Really! It looks like BB dogged a bullet this time and jobs should be saved. We are under a lot of pressure to perform. This deal has been under the microscope for months. Matthew Herper is one of the best biotech analysts and he makes some valid points:
Trial Succeeds, Amgen CEO Doesn't Have To Quit
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The success of a clinical trial of Amgen's AMGN +2.5% multiple myeloma drug Kyprolis will likely mean that the medicine will remain on the market and serve to ease investor concerns about the biotechnology company’s management team.
Amgen acquired Kyprolis when it purchased Onyx Pharmaceuticals for $10.4 billion last year. At the time, the medicine, which was seen as the key to the deal, had only been granted a conditional approval by the Food and Drug Administration based on a study without a control group in which 23% of patients who had failed other therapies responded to the new drug.
Most analysts expected today’s study, called Aspire, to be successful. But the chance that it wouldn’t was seen as a major risk to Amgen’s stock by some. In a video sent to investors in July, ISI Group biotechnology analyst Mark Schoenebaum predicted a 70% chance of success, but said that if it were to fail management, including Chief Executive Officer Robert Bradway, would wind up “in a big credibility hole” that they might not be able to climb out of. The Onyx deal was Bradway’s first significant move as CEO.
A second study of Kyprolis, called Focus, has yet to read out. Schoenebaum says investors are less optimistic on this trial, and much of the betting on Amgen shares will now be around what Focus will show.
In Aspire, Kyprolis was given on top of Celgene's CELG +0.96% Revlimid and dexamethasone; a control group only got Revlimid and dexamethasone. The study’s main goal was the time until patients’ myeloma progressed, or worse. It took 26.3 months for patients who received Kyprolis to experience disease progression, compared to 17.6 months for those on Revlimid. This was 8.7 months longer for patients who received Kyprolis than for those who did not.
Did patients on Kyprolis live longer? Amgen says there was a “trend” toward better overall survival, but that it was not statistically significant. It may be that time will lead to statistical significance, although Sally Church, of Icarus Consultants, sounded skeptical this morning on Twitter TWTR -1.5%.
twitter-tweet” lang=”en”>@dsobek @matthewherper when you see “trend in favour that did not reach stat sig” it rarely gets better. It could, but…
— Sally Church (@MaverickNY) August 4, 2014
Another big question is how safe Kyprolis was for patients’ hearts. There is already a warning regarding cardiac safety in the medicine’s package insert, but will these data be any worse? Amgen says that they are in line with the label, which may also lead investors to exhale. Robyn Karnauskas, an analyst at Deutsche Bank , forecasts that the data could also help Celgene by leading patients to be on that drug for longer.
Amgen shares are up 1% this morning, after jumping 6% last week when Bradway announced plans to cut as many as 2,900