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Noxafil close to approval for invasive fungal infections

Published on 25/09/06 at 06:06pm

Schering-Plough's Noxafil is set to gain European approval for patients at high risk of developing invasive fungal infections.

These infections can be life-threatening and most often occur in patients whose immune-systems have been compromised or suppressed, such as organ transplant patients or cancer patients undergoing chemotherapy or stem cell transplant.

It has been estimated that cases of invasive fungal infections have almost tripled in the US over the past 20 years.

According to analysts Datamonitor, an estimated nine million patients across the seven major markets are considered 'at risk' from invasive fungal infections with approximately 1.2 million actually affected in 2003.

The EMEA's committee for medicinal products for human use (CHMP) has also recommended approval of Noxafil for oropharyngeal candidiasis (OPC) as first-line therapy in patients who have severe disease or who are immuno-compromised, in whom response to topical therapy is expected to be poor.

Noxafil (posaconazole) is currently approved in the EU to treat some invasive fungal infections in adult patients with disease that is refractory to, or in patients intolerant of, certain commonly used antifungal agents.

If approved, the licence for preventative use and in OPC indications will expand the drug's use across the 25 EU countries, as well as Iceland and Norway.

Oliver Cornely, medical director of the University of Cologne, Germany, said: "This recommendation demonstrates how prevention with Noxafil has the potential to change medical practice in this area."

He added: "Invasive fungal infections are a leading cause of death in certain high-risk patient populations, so preventing these infections in the first place is critically important for these seriously-ill patients."

Noxafil is a novel triazole anti-fungal, used to treat more serious invasive fungal infections in patients who fail to respond to,  or are intolerant of,  other treatments.

Typical patients are those receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS). Other recipients include those undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD).

The drug is competing with Merck Sharp & Dohme's Cancidas (caspofungin) and Pfizer's Vfend (voriconazole), two anti-fungals already on the market licensed to treat invasive fungal infections which have both seen sales grow strongly in recent years. Vfend is in the same triazole class as Noxafil, whereas Cancidas is in the new echinocandin class.

The Noxafil recommendation is another move towards Schering-Plough's strategy to broaden its anti-infectives portfolio.

Dr Holger Rovini, lead analyst in infectious diseases for Datamonitor, said: "If approved, this drug will compete in a highly competitive market. It should do well, but will probably remain third after MSD and Pfizer's licensed drugs."

He added: "It will be interesting to see how the drug develops over the long term."

Datamonitor says the global systematic antifungal market will be worth almost $6 billion by 2014.  Growth will primarily be driven by Cancidas and other new entrants from the new echinocandin class, which the research firm expects to grow at a compound annual growth rate of 11% over the decade.

The analyst company warns that increasing competitiveness in the market will require a larger investment in pre-launch, with return on investment seen over a longer period.

 

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