Shire plans four key drug filings
pharmafile | May 17, 2005 | News story | Sales and Marketing |Â Â Â
Shire Pharmaceuticals hopes to strengthen its ADHD portfolio and establish itself in the global gastrointestinal market with a number of key drug filings this year.
The company updated investors on the progress of four drugs it aims to file this year in a review of its R&D pipeline.
The company's new ADHD (Attention Deficit Hyperactivity Disorder) treatment SPD503, is a non-stimulant treatment which it hopes to submit to the FDA in the fourth quarter of this year.
The UK company is already a major player in the ADHD market with its top-selling Adderall XR drug, but this could face generic competition next year.
Non-stimulant drugs are generally considered less effective than stimulants in treating ADHD, but Shire is hoping SPD503 will compete with Lilly's Strattera in the smaller non-stimulant market.
Another ADHD treatment, NRP104, could further bolster its position within this market. The drug is a stimulant that appears to be inactive until metabolised in the gastro-intestinal tract, which make it less open to overdose or abuse. NRP104 is being co-developed with New River Pharmaceuticals, which is due to publish phase III data on the drug shortly.
Meanwhile, SPD476 represents Shire's first global GI (gastrointestinal) drug and is expected to be filed in the US by the end of the year.
The drug is being filed for the treatment of ulcerative colitis, a disease of the large bowel and rectum in which the lining of the bowel becomes inflamed.
SPD476 has a novel formulation of mesalazine, the active ingredient used to treat the symptoms of ulcerative colitis. Unlike similar drugs on the market, it contains more of the active ingredient in a form that can prolong anti-inflammatory effect.
Shire hopes it will be approved for once-daily dosing, which would be an improvement on market leader Procter & Gamble's Asacol. Phase III trials of SPD476 demonstrated significant improvement over placebo in patients with acute, mild to moderate ulcerative colitis, with adverse effects similar to placebo.
The company also plans to resubmit its methylphenidate transdermal system (MTS) patch for ADHD. The drug, developed with Noven Pharmaceuticals, was rejected by the FDA in 2003.
Chief executive officer Matthew Emmens said the company aims to build on the success of 2004, when a wave of new drugs were approved in the US and Europe.
These were Fosrenol, Equetro, Pentasa, Xagrid and a new extended release version of Adderall.
Fosrenol is an innovative new treatment which controls phosphate levels in renal dialysis patients and gained European approval in early 2004.
Xagrid (anagrelide) reduces elevated platelet counts in 'at risk' patients with essential thrombocythaemia. It is licensed for use in patients intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by current therapy.
The drug has just suffered a setback in Scotland where clinical and cost-effectiveness watchdog the SMC has not recommended it for use, saying its cost-effectiveness has not been demonstrated.
Equetro is an extended-release carbamazepine formulation for bipolar disorder and Pentasa is a treatment for ulcerative colitis.
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