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Sep. 28, 2015, 7:03 AM
- As expected, the European Commission (EC) approves Praluent (alirocumab) for lowering low-density lipoprotein (LDL) cholesterol in certain adults with hypercholesterolemia. The approval follows CHMP's positive opinion in July. Praluent, co-developed by Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN), will be available in a single-dose (75 mg or 150 mg) pre-filled pen that patients can self-administer.
- The EC approved Amgen's (NASDAQ:AMGN) Repatha (evolocumab) in July.
- Previously: Amgen's Repatha cleared in Europe (July 21)
- Previously: Europe's CHMP give thumbs up to Regeneron and Sanofi's Praluent (July 24)
Sep. 21, 2015, 8:27 AM
- The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) will provide $17M in initial funding to Regeneron Pharmaceuticals (NASDAQ:REGN) to develop, test and manufacture a treatment for Ebola infection including an IND filing with the FDA. An option in the agreement provides for an additional $21M to fund a Phase 1 study in health volunteers, planned for January 2016, and further manufacturing and development studies.
- The product candidate is a monoclonal antibody developed with the company's VolociGene and VelocImmune technologies. Sanofi (NYSE:SNY) has opt-in rights pursuant to its 2009 antibody discovery and development agreement with Regeneron.
Sep. 18, 2015, 6:13 PM
- Mexico City-based generic drugmaker Representaciones e Investigaciones Medicas -- Rimsa -- is drawing interest from big pharma companies, particularly including Pfizer (PFE -1.9%), Sanofi (SNY -3%) and Abbott Laboratories (ABT -2.1%), Bloomberg reports.
- Rimsa could draw about $1B in a purchase by any of a list of suitors, which also could include Teva (TEVA -1.6%) and Takeda (OTCPK:TKPYY -1.9%).
- Healthcare spending rates in Mexico are expected to rise to be more in line with other emerging markets like Brazil and Chile. Spending is relatively low and the market is fragmented.
- Goldman Sachs is managing the sale.
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. 16, 2015, 10:42 AM
- Results from a Phase 4 study, called LIRA-LIXI, comparing Novo Nordisk's (NVO -0.1%) Victoza (liraglutide) to lixisenatide (Sanofi (SNY +1.4%)), both in combination with metformin, showed treatment with liraglutide lowered HBA1c -1.83% versus -1.21% (p<0.0001) significantly greater in patients with type 2 diabetes. The results were presented today at the 51st Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden.
- Data from the 26-week 404-subject trial also showed that liraglutide produced significantly greater reductions in fasting plasma glucose (p<0.0001) and mean nine-point self-measured plasma glucose (p<0.0001) compared to lixisenatide while producing greater postprandial increments for the meal following injection (p<0.0001). The safety profile was similar between the two groups.
- Victoza was administered once daily at any time irrespective of meals while lixisenatide was administered once-daily within an hour prior to the morning or evening meal.
- Victoza, a GLP-1 analog, was launched in the EU in 2009. A recombinant version was approved by the FDA under the brand name Saxenda in December 2014.
- Sanofi intends to file its NDA (brand name LixiLan) with the FDA in Q4 and its MAA in the EU in Q1 2016.
Sep. 15, 2015, 8:15 AM
- Amicus Therapeutics (NASDAQ:FOLD) intends to submit a New Drug Application (NDA) to the FDA in Q4 seeking approval for lead product candidate migalastat in Fabry disease (FD), an inherited lysosomal storage disorder caused by a deficiency in an enzyme called alpha-galactosidase A which leads to the accumulation of a type of fat in the body's cells. The condition, affecting one in 40,000 to 60,000 males, leads to progressive kidney damage, heart attack and stroke.
- Based on FDA feedback in a recent pre-NDA meeting, the application will use the reduction in disease substrate (kidney interstitial capillary GL-3) as the primary endpoint. The filing will also include the protocol for a Phase 4 study of the effect of migalastat on gastrointestinal symptoms associated with FD. The NDA will be reviewed under the FDA's Accelerated Approval pathway.
- The current standard of care treatment for FD is enzyme replacement therapy (ERT). Migalastat, being a pharmacological chaperone, has a unique mechanism of action. Many FD sufferers produce some alpha-galactosidase A that is capable of degrading substrate but the genetic mutation prevents it from being delivered to lysosomes in sufficient amounts to reduce GL-3 (type of fat). Migalastat binds to and stabilizes alpha-galactosidase A which increases its trafficking to lysosomes (acts as a "chaperone") which increases the breakdown of GL-3. As many as 50% of FD patients have the amenable mutations to respond to migalastat monotherapy.
- The company is developing a next-generation therapy that combines migalastat with ERT that will potentially enable all FD patients to benefit from migalastat treatment.
- Related tickers: (NYSE:SNY) (NASDAQ:SHPG)
Sep. 14, 2015, 7:21 AM
- Sanofi's (NYSE:SNY) LixiLan diabetes drug successfully met its primary endpoint of superior HbA1c reduction (average glucose over the previous three months) compared to Lantus (insulin glargine) in 736 patients with type 2 diabetes in a second Phase 3 clinical trial. The efficacy was evaluated over a 30-week period in patients not adequately controlled on basal insulin, alone or with one or two oral anti-diabetic agents. Treatment with metformin, if previously taken, was continued throughout the study. The results will be presented at a future medical conference.
- In July, Sanofi reported positive results in the first Phase 3 study in 1,170 patients.
- LixiLan is a fixed dose combination of insulin glargine 100 units/mL (Lantus) and lixisenatide (Lyxumia), a prandial GLP-1 receptor agonist invented by Zealand Pharma.
- Sanofi expects to file an NDA with the FDA in Q4 and an MAA with the European Medicines Agency in Q1 2016.
Sep. 14, 2015, 6:56 AM
- Sanofi (NYSE:SNY) enters into a multi-target peptide discovery and optimization collaboration with Tokyo-based PeptiDream.
- Under the terms of the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System technology to generate certain peptides against multiple targets of interest selected by Sanofi. PeptiDream will receive an undisclosed upfront payment, research funding, preclinical and clinical milestones and royalties of commercial sales.
- PeptiDream also has collaborations with Amgen (NASDAQ:AMGN), AstraZeneca (NYSE:AZN), Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), GlaxoSmithKline (NYSE:GSK), Novartis (NYSE:NVS), Mitsubishi Tanabe (OTCPK:MTZPY), Daiichi Sankyo (OTCPK:DSNKY), Merck (NYSE:MRK) and Ipsen (OTCPK:IPSEY).
Sep. 11, 2015, 9:39 AM
- Amgen (AMGN -0.8%) files an application with the FDA seeking clearance for a single once-per-month 420 mg injection of its cholesterol fighter Repatha (evolocumab). Presently, Repatha is available in a single-use 140 mg/mL prefilled autoinjector which requires three subcutaneous injections for a dose of 420 mg. One injection, obviously, would be much more patient-friendly for those patients requiring/preferring a once-per-month regimen.
- The FDA cleared Repatha, a PCSK9 inhibitor, on August 27, for lowering LDL-C (bad cholesterol).
- Sanofi (SNY -0.2%) and Regeneron's (REGN -0.4%) Praluent (alirocumab), Reptha's competitor, requires a subcutaneous injection every two weeks via a pre-filled syringe/pen.
Sep. 9, 2015, 7:56 AM
- Hamburg, Germany-based Evotec (OTCPK:EVTCY) enters into a four-year research collaboration with Pfizer (NYSE:PFE) in the field of tissue fibrosis. Under the terms of the agreement, the companies will explore potential novel mechanisms as targeted anti-fibrotics in multi-organ fibrosis. Evotec will contribute its drug discovery platform and Pfizer will contribute key technologies, industrial scope and expertise in drug development and marketing.
- Specific financial terms are not disclosed but include an upfront payment to Evotec and development- and sales-based milestones.
- Evotec inked collaboration deals with Sanofi (NYSE:SNY) a month ago in the field of cancer immunotherapies and diabetes. The firms established a five-year drug discovery collaboration in March.
- Evotech consummated a drug discovery deal in Alzheimer's disease with Johnson & Johnson (NYSE:JNJ) in November 2013.
Sep. 1, 2015, 5:43 PM
- In a regulatory filing, Ardelyx (NASDAQ:ARDX) discloses that Sanofi (NYSE:SNY) has notified it of its intent to terminate its option and license agreement for Ardelyx's portfolio of NaP2b inhibitors effective September 30.
- The agreement, consummated in February 2014, granted Sanofi an exclusive global license to conduct research with Ardelyx's NaP2b inhibitors (RDX002) for the treatment of hyperphosphatemia in patients with end-stage renal disease. If an attractive candidate was identified within the period, Sanofi could exercise its option to develop, manufacture and commercialize the NaP2b inhibitors, all of which are in early research phase.
- There is no payment due Ardelyx for the termination.
Sep. 1, 2015, 11:11 AM
- In a presentation today at the European Society of Cardiology Congress in London, pooled data from the ODYSSEY clinical trial program show Praluent (alirocumab) significantly lowered bad cholesterol (LDL-C). The analysis included 1,257 patients with heterozygous familial hypercholesterolemia (HeFH), a genetic predisposition for high cholesterol.
- At week 24, patients receiving Praluent experienced an average 56% greater reduction in LDL-C versus placebo (p<0.0001). Reductions were observed as early as week 4 and were maintained until week 78, the duration of therapy.
- Only ~20% of HeFH patients are able to reduce their LDL-C level below 100 mg/dL with statins. In this analysis, 75% of HeFH patients who added Praluent to their standard-of-care treatment (which included statins) were able to lower their LDL-C below 100 mg/dL.
- Praluent, approved by the FDA in July, was co-developed by Regeneron Pharmaceuticals (REGN -2%) and Sanofi (SNY -1.9%).
Aug. 31, 2015, 7:53 AM
- The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
- What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
- ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
- The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
- The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
Aug. 20, 2015, 8:01 AM
- Top line results from a 7,000-subject clinical trial, called EMPA-REG OUTCOME, show that Jardiance (empagliflozin), when added to standard of care, was superior in lowering cardiovascular (CV) risk in type 2 diabetics. The primary endpoint was the time to first occurrence of either CV death, non-fatal myocardial infarction or non-fatal stroke. About half of the deaths of people with type 2 diabetes are caused by CV disease.
- Full results will be presented on September 17 at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.
- Jardiance, co-developed by Boehringer Ingelheim and Eli Lilly (NYSE:LLY), is the only glucose-lowering drug that has demonstrated CV risk reduction. It was cleared in Europe in May 2014 and in the U.S. in July 2014.
- Related tickers: (NYSE:SNY) (NYSE:NVO) (NYSE:AZN)
Aug. 12, 2015, 10:15 AM
- Expecting FDA approval of its lead product candidate in a couple of months, Relypsa (RLYP -0.2%) inks an agreement with Sanofi (SNY -2.7%) under which its nephrology sales force will detail healthcare professionals on Patiromer FOS. The FDA's decision date or PDUFA, is October 21. Sanofi's efforts will complement the promotional activities of Relypsa's specialty sales force.
- Patiromer for Oral Suspension (FOS) is a high capacity oral potassium binder that treats hyperkalemia (excess potassium in the blood).
- Details are face-to-face presentations made by drug sales personnel to doctors. The intent is to sell physicians on the benefits of the product so they will write prescriptions for them, which are then filled in local pharmacies. The sales people "detail" instead of "sell" since they cannot accept a direct order for the product.
- Previously: Relypsa's Patiromer FOS successful controlling elevated potassium in heart failure patients (March 14)
Aug. 11, 2015, 10:15 AM
- In a letter published in the Journal of the American Medical Association (AMA), CVS Health (CVS -0.5%) urges heart specialists to revamp guidelines for treating patients with high cholesterol to provide clarity on how best to choose the best and most cost effective therapy now that expensive new drugs called PCSK9 inhibitors are now on (or will soon be on) the market.
- PCSK9 inhibitors, led by recently-approved Praluent (alirocumab) (SNY -0.4%)(REGN -0.8%) and soon-to-be-approved Repatha (evolocumab), are, at least initially, more than 20 times more expensive than statins. Pharmacy benefit managers, like CVS, aim to control costs by extracting significant discounts from manufacturers and controlling patient access to the pricier drugs.
- CVS wants the guidelines to include specific LDL targets, which older guidelines did before new ones issued in 2013 did away with them. The emphasis now is on a patient's risk of developing heart disease as the main determinant for more intensive treatment. Unsurprisingly, the American College of Cardiology and the AMA have shown scant enthusiasm for revisiting the issue.
- CVS Chief Medical Officer Dr. Troyen Brennan says that if the guidelines are not changed, then CVS will use its own targets, which will vary depending on each patent's medical history. "We expect patients to first use statins. If they can't use statins or can't make (NYSE:LDL) targets, then they would use PCSK9 inhibitors."
- The PDUFA date for Amgen's (AMGN -1%) Repatha is August 27.
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