Shire Pharmaceuticals of the UK gave an upbeat update on its product pipeline at an analysts briefing yesterday, highlighting four products due for filing through the remainder of 2005.
The company, which launched six products during 2004, is currently sitting on a pipeline that - at least in numerical terms - would make a much larger pharma company proud. However, Shire’s share price did not respond to the announcement, closing down fractionally at £5.69, although it had risen over the preceding days in anticipation of the presentation.
The highlight of the show was arguably SPD476, a drug for ulcerative colitis that in a Phase III clinical trial proved superior to placebo and also did better than Procter & Gamble’s Asacol (mesalamine), which leads the $500 million dollar-plus market for ulcerative colitis drugs [[22/01/02f]].
Shire believes SPD476, also based on mesalamine, could become the drug of choice for ulcerative colitis, as its novel delivery mechanism – getting the active drug directly to the colon where it is needed – should mean that high doses can be delivered in a simple, once-daily format, with minimal side effects. It is due for filing in the USA before the end of the year.
The UK firm also said that it planned to resubmit its methylphenidate patch, MTS, for the treatment of attention deficit hyperactivity disorder, partnered with Noven Pharmaceuticals, that was turned down by the US Food and Drug Administration in 2003 [[29/04/03b]]. Shire needs new product introductions to bolster its ADHD franchise as its Adderall XR (mixed amphetamine salts) product gears up for generic competition [[12/04/05d]] and weathers the effects of being withdrawn from the market in Canada [[04/03/05c]].
Shire now expects to file the new MTS application in the USA in the second quarter of this year, and says new clinical data should overcome the deficiencies in its first submission. Once filed, MTS is set for a six-month review period. The company is also planning a submission this year for two other ADHD treatments. These are the non-stimulant drug SPD503 (guanfacine) that will compete with Eli Lilly’s Strattera (atomoxetine HCl), and NRP104, a prodrug of amphetamine partnered with New River Pharmaceuticals that is said to have reduced potential for abuse.