FDA Purixan Approval Press Release

Nova Laboratories has secured U.S Food and Drug Administration (FDA) approval for its acute lymphoblastic leukaemia (ALL) product Xaluprine™, following a New Drug Application to the organisation in July 2013, which will be marketed in the US as Purixan™.

Nova Laboratories secures FDA approval for Xaluprine

UK pharmaceutical firm Nova Laboratories has secured U.S Food and Drug Administration (FDA) approval for its acute lymphoblastic leukaemia (ALL) product Xaluprine, following a New Drug Application to the organisation in July 2013.

The drug, which will be marketed in the US as Purixan, is a 20mg/ml oral suspension of existing ALL treatment mercaptopurine, which, prior to Xaluprine and Purixan has only been available in tablet form.

It was developed by Nova to meet a need for greater dosing accuracy and improved palatability for children, and has been designated orphan drug status by the FDA – given to products intended for the treatment of rare diseases or conditions.

Mercaptopurine has been available as a 50mg tablet for many years, but because the dose has to be adjusted according to body surface area, it has always been extremely difficult for parents or carers to administer an accurate dose to young children.

The oral suspension offers more consistent absorption than the tablet and allows doses to be individualised to an accuracy of 2mg. It is also easier for young patients to swallow and the natural raspberry flavour ensures good palatability, its makers claim.

The approval was based on clinical pharmacology research  to assess the bioequivalence of mercaptopurine tablets with that of the oral suspension version.

The product will now be distributed throughout the US by Rare Disease Therapeutics Inc.

Dr Stephen Hunger, chairman of the Children's Oncology Group ALL Disease Committee, Professor and Ergen Family Chair in Paediatric Cancer, and Director at the Center for Cancer and Blood Disorders at the University of Colorado School of Medicine, said:

“ALL therapy includes 6-mercaptopurine taken orally every day for 2-3 years.  Until now, the only FDA approved formulation of this drug available in the US has been pills, which can be very hard for young children to take.  This oral-suspension formulation should be much easier for young children to take and help parents to make sure that their children get the treatment that they need to cure ALL”.

On April 28, 2014, in a written announcement to Clinical Oncologists, the US Food and Drug administration said: “Compared to tablets, a suspension offers the advantage of more accurately delivering the desired dose to children with a wide range of weights using a consistent administration schedule.  A suspension will allow more flexibility in adjusting the dose” and that “a commercially produced suspension is more likely to provide a more consistent dose of 6-mercaptopurine than ad hoc compounded formulations. ”

Dr Hussain Mulla, head of clinical development for Nova said: “From our point of view we’re hugely proud that, thanks to this FDA approval, our product will contribute towards improved treatment of childhood cancer across the globe.

“We feel very privileged to be one of only a handful of UK-based companies to secure FDA approval of a new medicine, and for this to have been achieved with our first ever licensed product is especially pleasing.”

The FDA approved 95 New Drug Applications in 2013 – only nine of which were submitted by UK-based firms including four by GlaxoSmithKine. 

Traditionally a contract manufacturer on behalf of larger pharmaceutical firms, Nova first launched Xaluprine – its maiden licensed product – in Europe in 2012 following marketing authorisation from the European Commission.

Dr Mulla added: “Following success in Europe, we’re now looking to develop further worldwide markets to help children living with this disease.”

ENDS     29 April 2014

About mercaptopurine
Mercaptopurine has been used to treat children with ALL for the past 60 years. 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, all treatment protocols used by hematologists and oncologists throughout the world 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 the US 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).

Xaluprine™ offers more consistent absorption and allows doses to be accurately individualized to the child’s needs - down to 2mg dose increments, whereas standard mercaptopurine tablets are 50mg. The medicine is free from artificial colours, artificial flavoring and has no added sugar and so is particularly child-friendly. It is also easier for patients to swallow and the natural raspberry flavor ensures good palatability.

Xaluprine™ has been available in Europe 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 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-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.

Its core activity is manufacturing experimental medicines for some of the world’s biggest pharmaceutical companies and small biotech enterprises, who have spent years of research and development in creating them. The medicines then go on for clinical trials before being licensed for general use.

Nova also has an established business in compounding medicines which are tailored for individual patients, supplying them to almost every hospital in the UK as well as pharmacies and GP practices, and also veterinary practices.

Nova was established in 1994 by a small team of pharmacists and technicians and now has 185 highly-qualified employees. The company remains privately owned.

Forward-Looking Statement
This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Nova’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Nova’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Nova’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Nova undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise

For further press information, please contact:
Max Hammond
Gravitas Public Relations, 7 Lansdown Place, Cheltenham, GLOS, England, GL50 2HU
Tel: 00441242 211000
E: [email protected]


Download all our latest product lists, this months Newsletter and news articles from Nova Laboratories.


Career Opportunities

We welcome speculative enquiries and applications from anyone with experience in the pharmaceutical industry, the right attitude and relevant qualifications.

Know More

Contact Us

For all product enquires, please contact our customer services team on 0800 975 48 40 or alternatively you can email us at [email protected]