Lilly plans trio of launches
pharmafile | October 4, 2013 | News story | Research and Development, Sales and Marketing | lilly, pipeline
Lilly plans to launch at least three new medicines next year, senior managers announced during a meeting with analysts and investors.
They include two drugs to treat type 2 diabetes – dulaglutide and empagliflozin, the latter of which is co-marketed with Boehringer Ingelheim – and ramucirumab in advanced gastric cancer.
Lilly has high hopes in particular for dulaglutide after it beat its three nearest rivals in reducing blood sugar earlier this year.
The GLP-1 receptor agonist was better at helping patients keep their blood sugar level low compared to Bristol-Myers Squibb’s diabetes treatment Byetta, generic metformin and Merck’s blockbuster pill Januvia.
In the three studies dulaglutide 1.5mg was superior to placebo and to Byetta, metformin and Januvia in reducing HbA1c (haemoglobin A1c) levels, and a greater percentage of patients treated with dulaglutide 1.5mg achieved an HbA1c goal of less than 7% versus all active comparators.
The findings suggest Lilly’s drug could be a blockbuster with these levels of efficacy against potential rivals – although if approved, it would have to compete with Novo Nordisk’s GLP-1 Victoza, which was not used in the head-to-head trials, but would be its nearest probable competitor.
Investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin is also on Lilly’s slate for launch next year in this therapy area.
Meanwhile it hopes ramucirumab will be used as monotherapy in second-line gastric cancer, where it has received fast track designation from the FDA – the company has been buoyed by a second positive Phase III trial, with the RAINBOW combination therapy study demonstrating both improved overall survival and progression-free survival.
Lilly appears quietly confident of positive decisions on these three drugs from regulators in the US and Europe.
Perhaps even more surprising than these are the positive results it garnered this year for necitumumab in patients with metastatic squamous non-small cell lung cancer (NSCLC).
This was a drug that seemed doomed to failure until it shocked analysts by helping late-stage lung cancer patients live longer – data which could form the basis for a regulatory submission as early as 2014.
Necitumumab met its primary endpoint in its latest Phase III trial by increasing overall survival in stage IV metastatic NSCLC with an EGFR mutation – a remarkable turnaround given that a late-stage trial of necitumumab was stopped because of concerns about its potential to cause blood clots several years ago.
The performance of all these products is important because Lilly is counting on them to help the company improve its fortunes after next year.
“We’ve undertaken extensive efforts to transform our company to address the challenge of patent expirations and the demands of patients and payers for greater value from medicine,” said Lilly chief executive John Lechleiter.
“We’re seeing our strategy bear fruit, backed by clinical data that strengthens our confidence in our innovation-based strategy and in our ability to return to growth,” he added.
Generic erosion, particularly from the patent loss on antipsychotic Zyprexa, has hit Lilly hard recently – the drug was once Lilly’s biggest-selling product, bringing in $5 billion in 2010.
The group says it will also make share repurchases adding up to $5 billion for shareholders ‘over time’.
Adam Hill
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