Aug. 28, 2014, 2:15 PM| Aug. 28, 2014, 2:15 PM | 2 Comments
Aug. 28, 2014, 9:05 AM
- The FDA designates Pfizer's (NYSE:PFE) investigational Costridium difficile (C. difficile) vaccine candidate, PF-06425090, Fast Track. The Phase 2-stage product candidate is designed to prevent C. difficile-associated disease.
- C. difficile is a Gram-positive anaerobic bacillus that produces two exotoxins, toxin A and toxin B, that cause antibiotic-associated diarrhea.
Aug. 26, 2014, 8:18 AM
- Pfizer (NYSE:PFE) and Merck (NYSE:MRK) collaborate in a Phase 1b study evaluating the safety and tolerability of a combination therapy in patients with anaplastic lymphoma kinase-positive (ALK-positive) advanced or metastatic non-small cell lung cancer. The combination consists of Pfizer's Xalkori (crizotinib) and Merck's investigational anti-PD-1 Ab pembrolizumab.
- Crizotinib inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer and pembrolizumab harnesses the body's immune system to fight cancer cells.
Aug. 25, 2014, 10:18 AM
- The FDA approves Iroko Pharmaceuticals' Zorvolex (diclofenac) for the management of osteoarthritis pain. The agency cleared the NSAID for the treatment of mild-to-moderate pain in adults in October 2013.
- Related tickers: (PFE +0.1%) (MRK +0.9%) (OTCPK:BAYZF) (OTCPK:BAYRY +1.2%) (OTCQX:RHHBY +0.6%) (TEVA -0.5%) (MYL +0.8%) (PRGO -0.1%) (GSK +0.8%)
Aug. 22, 2014, 8:02 PM
- Durata Therapeutics (NASDAQ:DRTX) exercised its right to defer the $25M milestone payment due Pfizer (NYSE:PFE) that was triggered by the first commercial sale of Dalvance (dalbavancin). The milestone was established in 2009 as part of Durata's acquisition of Vicuron Pharmaceuticals from Pfizer.
- In lieu of the cash payment, Durata delivered a $25M promissory note to Pfizer that bears 10% interest compounded annually and matures on July 7, 2019.
Aug. 22, 2014, 3:32 PM
- The FDA clears ViiV Healthcare's Triumeq (abacavir 600 mg, dolutegravir 50 mg, lamivudine 300 mg) for the treatment of HIV-1 infection. The single-pill regimen combines the integrase strand transfer inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine.
- ViiV Healthcare is an HIV-focused company established in 2009 by GlaxoSmithKline (GSK -1.6%) and Pfizer (PFE +0.5%). Shionogi joined the venture in October 2012.
Aug. 21, 2014, 3:51 PM
- The FDA clears Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE following initial therapy.
- This expands its label beyond its initial indication as a treatment to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
- In 2007, Bristol-Myers Squibb (BMY) and Pfizer (PFE -0.3%) entered into a global collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by BMY.
Aug. 21, 2014, 11:47 AM
- Some observers believe Pfizer (PFE -0.4%) will rekindle its bid for AstraZeneca (AZN +3%) by late 2014. The British firm rejected its ₤71B offer in May. Pfizer walked away despite being within 7% of the price AstraZeneca wanted.
- Under British takeover rules, the negotiations could restart as early as August 26 if AstraZeneca invites Pfizer back to the table. Pfizer cannot initiate discussions until November 26. The rules also allow Pfizer to make a single offer via private phone call to AstraZeneca but this option is rarely used because the process stops if the target says no.
- It all depends on Ian Read's enthusiasm for a higher bid. This may be unlikely considering what happened in May.
Aug. 18, 2014, 8:56 AM
- Pfizer (NYSE:PFE) submits its NDA for palbociclib in combination with letrozole for the treatment of postmenopausal women with estrogen receptor positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.
- The FDA has 60 days to review the filing for completeness and acceptability.
- It designated palbociclib a Breatkthrough Therapy in April 2013.
Aug. 8, 2014, 5:55 AM
- Pfizer (NYSE:PFE) is facing an increasing amount of lawsuits by women who state that the pharmaceutical giant knew about the serious side effects of its anti-cholesterol drug Lipitor but never adequately warned the public.
- Lawsuits began to be filed after the FDA in 2012 warned that Lipitor and other statins had been linked to a "small increased risk" of diabetes. In the last five months, lawsuits have shot up from 56 to almost 1,000.
- The recent spike followed a decision by a federal judicial panel to consolidate all nationwide Lipitor diabetes lawsuits into a single Federal courtroom in Charleston, South Carolina. Pfizer opposed the consolidation, arguing it would promote copycat filings.
- PFE -0.9% premarket
Aug. 6, 2014, 2:00 PM
Jul. 30, 2014, 9:35 AM
- Pfizer (PFE -1.7%) enters into a definitive agreement to acquire Baxter International's (BAX +0.7%) vaccine business for $635M. The transaction includes a portion of Baxter's manufacturing facility in Orth, Austria.
- The deal is expected to close by the end of 2014. Pfizer says that it will not impact its guidance for the year.
Jul. 30, 2014, 4:49 AM
- Pfizer (NYSE:PFE) is still looking to complete it highly desired tax inversion, despite AstraZeneca's rejection of its £69.4B takeover bid in May.
- CEO Ian Read is lobbying in Washington for an overhaul of tax rules which he says put U.S. companies at a disadvantage, and predicts that reforms will take years to play out.
- Read says Pfizer is now "aggressively" pursuing acquisition options and a tax inversion is likely to be part of a future deal.
Jul. 29, 2014, 4:07 PM
- Pfizer (PFE -1.2%) CEO Ian Read says shareholders like his discipline in dealing with his attempted acquisition of AstraZeneca (AZN -1.1%). He says they are supportive of his decision to walk away after AZN's BOD rejected his ₤55 bid. The AZN board would not engage in negotiations unless Pfizer increased its offer to ₤59.
- Under U.K. law, AZN could reach out to PFE in August to rekindle the matter. PFE must wait six months (November) before it can take the initiative to restart the process.
- Mr. Read says his team continues to evaluate other potential deals.
Jul. 29, 2014, 10:10 AM
- The European Commission approves Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE.
- Apixaban is an oral selective Factor Xa inhibitor that decrease thrombin generation and blood clot formation. It is approved to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) and for the prophylaxis of venous thromboembolism (VTE).
- Apixaban was discovered by Bristol-Myers Squibb (BMY +1.3%) and has been co-developed with Pfizer (PFE +0.3%).
Jul. 29, 2014, 7:50 AM
- Pfizer (NYSE:PFE) Q2 results: Total Revenues: $12,773M (-1.5%), GIP: $3,547M, VOC: $2,579M, GEP: $6,513M, Other: $134M; Gross Profit: $10,453M (-2.6%); R&D Expense: $1,714M (+12.0%); SI&A Expense: $3,486M (-2.9%); Operating Income: $5,253M (-6.4%); Net Income: $2,912M (-79.3%); EPS: $0.45 (-77.5%); COGS: 18.2% (+5.1%); Gross Margin: 81.8% (-1.1%); Operating Earnings Yield: 41.1% (-4.9%); Net Earnings Yield: 22.8% (-79.0%).
- 2014 Guidance: Revenues: $48.7B - 50.7B from $49.2B - 51.2B; adjusted cost of sales: 19.0 - 20.0% (unch); R&D: $6.7B - 7.2B from $6.4B - 6.9B; SI&A: $13.3B - 14.3B from $13.5B - 14.5B; effective tax rate: 27.00% (unch); non-GAAP EPS: $2.20 - 2.30 (unch); GAAP EPS: $1.47 - 1.62 from $1.57 - 1.72.
Pfizer Inc is a research-based biopharmaceutical company. The Company has five operating segments: Primary Care; Specialty Care and Oncology; Established Products and Emerging Markets; Animal Health; and Consumer Healthcare.
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