PF-6425090

January 31, 2017 By Mark Terry , BioSpace.com Breaking News Staff At its annual financial report, Pfizer quietly indicated that it had canceled three pipeline projects from its programs. The three projects are PF-06291874, in Phase II trials for type 2 diabetes, PF-06815345 in Phase I for hyperlipidemia, and PF-06412562 for cognitive disorder. Clinicaltrials.gov indicates that Pfizer was testing PF-06291874 in more than 200 patients versus a placebo in diabetic patients who weren’t managing their blood glucose levels with metformin. The cognitive disorder PF-06412562 was being tested in was schizophrenia. Otherwise, the company’s fourth-quarter and full-year 2016 report showed $52.8 billion in revenue, an 11 percent operational growth. In the fourth quarter, Pfizer reported $13.6 billion in revenue, about a 1 percent operational decline. Financial reports only reflected three months of legacy Medivation operations. Pfizer acquired Medivation on September 28, 2016. It also acquired Anacor Pharmaceuticals on June 24, so the financial results only reflected partial year results. “I was pleased with the company’s overall performance during 2016,” Ian Read , Pfizer’s chairman and chief executive officer said in a statement, “and believe both of our businesses executed well despite a challenging operating environment. We generated attractive operational revenue and earnings growth driven by our major products within both the Innovative Health and Essential Health businesses. In addition to strong business performance, we allocated our shareholders’ capital to a variety of value-creating initiatives that included company and product portfolio acquisitions, share repurchases, an increase in our dividend and ongoing funding for our R&D and commercial organizations.” The company’s 2017 financial guidance suggests revenues slightly over 2016, with a 6 percent increase to adjusted diluted earnings per share (EPS) compared to 2016. “We expect to achieve this despite absorbing revenue headwinds totaling $4.5 billion, comprised of $2.4 billion resulting from anticipated generic competition, $1.2 billion due to the pending disposition of HIS and $0.9 billion due to adverse changes in foreign exchange rates since 2016,” Frank D’Amelio , executive vice president, Business Operations, and chief financial officer, said in a statement. “Excluding the negative impacts of the pending disposition of HIS and foreign exchange, the midpoints of our 2017 revenue and adjusted diluted EPS guidance ranges reflect 4 percent and 10 percent operational growth, respectively. Notably, our guidance for adjusted diluted EPS anticipates share repurchases totaling $5.0 billion in 2017, which are expected to more than offset potential dilution related to employee compensation programs.” Aside from brief descriptions of the abandoned programs on its website, the company made no mention of those programs in its annual report. It did update its pipeline developments. Avelumab, which Pfizer is developing with EMD Serono , was accepted for Priority Review in November 2016 by the U.S. Food and Drug Administration (FDA) in patients with metastatic Merkel cell carcinoma (MCC). PF-05280014 , a proposed biosimilar for Herceptin (trastuzumab), met its primary endpoint in November. PF-0641029 , a proposed biosimilar for Humira (adalimumab) met its primary objective in January 2017. PF-06425090 , a vaccine candidate for Clostridium difficile (C. Diff), had positive data in a Phase II trial in January 2017. PF-06836922 , partnered with OPKO Health , announced in December 2016 that this hCG-CTP, long-acting human growth hormone did not meet its primary endpoint for its Phase III trial. SPK-9001 , in collaboration with Spark Therapeutics , provided positive preliminary data in hemophilia B in December 2016.