Thu, May 7, 7:40 AM
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)
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. 16, 7:59 AM
- The Japanese Ministry of Health, Labour and Welfare grants priority review for AbbVie's (NYSE:ABBV) investigational two direct-acting (2-DAA) combination of ombitasvir/paritaprevir/ritonavir for the treatment of chronic HCV-1 infection. The once-daily all-oral treatment is ribavirin-free and interferon-free.
- AbbVie submitted its marketing application in Japan in February and expects clearance in H2.
- HCV affects as many as 2M Japanese. HCV genotype 1 accounts for 60 - 70% of the cases, with genotype 1b accounting for ~95% of the HCV-1s.
- Regulatory clearance in Japan will trigger a $30M milestone payment from Abbvie to Enanta Pharmaceuticals (NASDAQ:ENTA).
Thu, Feb. 12, 11:25 AM
- AbbVie (ABBV -0.5%) submits a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare seeking approval for its all-oral, ribavirin-free, interferon-free, 12-week antiviral treatment of ombitasvir/paritaprevir/ritonavir, dosed once daily, for the treatment of patients with chronic hepatitis C genotype 1 infection.
- The Phase 3 trial data supporting the application demonstrated an SVR12 of 95% (106 of 112 subjects) in a subgroup of treatment-naive, non-cirrhotic adult genotype 1b-infected Japanese patients with a high viral load (at least 100K IU/mL).
- 1.5M - 2M Japanese are infected with HCV, with HCV-1 being the most common genotype affecting 60 - 70% of infected people. Of this group, ~95% are infected with the sub-type 1b.
- Previously: AbbVie 2-DAA HCV treatment successful in Japan Phase 3 (Feb. 2)
- Related tickers: (GILD -0.3%)(MRK -0.2%)(ENTA -3.7%)
Fri, Feb. 6, 5:37 PM
Thu, Feb. 5, 12:26 PM| 1 Comment
Thu, Feb. 5, 7:49 AM
Fri, Jan. 16, 7:58 AM
- The European Commission approves AbbVie's (NYSE:ABBV) Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) for the treatment of chronic hepatitis C infection, genotypes 1 with or without ribavirin, including patients with compensated liver cirrhosis, HIV-1 co-infection, on opioid substitution therapy and liver transplant recipients. It its also approved, with ribavirin, for patients with chronic hepatitis C infection, genotype 4.
- HCV-1 is the most prevalent form in Europe (60% of cases). HCV-4 is the most common form in the Middle East, sub-Saharan Africa and Egypt with increasing prevalence in Italy, Greece and Spain.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD)
Dec. 22, 2014, 9:19 AM
- TheStreet's Adam Feuerstein says the price-containing Express Scripts/AbbVie exclusive Viekira Pak agreement may be a fatal blow to the current biotech bull market. He believes that PBM's like Express Scripts will be highly motivated to enter into exclusive deals in exchange for hefty discounts. Likely candidates for these arrangements would be cancer immunotherapies, many of which will cost $300K or more.
- The deal between a drug manufacturer and a pharmacy benefit manager (PBM) like Express Scripts should not be surprising considering the exorbitant prices for new therapies. This is one reason the FDA and EMA have extended priority review to new HCV drugs. Establishing a competitive market is be most effective way to moderate prices.
- The breathtaking ascent of Gilead's (NASDAQ:GILD) Sovaldi may be difficult to replicate, but there still is plenty of business out there for biotech firms.
- (NYSE:ABBV) (NASDAQ:ENTA) (NASDAQ:ESRX)
- Previously: Global drug tab will breach trillion dollar mark this year (Nov. 20, 2014)
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
Dec. 22, 2014, 9:17 AM
Dec. 22, 2014, 7:53 AM
- AbbVie (NYSE:ABBV) is up 4% on moderately-higher volume and Enanta Pharmaceuticals (NASDAQ:ENTA) is up 11% on light volume in response to AbbVie's deal with Express Scripts (NASDAQ:ESRX).
- Gilead Sciences (NASDAQ:GILD) is off 7% on high volume.
- Previously: AbbVie's new hepatitis C drug gets boost (Dec. 22, 2014)
Dec. 19, 2014, 3:46 PM
- The FDA approves AbbVie's (ABBV) Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) for the treatment of HCV genotype 1 infection, including those with compensated cirrhosis.
- Related tickers: (GILD +3.2%) (ENTA +3.9%)
- Previously: PDUFA date approaches for AbbVie HCV combo therapy (Dec. 18, 2014)
Dec. 18, 2014, 12:41 PM
- The FDA's PDUFA date for its Priority Review of AbbVie's (ABBV +1.2%) three-pronged combination HCV regimen is December 21. Since the date is Sunday, the agency may issue its decision tomorrow. One of the anti-virals, ABT-450 (ritonavir), was co-developed with Enanta Pharmaceuticals (ENTA +5%).
- Previously: AbbVie HCV regimen gets priority review (June 13, 2014)
Dec. 15, 2014, 12:36 PM
- Added to the Nasdaq Biotechnology Index, effective Dec. 22: AAVL, AERI, AKBA, ALDR, ALIM, AMPH, ANIP, ASPX, CARA, CGEN, CLDN, CNCE, ENTA, FLML, FMI, FOLD, FPRX, GWPH, HPTX, ICPT, INO, INSM, KITE, KPTI, MGNX, OPHT, PCYC, PETX, POZN, PTX, QLTI, RARE, RCPT, RDUS, RLYP, RTRX, RVNC, SAGE, TBPH, TTPH, VSAR, XLRN, ZFGN, ZSPH.
- Deleted: AMRN, AUXL, CRIS, EXPR, ICEL, ONTX, RIGL, ZGNX.
- Source: Press Release
Nov. 24, 2014, 8:06 AM
- Enanta Pharmaceuticals (ENTA -1.1%) FQ4 results: Revenues: $2.6M (+100.0%); Operating Expenses: $8M (+31.1%); Operating Loss: ($5.3M) (-12.8%); Net Loss: ($5M) (-13.6%); Loss Per Share: ($0.27) (-8.0%).
- FY2014 results: Revenues: $47.7M (+48.6%); Operating Expenses: $28.8M (+25.2%); Operating Income: $19M (+111.1%); Net Income: $34.4M (+621.2%); EPS: $1.80 (+368.7%); Quick Assets: $90.8M (-10.5%).
- No guidance given.
ENTA vs. ETF Alternatives
Enanta Pharmaceuticals Inc is a biotechnology company. It is engaged in the research and development of small molecule drugs for infectious diseases. The Company uses its chemistry-driven approach & drug discovery capabilities to develop its products.
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