Will AstraZeneca Get Bought After All?
Chris DeMuth Jr. • 20 Comments
Chris DeMuth Jr. • 20 Comments
The Preferred Way To Play The Allergan-Pfizer Break Up
Andrew Walker, CFA • 56 Comments
Andrew Walker, CFA • 56 Comments
Wed, Dec. 7, 4:17 AM
- Britain's Competition and Markets Authority has fined Pfizer (NYSE:PFE) a record £84.2M for its role in ramping up the cost of an epilepsy drug by as much as 2,600%.
- Pfizer used to market Epanutin itself, but it sold distribution rights to privately-held Flynn in September 2012, after which the product was debranded and its price soared.
- Pfizer plans to appeal all aspects of the verdict.
Mon, Dec. 5, 9:32 AM
- A Phase 3 study, BFORE, assessing Pfizer's (PFE -0.6%) BOSULIF (bosutinib) compared to Novartis' (NYSE:NVS) Gleevec (imatinib mesylate) for the first-line treatment of patients with chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) met its primary endpoint of showing BOSULIF's superiority as measured by major molecular response at month 12.
- Pfizer will pursue global regulatory approvals for the expanded use.
- BOSULIF is currently approved in the U.S. and EU for patients with Ph+ CML resistant to or intolerant of prior therapy. Bosutinib is an oral once-daily tyrosine kinase inhibitor that interferes with an enzyme called Bcr-Abl kinase which promotes CML. It was first approved in the U.S. in September 2012.
Fri, Dec. 2, 11:13 AM
- Guggenheim initiates coverage on Pfizer (PFE +0.5%) with a Neutral rating joining four other shops with like ratings (recent updates) and price targets between $33 - 38. Four other analysts who updated coverage this month rate it a Buy with price targets ranging from $35 - 38.
- Shares are currently exchanging hands at $31.66.
Thu, Dec. 1, 11:46 AM
- November monthly performance was: +2.44%
- 52-week performance vs. the S&P 500 is: +6%
- $0.18 in dividends were paid in November
- Top 10 Holdings as of 10/31/2016: Exxon Mobil Corp (XOM): 5.06236%, AT&T Inc (T): 5.00966%, Verizon Communications Inc (VZ): 3.95123%, Chevron Corp (CVX): 3.90836%, General Electric Co (GE): 3.34327%, Procter & Gamble Co (PG): 3.22338%, Wal-Mart Stores Inc (WMT): 2.96781%, Philip Morris International Inc (PM): 2.82773%, Pfizer Inc (PFE): 2.73807%, Merck & Co Inc (MRK): 2.31749%
Thu, Dec. 1, 9:31 AM
- November monthly performance was: +0.62%
- 52-week performance vs. the S&P 500 is: -5%
- No dividends were paid in November
- Top 10 Holdings as of 10/31/2016: Apple Inc (AAPL): 4.78232%, Microsoft Corp (MSFT): 3.6545%, General Electric Co (GE): 2.09427%, Procter & Gamble Co (PG): 1.43859%, Exxon Mobil Corp (XOM): 1.36332%, Wells Fargo & Co (WFC): 1.34175%, Intel Corp (INTC): 1.2948%, Bank of America Corporation (BAC): 1.2811%, Pfizer Inc (PFE): 1.22767%, Alphabet Inc C (GOOG): 1.22159%
Thu, Dec. 1, 8:27 AM
- A Phase 3 clinical trial assessing Pfizer's (NYSE:PFE) LYRICA (pregabalin) as adjunctive therapy in pediatric epilepsy patients (ages 4 - 16) with partial onset seizures met its primary endpoint of a statistically valid reduction in seizure frequency compared to placebo at the 10 mg/kg/day dose. The 2.5 mg/kg/day dose came up short, however.
- The 295-subject 12-week study was conducted at 76 sites in 18 countries.
- The safety profile was consistent with that observed in adult patients.
- Complete results will be submitted for presentation at an upcoming scientific conference and for publication.
- LYRICA is currently approved for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy in adults with partial onset seizures and neuropathic pain associated with spinal cord injury.
- Shares are up a fraction premarket.
Wed, Nov. 30, 8:54 AM
- A Phase 3 clinical trial, REFLECTIONS B3271002, comparing the safety and efficacy of Pfizer's (NYSE:PFE) biosimilar PF-05280014 to Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) met the primary endpoint of showing equivalence as measured by objective response rate (ORR), taken in combination with paclitaxel, in first-line patients with HER-positive metastatic breast cancer.
- A separate study, REFLECTIONS B3271004, in early breast cancer patients was also successful.
- The development of PF-05280014 is ongoing. According to ClinicalTrials.gov, there are four studies currently recruiting patients and five that are active with recruiting completed.
Tue, Nov. 29, 9:16 AM
- The FDA accepts under Priority Review the Biologics License Application (BLA) from Merck KGaA's (OTCPK:MKGAF)(OTCPK:MKGAY) EMD Serono unit seeking approval of avelumab for the treatment of patients with metastatic Merkel cell carcinoma (MCC), a Breakthrough Therapy, Fast Track and Orphan Drug designation.
- MCC is a rare and aggressive type of skin cancer that affects ~2,500 Americans each year.
- Priority Review status shortens the review clock to six months from the usual 10 months. The specific action date is not provided but should be around June 1, 2017.
- Avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody, is being co-developed by Merck KGaA and Pfizer (NYSE:PFE) for the treatment of a range of cancers under a strategic alliance inked in November 2014.
- The marketing application in Europe is currently under review.
Tue, Nov. 29, 7:26 AM
- Pfizer (NYSE:PFE) perks up 1% premarket on light volume on the heels of an upgrade by Barclays analyst Geoff Meacham. Citing improved prospects for accessing its overseas cash under a business-friendly Donald Trump administration, he upgrades the stock to Overweight with a $38 (19% upside) price target.
Tue, Nov. 22, 8:44 AM
- QuintilesIMS (NYSE:Q): will lead a collaborative initiative involving Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) and Pfizer (NYSE:PFE) with the goal of providing clearer and more proactive insight into how anti-cancer treatments are used in actual practice across key European markets. Specifically, the initiative aims to bridge the information gaps and inconsistencies in knowledge related to how oncology products are used, for which types of patients and indications and in what sequences and combinations. The ultimate goal is to improve the quality of care for cancer patients and improve outcomes.
- Financial details are not disclosed.
Mon, Nov. 21, 7:54 AM
Fri, Nov. 18, 3:26 PM
- Pfizer (PFE -0.6%) takes exception to the release of Medicaid rebate data to state lawmakers by the Texas Health and Human Services Commission. The agency, which initially said no, acquiesced after the Texas Attorney General determined that the release would not violate state law. The state Senate wanted the information as part of their efforts to manage drug costs.
- The company promptly filed a lawsuit requesting a temporary restraining order and preliminary injunction to prevent any further data disclosures. It also wants to be notified of any future requests. Pfizer claims that if other large customers were award of the pricing in Texas, it "would not be able to provide such pricing and rebates to every entity due to their unique differences in size, market and particular needs."
Fri, Nov. 18, 12:54 PM
- ViiV Healthcare, the HIV-focused company majority owned by GlaxoSmithKline (GSK -0.7%) and Pfizer (PFE -0.4%), initiates two Phase 3 studies assessing an injectable regimen of cabotegravir and rilpivirine for the treatment of HIV-1 infection. The studies, FLAIR and ATLAS, will evaluate the safety and efficacy of the two-drug combo, administered once per month, in both treatment-naive and treatment-experienced patients.
- According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is July/August 2018 for both studies. The estimated completion date for both is April/May 2022.
- Cabotegravir, developed by ViiV, in an integrase strand transfer inhibitor. It is also being evaluated in a tablet formulation.
- Rilpivirine [marketed as EDURANT by Janssen (JNJ -1.2%)] is a non-nucleoside reverse transcriptase inhibitor.
Thu, Nov. 17, 6:59 AM
- Britain's advisor to its National Health Service (NHS), the National Institute for Health and Care Excellence (NICE) continues its success with corralling prices from drug makers. Roche (OTCQX:RHHBY) and Bristol-Myers Squibb (NYSE:BMY) are the latest to extend discounts for access to the NHS.
- Roche cut the price to breast cancer drug Perjeta earlier this year as did BMY with leukemia med Sprycel.
- Novartis (NYSE:NVS) and Pfizer (NYSE:PFE) have also offered increased discounts of late. The specific amounts are confidential, however.
Tue, Nov. 15, 7:02 AM
- Pfizer (NYSE:PFE) prices a $6B debt offering consisting of five tranches:
- $1.00B aggregate principal amount of 1.700% notes due 2019.
- $1.00B aggregate principal amount of 2.200% notes due 2021.
- $1.75B aggregate principal amount of 3.000% notes due 2026.
- $1.00B aggregate principal amount of 4.000% notes due 2036.
- $1.25B aggregate principal amount of 4.125% notes due 2046.
- Net proceeds will fund the purchase of the company's 6.200% Senior Notes due March 15, 2019. Remaining proceeds will be used for general corporate purposes. Closing date is November 21.
Thu, Nov. 10, 7:35 AM
- As expected, the European Commission approves Pfizer's (NYSE:PFE) IBRANCE (palbociclib), in combination with an aromatase inhibitor [e.g., AstraZeneca's (NYSE:AZN) Arimidex (anastrozole)] for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The approval also covers the use of IBRANCE in combination with fulvestrant (AZN's FASLODEX) who have received prior endocrine therapy.
- Palbociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6, downstream signaling pathways which lead to cellular proliferation. When combined with an antiestrogen, it inhibits the growth of breast cancer by interfering with these pathways and promoting the deterioration of cancer cells (senescence).
- The advisory committee CHMP adopted a positive opinion in mid-September backing approval.