Wed, Nov. 11, 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.
Mon, Nov. 9, 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.
Fri, Nov. 6, 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.
Thu, Oct. 29, 9:13 AM| Thu, Oct. 29, 9:13 AM | Comment!
Thu, Oct. 29, 8:06 AM
- Gene editing firm Cellectis (NASDAQ:CLLS) announces that it has completed three production runs under GMP (Good Manufacturing Practice) conditions of its lead product candidate UCART19. The manufacturing process for Universal CARTs (UCARTs) yields frozen, off-the-shelf, allogeneic, engineered CAR T cells that can be used for a large patient population.
- TALEN-based gene editing is designed to suppress T cell alloreactivity and confer resistance to alemtuzumab [Sanofi's (NYSE:SNY) Lemtrada] to the T cells.
- EVP, Corporate Development David Sourdive says, "It is very exciting to lead a novel allogeneic gene therapy platform at the the critical time with an R&D concept is translated into a GMP clinical grade industrial product to be investigated in clinical studies."
- UCART19 is an allogeneic engineered T cell product in development for the treatment of CD19-expressing hematologic malignancies, including chronic lymphocytic leukemia and acute lymphoblastic leukemia.
- Shares are up 12% premarket on light volume.
Wed, Oct. 28, 5:39 PM
- Sanofi (SNY +1.9%) is recalling all of its U.S. market epinephrine pen injectors, used to treat severe allergic reactions, because the devices may be delivering incorrect amounts of the drug.
- All Auvi-Q injectors on the U.S. market -- about 490,000 packs, most of which contain two injectors -- are subject to the recall. The company estimates about 200,000 people in the U.S. have its injector.
- Mylan (MYL +1.8%), maker of the competing EpiPen, is up another 1.8% after hours. Sanofi shares were up 0.4% in late trading.
Mon, Oct. 12, 8:38 AM
- Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
- The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
- SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
- Related tickers and status premarket: (NASDAQ:REGN) +4%; (NASDAQ:AMGN) +3%; (NASDAQ:ESPR) +14%; (NYSE:SNY) +1%.
Tue, Oct. 6, 6:44 PM
- Leading pharmacy benefits manager Express Scripts (ESRX -1%) has settled an investor debate about which pricey cholesterol drug it will cover -- by saying it will cover both of them.
- Praluent, from Regeneron (REGN -2.9%) and Sanofi (SNY -0.7%), and Repatha, from Amgen (AMGN -1.8%), will both be included on Express Scripts' formulary. Each of the PCSK9 inhibitors is at least $14,000/year, significantly higher than the cost of now-generic statins, though more effective.
- The drugs are injectables that dramatically lower LDL (the "bad cholesterol").
- Express Scripts has said that the drugs won't be "budget busters," and that most prescriptions are getting rejected because patients don't meet medical criteria.
- In after-hours action: ESRX flat; REGN +0.1%; SNY +0.8%; AMGN flat.
Fri, Sep. 18, 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.
Thu, Sep. 17, 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%)
Mon, Aug. 31, 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.
Fri, Jul. 24, 3:48 PM| Fri, Jul. 24, 3:48 PM | 8 Comments
Fri, Jul. 24, 2:31 PM
- Esperion Therapeutics (NASDAQ:ESPR) has taken a dive, -20.4%, as the FDA approves Praluent (alirocumab), the competing cholesterol-lowering drug developed by Regeneron (NASDAQ:REGN) and Sanofi (SNY +0.2%).
- Praluent is the first cholesterol-lowering treatment in the PCSK9 inhibitor class.
- Esperion fell sharply in June in response to a positive FDA AdComm vote for Praluent, which stands to compete against Esperion's ETC-1002 cholesterol drug candidate (provided it's approved).
- Regeneron shares remain halted.
Fri, Jul. 10, 9:12 AM
Wed, Jun. 10, 10:25 AM
- Esperion Therapeutics (ESPR -24%) drops on a 3x surge in volume as investors apparently perceive more modest prospects for the company's cholesterol-lowering drug candidate, ETC-1002, after yesterday's positive Ad Comm vote for Regeneron (REGN -4.9%) and Sanofi's (SNY +0.7%) Praluent (alirocumab), which is now poised for approval sometime this summer.
- UBS analyst Andrew Peters remains undeterred. He maintains his Buy rating and $140 price target.
- Previously: Esperion cholesterol-lowering drug candidate successful in Phase 2 study (March 17)
Wed, Jun. 10, 8:41 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) slumps 4% premarket on light volume in response to yesterday's Ad Comm vote on its cholesterol-lowering med Praluent (alirocumab), co-developed with Sanofi (NYSE:SNY).
- The committee voted 13-3 in favor of approval, but only in combination with a statin or as monotherapy in patients who cannot tolerate statins. Ideally, the vote would have supported the use of alirocumab as unconditional monotherapy.
- SNY is up a fraction premarket on modest volume.
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