Eli Lilly & Co (LLY -1.81%) snagged a win (or at least avoided a loss) this week, announcing that its projected blockbuster GLP-1 agonist diabetes medication dulaglutide was comparable to current lead treatment Victoza (liraglutide) by Novo Nordisk (NVO -1.93%).
Non-inferiority?
The fanfare surrounding this 'non-inferiority' isn't necessarily inflated. This is the first time any GLP-1 has measured up to Victoza, measured by HbA1c levels over 26 weeks. This is an indicator of the average blood sugar levels in patients from the prior 90 days, and Lilly already proved superiority, not just non-inferiority, to AstraZeneca's (AZN 0.49%) Byetta (exenatide), Merck's (MRK 0.10%) Januvia and first-line diabetes treatment metformin.
It should be noted that Lilly's dosing would be once weekly as opposed to once daily and may gain some clinical benefit in patient compliance as a result of that easier regimen. Otherwise, however, dulaglutide and Victoza really are quite equitable. Side effects were similar, with gastrointestinal effects most common. Phase II studies have shown a weight-loss effect in patients, but Victoza and other GLP-1 drugs have similar benefits.
Full data from this trial (AWARD-6) were not released, but are expected to be presented later this year in addition to data from AWARD-2 (dulaglutide vs. insulin glargine) and AWARD-4 (dulaglutide+insulin lispro v. insulin glargine + insulin lispro ). AWARD-6 examined dulaglutide v. the maximum dosage of Victoza in 599 patients currently taking metformin.
Dulaglutide has already been submitted for marketing approval with both the FDA and EMA, and the company's medical director has projected approval this year. If approved, this would be a major victory for Lilly, following several pipeline failures for Alzheimer's disease (solanezumab), schizophrenia (pomaglumetad methionil) and rheumatoid arthritis.
About those competitors
Dulaglutide would be the first approved once-weekly and 'ready to use' GLP-1 agonist, and analysts project sales of dulaglutide to be anywhere from $700 million to $2 billion. Meanwhile, Eli Lilly continues to develop empagliflozin, an SGLT2 diabetes treatment, although it will likely lag dulaglutide's approval.
Interestingly, twice-a-day Byetta, also a GLP-1 agonist, was originally Eli Lilly's product with partner Amylin. When the two companies broke up, Amylin and Byetta were sold to Bristol-Myers Squibb (BMY -0.27%) and AstraZeneca (NYSE:AZN ); Bristol-Myers since sold its stake in diabetes to AstraZeneca.
Exenatide, the chemical name of Byetta, is also marketed as once-weekly dosing Bydureon by AstraZeneca. Bydureon is the only once-weekly GLP-1 agonist currently marketed, but Eli Lilly was careful to call dulaglutide 'ready to use', offering a direct contrast to the need for pre-mixing Bydureon prior to injecting it with a large needle.
The flurry of activity surrounding ownership of Amylin and Byetta/Bydureon set back sales of Bydureon, and now the positive results coming from Eli Lilly's dulaglutide may present significant competition to AstraZeneca as well. AstraZeneca is looking at a pen-delivery system that would solve both problems of pre-mixing and the large bore needle necessary for injection.
Looking at diabetes share, Eli Lilly is staunchly secure at least historically in the market as being the first to mass-produce insulin. Humalog is still a major product for Lilly, and AstraZeneca certainly suffers from not having any insulin product in its repertoire. However, Novo Nordisk is the behemoth to beat (or aspire to) when it comes to diabetes.
Novo Nordisk's Victoza currently owns about 70% of the GLP-1 market with sales on target to beat $2 billion this year. The Danish drug company comes from a position of superiority over the struggling Eli Lilly, particularly having recently reported fourth quarter earnings well above estimates. The company is most dominant in diabetes, although it also has reach in both hematology and other hormones, nabbing an approval for NovoEight last year for hemophilia and filing with the FDA and EMA last December for use of liraglutide in obesity.
Bottom line
Diabetes could be Eli Lilly's saving grace, and the company's historic presence in the field is on its side. 'Non-inferiority' to Victoza is perhaps not exciting investors as much as executives would like, as shares only received a slight bump with the announcement. However, it would nonetheless be an improvement over the dry spell inapprovals. And an approval is more important than anything to prove CEO John Lechleiter's strategy to continue focusing on R&D rather than the dealmaking and buyouts others in Big Pharma have turned to.
Lilly, besides having to prove itself by R&D, has been struggling from patent expirations such as its antidepressant Cymbalta and antipsychotic Zyprexa, but it has been having some positive news as of late. Fourth quarter sales were better than expected given the generic competition against Cymbalta, buffered by price increases in some of its other prescription drugs. From the R&D front, the company also released positive data in lung cancer for its blockbuster hopeful ramucirumab, an agent with weak success in stomach cancer but phase III failure for breast cancer.
Lilly hopes to secure approval for dulaglutide, empagliflozin and ramucirumab this year, but it is dulaglutide that leads the bunch on likelihood and projected peak sales. It is uncertain if non-inferiority is good enough to revive Lilly from its dry spell, but there is some solid potential.
