Generic Lovenox to dent Sanofi’s earnings

pharmafile | July 26, 2010 | News story | Sales and Marketing Lovenox, Sandoz, Sanofi-Aventis, generics 

A generic version of Sanofi-Aventis’ blockbuster anti-blood clot treatment Lovenox has just gained approval in the US, signaling a rapid erosion of revenue from the drug.

The injectable drug Lovenox (enoxaparin) is the best-selling hospital medicine in the US, and the gold standard in the important anti-thrombotic market.

Sandoz, the generics arm of Novartis, is the first company to be granted FDA approval to launch their own version of the drug. Difficulties in formulating and manufacturing the drug has held off generic competition until now, and the specialist nature of the drug means generic erosion won’t go as far as with some other drugs.

Analysts Jeffries International forecast that Sanofi will earn €3.18 billion from the drug in 2010, but will see this cut down to €1.71 billion by 2012.

Sandoz’s global head Jeff George said: “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.

“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, 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).

Sandoz and Momenta have been collaborating on their generic enoxaparin since 2003, and have 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 against the approval of the generic version.

Andrew McConaghie

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