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BioDelivery to Grant New Patents for its Marketed Drugs

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BioDelivery Sciences International, Inc. recently announced its decision to grant two new patents to extend the patent life for all three of its marketed products, Belbuca (buprenorphine) buccal film, Bunavail (buprenorphine and naloxone) buccal film, and Onsolis (fentanyl) buccal soluble film. Both the patents will be listed in the orange book.

BioDelivery’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. Shares of the company gained 8.5% while the industry registered an increase of 3.9%.



Please note that Belbuca was approved by the FDA in Oct 2015 for chronic pain management. Bunavail was approved by the agency in Jun 2014 as a maintenance drug for opioid dependence, while Onsolis was approved in 2009 for pain management.

The patent with serial no. 15/212,912 covers the composition of the BioErodible MucoAdhesive (BEMA) drug delivery technology, which forms the basis for Belbuca and Bunavail. It provides additional coverage for both the drugs up to Jul 2027. Additionally, the patent with serial no. 9,597,288 extends patent protection on Onsolis from Jan 2020 to Jul 2027.

We note that BioDelivery re-acquired North American rights to Onsolis from Meda and signed a licensing agreement with Collegium Pharmaceutical to market the drug in the U.S. in May 2016. Pursuant to the licensing agreement, BioDelivery will grant the patent upon receiving a $3 million milestone payment from Collegium, which is subject to securing the FDA approval of a supplemental application supporting the new manufacturer for Onsolis. BioDelivery is entitled to receive another $4 million milestone payment on first commercial sale of Onsolis.

We remind investors that Onsolis’ marketing was temporarily suspended in 2012, following discussions with the FDA regarding certain appearance-related issues raised by the agency during an inspection of Aveva’s manufacturing facility, the company’s North American manufacturing partner for Onsolis. Currently, Onsolis is expected to be re-launched in the U.S. by Collegium by mid-2017.

Zacks Rank & Key Picks

BioDelivery currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Heska Corporation and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018 over the last 30 days. The company posted positive surprises in three of the four trailing quarters with an average beat of 291.54%.

Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.

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