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BioXcel Therapeutics Enters Asset Sale Agreement with Teva

BioXcel Therapeutics (BTAI) announced that it has entered into an asset sale agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries (TEVA), for substantially all of the company's assets. This includes IGALMI sublingual film and the related pending supplemental New Drug Application of BXCL501 for potential at-home use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Concurrent with the execution of the asset sale agreement, BioXcel Therapeutics and its subsidiaries, OnkosXcel Therapeutics, LLC and OnkosXcel Employee Holdings, LLC, have commenced voluntary Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware to facilitate a court-supervised sale process, which is expected to include the auction of substantially all of the company's assets. To anchor the sale process, Teva will serve as the sole "stalking horse bidder" for the sale of the assets contemplated by the asset sale agreement. A stalking horse asset sale agreement establishes a strong baseline offer and is intended to help maximize value for all stakeholders through the Chapter 11 auction process.

Teva Bids to Acquire Innovative Neuroscience Product from BioXcel

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries (TEVA) announced it has made a bid to acquire an innovative neuroscience product from BioXcel Therapeutics (BTAI) through a court-supervised sale process. The novel dexmedetomidine sublingual film is under U.S. FDA review for potential at-home use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. If approved, it could become the first FDA-approved at-home treatment for this condition. If the transaction is completed, the asset would expand Teva's psychiatry portfolio and, pending FDA approval, could help address a meaningful unmet need for people living with complex mental health conditions. Teva has entered into an agreement with BioXcel Therapeutics, Inc., to serve as the "stalking horse bidder" in a court-supervised auction process, pursuant to Section 363 of Chapter 11 of the U.S. Bankruptcy Code, for the purchase of certain assets from BioXcel Therapeutics and its affiliates, including IGALMI, its dexmedetomidine sublingual film. As the stalking horse bidder, Teva's proposal establishes the initial bid for the assets. The proposed transaction does not involve the acquisition of BioXcel Therapeutics as a whole. Teva would acquire the agreed-upon assets if Teva is selected as the successful bidder during the auction, required conditions are satisfied, and the transaction is approved by the Bankruptcy Court. If Teva is not the successful bidder, Teva would be entitled to a break-up fee and expense reimbursement, subject to the terms of the agreement. Under the terms of the Agreement, Teva would acquire worldwide rights to the assets including dexmedetomidine sublingual film for an upfront payment of $57.5M and up to an additional $67.5M in contingent payments. These include a range of time-based payments linked to the timing of the pending FDA approval, including potential delays in approval, as well as payments tied to the achievement of specified sales milestones.

Aurinia Settles Patent Litigation with Teva Pharmaceuticals

Aurinia Pharmaceuticals (AUPH) announced that it and its subsidiary, Aurinia Pharma U.S., Inc., have entered into a settlement agreement with Teva Pharmaceuticals Inc. (TEVA) to resolve patent infringement litigation relating to Teva's filing of an Abbreviated New Drug Application seeking to market its generic 7.9 mg voclosporin oral capsules in the United States. Under the terms of the settlement, Teva has stipulated that Aurinia's U.S. Patent Nos. 10,286,036 and 11,622,991 (which expire in December 2037) are enforceable, valid, and would be infringed by commercial sales within the United States of its generic voclosporin product. The settlement further provides that Teva may launch its generic voclosporin product no earlier than December 7, 2036, unless certain defined contingencies occur earlier. Teva's ability to market its generic voclosporin product in the United States will also be contingent on Teva obtaining approval from the United States Food and Drug Administration. Aurinia's related patent infringement actions continue against each of DifGen Pharmaceuticals LLC, Dr. Reddy's Laboratories, Inc. and its affiliate, Galenicum Health S.L.U., Hikma Pharmaceuticals USA Inc., Lotus Pharmaceutical Co. Ltd. and its affiliate, Sandoz Inc., and Zydus Pharmaceuticals (USA) Inc. and its affiliate, in the United States District Court for the District of New Jersey.