PARSIPPANY, NJ and MOUNTAIN VIEW, CA -- (Marketwired) -- 04/23/14 -- The Medicines Company (NASDAQ: MDCO) and Tenaxis Medical, Inc. (Tenaxis) today 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 $58 million upfront on closing of the deal. The Medicines Company will also pay milestone payments of up to $112 million 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.
"We continue to execute our strategy for growth, building our presence in surgery and perioperative care," said Clive Meanwell, Chairman and Chief Executive Officer of The Medicines Company.
Adam Sharkawy, Senior Vice President and Global Innovation Group Leader for Surgery and Perioperative Care added, "A robust portfolio of solutions for intra-operative bleeding is expected to drive growth for us in this sector of hospital medicine. This acquisition will allow us to leverage and build our activities in surgery centers at leading US and European hospitals. In the US, we expect to deploy approximately 100 of our current engagement managers across these surgical product offerings."
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).
"We are excited to be involved in a transaction with The Medicines Company, which will allow more patients to have access to this beneficial technology," Ronald Dieck, President and CEO of Tenaxis commented. "We are proud of the surgical sealant technologies that we have developed and their impact on the wellbeing of patients. The Medicines Company is clearly committed to the area of intraoperative hemostasis and we look forward to working as a team to innovate in this area of medicine."
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, Inc.
Conference Call Information
There will be a conference call with The Medicines Company management today at 8:30 a.m. Eastern Time to discuss the Tenaxis acquisition, first quarter 2014 financial results, operational developments, and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at www.themedicinescompany.com.
Domestic Dial In: +1 (877) 359-9508
International Dial In: +1 (224) 357-2393
Passcode for both dial in numbers: 27882505
Replay is available from 11:30 a.m. Eastern Time following the conference call through May 7, 2014. To hear a replay of the call dial +1 855 859-2056 (domestic) and +1 404 537-3406 (international). Passcode for both dial in numbers is 27882505.
Wednesday, April 23, 2014
Saturday, April 5, 2014
FDA Accepts Biologic License Application for Fibrocaps Hemostatic Agent
The Medicines Company has announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. The FDA action date (PDUFA date) for Fibrocaps is January 31, 2015.
In August 2013, The Medicines Company announced that the Phase III trial, FINISH-3, which studied a total of 719 patients across 54 sites in the U.S. and Western Europe, met all of its primary and secondary hemostasis efficacy endpoints in each of four distinct populations: (1) spinal surgery; (2) hepatic resection; (3) soft tissue dissection; and (4) vascular surgery.
"We believe Fibrocaps has the potential to become an important hemostatic product -- complementary to Recothrom® Thrombin, topical (Recombinant) -- which will allow us to continue to serve leading US hospitals, leveraging our existing operations. Our previously announced EMA filing also suggests that Fibrocaps can be our first hemostat product in the European market," said Adam Sharkawy, PhD, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company.
"With the acceptance of the Fibrocaps BLA we now have 6 new molecular entity regulatory submissions under review at the FDA and the EMA," said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. "These applications span our three areas of focus in leading hospitals, namely: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. Each is designed to contribute to our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on the needs of leading hospitals worldwide."
In August 2013, The Medicines Company announced that the Phase III trial, FINISH-3, which studied a total of 719 patients across 54 sites in the U.S. and Western Europe, met all of its primary and secondary hemostasis efficacy endpoints in each of four distinct populations: (1) spinal surgery; (2) hepatic resection; (3) soft tissue dissection; and (4) vascular surgery.
"We believe Fibrocaps has the potential to become an important hemostatic product -- complementary to Recothrom® Thrombin, topical (Recombinant) -- which will allow us to continue to serve leading US hospitals, leveraging our existing operations. Our previously announced EMA filing also suggests that Fibrocaps can be our first hemostat product in the European market," said Adam Sharkawy, PhD, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company.
"With the acceptance of the Fibrocaps BLA we now have 6 new molecular entity regulatory submissions under review at the FDA and the EMA," said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. "These applications span our three areas of focus in leading hospitals, namely: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. Each is designed to contribute to our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on the needs of leading hospitals worldwide."
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