Agreements

Date: 2016-12-22

Type of information: Product acquisition

Compound: Odomzo® (sonidegib - LDE225)

Company: Sun Pharmaceutical Industries (India) Novartis (Switzerland)

Therapeutic area: Cancer - Oncology

Type agreement: product acquisition

Action mechanism: hedgehog signaling inhibitor. LDE225 (sonidegib) is an oral, investigational, selective smoothened inhibitor being studied in a variety of cancers. Smoothened (SMO receptor) is a molecule that regulates the hedgehog (Hh) signaling pathway, which plays a critical role in stem cell maintenance and tissue repair. This GPCR-like (G protein-coupled receptor) molecule was approved by the US FDA in July 2015 and by the EMA in August 2015.

Disease: adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

Details:

• • On December 22, 2016, Sun Pharmaceutical Industries announced its plans to acquire a branded oncology product, Odomzo®, from Novartis. The agreement has been signed between subsidiaries of both the companies and will close following anti-trust clearance and further closing conditions.  Odomzo® is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

Financial terms: The agreement has been signed for an upfront payment of US$ 175 million and additional milestone payments.

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Is general: Yes