January 14, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Now that Pfizer and Allergan are going to merge, the two companies’ leaders are trying to explain, or perhaps justify, the rationale behind the merger.
Cambridge, Mass.-based Biogen, Inc. indicated at the J.P. Morgan Healthcare Conference in San Francisco that it plans to hire 150 new employees. This is something of a surprise after the company’s October 2015 “Biogen Bombshell,” when the company announced it was laying off 11 percent of its staff and slashing several pipeline programs. That cut equaled 880 jobs.
However, Al Sandrock, Biogen’s chief medical office, said at J.P. Morgan that the company plans to add staffers to its neuroscience development staff. When asked about the layoffs, he said, “That’s behind us. We’re on the cusp of breakthroughs on neuroscience.”
There have been concerns about Biogen’s direction. The company has been a leader in multiple sclerosis (MS) therapeutics, but part of the Biogen Bombshell was a pivot as the company shifted focus toward the extremely difficult area of Alzheimer’s treatments.
Despite that, William Meyers, writing this week week for Seeking Alpha, said, “I believe Biogen will continue to ramp up revenue and profits in 2016. There are several events that could occur during the year that could drive the price considerably higher, possibly even beyond its 2016 high of $480.18 per share.”
The company’s fourth-quarter 2015 financials will be released next Thursday, Jan. 21, and Meyers notes that the most important thing to look at is sales of Tecfidera, for MS. Tecfidera generated $937.4 million in revenues in the third quarter of 2015, and $883.3 million in the second quarter of 2015. Year over year, it’s shown a 19 percent increase. It’s Biogen’s top selling drug, higher than Avonex, whose sales have decreased by 8 percent year over year.
Meyers writes that, “Tecfidera’s main advantage is that it is a pill, not an injection like most MS therapies. Hopefully revenue will be closing in on $1 billion in the fourth quarter and PML incidents will remain minimal.”
PML is progressive multifocal leukoencephalopathy, a very rare side effect that has been cited a couple times in connection with Tecfidera, although the connection appears to be somewhat tenuous. Nonetheless, those reports negatively affected stock prices.
Although it really doesn’t look like Tecfidera sales are faltering, the company’s fourth-quarter financials will be a clearer indication.
Meanwhile, Biogen has doubled down on two pipeline products: aducanumab for Alzheimer’s, which is now enrolling two Phase III clinical trials, and anti-Lingo-1, a potential therapy that could repair damage caused by multiple sclerosis through a process called remyelination. As promising as early data is, both areas are high-risk.
Sandrock reported that there will soon be a data readout on the Phase II study on 420 patients for anti-Lingo-1, as well as new studies being conducted on spinal muscular atrophy. Those are being conducted in collaboration with Ionis, formerly called Isis, in two Phase III studies. Biogen also is running Phase III trial for neuropathic pain.
Meyers also mentioned Biogen’s Plegridy, “a newer MS therapy that has been seeing a good ramp,” and Eloctate and Alprolix, which have recently hit the market for Hemophilia A and B, respectively, that are just starting to increase sales.
A lot of Biogen’s chips appear to be resting on aducanumab for Alzheimer’s, despite having spread out its risk over other products. In March 2015, Biogen released positive data on the drug in Phase I clinical trials, which made the stock soar to $480.18 per share. But investors have short attention spans and interest and enthusiasm for the product has faded—at least until the next time positive data is presented.
Aducanumab is focusing on “prodromal or mild” Alzheimer’s, which is to say, early-stage dementia, so if it even shows that it can slow down the course of the disease, it’s likely to find a strong place in a market without much competition.
And Biogen hasn’t abandoned MS by any means. It acquired MT-1303, an oral S1P receptor autoimmune drug through a licensing agreement with Mitsubishi Tanabe. It recently completed a Phase II trial and is shifting toward a late-stage study.
Biogen is currently trading for $269.99 per share.
