Is The Crisis Over For Amgen’s Kevin Sharer?
2 CommentsBy Ed Silverman // July 28th, 2008 // 8:31 am
Late Friday, the biotech released partial study results showing its experimental osteoporosis drug, denosumab, significantly reduced the risk of bone fracture in post-menopausal women in a large number of patients, triggering a rise of nearly 18 percent in its shares in after-hours trading.
That’s because denosumab, which targets a protein involved with bone-destroying cells, is seen as a key to Amgen’s future since the growth of its flagship anemia drugs - Epogen and Aranesp - have faltered over safety concerns that have brought Black Box warnings.
Even before the after-hours run-up to $63.49, Amgen shares have climbed about 28 percent over the last three months. In a research note this morning, Rodman & Renshaw analyst Michael King writes that “the worst is behind Amgen,” and that the upbeat news about denosumab more than compensates for disappointments over the anemia drugs, such as restricted Medicare coverage.
Whether this means Sharer no longer faces a crisis is unclear. Before the stock began climbing, he was named one of the worst ceo’s, and morale at Amgen has taken a hit among the setbacks of the past 18 months and subsequent layoffs. Shareholders, however, are obviously another story.
The 7,800 patient, three-year trial found that treatment with denosumab led to a statistically significant reduction in the incidence of new vertebral fractures, compared with treatment with a placebo. The study also showed the drug reduced the incidence of new non-spinal and hip fractures. Side effects included serious infections and malignancies, but were similar to the placebo group.
Some earlier trials of denosumab, which is also being developed as a treatment for bone loss in cancer patients, showed higher risk of infection with denosumab, leading to questions about whether the drug’s safety profile will be sufficient for regulatory approval. Full details of the trial will be presented at a medical meeting in September.
UPDATE: Steve Silver, a biotech analyst at Standard & Poor’s equity research, writes in an investor note that “adverse safety events were comparable to placebo, which we believe removes a key share-price overhang, positions Amgen for (denosumab’s) approval, and provides a platform for re-igniting earnings growth after 2010, following recent safety and competitive concerns with existing products.”
Hat tip to Reuters
Steveknows
I disagree with Mike King that this Deno announcement offsets the EPO/Aranesp difficulties. Amgen has been seriously damaged by the problem. So, if his statement is true, an offset just makes it even? With that kind of thinking, then Amgen is treading water or, just making things the same pre EPO/Aranesp problems.
Jeffrey Clark, CEO of Beaker.com - The Online Community for Life Sciences Professionals
For certain, Amgen needs a victory. They have been on a steady decline for quite some time in terms of financial performance, pipeline optimism and employee morale. Thousand Oaks is a different place from 4-5 years ago, just ask any of their current or former employees.
However, you have to confidence in Kevin Sharer. If you’ve met, he is an incredibly capable leader. Annapolis-bred, IMO, he has managed the playbook for big biotech/pharma correctly (but also cautiously) since taking over as CEO. Certainly, he has not been as aggressive as some others in terms of inorganic growth, however, he also has fallen victim to the ‘predictable surprises’ of an underperforming R&D function that was designed to feed his company’s pipeline & that would have kept Amgen in never-never land. Instead, they are struggling to get people to stop talking about Genentech & remember that ‘other CA biotech company’ just north of Los Angeles.