Agreements

Date: 2015-04-06

Type of information: Collaboration agreement

Compound: gene therapies for cardiovascular diseases

Company: BMS (USA - NY) uniQure (The Netherlands)

Therapeutic area: Cardiovascular diseases

Type agreement:

collaboration

Action mechanism:

gene therapy. 

Disease: cardiovascular diseases

Details:

* On April 6, 2015, BMS and uniQure announced an agreement that provides BMS with exclusive access to uniQure’s gene therapy technology platform for multiple targets in cardiovascular diseases. The collaboration includes uniQure’s proprietary gene therapy program for congestive heart failure that is intended to restore the heart’s ability to synthesize S100A1, a calcium sensor and master regulator of heart function, and thereby improve clinical outcomes for patients with reduced ejection fraction. Beyond cardiovascular diseases, the agreement also includes the potential for target-exclusive collaboration in other disease areas. In total, the companies may collaborate on ten targets, including S100A1. uniQure will lead discovery efforts and be responsible for manufacturing of clinical and commercial supplies using its vector technologies and its industrial, proprietary insect-cell based manufacturing platform. BMS will lead development and regulatory activities across all programs and be responsible for all research and development costs. BMS will be solely responsible for commercialization of all products from the collaboration.

uniQure and BMS anticipate the collaboration to be effective during the second quarter of 2015. The effectiveness of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. The initial issuance by uniQure of equity to BMS also is anticipated to close in the second quarter of 2015 and is subject to the approval by the shareholders of uniQure.

Financial terms:

Under the terms of the agreement, BMS will make near-term payments of approximately $100 million, including an upfront payment of $50 million to be made at the closing of the transaction, a $15 million payment for the selection of three collaboration targets, in addition to S100A1, to be made within three months of the closing and an initial equity investment in uniQure for a number of shares that will equal 4.9% of the total number of shares outstanding following such issuance, at a purchase price of $33.84 per share, or at least $32 million in total. BMS will acquire an additional 5.0% ownership before December 31, 2015, at a 10% premium, and will be granted two warrants to acquire up to an additional 10% equity interest, at a premium, based on additional targets being introduced into the collaboration. The parties have also agreed to enter into a supply contract, under which uniQure will undertake manufacturing of all gene therapy products under the collaboration.

uniQure will be eligible to receive research, development and regulatory milestone payments, including up to $254 million for the lead S100A1 therapeutic and up to $217 million for each other gene therapy product potentially developed under the collaboration. uniQure is also eligible to receive net sales based milestone payments and tiered single to double-digit royalties on product sales.

Latest news:

* On August 10, 2015, uniQure announced the receipt of an additional $53 million from BMS in accordance with the companies’ strategic collaboration to develop gene therapies to treat a range of cardiovascular diseases. BMS selected three new collaboration targets triggering a $15 million cash payment to uniQure. BMS also acquired an additional 1.3 million ordinary shares of uniQure priced at $29.67 per share, providing net proceeds to the Company of approximately $38 million. The purchase price represents an approximately 26% premium over uniQure’s closing price per ordinary share on August 7, 2015. After this second equity closing, Bristol-Myers Squibb owns 9.9% of uniQure’s outstanding ordinary shares.

Is general: Yes