FDA approves Kynamro to treat inherited cholesterol disorder

January 31, 2013, 2013, Hyderabad, India – The U.S. Food and Drug Administration approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C). 

HoFH, an inherited condition that affects about one out of every one million people in the United States, occurs when the body is unable to remove LDL-C, often called “bad” cholesterol, from the blood causing abnormally high levels of circulating LDL-C. For those with HoFH, heart attacks and death often occur before age 30. Kynamro is an orphan drug approval, meaning it was developed to treat a disorder affecting fewer than 200,000 people. In December 2012, the FDA approved Juxtapid (lomitapide) to reduce LDL-C, total cholesterol, apolipoprotein B, and non HDL-C in patients with HoFH.

“Kynamro, an injection given once a week, works with other lipid-lowering medications and diet to impair the creation of the lipid particles that ultimately give rise to LDL-C,” said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Kynamro were evaluated in a clinical trial of 51 patients with HoFH. On average, levels of LDL-C fell by about 25 percent during the first 26 weeks in those receiving the drug. Kynamro carries a Boxed Warning on the serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation of fat in the liver, which could lead to progressive liver disease with chronic use.

The FDA approved Kynamro with a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use, including prescriber and pharmacy certification, and documentation of safe-use conditions, which requires a prescription authorization form for each new prescription.

The most common adverse reactions in the clinical trial included injection site reactions, flu-like symptoms, nausea, headache and elevations in liver enzymes (serum transaminases).

The FDA is requiring four postmarketing studies for Kynamro: the development of a sensitive assay that binds double-stranded (ds) DNA; a study to assess for the presence of antibodies to ds-DNA in patients treated with Kynamro; a long-term registry of patients with HoFH to determine the long-term safety of Kynamro; and an enhanced pharmacovigilance program to monitor reports of malignancy, immune-mediated reactions, and hepatic abnormalities in patients treated with Kynamro.

Elbit Systems and Windward Team to Introduce Advanced Maritime Surveillance Solution for India

Hermes 900 Maritime Equipped with Maritime Patrol Radar (MPR) and EO & IR

January 31, 2013, Hyderabad, India– Elbit Systems Ltd. has teamed with Windward Ltd. to offer integrated maritime solutions for the Indian authorities. The joint solution combines Windward’s innovative satellite-based maritime analytics system, MarInt, with Elbit Systems’ wide range of solutions for maritime domain awareness, including Hermes^® 900 maritime patrol unmanned aircraft systems (UAS).

The co-operation between the two companies addresses the specific needs of India and its vast and complex maritime arena and will be demonstrated for the first time globally at the upcoming Aero-India 2013.The co-operation makes available a unique system adapted for very large maritime area monitoring, providing authorities with powerful means to control India's waters.

MarInt, Windward's proprietary satellite-based maritime analytics system, maps the global maritime activity in unprecedented details, based on data collected from various sources, such as commercial satellites, open-source data bases and other sensors. Covering any area of interest, regardless of the distance from shore, MarInt delivers maritime domain awareness over littoral or blue water areas, for Exclusive Economic Zone (EEZ) monitoring, fishery control, regional traffic analysis or port traffic management. After the routine maritime patterns are observed and learned, the system performs deep behavior analysis on every vessel spotted in the designated area of interest, in order to detect anomalous and suspicious behavior.

Operating 24/7, MarInt pinpoints "where is the perpetrator you didn't even know was there". This further enables tasking of unmanned assets such as UAS to patrol the designated areas, identify and track the suspicious vessels, significantly optimizing aerial patrol and increasing mission effectiveness while reducing cost.

The Maritime Hermes^® 900 is a new configuration of Elbit Systems’ largest UAS, adapted for maritime operations, carrying selectable mission payload of up to 350 kg., including maritime surveillance radar, Automatic Identification System (AIS), an electro-optical multi-sensor payload and electronic surveillance systems. It has the endurance to cover vast ocean areas, redundant line-of-sight and satellite communications links and radio relay, enabling operators to talk to local vessels while flying patrolling remote sea areas at extended ranges from shore.

Elbit Systems offers a wide variety of systems for maritime security including maritime patrol UAS, Naval C4I, Command and Control centers, SIGINT and EW systems, electro optic systems, unmanned vessel systems, communication solutions and radios, Cyber solutions, and more.

Hermes 900 Maritime Equipped with Maritime Patrol Radar (MPR) and EO & IR Payloads

Fuel and emergency flotation technologies lead the GKN Aerospace

GKN Aerospace supplies complete fuel systems, flexible fuel bladders, crashworthy and self-sealing systems, rotationally moulded tanks and range extender tanks with explosive suppressant and anti-slosh technology.

January 31, 2013, Hyderabad, India – GKN Aerospace’s display at Aero India, 2013 (Hall B, Stand 4.15) is focused on developments across two of the company’s market-leading businesses: fuel systems and emergency flotation systems.

On display will be a rotationally moulded fuel tank supplied for land vehicles alongside a model of the for the AW101 helicopter fitted with a GKN Aerospace emergency flotation system.

Manufacturing both in the US and the UK, GKN Aerospace supplies full turnkey packages from fuel storage to engine feed, as well as flexible fuel bladders, crashworthy and self-sealing systems plus rotationally moulded tanks and range extender tanks incorporating explosive suppressant and anti-slosh technology. Process and materials developments mean even stronger, lighter systems are now exploiting all the available space on the platform to maximise fuel load and airframe endurance, whilst minimising weight.

For the military market, GKN Aerospace’s fuel system technology offers the most rapid self-sealing on the market, providing 7.62mm to 20mm round protection to all types of fuel containment systems. This ballistically tolerant technology is typically integrated at the design phase of a vehicle but can also be retro-fitted or externally fitted to ensure fuel supply is maintained throughout front line operations - and has been proved effective in service.

The emergency flotation system for the AW101 aircraft, recently procured by the Indian Government, will be displayed on a scaled aircraft model. GKN Aerospace is an authority on the specification, design, manufacture and qualification of complete emergency flotation systems, designed to FAR / JAR 27 and 29. The company also continues to develop new materials and fabrication techniques to meet vital requirements for lighter weight equipment with extended performance and reliability - offering improved safety for crew and passengers.

GKN Aerospace provides full maintenance support for its proprietary and customer products as well as to the broader market. This includes inspection, leak repair and detection and damage repair including repair of nitrile rubber and modern polyurethane materials, self-sealing and crashworthy fuel cells.

GKN Aerospace has over 35 years of experience working with Indian industry and government. One of the company’s main customers is Hindustan Aeronautics Limited (HAL) and this relationship continues to grow following the establishment of a successful transfer of technology arrangement. GKN Aerospace also continues to explore new opportunities with a number of highly respected Indian companies and organisations.

Government of Andhra Pradesh and Gangwon Techno Park, South Korea sign MoU at BioAsia 2013

 MoU to cover the areas of Know-How Exchange, Information Sharing, Facilitation of Companies and Institutes Desiring Partnering and Education and Training

MoU signing between Government of Andhra Pradesh and Gangwon Technopark, KoreaL to R – T. Satyanarayana Rao I.A.S, Incharge MD – APIIC and Mr. InKyo Kim, President – Gangwon Technopark, Korea during BioAsia2013 Summit in Hyderabad

January 30, 2013, Hyderabad, India –The second day of BioAsia 2013 witnessed the signing of a significant MoU between the emerging Biotech leaders - Andhra Pradesh and South Korea.

The Memorandum of Understanding (MoU) was signed between the state undertaking of the APIIC (Andhra Pradesh Industrial Infrastructure Development corporation) and the Gangwon Technopark of South Korea.

The  MoU  was inked  by  Mr. InKyo Kim, President  of  Gangwang Technopark  and Sri  T Satyanarayana  Rao, IAS, Incharge APIIC  in the presence of  Sri Pradeep Chandra, the Principal Secretary, Industry and commerce of Government of Andhra Pradeshon the sidelines of BioAsia 2013.

Speaking on the occasion Sri Pradeep Chandra, the Principal Secretary, Industry and commerce of Government of Andhra Pradeshsaid, “The collaboration would be beneficial to both the partners engaged in the task of optimum exploitation of Biotech resources and products in the state.”

He further added,  “The potential of Bio-similar products  was to the tune of  5-10 Billion dollars  and the MoU will help  in  fine tuning  them with technology and  marketing  facilities to be  provided by the Asian country”.

  

Mr. InKyo Kim, President of Gangwon  Technopark  said,“The objective of our country  is to utilize the resources and facilities of APIIC promoted biotech installations  like  Genome Valley in Hyderabad to promote their marketing and  R & D of products  of both the institutions for common growth. We want to promote contribution of our products by over 30% to the overall industrial GDP.”