Tag: FDA

Health Care

Hong Kong Authority Approves Abraxane(R) as First-Line Treatment For Late-Stage Pancreatic Cancer

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The new treatment option provides substantial benefit in overall survival in patients with this devastating disease

HONG KONG, March 18, 2015 /PRNewswire/ — Celgene announced today that a new treatment option for late-stage pancreatic cancer is now available for use in Hong Kong. Approved by the Department of Health, Abraxane® (paclitaxel formulated as albumin-bound nanoparticles) is indicated for use in combination with gemcitabine, another chemotherapy drug, as first-line treatment for patients with late-stage (metastatic) pancreatic cancer. The approval provides hope for extending the lives of patients with metastatic pancreatic cancer and represents the first approved treatment for this aggressive disease in nearly eight years.

Abraxane® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology or nanotechnology. It disrupts the internal support structure of tumor cells, which is believed to interfere with their growth. Abraxane® in combination with gemcitabine has been shown to improve survival in patients with metastatic pancreatic cancer.[1]

Pancreatic cancer is one of the deadliest cancers globally and in Hong Kong

Pancreatic cancer is the seventh-leading cause of cancer-related death world-wide with 338,000 new cases diagnosed in 2012.[2] According to the Hong Kong Hospital Authority, pancreatic cancer is the number six cancer killer in Hong Kong with over 500 deaths every year.[3]

“The early stages of this cancer do not usually produce symptoms, so the disease is generally advanced when it is diagnosed,” said Dr. Kevin Loh, a medical oncologist from OnCare Cancer Center, Hong Kong.

“The disease is one of the deadliest cancers and treatment options are limited. Even with aggressive treatment, the prognosis of pancreatic cancer is poor – around 74% of patients die within the first year of diagnosis, and less than 6% will survive more than five years. In Hong Kong, the number of new cases reported annually is similar to the number of deaths, indicating poor survival rates,” commented Dr. Loh.

In fact, the pancreas is the only major cancer site for which no improvements in mortality rates is predicated for either males or females.[4] These data highlight the urgent need for new treatment advances in metastatic pancreatic cancer.

A new treatment option to help improve overall survival rate of patients with pancreatic cancer

The Department of Health’s approval of Abraxane® was based on the results of an open-label, randomized, international phase III clinical trial, one of the largest ever conducted in metastatic pancreatic cancer. The study included 861 participants and compared treatment with Abraxane® plus gemcitabine with gemcitabine alone. Participants treated with Abraxane® plus gemcitabine demonstrated a statistically significant improvement in overall survival with a 28% reduction in risk of death (8.7 vs 6.6 months; hazard ratio=0.72; P<0.001).[1,5]

Importantly, this is the first study to report long-term survivorship in a disease with very poor prognosis. Compared with patients treated with gemcitabine alone, patients treated with Abraxane® plus gemcitabine had a 59% (35% vs 22%) and 125% (10% vs 5%) increase in overall survival after 1 and 2 years of treatment, respectively.[5] This improved survival was sustained even after 3 years of treatment with Abraxane® plus gemcitabine. Grade 3 and higher side effects of neutropenia, fatigue, and peripheral neuropathy were reported more frequently in patients treated with Abraxane® plus gemcitabine versus gemcitabine alone.[1]

“The approval of Abraxane® for late-stage pancreatic cancer in Hong Kong is a big step toward bringing the first new treatment option in many years to people diagnosed with this deadly disease,” said Thomas Karalis, General Manager of East Asia, Celgene.

“We are beginning the important work of helping physicians and patients gain access to Abraxane® plus gemcitabine, which has shown statistically significant and clinically meaningful improvements in overall survival compared to gemcitabine alone. Celgene remains committed to developing innovative treatments to improve the lives of patients dealing with this devastating cancer disease,” he added.

About Pancreatic Cancer

Pancreatic cancer is the seventh-leading cause of cancer-related death world-wide and number six cancer killer in Hong Kong. The disease is not usually diagnosed until it is at an advanced stage. For this reason, most patients have a poor prognosis, with more than one-half of patients diagnosed after their cancer has spread to other organs (click the link to view the disease infographic and learn more about pancreatic cancer: Pancreatic cancer infographic).

About Abraxane® 

Abraxane® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. Abraxane® is formulated with albumin, a human protein, and is free of solvents. 

Abraxane® was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Abraxane® is now approved in more than 50 countries for the treatment of metastatic breast cancer.

In October 2012, Abraxane® was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Abraxane® is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Europe, Hong Kong, Japan, New Zealand and Singapore.

In September 2013, the FDA approved Abraxane® as first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Abraxane® is also approved for the treatment of metastatic pancreatic cancer in more than 40 countries.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.

For product and media related enquiries, please contact:

Edelman Public Relations Worldwide (Hong Kong)
Anna Wong
Tel: +852-2837-4769
Email: anna.wong@edelman.com

Celgene Limited (Hong Kong)
Jasmine Hoo
Tel: +65-6572-5124
Email: jhoo@celgene.com

References:

1.

Von Hoff DD, et al. N Engl J Med. 2013;369(18):1691-1703.

2.

World Cancer Research Fund International. Pancreatic cancer statistics. Available at:

http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/pancreatic-cancer-statistics

3.

Hong Kong Hospital Authority. Pancreatic Cancer. Available at:

http://www21.ha.org.hk/smartpatient/en/cancerin_focus/details.html?id=109

4.

Malvezzi M, et al. Ann Oncol. 2013;24(3):792-800.

5.

Goldstein D, et al. J Natl Cancer Inst. 2015;107(2):dju413.

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Health Care

FDA Approves 3D-Koning Breast CT

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— First Ever Cone Beam Breast CT for Diagnostic Imaging of the Breast

ROCHESTER, New York, Feb. 4, 2015 /PRNewswire/ — Koning Corporation, a leading developer of advanced medical imaging systems announced today that the FDA has approved their Koning Breast CT (KBCT) system and KBCT-guided biopsy bracket. This approval signals that KBCT has undergone and successfully completed all aspects of FDA’s rigorous Pre- Market Approval (PMA) process for medical devices to include extensive clinical study. KBCT is intended to provide three-dimensional (3D) images for diagnostic imaging of the breast.

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“This FDA approval represents a major step forward for breast imaging and women’s health care,” said Ruola Ning, PhD, Koning’s President and Founder, a pioneer and leading expert in Cone Beam CT Technology and sole inventor of cone beam breast CT technology. “KBCT represents a revolutionary advancement in breast cancer diagnosis. Breast cancer is a growing worldwide women’s health issue impacting hundreds of thousands of women. We are very proud to now be able to offer our technology to benefit women here in the United States.”

KBCT is the first ever commercially available, 3D breast CT scanner designed specifically to image the entire breast with a single scan without compression of the breast tissue. The system acquires hundreds of images in ten seconds producing ‘true’ 3D images allowing a fast procedure with excellent patient comfort. Optional accessories for KBCT include a biopsy bracket to enable KBCT-guided breast biopsies of suspicious lesions, and a collimator which is used to limit the x-ray beam to the area of interest. The biopsy bracket provides 3D targeting at comparable or lower radiation exposure compared to stereotactic guided biopsy.

In a September 2014 FDA Consumer Health Information “3D Technologies Poised to Change How Doctors Diagnose Cancer” (http://www.fda.gov/forconsumers/consumerupdates/ucm416312.htm) FDA reported that thanks to the regulatory work being done by a team of scientists at FDA that soon, three-dimensional (3D) images in actual 3D might help your doctor find hidden tumors and better diagnose cancers. The article indicated that: for patients, the (breast CT) procedure is more comfortable than regular mammography because the breast isn’t compressed. Also, there’s less radiation exposure than during a CT exam of the entire chest because only the breast is exposed to X-rays. The (breast CT) images have less distortion than mammography, and the system is optimized to differentiate between the breast’s soft tissue and cancer tissue. These images will be very different from 2D mammograms. They’re truly 3D images of the entire breast from any orientation. You can scroll through the slices (up and down, left and right) and get a unique view of the breast like never before. It gives doctors tremendous freedom in how they look at the interior of the breast and evaluate its structures. It’s almost like seeing the anatomy itself.

Over 680 patient scans on KBCT were conducted at Elizabeth Wende Breast Care (Rochester, New York) and the University of Rochester Medical Center (URMC-Rochester, New York), with additional collaboration at the University of Massachusetts Medical Center (Wooster, Massachusetts) which culminated in a large reader study conducted at the Medical College of South Carolina (MUSC) with Dr. Etta Pisano, a world renowned expert in Breast Imaging, serving as the Principal Investigator. “The results we have seen with 3D-KBCT have been remarkable compared to 2D imaging and there is no compression of the tissue making Breast CT a much more comfortable and painless procedure for women. I believe that 3D-KBCT will likely play a major role for multiple applications in breast imaging,” Dr. Pisano said.

About Koning

Koning Corporation is an International Medical Imaging Company with offices in New York and Tianjin, China (Koning (Tianjin) Medical Equipment Co. LTD), developing and marketing “state of the art” Cone Beam CT Scanners. Development of the KBCT has been supported in part by NIH grant (1R44 CA103236), SBIR Bridge Grant (2R44 CA 103236-05) and Federal Government Grant (W81XWH-09-1-0441). KBCT has been approved for sale in Canada, Australia, and the European Union (CE Mark). Koning anticipates CFDA approval for China soon.

Contact Information
John Neugebauer 
VP Sales and Marketing 
john.n@koningcorporation.com

David Conover
Public Relations and Communications 
david.conover@koningcorporation.com

http://www.koningcorporation.com

Phone: +1-585-214-2459

Fashion

UltraShape Wins NewBeauty Magazine Beauty Choice Award For Best Body-Contouring Treatment

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– UltraShape Is Recognized As A Breakthrough In Non-Invasive Abdominal Fat Reduction Thanks To Its Painless And Effective Ultrasound Technology

WAYLAND, Mass., Jan. 16, 2015 /PRNewswire/ — Syneron Medical Ltd. (NASDAQ: ELOS), a leading global aesthetic device company, announced today that NewBeauty Magazine awarded UltraShape® the “Best Body-Contouring Treatment” in its annual 2014 Beauty Choice Awards. As a winner in the coveted “Beauty Game Changers” category, UltraShape is recognized for its innovative ultrasound-based treatment that painlessly and permanently destroys fat in the abdominal area where fat is most resistant to diet and exercise.

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Featured alongside an elite list of outstanding aesthetic products, NewBeauty notes that UltraShape was chosen by a panel of thousands of readers, editors and beauty industry experts for its ability to deliver real, noticeable and highly customizable results “without surgery or hours spent in the gym.”

“As the number of satisfied UltraShape users continues to grow, we are honored to earn recognition from NewBeauty Magazine, further validating our leading position in the body shaping space,” said Dr. Shimon Eckhouse, Chairman of the Board of Directors for Syneron. “UltraShape represents the next generation in body-shaping with proven clinical outcomes and a superior safety profile, underscoring Syneron’s ongoing commitment to advancing treatment outcomes through technological innovation.”

“What sets UltraShape apart from other body shaping solutions is its fast outcomes with results visible in often as little as 2 weeks post first treatment,” says Amit Meridor, Chief Executive Officer of Syneron. “With UltraShape’s customizable treatments, for the very first time physicians are able to truly sculpt instead of bulk heat or freeze fat. UltraShape is a painless solution for those who cannot get rid of stubborn fat resistant to diet and exercise.”

The UltraShape System is the first and only non-invasive body shaping treatment that uses pulsed focused ultrasound energy to precisely target subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves and muscles intact. Unlike other body shaping technologies that use heat or freezing techniques, UltraShape uses a pure mechanical effect to destroy fat cells without inducing thermal damage. This unique feature of UltraShape technology results in a safe and comfortable treatment experience with no visible signs of treatment and no downtime.

The newest fat-blasting treatment on the block, UltraShape, with over 300,000 procedures performed worldwide, was cleared by the United States Food and Drug Administration (FDA) 510(k) for non-invasive reduction of abdominal circumference via fat cell destruction in April of last year.

About NewBeauty
NewBeauty® magazine is the definitive authority on all things beauty. Each issue of NewBeauty gives readers an in-depth look at the beauty industry’s latest products, cutting-edge innovations and breakthrough technologies. Whether it’s the latest high-powered skin care or in-office procedure, NewBeauty educates readers on the latest options for skin, face, hair, body, well-being and smile. The magazine’s comprehensive approach to its topics continues to solidify its reputation as the industry’s leading scientifically accurate, expert-driven and ethically balanced beauty resource. 

About Syneron Candela:

Syneron Candela is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint.  The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, tattoo removal, improving the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under three distinct brands, Syneron, Candela and CoolTouch, and has a wide portfolio of trusted, leading products including UltraShape, VelaShape, GentleLase, VBeam Perfecta, PicoWay and elos Plus.

Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Candela are located in Israel. Syneron Candela also has R&D and manufacturing operations in the U.S.  The company markets, services and supports its products in 86 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, mainland China, Japan, and Hong Kong and distributors worldwide.

For additional information, please visit http://www.syneron-candela.com.

SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including product efficacy, market acceptance of new products, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include  the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s most recent Annual Report on Form 20-F, and in the filings that Syneron Medical makes with the SEC, and other factors beyond the Company’s control. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, Syneron Medical Ltd.’s actual results, performance or achievements may vary materially from those expressed or implied by these forward-looking statements.  These forward-looking statements should not be relied upon as representing Syneron Medical Ltd.’s views as of any date after the date of this document. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Additional information can be found at www.syneron-candela.com

KELZ PR – +1-646-450-5359
Patty Mathews – pattymathews@kelzpr.com
Melissa Ben-Yoseph – Melissa@kelzpr.com 

Zack Kubow, The Ruth Group zkubow@theruthgroup.com, +1-646-536-7020
Hugo Goldman, Chief Financial Officer, Syneron Hugo.Goldman@syneron.com 
Syneron Medical Public Relations pr@syneron.com 

Health Care

Eiger Bio Receives Orphan Designation for Lonafarnib, a First In Class, Investigational Treatment for Hepatitis Delta Virus (HDV) Infection

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PALO ALTO, California, Dec. 22, 2014 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. today announced that lonafarnib has been granted Orphan Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).  The U.S. Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition. Orphan Designation qualifies the sponsor of the drug for various development incentives. Orphan designation also provides for a period of market exclusivity or protection against generic entry. Lonafarnib is a first in class, investigational treatment for patients infected with hepatitis delta virus (HDV).

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“We are committed to developing a therapy for the most insidious form of viral hepatitis, Hepatitis Delta, particularly as no FDA-approved therapies are currently available,” said David Cory, President and Chief Executive Officer of Eiger.  “We are pleased that the FDA and EMA have granted Orphan Designation to lonafarnib as a first in class, potential new therapy for HDV, a disease with great unmet medical need.”

About Lonafarnib 
Lonafarnib is a well-characterized, late stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle.  Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply.  Since prenylation is a host process, not under control of HDV, and lonafarnib inhibits prenylation, there is also a theoretical higher barrier to resistance with lonafarnib therapy.  Virus mutation, a common pathway to drug resistance, is not expected to be a potential pathway to lonafarnib resistance by HDV.     

Lonafarnib is not approved for sale for any indication.

About HDV

Hepatitis Delta is caused by infection with the hepatitis D virus (HDV) and is considered to be the most severe form of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals with hepatitis B (HBV), leads to more severe liver disease than HBV alone, and is associated with accelerated liver fibrosis, liver cancer, and liver failure. HDV is a disease with a significant impact on global health affecting ~15 million people worldwide. The prevalence of HDV varies between different parts of the world. HDV meets criteria for Orphan Designation in the United States (less than 200,000 people), Europe (less than 5 in 100,000 people), and Japan (less than 50,000 people).  Globally, HDV infection is reported to be present in approximately 4% – 6% of chronic hepatitis B carriers. In some parts of the world, including certain areas of China, Russia, Central Asia, Turkey, Africa, and South America, prevalence as high as 40% has been reported in HBV infected patients.

About Eiger
Eiger is a privately held biotechnology company focused on the research, development and commercialization of innovative therapies in viral hepatitis.  The company is focused on developing lonafarnib for the treatment of Hepatitis Delta Virus (HDV), the most severe form of viral hepatitis.  Lonafarnib is not approved for sale.  Eiger’s research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious liver diseases.  For additional information about Eiger and its R&D pipeline, please visit www.eigerbio.com.

Investors: Jim Shaffer, Eiger Bio, Inc., +1-919-345-4256, jshaffer@eigerbio.com

Health Care

Mylan receives tentative FDA approval for paediatric formulations of abacavir/lamivudine through innovative collaboration with ViiV Healthcare and Clinton Health Access Initiative

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LONDON and PITTSBURGH, Dec. 5, 2014 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients. This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavoured. The FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR) programme means the formulations meet all of the agency’s quality, safety and efficacy standards.

The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource limited countries including all low-middle  income, least developed countries and sub-Saharan Africa. Mylan’s products are expected to be eligible for purchase in early 2015.

The fixed dose combination of abacavir and lamivudine tablets for oral suspension 60 mg/30 mg and 120 mg/60 mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents for paediatric patients.

More than 70% of the approximately 3.4 million children living with HIV worldwide do not have access to appropriate care and medicines1. Improving those numbers will require medicines that are palatable to children and affordable to those living in resource-limited settings.

“The approval of abacavir and lamivudine tablets for oral suspension for marketing in developing markets demonstrates our commitment to providing the world’s 7 billion people with access to medicine and our continued leadership in enhancing access to ARVs to patients in developing countries,” Mylan CEO Heather Bresch said. “This new, flavoured, paediatric formulation is designed to help parents and caregivers give accurate doses of the medication depending on the weight of the child. The innovative work being done at Mylan, in combination with our partnership with ViiV and CHAI, has enabled us to develop this new product to treat children with HIV, a particularly vulnerable population.”

Dr. Dominique Limet, CEO ViiV Healthcare commented on the news, “Based on the need clearly identified by the Clinton Health Access Initiative in 2012, ViiV Healthcare became the first pharmaceutical company to fully fund the entire development process for a paediatric formulation of an HIV medicine which would then be transferred to another company for manufacture and distribution in the developing world.  I congratulate Mylan on this approval, made even more meaningful for us at ViiV Healthcare as it proved that this innovative approach to partnership can work.” 

David Ripin, Executive Vice President and Chief Scientific Officer for CHAI said, “We are pleased that our partnership with ViiV and Mylan has resulted in an important new paediatric formulation, moving from concept to FDA tentative approval in less than two years.  The new, flavoured dispersible medication will help meet the needs of over 500,000 children being treated for HIV in low middle income countries and demonstrates leadership and innovation on the part of both originators and generic suppliers together to address the needs of paediatric patients worldwide.  We are pleased to have participated in this innovative public-private partnership with the support of the UK Department for International Development.”

About abacavir/lamivudine
Abacavir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs interfere with the action of the reverse transcriptase enzyme to prevent the virus from replicating.

Abacavir/lamivudine was approved in the US in August 2004 under the brand name Epzicom and in Europe in December 2004 under the brand name Kivexa.

Kivexa and Epzicom are registered trademarks of the ViiV Healthcare group of companies.

About President’s Emergency Plan for AIDS Relief (PEPFAR)
PEPFAR is the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world. This historic commitment is the largest by any nation to combat a single disease internationally. In May 2004, in support of the President’s Emergency Plan, FDA announced a new initiative to help ensure that those being served by the Presidents’ Plan would receive safe, effective, and quality manufactured antiretroviral drugs. This new initiative included an expedited review process. Through guidance and an active outreach program to the pharmaceutical industry, FDA actively encouraged any sponsors worldwide to submit U.S. marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies – even if there was still patent or exclusivity market protection for the product in the U.S.

Important Safety Information (ISI) for abacavir and lamivudine tablets 60 mg/30 mg and 120 mg/60 mg for oral suspension

Please consult the full Prescribing Information for labeled safety information for abacavir and lamivudine tablets for oral suspension.

BOXED WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS.  See full Prescribing Information for complete boxed warning.

  • Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir-containing products.
  • Hypersensitivity to abacavir is a multi-organ clinical syndrome.
  • Patients who carry the HLA‑B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir.
  • Discontinue abacavir and lamivudine as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue abacavir and lamivudine if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
  • Following a hypersensitivity reaction to abacavir, NEVER restart abacavir and lamivudine or any other abacavir‑containing product.
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.
  • Severe acute exacerbations of hepatitis B have been reported in patients who are co‑infected with Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV) ‑1 and have discontinued lamivudine. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.

CONTRAINDICATIONS

  • Presence of HLA-B*5701 allele
  • Previous hypersensitivity reaction to abacavir or any other component of the product.
  • Hepatic impairment.

WARNINGS AND PRECAUTIONS

  • Hepatic decompensation, some fatal, has occurred in HIV-1/Hepatitis C Virus (HCV) co‑infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Discontinue abacavir and lamivudine as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both.
  • Immune reconstitution syndrome and redistribution/accumulation of body fat have been reported in patients treated with combination antiretroviral therapy.
  • Administration of abacavir and lamivudine is not recommended in patients receiving other products containing lamivudine- or zidovudine-containing products or emtricitabine-containing products.
  • Pancreatitis: Use with caution in paediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate.
  • Abacavir and lamivudine tablets 60 mg/30 mg and 120 mg/60 mg for oral suspension contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with phenylketonuria.

ADVERSE REACTIONS

  • Abacavir and lamivudine: The most commonly reported adverse reactions of at least moderate intensity (incidence >5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo, nausea and diarrhoea.
  • Abacavir: The most commonly reported adverse reactions of at least moderate intensity (incidence >5%) in paediatric HIV-1 clinical trials were fever and/or chills, nausea and vomiting, skin rashes and ear/nose throat infections.
  • Lamivudine: The most commonly reported adverse reactions of at least moderate intensity (incidence >15%) in paediatric patients were fever and cough.

DRUG INTERACTIONS

  • Ethanol: Decreases elimination of abacavir
  • Methadone: An increased methadone dose may be required in a small number of patients

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Category C abacavir and lamivudine should be used during pregnancy only if the potential benefit justifies the potential risk.
  • Nursing mothers: Both for the potential for HIV-1 transmission and potential for serious adverse reactions in nursing infants,  should be instructed not to breastfeed if they are receiving abacavir and lamivudine
  • Abacavir and lamivudine is not recommended in patients with creatinine clearance less than 50 mL per min.
  • Abacavir and lamivudine are contraindicated for patients with hepatic impairment.

About Clinton Health Access Initiative
CHAI was founded in 2002 with a transformational goal: help save the lives of millions of people living with HIV/AIDS in the developing world by dramatically scaling up antiretroviral treatment. Learn more about CHAI here: www.clintonhealthaccess.org

About Mylan Laboratories
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. Learn more at mylan.com.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

References:
1. WHO, UNAIDS and UNICEF, Global HIV/AIDS response: epidemic update and health sector progress towards universal access: progress report 2011, Geneva, 2011.

Mylan cautionary statement regarding forward-looking statements: This press release includes statements that constitute “forward-looking statements,” including with regard to Mylan’s product approvals, sales of products and strategy, future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: risks inherent in legal and regulatory processes; the impacts of competition; changes in economic and financial conditions of Mylan’s business; strategies by competitors or other third parties to delay or prevent product introductions; uncertainties and matters beyond the control of management; and the other risks detailed in Mylan’s filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.

GlaxoSmithKline cautionary statement regarding forward-looking statements: GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’s operations are described under Item 3.D “Risk factors” in the company’s Annual Report on Form 20-F for 2013.

Health Care

Biosafe Inaugurates Its Expanded China Business

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EYSINS, Switzerland, Nov. 14, 2014 /PRNewswire/ — Following the full registration of its product range by the Chinese FDA last April, Biosafe is gearing up its activities in the People’s Republic of China with a major expansion of its Shanghai-based operations, including staffing and facilities consolidation. Such expansion will enable Biosafe to support the many new developments in China within the Cord Blood Banking, Regenerative Medicine and Bioprocessing markets where the Group holds leadership.

(Logo: http://photos.prnewswire.com/prnh/20140407/679480)

To mark this significant business extension, Biosafe is today holding an official celebration event at the Grand Hyatt Hotel Shanghai, with a conference on stem cell therapy that will include a keynote presentation from Dr. Joanne Kurtzberg (Director, Pediatric Blood and Marrow Transplant Program, Duke University, USA).

Olivier Waridel, CEO of the Biosafe Group commented: “This expansion of our China operations underlines the commitment of Biosafe to cooperate with the Chinese cell therapy community, by working more closely with our clients and scientific partners in the People’s Republic of China. Biosafe looks forward to further developing close relationships with them and is enthusiastic about jointly supporting their efforts”.

About the Biosafe Group  

Founded in 1997 the Biosafe Group is active in the design, manufacture and marketing of automated cell processing systems. Headquartered in Switzerland and privately-owned, the Biosafe Group operates through regional subsidiaries (Geneva, Houston, Hong-Kong, Shanghai and Sao Paulo) and is present in more than 50 countries, either directly or through distributors.

For further information:
Christopher Bolton
CFO
Biosafe Group SA
+41-22-365-27-27
christopher.bolton@biosafe.ch
http://www.biosafe.ch

Health Care

Elekta’s Clarity Soft Tissue Visualization System Cleared for Use for Cancer Patients In China

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BEIJING, Nov. 5, 2014 /PRNewswire/ — Men with prostate cancer will be the first group of patients in China to benefit from the recent clearance of Elekta’s (EKTA-B.ST) Clarity™ soft tissue visualization system by the China Food and Drug Administration (CFDA). As part of Elekta’s premiere linear accelerator offering, Versa HD™, Clarity enables clinicians to use non-ionizing ultrasound technology to non-invasively image the prostate and surrounding soft tissues before patients begin treatment.

“As radiation oncology equipment becomes increasingly available to Chinese clinicians, and as demand grows, Elekta is providing world-class solutions, such as Clarity, to meet the specific needs of this market,” says Anming Gong, Elekta’s Managing Director for China.

The authorization for Clarity use in China follows the CFDA’s clearance in September of Elekta’s Versa HD™ linear accelerator, enabling Elekta to sell and market the system in China.

According to the International Agency for Research on Cancer, well over three million people are diagnosed with cancer every year in China1. Prostate cancer is the sixth most common cancer for men in China2.

1.

Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013.

2.

GLOBOCAN 2012 (IARC) (http://globocan.iarc.fr/Pages/fact_sheets_population.aspx)

For further information, please contact:

Gert van Santen, Group Vice President Corporate Communications, Elekta AB
Tel: +31-653-561-242
e-mail: gert.vansanten@elekta.com
Time zone: CET: Central European Time

Kris Walmsley, Corporate Communications Manager, Elekta AB
Tel: +46-70-537-9545
e-mail: kris.walmsley@elekta.com
Time zone: CET: Central European Time

About Elekta

Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both health care providers and patients, Elekta aims to improve, prolong and even save patient lives.

Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta employs around 3,800 employees globally. The corporate headquarters is located in Stockholm, Sweden, and the company is listed on NASDAQ Stockholm. Website: www.elekta.com

Health Care

Syneron Candela Announces FDA Clearance of PicoWay Picosecond Laser for Tattoo Removal

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WAYLAND, Massachusetts, November 4, 2014 /PRNewswire/ —

The Dual Wavelength PicoWay® Laser will be launched immediately in the US and featured at The American Society of Dermatologic Surgery Meeting, San Diego, November 6-9

Syneron Medical Ltd. (NASDAQ:ELOS), a leading global aesthetic device company, announced today the US Food and Drug Administration (FDA) clearance of the new PicoWay picosecond device. PicoWay is a state-of-the-art dual wavelength device, with 1064nm and 532nm wavelengths, which utilizes the proprietary PicoWay TechnologyTM to generate picosecond pulses for the removal of tattoos. The FDA clearance is for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength. The US launch of PicoWay will begin immediately, following the launch of the product in the international market in October.

     (Logo: http://photos.prnewswire.com/prnh/20120528/535447 )

PicoWay incorporates picosecond (one trillionth of a second) pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin. The high energy ultra-short picosecond laser pulse creates a strong photo-mechanical impact that optimizes fracturing of tattoo ink. The innovative PicoWay Technology is integrated into a proven, reliable Syneron Candela platform which offers high reliability, superior performance and low cost of ownership.

In support of the FDA 510(K) clearance, the performance of the PicoWay system was evaluated in a prospective, US multicenter study conducted by Eric Bernstein, MD, Arielle Kauvar, MD, and Tina Alster, MD as the primary investigators.  A large majority of subjects (86%) achieved at least 50% tattoo clearance after only 3 treatments based on blinded, independent review.  Device treatment also presented a favorable safety profile with no device-related serious adverse events, and low levels of pain or discomfort throughout the study.  

Dr. Eric Bernstein, President of Main Line Center for Laser Surgery, said, “PicoWay is an innovative and exciting breakthrough for tattoo removal. As a dual wavelength Nd:YAG laser, it delivers extremely high peak-power, picosecond pulses enabling the treatment of all skin types. What this means is extremely impressive results, which translate into very happy patients. PicoWay is a game-changing laser for tattoo removal, and could not have come at a better time.” 

Amit Meridor, Chief Executive Officer of Syneron Candela, said, “We expect a strong interest in PicoWay. Tattoo removal represents a significant market opportunity, with estimates that of the 45 million Americans with at least one tattoo, 20% want to have their tattoo removed. PicoWay provides a powerful new option, which clinical trials have shown to offer high rates of tattoo removal in very few treatments.”

Dr. Shimon Eckhouse, Chairman of the Board of Syneron Candela commented, “PicoWay represents a new era in aesthetic and dermatologic laser applications due to its mechanism of action which is mainly based on the photomechanical (photo-acoustic) effect compared to photo-thermal effect which is used in longer pulse duration aesthetic laser and IPL devices. With the shortest picosecond pulse and the highest peak power on the market the PicoWay enables efficient tattoo removal with less treatment sessions, more comfort to patients and new revenue streams for our customers. The different mechanism of action of the PicoWay turns it into a new aesthetic platform with wide range of new aesthetic applications that our scientists and doctors are working on. The highly trusted, reliable Candela platform used on the PicoWay was demonstrated in the multi-site clinical trials performed with the device in the US and internationally on a wide range of indications. This very high reliability and ease of use for the doctor are important advantages of the PicoWay”.

Dr. Arielle N.B. Kauvar, Clinical Professor of Dermatology at New York University, said, “The PicoWay laser allows us to treat a broader range of skin types and a wide array of tattoo ink colors. With the ultra-short picosecond pulse duration, there is minimal discomfort during treatment.  Professional and multicolored tattoos are cleared in very few treatment sessions offering greater patient convenience compared to longer treatment regimens.”

About Syneron 

Syneron Medical Ltd. is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint.  The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, improving the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under three distinct brands, Syneron, Candela and CoolTouch.  

Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Medical Ltd. are located in Israel. Syneron also has R&D and manufacturing operations in the U.S.  The company markets, services and supports its products in 86 countries.  It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.

For additional information, please visit http://www.syneron-candela.com.

SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS 

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, market acceptance of new products, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s most recent Annual Report on Form 20-F, and in the filings that Syneron Medical makes with the SEC, and other factors beyond the Company’s control. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, Syneron Medical Ltd.’s actual results, performance or achievements may vary materially from those expressed or implied by these forward-looking statements.  These forward-looking statements should not be relied upon as representing Syneron Medical Ltd.’s views as of any date after the date of this document. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Additional information can be found at http://www.syneron-candela.com

Contacts:
Zack Kubow, The Ruth Group zkubow@theruthgroup.com , +1-646-536-7020
Hugo Goldman, Chief Financial Officer, Syneron Hugo.Goldman@syneron.com
Syneron Medical Public Relations
pr@syneron.com

Health Care

Chinese Clinics and Cancer Patients to Benefit from Elekta’s Versa HD Radiation Therapy System

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— Advanced treatment system now available in Elekta’s second largest market

BEIJING, Sept. 30, 2014 /PRNewswire/ — Following US and European approvals of Elekta’s Versa HD™ linear accelerator, the China Food and Drug Administration (CFDA) has cleared the radiation therapy system for sale and marketing in the country.

According to the International Agency for Research on Cancer, well over three million people are diagnosed with cancer every year in China1, the most common types including lung, gastric, colorectal, liver and esophageal cancers2. Versa HD is designed to improve patient care and treat a wide range of tumors throughout the body.

Versa HD is equipped with the Agility™ multileaf collimator for high-speed, high-precision beam shaping to support extremely accurate tumor targeting and improved healthy tissue preservation. Together with High Dose Rate mode, Versa HD is able to improve clinical workflow by providing rapid delivery of more sophisticated therapies within standard radiotherapy treatment times.

Elekta’s Anming Gong, Managing Director for China, says: “As cancer rates continue to rise in China, the need for advanced and effective treatment becomes even greater. Versa HD will help support the government’s health care reform, which includes upgrading community and rural health care facilities by 2020.”

Versa HD has been overwhelmingly popular since its launch in 2013, with shipments made to 30 countries. Elekta has been present in China since 1982 and eight of 10 top cancer centers have Elekta linear accelerators. The introduction of Versa HD will strengthen Elekta’s leading position in the Chinese market.

1

Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013.

2

Report of incidence and mortality in China cancer registries, 2009 (doi: 10.3978/j.issn.1000-9604.2012.12.04)

For further information, please contact:
Gert van Santen, Group Vice President Corporate Communications, Elekta AB
Tel: +31 653 561 242, e-mail: gert.vansanten@elekta.com
Time zone: CET: Central European Time

Johan Andersson, Director, Investor Relations, Elekta AB
Tel: +46 702 100 451, e-mail: johan.andersson@elekta.com
Time zone: CET: Central European Time

The above information is such that Elekta AB (publ) shall make public in accordance with the Securities Market Act and/or the Financial Instruments Trading Act. The information was published at 07:30 CET on September 29, 2014.

About Elekta
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both health care providers and patients, Elekta aims to improve, prolong and even save patient lives.

Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta employs around 3,800 employees globally. The corporate headquarters is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker STO:EKTAB. Website: www.elekta.com.