Curis Says Roche Submits IND Application For Phase 2 Study Of Erivedge
Triggers $3M milestone from Roche!
Curis, Inc. ( CRIS ), an oncology-focused biotechnology company said Roche Holding AG ( RHHBY ) has filed an Investigational New Drug or IND application with the U.S. Food and Drug Administration or FDA to start a multicenter, Phase 2 clinical trial of Erivedge in patients with idiopathic pulmonary fibrosis or IPF, a chronic debilitating lung disease.
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Roche and Genentech, a member of the Roche Group (ROG.SW, RO.SW) develop and commercialize Erivedge under a collaboration agreement with Curis.
Ali Fattaey, president and chief executive of Curis, said: "...IPF represents a serious unmet medical need and patients suffering from this disease are in need of improved treatment options."
In my readings ....10-40 cases of IPF/10,000 adults in US=200-400K cases based on 200M adults in US?
This could be a huge NICHE add on indication..at just $1000 Tx cost per year we are looking at $200-400M in sales revs and Im sure they will get more than $1000/year if this proves out! Roche would never go forward if this was not big for them and royalties to CRIS will be as well!
Deja VU, I just read your post and I had 6,000 shares on Thursday also and I bought 10,000more on Friday @ $1.67. I had been keeping 6,000 and buying 2,000 more when it dips below $1.70 and then selling 2000 back when it gets back above $1.80. After seeing the stock do this twice recently I decided to take a chance and buy 10,000 this time as there seems to be a lot of support around $1.65. Hope we did the right thing.
Roche submitted the IND for a Phase 2 randomized, multi-center, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Erivedge in patients with IPF. Erivedge will be administered orally at a dose of 150 mg daily and the duration of treatment will be 52 weeks. The primary endpoint of the study is mean change in forced vital capacity (FVC) percent predicted from baseline to week 52 in patients with IPF. FVC is a measure of pulmonary function in patients with IPF. The secondary endpoints 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. According to Roche, following FDA review of the IND, the study is anticipated to start enrollment later this year and is expected to enroll approximately 130 patients. For additional information about the study, please refer to www.clinicaltrials.gov (study identifier: NCT02168530).
Idiopathic pulmonary fibrosis (IPF) is a chronic, debilitating lung disease with unknown cause that occurs in adults and has very poor prognosis. The disease is characterized by thickening or scarring of lung tissue (fibrosis) over time, resulting in decreased oxygen supply to the brain and other organs. Currently, there is no cure for IPF and life expectancy for most people is approximately 3 to 5 years after diagnosis. Respiratory failure is the most common cause of death due to IPF. The prevalence of IPF is approximately 1 per 5,000 in men and 1 per 7,700 in women. In the United States, the National Heart, Lung and Blood Institute estimates an incidence of approximately 10 to 40 per 10,000 adults.
...imo Roche would not go after this indication if the rewards were not there?
I get 200M adults in US off the cuff,so 200K to 400K cases US alone?