Lilly (LLY) Gets FDA Nod for Once-Daily Version of Synjardy
Eli Lilly and Company LLY announced the FDA approval of an extended-release formulation of its type II diabetes prescription drug Synjardy.
The approval provides patients with a type II diabetes treatment in a once-daily dosing option.
Synjardy XR tablet is a combination of Jardiance (SGLT-2 inhibitor), another type II diabetes drug in Lilly’s portfolio, and metformin, to help improve blood glucose levels in adults with type 2 diabetes when used along with diet and exercise.
Lilly’s share price has slipped 12.2% in the past one month, underperforming the 2.4% decrease witnessed by the Zacks classified Large-Cap Pharma industry.
Coming back to the latest release, Synjardy XR is the eighth diabetes medicine to be marketed by Lilly under its Jan 2011 partnership agreement with Boehringer Ingelheim. Other drugs developed under the partnership include Tradjenta, Jentadueto, Jardiance, Synjardy, Glyxambi, Basaglar and Jentadueto XR.
Interestingly, Synjardy XR is also the fourth FDA-approved treatment to contain Jardiance.Lilly’s diabetes franchise has been making it to the headlines lately. Last week, the company announced that the FDA has approved the inclusion of cardiovascular (CV) risk reduction data from the EMPA-REG OUTCOME study in Jardiance’s label.
Note that Jardiance had been approved in 2014 for lowering blood sugar in adults with type II diabetes. With the inclusion of the EMPA-REG OUTCOME data, the drug can be used to reduce the risk of cardiovascular death in adults with type II diabetes.
With about 50% of global deaths in type II diabetics resulting from CV disease, last week’s data addition to Jardiance’s label is expected to bolster sales of the drug significantly.
We remind investors that the diabetes market is pretty crowded given the presence of companies like Novo Nordisk A/S NVO, Johnson & Johnson JNJ and Merck & Co. Inc. MRK.
The Jardiance expanded indication is expected to give Lilly a competitive advantage over the other oral-type II diabetes medicines
Other diabetes drugs in Lilly’s portfolio like Glyxambi and Synjardy could also benefit as both belong to the Jardiance family. Approval of the extended-release version should propel sales of Synjardy further.
Meanwhile, in a separate press release, Lilly announced a 2% hike in its quarterly dividend to 52 cents per share from the previous payout of 51 cents. This amounts to an annual dividend of $2.08, resulting in an annual dividend yield of 3.1%. The revised dividend is payable on Mar 10, 2017, to shareholders of record as of Feb 15, 2017.
LILLY ELI & CO Price and Consensus
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Lilly has a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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