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)
Thu, Apr. 2, 6:44 PM
- Bind Therapeutics (NASDAQ:BIND) and Pfizer (NYSE:PFE) have agreed to extend the timeline for the second program in a collaboration to "create Accurins that optimize the therapeutic potential of two molecularly targeted oncology drugs in Pfizer's pipeline" through March 2016.
- The deadline for Pfizer to exercise an option to acquire an exclusive license for the first program remains Sep. 2015; a development milestone was achieved for the program last December. Bind states the extension for the second program gives the company and Pfizer more time to finish preclinical research.
- Shares have jumped to $6.00 AH.
Thu, Apr. 2, 7:11 AM
- In response to the Chinese government's failure to renew its import license, Pfizer (NYSE:PFE) decides to cease sales operations for its pneumococcal vaccine, Prevenar, in China. The move affects 200 employees there, but the company says it will help them find other positions within the 9,000-strong in-country workforce.
- No explanation is given as to why the license was not renewed. The company's action will create a near term shortage of the vaccine, as it continues to work with regulators to gain approval for Prevenar 7 and Prevenar 13.
Tue, Mar. 24, 5:34 PM
- A Phase 2a clinical trial evaluating Lpath's (NASDAQ:LPTN) candidate for advanced renal cell carcinoma (RCC), ASONEP, failed to achieve its primary efficacy endpoint of a statistically significant improvement in progression-free survival (PFS). The study enrolled RCC patients who had previously failed treatment with at least one anti-vascular endothelial factor (VEGF) agent and no more than one mTOR inhibitor. This patient population is considered "last line."
- To meet the endpoint, 25 of 39 patients needed to be progression-free at Month 2 of treatment, but the overall median time to progression was less than that. Seven patients were progression-free at least six months and three were progression-free for more than 29 months.
- ASONEP is an anti-S1P antibody formulated for systemic use. S1P is sphingosine-1-phosphate, a blood-borne lipid mediator that is a key regulator of vascular and immune systems. It is upregulated (there is more of it) in certain cancers so binding to it may potentially inhibit progression.
- The company will assess its options with a partner to explore areas that present the greatest chance of success for ASONEP. Another Phase 2 study is evaluating the ocular version, iSONEP, in wet age-related macular degeneration. Data readout should happen in Q2. Pfizer (NYSE:PFE) has an exclusive option for a global license. Pfizer has a time-limited right of first refusal for a license for ASONEP.
- LPTN is down 27% after hours on robust volume.
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Mon, Mar. 23, 1:55 PM
- Jeffries raises it price target on Pfizer (PFE +3.3%) to $45 citing improved prospects for the launch of Ibrance, higher growth in GEP driven by the Hospira acquisition and potential M&A deals.
- According to a survey of oncologists, peak sales of Ibrance could reach $13B, based on the assumption that it will be used in ~half of first-line hormonal therapy within one year.
- Based on the Hospira upside and evolving shift to emerging markets, GEP's revenues and earnings are trending ~14% above consensus by 2018.
- M&A will continue to be a potential catalyst considering the $117B it was prepared to spent for AstraZeneca.
Mon, Mar. 23, 12:38 PM
- The Federal Trade Commission grants early termination under the HSR Act of the waiting period of Pfenex's (PFNX -1.4%) exclusive collaboration deal with Hospira (PFE +3.2%) to develop and commercialize PF582, a biosimilar to Roche's (OTCQX:RHHBY +0.7%) Lucentis (ranibizumab). The action clears the way for Hospira's initial payment of $51M to Pfenex.
- Previously: Pfenex up on Hospira biosimilar deal (Feb. 10)
Mon, Mar. 23, 9:35 AM
- Pfizer (PFE +1.3%) and collaboration partner Eli Lilly (LLY +0.1%) plan to resume the Phase 3 clinical program for tanezumab for the treatment of chronic pain. The action will trigger a $200M payment from Lilly to Pfizer as stipulated in their agreement.
- The FDA instituted a partial clinical hold on tanezumab in December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed. The regulator lifted the partial hold after reviewing nonclinical data submitted in February 2015 characterizing the sympathetic nervous system response to tanezumab.
- Tanezumab is a humanized monoclonal antibody that inhibits (binds to) nerve growth factor (NGF), a regulator of pain processing and sensitivity. Pfizer was developing it for the treatment of osteoarthritis a few years ago, but stopped amid indications that it was associated with joint destruction. The pain med worked so well that a group of patients blew out joints that needed replacing. Pfizer shelved the program in light of the safety risk but rekindled it after a panel of outside experts recommended that a more specific patient population could benefit from anti-NGF therapies. It partnered with Lilly in 2013 to advance the program and share the risk.
Fri, Mar. 20, 1:02 PM
- According to Bloomberg, AstraZeneca's (AZN +2.6%) previously stated plan to increase revenue 75% by 2023 is looking a bit wobbly. In cancer, for example, it trails three competitors in immunotherapies for lung cancer. The FDA approved Bristol-Myers Squibb's (BMY +0.2%) Opdivo for the indication on March 4. AZN's candidate, MEDI4736, is still in clinical development with an NDA filing on tap for next year. Being late to the party means modest sales unless there is a profound advantage, something that MEDI4736 may not have unless combined with other drugs.
- If the company's sales growth fails to ramp, its valuation could slump and encourage another takeover bid. AZN currently sports a P/E of 79 versus the industry average of 25 (per msn money).
- Last year, CEO Pascal Soriot fought off a $117B bid from Pfizer (PFE +0.2%) telling investors that the firm could increase revenues to $45B by 2023. The company remains bullish, though. Spokesperson Esra Erkal-Paler says that the firm is making significant progress and that oncology drugs could represent 25% of sales by 2023, up from 12% in 2014. It is currently running clinical studies of AZD9291, a non-immune therapy, in lung cancer patients with a specific mutation who have relapsed after prior treatment. If it can beat rival Clovis Oncology (CLVS -2.4%) to the market, it could be worth as much as $3B per year.
- Mirabaud analyst Nick Turner says that even if all the drugs in the pipeline make it to the market, AZN will have to stretch to reach $45B in 2023 because two of its biggest sellers, Crestor (ttm sales=$5.5B) and Nexium (ttm sales=$3.7B), face declining sales from the loss of patent protection.
Wed, Mar. 18, 10:42 AM
- Paris, France-based Cellectis (Pending:CLLS) is set for its U.S. debut of 3.5M American Depositary Shares (ADSs) representing 3.5M ordinary shares at $36.83 per ADS. The company's stock currently trades on the Alternext market of Euronext in Paris under the symbol "ALCLS."
- The gene-editing firm develops CAR-T cancer immunotherapies, currently the "next big thing" in the treatment of cancer. Other emerging biotechs in the field sport valuations of $3B+ (NASDAQ:KITE) (NASDAQ:JUNO) (NASDAQ:BLCM) (NASDAQ:BLUE). In June 2014 it inked a deal with Pfizer (NYSE:PFE) to develop CAR-T therapies which included establishing a 10% stake in Cellectis.
- Cellectis' gene-editing technology allows it to create T-cells that express chimeric antigen receptors (CARs) that harness the immune system's power to target and kill cancer cells. Its uniqueness is the capability to create allogeneic CAR-T cells from healthy donors instead from the patients themselves. This creates the opportunity to develop "off-the-shelf" products that can be stored and distributed worldwide.
- Gene editing is a form of genetic engineering in which DNA is manipulated (inserted, deleted, repaired or replaced) from a precise location in the genome. Cellectis' technology and expertise enables it to edit any gene with a high degree of precision.
- 2014 financial performance (€M): Revenues: 26.5 (+108.7%); Operating Loss: (5.2) (+80.4%); Net Loss: (1.0) (+98.2%); CF Ops: 42.5 (+322.5%).
Thu, Mar. 12, 5:03 PM
- A post-market 107-patient Phase 4 study evaluating Pfizer's (NYSE:PFE) Lyrica (pregabalin) in adolescents, aged 12 - 17 years, with fibromyalgia (FM) failed to demonstrate a statistically significant difference in pain score versus placebo. The treatment difference was 0.66 points, which was an improvement of 1.60 points from baseline for pregabalin-treated patients and 0.94 for placebo (p=0.121). The company intends to submit the full results for publication.
- Lyrica is approved for five indications in the U.S., four of which address pain, including FM.
- FM is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue and disruptions to sleep, memory and mood. The specific cause is unknown and there is no cure. It affects almost 6M Americans.
Wed, Mar. 11, 10:01 AM
- Based on feedback from the FDA, Egalet (EGLT) now plans to submit a New Drug Application (NDA) for its abuse-deterrent, extended-release oral morphine product, Egalet-001, by the end of the year.
- The company will initiate a pivotal bioequivalence study comparing the 60 mg dose to Purdue's MS Contin later this month. Bioequivalence to MS Contin has already been demonstrated at the 15 mg and 30 mg doses.
- Egalet-001 incorporates the company's Guardian Technology to deter abuse. It utilizes injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
- Related tickers: (ZGNX -23.4%)(ACUR)(ALKS +0.5%)(PFE +0.6%)(ABBV +0.7%)(LCI +1.6%)(ACT +1.7%)(MNK +1.6%)(TEVA +2.6%)
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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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