Fri, May. 1, 10:44 AM
- According to Reuters, Pfizer (PFE +0.2%) is negotiating a takeover of Swedish Orphan Biovitrum, known as Sobi. The potential price is unknown but the Stockholm-based firm's market cap is 35.8B Swedish crowns (US$4.3B).
- Sobi develops medicines for orphan diseases in hemophilia, inflammation, inherited metabolic disorders and oncology. Its top sellers are Kineret (anakinra), an interleukin-1 (IL-1) antagonist for the treatment of rheumatoid arthritis and neonatal-onset multisystem inflammatory disease (NOMID), and Orfadin (nitisinone) for the treatment of hereditary tyrosinemia type 1, a genetic disorder characterized by excess levels of tyrosine in the blood.
- Pfizer has a relationship with Sobi via its marketing of the hemophilia treatment ReFactor AF, which Sobi manufactures.
Tue, Apr. 28, 8:14 AM
- Pfizer (NYSE:PFE) Q1 results ($M): Total Revenues: 10,864 (-4.3%); GEP: 5,014 (-16.3%); GIP: 3,075 (0.0%); Global Vaccines: 1,328 (+43.6%); Consumer Healthcare: 808 (+6.3%); Global Oncology: 528 (+8.2%); Net Income: 2,376 (+2.0%); EPS: 0.38 (+5.6%).
- Repurchased $6B in common stock, no additional buybacks this year.
- Non-GAAP EPS lowered due unfavorable foreign exchange trend vs. dollar.
- 2015 Guidance: Revenues: $44.0B - 46.0B from $44.5B - 46.5B; GAAP EPS: $1.32 - 1.47 from $1.37 - 1.52; Non-GAAP EPS: $1.95 - 2.05 from $2.00 - 2.10.
Tue, Apr. 28, 7:04 AM
Mon, Apr. 27, 5:30 PM
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Mon, Apr. 27, 4:36 PM
Mon, Apr. 27, 10:24 AM
- BioMarin Pharmaceuticals (BMRN +3.5%) concludes its rolling New Drug Application (NDA) with the FDA, as provided under Fast Track and Breakthrough Therapy designations, for drisapersen for the treatment of Duchenne muscular dystrophy (DMD), a fatal genetic disorder affecting ~20K children worldwide each year.
- DMD, usually affecting boys, is caused by a defective gene for dystrophin, an essential muscle protein.
- Drisapersen induces the skipping of dystrophin exon 51 which restores the proper dystrophin reading frame in ~13% of DMD patients. The FDA has also tagged it an Orphan Drug for DMD, which provides a seven-year period of market exclusivity for the indication, if approved.
- DMD-related tickers: (OTCPK:SPHDF)(PTCT -2.1%)(SRPT +2.2%)(CAPR -1.2%)(SMMT +0.9%)(PFE +0.4%)(RNA)(ROSG)(OTCQB:MRNA)
Thu, Apr. 23, 2:53 PM
Wed, Apr. 22, 12:56 PM
- The FDA designates Capricor Therapeutics' (CAPR +11.3%) lead product candidate, CAP-1002, an Orphan Drug for the treatment of Duchenne muscular dystrophy, a genetic disorder characterized by progressive muscle degeneration and weakness.
- CAP-1002, currently in Phase 2 development, is an "off-the-shelf" cell therapy that is derived from donor heart tissue and is infused directly into a patient's coronary artery via a catheter. In preclinical models, cardiosphere-derived cells have been shown to promote cardiomyogenesis (formation of new heart muscle) and angiogenesis (formation of new blood vessels) while inhibiting oxidative stress, inflammation and fibrosis.
- Duchenne-related tickers: (SMMT -6.8%)(PTCT +0.2%)(SRPT +0.1%)(BMRN)(PFE +0.1%)(RNA)(ROSG -1.9%)(OTCQB:MRNA +1.4%)
Tue, Apr. 21, 10:38 AM
- The FDA designates Pfizer's (PFE +0.2%) Xalkori (crizotinib) a Breakthrough Therapy for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC), a subgroup representing ~1% of NSCLC cases.
- Among the benefits of Breakthrough Therapy status is intensive guidance from the FDA on the most efficient development path, access to higher level agency managers and a rolling review of the New Drug Application (NDA).
- Xalkori is a kinase inhibitor that is currently approved for patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC.
- NSCLC is the most common form of lung cancer, accounting for 85% of cases. The five-year survival rate for advanced NSCLC is only 5%.
Tue, Apr. 21, 10:19 AM
- A 326-patient Phase 3 trial evaluating Pfizer's (PFE +0.3%) antibody-drug conjugate, inotuzumab ozogamicin, in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) met one of its two primary efficacy endpoints of a higher complete hematologic remission rate compared to standard-of-care chemotherapy. The other primary endpoint, overall survival (OS), needs more to time to assess. The results will be presented at an upcoming medical meeting.
- Inotuzumab ozogamicin is an investigational antibody-drug conjugate comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed in ~90% of B-cell cancers, linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is internalized into the cell where the cytotoxin calicheamicin is released to kill the cell.
Mon, Apr. 20, 12:33 PM
- The first patient has been dosed in a Phase 3 trial sponsored by Merck KGaA (OTCPK:MKGAY) and Pfizer (PFE +0.3%) to evaluate the PD-1 inhibitor avelumab in patients with advanced (stage IIIb/IV) non-small cell lung cancer whose disease has progressed after receiving platinum-based chemo. The open-label study will enroll ~650 patients across 290 sites in more than 30 countries, randomized 1:1 to receive either avelumab or docetaxel, regardless of PD-1 status.
- The primary endpoint is overall survival (OS). Secondary endpoints include overall response rate (ORR), progression-free survival (PFS) and patient-reported outcomes.
- Avelumab was discovered and developed by Merck KGaA. It entered into a strategic alliance with Pfizer in November 2014 to co-develop and co-commercialize the PD-1 inhibitor and to collaborate on up to 20 immuno-oncology clinical development programs, including combination trials, many of which will commence this year.
Wed, Apr. 15, 10:38 AM
- Based on the assessment by the independent Data Monitoring Committee, a Phase 3 study, called PALOMA-3, evaluating Pfizer's (PFE +0.6%) Ibrance (palbociclib), in combination with fulvestrant, in a specific type of breast cancer has been stopped early after the trial met its primary efficacy endpoint of an improvement in progression-free survival.
- PALOMA-3 compared the combination of palbociclib and fulvestrant to fulvestrant plus placebo in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer whose disease progressed during or after endocrine therapy.
- The data will be submitted for presentation at the upcoming American Society for Clinical Oncology (ASCO) meeting, May 29 - June 2, in Chicago.
- The FDA approved Ibrance, in combination with the aromatase inhibitor, letrozole, in February 2015 for the treatment of ER+/HER2- breast cancer. Aromatase is an enzyme that plays a key role in the biosynthesis of estrogen.
- Fulvestrant is an estrogen receptor down-regulator.
Wed, Apr. 8, 10:38 AM
- A Phase 3 trial, called ANNEXA-A, evaluating Portola Pharmaceuticals' (PTLA +2.7%) andexanet alfa as an antidote to the anticoagulant Factor Xa inhibitor Eliquis (apixaban) successfully achieved all primary and secondary endpoints with high statistical significance. Andexanet alfa produced rapid reversal of the anticoagulant effect of apixaban which was sustained for the duration of the infusion in healthy volunteers. Patients on anticoagulant therapy sometimes need a reversal agent in situations that present a risk of difficult-to-control bleeding, such as surgery or trauma.
- The company plans to submit the data from ANNEXA-A and ANNEXA-R (rivaroxaban) and initial data from a Phase 4 study as part of its Biologics License Application (BLA) to the FDA under an accelerated approval pathway by the end of this year.
- Eliquis is marketed by Bristol-Myers Squibb (BMY +0.7%) and Pfizer (PFE +0.3%). Rivaroxaban is marketed under the brand name Xarelto by Janssen (JNJ -0.1%).
Tue, Apr. 7, 4:36 PM
- Pfizer (NYSE:PFE) plans to commence a Phase 3 trial evaluating GlycoMimetics' (NASDAQ:GLYC) rivipansel for the treatment of vaso-occlusive crisis (VOC) by mid-year. Under the terms of the license agreement signed in October 2011, the dosing of the first patient will trigger a $20M milestone payment to GlycoMimetics.
- The study, originally set to begin in late 2014, was delayed due to manufacturing issues at Pfizer.
Tue, Apr. 7, 9:43 AM
- Pfizer (PFE +0.8%) and Merck KGaA finalize their co-promotion agreement regarding the former's anaplastic lymphoma kinase (ALK) inhibitor, XALKORI (crizotinib) for the treatment of non-small cell lung cancer. The co-promotion will occur in two waves. The first, beginning in Q2 and Q3, will roll out in the U.S., Canada, Japan and five European countries (France, Germany, Italy, Spain and the UK). In the U.S. and Canada, XALKORI will be co-promoted by EMD Serono, Merck KGaA's arm in these countries. The second wave, in China and Turkey, will start in 2016.
- This calendar year, Merck will receive reimbursement for its promotion of XALKORI. Starting in 2016, Pfizer and Merck will split the profits on an 80/20 basis. The contract in the "first wave" countries will be in effect through 2020 and from January 1, 2016 through 2021 in China and Turkey.
Mon, Apr. 6, 10:51 AM
- Following to its previously announced merger with Targacept (TRGT -10.9%), Catalyst Biosciences discloses that Pfizer (PFE +0.1%) has terminated its 2009 license agreement with Catalyst for its lead product candidate, CB 813d, for the treatment of hemophilia. When the contract formally ends on June 1, all rights will revert back to Catalyst.
- Targacept is currently assessing the implications of Pfizer's withdrawal on its proposed merger with Catalyst.
- Previously: Targacept and Catalyst Bio to merge (March 5)
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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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