As I stated in Part 1 of this week's review, it was an incredible busy week in the biotech sector, even on top of existing earnings reports. In part one, we took a look at the clinical data and partnership announcements that made waves this week. Now we'll take a closer look at the FDA rulings and mergers that shook the sector.
FDA rulings
In the plus column, Roche (RHHBY 3.45%) received yet another approved indication for its blockbuster cancer drug Avastin as a second-line treatment for patients with metastatic colorectal cancer. Avastin is already approved as a first-line treatment to be used in combination with a chemotherapy agent, but can now be continued into the second-line of treatments as the disease progresses, or if the patient stops responding to the first-line regimen. Roche is slowly whittling away the pain it will feel from Avastin's original patent expirations with each new indication.
Novartis (NVS 3.25%) also broke into the positive when it announced the approval of Bexsero in the European Union for the treatment of meningitis B. The news shouldn't come as too much of a shock,0 because the Committee for Medical Products for Human Use, or CHMP, which is the E.U. equivalent to the FDA panel, recommended approval of Bexsero back in November. As noted by Novartis, it will be the only meningitis-B vaccine approved for all age groups, including infants.According to Reuters, analysts are projecting that peak sales of the drug will top out around $600 million to $700 million.
Not all news coming across the wires was positive, though, with Impax Laboratories (IPXL +0.00%) receiving a dreaded complete response letter on Monday from the FDA for Rytary, its idiopathic Parkinson's disease drug. Once again, Rytary's efficacy and safety weren't in question. Instead, concerns were raised about a reinspection of Impax's Hayward facility, which it had ruled out when it filed its new drug application. With little clarity about what's troubling the FDA with regard to Rytary's manufacturing process, it could be another six months to a year before Impax gets Rytary before the FDA again.
Merger-mania
Last, but certainly not least, we had the $958 million buyout of MAP Pharmaceuticals (NASDAQ: MAPP) by Allergan (NYSE: AGN). MAP's lead product, Levadex, an inhaled migraine medication, initially failed to gain FDA approval in March last year because of manufacturing process concerns. Once again, as with Rytary, there were no concerns raised by the FDA with regard to safety or efficacy. MAP has refiled its NDA with the FDA and expects a ruling before April 15. For Allergan, which had licensing rights to Levadex within the U.S., this appears a smart move with a Levadex approval all but in the bag.
