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Curis and Roche File Label Expansion for Erivedge

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Curis, Inc. (CRIS) announced that partner Roche (RHHBY) has filed an Investigational New Drug (IND) application with the FDA to initiate a multicenter phase II clinical study on Erivedge in patients suffering from idiopathic pulmonary fibrosis (IPF).

We note that both Curis and Roche have entered into a collaboration agreement to develop and commercialize Erivedge. The phase II study will evaluate the safety and efficacy of Erivedge in patients suffering from IPF. The primary endpoint of the study is mean change in forced vital capacity (:FVC) percentage predicted from baseline to week 52 in patients suffering from IPF.

The secondary endpoints of the study include change in diffusion capacity of the lung for carbon dioxide (:DLCO), annualized rate of change in FVC, progression-free survival, time from randomization to first event of acute IPF exacerbation, change in quality of life measurements and safety.

The IND filing is currently under review by the FDA. We note that Erivedge is already approved for the treatment of basal cell carcinoma (BCC).

As per the collaboration agreement, Roche is responsible for the clinical development and commercialization of Erivedge while Curis is entitled for milestone payments along with royalties upon commercialization of Erivedge.

Roche expects to start enrollment for the study later in 2014 upon review by the FDA. The study is expected to enroll approximately 130 patients.

Earlier in the month, Curis re-initiated dosing in the single-agent clinical trial on pipeline candidate, CUDC-427. The candidate is being evaluated for the treatment of patients suffering from advanced and/or refractory solid tumors or lymphomas. Curis licensed worldwide rights for the manufacture, development and commercialization of CUDC- 427 from Roche.

Curis currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the healthcare sector may consider companies like Allergan (AGN) and Bayer (BAYRY). While Allergan carries a Zacks Rank #1 (Strong Buy), Bayer is a Zcaks Rank #2 (Buy) stock.

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