With the SPDR S&P Biotech Index up 23% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
M&A Mania ensues
The talk among the health-care sector last week was the monstrous amount of buying, selling, and deal offering going on with big pharma. This week we saw more offers as well as one completed deal.
Let's begin with the one concrete deal that we saw take place between Forest Laboratories and Furiex Pharmaceuticals (NASDAQ: FURX). The deal, which equals as much as $1.46 billion in value, has Forest purchasing Furiex for $95 per share in cash and $30 in contingent value depending on whether not its lead experimental drug eluxadoline is approved by the Food and Drug Administration. In turn, Forest Labs plans to sell the royalty rights to two therapies that Furiex currently collects revenue on to Royalty Pharma for $415 million. What makes this deal rather odd is that Forest is itself currently in the midst of being acquired by Actavis for more than $25 billion. Actavis gave its thumbs up for the deal and Furiex shareholders are getting a huge premium for a pipeline that I don't personally find to be all that impressive. It's a big win for Furiex shareholders, but the jury is still out for Actavis/Forest, in my opinion.
The offer mill continued to churn out huge developments between Pfizer (PFE 0.84%) and AstraZeneca, with Pfizer on early Friday morning offering up a $106 billion bid -- a 7% increase from its previous bid -- which would have equaled $84 per share. AstraZeneca rejected the takeover offer as inadequate and deemed that its current pipeline would be disrupted by a takeover. Of course, Pfizer would like the opportunity to enjoy the cost synergies of combining it and AstraZeneca's businesses, as well as the potential to move its headquarters overseas to save on taxes. Years from now we could be talking about billions in extra cash flow. For now, though, the deal appears to be as dead as a doornail in the eyes of AstraZeneca.
Clinically sound
In addition to M&A mania, two other companies managed to dazzle Wall Street with positive clinical results.
On Wednesday evening, Theravance (NASDAQ: THRX) reported positive results from the highest dose of TD-9855 in a mid-stage study for patients with fibromyalgia. According to the press release, the 5 mg dose of TD-9855 did not meet statistical significance for the primary endpoint, but the 20 mg dose provided statistically significant and clinically meaningful improvements in the primary and secondary endpoints relative to the placebo. In the 20 mg dose there was an observed 1.4 point reduction 11-point Numerical Rating Scale used to determine pain compared to a 0.9 point reduction for the placebo (this was the primary endpoint). The secondary endpoint – the Patient Global Impression of Change scale – also demonstrated that improvement favored the TD-9855 treatment arm with 48% versus 32% being described as "very much improved" or "much improved." Investors should take note, Theravance may wind up being a lot more than just a COPD drug development company.
Yesterday morning, Isis Pharmaceuticals (ISIS +2.44%) announced its final data from its phase 2 study of ISIS-APOCIIIrx as a monotherapy treatment for patients with familial chylomicronemia syndrome, or FCS. Based on Isis' findings, Isis was able to treat the three FCS patients with baseline triglyceride levels of 1,400 mg/dL or greater with 300 mg of its experimental therapy over 13 weeks and get all of their triglyceride levels below 500 mg/dL. Its interim analysis demonstrated a mean triglyceride reduction of 69%, an 81% mean reduction in APOC-III and APOC-III associated very low-density lipoprotein cholesterol (the bad kind), and a 78% increase in high-density lipoproteins (the good kind). Isis will now move forward with a phase 3 study of the drug which affects some 3,000 to 5,000 people worldwide. While this indication is unlikely to be a huge contributor to the company's top or bottom-line results if approved, it continues to solidify Isis' role as both a collaborator and innovator of a diverse number of in-house products.
A surprisingly bad result
But, as usual, they can't all be winners. Just ask shareholders in Endocyte (NASDAQ: ECYT), who saw their stock implode on Friday after it and partner Merck announced that the independent data safety monitoring board had recommended it stop its phase 3 trial involving vintafolide early for platinum-resistance ovarian cancer due to futility. What makes the failure so confusing is that in March the European equivalent of the FDA's panel recommended the approval of Vynfinit, the EU name for vintafolide, in Europe. Friday's news probably marks the end of the line for a PR ovarian cancer indication in the U.S., but I'd suggest Endocyte may still have life yet. The company is practically trading at its cash value based on proceeds from its share offering in April along with existing cash as of last quarter, and it has six clinical as well as three preclinical studies under way beyond the PR ovarian cancer study. Long story short, this was surprisingly bad news, but the move lower may wind up being a bit of an overreaction, all things considered.
