Oct. 20, 2014, 8:56 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF) initiate a Phase 3 clinical trial to assess the safety and efficacy of dupilumab administered concomitantly with topical corticosteroids for the treatment of adults with moderate-to-severe atopic dermatitis (AD). The 16-week randomized, double-blind, placebo-controlled multinational study will enroll ~700 patients.
- Dupilumab is a fully-human mAb that blocks IL-4 and IL-13 signalling. It was created using Regeneron's VelocImmune technology and is being co-developed with Sanofi.
- Dermatitis-related tickers: (NYSE:VRX) (NASDAQ:ANAC) (NYSE:GSK) (NYSE:PRGO)
Oct. 17, 2014, 9:30 AM
- Amgen (NASDAQ:AMGN) files suit in the U.S. District Court of Delaware against Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN) alleging infringement on three of its patents covering monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen seeks an injunction to prevent the manufacture, use and sale of Sanofi and Regeneron's PCSK9 inhibitor alirocumab.
- Amgen recently submitted its BLA to the FDA for its PCSK9 inhibitor evolocumab.
Oct. 7, 2014, 8:33 AM
- Danish biopharmaceutical firm Forward Pharma A/S (NASDAQ:FWP) is set for an IPO of 9.5M American Depository Shares at $20 - 22.
- Its lead product is FP187, a proprietary formulation of dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS), about to enter Phase 3 development.
- Meaningful revenues appear far in the distance, however. Patient recruitment for FP187's Phase 3 trial will take at least 18 months and the completion of the last patient's 48-week treatment will take a total of 30 months.
- The firm's operating losses for 2013 and 1H 2014 were $9M and $7.4M, respectively.
- MS-related tickers: (NASDAQ:BIIB) (NYSE:ABBV) (NYSEMKT:SYN) (NASDAQ:CNCE) (NYSE:SNY) (NASDAQ:XNPT) (NASDAQ:INO) (NASDAQ:OPXA) (NYSE:TEVA) (NASDAQ:ALKS) (NASDAQ:RCPT) (NASDAQ:AVNR) (NASDAQ:GCVRZ) (NYSE:NVS) (NASDAQ:QCOR)
Oct. 7, 2014, 5:03 AM
- Joining the list of pharmaceutical companies that face bribery claims in the Mideast and Africa, Sanofi (NYSE:SNY) has informed the DOJ and SEC about allegations of improper payments to doctors in Kenya and other East African nations.
- "We are committed to maintaining the highest ethical standards wherever we do business," says a company spokesman.
- Sanofi has hired New York law firm Weil Gotshal & Manges to look into the claims and the investigation is continuing.
Oct. 6, 2014, 11:41 AM
- Shares of micro cap Unilife (NASDAQ:UNIS) (OTC:UNISZ) jump 25% on a 6x surge in volume in response to its announcement of a long-term supply agreement with Sanofi (NYSE:SNY) (OTCQB:SNYNF).
- Under the terms of the agreement, Unilife will be the sole provider of cartridge-based wearable injectors for all of Sanofi's applicable large-dose volume drugs, excluding insulins, for a minimum of 15 years. Sanofi will have non-exclusive access to the wearable injectable technology and be allowed to make the technology available to its partners for use with applicable molecules under joint collaborations. Unilife maintains the right to enter into supply agreements with other pharma companies contingent on the preservation of Sanofi's non-exclusive access. Sanofi has the right to extend the agreement for additional periods.
- Unilife expects to receive ~$50M from the partnership, which includes an undisclosed upfront payment.
- Sanofi has five to ten molecules that will be delivered via wearable injectors.
Sep. 30, 2014, 7:20 AM
- Dupilumab, a fully human mAb being co-developed by Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF), met all primary and secondary endpoints in a 60-patient Phase 2a proof-of-concept study in patients with moderate-to-severe chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids.
- Dupilumab-treated patients demonstrated a statistically significant improvement in the size of nasal polyps which was the primary endpoint. Statistically significant improvements were also observed in the secondary endpoints of objective measures of sinusitis by CT scan, nasal air flow and patient-reported symptoms. Patients in the test group who had asthma demonstrated significant improvements in asthma control.
- Details of the study will be presented at a future medical conference.
- The companies plan to proceed with the clinical development of the drug for this indication.
Sep. 19, 2014, 7:18 AM
- The European Commission approves Novo Nordisk's (NYSE:NVO) Xultophy for the treatment of adult patients with type 2 diabetes to improve glycemic control in combination with oral glucose-lowering medicines when these alone or combined with basal insulin do not provide adequate glycemic control.
- Xultophy (IDegLira) is a once-daily injection combination of insulin degludec (Tresiba) and liraglutide (Victoza).
- Novo plans to launch the product in Europe in 1H 2015.
- Related tickers: (NYSE:NVS) (NYSE:LLY) (NYSE:MRK) (NYSE:SNY) (NYSE:AZN) (NYSE:GSK)
Sep. 18, 2014, 4:03 PM
- The FDA approves Eli Lilly's (LLY +1.1%) Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
- Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.
- Related tickers: (NVS +0.1%) (MRK +0.7%) (SNY +0.7%)(AZN +1.3%)(GSK +0.4%)
Sep. 11, 2014, 10:12 AM
- Genzyme (NYSE:SNY) (NASDAQ:GCVRZ) presents interim results from an extension study of Lemtrada (alemtuzumab) today at the European Committee for Research and Treatment in Multiple Sclerosis meeting in Boston.
- Approximately 70% of patients treated with an annual course of Lemtrada at the start of the first study and 12 months later did not receive further treatment with Lemtrada in years 3 and 4.
- Approximately 70% of the Lemtrada-treated patients demonstrated stable or improved disability scores for an additional two years beyond the two-year study period.
- In year 4, the relapse rates for the patients who received Lemtrada in the two trials (CARE-MS 1 and CARE-MS II) were 14% and 24%, respectively. These were comparable to the annualized relapse rates for the Lemtrada cohorts in the pivotal trials.
Sep. 11, 2014, 7:46 AM
- In an interview with Reuters, Genzyme's (NYSE:SNY) (NASDAQ:GCVRZ) chief of its multiple sclerosis franchise Bill Sibold says his firm intends to be a leader in the field via new products and acquisitions.
- He is confident about the commercial success of Lemtrada (alemtuzumab) and Aubagio (teriflunomide). Analysts forecast Lemtrada's peak sales at $437M and Aubagio's at $1.2B.
- Predictably, no word on acquisition targets, but he says that they are looking to acquire truly innovative products. "If the opportunity is the right opportunity, we'll evaluate it...We're well-resourced to execute our strategy."
- The firm expects an FDA decision on its revised marketing app for Lemtrada in Q4. The agency rejected its initial application last December.
Sep. 5, 2014, 8:11 AM
- In two Phase 3 clinical trials, Eli Lilly's (NYSE:LLY) basal insulin peglispro (BIL) demonstrated a statistically significant lower hemoglobin A1c (HbA1c) compared to Sanofi's (NYSE:SNY) Lantus (insulin glargine) at 26 and 52 weeks in patients with Type 1 diabetes.
- Both trials showed the rate of nocturnal hypoglycemia was significantly lower in patients taking BIL than those taking insulin glargine. In the open-label IMAGINE-1 trial, patients taking BIL reported a statistically significant higher rate of severe hypoglycemic events, however. In the the larger blinded IMAGINE-3 trial, the rate of severe hypoglycemic events in patients taking BIL was numerically lower that the insulin glargine arm but it was not statistically significant.
- Both trials showed a statistically significant difference in weight. The BIL cohort experienced weight loss with lower HbA1c compared to weight gain in the insulin glargine cohort.
- In IMAGINE-3, the BIL cohort showed statistically significant changes compared to insulin glargine in certain parameters: an increase in triglycerides and LDL cholesterol, a decrease in HDL cholesterol and increases in systolic and diastolic blood pressure. Some of these changes were not observed in IMAGINE-1.
- Lilly intends to submit its marketing application with regulators in Q1 2015.
Sep. 3, 2014, 11:03 AM
- Sanofi's (SNY +1.5%) vaccine division Sanofi Pasteur reports that its dengue vaccine candidate achieved its primary endpoint in a Phase 3 clinical trial conducted in Latin America. The vaccine demonstrated a 60.8% reduction in dengue disease cases in children and adolescents ages 9 - 16 years after a three-dose vaccination regimen. It also demonstrated efficacy across the four dengue serotypes. Vaccinated patients experienced an 80.3% reduction in the risk of hospitalization.
- The company intends to present its complete analysis of the trial results at the American Society of Tropical Medicine and Hygiene Annual Meeting in New Orleans, LA November 2 - 6, 2014.
Aug. 29, 2014, 9:05 AM
- People familiar with the situation say that the Belgian OTC drug maker Omega Pharma NV has attracted interest from a number of pharmaceutical companies including Perrigo (NYSE:PRGO), Boehringer Ingelheim, Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) and Sanofi (NYSE:SNY) (OTCQB:SNYNF).
- The tab for acquiring the business could be as high as 4B euros ($5.3B).
Aug. 22, 2014, 5:36 PM
Aug. 21, 2014, 8:07 AM
- Ilumina (NASDAQ:ILMN) has formed collaborative partnerships with AstraZeneca (NYSE:AZN), Janssen Biotech (NYSE:JNJ) and Sanofi (NYSE:SNY) to develop a universal next-generation sequencing (NGS) system focused on oncology. The system will employ an multi-gene panel that will be used for patient selection in clinical trials of targeted cancer therapies. Illumina plans to commercialize the tests after obtaining regulatory approval.
- The emergence of panel-based assays will be a paradigm shift from today's single-analyte companion diagnostics.
- An estimated 800 oncology drugs are in development worldwide. At present, 125 cancer driver genes, 71 tumor suppressors and 54 oncogenes that drive tumor growth through 12 cellular signalling pathways have been discovered.
Aug. 20, 2014, 7:27 AM
- Share of Amicus Therapeutics (NASDAQ:FOLD) are up 37% premarket on light volume in response to its report of positive results for its Fabry disease drug candidate, migalstat HCL, in a Phase 3 clinical trial (Study 012).
- Study 012 compared oral migalstat to standard-of-care enzyme replacement therapies (ERT), Fabrazyme (agalsidase beta) (NYSE:SNY) and Replagal (agalsidase alfa) (NASDAQ:SHPG), for Fabry disease. The co-primary endpoints were the mean annualized changes in estimated glomerular filtration rate (eGFR) and measured (iohexol) GFR (mGFR) assessed by descriptive comparisons on migalstat and ERT over 18 months.
- The statistical analysis of the results was based on 54 of the 60 subjects in the study that had GLP HEK-amenable mutations. All patients were treated with ERT for a minimum of 12 months prior to the start of the trial.
- Migalstat had a comparable effect to ERT on patients' kidney function (measured by the change in eGFR and mGFR). Levels of the biomarker plasma lyso-Gb3 remained low and stable in patients with amenable mutations who switched from ERT to migalstat. Of the 48 patients with GLP HEK-amenable mutations who completed Study 012, 46 (96%) elected to continue with the 12-month treatment extension. 45 remain on migalstat today as their sole treatment for Fabry disease.
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