Monitoring International Trends posted August 2015

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Monitoring International Trends

posted August 2015

The NBA monitors international developments that may influence the management of blood and blood products in Australia. Our focus is on:

  • Potential new product developments and applications;

  • Global regulatory and blood practice trends;

  • Events that may have an impact on global supply, demand and pricing, such as changes in company structure, capacity, organisation and ownership; and

  • Other emerging risks that could potentially put financial or other pressures on the Australian sector.

A selection of recent matters of interest appears below. Highlights include:

  • Baxalta published data suggesting that BAX 855 has the potential to provide strong bleed prevention in haemophilia A patients with twice weekly dosing. (Section 1)

  • Baxalta reported that 100 per cent of the von Willebrand patients treated with BAX 111 achieved success in the management of bleeding episodes. (Section 1)

  • CSL is recruiting patients for a Phase IIB study of its drug CSL112 for acute coronary syndrome. (Section 1)

  • Researchers say they are nearing approval by the FDA for a small device that allows trauma medics to monitor rate of blood loss more precisely. (Section 1)

  • The US Food and Drug Administration (FDA) accepted for review CSL Behring's Biologics License Application for its recombinant factor VIII single-chain drug, CSL 627, designed for molecular stability in treating haemophilia A. (Section 2)

  • Swissmedic accepted for review a Marketing Authorization Application for CSL Behring’s long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) for the prophylaxis and treatment of bleeding episodes in haemophilia B. This rIX-FP allows dosing intervals up to 14 days. (Section 2)

  • ADMA Biologics has submitted its Biologics License Application to the FDA seeking marketing authorization for RI-002. This is a plasma-derived, polyclonal, intravenous immune globulin derived from human plasma. (Section 2)

  • The FDA granted Fresenius Kabi approval for a labelling change that permits blood centres to use the Fenwal Amicus system for the storage of Amicus-derived platelets in plasma for up to seven days. (Section 2)

  • Remedium Technologies has FDA 510(k) clearance to market its Hemogrip patch. The patch controls bleeding occurring from access to veins or arteries during surgery. (Section 2)

  • Swedish Orphan Biovitrum (Sobi) decided to exercise its opt-in right to take over final development and commercialisation of Alprolix (long acting recombinant factor IX for haemophilia B) for Europe, North Africa, Russia and some Middle Eastern markets. Biogen has led development for Alprolix, has manufacturing rights, and has commercialisation rights in North America and other regions in the world excluding the Sobi territory. (Section 3)

  • Cerus Corporation announced that Unyts, headquartered in Buffalo, had signed a three-year purchase agreement for the INTERCEPT Blood System for platelets and plasma. `

  • Baxalta reported revenues for the second quarter and first half of 2015, which exceeded expectations. (Section 3)

  • Baxalta has a contract fractionation agreement with Sanquin Blood Supply Foundation to enhance supply and support growth in global demand for plasma-based therapies. Sanquin has submitted the production line for approval in Europe, which will provide additional manufacturing flexibility. (Section 3)

  • On 4 August, Shire went public with a $US 30 billion bid for Baxalta that had already been made privately and been rejected. Baxalta said later that day that Shire's

$US 45.23-per-share bid "significantly undervalues" the young company. (Section 3)

  • CSL announced that it had secured the necessary approvals required to proceed with the acquisition of the influenza vaccines business of Novartis. (Section 3)

  • Pfizer offered concessions in seeking EU regulatory approval for its $US 15 billion takeover of rival Hospira. (Section 3)

  • Therapure Biopharma received $C 20 million contribution from the Canadian government. Therapure has developed a proprietary technology called PlasmaCap Expanded Bed Adsorption, which it says increases protein yields from plasma, separates them faster, and costs less. (Section 4)

  • A biosafety level 4 laboratory in Tokyo is Japan’s first facility able to handle Ebola. (Section 4)

  • A Transylvanian electronic music festival offered its potential audience free or discounted tickets in exchange for blood donations to the National Institute of Blood Transfusion. (Section 4)

  • A Californian study showed that haemophilia accounted for the largest share of the State’s expenditure on outpatient drugs for publicly insured children with serious chronic illnesses. (Section 4)

  • A study found that patients who received an allogeneic blood transfusion during lumbar spine surgery were at higher risk for surgical site infection, urinary tract infection and overall postoperative infections. (Section 5)

  • Researchers found that the clinical benefits of minimally invasive aortic valve replacement via lower hemi-sternotomy include decreased transfusion requirements, decreased ventilation times, and shorter ICU and hospital stays. (Section 5)

  • A report suggested patients who experienced simultaneous bilateral anterior approach total hip arthroplasty enjoyed low rates of perioperative complications and excellent clinical outcomes. (Section 5)

  • Researchers found that iron bio-fortified pearl millet resolved iron deficiency in a group of school-aged children in India within four to six months (Section 5)

  • A randomized study confirmed that CSL Behring’s Kcentra (4-factor prothrombin complex concentrate) reversed the anticoagulation effects of vitamin K antagonists (VKA) at a faster rate than plasma in patients requiring emergency invasive procedures. (Section 5)

  • Scientists funded by Australia’s National Heart Foundation have been working towards a revolutionary treatment for blood clots that could be administered by paramedics without the need for specialised equipment. (Section 5)

  • St. Teresa Medical enrolled the first patient in its UK clinical trial of its Surgiclot wound dressing to reduce blood loss. (Section 5)

  • BioLife Solutions announced that manufacturing process validation has begun to support a new product, directed towards cryopreservation, including freezing of platelets for subsequent clinical use. (Section 5)

  • The adoption of new reporting standards may have reduced the proportion of studies reporting positive research findings among large-budget clinical trials funded by the US National Heart, Lung and Blood Institute. (Section 6)

  • At Stanford University’s School of Medicine, infusions of blood plasma from young people are being given to patients with mild to moderate Alzheimer’s disease. Doctors are looking for cognitive improvements. (Section 6)

  • Researchers have developed a system that mimics the human circulatory system. They coupled it with an optical technique that can provide quantitative in vivo information on individual red blood cells. (Section 6)

  • A group of downhill skiers have been trying to verify whether endurance performance can be improved by living at high altitudes while training at lower levels, (Section 6)

  • Scientists at the University of Pennsylvania have been investigating a new approach to vaccines, creating immunity without vaccination. (Section 7)

  • European drug regulators recommended GlaxoSmithKline's Mosquirix (malaria vaccine) as safe and effective to use in at risk babies in Africa. (Section 7)

  • The United Nations Food and Agriculture Organization (FAO) warned in late July that timely intervention was essential to prevent the highly virulent avian flu virus H5N1 (which had already spread to five West African countries in six months) from spreading further. (Section 7)

  • A study found that two doses of H7N9 avian flu vaccine produced an adequate immune response in 2 per cent of adults vaccinated, but two distinct adjuvants increased that to 57 per cent and 84 per cent respectively. (Section 7)

  • Scientists found significantly fewer serious cardio-respiratory events possibly related to influenza in study participants 65 years of age and older who received a higher-dose split-virus inactivated influenza vaccine compared with a standard-dose split-virus inactivated influenza vaccine. (Section 7)

  • On 27 July, the final South Koreans suspected of possibly being infected with MERS were released from self or mandatory quarantine. (Section 7)

  • The Kingdom of Saudi Arabia continues to notify the World Health Organisation (WHO) of MERS cases. A surge in numbers has been observed ahead of the Hajj pilgrimage.

  • Scientists in Switzerland have found an antibody that neutralises multiple strains of Mers-CoV. They found in mice that the antibody could be used both prophylactically and therapeutically. (Section 7)

  • After a delay awaiting approval, plasma donated by Ebola survivors was administered to Ebola patients in West Africa. (Section 7)

  • The US Department of Health and Human Services (HHS) has issued a two-year

$US 19.7 million task order to Emergent BioSolutions’ Baltimore Bayview Center for Innovation in Advanced Development and Manufacturing (CIADM) to produce a novel therapeutic drug to treat Ebola virus disease. (Section 7)

  • The FDA awarded OraSure Technologies' rapid Ebola test special status, allowing marketing of the test for use in areas where the virus is still circulating while the company works toward final approval. (Section 7)

  • A vaccine against Ebola was reported to be 100 per cent successful in trials in Guinea. The vaccine is made by Merck. (Section 7)

  • Research has found that urine from black flying foxes poses biggest Hendra virus risk to horses, following a confirmed Hendra case in far north Queensland. (Section 7)
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