Thu, Feb. 5, 7:05 AM| 6 Comments
Wed, Feb. 4, 3:41 PM
- The FDA accepts for review the supplemental New Drug Application (sNDA) submitted by Pfizer (PFE +0.3%) seeking clearance for the use of Xeljanz (tofacitinib citrate) to treat adult patients with moderate-to-severe plaque psoriasis. The anticipated PDUFA date will be in October.
- Xeljanz is a small molecule Janus kinase (JAK) inhibitor that is currently approved in 37 countries for the treatment of patients with moderate-to-severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Tue, Feb. 3, 5:23 PM
- As expected, the FDA approves Pfizer's (NYSE:PFE) Ibrance (palbociclib) for the treatment of postmenopausal women with advanced estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer who have not yet received an endocrine-based therapy.
- Peak sales of Ibrance could reach $4B by 2020.
- Previously: Approval appears likely for Pfizer breast cancer candidate (Jan. 8)
Sat, Jan. 31, 12:35 PM
- The FDA approves Zogenix's (NASDAQ:ZGNX) Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek, a formulation technology that provides abuse-deterrent features without changing the release properties of hydrocodone.
- BeadTek incorporates pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents.
- The company intends to transition all Zohydro strengths to the BeadTek version in Q2. In H2, it expects to submit the results from its ongoing Human Abuse Liability Studies, which will further characterized the abuse-deterrent properties of the BeadTek formulation, to the FDA.
- Related tickers: (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NYSE:PFE)
Fri, Jan. 30, 8:37 AM
- Pfizer (NYSE:PFE) terminates its development agreement with Repligen (NASDAQ:RGEN) for compounds to treat spinal muscular atrophy, effective April 26. The collaboration was originally signed in late 2012.
- Previously: Repligen gets first milestone payment from Pfizer for SMA program (Sept. 4, 2013)
Tue, Jan. 27, 7:43 AM
- Pfizer (NYSE:PFE) Q4 results ($M): Revenues: 13,118 (-3.2%); GEP: 6,407 (-10.5%); GIP: 3,748 (+2.8%); Global Vaccines: 1,318 (+17.9%); Consumer Health: 953 (+1.1%); Global Oncology: 609 (+9.5%); Other: 83 (-38.5%).
- COGS: 2,701 (-3.3%); R&D Expense: 3,209 (+77.2%); SI&A Expense: 3,982 (-4.1%); Net Income: 1,228 (-52.2%); EPS: 0.19 (-51.3%).
- Gross Profit: 10,417 (-3.2%); COGS: 20.6% (-0.1%); Gross Margin: 79.4% (0.0%); Operating Earnings: 3,226 (-32.8%); Operating Earnings Yield: 24.6% (-11.1%); Net Earnings Yield: 9.4% (-50.6%).
- Key Product Sales: Lyrica: 1,385 (+9.9%), Prevnar Family: 1,301 (+16.3%), Enbrel (ex. US & Canada): 1,004 (-0.1%); Celebrex: 550 (-31.1%); Lipitor: 572 (-6.4%); Viagra: 457 (-4.0%); Zyvox: 343 (-0.9%); Norvasc: 282 (-9.6%); Sutent: 310 (-0.6%); Premarin Family: 290 (-3.0%).
- 2015 Guidance: Revenues: $44.5B - 46.5B; GAAP EPS: $1.37 - 1.52; non-GAAP EPS: $2.00 - 2.10.
Tue, Jan. 27, 7:03 AM
Mon, Jan. 26, 5:30 PM
Mon, Jan. 26, 4:55 PM
- Pfizer (NYSE:PFE), through Gavi the Vaccine Alliance, will discount its pneumonia vaccine, Prevenar 13, 20 cents for the world's most resource-limited countries. The per-dose price will drop from $3.30 to $3.10 for the four-dose vial product. The discounted price will be extended to all Gavi-eligible and Gavi-graduated countries through 2025.
- Previously: Pfizer Prevanar 13 helps to almost halve certain type of pneumonia (March 12, 2014)
Sat, Jan. 24, 8:25 AM
- In a low-yield world, the newly launched iBillionaire High Dividend Index - which tracks the trading moves of 25 investing-savvy billionaire investors such as Stanley Druckenmiller, James Dinan and Nelson Peltz - actually lives up to its name with a dividend yield of 5.34%.
- At 24%, the index has a high allocation of energy shares, including OXY, TRP, CNP, COP, BP, ATLS, CVI, WMB, APL, RIG and ARP.
- Also worth noting is that the index contains some high-yielding mortgage REITs, an area most investors hate right now but where billionaires seem to find value; examples are NRF, AGNC and CIM.
- No mutual fund or ETF tracks this index, but it offers a fishing pond of income investment ideas to research further.
- The top 20 holdings: TLM, CVC, GM, TIME, AEE, D, STAY, KMI, TROX, EXC, STNG, PPL, IRM, PFE, KKR, KAR, F, MIC, LO, ABBV.
Thu, Jan. 22, 11:46 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for an expanded label for Pfizer's (PFE -0.2%) Prevenar 13 to include the prevention of pneumonia in patients at least 18 years old caused by the 13 pneumococcal serotypes in the vaccine.
- Prevenar's current indication in Europe is for the prevention of invasive pneumococcal disease in the same population.
- A final decision from the European Commission usually takes ~60 days.
Mon, Jan. 19, 5:38 PM
- The FDA grants Fast Track status to privately-held Marathon Pharmaceuticals' corticosteroid MP-104 (deflazacort) for the treatment of Duchenne Muscular Dystrophy (DMD).
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
- DMD-related tickers: (NASDAQ:SRPT) (NASDAQ:PTCT) (NYSE:PFE) (NASDAQ:RNA) (OTCQB:MRNA) (NASDAQ:ROSG)
Mon, Jan. 19, 5:11 PM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Cosentyx (secukinumab) as a first-line systemic treatment for adult patients with moderate-to-severe psoriasis. It is the first interleukin-17A inhibitor cleared in Europe.
- Cosentyx is also cleared for sale in Australia and Japan. FDA approval is imminent considering the unanimous positive vote by the Dermatologic and Ophthalmic Drugs Advisory Committee in October.
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Thu, Jan. 8, 7:55 PM
- The FDA approves Daiichi-Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
- Edoxaban is an anticoagulant that inhibits factor Xa. It was approved in Japan in 2011 for the prevention of venous thromboembolism in patients undergoing total knee replacement surgery, total hip replacement surgery and hip fracture surgery.
- Anticoagulant-related tickers: (NASDAQ:ISIS) (NYSE:BAX) (NASDAQ:PTLA) (NASDAQ:MSLI) (NYSE:MRK) (NYSE:JNJ) (NASDAQ:MDCO) (NASDAQ:SCLN) (NYSE:PFE) (NYSE:BMY) (NYSE:AZN) (OTCPK:BAYRY)
Thu, Jan. 8, 12:48 PM
- Pfizer's (PFE +1.8%) discussions with the FDA concerning its New Drug Application for Ibrance (palbociclib) have reached the labeling stage. The company reports that the regulator informed it that there are no plans for an advisory committee meeting on its submission. Approval appears virtually certain. The PDUFA date is April 13.
- Ibrance, if approved, will be indicated, in combination with letrozole, for the first-line treatment of treatment-naive postmenopausal women with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
- Analysts believe the product could generate as much as $4B in sales by 2020.
- Previously: FDA grants priority review for Pfizer's breast cancer drug (Oct. 13, 2014)
PFE vs. ETF Alternatives
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.
Other News & PR