Key Developments: Pfizer Inc (PFE)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
Pfizer Inc Announces Plan For Split-Off Of Zoetis Inc
Pfizer Inc announced its intention to split off its remaining interest in Zoetis Inc, through an exchange offer. Zoetis, formerly Pfizer`s animal health business, completed its Initial Public Offering (IPO) in February 2013. In the exchange offer, Pfizer shareholders can exchange all, some or none of their shares of Pfizer common stock for shares of Zoetis common stock owned by Pfizer. The exchange offer is anticipated to be tax-free for participating Pfizer shareholders in the United States, except with respect to cash received in lieu of a fractional share. The completion of the full separation of Zoetis is expected to be accretive to Pfizer`s earnings per share beginning in 2014. Pfizer also announced that, in connection with the planned split-off, it has received a waiver of the 180-day lock-up from the joint book running managers of the Zoetis IPO. The exchange offer is designed to permit Pfizer shareholders to exchange their shares of Pfizer common stock for shares of Zoetis common stock at a 7% discount, subject to an upper limit of 0.9898 shares of Zoetis common stock per share of Pfizer common stock. If the upper limit is not in effect, for each $100.00 of shares of Pfizer common stock accepted in the exchange offer, tendering shareholders would receive approximately $107.52 of Zoetis common stock. Full Article
Pfizer Inc Halts Study Of Lymphoma Drug Unlikely To Help Survival-Reuters
Reuters reported that Pfizer Inc, which has been on a hot streak with three recent approvals of cancer drugs, stumbled on May 20, 2013, saying it was halting a late-stage trial of a drug for aggressive non-Hodgkin lymphoma after independent monitors found it was not likely to improve survival. Pfizer said it would continue to study the experimental drug, inotuzumab ozogamicin, in other hematologic cancers. No new or unexpected safety problems were identified by the independent monitors, Pfizer said. The study tested inotuzumab in combination with Roche Holding's Rituxan in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who were not candidates for intensive high-dose chemotherapy. That combination was compared with patients who got either Rituxan and Teva's Treanda or Rituxan and the chemotherapy drug, gemcitabine. During a planned interim analysis, an independent Data Monitoring Committee concluded that inotuzumab ozogamicin plus Rituxan would not improve overall survival compared with the other drug regimens. Full Article
Pfizer Inc Lowers FY 2013 Guidance
Pfizer Inc announced that its fiscal 2013 guidance has been updated to reflect the following: Reported Revenues: The changes in foreign exchange rates in relation to the U.S. dollar from mid-January 2013 to mid-April 2013, notably the weakening of the Japanese yen; Adjusted Diluted EPS: The aforementioned changes in foreign exchange rates ($0.04 per share) as well as the impact of the Zoetis IPO ($0.02 per share) noted above; and Reported Diluted EPS: The aforementioned changes in foreign exchange rates and the impact of the Zoetis IPO as well as the gain associated with the transfer of certain product rights to Pfizer's joint venture with Zhejiang Hisun Pharmaceuticals (Hisun) in China and an asset impairment charge. For fiscal 2013, the Company now expects Reported Revenues of $55.3-$57.3 billion (previously $56.2-$58.2 billion); Reported Diluted EPS of $1.44-$1.59 (previously $1.50-$1.65); and Adjusted Diluted EPS of $2.14-$2.24 (previously $2.20-$2.30). According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $57.25 billion and EPS of $2.28 for fiscal 2013. Full Article
Merck & Co Inc And Pfizer Inc Enter Worldwide Collaboration Agreement To Develop and Commercialize Ertugliflozin, an Investigational Medicine For Type 2 Diabetes
Merck & Co Inc and Pfizer Inc announced that they have entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer`s ertugliflozin (PF-04971729), an investigational oral sodium glucose cotransporter (SGLT2) inhibitor being evaluated for the treatment of type 2 diabetes. Ertugliflozin is Phase III ready, with trials expected to begin later in 2013. Under the terms of the agreement, Merck, through a subsidiary, and Pfizer will collaborate on the clinical development and commercialization of ertugliflozin and ertugliflozin-containing fixed-dose combinations with metformin and JANUVIA (sitagliptin) tablets. Merck will continue to retain the rights to its existing portfolio of sitagliptin-containing products. Pfizer has received an upfront payment and milestones of $60 million and will be eligible for additional payments associated with the achievement of pre-specified future clinical, regulatory and commercial milestones. Merck and Pfizer will share potential revenues and certain costs on a 60/40% basis. JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Full Article
European Regulators Reject Pfizer Inc's Arthritis Drug-Reuters
Reuters reported that European regulators declined to approve marketing of Pfizer Inc's new rheumatoid arthritis treatment Xeljanz, citing the risks of the drug compared with its potential benefit, the Company said on April 25, 2013. Pfizer said it plans to appeal and 'immediately seek a re-examination of the opinion' by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Full Article
Merck KGaA's EMD Serono Appeals Court Decision On Collaboration Agreement With Pfizer Inc
Merck KGaA announced that a Pennsylvania appellate court recently decided that the collaboration agreement that EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, and Pfizer Inc. entered into in July 2002 for the co-promotion of the multiple sclerosis treatment Rebif (interferon beta-1a) extends until December 31, 2015. EMD Serono, which developed Rebif, had contended that the collaboration should end on December 31, 2013, based on the provisions of the agreement governing extension of the term, and had filed a complaint seeking a court declaration to that end. A lower court ruled that the agreement extends through 2015 and the appellate court affirmed that decision. EMD Serono has asked the appellate court to reconsider ruling. Unless the court grants the request on or before June 7, it will be deemed denied. Full Article
Pfizer IncPfizer’s Palbociclib (PD-0332991) Receives Food And Drug Administration Breakthrough Therapy Designation For Potential Treatment Of Patients With Breast Cancer
Pfizer Inc announced that investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has received Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for the potential treatment of patients with breast cancer. Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine if it is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Breakthrough Therapy designation was based on preliminary Phase 2 data in this patient population. Interim data presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium showed that women treated with the combination of palbociclib plus letrozole achieved a statistically significant improvement in median progression free survival (PFS) compared to women who received letrozole alone (26.1 months and 7.5 months, respectively). Full Article
Pfizer Inc, Novartis AG And Abbott Laboratories Weigh Bids For Brazil's Ache Laboratorios Farmaceuticos-Reuters
Reuters reported that at least three of the world's top drugmakers are bidding for Brazil's Ache Laboratorios Farmaceuticos in an auction that may value the group at more than $5 billion. Pfizer Inc, Novartis AG and Abbott Laboratories are all weighing second-round bids to acquire the company. Bids are due in the second half of April. Privately owned Ache is attractive to drug companies looking to increase their footprint in the growing market of Latin America. GlaxoSmithKline Plc showed early interest but has dropped out of the running. Full Article
Pfizer Inc Gets New Rebuff From UK Cost Body For Cancer Drug-Reuters
Reuters reported that Pfizer Inc has suffered a second rejection in two days from Britain's health cost watchdog NICE as its new kidney cancer drug Inlyta was turned down for use on the state health service. The National Institute for Health and Clinical Excellence (NICE) said the new treatment was not a cost-effective use of National Health Service resources. Full Article
Pfizer Inc Announces Results From REMINDER Trial Showing Statistically Significant Risk Reductions In Primary Composite Efficacy Endpoint
Pfizer Inc announced results from the REMINDER trial showing statistically significant risk reductions in the primary composite efficacy endpoint. The composite endpoint was defined as the time to first event of cardiovascular (CV) mortality, re-hospitalization or extended initial hospital stay due to diagnosis of heart failure (HF), sustained ventricular tachycardia or fibrillation, ejection fraction (EF) ≤40% after 1 month, or an elevation of BNP/ NT-proBNP after one month. The REMINDER trial was a randomized, double-blind trial, involving 1,012 patients with acute ST-segment elevation myocardial infarction (STEMI) without a history of HF or EF <40% and without signs of HF. Patients received, preferably before myocardial reperfusion, either eplerenone (25-50 mg OD) or placebo in addition to standard therapy. Treatment was initiated within the first 24 hours of symptom onset (preferably within first 12h). The REMINDER trial demonstrated a statistically significant 42.9% relative risk reduction in the primary endpoint with p < 0.0001 (95% confidence interval [CI] 0.439, 0.742) in patients with acute STEMI when eplerenone was initiated within the first 24 hours of onset of symptoms. Overall, the adverse events reported in the REMINDER trial were consistent with those already known for eplerenone, primarily hyperkalemia. Eplerenone is not approved for use in the patient population studied in the REMINDER trial in any market. Full Article
RPT-FEATURE-Pfizer takes its shot at a vaccine for evasive superbug
CHICAGO, May 23 - Kathrin Jansen is a microbiologist with at least two breakthrough vaccines to her name: she brought the cervical cancer vaccine Gardasil to market for Merck and helped develop the $4 billion a year pneumonia and meningitis vaccine Prevnar 13 for Pfizer.
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