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Baxter to launch HyQvia in US next week

The PID drug has been used in Europe for over a year

Baxter building

Baxter has confirmed it will launch its HyQvia replacement therapy for primary immunodeficiency (PID) in the US next week, more than a year after it was first introduced in Europe.

HyQvia is the first immunoglobulin (IG) product for PID that can be delivered subcutaneously once a month, and has entered a market estimated at around $2bn worldwide, in which around two thirds of patients are still treated intravenously.

The product requires only one dose at one injection site - compared to other subcutaneous and intravenous drugs that require weekly or bi-weekly treatment with multiple infusion sites per course, said Ludwig Hantson, president of Baxter BioScience.

He said: "Our goal for HyQvia is to be the preferred and leading subcutaneous treatment for PID,” adding the company intends to launch the product in the US "at a price premium" to intravenous IG products.

HyQvia was initially turned down by the FDA, which wanted more information on the possible effects of the drug on reproduction, development and fertility.

Baxter is aiming to extend the use of HyQvia into additional indications in the coming years - including neurological uses - and analysts have suggested HyQvia could be a $1.5bn product at peak.

Healthy sales increase in Q3

Baxter announced the planned launch as it reported a buoyant 13% increase in revenues to $4.2bn, with its soon-to-be-separated biopharma unit growing 8% to $1.7bn, mainly on the back of strong performances for haemophilia drugs such as Advate, Rixubis and Feiba, which grew 11% to $942m.

The revenue figure excludes the company's vaccines business, which is in the process of being sold to Pfizer for $635m.

Group net income slipped a little to $468m from $544m a year earlier, mainly because of the ongoing costs of the biopharma spin-out to create a new company called Baxalta - which is due to complete by the middle of next year - and costs associated with its 2013 acquisition of medical technology firm Gambro.

The company is expecting some decline in market share for its big-selling haemophilia A product Advate from Biogen Idec's long-acting rival Eloctate, but will be filing its own long-acting product BAX 855 by the end of the year and hopes it will reach the market in 2015.

Chief financial officer Robert Hombach told investors yesterday that the company expects to incur a $300m charge from the company split, with around half of that total booked in the first half of 2015, although he added that "both companies will have the opportunity to reduce a meaningful portion of these costs over the next several years post-spin."

Article by
Phil Taylor

17th October 2014

From: Sales



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