The Medicines Company and Tenaxis Medical have announced an agreement for The Medicines Company to acquire Tenaxis.
Tenaxis’s sole product, which mechanically seals both human tissue and artificial grafts is approved, but not launched in the US – having received US PMA approval from the FDA in March 2013 as a vascular sealant.
The product is also approved with a European CE Mark as a surgical sealant applicable to cardiovascular, general, urological, and thoracic surgery.
The addition of the Tenaxis product adds another solution for surgical bleeding to The Medicines Company’s portfolio which also includes the marketed product, RecoThrom (aqueous, recombinant human Thrombin) and the investigational product, Fibrocaps (a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery) which has completed phase III trials and is under FDA and EMA review.
Under the terms of the agreement, The Medicines Company will pay $58m upfront on closing of the deal. The Medicines Company will also pay milestone payments of up to $112m contingent upon achieving certain commercial and – in pursuit of even broader indications – regulatory approval milestones. The transaction is subject to the satisfaction of customary closing conditions.
The Medicines Company chairman and CEO Clive Meanwell said: "We continue to execute our strategy for growth, building our presence in surgery and perioperative care."
In a pivotal trial in vascular surgery, the Tenaxis sealant was effective when used as prophylactic treatment on native vessels and grafts, reducing the incidence of bleeding within the first minute after removal of vascular clamps.
The Tenaxis sealant was compared to Gelfoam Plus, a topical hemostat containing a low concentration of thrombin (125 Units/mL), in the clinical trial used to support licensure (N=217; 1:1 randomization). The Tenaxis surgical sealant was shown to be superior to Gelfoam Plus based on a statistically significantly lower incidence of suture hole bleeding at the time of clamp release (60.5% vs. 39.6% of anastomotic sites at Time 0; p = 0.0001); the 20% difference at the time of clamp release persisted at 10 minutes (82% vs. 72%).
Superiority was demonstrated in several types of surgical procedures (extremity bypass, hemodialysis access grafting, and other vascular procedures).
The boards of directors of both companies have unanimously approved the agreement.
Gibbons P.C. served as legal advisor for the transaction for The Medicines Company. Leerink Swann & Co. served as financial advisor and Wilson Sonsini Goodrich & Rosati, PC served as legal advisor for the transaction for Tenaxis Medical.