Cubist Pharmaceuticals: An Extraordinary Arbitrage Opportunity
Cubist And The Threat Of Antibiotic Resistance
Cubist Pharmaceuticals: Doomsday Preparation Update
Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Tue, Mar. 22, 5:37 PM
- Merck (NYSE:MRK) is up 0.9% after a quick 3.7% spike after hours, and Gilead Sciences (NASDAQ:GILD) down 2.1%, as a jury has decided that Merck's 2002 patents related to sofosbuvir are valid, lending credence to Merck's argument that Gilead is infringing via its Pharmasset unit, acquired in 2011.
- Gilead's Sovaldi and Harvoni were ruled last month to infringe on Merck patents, and the next step was to decide the validity of the Merck patents.
- The case now proceeds to damages owed. Sovaldi and Harvoni brought $19.2B in global sales last year.
- Merck has demanded more than $2B in damages and 10% of Gilead's sales of the products going forward.
- Previously: Merck after a big slice of Gilead's sofosbuvir pie (Mar. 08 2016)
Thu, Mar. 17, 5:21 PM
- Thinly traded nano cap CymaBay Therapeutics (NASDAQ:CBAY) is down 16% after hours on robust volume in response to its announcement of results in a Phase 2 pilot study assessing Orphan Drug-tagged MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH), an inherited disorder characterized by abnormally high levels of bad LDL cholesterol (LDL-C) leading to premature cardiovascular disease.
- The 12-week, open-label, dose escalation trial enrolled 13 HoFH patients. All were receiving ezetimibe [Merck's (NYSE:MRK) Zetia] and were on maximum statin therapy. None were being treated with lomitapide [Aegion's (NASDAQ:AEGN) Juxtapid], mipomersen [Sanofi's (NYSE:SNY) Kynamro] or a PSCK9 inhibitor. The average baseline LDL-C level was 368 mg/dL (optimal level: less than 100 mg/dL). Subjects received 50 mg of MBX-8025 once daily for four weeks.
- Two per-protocol analyses were performed on 12 subjects (one was excluded due to missed apheresis visits). A responder analysis showed three patients experienced a reduction in LDL-C greater than 30%, five patients at least 20% and seven patients at least 15%. The average maximum decrease was 19%. A second analysis, averaging values across all doses and dosing periods, showed an overall average decrease in LDL-C of 10%, with eight subjects showing a mean decrease of 16% and three greater than 20%. Four patients showed a mean increase in LDL-C of 4%.
- Mean PCSK9 was elevated at baseline and increased significantly during treatment by an average of 43%, which was unexpected, and creates the need to assess the combination of MBX-8025 and a PCSK9 inhibitor [Amgen's (AMGN +0.1%) Repatha (evolocumab) or Regeneron (NASDAQ:REGN) and Sanofi's Praluent (alirocumab)] in a pilot study.
- MBX-8025 is an agonist of peroxisome proliferator-activated receptor delta, a nuclear receptor that regulates genes involved in lipid transport, storage and metabolism in liver and muscle.
- Previously: CymaBay product candidate an Orphan Drug for severe hypertriglyceridemia (April 22, 2015)
Tue, Mar. 8, 9:13 AM
- Sydney, Australia-based Benitec (NASDAQ:BNTC) announces that its DNA-directed RNA interference (ddRNAi) candidate, BB-HB-331, showed robust and durable hepatitis B virus (HBV) suppression in vivo following a single administration.
- The HBV suppression activity of BB-HB-331 was assessed in the Phoenix mouse model in which murine liver cells were replaced by human hepatocytes which made them susceptible to HBV infection. Once infected, the mice received a single systemic injection of BB-HB-331. Serum antigen levels, HBV viral proteins and extracellular HBV DNA were measured once per week for the duration of the eight-week study.
- Results showed a 1.83 log knockdown of serum HBV DNA, equivalent to a 98.5% reduction of circulating HBV. In addition, intracellular HBV DNA was reduced 94.9% while HBV surface antigen (HBsAg) and e antigen (HBeAg) were reduced by 97.6% and 92.6%, respectively. The results validated the previously reported in vitro findings.
- BB-HB-331 combines the gene silencing of RNA interference with the therapeutic potential of gene therapy. It is comprised of an AAV8 capsid (protein shell of a virus) and recombinant DNA engineered to express three short hairpin RNAs that target and inhibit viral RNA expressed from three regions across multiple HBV genotypes. The company plans to advance BB-HB-331 to clinical development.
- Previously: Benitec Biopharma's ddRNAi therapeutic candidate shows potent anti-HBV antigen activity in preclinical testing; shares up 14% (Dec. 7, 2015)
- HBV-related tickers: (NASDAQ:GILD)(OTCQB:COCP)(NYSE:GSK)(NASDAQ:IONS)(NASDAQ:DVAX)(NYSE:JNJ)(NASDAQ:ARWR)(NYSE:MRK)(NASDAQ:CTRV)(NASDAQ:ABUS)(NYSE:SNY)(NASDAQ:ALNY)(NYSE:BMY)
- Update: Shares up 26% in early trading.
Wed, Feb. 17, 8:55 AM
- Micro cap Regulus Therapeutics (NASDAQ:RGLS) is up 43% premarket on robust volume in response to its announcement of positive interim results from a Phase 2 clinical trial assessing RG-101, in combination with other antivirals, in patients with chronic hepatitis C virus (HCV) infection.
- The study was designed to evaluate a four-week treatment regimen of 2 mg/kg of RG-101 at Day 1 and Day 29, in addition to four weeks of once/daily Harvoni (ledipasvir/sofosbuvir), Olysio (simeprevir) or Daklinza (daclatasvir). Seventy-nine HCV-1 and HCV-4 patients are enrolled, while 38 have been evaluated through eight weeks of follow up. Of these, 97% (n=37/38) had HCV RNA viral loads below the limit of quantification (SVR12). For those assessed through 12 weeks of follow up, 100% (n=14/14) remained below the level of detection.
- The primary endpoint analysis (12 week follow up) for all 79 subjects should be available in late Q2.
- RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
- Related tickers: (NASDAQ:GILD)(NYSE:JNJ)(NYSE:BMY)(NYSE:ABBV)(NYSE:MRK)
Thu, Feb. 11, 7:21 AM
- Incyte (NASDAQ:INCY) terminates its Phase 3 clinical trial assessing Jakafi (ruxolitinib), in combination with chemo agent capecitabine, for the second-line treatment of advanced or metastatic pancreatic cancer after an interim analysis failed to show sufficient efficacy.
- Based on these data and the interim analysis of the Phase 2 sub-study of Jakafi, in combination with Bayer's (OTCPK:BAYRY) STIVARGA (regorafenib), in patients with metastatic colorectal cancer and high C-reactive protein (CRP), the company will stop all Jakafi studies in solid tumors, including Phase 2 trials in breast and lung cancer. It will also discontinue its dose-finding study of INCB39110 ( a selective JAK1 inhibitor) as first-line treatment for pancreatic cancer.
- Data from all the discontinued trials will be analyzed and shared with the scientific community over the next few months.
- Ongoing studies of Jakafi and selective JAK1 inhibitors in hematology will continue as will those assessing selective JAK1 inhibition in solid tumors based on different hypotheses. These include a series of studies evaluating INCB39110 in combination with Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) and Incyte's epacadostat and INCB50465. A Phase 1/2 trial will also be conducted assessing INCB39110 plus AstraZeneca's (NYSE:AZN) TAGRISSO (osimertinib).
- Jakafi is a JAK1/JAK2 inhibitor cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
- Shares are off 10% premarket on light volume.
Thu, Feb. 4, 11:01 AM
- ImmunoGen (IMGN +9.7%) establishes a clinical research collaboration with Merck (MRK -1.4%) to evaluate the combination of IMGN's mirvetuximab soravtansine and Keytruda (pembrolizumab) for the treatment of patients with folate receptor (FR) alpha-positive ovarian cancer. The combination therapy will be added to IMGN's Phase 1b/2 clinical trial called FORWARD II. The agreement, through a Merck subsidiary, includes an option to expand the collaboration to include a Phase 3 study if the results are positive.
- Mirventuximab soravtansine is an antibody-drug conjugate (ADC) that contains a monoclonal antibody (mirventuximab) that binds to FRalpha-positive tumor cells thereby delivering its cytotoxic payload, soravtansine or DM4.
- KEYTRUDA helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
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
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.
Dec. 4, 2015, 12:01 PM
- Relypsa (RLYP +16.6%) jumps on increased volume in response to rumors that Merck (MRK +0.5%) may be eyeing the company. Actelion Pharmaceuticals (OTCPK:ALIOY -0.4%) is another rumored suitor considering AstraZeneca's (AZN +0.4%) recent takeover of ZS Pharma (ZSPH -0.1%).
- Relypsa's sole product is Veltassa (patiromer for oral suspension) for the treatment of hyperkalemia (abnormally high levels of serum potassium), cleared by the FDA on October 21.
- Previously: Good news is bad news for Relypsa; shares down 26% premarket after approval of Veltassa (Oct. 22)
- Previously: ZS Pharma take out by AstraZeneca puts the spotlight on Relypsa; shares rise 17% premarket (Nov. 6)
Sep. 17, 2015, 1:44 PM
- Eli Lilly (LLY +6.7%) jumps on 30% higher volume in response to its announcement of results from a Phase 3 clinical trial, called EMPA-REG, that showed patients with type 2 diabetes at high risk of cardiovascular (CV) events treated with Jardiance (empaglifozin), in addition to standard-of-care treatment, experienced a significant reduction in both CV risk and death.
- Specifically, patients taking Jardiance showed a 14% reduction in the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke and a 38% reduction in the risk of CV death. Treatment with Jardiance also resulted in a 32% reduction in all-cause mortality and a 35% reduction in heart failure-related hospitalization, all versus placebo. The data were presented today at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden and published in the New England Journal of Medicine.
- EMPA-REG was a long-term, multicenter, double-blind, placebo-controlled study involving more than 7,000 people across 42 countries with type 2 diabetes at high risk of CV events. The median observation period was 3.1 years.
- Almost 400M people worldwide have diabetes. As many as 95% of the cases are type 2.
- Jardiance was co-developed with privately held Boehringer Ingelheim under the companies' January 2011 diabetes alliance.
- Related tickers: (SNY +0.1%)(NVO -0.7%)(MRK -0.8%)
Sep. 17, 2015, 7:59 AM
- Interim results from a Phase 2 clinical trial evaluating Achillion Pharmaceuticals' (NASDAQ:ACHN) NS5A inhibitor odalasvir (ACH-3102), in combination with Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir), without ribavirin, in HCV-1 patients showed a 100% cure rate (SVR12) in HCV-1 patients (n=6/6) after six or eight weeks of treatment.
- The Phase 2 trial was an open-label, randomized, partial-crossover study to assess the safety, tolerability and efficacy of six or eight weeks of odalasvir and sofosbuvir, without ribavirin, in patients with HCV-1 infection. Eighteen patients were initially enrolled, including six as observational (group 1). Twelve patients completed eight weeks of treatment (50 mg odalasvir/400 mg sofosbuvir) while the observational group received nothing. All twelve subjects achieved SVR24. Following this phase, the six observational patients plus six additional patients (group 2) received six weeks of treatment with the same combo regimen. All achieved SVR24. Six additional rollover patients (group 3) were treated for six weeks with the combo regimen and all achieved SVR12.
- In a summary that is a bit confusing, the company states that 18 subjects (groups two and three) achieved SVR12 after six weeks of therapy, although it states that only group 3 (n=6) achieved this. Also, the total number of patients in groups 2 and 3 is 12 (6 + 6). Group 1 (n=6) is apparently included as well?
- In May, the company inked a global license and commercialization deal with Janssen Pharmaceuticals (NYSE:JNJ) for HCV products containing one or more of Achillion's HCV assets, including odalasvir, ACH-3422 and sovaprevir.
- Previously: Achillion inks collaboration deal with J&J's Janssen Pharmaceuticals in hep C (May 19)
- ACHN is up 5% premarket on light volume.
- Related tickers: (NYSE:MRK) (NYSE:BMY) (NYSE:ABBV)
Aug. 4, 2015, 10:00 AM
- Thinly traded micro cap Codexis (CDXS +23.1%) is up on average volume in response to its announcement after the close yesterday that it licensed its CodeEvolver platform technology to Merck (MRK -0.1%), the second member of Big Pharma to sign on.
- Under the terms of the agreement, Merck has a non-exclusive license to use the CodeEvolver protein engineering platform technology to develop novel enzymes for use in the manufacture of Merck's pharmaceutical products. Codexis is eligible to receive up to $18M over the next 15 - 24 months, $5M up front and $13M related to certain technology transfer milestones. It is also eligible to receive up to a maximum of $15M for each pharmaceutical ingredient using novel enzymes developed with CodeEvolver by Merck and used in commercial manufacturing.
- Codexis will host a conference call this morning at 11:00 am ET to discuss the deal.
Jul. 31, 2015, 8:47 AM
- An interim analysis of data from a Phase 3 ring vaccination trial in Guinea shows Merck's (NYSE:MRK) Ebola vaccine candidate, rVSV-ZEBOV, was 100% effective in protecting people from Ebola virus infection within six to 10 days of vaccination (p=0.0036). The preliminary conclusions will be published online today in The Lancet.
- Over 4,000 people have received the vaccine to date. Merck licensed rVSV-ZEBOV from NewLink Genetics (NASDAQ:NLNK) who licensed it from the Public Health Agency of Canada.
- The make the vaccine, a virus similar to the rabies virus called vesicular stomatitis virus is weakened by removing one of its genes which is then replaced with a single Ebola virus gene that, by itself, cannot cause disease.
- Two other trials assessing rVSV-ZEBOV are ongoing: a Phase 3 study, called STRIVE, in Sierra Leone and a Phase 2, called PREVAIL, in Liberia.
- MRK is up a fraction premarket. NLNK is up 9% on light volume.
May 29, 2015, 5:24 PM
- Bristol-Myers Squibb (NYSE:BMY) stumbled 7% today on a 4.5x surge in volume in response to the presentation of an abstract (#109) at ASCO that underwhelmed many investors. The data were from Phase 3 study, called CheckMate-057, assessing the company's PD-1 inhibitor, Opdivo (nivolumab) compared to the standard-of-care chemotherapy agent docetaxel in treatment-experienced patients with advanced, non-squamous non-small cell lung cancer, the most common form of lung cancer. A drug used after another (treatment experienced) is called a second line setting.
- The study met its primary endpoint of a statistically significant 27% reduction in the risk of cancer progression or death compared to docetaxel (p=0.0015). The trial also evaluated the efficacy of Opdivo compared to docetaxel by the level of PD-L1 expression, 1%, 5% and 10%. As expected, the median overall survival (OS) in the Opdivo group was significantly longer than the chemo cohort for all three levels where PD-L1 was highly expressed (greater than or equal to 1, 5, 10%).
- What raised eyebrows was the absence of a treatment benefit compared to docetaxel in the three groups with low PD-L1 expression (<1%, <5%, <10%). Median OS was barely higher in the Opdivo group with <1% expression and lower than docetaxel in the other two. This potentially opens the door for eventual competitors such as Roche (OTCQX:RHHBY) and Merck (NYSE:MRK) whose offerings show strong efficacy in tumors that highly express PD-L1. Had Opdivo shown a significant OS advantage in low PD-L1 expression tumors, its dominance in the second line setting would have been virtually assured.
- CheckMate-057 was stopped early based on the successful achievement of its primary endpoint, per the recommendation of the independent Data Monitoring Committee.
- Previously: Phase 3 study stopped early after Bristol-Myers' Opdivo hits efficacy endpoint (April 17)
Apr. 28, 2015, 9:12 AM
Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products worldwide. It is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets vaccines and... More
Industry: Drug Manufacturers - Major
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