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%)
Nov. 17, 2014, 9:57 AM
- In the first part of the ANNEXA-A Phase 3 study, andexanet alfa produced a rapid and almost complete reversal (94%) (p<0.0001) compared to placebo of the anticoagulant effect of Eliquis (apixaban) in healthy volunteers ages 50 - 75 as measured by anti-Factor Xa activity. The results will be presented today at the American Heart Association meeting in Chicago.
- Eliquis is indicated for the treatment of blood clots due to nonvalvular atrial fibrillation and venous thromboembolism. Currently, there is no antidote to Eliquis despite the need for a method to reverse its anticoagulation effects in certain clinical situations such as a major bleeding event or emergency surgery.
- In the first part of the study, healthy volunteers were given Eliquis 5 mg daily for four days and then randomized in a 3:1 ratio to andexanet alfa administered as a 400 mg IV bolus or placebo. In the second part, healthy volunteers will be given Eliquis 5 mg twice daily for four days and then randomized in a 3:1 ratio to andexanet alfa administered as a 400 mg IV bolus followed by a continuous infusion on 4 mg/minute for 120 minutes or to placebo.
- Portola Pharmaceuticals (PTLA +0.1%) is collaborating with Pfizer (PFE -1.3%) and Bristol-Myers Squibb (BMY +0.4%) on the product's development.
- Previously: Portola Pharma anticoagulant antidote Phase 3 trial successful
Nov. 17, 2014, 4:06 AM
- Pfizer (NYSE:PFE) will pay $850M for rights to a cancer drug being developed by Merck KGaA (OTCPK:MKGAY), puncturing investor expectations of a renewed bid for AstraZeneca (NYSE:AZN).
- As a result of the upfront payment, Pfizer has lowered its forecast of 2014 EPS to $1.40-$1.49 from $1.50-$1.59.
- The agreement also calls for Pfizer to pay as much as $2B to Merck if the immunotherapy drug, known as MSB0010718C, meets commercial and regulatory goals.
Nov. 13, 2014, 11:56 AM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee meets on November 24, 25 to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also review the efficacy of ESI and the overall risk benefit profile of injecting steroids in the epidural space to treat pain. Regulatory options will also be discussed which could include changes to product labeling.
- Briefing doc
- Related tickers: (MRK +0.7%)(PFE +0.2%)(BMY -1.3%)(NVS +2%)
Nov. 11, 2014, 4:52 PM
- A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
- Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
- Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
- Amgen plans to present the complete results at a future medical conference.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NASDAQ:CELG) (NYSE:NVS) (NASDAQ:DERM) (NASDAQ:IDRA) (NYSE:HSP) (NYSE:PFE) (NYSEMKT:CANF) (NYSE:MRK)
Oct. 28, 2014, 8:04 AM
- Pfizer (NYSE:PFE) Q3 results ($M): Total Revenues: 12,361 (-2.2%); GIP: 3,490 (-4.1%); VOC: 2,511 (+13.4%); GEP: 6,239 (-6.5%); Other: 121 (+7.1%).
- COGS: 2,368 (+3.5%); R&D Expense: 1,802 (+10.8%); SI&A Expense: 3,556 (+4.7%); Net Income: 2,666 (+2.9%); EPS: 0.42 (+7.7%).
- Gross Profit: 9,993 (-3.5%); COGS: 19.2% (+5.9%); Gross Margin: 80.8% (-1.3%); Operating Profit: 4,635 (-13.1%); Operating Earnings Yield: 37.5% (-11.1%); Net Earnings Yield: 21.6% (+5.3%).
- Product Sales: Lyrica: 1,317 (+16.0%); Prevnar Family: 1,139 (+18.8%); Enbrel (ex-U.S. & Canada): 955 (+2.5%); Celebrex: 764 (+1.6%); Lipitor: 490 (-8.1%); Viagra: 427 (-7.2%); Zyvox: 339 (+6.3%); Norvasc: 270 (-10.9%); Sutent: 287 (+3.2%); Premarin Family: 264 (-4.3%).
- 2014 Guidance: Revenues: $48.7B - 49.7B from $48.7B - 50.7B; COGS: 18.5 - 19.0% from 19.0 - 20.0%; R&D: $6.9B - 7.2B from $6.7B - 7.2B; SI&A: $13.5B - 14.0B from $13.3B - 14.3B; tax rate: 27% (unch); EPS: $1.50 - 1.59 from $1.47 - 1.62; non-GAAP EPS: $2.23 - 2.27 from $2.20 - 2.30.
Oct. 28, 2014, 7:01 AM
Oct. 27, 2014, 5:30 PM
- ACI, AET, AGCO, AIXG, ALR, AME, AMTD, AN, AXE, BP, CAS, CIT, CMI, CNC, CNX, COH, CPLA, CRY, CVLT, CYNO, DD, DIN, ECL, ENTG, FCX, FDP, FLWS, FMER, GLPI, GLW, HCA, HMC, HOT, HRS, ICON, IIVI, IPGP, LH, MDSO, MLM, MMC, MSM, MSO, MWV, NBL, NCI, NVS, PCAR, PCG, PES, PFE, PH, POR, RDWR, SAIA, SAVE, SCHN, SCOR, SHW, SIRI, SNCR, ST, SYRG, TECH, TKR, TRW, TTS, TWI, UBS, UTHR, VDSI, VRTS, VSH, WAB, WHR, XYL
Oct. 27, 2014, 9:26 AM
- Durect Corp. (NASDAQ:DRRX) and Pain Therapeutics (NASDAQ:PTIE) drop 46% and 54%, respectively, on robust volume after Pfizer (NYSE:PFE) decides to discontinue its agreement to development and commercialize Romoxy (oxycodone).
- Pfizer will return all rights, including the responsibility for regulatory activities to Pain, who licensed the product from Durect.
Oct. 24, 2014, 7:16 AM
- Pfizer's (NYSE:PFE) announcement yesterday of an $10B stock repurchase plan deflates expectations that it will make another run at AstraZeneca (NYSE:AZN). Under British takeover rules, it could do so in November. In any event, the change in U.S. tax regulations making inversions less attractive makes a mega-deal like this unlikely.
Oct. 23, 2014, 5:55 PM
Oct. 23, 2014, 4:23 PM
Oct. 22, 2014, 11:31 AM
- The European Commission approves privately-held Switzerland-based Ferring Pharmaceuticals' Cortiment (budesonide) for the induction of remission in patients with active mild-to-moderate ulcerative colitis. Budesonide is a locally acting glucocorticosteroid.
- Ferring licensed Cortiment from Cosmo Pharmaceuticals SpA for the EU, Asia (ex-Japan), Australia, Canada, Latin America and Africa. The product is sold under the brand name Uceris in the U.S. by Salix Pharmaceuticals (SLXP -0.2%).
- UC-related tickers: (NASDAQ:VBLX) (RCPT)(OTCPK:TKPHF)(OTCPK:TKPYY +0.2%)(ATHX +2.3%)(SHPG +1.3%)(PFE +0.7%)(ABT -0.4%)(ABBV +1.2%)(CNDO +1.1%)(JNJ +1%)(SGYP -3.2%)
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