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February 1, 2013
11:31 EDTVRTXVertex cystic fibrosis drug to be made available in Ireland
Dr. James Reilly TD, Ireland's Minister for Health, announced that Kalydeco, a medicine for the treatment of cystic fibrosis in patients who have the G551D mutation, will be made available for patients in Ireland from March 1st. The decision was made following a request from the Director General Designate of the HSE, Tony O'Brien for a policy direction, prior to its implementation. As with all new drugs Kalydeco was assessed by the National Centre for Pharmacoeconomics in January. The assessment acknowledged the benefits of the drug including significant improvements in lung function, increased body weight, improvement in patientsí quality of life and a 55% reduction in pulmonary exacerbations. The assessment did however highlight the high cost of the drug at over EUR234K per patient per annum and the significant budget impact at over EUR28M per annum. The NCPE recommended against reimbursing the drug at the submitted price but suggested mechanisms such as a risk sharing scheme in addition to a price reduction could enable patients to gain access to Kalydeco. The NCPE recommendation led to follow-up discussions between the HSE Corporate Pharmaceutical Unit and the company, Vertex Pharmaceuticals. These discussions provided a mechanism where the drug could be made available to patients whilst at the same time reducing significantly the budget impact of the drug. They were considered by the HSE Drugs Group and a positive recommendation was made supporting the provision of Kalydeco for Irish CF patients.
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16:07 EDTVRTXVertex sees FY15 KALYDECO net revenues $560M-$580M
FY15 revenue consensus $1.19B. KALYDECO net revenues reflect use of KALYDECO by eligible patients in Australia following the completion of reimbursement discussions in late 2014; use of KALYDECO in some people in the United States with the R117H mutation following FDA approval in late 2014; the completion of reimbursement discussions for gating mutations in certain European countries; and use of KALYDECO in children with CF ages 2 to 5 with the G551D or other gating mutations in the United States, based on potential approval in March 2015. Vertex expects that its combined non-GAAP R&D and SG&A expenses in 2015 will be in the range of $1.05B-$1.1B. The increase as compared to 2014 is primarily a result of launch preparation activities for lumacaftor in combination with ivacaftor and the planned pivotal Phase 3 development program for VX-661 in combination with ivacaftor.
16:05 EDTVRTXVertex reports Q4 adjusted EPS (55c), consensus (65c)
Reports Q4 revenue $145M, consensus $137.49M. Reports Q4 revenues of $124M from KALYDECO in CF.
15:37 EDTVRTXNotable companies reporting after market close
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