Sanofi's Trying To Go On Offense While Playing Defense
Stephen Simpson, CFA
Stephen Simpson, CFA
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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
Tue, Feb. 9, 6:08 AM
- Sanofi (NYSE:SNY): Q4 EPS of €1.31
- Revenue of €9.28B (+2.3% Y/Y).
- The board propose dividend of €2.93 in FY15.
- 2016 Guidance: Sanofi expects 2016 Business EPS to be broadly stable at CER, barring unforeseen major adverse events.
Wed, Feb. 3, 2:24 AM
- The first known case of Zika virus transmission in the U.S. has been reported by the Centers for Disease Control and Prevention, which confirmed it was contracted through sex and not a mosquito bite.
- Zika had been thought to be spread only by mosquitoes of the Aedes genus, so sexual contact as a mode of transmission would be a potentially alarming development.
- Sanofi (NYSE:SNY) and NewLink Genetics (NASDAQ:NLNK) have both recently announced project launches to develop a vaccine against the disease.
- Previously: WHO declares Zika virus a public health emergency (Feb. 02 2016)
- Update: The New York Times reports that there have been only three reports related to possible sexual transmission: one in 2008, one in 2013 and one recently. The first two cases were men who had genital pain and blood in their semen, pointing to possible infection in the testes or prostate. Details about the third case were not available. The CDC has issued tentative guidelines suggesting pregnant women avoid contact with semen from men who have been in Zika-associated areas and men to wear condoms. Very little is known about this potential route of Zika transmission. Also, the cases of microcephaly in babies born to Zika-infected mothers may be due to other factors. The evidence at present is circumstantial.
Fri, Jan. 29, 4:50 AM
- The World Health Organization is ringing a global alarm over the Zika virus, saying that the disease is "spreading explosively" in the Americas, and will convene a special meeting on Monday about whether to declare a public health emergency.
- While there is no approved vaccine, U.S. health officials and drugmakers could start working on an experimental one soon.
- Both GlaxoSmithKline (NYSE:GSK) and Sanofi (NYSE:SNY) are considering developing a treatment.
- Previously: Obama calls for rapid Zika research (Jan. 27 2016)
Fri, Jan. 22, 7:22 AM
- The Japanese Ministry of Health, Labour and Welfare approves Amgen's (NASDAQ:AMGN) Repatha (evolocumab) for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have a high risk of cardiovascular events and do not adequately respond to statins.
- Repatha was developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY). The marketing application was filed in March 2015. It is the first PCSK9 inhibitor approved there.
- Regeneron (NASDAQ:REGN) and Sanofi (NYSE:SNY) are playing catch up with Praluent (alirocumab). They reported successful Phase 3 data in July.
Tue, Jan. 19, 9:17 AM
Mon, Jan. 11, 11:45 AM
- Sanofi (SNY -0.6%) and privately held Warp Drive Bio expand and revise their long-term collaboration that began in 2012 to leverage Warp Drive's proprietary SMART (Small Molecule Assisted Receptor Targeting) and Genome Mining platforms to discover novel oncology drugs and antibiotics, specifically therapeutics targeting key human oncogenes like RAS, which has one of the highest mutation rates in cancer, and new antibiotics targeting Gram-negative bacteria.
- The initial focus will be on three defined oncology programs targeting different mutants and states of RAS and one antibiotic program.
- Under the terms of the agreement, Warp Drive will lead the research effort for five years while Sanofi will receive exclusive global licenses to develop and commercialize the candidates discovered during the research term. Warp Drive is eligible to receive over $750M across the four programs, including an equity investment by Sanofi, various milestones and R&D services.
Fri, Jan. 8, 7:53 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and development partner Sanofi (NYSE:SNY) announce that the FDA has accepted for review the Biologics License Application (BLA) for sarilumab for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA). The agency's action date (PDUFA) is October 30.
- Sarilumab is a human monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin 6 (IL-6). By blocking the binding of IL-6 to its receptor, it interrupts the resultant cytokine-mediated inflammatory signalling.
- Previously: Sanofi and Regeneron's sarilumab successful in late-stage arthritis study (Nov. 9, 2015)
Tue, Jan. 5, 9:54 AM
- Struggling MannKind (MNKD -26.2%) is down on average volume in response to its announcement that Sanofi (SNY +0.1%) has terminated its license and collaboration agreement for the development and commercialization of Afrezza (insulin human) Inhalation Powder. The transition back to MannKind will proceed promptly and should be completed in no more than 180 days.
- Sanofi's exit was widely expected since its February launch of Afrezza in the U.S. never gained traction. It reported only €2M in Afrezza sales in Q3.
- The company will host a conference call today at 4:30 pm ET to discuss the matter.
- Previously: Uptake of MannKind's Afrezza remains tepid; shares down 50% since late October (Nov. 11, 2015)
- Previously: MannKind cuts staff again due to slower-than-expected revenues (Oct. 1, 2015)
- Previously: Market penetration for MannKind's Afrezza progressing in fits and starts (June 3, 2015)
Dec. 24, 2015, 7:13 AM
- The FDA approves Eagle Pharmaceuticals' (NASDAQ:EGRX) non-alcohol formulation of the taxane chemo drug docetaxel for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, adenocarcinoma and head and neck cancer.
- The need for a version with no alcohol arose in June 2014 when the FDA issued a Drug Safety Communication warning that patients receiving docetaxel may exhibit symptoms of alcohol intoxication after treatment. Manufacturers of the product for sale in the U.S. were required to revise their labeling to specify the alcohol content and include a drug safety warning.
- Docetaxel was originally developed by Sanofi (NYSE:SNY) which promoted it under the brand name Taxotere. Generic versions have been available since 2011. The alcohol content of currently marketed formulations ranges from 2.0 to 6.4 grams per 200 mg dose.
- Eagle has an exclusive licensing agreement with Teikoku Pharma USA to commercialize the product in the U.S. According the Eagle, annual U.S. sales of generic docetaxel are ~$75M. Shipments should commence in January.
Dec. 23, 2015, 8:02 AM
- Zealand Pharma A/S (OTCPK:ZLDPF)(OTCPK:ZLDPY) earns a $20M milestone payment from licensee Sanofi (NYSE:SNY) triggered by the latter's submission of a New Drug Application (NDA) to the FDA seeking clearance of LixiLan, a single injection, fixed-ratio combination of lixisenatide and insulin glargine, for the treatment of type 2 diabetics.
- Lixisenatide, a once-daily prandial GLP-1 receptor agonist invented by Zealand, is marketed ex-U.S. by Sanofi as Lyxumia for type 2 diabetes (Sanofi's NDA is currently under review by the FDA). Sanofi markets insulin glargine globally as Lantus.
- Sanofi's LixiLan submission included a Priority Review Voucher that will shorten the review clock to six months, if accepted. The company intends to submit its Marketing Authorization Application (MAA) for LixiLan in Europe in Q1.
- Zealand's total 2015 milestone revenue is now DKK159M (21M euros), in line with previously announced revenue guidance. It has also earned Lyxumia-based royalties of DKK20.6M (2.7M euros) through Q3.
- Remaining milestones from the Sanofi license agreement could reach $140M, plus tiered low-double-digit royalties from lixisenatide sales and fixed low-double-digit royalties from LixiLan sales.
Dec. 22, 2015, 5:05 PM
- Merrimack Pharmaceuticals (NASDAQ:MACK) submits an amendment to its ongoing Phase 2 clinical trial assessing MM-121 in patients with heregulin-positive non-small cell lung cancer (NSCLC) to the FDA requesting a change in the primary endpoint to overall survival (OS). If approved, it will accelerate the development process by providing the data to support a New Drug Application (NDA).
- Under the amendment, the company expects to enroll ~280 heregulin-positive NSCLC patients who will be randomized to receive MM-121 plus the investigator's choice of docetaxel or pemetrexed or docetaxel or pemetrexed alone. Eligible patients must have failed no more than three prior lines of therapy for locally advanced or metastatic disease and, where applicable, prior PDL1 therapy.
- MM-121 is a fully human monoclonal antibody that binds to a receptor on tumor cells called ErbB3, which is activated by the growth factor heregulin. ErbB3 signaling is thought to play a key role in tumor growth and resistance to cytotoxic and anti-endocrine therapies. MM-121 blocks ErbB3 signaling which enhances the anti-tumor effect of the combination drug.
- Sanofi (NYSE:SNY) returned the rights to MM-121 to the company in June of last year.
- Separately, Merrimack closed a $175M debt offering via private placement that will fund the further development of MM-121, among other priorities. The senior secured notes bear interest of 11.5% and mature on December 15, 2022.
- Previously: Sanofi pulls the plug on Merrimack mAb for cancer (June 20, 2014)
Dec. 21, 2015, 5:37 PM
Dec. 16, 2015, 5:01 PM
- The FDA grants final approval for Eli Lilly's (NYSE:LLY) long-acting insulin analog Basaglar (insulin glargine injection) to improve glycemic control in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
- The agency issued tentative approval in August 2014 due to a then-pending patent dispute with Sanofi (NYSE:SNY). The disagreement was resolved in September.
- Previously: Lilly and Sanofi settle Basaglar patent fight (Sept. 28)
- Previously: Lilly gets tentative approval for diabetes drug (Aug. 19, 2014)
Dec. 15, 2015, 3:59 AM
- Sanofi (NYSE:SNY) has entered exclusive negotiations with Boehringer Ingelheim on a possible exchange of its animal health business for the German group's consumer health operation.
- Since the Sanofi division is valued at €11.4B and Boehringer's at €6.7B, the latter would pay the French drugmaker €4.7B as part of the deal.
- Boehringer's Chinese consumer healthcare unit would be excluded from the transaction.
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.
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
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