Zibor(R), A Second-generation Low Molecular Weight Heparin, Only One Licensed In The UK

Main Category: Blood / Hematology
Also Included In: Cardiovascular / Cardiology;  Vascular
Article Date: 24 Sep 2008 - 3:00 PST

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Archimedes Pharma UK Limited, the UK based, pan-European specialty pharmaceutical company, announces the launch of Zibor® (bemiparin sodium) to the UK market. A second-generation low molecular weight heparin (LMWH), Zibor is the only LMWH licensed in the UK for post-operative initiation of thromboprophylaxis in any patients undergoing orthopaedic and general surgery. Already used by over 5 million patients worldwide, Zibor enters the UK market as the lowest priced LMWH.

Jig Patel, Consultant Orthopaedic Surgeon at University College Hospital, London commented that, "Effective thromboprophylaxis is sadly underutilized in the UK. This is probably reflected in the numbers of patients readmitted to hospital with thrombosis complications following surgery and the costs associated with this. The availability of Zibor offers physicians an additional treatment option for this serious condition."

Zibor is a potent anti-thrombotic with demonstrated efficacy and safety in published clinical trials. Zibor has the highest anti-factor Xa:IIa ratio of all licensed LMWHs. A higher anti-factor Xa:IIa ratio has been suggested to be associated with greater anti-thrombotic activity without increasing the risk of bleeding.1

The use of anti-thrombotics including proven therapies like LMWHs greatly reduces patient risk of developing venous thromboembolism (VTE) and pulmonary embolism (PE), serious conditions requiring immediate medical intervention.1 VTE alone accounts for an estimated 25,000 hospital deaths annually in the UK and up to 60% of patients undergoing orthopaedic surgery and 40% of patients undergoing general surgery develop VTE if not given appropriate thromboprophylaxis.2 Treatment of thromboembolism is costly and patients often develop serious long-term complications, adding to the cost burden on the Health Service.3

Post-operative administration of thromboprophylaxis offers further therapeutic advantages and cost-containment benefits. Specifically, it has been linked to a decreased risk of bleeding complications following surgery.4 Additionally, patients receiving thromboprophylaxis which is initiated post-surgery may be admitted to hospital on the day of surgery, rather than the day prior for pre-operative prophylaxis, reducing secondary care costs.

Richard de Souza, CEO of Archimedes said: "Zibor can be clearly differentiated from its competitors and addresses a large and growing market. The product offers doctors in the UK a new option with an approved on-label indication for treating patients undergoing orthopaedic and general surgery. Furthermore, Zibor has the potential to contribute savings in both primary and secondary care."

Zibor is administered as a subcutaneous injection and is available as prefilled syringes in five different strengths.

Exclusive UK commercial rights to Zibor have been licensed from Laboratorios Rovi Pharmaceuticals, a Spanish integrated and specialist pharmaceutical company.

About Zibor

Zibor (bemiparin sodium) is the first of the second generation low molecular weight heparins (LMWHs) indicated for the prevention of venous thromboembolism in patients undergoing orthopaedic and general surgery. It is the only injectable LMWH for which the UK licence includes administering the first dose post-operatively, a treatment regimen that reflects routine clinical practice and which can offer cost savings to healthcare providers. Zibor has the highest anti-factor Xa:IIa ratio of all licensed products. A higher anti-factor Xa:IIa ratio has been suggested to be associated with greater anti-thrombotic activity without increasing the risk of bleeding.

Archimedes Pharma Ltd has licensed exclusive commercial rights to Zibor for the UK from Laboratorios Rovi Pharmaceuticals, a Spanish integrated and specialist pharmaceutical company.

About Archimedes Pharma

Archimedes Pharma is a pharmaceutical company marketing an expanding portfolio of products to specialist prescribers in major European territories whilst building a platform for its future growth through the development of a high-value pipeline from its world-class drug delivery technologies.

Archimedes' strategy is to expand its current European commercial presence through partnering and acquisition. It is also building a robust pipeline of in-house products in pain, Parkinson's disease and critical care by applying its drug delivery technologies to proven molecules which have yet to achieve their market potential due to their current mode of delivery. This approach greatly reduces the development risk while promising significant clinical - and thus commercial - benefits. Archimedes' lead product NasalFent®, intranasal fentanyl for rapid relief of breakthrough cancer pain is based on Archimedes' PecSys™ technology and is in Phase III clinical development. This product, which has blockbuster potential, is targeted for launch in 2009.

Archimedes technologies - ChiSys®, PecSys™ and TARGIT® - are also used in a number of partnered products in late-stage clinical development. Additionally, Archimedes' innovative drug delivery technology has proven potential for vaccine delivery with pre-clinical and clinical studies of nasally administered vaccines demonstrating enhanced immune response.

Archimedes marketed products include Gliadel, a biodegradable wafer impregnated with an anti-cancer drug, carmustine, for high-grade glioma; Zomorph, an oral sustained release morphine product for pain; Nozinan, a neuroleptic used in psychiatry and as a supportive therapy for cancer patients; and Pabrinex, a high potency vitamin formulation used to treat the symptoms of malnutrition especially in patients with acute alcohol problems.

Archimedes Pharma is based in Reading, UK and has development facilities in Nottingham, UK. The Company was founded in December 2004 and is backed by Warbug Pincus, a leading private equity investor with extensive experience in the healthcare sector. In 2007, Archimedes had sales of US $40million.

http://www.archimedespharma.com

References

1. Chapman TM, Goa KL. Bemiparin: a review of its use in the prevention of venous thromboembolism and treatment of deep vein thrombosis. Drugs 2003;63(21):2357-77

2. Geerts WH, Heit JA, Clagett GP, et al. Prevention of venous thromboembolism. Chest 2001;119(1 Suppl):132S-75S

3. House of Commons Health Committee. The prevention of venous thromboembolism in hospitalized patients. In: http://www.parliament.uk. Available here. Accessed on 10 Sept 2008

4. Hull RD, Pineo GF, Francis C, et al. Low-molecular-weight heparin prophylaxis using dalteparin in close proximity to surgery vs warfarin in hip arthroplasty patients: a double-blind, randomized comparison. The North American Fragmin Trial Investigators. Arch Intern Med 2000;160!14):2199-207

Archimedes Pharma