Pfizer, Inc. (PFE - Free Report) announced that it has received Breakthrough Therapy designation for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, from the FDA. The candidate is being developed as a preventive treatment for invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adult patients.
The designation was granted on the basis of positive immunogenicity data from a phase II study of the multivalent pneumococcal conjugate vaccine in adults aged 60 to 64 years. Data from this mid-stage study will be presented at a future date. A phase III study is expected to be initiated in a few months.
The designation is aimed at accelerating the development and review of drugs intended to treat serious or life-threatening diseases. The vaccine candidate also enjoys Fast Track designation, which was granted in October 2017.
Pfizer’s stock has outperformed the industry this year so far. Pfizer’s shares have risen 20.7% compared with the industry’s increase of 6.8%.
Pfizer has a strong pipeline and it expects to get approximately 25 to 30 drug approvals through 2022, which includes about 15 products with blockbuster potential and line-extensions for Xtandi, Ibrance & Xeljanz/XR. Half of these potential blockbusters are expected to be approved by 2020.
The company has four oncology drugs under FDA’s priority review with decisions expected this month. A key candidate is its immuno-oncology candidate, Bavencio (avelumab), which is being evaluated for several 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.
The company’s late-stage pipeline candidates in non-oncology segment 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 studies include Roche’s (RHHBY - Free Report) blockbuster oncology drugs Rituxan and Avastin, and AbbVie’s (ABBV - Free Report) blockbuster rheumatoid arthritis drug, Humira. A biosimilar version of Roche’s Herceptin is under review in the United States and was approved in Europe in July
Pfizer is developing 13 biosimilar molecules in different stages of clinical studies. It has plans to launch five biosimilars over the next two years. Pfizer markets Inflectra, a biosimilar version of Merck/J&J’s Remicade, in the United States. In Europe, Pfizer markets biosimilar versions of Amgen’s (AMGN - Free Report) 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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