Pfizer Inc.
 (PFE)

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  • Nov. 22, 2015, 8:23 PM
    • In what would be the largest "inversion" deal ever, the boards of Pfizer (NYSE:PFE) and Allergan (NYSE:AGN) have agreed to merge, reports the WSJ, with an official announcement perhaps coming tomorrow.
    • The deal, of course, comes days after Treasury issued new rules aimed at curbing such deals, but analysts say the new measures don't put this particular merger at risk. Global antitrust regulators will be sure and have their say, though.
    • Pfizer CEO Ian Read - an outspoken critic of high U.S. corporate tax rates - will lead the combined company, says the Journal, with Allergan CEO Brent Saunders serving as president and COO.
    • The final terms would have Allergan shareholders receiving 11.3 Pfizer shares for each share of AGN they own, say sources, and there's also a small cash component. Pfizer closed Friday at $32.18, making just the stock portion worth $363.63 vs. Allergan's close of $312.84.
    • The companies are planning for seven to nine months before closing. The combined entity is then expected to evaluate splitting into two businesses - one focused on patent-protected products and the other on drugs that have already lost it (or are close to).
    • Previously: Pfizer said to be near deal to buy Allergan for as much as $380/share (Nov. 18)
    • Previously: Will the new inversion rules derail a Pfizer-Allergan deal? (Nov. 20)
    | Nov. 22, 2015, 8:23 PM | 90 Comments
  • Nov. 20, 2015, 2:24 AM
    | Nov. 20, 2015, 2:24 AM | 11 Comments
  • Nov. 19, 2015, 11:14 AM
    | Nov. 19, 2015, 11:14 AM | 29 Comments
  • Nov. 19, 2015, 7:27 AM
    • Servier exercises its option under its February 2014 collaboration agreement with Cellectis (NASDAQ:CLLS) to acquire exclusive worldwide rights to UCART19, Cellectis' lead CAR-T candidate that is about to enter Phase 1 development for chronic lymphocytic leukemia and acute lymphoblastic leukemia.
    • Under the terms of the agreement, Cellectis will receive an upfront payment of $38.2M, up to $300M in milestones, R&D financing and royalties on commercial sales.
    • Separately, Servier inks a global license and collaboration deal with Pfizer (NYSE:PFE) to co-develop and commercialize UCART19 under which the companies will work together on clinical development including sharing costs. Pfizer will be responsible for commercialization of UCART19 in the U.S. and Servier will be responsible for commercialization outside of the U.S.
    • Pfizer's agreement with Servier is outside of its deal with Cellectis that was signed in June 2014, which did not include UCART19.
    • The value proposition of UCART19 is that is based on engineered T cells from non-patient donors (allogeneic) and will be offered "off the shelf." Other CAR-Ts use the patient's own cells (autologous).
    | Nov. 19, 2015, 7:27 AM
  • Nov. 18, 2015, 8:30 PM
    • Pfizer (NYSE:PFE) is in advanced talks to buy Allergan (NYSE:AGN) for $370-380/share, according to multiple reports.
    • The companies are aiming to announce an agreement as soon as Monday, but the U.S. Treasury Department’s letter on tax inversion deals could delay the final agreement and change the terms.
    • A deal at $380/share would value AGN at nearly $150B and be the biggest health care deal ever, as well as the largest acquisition this year.
    | Nov. 18, 2015, 8:30 PM | 21 Comments
  • Nov. 18, 2015, 5:06 PM
    • The U.S. Treasury Department will announce new tax rules this week to discourage, if not outright ban, tax inversion deals. In a letter to Congress, Treasury Secretary Jack Lew promises "targeted guidance."
    • Ireland-domiciled Allergan (NYSE:AGN) is off 4% after hours on increased volume on the perception that potential suitor Pfizer (NYSE:PFE) may get cold feet for a deal if the tax advantages are taken away.
    | Nov. 18, 2015, 5:06 PM | 34 Comments
  • Nov. 18, 2015, 10:31 AM
    • Thermo Fisher Scientific (TMO +0.4%) enters into a long-term agreement with Novartis (NVS +0.6%) and Pfizer (PFE +0.6%) to develop and commercialize a multi-marker, universal next-generation sequencing (NGS) oncology test that will serve as a companion diagnostic for non-small cell lung cancer (NSCLC). The collaboration has the potential to accelerate the development and registration on several new drugs targeting NSCLC.
    • The test will be developed using Thermo's Ion PGM Dx system and Oncomine assays, based on the its Ion AmpliSeq technology which enables simultaneous sequencing of hundreds of genes with high reproducibility and rapid turnaround time.
    • Financial terms are not disclosed.
    | Nov. 18, 2015, 10:31 AM
  • Nov. 18, 2015, 8:48 AM
    • Results from a Phase 3 clinical trial, PROFILE 1029, in treatment-naive East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) show treatment with Pfizer's (NYSE:PFE) kinase inhibitor XALKORI (crizotinib) significantly prolonged progression-free survival compared to standard chemotherapy.
    • The data will be presented at a future medical meeting.
    • The FDA cleared XALKORI in August 2011.
    | Nov. 18, 2015, 8:48 AM | 4 Comments
  • Nov. 18, 2015, 7:56 AM
    • The FDA designates Pfizer (NYSE:PFE) and alliance partner Merck KGaA's (OTCPK:MKGAF)(OTCPK:MKGAY) Orphan Drug- and Fast Track-tagged avelumab a Breakthrough Therapy for the treatment of Merkel cell carcinoma, a rare type of skin cancer also known as neuroendocrine carcinoma of the skin. It strikes ~1,500 Americans each year.
    • Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
    • The data supporting the designation was generated in a Phase 2 study called JAVELIN Merkel 200. Additional data from the trial will be presented at a medical conference in 2016.
    • Avelumab (MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. The companies inked a strategic alliance in November 2014 to co-develop and co-commercialize the product.
    | Nov. 18, 2015, 7:56 AM
  • Nov. 17, 2015, 1:00 PM
    • AstraZeneca's (AZN +1.7%) Tagrisso (osimertinib), cleared by the FDA four days ago, will cost $12,750 for a month's supply. According to the company, the price is comparable to Pfizer's (PFE +0.4%) XALKORI (crizotinib) and Novartis' (NVS +1%) ZYKADIA (ceritinib).
    • The company believes Tagrisso could be a blockbuster, generating peak sales of $3B per year.
    | Nov. 17, 2015, 1:00 PM | 6 Comments
  • Nov. 13, 2015, 8:33 AM
    • Based on its analysis of unblinded trial data, the independent Data Monitoring Committee (DMC) recommends Merck's (NYSE:MRK) REVEAL outcomes study of anacetrapib continue with no changes. According to clinicaltrials.gov, the estimated completion date for the 30,000-subject trial is January 2017.
    • Anacetrapib inhibits a protein called cholesterol ester transfer protein (CETP), which is designed to elevate HDL cholesterol (the "good" cholesterol). CETP inhibitors were all the rage a few years ago over their potential to provide more cardioprotective benefits than lowering LDL cholesterol (the "bad" cholesterol). Big Pharma's efforts to push CETP inhibitors over the finish line hit fell flat due to toxicity and less-than-expected efficacy. Eli Lilly (NYSE:LLY), Roche (OTCQX:RHHBY), and Pfizer (NYSE:PFE) all abandoned their programs.
    • Merck has not given up, however. It ran a 1,623-subject study, DEFINE, which showed that anacetrapib was both safe and effective and raised HDL by 150%. REVEAL, initiated in 2011, is designed to settle the issue once and for all. The trial will cost upwards of $500M to complete so the company is banking on a positive outcome.
    | Nov. 13, 2015, 8:33 AM | 4 Comments
  • Nov. 12, 2015, 12:21 PM
    • The U.S. Court of Appeals for the Federal Circuit validates the patent covering Merck's (MRK -0.9%) Cubicin (daptomycin for injection) that expires on June 15, 2016 but invalidates four additional patents that expire in 2019 and 2020. Its ruling affirms a lower court's decision made in December 2014 in a patent litigation suit between Cubist Pharmaceuticals, acquired by Merck in December 2014 and Hospira, acquired by Pfizer (PFE -0.7%) in September 2015.
    • Merck is currently considering its options. The decision by the appeals court clears the way for generic competition next year. Cubicin is Merck's fastest growing drug, generating $187M, $293M and $325M in sales in Q1, Q2 and Q3, respectively.
    | Nov. 12, 2015, 12:21 PM | 5 Comments
  • Nov. 12, 2015, 11:59 AM
    • A study by not-for-profit ethics and governance watchdog Bioethics International (BI) of all clinical trials submitted to the FDA for drugs approved in 2012 showed a wide range of disclosure of results with almost all falling far short of full transparency. The lack of sharing of all trial data has been one contributor to the erosion of public trust in drug companies. According to BI President Jennifer Miller, Ph.D., only 12% of Americans believe that pharmaceutical firms are honest and ethical.
    • Companies were ranked by both legal requirements to disclose data per the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA) and the ethical standard that all human-based research should be publicly available in order to contribute to generalized knowledge.
    • The cross-sectional analysis of the 2012 data showed that 39 new medicines and 48 new drug entities were cleared by the FDA, 15 by 10 large firms. Researchers identified 318 relevant clinical studies (out of a total of 342) involving 99,599 participants. A median of 57% of the trials were registered, 20% reported results in clinicaltrials.gov, 56% were published and 65% were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 study.
    • Gilead Sciences (GILD -1.1%) didn't fare too well, providing only 21% of the data on its HIV combo med Stribild. Sanofi (SNY -3%) was also cited for its lack of reported data on MS drug Aubagio. Firms scoring well included GlaxoSmithKline (GSK -1.2%), Johnson & Johnson (JNJ -0.9%) and Pfizer (PFE -0.4%). All disclosed 100% of their trial data for at least one drug.
    • BI is in the process of expanding its rankings to include other years.
    • On a positive note, the major players have indicated a keen interest in doing a better job sharing trial data, motivated, no doubt, by the work of interested observers such as BI.
    • ETFs: BIB, BIS GRX, IRY, IXJ, BME
    | Nov. 12, 2015, 11:59 AM | 61 Comments
  • Nov. 6, 2015, 3:09 AM
    • In addition to providing tax benefits, a Pfizer (NYSE:PFE) merger with Allergan (NYSE:AGN) could bolster the U.S. drugmaker's growth prospects should it decide to sell or spin off its off-patent portfolio.
    • Many Wall Street analysts believe Pfizer will decide to split late next year, as the company already treats its "established products" division and its "innovative" patent-protected medicines business as if they were separate units.
    • Such a split would boost the company's profitability, because in-patents drugs command much higher prices that rise every year vs. off-patent medicines that become commoditized and their prices decline.
    | Nov. 6, 2015, 3:09 AM | 10 Comments
  • Nov. 4, 2015, 9:12 AM
    • Darmstadt, Germany's Merck KGaA (OTCPK:MKGAF) (OTCPK:MKGAY) and development partner Pfizer (NYSE:PFE) announce the initiation of an international Phase 3 clinical trial evaluating PD-L1 inhibitor avelumab (MSB0010718C) versus platinum-based doublet chemotherapy in treatment-naive advanced non-small cell lung cancer (NSCLC).
    • The open-label, randomized study will enroll ~420 subjects with recurrent or Stage IV PD-L1+ NSCLC across 240 sites around the world. Participants will receive either avelumab or the investigator's choice of platinum-based chemo based on the patient's histology (squamous or non-squamous) as first-line treatment. The primary endpoint is progression-free survival. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is February 2018. The estimated study completion date is June 2023.
    • This is the second Phase 3 trial assessing avelumab in NSCLC. The first, initiated in April of this year, is evaluating the PD-L1 inhibitor in patients whose disease has progressed after receiving platinum-based doublet chemo compared to docetaxel. According to clinicaltrials.gov, the estimated study completion date is October 2021.
    • The companies inked a strategic alliance in November 2014 to co-develop and co-commercialize avelumab.
    | Nov. 4, 2015, 9:12 AM | 1 Comment
  • Nov. 3, 2015, 9:32 AM
    • A Phase 2b clinical trial, LATTE 2, assessing long-acting injectable formulations of Viiv Healthcare's (NYSE:GSK) (NYSE:PFE) (OTC:SGIOF) (OTCPK:SGIOY) cabotegravir and Janssen's (NYSE:JNJ) EDURANT (rilpivirine) for the maintenance treatment of HIV-1 infection met its primary endpoint at 32 weeks. The results showed the two-injectable-drug regimen was comparable in maintaining viral suppression rates to a three-drug oral regimen of cabotegravir and two nucleoside transcriptase inhibitors.
    • Viral suppression rate (plasma HIV-1 RNA <50 c/ml) at week 32 for the two-drug regimen dosed every eight weeks was 95% and 94% for those dosed every four weeks. This compared favorably to 91% for the three-drug regimen.
    • Patients on the four-week regimen reported more adverse events (AEs) leading to withdrawal (5%; n=6) than those on the eight-week regiment (2%; n=2) and those on the oral regimen (2%; n=1). The most common AE was injection site pain (93% of injection recipients). Two patients in the eight-week cohort withdrew for injection intolerance. Two patients, one in the eight-week group and one in the oral group, experienced virologic failure.
    • Cabotegravir is an investigational integrase strand transfer inhibitor and analogue of ViiV's Tivicay (dolutegravir). It is being evaluated as a once-daily oral tablet and as a long-acting intramuscular injection.
    • The results will be presented at an upcoming scientific conference.
    | Nov. 3, 2015, 9:32 AM | 1 Comment
Company Description
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.