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Sanofi's next-generation insulin shows promise
Sanofi just announced favorable phase 3 results for its new investigational insulin, U300, when compared to Lantus, its top-selling synthetic insulin, which generated $6.6 billion in revenue in 2012.
The upcoming patent expiration of Lantus in 2015 has caused concern among Sanofi shareholders since it represents the core of Sanofi's diabetes business, which is the second largest in the world after industry leader Novo Nordisk. Novo hit a snag earlier this year when its competing long-acting insulin, Tresiba, was rejected by the Food and Drug Administration, despite being approved in the EU and Japan.
Sanofi's newly released results from its EDITION II phase 3 study showed that U300 showed similar blood-sugar control as Lantus, with 23% fewer patients experiencing adverse events from low blood sugar levels at night.
The results were consistent with an earlier study, EDITION I, and was also conducted on patients with type 2 diabetes currently using basal insulin with mealtime insulin or an oral medication. In addition, Sanofi announced that it had met its primary endpoint in the six-month EDITION III, EDITION IV, and EDITION JP I studies, and full results from those trials will be presented next year.
Sanofi expects to submit U300 for regulatory approval in the U.S. and Europe in the first half of 2014. If approved, it should alleviate concerns about Lantus' looming patent expiration, so this is definitely a long-term positive catalyst for the stock.
Unilife set to soar on a new deal with Novartis
It's also going to be a busy morning for Unilife, which could surge today after striking a new deal with pharma giant Novartis (NYSE: NVS ) yesterday. Unilife makes prefilled syringes for other companies. Its syringes have retractable needles, like ballpoint pens, which protect medical professionals and patients from accidental injury and contamination.
This new deal with Novartis matters a lot since Unilife has been heavily dependent on one other large customer, Sanofi. Unilife and Novartis' original collaborative relationship commenced back in 2011. Another notable customer is Biodel, a much smaller biotech focusing on diabetes treatments.
Over the past five years, Unilife's volatile stock price has been mostly governed by such deals. The company is currently unprofitable, and its annual revenue has declined 75% over the past three years. As a result, its share price has steadily declined nearly 60% since its market debut in February 2010, although the stock has climbed back over 80% since the beginning of the year.
The reason for this rally was optimism that new deals with Sanofi, Biodel, and Novartis would lead to milestone and royalty payments that would revive its top-line growth. But many of Unilife's critics believe the company has a long way to go before those payments can translate into stable top-line growth and profitability.
The financial terms of the Novartis deal are confidential, but the companies have announced that Novartis will use Unilife's customized syringe, tubing, controller, and pump device for the administration of a novel investigational drug into a targeted organ.
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