Eli Lilly is hoping to restart a phase III trial programme for pain treatment tanezumab later this year, providing the US FDA relaxes a block on testing of the drug.
The antibody drug targets nerve growth factor (NGF) and – if approved – would represent a completely new drug class for chronic pain conditions, including osteoarthritis and cancer-related pain.
Tanezumab was placed under a complete clinical hold by the FDA in 2010 after being linked to a rare side effect called osteonecrosis, although this was relaxed after an advisory panel concluded there was no evidence the reported cases were caused by the drug.
In 2012 however a new partial clinical hold on the entire class of anti-NGF drugs – which also includes fulranumab from Johnson & Johnson (J&J) and Regeneron’s fasinumab (REGN475) – after peripheral nervous system effects were seen in animal studies.
Trials in pain could continue if patients were selected carefully, said the agency, although it still wanted to see some non-clinical data on tanezumab and other drugs in the class before it would allow the studies to restart.
Lilly licensed co-development rights to tanezumab from Pfizer in 2013, hoping for a renaissance in the NGF class that at before the clinical hold been predicted to become a $10bn-plus category, and at the time Pfizer indicated it expected to file that data with the US regulator in the first half of 2014.
Advancing the programme into phase II will result in Lilly paying a $200m milestone payment to Pfizer, said Lilly’s chief financial officer Derica Rice. The company also suggested that if studies to resume results will probably not be available until “beyond 2016”.
Revenues slide
Sales fell 12% to $5.1bn at Lilly as generic competition to osteoporosis drug Evista (raloxifene) and antidepressant Cymbalta (duloxetine) took hold. The two drugs lost $700m in US sales during the fourth quarter, taking the revenue impact for the full year above $4bn.
The company has revised its guidance for 2015 downwards, saying it now expects full-year revenues of $19.5bn-$20.0bn rather than its earlier estimate of $20.3bn-$20.8bn, although it has kept its earnings per share prediction at $3.10-$3.20.
Lilly is banking on the performance of a crop of products launched last year – Cyramza (ramucirumab) for gastric cancer and Jardiance (empagliflozin) and Trulicity for diabetes – to halt the decline in its revenues.
Cyramza achieved sales of $34m in the fourth quarter, but Lilly has not divulged initial sales of the other two drugs.