Sanofi (SNY) - NYSE
  • Fri, Apr. 1, 7:44 AM
    • Regeneron Pharmaceuticals (NASDAQ:REGN) and co-developer Sanofi (NYSE:SNY) announce successful results from two Phase 3 clinical trials evaluating dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD).
    • Both studies, LIBERTY AD SOLO 1 and SOLO 2, met their primary endpoints and demonstrated significant improvements in measures of overall disease severity, skin clearing, itching, quality of life and mental health. These are the first Phase 3 trials of a systemic therapy that show this level of benefit in moderate-to-severe AD. There are no currently approved systemic therapies in the U.S. for the condition.
    • There were 1,379 adults with moderate-to-severe AD enrolled in the two identical studies. They were randomized to receive 300 mg of dupilumab subcutaneously once per week, 300 mg every two weeks or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously or placebo.
    • For SOLO 1 and SOLO 2, 37% and 36% of patients, respectively, in the 300 mg once/week cohort and 38% and 36% of the 300 mg every two weeks cohort achieved clearing or near-clearing of skin lesions compared to 10% and 8.5% for placebo (p<0.0001). This was the primary endpoint.
    • The improvements in another metric, EASI score, from baseline were 72% and 69%, 51% and 44% and 15% and 12%, respectively, for the three groups (p<0.0001).
    • The proportions of patients achieving EASI-75 (75% improvement in AD symptoms) were 52.5% and 48%, 51% and 44% and 15% and 12%, respectively, for the three groups (p<0.0001). This was the key secondary endpoint in the U.S. and one of the primary endpoints in the EU.
    • The overall rate of adverse events was 65 - 73% for dupilumab and 65 - 72% for placebo. The rate of serious adverse events was lower for dupilumab (1 - 3%) versus placebo (5 - 6%). Adverse events for dupilumab that were higher than placebo were injection site reactions (10-20% vs. 7-8%) and conjunctivitis (7-12% vs. 2%). No patient discontinued dupilumab therapy due to an injection site reaction. One discontinued due to conjunctivitis.
    • Dupilumab, a fully human monoclonal antibody, works by binding to (inhibiting) interleukin-4 (IL-4) and interleukin-13 (IL-13), two cytokines that play key roles in the pathogenesis of AD. The FDA designated it a Breakthrough Therapy for AD in November 2014. A New Drug Application (NDA) should be submitted by Q3.
    • More detailed results from the two studies will be presented at future medical conferences.
    • Now read Regeneron - A Review: Strong Returns Look Likely for 2016 and Beyond
    | Fri, Apr. 1, 7:44 AM | 6 Comments
  • Thu, Mar. 31, 11:42 AM
    • AstraZeneca's (AZN +0.1%) cardiac med BRILINTA (ticagrelor) is now the preferred antiplatelet therapy over clopidogrel for the treatment of patients with acute coronary syndrome (ACS) who have received a coronary stent and in non-ST Elevation acute coronary syndrome. The new guideline on the duration of dual antiplatelet therapy was recently issued by the American College of Cardiology and American Heart Association.
    • The data supporting the change was generated in the PEGASUS-TIMI 54 study. The new approach supports the continuation of antiplatelet therapy beyond 12 months in prior heart attack patients who are not at high bleeding risk.
    • The FDA approved Brilinta at a 60 mg dose in September 2015 in patients with a history of heart attack. It is indicated to reduce the rate of CV death, heart attack and stroke in patients with ACS or a history of heart attack. AstraZeneca expects it to generate peak sales of $3.5B.
    • Clopidogrel, commercialized by Bristol-Myers Squibb (BMY +0.1%) and Sanofi (SNY -0.7%) under the brand name Plavix, was cleared by the FDA for ACS patients in February 2002. It is now off patent and available in generic form.
    • Now read High-Yield AstraZeneca Offers A Compelling Risk/Reward Ratio 
    | Thu, Mar. 31, 11:42 AM | 2 Comments
  • Thu, Mar. 31, 3:07 AM
    • Two mosquito species that carry the dangerous Zika virus may inhabit a wider range of North America than previously thought.
    • A new study published in the New England Journal of Medicine shows the potential range of the Aedes aegypti mosquito blanketing the southern U.S. and reaching as far north as San Francisco, Kansas City, and NYC.
    • The likely extent of another Zika-carrying mosquito species, Aedes albopictus, stretches across the Southwest and covers most of the eastern U.S., including northern New England, according to a study by the CDC.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Thu, Mar. 31, 3:07 AM | 11 Comments
  • Thu, Mar. 24, 7:00 AM
    • Trading in Portola Pharmaceuticals (NASDAQ:PTLAhalted at 6:55 am ET this morning pending news.
    • Update: Top-line results from the Phase 3 APEX study evaluating the superiority of extended-duration anticoagulation with oral betrixaban compared to standard-of-care anticoagulation with injectable enoxaparin [Sanofi's (NYSE:SNY) Lovenox (enoxaparin sodium injection] for the prevention of blood clots [venous thromboembolism (VTE)] in acute medically ill patients failed to achieve its primary endpoint in the first cohort.
    • The 7,513-subject study was designed to assess the relative risk of the two therapies as measured by a composite endpoint of ultrasound-detected (asymptomatic) proximal deep venous thrombosis (DVT), symptomatic DVT, non-fatal pulmonary embolism (PE) or VTE-related death in high-risk acute medically ill patients treated with oral betrixaban for 35 - 47 days compared to standard-of-care- injectable enoxaparin for 6 - 14 days.
    • The study population consisted of three pre-specified patient groups: Cohort 1 - patients with elevated D-dimer levels (62% of the population); Cohort 2: patients with elevated D-dimer levels aged at least 75 years (91% of the population) and the overall study population. D-dimer is a test for inappropriate blood clots.
    • The trial incorporated an enrichment strategy and statistical analysis plan derived from FDA guidance. Per the protocol, the primary efficacy analysis was performed on Cohort 1. The p value had to be no higher that 0.05 in order to test Cohort 2 which, in turn, had to have a p value no higher than 0.05 in order to test the overall study population.
    • The p value in Cohort 1 was 0.054, slightly above the threshold to proceed to Cohort 2, which had a p value of 0.029. The overall population's p value was lower still, 0.006. The relative risk calculation favored betrixaban in all three cohorts, showing a 19 - 24% lower risk of events compared to enoxaparin.
    • The company believes the data in Cohort 1 were strong enough to support the full assessment in Cohort 2 and the overall study population. It also believes the data are robust enough to support a New Drug Application (NDA) later this year. As such, it intends to discuss the data with regulatory agencies.
    • According to the company, ~20M acute medically ill patients in the G7 countries are at risk of developing VTE while hospitalized or following discharge. More than 1M VTEs and 150K VTE-related deaths occur in this population each year despite the use of injectable enoxaparin.
    • Fast Track-tagged betrixaban is a once-daily orally administered Factor Xa inhibitor anticoagulant.
    • Management will host a conference call this morning at 8:30 am ET to discuss the study.
    • Shares are down 24% premarket on robust volume.
    | Thu, Mar. 24, 7:00 AM | 17 Comments
  • Wed, Mar. 23, 7:04 AM
    • Results from a Phase 3 clinical trial, ODYSSEY ESCAPE, evaluating Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi' s (NYSE:SNY) Praluent (alirocumab) Injection in patients with heterozygous familial hypercholesterolemia (HeFH) who require chronic apheresis therapy showed those who added Praluent to their existing treatment regimen reduced the frequency of their apheresis therapy by 75% compared to placebo (p<0.0001). In addition, 63% of patients receiving Praluent no longer required apheresis compared to zero for placebo. This is the first time a PCSK9 inhibitor has demonstrated that it can reduce the frequency of apheresis therapy.
    • The study involved 62 HeFH patients in the U.S. and Germany. They were randomized to receive either 150 mg of Praluent subcutaneously every two weeks or placebo. During the first six weeks patients remained on their established apheresis schedule. The following 12 weeks the frequency of apheresis was adjusted based on their LDL-C response to treatment.
    • Heterozygous familial hypercholesterolemia is an inherited form of high cholesterol that leads to early heart attacks in both men and women. Many required routine (1 - 2 times/week) apheresis therapy to remove LDL-cholesterol from their blood. Apheresis is a procedure in which the patient's blood is passed through an apparatus to remove a particular constituent. It is time-consuming (takes ~three hours) and expensive ($100k/year).
    • Praluent was cleared in the U.S. in July 2015 and in the EU two months later.
    • Related ticker: (NASDAQ:AMGN)
    | Wed, Mar. 23, 7:04 AM | 4 Comments
  • Sun, Mar. 20, 11:05 AM
    • On an inexorable march across the hemisphere, the Zika virus has begun spreading through Puerto Rico, now the United States' front line in a looming epidemic.
    • A quarter of the island's 3.5M people will likely get the Zika virus within a year, according to the Centers for Disease Control and Prevention, and eventually 80% or more may be infected.
    • The territory's first Zika case was confirmed in December, and the governor declared a health emergency on Feb. 5.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Sun, Mar. 20, 11:05 AM | 20 Comments
  • 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)
    | Thu, Mar. 17, 5:21 PM
  • Thu, Mar. 17, 6:27 AM
    • The FDA approves Bayer's (OTCPK:BAYRY) KOVALTRY Antihemophilic Factor (Recombinant), an unmodified full-length factor VIII compound for the treatment of children and adults with hemophilia A. KOVALTRY can be used two to three times per week in adolescents and adults and up to every other day in children.
    • Hemophilia A, or factor VIII deficiency, affects 16,000 Americans.
    • KOVALTRY was cleared in the EU and Canada in February.
    | Thu, Mar. 17, 6:27 AM | 6 Comments
  • Wed, Mar. 16, 3:30 PM
    • Amgen (AMGN +0.4%) chief Robert Bradway says, "We are thankful that the jury weighed the evidence carefully and recognized the validity of Amgen's patents on Repatha (evolocumab), our innovative biologic molecule that reduces LDL [bad] cholesterol."
    • Earlier today, a jury in a Delaware federal court found the defendants Regeneron Pharmaceuticals (REGN +0.5%) and Sanofi (SNY -1.1%) failed to prove Amgen's patents, Nos. 8,829,165 and 8,859,741, invalid for lack of written description and enablement. In patent law, description and enablement means that, in order to to be considered for a patent, the product specification must clearly describe the manner and process of making and using the invention such that it enables another party skilled in the art to make and use it, which the jury believed Amgen had done.
    • Prior to the case going to jury, the Court dismissed the defendants' case on obviousness, meaning there is no combination of "prior art" (previously patented products) that would bring the patentability of evolocumab into question.
    • Prior to the trial, both Regeneron and Sanofi acknowledged infringing on seven patent claims of '165 and '741. They intend to appeal today's ruling.
    | Wed, Mar. 16, 3:30 PM
  • Wed, Mar. 16, 11:52 AM
    • Nasdaq has suspended trading in Regeneron Pharmaceuticals (REGN +2.6%) pending news. One possibility is a ruling on its patent fight with Amgen (AMGN -0.4%) over their PCSK9 inhibitors [Praluent (alirocumab) versus Repatha (evolocumab)].
    • Here's an SA article by Markman Advisors for background.
    • Update: Amgen patents upheld per report by Evercore ISI's Mark Schoenebaum. Permanent injunction hearing set for March 23 - 24. Regeneron to appeal. Judge ruled that Amgen failed to establish sufficient evidence of willful infringement (win for Regeneron).
    • Update #2: Judge ruled that two Amgen patents covering antibodies targeting PCSK9 are valid. Regeneron and development/commercialization partner Sanofi (SNY -1.7%) intend to appeal the decision. The availability of Praluent is not affected at this time. Trading in REGN to resume at 1:00 pm ET. Initial trading has shares down only 1%.
    | Wed, Mar. 16, 11:52 AM | 24 Comments
  • Fri, Mar. 11, 10:12 AM
    • Regeneron Pharma (REGN -0.3%) says its sarilumab rheumatoid arthritis drug met its primary endpoint as being superior to a competitor’s drug in improving signs and symptoms of the disease, according to a phase 3 study.
    • REGN says the drug developed with Sanofi (SNY +1.4%) also met secondary endpoints in improving signs and symptoms in patients with active rheumatoid arthritis.
    • Sarilumab was being compared with adalimumab, marketed by AbbVie (ABBV +1.1%) as Humira.
    | Fri, Mar. 11, 10:12 AM | 25 Comments
  • Wed, Mar. 9, 2:20 AM
    • Sexual transmission of the Zika virus is more common than previously thought, according to the World Health Organization.
    • After a meeting of its emergency committee on Tuesday, the U.N. health agency said there was also increasing evidence that a spike in birth defects and neurological problems are caused by the disease.
    • Local transmission of Zika has now been reported in 31 countries across Latin America and the Caribbean.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Wed, Mar. 9, 2:20 AM | 6 Comments
  • Tue, Mar. 8, 9:37 AM
    • Sanofi Pasteur (SNY +0.2%) and Merck (MRK -0.3%) will terminate their 50/50 joint venture, established in 1994, developing and commercializing vaccines in Europe. Once the JV is dissolved, expected by year-end, the companies will integrate their respective vaccine businesses into their own operations.
    • In a joint statement, the companies explain their rationale: "After carefully considering our individual strategic priorities, alongside the economic and regulatory environments for vaccine operations in the [EU], we have mutually agreed that it is in our best interests to manage our vaccine product portfolios independently. We believe that focusing our efforts on opportunities unique to our respective companies will better position us to drive growth, execute in a more efficient manner and optimize vaccine coverage."
    | Tue, Mar. 8, 9:37 AM
  • 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)
    • Update: Shares up 26% in early trading.
    | Tue, Mar. 8, 9:13 AM | 8 Comments
  • Thu, Feb. 25, 3:25 PM
    | Thu, Feb. 25, 3:25 PM | 4 Comments
  • Tue, Feb. 23, 9:02 AM
    • Results from a Phase 3b study, SWITCH 1, showed type 1 diabetics treated with Novo Nordisk's (NYSE:NVO) Tresiba (insulin degludec) experienced significantly lower rates of hypoglycemia (low blood sugar) compared to those treated with Sanofi's (NYSE:SNY) Lantus (insulin glargine U100).
    • The 501 subjects in the trial were randomized to crossover treatment with Tresiba and Lantus in combination insulin aspart. The timing of the daily injections of both products was randomized to occur in either the morning or evening. The primary endpoint was the number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycemic episodes during the 16-week maintenance period.
    • The data showed Tresiba was non-inferior (no worse than) to Lantus in the rate of severe or blood glucose-confirmed symptomatic hypoglycemic episodes. The observed rates were 2,201 per 100 patient years and 2,463 per 100 patient years, respectively. Tresiba's 11% reduction was statistically valid.
    • Patients receiving Tresiba also showed a statistically significant lower rate of nocturnal severe or blood glucose-confirmed hypoglycemic episodes of 36% compared to Lantus. The proportion of patients experiencing hypoglycemia during the maintenance period also favored Tresiba, 10% versus 17%.
    • Lantus is Sanofi's top seller, posting €6.4B in sales last year.
    • Tresiba was cleared in Europe in January 2013 and in the U.S. in September 2015.
    • For interested night owls, Novo will host a conference call tomorrow morning at 2:30 am ET to discuss the data.
    • Previously: Novo's long-acting Tresiba beats insulin glargine in late-stage study in T2D (Jan. 29)
    | Tue, Feb. 23, 9:02 AM | 2 Comments
Company Description
Sanofi engages in the research, production and distribution of pharmaceutical products. It operates through the following segments: Pharmaceuticals, Human Vaccines, Animal Health, and Others. The Pharmaceuticals segment includes research, development, production and sales activities relating to... More
Sector: Healthcare
Industry: Drug Manufacturers - Major
Country: France