Opiant Pharmaceuticals, Inc., a specialty pharmaceutical company developing pharmacological treatments for addictions and drug overdose, and Consort Medical plc ("Consort") (LSE: CSRT), a leading contract development and manufacturing organization, today announced a development and manufacturing agreement for Opiant’s OPNT003 (intranasal nalmefene), a potent, long-acting opioid antagonist for the treatment of opioid overdose.

Under this agreement, Aesica and Bespak, wholly-owned subsidiaries of Consort, will work with Opiant to produce a pre-filled delivery nasal spray with nalmefene. As part of the agreement, Aesica will supply Opiant with clinical samples and registration batches for the purposes of performing clinical studies and obtaining regulatory approvals. Further, upon approval by the U.S. Food and Drug Administration (FDA), Aesica and Bespak will manufacture and supply the commercial device for Opiant.

"We are extremely pleased to be working with a group as highly-regarded as the Consort team," said Roger Crystal, M.D., Chief Executive Officer of Opiant.  "OPNT003 has the potential to be a transformative treatment for opioid overdose, and Consort’s significant expertise in inhalation technologies will help support our lead product candidate through commercialization."

"We are delighted to announce this agreement with Opiant, which highlights our expertise in the nasal delivery of drugs and the value of our unique offering of providing both drug manufacturing and delivery capabilities alongside one another," said Jonathan Glenn, Consort’s Chief Executive Officer.

Following the completion of OPNT003 formulation studies, Opiant intends to initiate a confirmatory pharmacokinetic study in early 2019.  Based on previously obtained feedback from the FDA, Opiant intends to pursue a 505(b)(2) development path for OPNT003.  Opiant anticipates the potential to submit a New Drug Application for the drug and intranasal delivery device combination in 2020.  Opiant retains full commercial rights to OPNT­003, and this development work is largely funded by a $7.4 million National Institutes of Health (NIH) grant.

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