Sanofi's Trying To Go On Offense While Playing Defense
Stephen Simpson, CFA
Stephen Simpson, CFA
Best Ideas For 2014: Long GCVRZ
Chris DeMuth Jr. • 314 Comments
Chris DeMuth Jr. • 314 Comments
3 Reasons Why Sanofi Rights (GCVRZ) Could Return 50% This Year
Chris DeMuth Jr. • 174 Comments
Chris DeMuth Jr. • 174 Comments
Dec. 11, 2015, 7:48 AM
- Sanofi (NYSE:SNY) and Regeneron (NASDAQ:REGN) edge out Amgen (NASDAQ:AMGN) for preferred access status for their PCSK9 inhibitor Praluent (alirocumab) in UnitedHealth Group's (NYSE:UNH) OptumRx and UnitedHealthcare for Commercial, Medicare and Managed Medicaid patients. Praluent is now on formularies covering more than 100M patients in the U.S., including Express Scripts and Aetna.
- Amgen's Repatha (evolocumab) is the preferred offering in CVS Health and the exclusive PCSK9 inhibitor for members of Harvard Pilgrim Health System. Express Scripts offers it as well. Patients covered in UnitedHealth's Oxford unit can transition to Repatha if a 12-week regimen of Praluent fails to do the job.
- Previously: Repatha and Praluent go toe-to-toe in PBMs (Dec. 1)
Dec. 1, 2015, 12:53 PM
- In a shining example of the beauty of competition, Amgen (AMGN +0.5%) is battling fiercely with Sanofi (SNY) and Regeneron (REGN -0.4%) for favored status of its cholesterol fighter Repatha (evolocumab) versus Praluent (alirocumab) in the leading pharmacy benefit managers (PBMs).
- Amgen won preferred listing in CVS Health (CVS +1.4%) and an exclusive deal with Harvard Pilgrim Health System. Express Scripts (ESRX +1.2%) covers both PCSK9 inhibitors while UnitedHealth's (UNH +2.5%) Oxford unit is taking a different approach. Plan members will have to try Praluent first. If it fails to do the job after 12 weeks, then they can try Repatha.
- UnitedHealth and its OptumRx PBM are largest unsigned accounts and are, no doubt, getting substantial exposure to the companies' representatives.
Nov. 27, 2015, 4:42 PM
- Sanofi (NYSE:SNY) is up 1% after hours on news it's working with investment bank Lazard to prepare a sale or listing of Merial, its animal health unit, which could value the division up to €12B (about $12.7B), Reuters is reporting.
- On an investor day Nov. 6, new chief Olivier Brandicourt discussed cost cuts and acquisitions, but hinted at strategic options for unloading Merial and its European generics business due to limited synergies.
- Lazard has a close relationship with Sanofi via the drugmaker's chairman, Serge Weinberg. Sanofi may favor an IPO for the unit to avoid antitrust challenges in selling to a rival, sources told Reuters.
- Merial has about 6,500 employees and expects to exceed €2.4B in sales this year.
- The generics business is worth up to €3B, but any divestment faces a longer path with heavy legal disentanglement ahead, and wouldn't start until the second half of next year.
Nov. 24, 2015, 7:38 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announce the completed enrollment of ~18,000 patients in their global Phase 3 study, ODYSSEY OUTCOMES, evaluating the potential cardiovascular (CV) benefits of cholesterol fighter Praluent (alirocumab) after an acute coronary syndrome (ACS). The trial is designed to determine if the addition of Praluent to intensive statin therapy reduces major adverse cardiac events in patients who have had an ACS (e.g., heart attack or unstable angina). The primary endpoint is time to first occurrence of coronary heart disease death, acute myocardial infarction (heart attack), hospitalization for unstable angina or fatal or non-fatal ischemic stroke. The study should be completed in 2017.
- The global ODYSSEY program includes 16 Phase 3 trials conducted across more than 2,000 medical centers around the world. More than 25,000 patients will be evaluated.
Nov. 23, 2015, 9:18 AM
- Round one in the Repatha (evolocumab) versus Praluent (alirocumab) competition goes to Amgen (NASDAQ:AMGN). After evaluating both PCSK9 inhibitors, Pharmacy benefit manager CVS Health (NYSE:CVS) exclusively adds Amgen's Repatha to its commercial formularies, effectively shutting out Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent.
- No word yet on the decisions from other PBMs.
Nov. 20, 2015, 5:08 AM
- In a bid to increase the number of leads for new medicines, pharmaceutical companies are experimenting with novel ways to share early-stage research.
- AstraZeneca (NYSE:AZN) and Sanofi (NYSE:SNY) have just agreed to share 210,000 of their proprietary chemical compounds from their respective libraries in a new twist to boost open innovation.
- No money will change hands and both companies will be free to use the compounds without restrictions.
Nov. 18, 2015, 1:14 PM
- Britain's National Institute for Health and Care Excellence (NICE), which advises the National Health Service (NHS) on costs, procedures and technologies with the aim of better managing the cost/benefit of services, issues draft guidance not recommending Amgen's (AMGN +0.7%) Repatha (evolocumab) for the treatment of high cholesterol and mixed dyslipidemia.
- The committee determined that Repatha was effective in lowering LDL cholesterol ("bad" cholesterol) in patients with primary hypercholesterolemia, but cited the lack of evidence that it reduces the risk of cardiovascular disease-related events such as heart attacks, strokes and angina, which claim 150K English lives each year. It also doubted the reliability of the company's cost-effectiveness data, citing the use of the Framingham risk equations, which overestimate CVD risk in the UK population, and an unrealistically high factor to adjust the CVD risk in people with heterozygous-familial hypercholesterolemia.
- "The Committee concluded that the degree of uncertainty in the cost-effectiveness evidence was too high for it to be able to make well-founded recommendations about evolocumab." The public has until December 8 to comment on the draft guidance, which will be reviewed and discussed at the next NICE meeting on January 13.
- Sharpen that pencil, Amgen.
- Related tickers: (SNY +1.6%)(REGN +1.7%)
Nov. 16, 2015, 1:18 PM
- Based on feedback from the FDA at an End-of-Phase 2 meeting, Protalix BioTherapeutics (PLX +3.8%) intends to proceed with two Phase 3 trials assessing lead product candidate PRX-102 for the treatment of Fabry disease, an inherited disorder characterized by the buildup of a type of fat in the body's cells.
- One trial will be a randomized, multicenter, placebo-controlled study assessing the 1 mg/kg dose of PRX-102 in treatment-naive Fabry patients. The company believes that a small sample size will be sufficient to achieve statistical significance with a study duration of only six months. The primary endpoint will be the effect on gastrointestinal symptoms.
- The other trial will be a head-to-head superiority study comparing PRX-102 to Sanofi's (SNY -0.3%) Fabrazyme (agalsidase beta). The primary endpoint will be an improvement in eGFR (estimated Glomerular Filtration Rate), a measure of kidney function/damage.
- The company believes that no additional non-clinical studies are required to support a Biologics License Application (BLA). More details on the design of the trials will be provided after the study protocols have been approved.
- Both trials should commence in early 2016.
- PRX-102 is chemically modified version of a recombinant therapeutic enzyme called alpha-Galactosidase-A protein.
Nov. 12, 2015, 11:59 AM
- A study by not-for-profit ethics and governance watchdog Bioethics International (BI) of all clinical trials submitted to the FDA for drugs approved in 2012 showed a wide range of disclosure of results with almost all falling far short of full transparency. The lack of sharing of all trial data has been one contributor to the erosion of public trust in drug companies. According to BI President Jennifer Miller, Ph.D., only 12% of Americans believe that pharmaceutical firms are honest and ethical.
- Companies were ranked by both legal requirements to disclose data per the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA) and the ethical standard that all human-based research should be publicly available in order to contribute to generalized knowledge.
- The cross-sectional analysis of the 2012 data showed that 39 new medicines and 48 new drug entities were cleared by the FDA, 15 by 10 large firms. Researchers identified 318 relevant clinical studies (out of a total of 342) involving 99,599 participants. A median of 57% of the trials were registered, 20% reported results in clinicaltrials.gov, 56% were published and 65% were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 study.
- Gilead Sciences (GILD -1.1%) didn't fare too well, providing only 21% of the data on its HIV combo med Stribild. Sanofi (SNY -3%) was also cited for its lack of reported data on MS drug Aubagio. Firms scoring well included GlaxoSmithKline (GSK -1.2%), Johnson & Johnson (JNJ -0.9%) and Pfizer (PFE -0.4%). All disclosed 100% of their trial data for at least one drug.
- BI is in the process of expanding its rankings to include other years.
- On a positive note, the major players have indicated a keen interest in doing a better job sharing trial data, motivated, no doubt, by the work of interested observers such as BI.
- ETFs: BIB, BIS GRX, IRY, IXJ, BME
Nov. 11, 2015, 1:00 PM
- Alnylam Pharmaceuticals (ALNY +1.1%) and development partner The Medicines Company (MDCO -0.8%) announce positive results from their ongoing Phase 1 clinical trial evaluating ALN-PCSsc for the potential treatment of high cholesterol. The data were presented at the American Heart Association Scientific Sessions in Orlando, FL.
- As previously reported, subcutaneous administration of ALN-PCSsc reduced LDL-C (bad cholesterol) up to 83% (average maximum: 59 - 69%). New data showed the effects were highly durable and could support a twice/year dosing regimen, significantly longer than Amgen's (AMGN +0.6%) Repatha (evolocumab), dosed every two weeks or once/month, and Sanofi (SNY +0.3%)/Regeneron's (REGN +1%) Praluent (alirocumab), dosed every two weeks.
- Specifically, the maximum PCSK9 knockdown was 89% (average 80.3 - 84.3%) and the maximum LDL-C reduction was up to 78% (average 54.3 - 64.3%) after a single injection of ALN-PCSsc. At day 180, LDL-C reduction was as high as 53% (average 47%) in the 300 mg cohort. No clinically significant drug-related adverse events were seen.
- In the multiple dose cohorts (n=45), the maximum PCSK9 knockdown and LDL-C reduction were 94% (av. 86.9 - 90.1%) and 83% (av. 59.0 - 69.8%), respectively. At day 208, the LDL-C reduction was as high as 60% (av. 44.4%). In clinical trials, the mean LDL-C reductions observed for Repatha and Praluent were 64% (week 12) and 58% (week 24), respectively.
- Both Repatha and Praluent bind to PCSK9 in the blood. ALN-PCSsc turns off PCSK9 synthesis in the liver.
- The Medicines Company plans to initiate a Phase 2 study by year end with a Phase 3 trial to follow in 2017.
- The companies will host a conference call this afternoon at 4:30 pm ET to discuss the data.
Nov. 11, 2015, 11:02 AM
- Struggling MannKind (MNKD -16.3%) is down again today on increased volume as investors throw in the towel over the continued slow ramp of Afrezza (insulin human) Inhalation Powder. Product shipments to exclusive licensee Sanofi (SNY N/A) were only $4.1M in Q3. Shares have lost half their value in the past two weeks. Earlier, Sanofi reported Afrezza sales of €2M in Q3.
- During the earnings call, management fielded questions about a possible exit by Sanofi, a real possibility at this point. If it happens, the company has the consolation that will not have to pay back the loans from Sanofi for 10 years. Management also stated that its current resources will be sufficient to fund operations into 2017.
Nov. 11, 2015, 7:52 AM
- A post-hoc analysis of six Phase 3 clinical trials showed that 74% of patients receiving Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) (75 mg) were able to reach their pre-specified LDL cholesterol (LDL-C) targets within eight weeks of adding the drug to their standard-of-care treatment, including statins. In the 26% of patients whose Praluent dose was increased to 150 mg, most (61%) were able to achieve their LDL-C target, with an average additional reduction in LDL-C of 14%. The data were presented at the American Heart Association Scientific Sessions in Orlando, FL.
- The results are based on a pooled post-hoc analysis of 1,291 patients with high cardiovascular (CV) risk or an inherited form of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).
- The incidence of adverse events was comparable for the two doses in the placebo-controlled studies (66%) and in the ezetimibe (Merck's Zetia)-controlled studies (55% vs. 56%).
- In a separate pooled post-hoc analysis of 3,499 patients, subjects with diabetes (n=1,051) who initially received Praluent (75 mg or 150 mg every two weeks) experienced mean percent reductions in LDL-C of 44% and 58%, respectively, compared to placebo at week 24 (p<0.0001).
- A third post-hoc analysis of 4,974 patients did not find an increased risk of diabetes-related adverse events among those who did not have diabetes when they entered the trials, regardless of whether they were receiving Praluent or were in a control group. There was no evidence that Praluent affected the incidence of new-onset diabetes or pre-diabetes.
- Praluent, a PCSK9 inhibitor, was cleared by the FDA in July 2015.
Nov. 9, 2015, 6:32 PM
- A lawsuit seeking at least $236M is charging Sanofi (SNY -2.5%) with delaying development on Lemtrada, its multiple sclerosis drug, in order to avoid $708M it would owe to rights holders tied to its deal to purchase Genzyme.
- Development of Lemtrada was in process at Genzyme when Sanofi purchased the company, and the deal included tradable certificates worth money if Lemtrada was approved by March 31, 2014.
- American Stock Transfer & Trust Co., a trustee for those rights holders, says Sanofi intentionally took a "slow path" to approval despite promising "diligent efforts" to meet the goals.
- The trustee also charges that after November 2014 approval, Sanofi underfunded marketing for the drug and actively promoted another, meaning that sales benchmarks were missed.
Nov. 9, 2015, 12:40 PM
- Sanofi (SNY -2.9%) and development partner Regeneron Pharmaceuticals (REGN -0.1%) announce results from a pivotal Phase 3 clinical trial, SARIL-RA-TARGET, evaluating their investigational human antibody sarilumab in patients with rheumatoid arthritis (RA). The study met both co-primary efficacy endpoints as well as secondary objectives.
- SARIL-RA-TARGET enrolled 546 RA patients who responded inadequately or were intolerant of TNF-alpha inhibitors. Subjects were randomized to one of three treatment groups self-administered every other week: sarilumab 200 mg, sarilumab 150 mg or placebo.
- The two co-primary endpoints were the reduction in signs and symptoms of RA at Week 24 and the improvement in physical function at week 12, both versus placebo. The proportion of patients achieving ACR20 (20% improvement in symptoms) was 61% for the 200 mg arm, 56% in the 150 mg arm and 34% for placebo (p<0.0001). The change in physical function at week 12 versus baseline was statistically superior to placebo for both the 200 mg arm (p=0.0004) and the 150 mg arm (p=0.0007).
- Secondary endpoints achieved included the proportion of patients achieving ACR50 (200 mg: 41%, 150 mg 37%, placebo: 18%; p<0.0001) and the proportion achieving ACR70 (200 mg: 16%; p=0.0056; 150 mg: 20%; p=0.0002; placebo: 7%).
- Treatment-emergent adverse events were 65% in the 200 mg group, 66% in the 150 mg group and 50% for placebo. Serious adverse events were higher for placebo than the 200 mg group (5% vs. 3%) and comparable to the 150 mg group (3%). The most frequent adverse event was infection (200 mg: 30%, 150 mg: 22%, placebo: 27%).
- Sarilumab is a human mAb that is an IL-6 inhibitor. By blocking the binding of IL-6 to its receptor, it interrupts the resultant cytokine-mediated inflammatory signalling.
- The Biologics License Application (BLA) was recently submitted to the FDA.
- Previously: Regeneron/Sanofi IL-6 monoclonal antibody successful in Phase 3 arthritis study (May 21)
Nov. 6, 2015, 8:33 AM
- At its Investor Relations event today, Sanofi (NYSE:SNY) presented its strategic roadmap for the period 2015 - 2020. Highlights included:
- Compounded annual sales growth expected to be 3 - 4% over the period; mid-single-digit growth over the second half of the period. Six major product launches (Toujeo, Praluent, Dengvaxia, sarilumab, LixiLan, dupilumab) are expected to generate aggregate peak sales of €12B - 14B. Up to 18 new products are on track for market release by 2020.
- Targeted cost savings of €1.5B will be largely reinvested to drive growth. R&D investments will be increased up to €6B by 2020.
- Strategic options will be explored for Merial animal health, which is profitable but lacks synergy with the company's other units, and the European generics business, where geographic synergies are limited and market complexity is increasing.
- The company intends to build competitive positions in multiple sclerosis, oncology, immunology and consumer healthcare. It will maintain its leadership in diabetes and cardiovascular, vaccines, rare diseases and emerging markets.
- Previously: Sanofi reorganizes into five business units to drive growth (July 15)
Nov. 6, 2015, 7:13 AM
- Sanofi (NYSE:SNY) and Lexicon Pharmaceuticals (NASDAQ:LXRX) ink a collaboration and license deal to develop and commercialize sotagliflozin (LX4211), an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2) for the treatment of diabetes.
- Under the terms of the agreement, Lexicon will receive an upfront payment of $300M, milestones up to $1.4B and double-digit royalties on net sales. Lexicon will be responsible for all clinical development related to type 1 diabetes and will retain an exclusive option to co-promote and have a significant role in the commercialization of sotagliflozin, in collaboration with Sanofi, in the U.S. Sanofi will be responsible for all clinical development and commercialization activities of sotagliflozin for type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for type 1 diabetes ex-U.S. Lexicon will share in the funding of some of the type 2 development costs over the next three years, up to an aggregate of $100M.
- Sotagliflozin is currently being evaluated in two Phase 3 studies in type 1 diabetes, with top-line results expected in H2 2016. Phase 3 trials in type 2 diabetes should start in 2016. Results from mid-stage trials were encouraging. Patients receiving sotagliflozin showed reduction of blood sugar (HbA1c), improvement in glycemic variability and reduced meal-time (prandial) insulin dose compared to placebo in type 1 diabetics. Mid-stage studies in type 2 diabetics, including those with renal impairment, showed lowering of HbA1c, weight loss and improvements in blood pressure. No increase in hypoglycemic events were observed compared to background therapy. Adverse events were similar to other products in this class and were reflective of the urinary excretion associated with sotagliflozin's inhibition of SGLT-2, a transporter responsible for most of the glucose reabsorption by the kidney.
- LXRX is up 23% premarket on light volume. SNY is down 6% also on light volume.
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
Industry: Drug Manufacturers - Major
Other News & PR