Shire PLC (ADR) (NASDAQ:SHPG) had recently heralded a rare liver disease drug SHP625 as an example of its development program. However, the drug has flopped against both the primary and secondary end points in the first of many Phase II studies.
Researchers for Shire had focused on serum bile acid levels and pruritis endpoints for 20 pediatric patients with Alagille syndrome. Shire reported that the mean serum bile acid levels and pruritis had dropped by the end of week 13 for both the drugs.
Shire had acquired SHP625 in a $260 million deal to buy Lumena eleven months ago. Shire expected to get a speedy approval for the drug. Along with LUM002, the potential sale of the drug was estimated at $3 billion.
However, according to Bernstein’s Ronny Gal, the latest development has cast a shadow over the whole program. The program has two more mid-stage studies that will be read out later in the year. Gal recognizes that though the effort will not be abandoned, the latest failure makes it difficult for Shire in the short term.
Gal further adds that while the smaller trail is tougher to accept, the lack of substantial serum bile acid reduction from IMAGO makes the full SHP625 program less likely to succeed. The sales of the drug are pegged at around $2 billion by Gal.
Talking on the latest development, Philip Vickers, Shire’s R&D chief stated that the company has gained important insights in the development of the SHP625 program.
In related news, Shire PLC (ADR) (NASDAQ:SHPG) announced that the USFDA has accepted for filing the New Drug Application for lifitegrast and granted a Priority Review designation. Lifitegrast is a new treatment for dry eyes in adults if approved would be the first to address both signs and symptoms. The FDA is expected to give a decision on October 25, 2015.