Novo Nordisk has had sales of $2.3 billion in the first nine months of the fiscal year for Novo Nordisk, representing 12% growth. Novo continues to be the leader in the diabetes market with a huge portfolio of insulin drugs. The company had a global insulin share of 48%, including 40% in the United States as recent as the third quarter. More importantly, in what is considered new generation treatments, Novo has a share of 46% globally and 39% in the United States.
Biodel is hoping its treatments will improve the time for diabetes patients when injecting insulin. Old-school insulin injections take 120 to 180 minutes for patients. New, rapid-acting methods take 50 to 70 minutes, which greatly boosts prior performances. However, Biodel has shown in several studies that it can improve on the success of Novo and Eli Lilly with shorter delivery times. Results have also shown that those taking the insulin need a lower amount throughout the day from Biodel versus other companies existing insulin injections.
The small setback from Biodel's clinical trials was a higher pain level at the point of impact than other existing drugs. This higher rate was minimal and was only listed as "mild" pain for those that reported it. Better yet, Biodel's BIOD-250 provided better injection site results than other Biodel drugs such as BIOD-090 and BIOD-100.
On Dec. 17, Biodel announced it had entered a manufacturing agreement with Becton Dickinson (BDX). Biodel shares were up by double digits on the announcement, which should power an already strong pipeline. The deal gives Biodel exclusive rights to Becton Dickinson's BD Uniject SCF Disposable Auto-Disable Injection System for delivery of liquid glucagon to treat severe hypoglycemia. Even though the glucagon market isn't as big as insulin, it presents a large opportunity for a company with a market capitalization under $50 million.Every year, over 200,000 people are hospitalized for severe hypoglycemia. Fewer than 10% of high-risk patients carry an emergency kit. The current kits are bulky and costly, a problem that could be solved by Biodel. A current market worth $125 million in the United States is believed to expand significantly, according to Biodel. Look at this list of upcoming catalysts:
- First half of 2014: top-line data phase 1 concentrated ultra-rapid-acting insulin
- First half of 2014: possible phase 3 trial for RHI ultra-rapid-acting insulin
- Second half of 2014: submit IND glucagon
- Second half of 2014: initiate pivotal clinical trial glucagon
- 2015: submit NDA glucagon