Key Updates to 5 of Pfizer’s Investigational Compounds
Pfizer (NYSE:PFE) is a biotech stock that I have long held in tax-favored accounts. It is the largest of my portfolio holdings devoted to healthcare. It is among the largest research and development based companies in America. While the company has had its ups and downs, it remains a reliable stock. As a long-term investor, I am concerned with the sustainability of the company’s earning potential in the future. Thus, the purpose of this article is to follow up on my prior article to provide an update on some of the more developmental-stage compounds in the pipeline that could result in revenue-generating treatments years down the road. Aside from what I covered in the prior article, there are five compounds that have had significant progress in 2014, and these compounds are rLP2086, PF-05082566, dacomitinib, ALO-02, and tafamidis.
First, the U.S. Food and Drug Administration granted “Breakthrough Therapy” designation to Pfizer’s vaccine candidate, bivalent rLP2086. This compound is currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in adolescents and young adults 10 to 25 years old. Pfizer is conducting a global clinical development program for rLP2086, which includes Phase 2, Phase 2b, and Phase 3 randomized controlled trials evaluating more than 20,000 participants, about 14,000 (or a 2:1 assignment ratio, as we say in epidemiology) of whom will receive the investigational vaccine. Pfizer intends to submit a Biologics License Application to the FDA by mid-2014.
Pfizer also announced an agreement with Merck (NYSE:MRK) pursuant to which Pfizer will conduct a Phase 1 study to evaluate the safety and tolerability of the combination of Merck’s MK-3475 and PF-05082566, Pfizer’s investigational, fully humanized monoclonal antibody that stimulates signaling through 4-1BB (CD-137), a protein involved in regulation of immune cell proliferation and survival. This agreement does not provide for any collaboration between Pfizer and Merck following the completion of this study. Pfizer is currently evaluating PF-05082566 in a Phase 1 study as a single agent in multiple tumor types, as well as in combination with rituxumab in non-Hodgkin’s lymphoma patients.
An important update was that Pfizer announced top-line results from two Phase 3 clinical trials of dacomitinib in patients with previously treated advanced non-small cell lung carcinoma. Neither study met its primary endpoint. In the ARCHER 1009 trial, dacomitinib did not demonstrate statistically significant improvement in progression-free survival compared with erlotinib, and in the BR.26 trial, dacomitinib did not prolong OS versus placebo. A third Phase 3 trial, ARCHER 1050, is ongoing and evaluating progression-free survival of dacomitinib in treatment-naïve patients with epidermal growth factor receptor-mutant advanced non-small cell lung carcinoma. Results from this study are expected in 2015.
Pfizer announced top-line results from a Phase 3 study of ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate to severe chronic low back pain. In this study, ALO-02 met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo in the mean change in the daily average pain numerical rating scale scores from baseline to the final two weeks of the double-blind treatment period.
Finally, Pfizer also initiated a global Phase 3 program for tafamidis in transthyretin cardiomyopathy, the first study of its kind in this rare, progressive, and universally fatal disease. Tafamidis is approved for the treatment of transthyretin familial amyloid polyneuropathy in the European Union and Japan under the trade name Vyndaqel. So this compound is not as investigational as some of the others mentioned in this article, but if a new condition can be included, it will help maximize revenues and extend any patents on the drug.
In summary, there were five major updates for investigational compounds in 2014 made that investors should be aware of, one of which is licensed for use in other conditions outside of the U.S. These compounds show promise. While many do not make it past Phase 1 or Phase 2 trials, those that do could develop into substantial sources of future revenues. Thus, investors should be on the lookout for data releases and updates surrounding these trials.
Disclosure: Christopher F. Davis is long shares of Pfizer.