LINK HEALTHCARE RECEIVES PBS REIMBURSEMENT FOR ALLMERCAP™
– The product is a mercaptopurine oral liquid suspension for the treatment of Acute Lymphoblastic Leukaemia
– ALLMERCAP™ is a child-friendly formulation offering more flexible, accurate & consistent dosing than the tablet form
– LINK has partnered with Nova Laboratories to make the liquid suspension available in Australia
Sydney/Pretoria/Singapore/Hong Kong/Kuala Lumpur/Tokyo/Auckland: 13 February 2015
Specialist pharmaceutical and medical technologies business, LINK Healthcare (‘LINK’) has received PBS listing from 1 March 2015 for ALLMERCAP™, a product licensed through a partnership with the UK Company, Nova Laboratories. The streamlined Authority Required listing is for the treatment of Acute Lymphoblastic Leukaemia (ALL) in paediatric patients when the tablet form is unsuitable.
The mercaptopurine oral liquid suspension was developed by Nova to meet a need for greater dosing accuracy and flexibility, combined with improved palatability for children. Mercaptopurine has been available as a 50mg tablet for many years, but because the dose has to be carefully adjusted according to a patient’s body surface area, it has always been extremely difficult for parents and carers to administer an accurate dose to young children.
ALLMERCAP™ offers more consistent and predictable absorption than the tablet and provides greater ability to accurately administer individualised doses to meet the child’s needs – down to 2mg dose increments, whereas standard mercaptopurine tablets are 50mg. The natural raspberry flavoured suspension is free from artificial colours and artificial flavouring, and so is particularly child-friendly. The pleasant flavour offers good palatability, assisting treatment compliance.
The US Food and Drug administration (FDA) said on 28 April 2014: “Compared to tablets, a suspension offers the advantage of more accurately delivering the desired doses to children with a wide range of weights using a consistent administration schedule” in a written announcement to Clinical Oncologists.
The FDA also stated that “a commercially produced suspension is more likely to provide a more consistent dose of 6-mercaptopurine than ad hoc compounded formulations”.
Mr John Bacon, Chairman of LINK Healthcare said:
“After receiving marketing approval in 2014 we were pleased to receive PBS listing for the product, meaning more accessibility for patients with ALL, the most common form of cancer diagnosed in children.”
Dr Hussain Mulla, Head of Clinical Development for Nova said:
“From our point of view we’re grateful to receive reimbursement in Australia. It further contributes to improved treatment of childhood cancer across the globe.”
The use of mercaptopurine is considered integral to treating children with ALL and its efficacy in the treatment of ALL has been established over many years through a number of national and international trials. Consequently, treatment protocols used by haematologists and oncologists for treating ALL include oral mercaptopurine.
However, throughout this period an enduring difficulty for patients, caregivers and healthcare professionals, and particularly those looking after children, has been the lack of a suitable formulation of mercaptopurine. Only a 50mg tablet formulation of mercaptopurine has ever been marketed in Australia but since the dose has to be adjusted according to body surface area, it has always been extremely difficult to administer the correct dose to younger children. The need for an age appropriate mercaptopurine formulation was highlighted at a FDA Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (December 15th, 2009).
ALLMERCAP™ has been available in Europe (under the Xaluprine™ name) since July 2012. A dedicated website, www.xaluprine.com, was launched in January 2013 to support healthcare professionals, patients and caregivers using the product.
About LINK Healthcare (Australia, New Zealand, Southern Africa, Singapore & Japan)
LINK Healthcare is a privately owned specialist pharmaceutical and medical technologies business.
LINK’s mission is to strive for excellence in the marketing of vitally important and unique range of specialists products that enhance the well-being of people throughout the regions of Australia, New Zealand, Asia and Southern Africa.
LINK provides exceptional regulatory, sales, marketing, customer-service and supply chain infrastructure and is partnered with major blue chip pharmaceutical companies from around the world, allowing the company to offer a unique and substantial portfolio of ‘medicine that matters.’
LINK Healthcare has an extensive range of prescription pharmaceuticals in essential therapeutic areas including Allergy, Anaphylaxis, Analgesia/Anaesthesia, Anti-infective, Anti-retroviral, Cardiology, Endocrinology, ENT, Gastroenterology, Intensive care, Metabolic disease, Neurology, Oncology, Orphan Drugs, Palliative care, Psychiatry, Radiography, Transplantation and Toxicology.
In Australia and Southern Africa the group also commercialise a unique range of medical technology products focused in the specialist areas of advanced wound care, diabetes and point of care testing.
For more information about LINK Healthcare visit www.linkhealthcare.com.au
About Nova Laboratories
Nova Laboratories has developed a worldwide reputation for consistently being at the forefront of technological exploration and clinical standards. The company has MHRA and FDA approved, state-of-the-art facilities in Leicester, England, where it has developed world class expertise in aseptic processing of complex pharmaceuticals, using sterile isolator technology.
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