Healthcare Industry News: bivalirudin
News Release - July 2, 2007
The Medicines Company Reacquires Angiox(R) (Bivalirudin) Rights in Europe from NycomedCompany Announces Global Expansion Starting in Europe and Provides Second Quarter and Full-Year Revenue Guidance
PARSIPPANY, N.J.--(HSMN NewsFeed)--The Medicines Company (NASDAQ: MDCO ) announced today that it has reacquired all development, commercial and distribution rights for its product Angiox® (bivalirudin) in Europe from Nycomed. Angiox is an anticoagulant used in patients undergoing percutaneous coronary interventions (PCI), commonly referred to as angioplasty. The product is approved in 26 European markets.
The Medicines Company currently sells Angiomax® (bivalirudin) in the United States, which comprises approximately one-third of the worldwide PCI market with approximately one million procedures annually. This transaction gives The Medicines Company a direct presence in European markets where more than one million PCI procedures are performed annually, with an estimated annual growth rate above 10 percent. Another one million PCI patient procedures are performed annually in the rest of the world.
"This is our first step directly into international markets. By selling Angiox ourselves in Europe, where the product's patent extends through mid-2015, we can anticipate product growth well into the next decade," said Clive Meanwell, Chairman and CEO of The Medicines Company. "Establishing operations in Europe also sets up the channel for commercialization of our pipeline of acute care product candidates, including Cleviprex(TM) (clevidipine) and cangrelor. We appreciate the contributions made by Nycomed to the establishment of Angiox in Europe, and we look forward to our collaboration during the transition period."
Under terms of the agreement, The Medicines Company will pay Nycomed:
- $20 million today,
- $5 million upon European health regulators approving an expanded Angiox product label to include findings of the ACUITY trial, and
- $20 million in 2008.
"We believe the value proposition for Angiox is universal," said John Kelley, President and COO of The Medicines Company. "Based on results from global clinical studies such as REPLACE-2 and ACUITY, PCI patients throughout the world, including Europe, benefit with improved outcomes and lower costs when heparin is replaced by Angiomax/Angiox. We expect to leverage these advantages using our team's broad and deep experience in global product commercialization."
Last month, the European Society of Cardiology (ESC) published new guidelines on the treatment of acute coronary syndromes (ACS) recommending use of Angiox to replace heparins (unfractionated or low-molecular weight) and platelet GP IIb/IIIa inhibitors in ACS patients undergoing PCI. This builds on earlier ESC guidelines recommending use of Angiox to replace heparins in patients undergoing PCI. An application for marketing authorization is currently under review with European regulatory authorities to expand the approved uses of Angiox to include the emergency use of Angiox in ACS patients undergoing PCI.
"Angiox is a strong product that has enabled Nycomed to create a significant position within the European hospital specialist sector," said Kerstin Valinder, Executive Vice President, Business Development, Nycomed. "We reviewed our product portfolio following the acquisition of ALTANA Pharma and have agreed with The Medicines Company that the timing was appropriate for this transition. Nycomed remains committed to a strategy of strengthening its product pipeline through both in-house research and in-licensing partnerships."
Financial Impact of Transaction
Nycomed will not order additional product during the second half of 2007 under the terms of the agreement. Therefore full-year international revenue guidance for Angiomax/Angiox is lowered from $10 million to $5 to $7 million. Also in 2007, The Medicines Company expects to incur approximately $10 to $12 million in commercial and distribution services paid to Nycomed.
The Medicines Company expects full-year international sales of Angiomax/Angiox in 2008 to be in the range of $15 to $20 million and to have a dilutive impact on after-tax net income of $0.15 to $0.20 per share before amortization of transaction costs.
The Company expects after-tax net income before amortization of transaction costs to be accretive in 2009. The Company expects to incur costs relating to the amortization of the transaction in 2007, 2008, and 2009 that will impact after-tax net income, but is not yet able to estimate the timing or amount of such costs.
By 2011, the Company expects full-year international sales of Angiox to be in the range of $90 to $110 million.
Based upon available hospital discharge data, The Medicines Company estimates a six-percent decline in PCI procedure volume in the United States for 2007 compared to 2006. As a result, the Company is revising its full-year U.S. Angiomax sales guidance to $250 to $260 million from a previously reported $266 to $276 million. Including international revenues noted above, the revised full-year Angiomax sales guidance is $255 to $267 million, compared to a previously reported $276 to $286 million. For the quarter ended June 30, 2007, the Company expects total net revenue to be in the range of $56 to $58 million.
The Medicines Company plans to announce second quarter 2007 financial results later in July. At that time the Company will provide an update on expected 2007 full-year expenses and net income based upon completion of analysis of transaction and transition costs from the Nycomed transaction.
There will be a conference call with management of The Medicines Company today at 9:00 A.M. Eastern Time to discuss the agreement with Nycomed, European expansion plans, financial guidance and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at The Medicines Company website at www.themedicinescompany.com.
The dial in information is listed below:
U.S. Dial In: 800-289-0572
International Dial In: 913-981-5543
Replay is available from noon Eastern Time following the conference call through July 23, 2007. To hear a replay of the call, dial 888-203-1112 (U.S.) and 719-457-0820 (international). The passcode for both dial in numbers is 1262410.
Angiomax/Angiox is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in bleeding complications remain evident even in high-risk patients.
In the United States, Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and with provisional GPIIb/IIIa inhibition in patients undergoing PCI. Angiomax is also indicated in patients with, or at risk of, HIT/HITTS undergoing PCI. Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax® (bivalirudin) in the U.S. and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and Angiomax®/Angiox® that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," "estimates," "projects" and similar expressions are intended to identify forward-looking statements, and all guidance to future revenues, expenses and income are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. For example, the revenue results for the quarter ended June 30, 2006 are preliminary and subject to change. Important factors that may cause or contribute to such differences include the extent of the commercial success of Angiomax; the Company's success in taking over the commercial functions previously performed by Nycomed in Europe and Nycomed's success in its performance of sales and distribution functions during the transition period described above; the impact of FAS 123R on the Company's financial results; whether clinical trial results of the Company's product candidates will warrant submission of applications for regulatory approval on a timely basis or at all; whether the Company's product candidates will receive approvals from regulatory agencies on a timely basis or at all; whether physicians will accept clinical trial results; the impact of government regulation on the Company's business; the potential impact of health care reform on the Company's business; and the effects of exchange rate fluctuations and other international economic, political and other risks. Such factors and others are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on May 9, 2007, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this press release.
Source: The Medicines Company
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