Last year's FDA delay on Novo Nordisk's Tresiba was a major setback for the long-acting insulin that analysts said would severely dampen its earnings potential. But in the ever-changing pharma landscape, a new development has Novo CEO Lars Rebien Sørensen thinking the company may still get Tresiba to the U.S. market ahead of any significant competition.
Last year's stinging FDA rejection for Novo Nordisk's Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.
Three's a charm for Novo Nordisk and its recombinant Factor XIII compound for a rare bleeding disorder. After receiving a complete response letter in 2012 and then again this August, the drugmaker has gotten FDA approval for Tretten. It is an end-of-the year win in what has been a sometimes difficult year for the Denmark-based company.
In February, the FDA refused to approve diabetes drug Tresiba and its sister drug Ryzodeg without more safety data. But Novo Nordisk waited two days to reveal that info to the public--and Danish authorities aren't happy about that.
Novo Nordisk, the world leader in insulin products, took a big hit this year when the FDA denied approval of its newest long-lasting insulin drug, Tresiba. But CEO Lars Rebien Sørensen is taking every opportunity to let the markets know that Novo has lots of growth in its business.
As Lilly Diabetes President Enrique Conterno tells Bloomberg, the company plans to lean on its broad product portfolio to grow sales, rather than sending out legions of reps to push new drugs brand-by-brand.
Novo Nordisk's quarterly sales hit 21.38 billion kroner, or about $3.8 billion. Profits amounted to 6.7 billion kroner. And now, the company expects 2013 sales to grow by 11% to 13%, with operating profits up 12% to 15%; previously it was looking for sales growth of 9% to 11%.
The prevalence of diabetes is growing globally, and with that the size of the diabetes drug market. But the market has gotten increasingly competitive and increasingly complex. All of the top 10 best-selling drugs in the diabetes category are blockbusters, according to EvaluatePharma. So who makes them? Check out the report >>
Novo Nordisk's current blockbuster, Victoza, continues to rack up impressive sales increases despite the FDA's refusal to approve the Danish drugmaker's blockbuster hopeful Tresiba. But now, more trouble is looming, or so say analysts from Bank of America Merrill Lynch.
As a major medical meeting brings the spotlight to new diabetes drugs this month, Sanofi has begun reaching out to the media to secure center-stage status for data on its new therapies. The French drug giant has a next-generation version of its best-selling insulin drug Lantus as well as a combo therapy that have implications for its future in the market.