bammie schreef op 3 juli 2014 09:14:
Salix Pharmaceuticals (NASDAQ: SLXP )
The big day is almost here for Salix Pharmaceuticals, a diversified pharmaceutical company that shocked investors in November when it agreed to buy Santarus for $2.6 billion in cash At the time, the purchase price for Santarus seemed a bit steep, but the deal's true value may come down to a decision later this month from the Food and Drug Administration.
On or before July 16, the FDA is expected to hand down its ruling on ruconest, an investigational treatment for hereditary angioedema, a rare genetic disorder that can cause swelling of the face and airways, as well as abdominal cramping. Since hereditary angioedema, or HAE, is a rare disease, any approved therapies to treat HAE get lengthy periods of patent exclusivity, as well as the ability to attach a lofty price tag to their approved compound.
In phase 3 studies, Santarus and its collaborative partner Pharming Group noted that ruconest met its primary endpoint of a statistically significant difference in the time it took for the beginning of symptom relief relative to the placebo. The ruconest arm median time to relief was 90 minutes compared to a full 152 minutes for the placebo group. The therapy was generally well-tolerated and treatment-emergent adverse events were more prevalent in the control arm than in the ruconest intent-to-treat group, implying safety as well.
If approved, I suspect ruconest has the potential to generate $300 million in peak sales within the U.S. and it could double that figure by also finding success in the EU. Of course, Salix is going to have quite the crowded field to contend with, including global pharmaceutical giant Shire (NASDAQ: SHPG ) Shire purchased ViroPharma in order to get its hands on the FDA-approved HAE medication, Cinryze, to complement its own in-house therapy Firazyr, among other reasons. In its first-quarter results, Shire noted an 80% rise in Firazyr sales to $74.9 million, while Cinryze sales added $85.6 million. In other words, Shire isn't going to go quietly into the night.
Things are about to get interesting for Salix shareholders one way or another, and I suggest you grab some popcorn and take a front-row seat. POPCORN and UP MR.V. :)