimenda capsules are expected to be the first once-daily fixed dose combination product for Alzheimer's disease available for the US market. The drug is designed to simplify the initiation of combination therapy by providing the most convenient means to introduce combination therapy to patients who are already taking donepezil. Adamas is on track to submit its first NDA for Arimenda in 2013.

IMDx GBS (IntelligentMDx) test system for Group B Streptococcus receives CE mark

Tue, 15 May 2012 23:00:00 GMT

The IMDx GBS for Abbott m2000, from IntelligentMDx, an automated, high-throughput, qualitative in vitro diagnostic test designed for the rapid detection of Group B Streptococcus (GBS) for use in screening pregnant women and those in labor who may be infected with the pathogen, has received CE mark approval. The system utilizes real time PCR, operates on the Abbott m2000 system and addresses the needs of hospitals to rapidly screen large numbers of patients for GBS and make quick informed decisions about antibiotic treatment.

Positive data from EVOLVE trial of Synergy Cardiac Stent system (Boston Scientific)

Tue, 15 May 2012 23:00:00 GMT

Data from the EVOLVE trial shows the Synergy everolimus-eluting Coronary Stent system, from Boston Scientific, demonstrated non-inferior results in treating de novo coronary artery lesions at one year compared to the Promus Element everolimus-eluting stent system. The trial reported one-year clinical and six-month intravascular ultrasound (IVUS) outcomes data, evaluating the safety and effectiveness of the Synergy stent. Data demonstrated that both versions of the Synergy Stent (loaded with both full- and half-dose everolimus) are clinically non-inferior to the Promus Element stent. There were no significant differences between groups for all IVUS parameters evaluated at 6 months, including neointimal area, stent or lumen area, net volume obstruction, incomplete stent apposition or minimum lumen diameter. The EVOLVE trial data are expected to support CE Mark approval, which is expected later this year.

Phase III study of Torisel (Pfizer) for Renal Cell Carcinoma does not meet primary endpoint

Tue, 15 May 2012 23:00:00 GMT

The Phase III INTORSECT (B1771003) study, evaluating Torisel (temsirolimus), from Pfizer, in patients with advanced Renal Cell Carcinoma whose disease had progressed after sunitinib malate therapy, did not meet the primary endpoint of prolonging progression free survival when compared to sorafenib. Although survival was numerically higher in patients treated with temsirolimus, the difference was not statistically significant. Overall survival, a secondary endpoint in the study, showed statistical significance favoring patients randomized to the sorafenib arm. In another pivotal Phase III study, Torisel demonstrated median overall survival in previously untreated patients of 10.9 months in patients with advanced RCC with poor prognostic risk, compared with 7.3 months for interferon-alpha (IFN-a). Full efficacy and safety data from this study will be presented at an upcoming major medical congress.

Tivozanib (Astellas) success in TIVO-1 study for Renal Cell Carcinoma

Tue, 15 May 2012 23:00:00 GMT

Tivozanib from Astellas/Aveo Pharma is the first treatment to demonstrate greater than one year median PFS in treatment naive patients with metastatic Renal Cell Carcinoma (pre-specified sub-analysis). Treatment with tivozanib resulted in the longest reported median PFS to date in TIVO-1 study, a pivotal study: 12.7 months compared to a median PFS of 9.1 months for sorafenib.( HR = 0.756, p=0.0371). In patients who were pre-treated with systemic therapy, including cytokines (30% of the study population), tivozanib demonstrated an improvement in median PFS of 11.9 months compared with a median PFS of 9.1 months for sorafenib.The efficacy advantage of tivozanib over sorafenib was consistent across subgroups in the study (HR = 0.797, p=0.042) The objective response rate (ORR) for tivozanib was 33% compared to 23% for sorafenib (p=0.014). Tivozanib was generally well-tolerated, demonstrating a combination of superior efficacy and tolerability along with a lower rate of dose interruptions and reductions. The most common reported side effect for Tivozanib was hypertension, common with VEGFR inhibitors. The most common side effect of sorafenib was hand foot syndrome. The rate of dose interruption due to adverse events was 18% with tivozanib and 35% for sorafenib.

Lu AA 21004 successful Phase III trials in Depression

Mon, 14 May 2012 23:00:00 GMT

Lundbeck announced positive top-line results from three recently completed phase III clinical studies of Lu AA21004, an investigational drug for the treatment of adults with major depressive disorder (MDD) using dosages from 10 to 20mg. The positive results from these three studies showed that Lu AA21004 statistically significantly reduced depression symptoms in patients with MDD compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Further analysis of the data is ongoing and data are expected to be presented at upcoming medical conferences. Lundbeck and its partner Takeda plan to submit a New Drug Application to the FDA during the second half of 2012. Separately, Lundbeck plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and to Health Canada for Lu AA21004 during the second half of this year.

REPRISE 1 trial reports for Lotus Aortic Valve System (Boston Scientific)

Mon, 14 May 2012 23:00:00 GMT

The REPRISE I feasibility trial, evaluated the acute safety of the Lotus Aortic Valve System from Boston Scientific, in patients with severe Aortic Valve Disease. Data presented at the annual EuroPCR Scientific Program in Paris demonstrated successful deployment of the valve in all patients with virtually no paravalvular regurgitation after valve placement or at discharge. REPRISE I is a prospective, single-arm feasibility study that enrolled 11 patients at three sites in Australia. The primary endpoint is defined as successful device implantation without in-hospital major adverse cardiovascular or cerebrovascular events (MACCE) through discharge or seven days post-procedure (whichever comes first). In-hospital MACCE includes death,heart attack, major stroke, and conversion to surgery or repeat procedure due to valve-related dysfunction. All patients had severe symptomatic Aortic Stenosis and were considered at high risk for surgical valve replacement.No in-hospital MACCE were reported in 91 percent (10 of the 11) of patients. One stroke and no deaths were observed. No moderate or severe paravalvular regurgitation was present after valve placement or at discharge.

Positive results in Phase III trial of BST-CarGel (Piramal Healthcare) for Tissue Repair

Sun, 13 May 2012 23:00:00 GMT

A pivotal Phase III clinical trial of BST-CarGel, from Piramal Healthcare, reveals that when used for Tissue Repair, the treatment results in more repair cartilage of higher quality at 12 months than microfracture, the current orthopaedic standard of care, with a similar safety profile. The trial also met both primary endpoints by reaching statistical significance over microfracture in the degree of filling treated lesions and the quality of the new tissue. The trial was conducted to evaluate BST-CarGel efficacy at 12 months in repairing cartilage lesions and improving patient clinical symptoms, compared to a surgical control called microfracture, the current standard of care. BST-CarGel is a novel chitosan-based liquid scaffold (EU class III Med. Dev.) that is first mixed with autologous whole blood and then implanted into a debrided cartilage defect prepared with bone marrow stimulation where it provides biodegradable scaffolding for cartilage regeneration. BST-CarGel is CE mark approved in the EU and Piramal Healthcare plans to launch BST-CarGel for commercial sale in the fourth quarter of the 2012.

Viramune (Boehringer) patent expires on 22 May 2012

Sun, 13 May 2012 23:00:00 GMT

Zhejiang Huahai Pharmaceutical has agreed with Breckenridge Pharmaceutical to market, in the USA, a generic version of Viramune (nevirapine) currently marketed by Boehringer Ingelheim for HIV treatment. The US patent for Viramune expires on 22 May 2012.

FDFA Advisory Committee recommends QUAD (Gilead) for HIV treatment

Sun, 13 May 2012 23:00:00 GMT

The FDA Antiviral Drugs Advisory Committee voted 13-1 that Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) from Gilead Sciences, is a safe and effective drug for HIV patients who have not received prior treatment for the disease.The FDA is expected to take action on the application for Quad by August 27.

FDA approves Fabior (Allergan) for Acne vulgaris in 12 year olds and upwards

Fri, 11 May 2012 23:00:00 GMT

The FDA has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%, from Allergan, for the treatment of Acne vulgaris in patients 12 years of age and older. It is the only retinoid in a topical foam formulation approved for this indication in the US. The approval of tazarotene foam was based on two multi-centre, randomized, double-blind, vehicle-controlled pivotal Phase III studies conducted in the US and Canada.

Lumax 740 defibrillator (Biotronik) is FDA approved

Thu, 10 May 2012 23:00:00 GMT

Biotronik has received FDA approval of its new Lumax 740 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds). Lumax 740 helps physicians monitor and treat their patients' arrhythmias and heart failure under ever-changing medical conditions. Lumax 740 is more informative to help manage a patient's heart failure progression; more specific to help reduce the chances of patients receiving an inappropriate shock as confirmed by the ECOST1 study; and is more durable with extended longevity

FDA Advisory Comittee recommends Lorqess (Arena/Eisai)for weight loss

Thu, 10 May 2012 23:00:00 GMT

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended approval for Lorqess(lorcaserin) as a prescription weight-loss medicine in an 18-4 vote with one abstention. The Committee considered that the available data demonstrated the potential benefits of weight loss with lorcaserin outweigh its possible risks of valvular heart disease, adverse cardiovascular events or malignancies when used long-term in a population of overweight and obese patients. FDA is expected to make its decision on lorcaserin by 27 June