GSK receives FDA approval of an additional Promacta®; Jardiance Tablets For Adult Type 2 Diabetes available In U.S. Pharmacies Print E-mail
By Staff and Wire Reports   
Tuesday, 26 August 2014 19:25
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 26, 2014. GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta® (eltrombopag) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).1

SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets. 2 Eltrombopag, an oral thrombopoietin (TPO) receptor agonist, works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.

"FDA approval of Promacta addresses a significant treatment need for this very rare but serious blood disorder in those who have failed current treatment options," said Dr. Paolo Paoletti, President of Oncology, GSK. "Through collaboration with the National Institutes of Health, whose studies demonstrate the potential for Promacta to achieve a haematologic response in at least one lineage – red blood cells, platelets, or white blood cells – patients now have a treatment option where one didn't previously exist."

Promacta gained Breakthrough Therapy designation status from the FDA in January 2014 and Priority Review in April 2014. Today's approval by the FDA is based on results from an investigator-sponsored Phase II study (09-H-0154) conducted by the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH). The study demonstrated a haematologic response in SAA patients treated with eltrombopag who had an insufficient response to IST:1

-- Forty per cent (95% CI, 25, 56) of patients (N=17) experienced a haematologic response in at least one lineage – platelets, red blood cells (RBC), or white blood cells (ANC) – after Week 12.1
-- In the extension phase, eight patients achieved a multi-lineage response; four of these patients subsequently tapered off treatment and maintained the response (median follow up 8.1 months, range 7.2-10.6 months).
-- Ninety-one per cent of patients were platelet transfusion-dependent at baseline; the platelet transfusion-free period in responders ranged from eight to 1,096 days (median 200 days).
-- Eighty-six per cent of patients were RBC-transfusion dependent at baseline; the RBC transfusion-free period in responders ranged from 15 to 1,082 days (median 208 days).1

The most common adverse reactions (>/=20%) in the single-arm, open-label trial, in 43 patients with SAA who received Promacta were: nausea (33%), fatigue (28%), cough (23%), diarrhoea (21%), and headache (21%). In this trial, patients had bone marrow aspirates evaluated for cytogenetic abnormalities. Eight patients had a new cytogenetic abnormality reported, including five patients who had complex changes in chromosome 7. If new cytogenetic abnormalities are observed, discontinuation of Promacta should be considered.



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Jardiance® (empagliflozin) tablets are now available by prescription in pharmacies across the United States, including Walgreens, Rite Aid, Kroger and many other leading chain and independent retailers, according to Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY). The U.S. Food and Drug Administration (FDA) approved JARDIANCE on August 1, 2014 as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

"As a testament to the joint commitment by Boehringer Ingelheim and Lilly to improve care for people with diabetes, our alliance is proud to make JARDIANCE available so quickly following its approval by the FDA," said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe JARDIANCE is an exciting new treatment option with the potential to help many of the millions of adults with type 2 diabetes who have difficulty controlling their blood sugar levels."

JARDIANCE, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2) inhibitor. JARDIANCE works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels in adults with type 2 diabetes who have elevated blood glucose levels.

Patients should not take JARDIANCE if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in JARDIANCE. JARDIANCE can cause some people to have dehydration (the loss of body water and salt), which may lead to a drop in blood pressure, and may cause patients to feel dizzy or faint.

The JARDIANCE Simple Savings co-pay support program is available online and in many doctors' offices for patients who qualify. For terms and conditions and any questions regarding eligibility or benefits, visit JARDIANCEsavings.com or call 1-866-279-8990.

The FDA approval of JARDIANCE was based on results from a large clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE significantly reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months) after 24 weeks as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. Although JARDIANCE is not approved for lowering weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.

The most common adverse reactions associated with JARDIANCE were urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients treated with the combination of JARDIANCE and sulfonylurea or insulin.

To learn more about JARDIANCE and for full prescribing information visit: www.JARDIANCE.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.



Also Tuesday:



Amedica Corporation (Nasdaq:AMDA)
, a commercial biomaterial company focused on silicon nitride ceramics as a material platform to develop, manufacture and sell novel medical devices, is pleased to announce that its board of directors has elected Dr. B. Sonny Bal, M.D., J.D., M.B.A., to serve as its chairman of the board of directors.

Analogic Corporation (Nasdaq:ALOG)
announced today that it will conduct a conference call on Monday, September 15, 2014, at 5:00 p.m. (ET) to discuss results for the fourth quarter and fiscal year ended July 31, 2014.

Anavex Life Sciences Corp. (OTCQB:AVXL)
, a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, has selected The Alfred Hospital in Melbourne, Australia as the lead site for its upcoming Phase 2a clinical trial for ANAVEX 2-73, which is being developed as a potential disease-modifying treatment for Alzheimer's disease.

Applied Genetic Technologies Corporation (Nasdaq:AGTC),
a clinical-stage biotechnology company developing adeno-associated virus (AAV)-based gene therapy products for the treatment of rare eye diseases, today announced that Sue Washer, President and CEO will participate at the Citi 9th Annual Biotech Conference on Thursday, September 4th in a panel discussion entitled "Emerging Ophthalmology Therapies: Getting 20/20 on the Drug Landscape."

EDAP TMS SA (Nasdaq:EDAP)
, the global leader in therapeutic ultrasound, announced its participation in the Seventh International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer, which took place in Los Angeles, August 21-23, 2014.

ID Global Corp. (OTC:IDGC)
is pleased to announce that it has executed a purchase agreement for fifty-million (50,000,000) shares of common stock in United Treatment Centers, Inc. (OTC:UTRM).

iKang Healthcare Group, Inc. (Nasdaq:KANG)
, the largest provider in China's fast growing private preventive healthcare services market in terms of revenue in 2013, today issued a statement to clarify that the consensus estimate of iKang's net revenue for the fiscal year ending March 31, 2015 reported by Thomson Reuters was incorrectly stated to be US$323 million while the correct number should be US$289.1 million.

Kite Pharma, Inc. (Nasdaq:KITE)
, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced its participation at Citi's 9th Annual Biotech Conference at the Mandarin Oriental in Boston on Wednesday, September 3rd, at 6:00pm ET.

LifeVantage Corporation (Nasdaq:LFVN)
, a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, announced today that it will release financial results for its fourth quarter and full year ended June 30, 2014, after the market closes on Wednesday, September 10, 2014.

Macrocure Ltd. (Nasdaq:MCUR)
, a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced financial and operating results for the three and six months ended June 30, 2014.

MELA Sciences, Inc. (Nasdaq:MELA)
, developer of the MelaFind® system, a non-invasive optical diagnostic tool that assists dermatologists in the diagnosis of melanoma at its most curable and cost-effective stage and that has received both FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union, today announced it has executed a research agreement with Columbia University in which MELA and Columbia will collaborate to explore potential next generation capabilities and features of the MelaFind system and other enhancements to the system's range and ease of use.

OSL Holdings (OTCQB: OSLH)
, a socially conscious business dedicated to consumer advocacy, social activism and the advancement of civil liberties through the power of commerce, released today a letter to shareholders from OSL Holdings' Chief Business Development Officer, Steve Gormley.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that David Chaplin, Ph.D., CEO, will present a corporate overview at the Rodman and Renshaw Annual Global Investment conference on Tuesday, September 9, 2014 at 1:15 p.m. Eastern Time.

Prothena Corporation plc (Nasdaq:PRTA)
, a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, today announced that Timo Siepmann, MD, will present new interim data from an ongoing clinical study sponsored by Prothena that identify potential new biomarkers for Parkinson's disease. 

Skullcandy Inc. (Nasdaq:SKUL)
announced a strategic collaboration with the University of Southern California (USC) Center for Body Computing (CBC) to present the premier USC CBC SLAM at the annual Body Computing Conference to be held on the USC Los Angeles campus on October 3.

Spine Pain Management, Inc. (OTCQB:SPIN)
, a technology-driven, financial services, medical device, and healthcare solution company servicing the multi-billion dollar spine injury sector, today announced the addition of Peter Dalrymple to the Board of Directors.

Transcat, Inc. (Nasdaq:TRNS)
, a leading provider of accredited calibration and compliance services and distributor of professional grade handheld test, measurement and control instrumentation, announced today that it has executed an amendment to its $20 million secured revolving credit agreement, increasing the funds available under the amended credit facility to $30 million.

ZS Pharma (Nasdaq:ZSPH)
, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced that a pre-specified subset analysis of data from ZS003, a pivotal Phase 3 trial of ZS-9 (sodium zirconium cyclosilicate), its investigational treatment for hyperkalemia, will be presented as an oral presentation during the State of the Art and Featured Research Sessions at the European Society of Cardiology (ESC) Congress in Barcelona, which is taking place from August 30 to September 3, 2014.



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