The Biggest News of the Week in Biotech: Alexion Pharmaceuticals, Inc. (ALXN), Synageva Biopharma Corp (GEVA), Vertex Pharmaceuticals Incorporated (VRTX)
After a mostly red week, stocks gapped higher Friday morning with the latest jobs report. The jobless rate fell to 5.4%, the lowest since 2008, and a 230,000 payroll increase in April followed a weak March (85,000, the lowest in almost 3 years).
The numbers boosted optimism that the economy is indeed growing, but not so fast that it warrants an interest rate hike yet this spring. Most market participants expect rate increases late this summer, most liklely in September. Equities rallied as a result.
After a rough two weeks, the move was a welcome respite, especially in the life sciences.
The biggest news of the week for biotech investors – Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) will buy the ultra orphan drug developer Synageva Biopharma Corp (NASDAQ:GEVA) for $8.4 billion. The portfolios mesh well; both companies develop and market drugs for extremely rare conditions, allowing them to set jaw-dropping prices (at upwards of $500,000 annually, Alexion’s Soliris was the most expensive drug globally for years) with little push-back from patients or payers.
Alexion will put up $115 in cash and 0.6581 Alexion shares for each share of Synageva, a 140% premium to GEVA’s share price the day before. That’s a significant premium for access to Synageva’s pipeline and only late-stage product, Kanuma (sebelipase alfa), for LAL Deficiency. At about 10 times Kanuma’s estimated peak sales (the biologic is not yet approved), Alexion is either betting that Wall Street is way off with its sales estimates, or that Synageva’s pipeline has real promise.
In addition, on Friday, the FDA released briefing documents for Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) upcoming advisory panel meeting regarding Orkambi, a combination of Kalydeco and lumacaftor for a particular subset of cystic fibrosis patients. The actual panel meeting is Tuesday, May 12, and the approval decision is expected by July 5.
The briefing materials weren’t exactly a glowing recommendation of Orkambi, and VRTX dipped in Friday’s early trading. Within an hour, however, the stock had recovered its losses and then some as investors digested what looks to be a likely approval (though not a shoe-in). The FDA reviewer raised questions about the clinical benefit of Orkambi (a small change in FEV1) as well as the benefit over Kalydeco alone. Essentially, the reviewers wonder whether Kalydeco alone tested against a placebo or the combination in a large study, would produce the same results. Regardless, and the reason the stock recovered, it looks like there’s not enough to knock down an approval, especially with a panel of clinicians who understand what F508del CF patients are dealing with.