Yesterday, 7:38 AM| Comment!
Yesterday, 7:30 AM
- A Phase 3 study, GIFT-1, evaluating AbbVie's (NYSE:ABBV) investigational, all-oral, interferon-free, ribavirin-free, two direct-acting (2-DAA) antiviral combination of ombitasvir/paritaprevir/ritonavir for the treatment patients with HCV-1b infection met its primary endpoint demonstrating a high cure rate.
- In a subgroup of treatment-naive, non-cirrhotic adult HCV-1b Japanese patients who were eligible for interferon therapy and had a high viral load, the cure rate was 95% (n=106/112) determined by sustained virologic response 12 weeks after the completion of therapy (SVR12). The cure rate in HCV-1b patients with compensated cirrhosis was 91% (n=38/42).
- In an intent-to-treat analysis, the cure rate was 98% (n=104/106) in HCV-1b patients without cirrhosis. This population included every patient that was randomized to placebo during the test period and then received at least one dose of 2-DAA combo in the open label stage.
- The data were presented at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.
- AbbVie's regulatory application for the 2-DAA candidate is currently under priority review by the Japanese Ministry of Health, Labour and Welfare.
- As many as 2M Japanese are infected with HCV. Up to 70% are infected with genotype 1. About 95% of the HCV-1s are sub-type 1b.
- Previously: AbbVie's 2-DAA HCV-1 candidate gets priority peview in Japan (April 16)
- Related tickers: (NASDAQ:GILD) (NYSE:MRK) (NASDAQ:ENTA)
Thu, May 21, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Thu, May 21, 9:30 AM
- Alongside Goldman's list of 50 stocks appearing most as top holdings at hedge funds is its list of the 50 top shorts.
- New additions this quarter: Baxter Intl (NYSE:BAX), UPS, Marriott (NASDAQ:MAR), NextEra (NYSE:NEE), Ford (NYSE:F), National Oilwell Varco (NYSE:NOV), McDonald's (NYSE:MCD), M&T Bank (NYSE:MTB), CenturyLink (NYSE:CTL), Amgen (NASDAQ:AMGN), Pioneer Natural (NYSE:PXD), Duke Energy (NYSE:DUK), Seagate (NASDAQ:STX), AbbVie (NYSE:ABBV), Cisco (NASDAQ:CSCO).
- The full list (in order of $ value of short interest): AT&T (NYSE:T), Disney (NYSE:DIS), IBM, Verizon (NYSE:VZ), Intel (NASDAQ:INTC), Kinder Morgan (NYSE:KMI), Exxon (NYSE:XOM), Pfizer (NYSE:PFE), J&J (NYSE:JNJ), Deere (NYSE:DE), Caterpillar (NYSE:CAT), Exelon (NYSE:EXC), GE, Boeing (NYSE:BA), Halliburton (NYSE:HAL), Fox (NASDAQ:FOXA), Comcast (NASDAQ:CMCSA), UTX, Regeneron (NASDAQ:REGN), Merck (NYSE:MRK), salesforce.com (NYSE:CRM), AbbVie (ABBV), Conoco (NYSE:COP), Wal-Mart (NYSE:WMT), Eli Lilly (NYSE:LLY), Celgene (NASDAQ:CELG), Schlumberger (NYSE:SLB), AutoZone (NYSE:AZO), Wells Fargo (NYSE:WFC), Emerson (NYSE:EMR), McDonald's (MCD), Reynolds (NYSE:RAI), Target (NYSE:TGT), Accenture (NYSE:ACN), Coca-Cola (NYSE:KO).
Fri, May 8, 1:15 PM
- Mechelen, Belgium-based Galapagos N.V. (OTC:GLPGF) is set for its IPO of 3.776M American Depositary Shares (ADSs) at ~$41 per ADS (based on recent prices and 1.12 euro/dollar exchange rate). The offering also includes 944K ordinary shares that will be sold in Europe and ex-U.S. countries in a private placement. Each ADS represents the right to receive one ordinary share. The closings of the U.S. offering and the ex-U.S. private placement will be conditioned on each other. Some reallocation may occur. Shares will trade under the symbol "GLPG."
- The clinical stage biotech discovers and develops small molecule medicines with novel mechanisms of action that address high unmet medical needs. Its most advanced candidates are in inflammatory-related diseases. These include GLPG0634 (filgotinib) in three Phase 2b trials for rheumatoid arthritis and one Phase 2 for Crohn's disease; GLPG1205 in a Phase 2a trial for ulcerative colitis and GLPG1690 about to enter a Phase 2a study in idiopathic pulmonary fibrosis. Filgotinib is being developed under a collaboration with AbbVie (ABBV +1.1%). Its partnership with J&J's (JNJ +1.9%) Janssen Pharmceutica NV, which began in 2007, to develop 1205 and 1690 ended in March by mutual agreement.
- 2014 Financials (€M): Revenues: 69.4 (-9.4%); Operating Expenses: 36.6 (+116.6%); Net Income: 33.2 (+510.0%); Cash Burn: (75.6) (-999%).
- Previously: Galapagos JAK-1 inhibitor successful in Phase 2 rheumatoid arthritis study (April 14)
- Previously: Galapagos and Janssen part ways in inflammation alliance (March 17)
Thu, May 7, 5:30 PM
- In a setback for branded drug makers, the California Supreme Court rules that financial payments from makers of patented drugs to competitor firms to delay the commercialization of cheaper generic versions of their branded medicines, called pay-to-delay deals, illegally restrain trade and violate the Cartwright Act, the state's primary antitrust law.
- The court reversed a summary judgement to Bayer (OTCPK:BAYRY) and Barr, whose $398.1M deal blocked the launch of generic versions of the antibiotic Cipro (ciprofoxacin) for almost seven years. It found it was immaterial that the companies' agreement settled patent litigation since antitrust principles prohibit a patentee's purchase of a potential competitor's consent to stay out of the market, even when the patent is likely valid.
- The Court's rule also applies to collusive non-cash settlements. An excerpt from its opinion reads: "courts considering Cartwright Act claims should not let creative variations in the form of consideration result in the purchase of freedom from competition escaping detection."
- The U.S. Federal Trade Commission filed a lawsuit last year against AbbVie (NYSE:ABBV), Abbott Laboratories (NYSE:ABT) and Teva Pharmaceutical Industries (NYSE:TEVA) charging the firms with violating antitrust laws and harming consumers with their pay-to-delay transactions related to AndroGel testosterone replacement therapy.
Thu, May 7, 11:13 AM
- Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
- Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
- The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
- Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
- Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
- Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (MRK +0.4%)(LLY -0.1%)(PFE +0.3%)(BMY +0.7%)(GSK -4.1%)(OTCQX:RHHBY -1.1%)(SNY -0.6%)(OTCPK:BAYRY -0.5%)(NVS +0.1%)(AZN -0.3%)(JNJ +0.2%)(ABT -0.1%)(ABBV +0.1%)
Thu, May 7, 7:23 AM
- The FDA designates venetoclax (RG7601, GDC-0199/ABT-199) a Breakthrough Therapy for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have genetic mutation known as a 17p deletion. Patients in this classification generally have poor prognoses.
- Venetoclax selectively binds to and inhibits Bcl-2 proteins which play a key role in apoptosis (cell death). Bcl-2s are highly expressed in blood cancers. The drug candidate is being jointly developed by Roche (OTCQX:RHHBY) and AbbVie (NYSE:ABBV).
- Breakthrough Therapy status allows for more intensive guidance from the FDA on the most efficient development path, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
Wed, Apr. 29, 9:22 AM
- The FDA accepts for review the Biologics License Application (BLA) for Zinbryta (daclizumab high-yield process) for the treatment of patients with relapsing forms of multiple sclerosis (MS). The drug was co-developed by Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV).
- Daclizumab is a new form of humanized monoclonal antibody that selectively binds to interleukin-2 (IL-2) receptor subunit CD25, a protein that is over-expressed on T cells that become abnormally activated in MS. It modulates IL-2 signaling without causing general immune cell depletion.
- Zinbryta is the next-generation MS offering that builds on the success of Biogen's $2.9B blockbuster Avonex (interferon beta-1a).
- The European Medicines Agency validated (accepted for review) Zinbryta's Marketing Authorization Application (MAA) last month.
- Previously: Zinbryta trumps Avonex in MS trial (Sept. 12, 2014)
Sat, Apr. 25, 5:48 PM
- Preliminary data from a Phase 3 study, RUBY-1, evaluating AbbVie's (NYSE:ABBV) Viekirax (ombitasvir/paritaprevir/ritonavir) + Exviera (dasabuvir), with or without ribavirin, for 12 or 24 weeks in treatment-naive, non-cirrhotic HCV-1 patients with severe renal impairment (stage 4 or 5), including those on hemodialysis, showed a 100% SVR4 rate (n=10/10) (sustained virologic response four weeks after treatment). Enrollment is 20 patients, but only half had reached week 4 post treatment at the data cutoff.
- The primary endpoint of the trial is the percentage of patients achieving SVR12. Cohort 1 consists of 20 patients without cirrhosis while cohort 2 has 20 patients with or without compensated cirrhosis.
- The data were presented at the 50th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY)
Fri, Apr. 24, 12:57 PM
- Privately-held French biotech medDay Pharmaceuticals reports results from a Phase 3 clinical trial (MS-SPI) evaluating MD1003, a pharmaceutical-grade biotin, for the treatment of primary and secondary progressive multiple sclerosis. The study met its primary endpoint in the intent-to-treat population with 12.6% of patients treated with MD1003 showing an improvement in EDSS (Expanded Disability Status Scale) or TW25 (a timed 25-foot walk) at Month 9 compared to 0% for placebo (p=0.0051).
- Secondary analyses showed evidence of a decrease in the risk of disease progression. Mean EDSS scores in the treatment group between the start of treatment and Month 12 decreased (-0.03) compared to progression (+0.13) in the placebo cohort (p=0.015). Four percent of patients in the MD1003 group showed EDSS progression at Month 9 confirmed at Month 12 compared to 13% for placebo (p=0.07).
- Biotin is a B-vitamin known as vitamin H or coenzyme R. It plays a key role in cell growth, the production of fatty acids and the metabolism of fats and amino acids.
- The data were presented at the American Academy of Neurology Annual Meeting in Washington, DC. Full results will be submitted for publication in a peer-reviewed journal.
- MS-related tickers: (BIIB -5.9%)(SNY +0.3%)(NVS -0.9%)(TEVA +1.4%)(FWP -0.3%)(OPXA)(RCPT +0.1%)(CHRS -3.3%)(ABBV +1.7%)
Fri, Apr. 24, 9:05 AM
- At the Liver Meeting in Europe, Merck (NYSE:MRK) presented data from its ongoing C-EDGE pivotal Phase 3 study evaluating its HCV combination of grazoprevir/elbasvir (100mg/50mg) in patients with genotypes 1, 4 or 6.
- Overall, treatment-naive patients treated with the combo for 12 weeks without ribavirin (RBV) showed a cure rate (sustained virologic response 12 weeks after therapy or SVR12) of 95% (n=299/316). Treatment-naive patients co-infected with HIV treated for 12 weeks, without RBV, also showed a cure rate of 95% (n=207/218).
- Treatment-experienced HCV patients treated with the combo, with and without RBV showed cure rates of 94% (n=98/104) and 92% (n=97/105), respectively. Treatment-experienced HCV patients treated for 16 weeks, with and without RBV, showed cure rates of 97% (n=103/106) and 92% (n=07/105), respectively.
- Cure rates in cirrhotic patients ranged from 89 - 100%; non-cirrhotic: 93 - 97%; genotype 1a: 90 - 95%; genotype 1b or other g-1: 96 - 100%; genotype 4: 60 - 100% and genotype 6: 75 - 100%.
- The results were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY)
Thu, Apr. 23, 11:55 AM
- An interim analysis of a Phase 2/3 trial, C-SURFER, evaluating Merck's (MRK -0.1%) investigational once-daily regimen of grazoprevir and elbasvir in patients with advanced kidney disease infected with the HCV-1 virus showed a 99% (n=115/116) cure rate (SVR12) after 12 weeks of treatment.
- The data will be presented at this week's 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Grazoprevir is an NS3/4A protease inhibitor and elbasvir is an NS5A complex inhibitor. Several weeks ago, the FDA designated the combo a Breakthrough Therapy for the treatment of HCV-1 in patients with end-stage renal disease on hemodialysis and patients with chronic HCV-4 infection.
- Breakthrough Therapy status provides for more intensive FDA guidance on development, the involvement of more senior managers and a rolling review of the New Drug Application (NDA).
- Previously: Merck HCV combo med tagged a Breakthrough Therapy for HCV-4 and HCV-1 dialysis patients (April 8)
- Related tickers: (GILD +0.4%)(ABBV -1.6%)
Thu, Apr. 23, 10:48 AM
- The FDA accepts AbbVie's (ABBV -1.7%) New Drug Application (NDA) for its all-oral, interferon-free, two direct-acting antiviral (2-DAA) for the treatment of patients with chronic HCV genotype 4 infection under Priority Review, which shortens the agency's review clock to six months.
- AbbVie's regimen consists of a fixed-dose combination of ombitasvir, paritaprevir and ritonavir, with ribavirin.
- Related ticker: (ENTA -2.1%)
Thu, Apr. 23, 8:17 AM
- AbbVie (NYSE:ABBV) Q1 results ($M): Total Revenues: 5,040 (+10.5%); U.S.: 2,650 (+19.0%); Intl: 2,390 (+2.3%); Net Income: 1,022 (+4.3%); GAAP EPS: 0.63 (+3.3%); Operating Earnings: 1,687 (+24.9%).
- Key Product Sales: Humira: 3,111 (+18.0%); Synagis: 335 (-5.4%); Lupron: 192 (+1.6%); Synthroid: 186 (+18.5%); Kaletra: 180 (-7.7%).
- Viekira Pak sales not disclosed.
- 2015 Guidance: EPS: $3.57 - 3.77 from $3.91 - 4.11; Non-GAAP EPS: $4.10 - 4.30 from $4.05 - 4.25.
Thu, Apr. 23, 7:55 AM
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