On a generally sanguine day during which the Dow Jones Industrial Average
Let's highlight 3 biotechs made even more dramatic negative moves today.
Change in Price
Biosante's sexual dysfunction drug, LibiGel, works -- just not significantly better than the placebo it faced off against in phase 3 trials. Without strong efficacy data, FDA approval is essentially out the window. Antares Pharma was not immune to facing investors' wrath over LibiGel's failure, as Biosante uses Antares' gel to deliver its medication. The condemnation of Anteres is probably overblown; the company also has its delivery system licensed out to Jazz Pharmaceuticals
InterMune's drug pirfenidone treats a life-threatening lung disease, IPF, but can't get approval in the U.S. The FDA was concerned that only half of the company's phase 3 trials came back with positive results. Shares plunged 75% when the FDA said the company would need to run an additional trial before approval, overriding the advisory panel's narrow recommendation for approval.
Although the drug is approved in Europe under the name Esbriet, Intermune's latest rejection came from Germany's health organization, which recommended to the country's reimbursement authority that the drug holds "no or low additional benefit." Ouch! Analysts expect Esbriet to notch sales over half a billion dollars in 2014, but it's unclear over how much a setback this could be to that target.
The best way to track the latest developments surrounding the companies mentioned above is to add them to our free My Watchlist feature:
- Add YM BioSciences to My Watchlist.
- Add Jazz Pharmaceuticals to My Watchlist.
- Add InterMune to My Watchlist.
- Add BioSante Pharmaceuticals to My Watchlist.
- Add Ampio Pharmaceuticals to My Watchlist.
- Add Antares Pharma to My Watchlist.
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