Fresh off Afinitor failure, Novartis turns tide with Signifor LAR approval

It's been a good news, bad news week for Novartis ($NVS) and its oncology business. Monday, the Swiss drugmaker won FDA approval for a long-acting version of Signifor, to treat acromegaly, a rare endocrine disorder. But Friday, Novartis announced that Afinitor fell short in a HER2-positive breast cancer trial, dashing hopes for what could have been a lucrative new indication.

A $1.3 billion drug for Novartis last year, Afinitor (everolimus) already has a tool chest full of indications, including kidney and pancreatic cancer, HER2-negative breast cancer, and tuberous sclerosis complex complications. But HER2-positive breast cancer is a different beast, and Afinitor didn't come through as an add-on to Herceptin and chemo in previously untreated patients.

So, the Signifor LAR approval was a welcome counterpoint. It adds to the company's rare-disease arsenal, and sets the stage for growth in that franchise. A twice-daily version of Signifor is approved to treat Cushing's disease, but so far, the drug hasn't brought in enough sales to rank among Novartis' top 20 products, and the company hasn't broken out its individual numbers.

Novartis Oncology President Bruno Strigini

"The FDA approval of Signifor LAR for acromegaly marks an important day for physicians and patients living with difficult-to-treat pituitary conditions and underscores our continued commitment to helping patients manage rare diseases," Novartis Oncology President Bruno Strigini said in a statement. Novartis plans to ask FDA to approve the LAR formulary for that same use in 2016.

Plus, the new Signifor formula could help make up sales lost to Sandostatin LAR copycats. That drug lost patent protection earlier this year; together with its shorter-acting version, it brought in almost $1.6 billion in 2013, and is holding its own with $1.2 billion so far in 2014.

- read the Signifor news from Novartis
- get the Novartis announcement on Afinitor

Special Reports: Top 20 orphan drugs by 2018 - Afinitor | Top 15 Drug Launch Superstars - Afinitor - Novartis | The top 10 pharma companies by 2013 revenue - Novartis

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