Data on Novartis’ Afinitor (AZN) (BAYRY) (JNJ) (NVS) (PFE)

Affecting roughly one to two million people on a worldwide basis, these tumors are also known as renal angiomyolipomas associated with tuberous sclerosis complex (TSC).

Afinitor is approved in the US for the treatment of adults with renal angiomyolipomas and TSC, who do not require immediate surgery. The drug is approved in the EU under the trade name Votubia for the treatment of adults with renal angiomyolipoma associated with TSC who are at risk of complications but who do not require immediate surgery.

Votubia is also approved for the the treatment of patients (3 years and older) with subependymal giant cell astrocytoma (SEGA) associated with TSC, who require therapeutic intervention but are not suitable for surgery.

We note that in Jul 2012, Afinitor received approval in the EU for the treatment of HR+ HER2- advanced breast cancer in combination with exemestane, in postmenopausal women whose cancer has progressed on an aromatase inhibitor.

Phase III data on Afinitor has shown that median progression-free survival (PFS) was more than doubled in patients treated with Afinitor plus Pfizer’s (PFE) Aromasin (exemestane) compared to patients on Aromasin alone. Treatment with Afinitor improved the median PFS to 7.8 months from 3.2 months with Aromasin ne alone.

EU approval came shortly after Novartis gained approval from the US Food and Drug Administration (FDA) for Afinitor in advanced breast cancer with exemestane, after the failure of treatment with Femara (letrozole) or AstraZeneca’s (AZN) Arimidex (anastrozole).

Afinitor generated sales of $524 million in the first nine months of 2012, up 82% year over year. The strong growth was mainly due to its approval in advanced breast cancer. Novartis projects incremental sales of around $1 billion for this new indication.

We are pleased with Novartis’ progress with the expansion of Afinitor’s indications. We have a Neutral recommendation on Novartis as of now. Novartis currently carries a Zacks Rank #2 (Buy).

Other pharma stocks which currently look attractive are Johnson & Johnson (JNJ) and Bayer (BAYRY).