Biotech Values

[DewDiligence]

Sandoz Announces First Generic of ‘Gold Standard’ Anti-Thrombotic Lovenox

[Novartis’ own PR on the FDA approval of generic Lovenox answers the question of whether generic Lovenox is approved for ACS as well as DVT: it is. The FDA’s own PR on the generic-Lovenox approval implied that ACS was excluded (#msg-52575668), but I noted in #msg-52576515 that the FDA’s omission of ACS was an oversight that would be corrected in short order. Evidently, it already has been.

NVS’ PR does not say anything about the pricing of generic Lovenox, but investors will presumably know the consequential details on pricing fairly soon.]

http://www.novartis.com/newsroom/media-releases/en/2010/1433879.shtml

›July 23, 2010 17:22 CET

• Sandoz is the first company to receive US approval to market a more affordable generic version of the leading hospital-based medication in the US

• US 2009 sales of Lovenox® were USD 2.7 billion

• Enoxaparin launch demonstrates Sandoz focus on differentiated and complex products, and underscores status as a global leader

Holzkirchen, July 23, 2010 - Sandoz today announced the introduction of enoxaparin sodium injection, the first generic version of Lovenox, in the US. Product shipment began immediately following approval by the US Food and Drug Administration (FDA).

According to IMS data, enoxaparin sodium injection is the best-selling hospital medicine in the US, and has been described as the 'gold standard' for anti-thrombotic treatments. Lovenox, the reference product, recorded US sales of USD 2.7 billion in 2009 and has been used to treat an estimated 200 million patients worldwide since it was launched.

"Sandoz is the first company to launch generic enoxaparin sodium in the US, delivering on our strategy of being first-to-market with key products, and underscoring our leadership in differentiated products," said Jeff George, global head of Sandoz. "We welcome the FDA decision to approve our enoxaparin application, and are now looking forward to significantly increasing patient and payor access to this vital medicine, by providing a high-quality, more affordable version."

The Sandoz product, developed in collaboration with Momenta Pharmaceuticals, Inc., is indicated for use in prophylaxis and for treatment of deep vein thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, and the treatment of acute ST-segment elevation myocardial infarction [STEMI]. [Unstable angina and STEMI are together referred to as Acute Coronary Syndromes or ACS.]

Enoxaparin, a low molecular weight heparin (LMWH) is an anticoagulant that helps to prevent thrombosis. Thrombosis is the formation of a blood clot in the blood vessels in the absence of bleeding. Enoxaparin is made up of a complex blend of low molecular weight substances (oligosaccharides) derived from heparins, and therefore requires sophisticated analytical methods on the part of the manufacturer to ensure accurate and reliable characterization, development and production.

Collaborating since 2003, Sandoz and Momenta provided the FDA with substantial data that demonstrated the equivalence of the Sandoz generic to Lovenox, and addressed potential immunogenicity issues. The FDA also denied two related Citizens' Petitions.

Sandoz specializes in the development, production and marketing of differentiated products ranging from biosimilars to complex injectables and inhalables. These products leverage complex ingredients, formulations, delivery mechanisms or underlying technologies to add value for patients and payors by going well beyond "standard" generics.

About Sandoz

Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of approximately 1000 compounds and sells its products in more than 130 countries. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), and Oriel Therapeutics (US). In 2009, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.5 billion.‹