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Thu, Feb. 4, 9:50 AM
- The FDA approves Merck's (MRK -1.9%) supplemental New Drug Application (sNDA) for single-dose EMEND (fosaprepitant dimeglumine) for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving moderately emetogenic chemotherapy. It is the first intravenous single-dose NK1 receptor antagonist approved in the U.S.
- A one-to-three-day IV formulation was cleared in February 2008.
Wed, Feb. 3, 7:10 AM
- Merck (NYSE:MRK) Q4 results ($M): Total Revenues: 10,215 (-2.5%); Pharmaceutical: 9,027 (-3.7%); Animal Health: 830 (-6.2%).
- Net Income: 976 (-86.7%); EPS: 0.35 (-86.2%); Non-GAAP EPS: 0.93 (+6.9%).
- Key Product Sales: Januvia: 921 (-14.9%); Zetia: 691 (+4.4%); Gardisil: 497 (+39.6%); Janumet: 526 (-7.7%); Remicade: 396 (-28.9%); Isentress: 374 (-10.5%); Keytruda: 214 (+328%); Cubicin: 322 (+999%); Vytorin: 308 (-16.8%).
- 2016 Guidance: Revenues: $38.7B - 40.2B; EPS: $1.96 - 2.23; Non-GAAP EPS: $3.60 - 3.75.
- Shares are off a fraction premarket.
Wed, Feb. 3, 6:49 AM
Tue, Feb. 2, 5:30 PM
Tue, Feb. 2, 8:20 AM
- The FDA grants preliminary approval of Impax Laboratories' (NASDAQ:IPXL) generic version of Merck's (NYSE:MRK) cholesterol med VYTORIN (ezetimibe and simvastatin) in the 10/10, 10/20, 10/40 and 10/80 mg strengths. According to IMS Health, U.S. sales for the four strengths in 2015 were $714M.
- Preliminary approval means that the New Drug Application meets all the quality, safety and efficacy standards for clearance but is subject to an automatic stay of final approval for up to 30 months pending the resolution of a patent infringement suit.
- Shares are up 19% premarket but only on turnover of 100.
Tue, Feb. 2, 8:02 AM
- The FDA designates privately held Cambridge, MA-based Nimbus Therapeutics' NDI-010976 for Fast Track review for the treatment of nonalcoholic steatohepatitis (NASH).
- NDI-010976 inhibits an enzyme called aceyl-COa carboxylase that plays a key role in the metabolism of fatty acids. A Phase 2 clinical trial is expected to commence in H1.
- NASH-related tickers: (NASDAQ:ICPT)(NASDAQ:TBRA)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:DRRX)(NASDAQ:CNAT)(NASDAQ:VBLT)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)(OTCPK:GNFTF)(NYSEMKT:CANF)
Fri, Jan. 29, 12:55 PM
- Although, Merck (MRK +2.4%) is playing catch-up to Gilead Sciences (GILD -4.9%) and AbbVie (ABBV -3.2%), analysts say Zepatier (elbasvir/grazoprevir) could still pull in $2B+ in peak sales by 2020, considering the company's likely strategy of focusing on particular HCV niches like patients with kidney problems or those receiving opioid antagonist therapy to treat their addiction.
- The company has set Zepatier's list price at $54,600 for a 12-week regimen, significantly under Gilead's Harvoni at $94,500 and AbbVie's Viekira Pak at $83,319, although the net prices, assuming ~10% discount off Merck's drug, will be roughly in line considering the more significant discounting by the others.
- Merck's pricing will certainly not be an issue as it seeks inclusion onto commercial formularies. One more competitor, though, should lead to more interesting battles over pricing as contracts come up for renewal, particularly in the PBM space.
Thu, Jan. 28, 6:08 PM
- The FDA approves Merck's (NYSE:MRK) once-daily single-tablet combination therapy, Zepatier (elbasvir/grazoprevir), with or without ribavirin, for the treatment of adults with chronic hepatitis C infection (HCV) genotypes 1 and 4. The agency accepted the NDA for review in July 2015.
- Related tickers: (NASDAQ:GILD)(NYSE:ABBV)(NYSE:BMY)
- Previously: FDA action date approaches for Merck's HCV single tablet combo (Jan. 26)
Wed, Jan. 27, 3:30 PM
- As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
- Only Biogen and Abbott have bucked the trend.
- Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
- ETFs: BIB, BIS, CNCR
Wed, Jan. 27, 9:02 AM
- The FDA accepts for review Merck's (NYSE:MRK) Biologics License Application (BLA) seeking clearance of bezlotoxumab for the prevention of Clostridium difficile (C. diff) infection recurrence. The agency's action date (PDUFA) is July 23.
- The company's marketing application in Europe is also under review.
- Bezlotoxumab is a human monoclonal antibody that is designed to work as an antitoxin by neutralizing C. diff toxin B, which can damage the gut wall and cause inflammation, leading to C.diff-associated diarrhea. It is co-administered with standard-of-care antibiotics.
- C. diff infection is one of the most common hospital inpatient-associated infections in the U.S. It's very stubborn and recurs frequently. There are no currently approved therapies for preventing recurrence.
Tue, Jan. 26, 12:13 PM
- The FDA's PDUFA date for its Priority Review of Merck's (MRK +1.1%) once-daily, single-tablet combination therapy, grazoprevir/elbasvir (100 mg/50mg), for the treatment of chronic hepatitis C infection (HCV) genotypes 1,4 or 6 is Thursday.
- The Breakthrough Therapy-tagged product candidate is a combination of an NS3/4A protease inhibitor (grazoprevir) and an NS5A replication complex inhibitor (elbasvir). In clinical studies, it demonstrated HCV cure rates as high as 100% after eight weeks of treatment.
- The action date by European regulators is mid-year.
- Previously: Merck's marketing application for HCV combo elbasvir/grazoprevir in Europe gets slower standard review (Dec. 18, 2015)
Mon, Jan. 25, 6:50 AM
- Affimed N.V. (NASDAQ:AFMD) and a subsidiary of Merck (NYSE:MRK) establish a clinical trial collaboration whereby Merck will supply KEYTRUDA (pembrolizumab) to Affimed in a Phase 1b clinical trial assessing the combination of the PD-1 inhibitor and Affimed's lead product candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with Takeda (OTCPK:TKPHF)(OTCPK:TKPYY) and Seattle Genetics' (NASDAQ:SGEN) ADCETRIS (brentuximab vedotin). The objective of the study, to be conducted by Affimed and expected to commence in H1, is to establish a dosing regimen of the combo as well as its safety and efficacy.
- In preclinical patient derived xenograft models, the combination eradicated up to 90% of tumors. The collaboration may expand to include a Phase 3 trial if the Phase 1b is successful.
- AFM13 is a bispecific antibody that binds to a protein expressed in a range of T-cell and B-cell lymphomas called CD30 and to a protein expressed on the immune system's natural killer cells called CD16A, both of which play key roles in the activation of the immune system to detect and kill cancer cells.
- Shares are up 13% premarket on average volume.
Thu, Jan. 21, 9:56 AM
- Regulus Therapeutics (RGLS -4.2%) announces that enrollment is now complete in its Phase 2 clinical trial assessing the combination of RG-101 with multiple approved direct-acting antivirals [Gilead's HARVONI (ledipasvir/sofosbuvir), J&J's OLYSIO (simeprevir), Bristol-Myers' Daklinza (daclatasvir)] in treatment-naive patients with HCV infection, genotypes 1 or 4.
- 78 patients have been randomized to receive a single subcutaneous injection of 2mg/kg of RG-101 followed by 28 days of once-daily oral antivirals (one of the three) followed by another subcutaneous injection of 2 mg/kg of RG-101 on Day 29. Interim results should be available in mid-February. Primary endpoint results (SVR12) should be announced in late Q2.
- The company says its ultimate goal is to develop a single-visit combination therapy for HCV infection.
- Related tickers: (GILD -0.9%)(ABBV +0.7%)(MRK -0.3%)(JNJ -1.1%)(BMY -0.9%)
Tue, Jan. 19, 4:51 PM
- Privately-held Eiger BioPharmaceuticals completes enrollment in a Phase 2 clinical trial assessing three (50 mg, 75 mg, 100 mg) once-daily doses of Sarasar (lonafarnib), in combination with 100 mg of ritonavir [AbbVie's (NYSE:ABBV) NORVIR] once daily, in patients with chronic hepatitis delta (HDV) infection. The study consists of 24 patients with four placed in one of six treatment groups: three dosage arms for 12 or 24 weeks. Enrollment was completed in less than four months.
- Lonafarnib inhibits an enzyme called farnesyltransferase, which plays a key role in the modification of proteins in a process called prenylation. HDV uses this host cell process inside liver cells to complete an essential step in its life cycle. Lonafarnib blocks the cycle at the assembly stage, which may present a higher bar for the virus to develop resistance to therapy. It is designated an Orphan Drug in the U.S. and Europe and tagged for Fast Track review by the FDA.
- HDV, occurring only as a co-infection with HBV, represents one of the most pernicious forms of viral hepatitis. It causes more severe liver disease than HBV alone and is associated with more rapid liver fibrosis (scarring), liver cancer and liver failure. As many as 15M people worldwide are HDV-positive. It is particularly prevalent in Mongolia and Pakistan (as many as 60% of the HBV cases).
- Hepatitis-related tickers: (NASDAQ:GILD)(NYSE:MRK)(NYSE:JNJ)(NYSE:BMY)
Sun, Jan. 17, 6:02 PM
- The European Commission approves the first biosimilar referencing Amgen's (NASDAQ:AMGN) Enbrel (etanercept). The product, branded as BENEPALI, was developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB).
- Samsung Bioepis and Biogen established their partnership in 2012 with the aim of developing affordable biologics. Biogen will lead the commercialization and distribution of BENEPALI in the 28 EU member states in addition to Norway, Iceland and Liechtenstein. The product launch will commence in the next few weeks.
- Samsung Bioepis is also partnering with Merck (NYSE:MRK) on developing biosimilars in certain territories under a February 2013 agreement. Their Enbrel biosimilar, branded as BRENZYS (formerly SB4), was cleared in South Korea in September. Merck has global rights to SB4 except in the U.S., EU and Japan.
- Enbrel is Amgen's top seller, generating $5.3B in sales over the most recent four quarters.
- Previously: Merck's Enbrel biosimilar cleared in Korea (Sept. 8, 2015)
Fri, Jan. 15, 7:47 AM
- Merck (NYSE:MRK) settles a multi-district class action lawsuit in New Jersey federal court involving persons who purchased Merck stock between May 21, 1999 and October 29, 2004, who sought damages related to losses precipitated by the company's statements regarding Vioxx.
- Under the terms of the agreement, Merck will pay $830M to settle all claims plus an additional amount for approved attorneys' fees and expenses. Net of insurance coverage, the company will pay ~$680M, for which it will take the charge in Q4 2015.
- The company still faces individual suits related to Vioxx, a non-steroidal anti-inflammatory drug approved in 1999 but withdrawn from the market in 2004 due to an increase risk in cardiovascular events.
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