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Wed, Jan. 21, 11:41 AM
- Merck (MRK) plans to withdraw its hepatitis C medicine, Victrelis (boceprevir), from the U.S. market by the end of this year due to declining demand in the wake of the Gilead Sciences (GILD +1.1%) juggernaut. Victrelis will remain available internationally.
- Vertex Pharmaceuticals (VRTX +0.4%) pulled its offering, Incivek (telaprevir) in August for the same reason and exited the hepatitis arena.
- Merck is not giving up yet. It plans to file an NDA by mid-year for an all-oral ribavirin-free hep C regimen, grazoprevir/elbasvir.
Dec. 29, 2014, 3:35 PM
- The FDA approves Vertex Pharmaceuticals' (VRTX +1%) supplemental new drug application (sNDA) expanding the label of Kalydeco (ivacaftor) to include patients aged 6 and older with cystic fibrosis (CF) who have the R117H mutation in the CFTR gene. Kalydeco is now approved for the treatment of CF in patients with one of 10 mutations: R117H, G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D.
- Approximately 500 people in the U.S. at least six years old with CF have the R117H mutation. Kalydeco is now approved to treat ~3,100 CF patients in the U.S. with one of the specific mutations.
- Previously: Ad Comm vote positive for Kalydeco label expansion (Oct. 21)
- Previously: Vertex applies for a label expansion for Kalydeco (June 30)
Dec. 19, 2014, 5:36 PM
Nov. 20, 2014, 8:03 AM
- The Cystic Fibrosis Foundation sells the royalty stream it receives from Vertex Pharmaceutics (NASDAQ:VRTX) to Royalty Pharma for $3.3B. It plans to reinvest the money into new research efforts.
- The transaction is an example of successful mission investing, a growing trend in philanthropy. Instead of giving charitable grants, the foundation acts as a business partner by making an investment and expecting a share of the profits.
- Vertex's Kalydeco (ivacaftor), which helps CF patients with a rare genetic mutation, costs more than $300K per year. CF Foundation Chief Robert J. Beall says, "While the drug's high price may have boosted the royalties the foundation gets, we would give up our royalties in a second to drive down the prices. We were not at the pricing table." He adds that the foundation has no plans to subsidize the cost of drugs to patients. "What we're really excited about is the move to a one-time cure." At present, the meds are daily therapies.
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Nov. 14, 2014, 12:00 PM| 41 Comments
Nov. 5, 2014, 7:55 AM
- Vertex Pharmaceuticals (NASDAQ:VRTX) files an NDA with the FDA and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for a fully co-formulated combination of lumacaftor and ivacaftor for patients at least 12 years old with cystic fibrosis (CF) who have two copies of the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene.
- There are ~22,000 people who fit this profile in North America, Europe and Australia.
- The FDA tagged it a Breakthrough Therapy in late 2012. The NDA includes a request for Priority Review which, if approved, will shorten the regulatory review time to ~eight months. Europe's Committee for Medicinal Products for Human Use (CHMP) granted the company's request for Accelerated Assessment of its MAA which shortens the review time to ~150 days.
Oct. 28, 2014, 6:57 PM
- Vertex Pharmaceuticals (VRTX +2.2%) Q3 results: Revenues: $179M (-19.3%); Product Sales: $137.1M (-26.6%); Kalydeco Sales: $126.8M (+25.4%); Operating Expenses: $266.2M (-13.0%); Operating Loss: ($142.2M) (-15.0%); Net Loss: ($170.1M) (-37.1%); Loss Per Share: ($0.72) (-33.3%); Quick Assets: $1.48M (+0.7%).
- 2014 Guidance: Revenues: $520M - 550M (unch); Kalydeco sales: $470M - 500M (unch); Operating Expenses: $910M - 920M from $890M - 930M.
Oct. 28, 2014, 4:10 PM| Comment!
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Jul. 29, 2014, 4:40 PM
- Vertex Pharmaceuticals (VRTX) Q2 results: Total Revenues: $138.4M (-55.5%), Product Sales: $122.3M (-52.0%), Kalydeco Sales: $113.1M (+13.7%); Operating Expenses: $319.3M (-13.2%); Net Loss: ($159.4M) (-158.3%); Loss Per Share: ($0.68) (-161.5%); Quick Assets: $1,219.2M (-16.8%).
- 2014 Guidance: Revenues: $520M - 550M (unch); Kalydeco sales: $470M - 500M (unch); Operating Expenses: $$890M - 930M (unch).
Jul. 29, 2014, 4:05 PM| Comment!
Jul. 10, 2014, 8:13 AM
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