GSK says it will start making its BPH drug Avodart (dutasteride) at its facility in Poznan, Poland when it completes a PLN70m (€17m) capacity upgrade in January next year.
The UK drugmaker said that the plant, which will take over production from a facility in France, will be fitted out with PLN54m worth of new manufacturing equipment and produce around 600m Avodart soft gelatine capsules each year
GlaxoSmithKline (GSK) Poland said that while the move is motivated by a desire to reduce costs, the transfer also indicates the breadth of its global drug manufacturing network.
Jerzy Toczyski, president of GSK Poland, explained that: “The fact that the product will be manufactured and packaged in Poznan shows great potential and confidence [in the unit’s facilities and personnel].”
The plant, which has been the focus of some PLN400m of infrastructure investment since GSK acquired it from Polfa Pozana in 1998, will supply Avodart to around 80 pharmaceutical markets around the world.
Decision Resources recently said that Avodart, which generated revenue of £399m (€277m) in 2008, will be replaced as its proprietary clinical “gold standard” drug for benign prostatic hyperplasia treatment by Duodart, also made by GSK, in 2013.
Avodart is also due to loose patent protection for BPH in the US in 2015 and is likely to face an increasing number of generics challenges in the interim from non-branded drug producers.
However, despite these issues, GSK still appears to have plans for the drug, specifically as an agent that reduces the risk of prostate cancer.
In April GSK reported clinical data showing that Avodart cut the risk of developing the disease 23 per cent in men aged 50 to 75 who have elevated prostate-specific antigen levels.
The findings, reported at the American Urological Association’s meeting in Chicago, also showed the drug did not increase the incidence of high-grade tumours compared with the control group, which has been a problem for other candidate treatments.
As a result, market analysts said that approval in this indication could see Avodart generate sales of $1bn, which would undoubtedly be a boost for GSK, particularly as patent loss looms.
However, this optimism was tempered later in the year when the firm withdrew its application from the US Food and Drug Administration (FDA), telling the Associated Press that it plans to submit an updated dossier.
Speaking at the time of the withdrawal in November, GSK said it planned to file Avodart for prostate cancer “shortly” in both the US and Europe, although as yet has not done so.