Pfizer Inc.(PFE)- NYSE
  • Today, 9:36 AM
    • ARIAD Pharmaceuticals (ARIA +1.5%) completes the rolling submission of its New Drug Application (NDA) to the FDA seeking approval of Breakthrough Therapy- and Orphan Drug-tagged brigatinib for the treatment of patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to Pfizer's (PFE -0.2%XALKORI (crizotinib). The company has requested accelerated review of the filing.
    • Brigatinib is an oral inhibitor of an enzyme called anaplastic lymphoma kinase (ALK). The abnormal expression of ALK is a key driver of certain types of non-small cell lung cancer, neuroblastomas and anaplastic large cell lymphoma. It is not generally expressed in normal adult tissues so it is a promising therapeutic target.
    | Today, 9:36 AM | 1 Comment
  • Yesterday, 12:46 PM
    • Dr. Reddy's Laboratories (RDY +0.8%) announces the commercial availability of its generic version of Pfizer's (PFE +0.7%) cardiac med Nitrostat (nitroglycerin) for the treatment/prevention of chest pain (angina pectoris) due to coronary artery disease.
    • According to IMS Health, the U.S. market is $110M for the sublingual tablet brand.
    | Yesterday, 12:46 PM | 4 Comments
  • Thu, Aug. 25, 9:14 AM
    • The FDA designates Mallinckrodt's (NYSE:MNK) Synacthen (tetracosactide) depot formulation (long acting) for Fast Track review for the treatment of Duchenne muscular dystrophy (DMD). A Phase 1 study is underway.
    • Synacthen, a 24-amino acid melanocortin receptor agonist, is a synthetic version of the natural hormone ACTH (adrenocorticotrophic hormone). It is currently approved ex-U.S. to test if the adrenal glands are working properly and to treat adrenocortical insufficiency.
    • DMD is an inherited disorder caused by the absence of a protein called dystrophin. It is characterized by progressive muscle degeneration and weakness.
    • 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:BMRN)(NASDAQ:SMMT)(NASDAQ:PTCT)(NYSE:PFE)(OTCQB:MRNA)(NASDAQ:CATB)
    | Thu, Aug. 25, 9:14 AM | 10 Comments
  • Wed, Aug. 24, 3:08 PM
    • She's at it again. Democratic nominee for President Hillary Clinton takes a dim view of Mylan's (MYL -5.4%) bullish pricing for its EpiPen (epinephrine injection), an auto-injector used to treat allergic reactions in an emergency. The company has raised the price five-fold since 2007.
    • In a statement, she says, "Over the last several years Mylan Pharmaceuticals has increased the price of EpiPens by more than 400%. They're now charging up to $600 for a two-EpiPen set that must be replaced every 12 - 18 months. This both increases out-of-pocket costs for families and first responders and contributes to higher premiums for all Americans and their employers. This is outrageous - and it's just the latest troubling example of a company taking advantage of its customers. I believe our pharmaceutical and biotech industries can be an incredible source of American innovation, giving us revolutionary treatments for debilitating diseases. But it's wrong when drug companies put profits ahead of patients, raising pricing without justifying the value behind them. I am calling on Mylan to immediately reduce the price of EpiPens."
    • Her comments have stoked selling in the biotech/pharma sector, just like it did when Ms. Clinton had Valeant Pharmaceuticals (VRX -1.3%) in her sights a few months ago.
    • Previously: Mylan slumps on senator's inquiry into EpiPen price hikes (Aug. 23)
    • Representative tickers: (IBB -2.6%)(AMGN -1.8%)(VRX -1.3%)(BIIB -2.5%)(PFE -0.6%)(BMY -1.9%)(MRK -1.2%)(GILD -1%)(AGN -3%)
    | Wed, Aug. 24, 3:08 PM | 720 Comments
  • Wed, Aug. 24, 3:10 AM
    • AstraZeneca (NYSE:AZN) has agreed to sell its small-molecule antibiotics operations to Pfizer (NYSE:PFE) in a transaction that could eventually be worth $1.575B.
    • The deal will allow AstraZeneca to focus on three main therapy areas and realize value "from the strong portfolio of established and late-stage small molecule antibiotics."
    • Pfizer will pay $550M upfront plus $175M in January 2019 and as much as $850M in milestones and sales-related payments.
    • The U.S. company will receive approved antibiotics Merrem, Zinforo and Zavicefta, and clinical-development treatments ATM-AVI and CXL. (PR)
    | Wed, Aug. 24, 3:10 AM | 18 Comments
  • Tue, Aug. 23, 8:09 AM
    • CytoDyn (OTCQB:CYDY) announces that 10 of 11 (one failure) patients in its Phase 2b extension study of HIV therapeutic candidate PRO 140 have experienced two years of complete viral suppression (plasma HIV-1 RNA <40 copies/mL). Patients in the study received a 350 mg dose of PRO 140 once weekly via subcutaneous injection in place of their HAART (multiple antiretroviral) regimens. In the next two months, nine more patients will reach their two-year benchmarks.
    • 40 patients were originally enrolled in the Phase 2b trial with 35 evaluable. 20 of the 35 (~57%) had viral suppression at the end of the 12-week study period and were eligible for the extension arm. 15 of the 20 were granted entry into the extension phase, but four of the 15 were disqualified due to lack of follow-up or issues unrelated to PRO 140.
    • The PRO 140 antibody is a viral entry inhibitor that targets the CCR5 (C-C chemokine receptor type 5) co-receptor, a protein on the surface of white blood cells that acts as a receptor for chemokines, signalling proteins that induce chemotaxis (chemical-induced movement) in nearby cells. This is the process by which the immune system's T cells are attracted to specific targets. HIV uses CCR5 to enter and infect host cells.
    • PRO 140 will compete against the only other CCR5 antagonist approved for the treatment of HIV infection, ViiV Healthcare's (NYSE:GSK)(NYSE:PFESelzentry (maraviroc).
    • PRO 140's value proposition compared to Selzentry (and HAART) is less toxicity, fewer side effects and once-weekly administration versus daily. According to the company, only ~20% of HIV patients have a completely suppressed viral load.
    • Previously: HIV patients receiving CytoDyn's PRO 140 doing well after one year of treatment (Sept. 21, 2015)
    | Tue, Aug. 23, 8:09 AM | 28 Comments
  • Mon, Aug. 22, 7:02 AM
    • Medivation (NASDAQ:MDVN) is up 19% premarket on the news that Pfizer (NYSE:PFE) will acquire it for $81.50 a share (~14B). The deal should close by Q4. Pfizer will host a conference call this morning at 9:00 am ET to discuss the transaction.
    | Mon, Aug. 22, 7:02 AM | 33 Comments
  • Sun, Aug. 21, 6:39 PM
    • Pfizer (NYSE:PFE) is close to a $14B deal to acquire cancer drugmaker Medivation (NASDAQ:MDVN), FT says.
    • The price is about 1/3 higher than Medivation's closing price on Friday.
    • Pfizer would be beating out rivals including Celgene (NASDAQ:CELG), Gilead (NASDAQ:GILD), Sanofi (NYSE:SNY), Merck (NYSE:MRK) and AstraZeneca (NYSE:AZN), who have been pursuing Medivation for months.
    • Medivation has already rejected two "inadequate" bids from Sanofi, the last for $11B ($58/share).
    • Shares of Medivation have more than doubled in the last six months.
    • Medivation makes the leading prostate cancer drug, Xtandi, which is expected to generate $5.7B in annual revenue by 2020.It is also developing an experimental drug called Talazoparib, which is designed to stop tumor cells from multiplying by damaging their DNA.
    • Update: It's official. Pfizer will acquire Medivation for $81.50 a share (~$14B). The deal will be immediately accretive to Pfizer's non-GAAP EPS, adding ~$0.05 in the first full year after the transaction closes, expected by Q4. Its 2016 guidance will be unaffected. The deal will be financed with existing cash. Pfizer will host a conference call this morning at 9:00 am ET to discuss the acquisition.
    | Sun, Aug. 21, 6:39 PM | 92 Comments
  • Sat, Aug. 20, 3:12 PM
    • The FDA approves Pfizer's (NYSE:PFE) abuse-deterrent TROXYCA ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the management of pain severe enough to require around-the-clock long-term opioid treatment and for which alternative treatment options are inadequate.
    • The product is formulated in pellets with a core of sequestered naltrexone hydrochloride, an opioid antagonist, surrounded by the pain medication oxycodone hydrochloride. When taken as directed, the naltrexone remains sequestered while the patient receives extended-release oxycodone. When the pellets are crushed, naltrexone is released which counteracts the effects of the opioid.
    | Sat, Aug. 20, 3:12 PM | 19 Comments
  • Wed, Aug. 17, 1:30 PM
    • In-play Medivation (MDVN +2.1%) perks up on modestly higher volume on the news that Merck (MRK -0.3%) has joined Sanofi (SNY -0.5%), Celgene (CELG +0.3%), Gilead Sciences (GILD +1.7%), Pfizer (PFE +0.6%) and AstraZeneca (AZN -0.2%) as potential acquirers.
    • Medivation has already rejected two "inadequate" bids from Sanofi, the last for $11B ($58/share).
    | Wed, Aug. 17, 1:30 PM | 36 Comments
  • Tue, Aug. 16, 10:50 AM
    • Viiv Healthcare, the HIV company formed by GlaxoSmithKline (GSK +0.2%) and Pfizer (PFE -0.3%), launches a Phase 3 program to develop a two-drug regimen of Tivicay (dolutegravir) and Epivir (lamivudine) for treatment-naive adults with chronic HIV-1 infection.
    • The late-stage program consists of two Phase 3 studies, GEMINI 1 and GEMINI 2, that will compare the two-drug regimen against a three-drug regimen of dolutegravir plus Gilead Sciences' (GILD -0.4%) Truvada [emtricitabine/tenofovir disoproxil fumarate (NYSE:TDF)] in ~1,400 subjects. Both are designed to demonstrate non-inferiority of the two-drug approach. The primary efficacy endpoint will be measured at Week 48, but patients will be followed/evaluated through Week 148.
    | Tue, Aug. 16, 10:50 AM | 4 Comments
  • Thu, Aug. 11, 1:06 PM
    • Micro cap Nymox Pharmaceutical (NYMX +31.4%) perks up on more than a 12x surge in volume in response to its announcement that it expects to file a marketing application (presumably in the U.S.) within the next two quarters seeking approval of fexapotide for the treatment of men with an enlarged prostate, called benign prostate hyperplasia or BPH. In addition, the company says it does not envision needing more cash for the pre-marketing development of fexapotide (it will need new capital for commercialization, though). It intends to partner with a larger company once fexapotide is approved, provided satisfactory terms can be agreed upon.
    • Fexapotide is administered directly into the prostate via a transrectal injection that does not require anesthesia or sedation. Results from long-term studies (seven years of follow-up) showed a prostate cancer incidence rate of only 1.3% in men treated with fexapotide compared to ~23% in the general population and ~20% in men treated with PDE5 inhibitors for erectile dysfunction [Pfizer's (NYSE:PFE) Viagra, Eli Lilly's (NYSE:LLY) Cialis, Bayer (OTCPK:BAYRY) and GlaxoSmithKline's (NYSE:GSK) Levitra].
    • Previously: Nymox's lead product candidate reduces incidence of prostate cancer in long-term study; shares up 29% (June 22)
    | Thu, Aug. 11, 1:06 PM | 7 Comments
  • Thu, Aug. 11, 9:12 AM
    • Ascendis Pharma A/S (NASDAQ:ASND) initiates a Phase 3 clinical trial, called heiGHt, evaluating lead product candidate TransCon Growth Hormone for the treatment of children with growth hormone deficiency (GHD). The trial design mirrors its successful Phase 2 study.
    • The open-label, active-controlled non-inferiority study will enroll ~150 treatment-naive children with GHD. Participants will receive either a once-weekly injection of TransCon Growth Hormone (0.24/mg/kg/week) or daily injections of 34 ug/kg of Pfizer's (NYSE:PFE) Genotropin (somatatropin [rDNA origin] for injection) which equals the weekly TransCon dose.
    • The primary endpoint is height velocity after 12 months of treatment. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is November 2018. The estimated study completion date is December 2018.
    | Thu, Aug. 11, 9:12 AM
  • Wed, Aug. 10, 11:04 AM
    • The USPTO issues U.S. Patent No. 9,408,837 covering Kitov Pharmaceuticals' (KTOV -0.9%) lead product candidate KIT-302. The patent, "Ameliorating Drug-Induced Elevations In Blood Pressure By Adjunctive Use Of Antihypertensive Drugs," was issued yesterday and can extend until May 22, 2029.
    • KIT-302 is a combination drug that treats osteoporosis-related pain (celecoxib, branded as Celebrex by Pfizer (PFE +0.2%) and hypertension (amlodipine besylate, branded as Norvasc). Kitov expects to submit its New Drug Application (NDA) to the FDA by year end via the abbreviated 505(b)(2) pathway. If all goes well, approval could be granted in 2017.
    • Read now Recent Announcements Keep Kitov's Development On Track 
    | Wed, Aug. 10, 11:04 AM | 1 Comment
  • Wed, Aug. 10, 9:44 AM
    • The FDA accepts privately held Marathon Pharmaceuticals, LLC's New Drug Applications (NDAs) seeking approval of deflazacort for the treatment of Duchenne muscular dystrophy (DMD). The agency will review the applications under Priority Review status which shortens the review clock to six months from the usual 10 months.
    • The company submitted two NDAs, one for an oral suspension formulation and one for an immediate-release tablet formulation.
    • The FDA action date (PDUFA) should be in February 2017.
    • Deflazacort is a steroid called a glucocorticoid. It is a derivative of prednisone with less side effects.
    • DMD-related tickers: (SRPT -8.8%)(BMRN -1%)(SMMT)(PTCT -1.2%)(PFE -0.2%)(OTCQB:MRNA)
    | Wed, Aug. 10, 9:44 AM | 10 Comments
  • Tue, Aug. 2, 10:28 AM
    • Along with the release of its Q2 results, Pfizer (PFE -3%) has disclosed a $486M settlement of nationwide litigation relating to its Celebrex and Bextra pain-relieving drugs.
    • The accord is subject to negotiation of a final agreement and court approval, but Pfizer has set aside enough reserves to cover the entire settlement.
    | Tue, Aug. 2, 10:28 AM | 7 Comments
Company Description
Pfizer, Inc. is a research-based, global biopharmaceutical company, which engages in the manufacture of vaccines and injectable biologic medicines. It operates through the following segments: Global Innovative Pharmaceutical, Global Vaccines, Oncology and Consumer Healthcare, and Global... More
Sector: Healthcare
Industry: Drug Manufacturers - Major
Country: United States