Mallinckrodt Diversifies Hospital Growth Portfolio, Acquiring Three Commercial-Stage, Global Specialty Hemostasis Brands From The Medicines Company

CHESTERFIELD, United Kingdom, Dec. 18, 2015 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced that it has entered into a purchase agreement with The Medicines Company (NASDAQ: MDCO) under which subsidiaries of Mallinckrodt plc will acquire a global portfolio of three commercial-stage topical hemostasis drugs – RECOTHROM® Thrombin topical (Recombinant), PreveLeak™ Surgical Sealant, and RAPLIXA™ (Fibrin Sealant) – for an initial payment of approximately $175 million, inclusive of existing inventory. The transaction also includes potential added future considerations in the form of payments for achieving certain milestones, and is expected to be financed from cash on hand.

"Addition of this innovative portfolio of branded hemostats to our hospital platform is another demonstration of Mallinckrodt's 'acquire to invest' business strategy. Products that help control bleeding are essential to the vast majority of surgical practices. Yet this category – a market that has been estimated at $750 million in the U.S. and at least $1 billion globally – is an area in hospital products that has seen relatively little innovation and investment in recent years," said Mark Trudeau, Chief Executive Officer and President of Mallinckrodt.

Trudeau continued, "Acquiring and promoting leading hemostasis brand RECOTHROM alongside OFIRMEV® (acetaminophen) injection broadens Mallinckrodt's impact in the surgical suite for patients and physicians, and creates a strong framework to broadly commercialize innovative, highly durable new agents PreveLeak and RAPLIXA, which carry intellectual property protection to 2028 and 2031, respectively. As we continue to further diversify our portfolio, we're excited about the volume growth opportunity these products will add to our hospital offering for years to come."

On a reported U.S. GAAP1 basis, Mallinckrodt expects the transaction to be dilutive to its fiscal 2016 earnings per share (EPS); however, on an adjusted basis, the company expects the transaction to be neutral to EPS in fiscal 2016. On both a U.S. GAAP and adjusted basis, the company expects the transaction to be accretive to EPS beginning in fiscal 2017. Assuming a closing in the second quarter of fiscal 2016, the company expects the new products will add between $40 million and $45 million in incremental revenue in fiscal 2016, and provide low double-digit organic growth starting in fiscal 2017.

Through this acquisition, the company is expected to capitalize on synergies with Mallinckrodt's current U.S. commercial team focused on pain management in hospital surgical practice with OFIRMEV, the company's intravenous acetaminophen product indicated for the management of mild to moderate pain, and management of moderate to severe pain with adjunctive opioid analgesics. With expanded product offerings including OFIRMEV, RECOTHROM, PreveLeak and RAPLIXA, and with focused promotion, the company's commercial organization – supported by Mallinckrodt's strong sales, market access, national accounts and medical affairs teams – is expected to broaden access for patients who would benefit from these analgesic and hemostasis drugs.

Hemostasis Products

Each of the three drugs being acquired is approved by the U.S. Food and Drug Administration (FDA) and also in a number of other countries.

Introduced in 2009, RECOTHROM is widely used in the U.S., and is the first and only recombinant topical thrombin approved for use in adult and pediatric patients. It is FDA-approved as a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM is also marketed internationally through distributors.

Upon closing, Mallinckrodt will invest in the commercial launch and ongoing market development of both PreveLeak and RAPLIXA in fiscal year 2016. Both have shorter preparation times and are easier to use and store than similar products in their categories. PreveLeak is more flexible than hemostasis glue products, is a surgical sealant and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. PreveLeak is currently marketed in Europe through distributors. 

RAPLIXA is the first and only powder fibrin sealant in ready-to-use room temperature form, with the RAPLIXASpray™ device allowing for even application over a diffuse bleeding site and greater versatility. RAPLIXA is comprised of human-plasma derived fibrinogen and thrombin and FDA-approved as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and is applied directly or by using the RAPLIXASpray device.

The Medicines Company Adds Novel, Approved, Surgical Sealant to Its Surgical Hemostasis Portfolio Acquires Tenaxis Medical, Inc.

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.

ArterX™ Clinical Trial Results Announced at Veith Meeting

MOUNTAIN VIEW, Calif., Nov. 18, 2010 /PRNewswire/ -- US clinical trial results for Tenaxis' investigational vascular surgical sealant, ArterX, were presented today at the Veith Meeting in New York.  William M. Stone, MD of the Mayo Clinic, Scottsdale AZ reported a more than 20% margin of improvement for ArterX Surgical Sealant in the sealing of vascular suture lines compared with a control group featuring a commercially available gelatin foam/thrombin combination.
In a presentation titled "A Novel More Effective Glue-Sealant (ArterX) for Hemostasis at Vascular Suture Lines and Other Sites," Dr. Stone reported that ArterX Surgical Sealant achieved immediate hemostasis more than 60% of the time in a 217 patient clinical trial conducted at 11 different hospitals in the US.
President and CEO, David Smith, commented, "We are delighted with the preliminary results of our US clinical trial.  We were also able to show a statistically significant reduction in operating time of 36 minutes in the ArterX group, and ArterX patients were discharged from hospital after 4.1 days, an improvement of 1.3 days over the control group. If approved, we believe that ArterX Surgical Sealant will yield economic benefits for surgeons and hospitals that adopt it."
ArterX Surgical Sealant is currently under review by the FDA and is not available for sale in the USA.
ArterX is CE marked for the EU.

Tenaxis Medical, Inc. Announces 'Fileable' Status of PMA

MOUNTAIN VIEW, Calif., Oct. 25 /PRNewswire/ -- Tenaxis Medical submitted its PMA to the FDA on July 27, 2010 and has now received confirmation from the FDA that "we have made a threshold determination that the PMA is sufficiently complete to permit a substantive review and is, therefore, suitable for filing."
In the pivotal study designed to demonstrate superiority, the ArterX Surgical Sealant was compared to a thrombin soaked gelatin-sponge hemostat to reduce or eliminate suture line bleeding.  President & Chief Executive Officer, David Smithcommented, "We are delighted that the FDA has made the determination to substantively review the PMA. We are continuing to prepare for our US launch and this was an important milestone."
About Tenaxis Medical, Inc.
Incorporated in 2004 and located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company. It develops novel, high performance sealants for use in vascular and general surgery.  In addition to the ArterX Surgical Sealant, the company is developing a second high performance sealant for use throughout the gastrointestinal tract, and an anti-adhesion agent that can be delivered laparoscopically to help prevent or reduce pelvic and abdominal adhesions.
CONTACT: Ronald Dieck, +1-650-691-9016, ext. 110, for Tenaxis Medical, Inc.

Tenaxis seals a $9.6M deal for surgical product

Tenaxis Medical, a developer of sealants that close surgical incisions, has raised $9.6 million of an expected $16.6 million in equity, according to a filing with the SEC. The company’s ArterX Vascular Sealant can achieve hemostasis, or cause bleeding to stop, in 15 seconds after it is applied to a suture line. Tenaxis is currently working on a new sealant for the gastrointestinal tract as well. The company was founded in 2004 and is based in Mountain View, Calif.

Tenaxis Medical Says German Court Nullifies CryoLife 'Kowanko' Patent

The shares of CryoLife, Inc. (CRY: News ) plunged 17.45% in the after-hours trading on Thursday, following the statement by privately held Tenaxis Medical, Inc. regarding the German court nullification of CryoLife 'Kowanko' patent.
Tenaxis Medical noted that the German Federal Patent Court in Munich has indicated their intention to nullify the German Kowanko patent assigned to Kennesaw, Georgia-based CryoLife. The patent is the German part of the European Patent 0 650 512 and is key intellectual property relating to the BioGlue Surgical Adhesive which is marketed worldwide by CryoLife, a processor and distributor of implantable living human tissues for use in cardiac and vascular surgeries.
Ronald Dieck, President and Chief Executive Officer of Tenaxis Medical, said, "We have always believed our intellectual property protection to be strong and we elected to initiate a nullity action in Germany to reinforce our position in this field and maximize the value of our own portfolio. In our review it became clear that the German Kowanko patent was not a valid patent. This assessment will be supported by the upcoming written decision of the Federal Patent Court in Munich, which has indicated that they will nullify the patent."
Dieck added that the company is confident that the Court's decision will lead to the stay of the patent infringement action brought by CryoLife against Tenaxis Medical's product ArterX Vascular Sealant before the Duesseldorf District Court in Germany, pending the outcome of any appeal by CryoLife against the decision of the Federal Patent Court.