Dec. 19, 2014, 12:48 PM
- Pfizer's (PFE +0.2%) receipt of the European Commission's marketing authorization for Duavive (conjugated estrogens/bazedoxifene) triggers a milestone payment for an undisclosed amount to development partner Ligand Pharmaceuticals (LGND +1.4%).
- Duavive is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom progestin-containing therapy is not appropriate. It pairs conjugated estrogens with an estrogen agonist/antagonist, known as a selective estrogen receptor modulator. Bazedoxifene is used instead of progestin in order to protect the uterine lining against hyperplasia that may result from estrogen alone therapy.
Dec. 18, 2014, 8:52 AM
- A Phase 3 clinical trial assessing a controlled-release (CR) formulation of Pfizer's (NYSE:PFE) Lyrica (pregabalin) for the treatment of postherpetic neuralgia (pain after shingles or PHN) met its primary efficacy endpoint of time to loss of therapeutic response (LTR), or durability of effect, in pain reduction compared to placebo. The time to LTR in the double blind phase (<30% pain response relative to baseline mean pain) occurred in 13.9% of the patients in the test group versus 30.7% of patients in the control group. The results were statistically significant.
- The company plans to submit the final results from the study for publication after analyses are done.
- The value proposition of a CR formulation is once-daily dosing. Currently, Lyrica is dosed 2-3 times per day depending on the indication.
Dec. 17, 2014, 10:10 AM
- Pfizer (PFE +0.2%) initiates a Phase 2 clinical trial assessing its investigational compound, PF-06252616, in boys with Duchenne Muscular Dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness. It occurs in ~1 in 3,500 male births worldwide.
- The study will evaluate the safety, tolerability and efficacy of PF-06252616 in boys aged 6 to <10 years old diagnosed with DMD regardless of genotype.
- The FDA designated PF-06252616 an Orphan Drug in July 2012 and Fast Track in November 2012.
- DMD-related tickers: (SRPT +4.1%)(RNA +0.1%)(PTCT +1.6%)(OTCQB:MRNA +5.8%)(ROSG +0.4%)
- Previously: Catabasis Pharmaceuticals' CAT-1004 tagged an Orphan Drug for DMD (Nov. 24, 2014)
Dec. 16, 2014, 10:38 AM
Dec. 15, 2014, 12:25 PM
Dec. 15, 2014, 8:56 AM
- Opko Health (NYSE:OPK) is up 14% premarket on robust volume in response to its deal with Pfizer (NYSE:PFE). The latter will be pay Opko an upfront fee of $295M and up to $275M in regulatory milestones for the global rights to hGH-CTP, a long-acting growth hormone. Its value proposition is a once-weekly injection, a significant improvement over the once-daily standard of care.
- Opko acquired the rights to hGH-CTP via its takeout of Israel-based Prolor last year.
- Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
Dec. 11, 2014, 7:15 AM
- In a small trial of 29 people with severe lumbar spinal stenosis, the most common cause of lower back pain, Pfizer's (NYSE:PFE) Lyrica (pregabalin) did not perform any better than placebo in relieving pain.
- Lyrica is not approved for the indication, but the company funded the study to explore the potential label expansion. In spinal stenosis, the canals where the nerves pass through the spine narrow due to conditions such as arthritis. The narrowed passages pinch the nerves causing chronic pain.
- The product is currently approved for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for adults with partial onset seizures, fibromyalgia and neuropathic pain associated with spinal cord injury.
- Lyrica generated $4.9B in sales the past four quarters.
Dec. 10, 2014, 9:48 AM
Dec. 9, 2014, 9:23 AM
- Pfizer (NYSE:PFE) strikes a deal with privately-held Philadelphia, PA-based Spark Therapeutics to development a treatment for hemophilia based on Spark's gene therapy platform. Spark expects a Phase 1/2 trial in hemophilia B to start in the first half of next year. Pfizer will assume responsibility for the late-stage development.
- Under the terms of the agreement, Spark will receive a $20M upfront payment and up to $260M in regulatory- and development-based milestones.
- Kings College London professor Michael Linden will lead the effort under a two-year contract with Pfizer.
Dec. 1, 2014, 8:10 AM
- Pfizer (NYSE:PFE) finalizes its buy of Baxter International's (NYSE:BAX) NeisVac-C (meningitis - MenC) and FSME-IMMUN/TicoVac (tick-borne encephalitis) vaccines and a portion of Baxter's facility in Orth, Austria where the products are made. The $635M deal was announced in late July.
- Previously: Pfizer buys Baxter's vaccine business
Nov. 28, 2014, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Nov. 28, 2014, 4:54 AM
- Pfizer's (NYSE:PFE) attempt to gain control of AstraZeneca (NYSE:AZN) through a £69.4B ($110B) takeover bid in May would have collapsed on changes to U.S. tax inversion laws, announced Astrazeneca's chief exec, cooling off speculation of another bid for the U.K. pharmaceutical company.
- "If we had agreed to a deal at the time, probably that deal would have fallen apart by now, just like the AbbVie/Shire deal, and created enormous destruction and disruption in our company," said Pascal Soriot in an interview with CNBC.
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 21, 2014, 8:04 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Celgene's (NASDAQ:CELG) Otezla (apremilast) for two indications: 1. the treatment of adult patients with moderate-to-severe plaque psoriasis who failed to respond to, or who are contraindicated for or are intolerant to, other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA); 2. alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. A final decision from the European Commission usually takes about 60 days.
- Apremilast is a PDE4 inhibitor specific for cyclic AMP (cAMP). PDE4 inhibition results in increased cAMP levels which is thought to indirectly modulate the production of inflammatory mediators.
- The FDA approved Otezla in March.
- Previously: FDA approves Otezla
- Previously: Otezla label expansion cleared in the U.S.
- Related tickers: (NYSE:PFE) (NYSE:SNY) (OTCQB:SNYNF) (NYSEMKT:PLX) (NASDAQ:SHPG)
Nov. 21, 2014, 7:38 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval for Genzyme's (NYSE:SNY) (OTCQB:SNYNF) Cerdelga (eliglustat) capsules for the treatment of certain adults with Gaucher disease type 1. A final decision by the European Commission usually takes about 60 days.
- The FDA approved Cerdelga in August. It was the first oral therapy approved as a first-line treatment for Gaucher.
- Previously: FDA approves new drug for Gaucher's disease
- Related tickers: (NYSE:PFE) (NYSEMKT:PLX) (NASDAQ:SHPG)
Nov. 20, 2014, 1:36 PM
- The FDA approves Purdue Pharma's Hysingla ER (hydrocodone bitartrate) for pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
- Hysingla ER incorporates abuse-deterrent properties that make the tablet difficult to crush, break or dissolve and it forms a viscous hydrogel that makes it difficult to prepare for injection.
- The agency is requiring postmarketing studies of Hysingla ER to assess the effects of its abuse-deterrent properties on the risk of abuse and the consequences of that abuse in the community. Purdue is also required to make educational programs available to healthcare professionals on now to safely prescribe ER/LA opioid analgesics in addition to medication guides and patient counseling documents.
- Opioid-related tickers: (ZGNX -0.8%)(PFE +0.2%)(EGLT +4.5%)(ACUR)(MNK +0.9%)(ABBV)(TEVA -0.1%)(ALKS +1.5%)
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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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