Both Bristol-Myers Squibb and Pfizer are near their 52-week high, and any positive news relating to Eliquis could push them over that mark. Pfizer remains as volatile a stock as ever, though its up 10% from the beginning of the year. Bristol-Myers Squibb has climbed almost 20% from this time last year, and its recent acquisition of Amylin (AMLN) could help push it into the $40 range.
The FDA has delayed the approval of the drug once again, citing that it needs further clinical data for the support of the treatment from the two companies. The move is a surprising one by the regulatory body as the drug is seen as having the potential to be a blockbuster. Specifically it wants "on data management and verification." At the very least this will mean that we will have to wait a few months for the drug to be approved finally. At the very worst it could mean that the drug will never be approved for marketing in the US. However, I do feel that this second option is not really feasible. Many analysts agree with me on this point saying that, in the long run, Eliquis will still most likely be the drug that dominates the blood thinner market. In short, the delay is just a formality. Hopefully this is correct for the sake of shareholders in both companies. Eliquis is aimed at replacing Warfarin, a popular blood thinner currently on the market. Other major companies are also working on other options to replace Warfarin, with mixed results.
Bristol-Myers Squibb and Pfizer now need to respond to the FDA. As of yet, they have not given a timeline for their response. From the moment that they give their response the FDA will have six months to give a final ruling regarding the drug. If Bristol-Myers Squibb and Pfizer had to do a completely new trial it could have delayed approval of the drug by years rather than months. A Bristol-Myers Squibb spokesperson did say that the "significant operational complexity" of the trials and studies could be the reason why the FDA is not quick to give its approval. Further explanation may be required for the regulatory body to be convinced that the drug is indeed safe and effective.
Following the news of the delay shares in both companies dropped, although a direct correlation between the drop in share prices and the delay cannot, as yet, be formally established. Either way, both companies have stabilized their price and look to make moves while the Eliquis matter is dealt with.
Although this is a setback for Bristol-Myers Squibb and Pfizer. I really do believe that the drug will be approved eventually and will become the dominant blood thinner on the market. Naturally, dominance in this very important area will also mean an increase in revenue for the company as well as an increase in returns for shareholders.
But neither company is struggling at the moment. Bristol-Myers Squibb, as I mentioned, was able to shell out $5.3 billion to acquire Amylin and the hope is that it can provide the necessary background to increase sales of Amylin's Bydureon drug. One analyst has predicted that sales of Bydureon need to reach $1.5-$2 billion to make the acquisition price worth it, and that this is within the realm of possibility.
Pfizer, on the other hand, remains one of the hottest stocks around. It recently hit its 52 week high and is still lingering near that number. The spike is attributed to Pfizer's announcement that its board approved a $.22 dividend in the third quarter. But the high regards don't end there. Pfizer was also named a Top 25 Dividend Giant as well as a Top 15 Analyst Pick. Certainly not so bad for a company that may be on the verge of a major development with Bristol Myers Squibb.
The two companies are certainly among the better plays in the pharmaceutical industry. Other good plays include Abbott Labs (ABT) which has experienced something of a breakthrough with its drug HUMIRA (adalimumab) in adults with severe axial spondyloarthritis (axSpA), a rare disorder.
Recently it announced that the European Committee for Medicinal Products for Human Use (CHMP) "issued a positive opinion" regarding the drug. This means that Abbott is close to having the only drug on the market that exists for this purpose. The only thing that is still required is European Commission approval.
Novartis (NVS) is also on top of things it would appear. The drug company recently received approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency ((NYSEMKT:EMA)) for its drug Afinitor (everolimus) tablet. CHMP has also recommended that the European Commission approve the drug. This will be a huge breakthrough as the drug is aimed at treating breast cancer.
Bristol-Myers Squibb and Pfizer are well worth watching right now, but even more worth buying into. Both are selling at higher prices than the beginning of this year, but there's enough evidence to suggest that both are poised for big third and fourth quarters. If Bristol-Myers Squibb and Pfizer are finding success even as Eliquis is delayed, there's no telling how high the ceiling may be if they find a breakthrough. If the two companies can get in with their stroke prevention drug, the under $23 and under $35 price tag for Pfizer and Bristol-Myers Squibb, respectively, may seem like an absolute steal.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.