Pfizer, Inc. PFE announced that it has received Breakthrough Therapy designation for its pipeline candidate, PF-06651600 from the FDA. The candidate is being developed for alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.
The designation was granted based on positive data from a phase II study on PF-06651600, an oral JAK3 inhibitor for the said indication. Data from this mid-stage study is expected to be presented at the 2018 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris later this month.
The designation is aimed at accelerating the development and review of drugs intended to treat serious or life-threatening diseases. Alopecia areata is one such disease as no FDA approved drugs are presently available to treat this condition, which can ultimately lead to high levels of depression and anxiety in patients.
Pfizer’s stock has outperformed the industry this year so far. Pfizer’s shares have risen 15.5% compared with the industry’s increase of 3.8%.
Pfizer boasts a strong pipeline and expects approximately 25 to 30 drug approvals through 2022, including around 15 products that have blockbuster potential and line-extensions for Xtandi, Ibrance & Xeljanz/XR. Half of these potential blockbusters are expected to receive approval by 2020.
Pfizer has four oncology medicines, which are under FDA’s priority review with decisions on all four expected this month. A key candidate in the oncology pipeline is Bavencio (avelumab), which is being evaluated for different types of cancer. Bavencio is already approved in metastatic Merkel cell carcinoma in the United States, Europe and Japan. It has also received accelerated approval for second-line treatment of locally advanced or metastatic urothelial carcinoma in the United States.
Interesting non-oncology late-stage pipeline candidates include Vyndaqel/tafamidis (transthyretin cardiomyopathy), PF-04965842 (JAK selective inhibitor for atomic dermatitis) tanezumab (osteoarthritis pain, chronic low back pain, and cancer pain) and fidanacogene elaparvovec/PF-06838435 (gene therapy for hemophilia B).
Pfizer also boasts a strong biosimilars pipeline. Biosimilars in late-stage development include biosimilar versions of Roche’s RHHBY blockbuster cancer drugs Rituxan and Avastin, and AbbVie’s ABBV blockbuster rheumatid arthritis drug, Humira. A biosimilar version of Roche’s Herceptin is under review in the United States and was approved in the EU in July
Pfizer is evaluating 13 biosimilar molecules in various stages of development. It hopes to launch five biosimilars in the next two years. In the United States, Pfizer markets Inflectra, its first biosimilar version of Merck/J&J’s Remicade. In Europe, Pfizer markets biosimilar versions of Amgen’s AMGN drugs, Neupogen and Epogen. In the United States, a biosimilar version of Epogen was approved in May while a biosimilar of Neupogen was approved in July.
Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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