Benzinga | Aug 4, 2021 07:31AM EDT

BioDelivery Sciences International To Acquire US And Canadian Rights To ELYXYB From Dr. Reddy's Laboratories For Upfront Payment Of $6M Plus An Additional $9M

The only FDA-approved, ready-to-use oral solution for the acute treatment of migraine with or without aura in adults

First step to building a growth platform in Neurology

Patent protection until 2036

RALEIGH, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, announced today that it entered into an agreement on August 3, 2021 with Dr. Reddy's Laboratories Limited to acquire the U.S. and Canadian rights to ELYXYB (celecoxib oral solution), the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.

"ELYXYB represents an excellent strategic fit for BDSI and a very attractive opportunity to diversify our product portfolio by expanding into the dynamic migraine market, deepening our presence in Neurology, a logical adjacency to our pain franchise," stated Jeff Bailey, CEO of BDSI.

"ELYXYB will contribute nicely to the Company's revenue growth and profitability over time. This transaction leverages our commercial expertise and much of our existing infrastructure. We see this acquisition as establishing a great growth platform in Neurology. Further, the deal structure is attractive, allowing us to maintain our strong balance sheet and position us to pursue additional value-enhancing business development opportunities," Bailey concluded.

ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption1. This allows for the administration of a lower dose of drug to achieve therapeutic effect relative to a conventional oral solid dosage form. In pivotal studies, ELYXYB demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks. The results from pivotal studies established the efficacy of ELYXYB in the treatment of acute migraine. For adult patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options. ELYXYB's unit-dose oral solution makes it convenient for patients to take it immediately upon emergence of acute migraine attacks.

With over 13 million migraine patients receiving prescription drug treatment in the U.S. in 2020, the dynamic migraine market continues to grow and evolve, including with new product introductions. BDSI will be conducting an ELYXYB pediatric study which has the potential to address the significant unmet need in the pediatric patient population.

Under the terms of the agreement, ELYXYB will be acquired for an upfront payment of $6 million, plus an additional $9 million on August 3, 2022. BDSI will make tiered quarterly earn-out payments on potential net sales ranging from the high single digits to the low double digits. Additional payments will be made contingent upon the achievement of certain regulatory and sales milestones. The impact of the acquisition is estimated to be cash flow accretive within approximately 24 months of commercial launch, currently planned for Q1 2022. The closing of the transaction is subject to satisfactory completion of customary closing conditions, including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).

"We are excited to acquire ELYXYB," said Thomas Smith, MD, Chief Medical Officer at BDSI, and a former thought leader in the migraine space with over 30 years of experience both as a physician and with multiple migraine product developments and launches. The clinical data are quite compelling, including a meaningful speed of onset with Tmax achieved in approximately 60 minutes. Additionally, in the two pivotal studies conducted, the percentage of patients achieving Most Bothersome Symptom (MBS) freedom at two hours post-dose was significantly greater among patients receiving ELYXYB, compared to those receiving placebo. In Study 2, the percentage of patients achieving headache pain freedom two hours post-dose was significantly greater among patients receiving ELYXYB, compared to those receiving placebo. We believe that this profile, coupled with the ready-to-use oral solution, make ELYXYB an attractive option for the acute treatment of migraine in adults."

The Company plans to conduct a BDSI investor day early in the fourth quarter, where further details regarding ELYXYB will be shared.

Please see Important Safety Information about ELYXYB below.