Revamped Wyeth drug gets EU go-ahead

By Anna Lewcock

- Last updated on GMT

Related tags: Coagulation, Wyeth

An improved version of Wyeth's haemophilia B treatment BeneFix -
the only recombinant Factor IX product available on the market -
kitted out with a host of new user-friendly features, has been
approved in the EU.

Wyeth Pharmaceuticals has updated its existing BeneFix nonacog alpha (recombinant coagulation Factor IX) product, in a bid to make the treatment more convenient, simpler and safer for patients to use. The treatment is used for the prevention and control of bleeding in patients with haemophilia B (congenital Factor IX deficiency), and was first approved ten years ago in the US. The key improvements of the product include the approval of a lower diluent volume (5ml) for all dosage strengths, which could lower the total volume of product that patients have to infuse. The diluent will also now come in a pre-filled syringe, which reduces the number of components patients have to contend with and hopefully leads to a faster preparation process, according to Wyeth. Wyeth has also introduced a larger IU vial, with its new 2000 IU dosage strength now the largest unit dosage vial offered for haemophilia B treatment. As many patients are forced to use several vials to achieve their required Factor IX dose, this larger vial will mean that some patients will be able to use less vials - again allowing for easier and faster preparation, according to the company. The final feature to be added to the BeneFix product is a needleless reconstitution device, which is again intended to make the preparation process simpler and quicker, as well as removing the risk of needlestick injuries during reconstitution. Wyeth is hoping that these additional features, approved this week by the European Medicines Agency (EMEA), will make its BeneFix product a more attractive option to haemophilia B patients, and also have a corresponding positive effect on product sales. As it is, Wyeth already emphasises the safety advantages the recombinant BeneFix product has over other plasma-based Factor IX products. BeneFix is manufactured using recombinant DNA technology, and is both plasma- and albumin-free (unlike other Factor IX products), making it inherently free of the risk of blood-borne pathogens such as HIV, hepatitis and parovirus. BeneFix has a half-life of 19.4 hours, similar to plasma-derived Factor IX products, but does have a lower recovery level than its plasma-based counterparts. 'Recovery' is the level of circulating Factor IX in the blood after a certain period of time, with BeneFix achieving 28 per cent lower recovery than plasma-derived Factor IX and requiring 20 - 40 per cent more product to achieve the proper amount of circulating factor. However, Wyeth has high hopes the revamped haemophilia treatment which is currently manufactured in its Andover facility in the US and finished at its plant in Algete, Spain. "What is important is that it really does give patients the opportunity for a more convenient option for their treatments,"​ Gill Markham of Wyeth Pharmaceuticals told "We hope to see more patients moving from plasma-based treatments to the recombinant Factor IX." ​ BeneFix brought in revenues of $357.6m (€265.2m) over 2006, and is only a little behind last year's figures for the half year 2007, having brought in net revenues of just over $150m so far. Wyeth also has a seond haemophilia treatment on its books, ReFacto, a recombinant Factor VIII treatment for haemophilia A, and is hoping to strengthen its haemophilia franchise further. Back in February Wyeth announced the signing of two research agreements based on the development of new haemophilia treatments. A collaboration with San Diego-based MediVas aims to come up with new haemophilia treatments that extend the duration of action of recombinant factor treatments, and a similar second deal with French firm Nautilus Biotech focusing specifically on Factor IX proteins. The new BeneFix product was approved by the US Food and Drug Administration back in March and is now available on the US market, with Wyeth anticipating the launch of the revamped product in various EU markets from Q4 this year.

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