Trending
Stocks.org
You are at:»»BioDelivery Sciences Receives Favorable Court Ruling
biodelivery

BioDelivery Sciences Receives Favorable Court Ruling

1205
By on BioPharma

On Wednesday, BioDelivery Sciences received a positive court ruling when the judge presiding over the case between Reckitt Benckiser and BioDelivery Sciences dismissed the case for procedural reasons. Reckitt had been suing BioDelivery Sciences over infringement of U.S. patent No. 8,475,832 and was attempting to block BioDelivery Sciences from launching its Bunavail product pending an approval near the product’s PDUFA date of June 7.

With the dismissal, BioDelivery Sciences will be free to launch Bunavail pending an approval. Although we expect Reckitt to refile its lawsuit if Bunavail is approved, we believe that Reckitt’s chances of receiving a preliminary injunction have been reduced. Management believes Reckitt may file for its preliminary injunction in another jurisdiction, which we would view as an admission of how poorly Wednesday’s hearing with Judge Terrence W. Boyle went for Reckitt.

Following discussions with management, the FDA review is tracking well; however, this is no guarantee of an approval. We believe the company has proven bioequivalence to the tablet formulation within the FDA’s standards, while the safety study showed the product was at least as safe as the brand but may have a benefit in reduced gastrointestinal adverse events given the improved absorption. While the CMC side is likely the largest risk in the review process, management has significant experience in manufacturing the BEMA technology given the Onsolis approval in 2009. Pending an approval, the company will launch the product in third quarter 2014.

Aside from the Bunavail PDUFA date on June 7, we also continue to expect to hear data from the second BEMA Buprenorphine Phase III clinical trial results in opioid-experienced patients with moderate to severe chronic pain to read out in early July. We also expect an interim analysis from the company’s recently initiated clonidine Phase III in neuropathic pain during the third quarter; final results could read out before the initial timeline of first quarter 2015.

Analysts continue to believe that the next six months for the company will be transformational ahead of the second of two pivotal data readouts and the potential launch of Bunavail into an over $1.5 billion market with a highly concentrated prescriber base. Bunavail will be a best-in-class product for the opioid addiction treatment market given the flexibility in dosing and the clinical profile that emerged from the company’s safety study. We continue to view BioDelivery Sciences as one of our top small-cap ideas based on what we believe will be positive developments for the company’s two main pipeline products, with Bunavail set to receive an approval in mid-2014 and top-line results from the company’s second pivotal BEMA buprenorphine chronic pain study by mid-year.

Get Free Updates and Stock Alerts!



*We only send one email per week
Share.

Related Posts

Get Winning Stock Alerts!

Our track record speaks for itself! Our last 7 alerts have delivered combined gains in excess of 300% and there are no signs of slowing down. Join UltimateStockAlerts.com now before you miss out on our next big runner!

We will never sell or share your information.
Close