Sandoz announces agreement with The Medicines Company to launch an authorized generic of ANGIOMAX®
Jul 09, 2015
Princeton, New Jersey, July 9, 2015 – Sandoz today announced the US launch of an authorized generic of ANGIOMAX® (bivalirudin) for injection, following completion of a supply and distribution agreement with The Medicines Company.
Bivalirudin is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). In addition, bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as listed in the REPLACE-2 trial [see CLINICAL STUDIES (14.1) of approved package insert available at DailyMed.NLM.NIH.gov.] is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI). Bivalirudin is also indicated for patients with, or at risk of, heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI. Bivalirudin in these indications is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin [see DOSAGE AND ADMINISTRATION (2.1) and CLINICAL STUDIES (14.1) of approved package insert]. The safety and effectiveness of bivalirudin have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.
“This agreement with The Medicines Company for an authorized generic bivalirudin reflects our commitment to making high-quality generic injectables available to patients and health care professionals in the US,” said Peter Goldschmidt, President of Sandoz Inc.
According to IMS Health, US sales for the branded version of bivalirudin for injection were approximately USD $485 million for the 12 months ending in April 2015. Sandoz will market bivalirudin in a 250mL 10pack lyophilized vial injection, the same injection as the branded Angiomax.
Bivalirudin is contraindicated in patients with:
Active major bleeding; Hypersensitivity (e.g., anaphylaxis) to Angiomax or its components [see ADVERSE REACTIONS (6.3) of approved package insert].
Although most bleeding associated with the use of bivalirudin in PCI/PTCA occurs at the site of arterial puncture, hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of bivalirudinadministration [see ADVERSE REACTIONS (6.1)]. Bivalirudin should be used with caution in patients with disease states associated with an increased risk of bleeding.
Coronary Artery Brachytherapy
An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of bivalirudin in gamma brachytherapy.If a decision is made to use bivalirudin during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels [see ADVERSE REACTIONS (6.3)].
In addition to bleeding episodes, the following adverse reactions were commonly reported with Angiomax (bivalirudin):
Hypotension, hypertension, bradycardia, nausea, vomiting, dyspepsia, back pain, pain, pain at the site of injection, insomnia, pelvic pain, anxiety, abdominal pain, fever and nervousness.
The following serious non-bleeding adverse events were reported rarely in trials with Angiomax (bivalirudin):
The foregoing release contains forward-looking statements that can be identified by words such as “launch,” “commitment,” “will,” or similar terms, or by express or implied discussions regarding potential revenues from bivalirudin for injection. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that bivalirudin for injection will be commercially successful in the future. In particular, management’s expectations regarding bivalirudin for injection could be affected by, among other things, unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of bivalirudin for injection; global trends toward health care cost containment, including ongoing pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; unexpected safety issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable products to patients and customers around the globe.
The Sandoz global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines. Sandoz also holds leading global positions in key therapeutic areas ranging from generic injectables, dermatology and respiratory to cardiovascular, metabolism, central nervous system, pain and gastrointestinal.
Sandoz develops, produces and markets finished dosage form (FDF) medicines as well as intermediary products including active pharmaceutical ingredients (APIs) and biotechnological substances. Nearly half of the Sandoz portfolio is in differentiated products – medicines that are scientifically more difficult to develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions, including Hexal (Germany), EBEWE Pharma (Austria), and Fougera Pharmaceuticals (US).