PF-06412562

February 2, 2017 By Alex Keown , BioSpace.com Breaking News Staff NEW YORK – Pfizer could be looking to sell off a number of non-core assets in cardiology, urology and primary care in order to raise cash and streamline its portfolio, Bloomberg reported, citing people familiar with the matter. The drugs Pfizer could sell off generate sales of more than $700 million annually and could command more than $2 billion from a potential buyer. According to Bloomberg, Pfizer has secured the services of J.P. Morgan Chase & Co. to assist with the possible sale. Neither Pfizer nor J.P. Morgan commented on the possible sale. Earlier this week, Pfizer said it anticipated more generic competition throughout 2017. Despite those challenges, or because of them, Pfizer said it would continue to flex its M&A muscle as long as it creates shareholder value, Bloomberg said in its report on Pfizer’s fourth-quarter earnings report. During a conference call with reporters, chief executive officer Ian Read said that possible changes in the U.S. tax code under the administration of President Donald Trump might make some deals more financially palatable to the company. Potential deals could generate more jobs and revenue, Read said. However, during the conference call, Read said it was unlikely that Pfizer would wait to see if Trump’s proposed tax cuts are enacted and would strike quickly if the right deal came along, which could be a possible hint the company already has its sights set on a potential deal and doesn’t want to wait. Some think Pfizer could be looking at acquiring Bristol-Myers Squibb , which slashed its earnings projections for 2017, due in part to stumbles by its lead PD-1 inhibitor Opdivo. Although Pfizer was unable to merge with Allergan due to new tax rules, the company remained busy last year with acquisitions, including deals to acquire Anacor Pharmaceuticals and Medivation . While the deals could spur new revenues for Pfizer, the company has hopes that its pipeline will spin out five drug approvals over the next year. During the conference call, Mikael Dolsten , Pfizer ’s president of worldwide research and development, touted one drug, avelumab, a PD-L1 inhibitor for the treatment of metastatic Merkel cell carcinoma. Dolsten said the U.S. Food and Drug Administration is expected to rule on avelumab later this year. Earlier this week, Pfizer announced it had cancelled three pipeline programs : PF-06291874, in Phase II trials for type 2 diabetes, PF-06815345 in Phase I for hyperlipidemia, and PF-06412562 for cognitive disorder. While the company has hopes for its five experimental drugs, Pfizer is also hoping some of its newer drugs will offset flagging sales in older ones that are being challenged by generics. Drugs the company is hoping will continue to be strong revenue drivers include breast cancer drug Ibrance, which is Pfizer’s fastest-growing drug. In 2016, Ibrance generated $2.1 billion in sales, which was a massive jump from $723 million the drug brought in in 2015. The drug received an expansion approval by the FDA last year. Another drug the company is seeing strong growth in is the anticoagulant Eliquis. Co-developed with Bristol-Myers Squibb , Eliquis was initially approved to cut stroke and blood clotting risk in patients with non-valvular atrial fibrillation. It has expanded for use in hip or knee replacement patients, and patients with risk of deep vein thrombosis and pulmonary embolism. Eliquis generated $1.59 billion globally last year, a 50 percent growth over 2015.

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.