NEW YORK (AP) — Shares of drug development contractor PPD Inc. fell Thursday after the company said it would take several more years to seek European approval of the diabetes treatment candidate alogliptin. The company’s partner, Takeda Pharmaceutical, is postponing a submission with European regulators as it conducts an additional two-year study on the drug candidate. Wilimington, N.C.-based PPD said it would not receive an expected $10 million payment from Japan-based Takeda in 2009 and a submission isn’t expected until 2012. The stock shed 71 cents, or 3.4 percent, to reach $20.32 in midday trading. Shares have traded between $17.97 and $45.72 over the last 52 weeks. In March, PPD made a similar announcement, saying it no longer expected a $25 million payment from Takeda after that company raised concerns of a regulatory delay for alogliptin. PPD also said the Food and Drug Administration does not believe the existing study data for the drug is sufficient to meet certain requirements. That agency has a June 26 deadline for making a decision on the drug candidate’s status. Deutsche Bank-North America analyst Ross Muken reaffirmed his “Hold” rating on PPD, but cut the price target to $22 from $22.50, citing uncertainties with alogliptin. “While this should not come as a major surprise to investors given the FDA statement in March, the lengthy nature for the study was a surprise,” he said, in a note to investors. “This underlies our thesis that PPD’s discovery segment introduces an added element of uncertainty.” He also lowered his full-year profit outlook to $1.45 per share from $1.50 per share. Meanwhile, William Blair & Co. analyst John Kreger reaffirmed a “Market Perform” rating, saying FDA approval will likely also be delayed because of new cardiovascular safety guidelines. He also lowered his profit outlook for the year, to $1.34 from $1.40. The delays have been a key setback for the companies’ diabetes program as they try to position themselves in the highly competitive diabetes treatment market. Alogliptin is part of the DPP-4 class of diabetes drugs, which works by controlling blood sugar. Merck & Co. already markets a drug in that class, called Januvia, while Bristol-Myers Squibb Co. and AstraZeneca have their drug candidate saxagliptin, or Onglyza, under FDA review. Other competitors include drugs from the GLP-1 class, which also control blood sugar. They include Amylin Pharmaceuticals Inc. and Eli Lilly’s Byetta, with a next-generation version called exenatide LAR under review. Novo Nordisk, meanwhile, is seeking approval for its GLP-1 drug, liraglutide.
