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Vertex Pharmaceuticals: Kalydeco And Financials

May 1, 2013

Vertex Pharmaceuticals has a conference call on April 30, 2013, to review 1st Quarter 2013 financial results and recent progress in development programs for Cystic Fibrosis (CF) and Hepatitis C (HCV).  Investors, CF patients, and CF advocacy groups are watching closely to see what the status and finances are for the commercialization of orphan drug Kalydeco (Ivacaftor) for the treatment CF.

Vertex Pharmaceuticals’ 1st Quarter 2013 earnings conference call reports net product revenues of $61.8 million, compared to $18.4 million for the 1st Quarter 2012 – more than tripling. With strong international markets for Kalydeco, the company raises its “full-year guidance for Kalydeco sales to a range of $300-$340 million, up $20 million from its previous projections”.

Per FoxBusiness.com, the sales of Kalydeco in the US will need new regulatory approvals, as the “majority of eligible patients are already receiving the drug. The company is conducting clinical studies with several pipeline drugs (see updates to CF Program below) that could expand its reach to more than half of all patients with CF …”. Chief Commercial Officer Stuart Arbuckle during the conference call says that, “What is going to lead to growth in the US is those new indications that we’re working on.”

Updates to the CF Development Program are presented :

I – Label-Expansion Studies for Kalydeco Monotherapy

Three Phase III label-expansion studies are ongoing :

  1. CF patients ages 6 and older who have at least 1 copy of R117H mutation; enrollment is ongoing
  2. CF patients ages 6 and older who have at least 1 non-G551D CFTR gating mutation; enrollment is complete; 1st data expected in 2nd half of 2013
  3. CF patients ages 2-5 who have a gating mutation; enrollment is ongoing.

There is also a Phase II proof-of-concept study (enrollment is ongoing) evaluating Kalydeco in patients with CF who have clinical evidence of residual CFTR function. Vertex Pharmaceuticals believes that Kalydeco monotherapy “may be able to treat between 10-15% of the estimated 70,000 CF patients worldwide, pending results of clinical studies.”

II – Phase III Study for VX-809 In Combination with Kalydeco

A Phase III study for VX-809 + Kalydeco is recently announced. This study consists of two 24-week Phase III studies in patients ages 12 and older with 2 copies of the most common mutation in the CFTR gene – F508del. Enrollment is currently underway. Nearly half (50%) of patients with CF have 2 copies of the F508del mutation. A February 26, 2013 press release provides additional information.

III – Phase II Data for VX-661 In Combination With Kalydeco

On April 18, 2013, Vertex Pharmaceuticals announces the positive results from a Phase II Study of VX-661 + Kalydeco for CF patients with 2 copies of the F508del mutation.

Outside of the positive news on Kalydeco, Vertex Pharmaceuticals did not report positive numbers for the company’s Hepatitis C drug Incivek :

•   Reports 4th straight quarter of losses
•   Slumping sales
•   US sales dropped 42.4% to $205.6 million.

References

Vertex Pharmaceuticals April 30, 2013 Press Release for Q1 2013 Financial Results & Review of Recent Progress in Development Programs for Cystic Fibrosis and Hepatitis C

Vertex Pharmaceuticals April 30, 2013, Q1 2013 Financial Results Conference Call.

Please Note: “Dollar Symbol Gold” by Rugby471 (Own work) [GFDL] | Wikimedia Commons.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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