Thu, Apr. 16, 4:41 PM
- In a regulatory filing, Ascendis Pharma (NASDAQ:ASND) discloses that collaboration partner Sanofi (NYSE:SNY) has decided to cease development of TransCon Insulin, but will continue its work with TransCon peptide and evaluation of additional applications of the TransCon Technology.
- The aim of TransCon is to extend the duration of a drug's action in the body. It combines the benefits of prodrug and sustained release technologies. The inactive prodrug releases the unmodified active parent drug at a predictable rate governed by pH and temperature conditions.
- Shares are off 3% after hours but the turnover is only 200.
Mon, Apr. 6, 5:30 PM
- VBI Vaccines (NASDAQ:VBIV) and Sanofi Pasteur (NYSE:SNY) enter into a research collaboration to apply VBI's LPV (Lipid Particle Vaccine) formulation technology to a Sanofi vaccine candidate with the aim of improving its stability. The collaboration provides Sanofi with the option to acquire certain worldwide rights to use LPV in its vaccines. Financial terms are not disclosed.
Mon, Mar. 30, 11:49 AM
- The Japanese Ministry of Health, Labour and Welfare approves Genzyme's (SNY +0.4%) Cerdelga (eliglustat) for the oral treatment of patients with Gaucher disease type 1.
- Gaucher disease affects fewer than 10,000 people worldwide. It is characterized by an insufficient amount of an enzyme, glucocerebrosidase, that breaks down a certain type of fat molecule. As a results, lipid engorged cells (Gaucher cells) build up in different parts of the body, principally the spleen, liver and bone marrow. The accumulation causes spleen and liver enlargement, anemia, excessive bleeding and bruising and bone disease. Cerdelga inhibits the enzyme glucosylceramide synthase, which reduces the production of the offending fat molecule glucosylceramide.
- Cerdelga was approved by the FDA in August 2014, the European Commission in January 2015 and the Australian Therapeutic Goods Administration in February 2015.
Fri, Mar. 27, 11:48 AM
- According to a source close to the matter, Sanofi (SNY +2.2%) intends to launch its long-acting insulin, Toujeo (insulin glargine 300 IU/mL), in the U.S. on Monday, which is consistent with its earlier statement that it planned to launch at the beginning of Q2.
- Toujeo, approved by the FDA on February 25, is a once-daily injection of basal insulin that has three times more insulin per mL than its top-selling Lantus (insulin glargine [rDNA origin] 100 IU/mL).
- Sanofi will have the long-acting insulin market to itself for a while. Novo Nordisk (NVO +0.9%) plans to resubmit its NDA for its offering, Tresiba (insulin degludec), shortly, but approval won't happen until next year at the earliest. Eli Lilly (LLY +0.2%) postponed its NDA for basal insulin peglispro until "after 2016" so it can assess its effects on the liver.
- Previously: Novo Nordisk trys again with Tresiba and Ryzodeg NDA resubmission to FDA (March 26)
- Previously: Side effect of Lilly basal insulin potentially delays regulatory filings past 2016 (Feb. 23)
Thu, Mar. 26, 1:38 PM
- Novo Nordisk (NVO +7.4%) says it will submit the prespecified interim analysis of the DEVOTE cardiovascular (CV) outcomes trial, a randomized, double-blind global study comparing long-acting Tresiba (insulin degludec) to Sanofi's (SNY -2.3%) Lantus (insulin glargine), to the FDA as part of the resubmission of its New Drug Application (NDA) that the FDA rejected in February 2013.
- At that time, the agency sent the company a Compete Response Letter (CRL) to its NDA filed in September 2011 requesting additional CV data from a dedicated CV outcomes trial. The letter also stated that neither Tresiba nor Ryzodeg could be approved until certain violations cited in a December 12, 2012 Warning Letter were resolved.
- Ryzodeg combines Tresiba with fast-acting insulin aspart. The European Commission approved both Tresiba and Ryzodeg in January 2013.
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Fri, Mar. 20, 7:32 AM
- Sanofi (NYSE:SNY) enters into a five-year drug discovery collaboration with Hamburg, Germany-based Evotec AG focused on latter's small molecule discovery platforms. Both firms will combine their libraries of approximately 1.7M compounds and offer them for screening to Evotec's business partners. The agreement also defines the conditions under which the partners intend to jointly advance a portfolio of (primarily) oncology-related projects, including five in the preclinical stage. In a joint effort, Evotec will search and incubate projects generated at its Toulouse, France facility into its pipeline.
- Under the terms of the contract, Evotec will receive a €40M upfront cash payment as part of a minimum €250M five-year financial commitment.
Thu, Mar. 19, 7:41 AM
- Amicus Therapeutics (NASDAQ:FOLD) jumps 20% premarket on higher-than-normal volume in response to its announcement of accelerated schedules for its migalastat regulatory applications for the treatment of Fabry disease in the U.S. and Europe.
- Based on a Type C (late development stage) meeting with the FDA, the company intends to submit its New Drug Application (NDA) in H2. The agency agreed to review the application under its Accelerated Approval pathway. A Phase 4 (post-approval study) will be required so several protocol designs were discussed.
- Based on a meeting with the European Commission (EC), Amicus intends to submit its Marketing Authorization Application (MAA) in Q2 instead of mid-year. The company will request Accelerated Assessment of the MAA, which Rapporteurs (EC representatives assigned to provide guidance to application sponsors) indicated support for.
- Amicus will host a conference call this morning at 8:00 am ET to discuss its global regulatory strategy for migalastat monotherapy for Fabry disease.
- Related tickers: (NYSE:SNY) (NASDAQ:SHPG) (NYSEMKT:PLX)
Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Mon, Mar. 16, 8:26 AM
- A Phase 3 study evaluating Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) in patients with hypercholesterolemia showed that patients receiving Praluent 150 mg every two weeks lowered their low-density lipoprotein cholesterol (LDL-C) by an additional 62% (p<0.0001) at Week 24 compared to placebo, with consistent LDL-C lowering maintained over 78 weeks (56% reduction, p<0.0001).
- The trial, call ODYSSEY LONG TERM, assessed Praluent 150 mg (n=1,553) compared to placebo (n=788) in patients judged at high cardiovascular (CV) risk and who were receiving the maximum tolerated dose of statin therapy with or without other lipid-lowering treatment. Patients self-administered a subcutaneous injection of Praluent every two weeks via a pre-filled syringe.
- At Week 24, 81% of patients in the Praluent cohort achieved their pre-specified LDL-C goal compared to 8.5% for placebo (p<0.0001).
- Praluent is an investigational human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Inhibiting PCSK9 frees up more LDL receptors on the surface of liver cells which enables the more LDL-C to be removed from the blood.
- Alirocumab and Amgen's (NASDAQ:AMGN) evolocumab are the front-runners to dominate the post-statin cholesterol-lowering market. They will be competing right out the blocks in the U.S. The FDA's PDUFA dates are July 24 alirocumab and August 27 for evolocumab. Praluent is being co-developed by Sanofi (NYSE:SNY).
Tue, Mar. 10, 3:55 AM
- Prescription drug spending rose by a record 13% in the U.S. last year, the biggest annual increase in over a decade.
- "For the past several years, annual drug spending increases have been below the annual rate of overall health-care inflation in the U.S.," said Glen Stettin, senior vice president at Express Scripts. "But that paradigm is shifting dramatically as prices for medications increase at an unsustainable rate."
- Spending on specialty medicines, such as those for inflammatory diseases, multiple sclerosis, cancer and hepatitis C rose an unprecedented 31%.
Thu, Mar. 5, 8:52 AMAbbVie's high-priced takeout of Pharmacyclics bodes well for other biotechs with high potential drugs
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
Tue, Mar. 3, 11:46 AMPotential Afrezza discounts and challenging competitive landscape behind Goldman downgrade of MannKind
- As Ben Levisohn reports, Goldman Sachs analyst Jay Olson downgraded MannKind (MNKD -9.6%) after he revised his valuation model to include net discounts to Afrezza of 40% instead of 20% in light of the downward price pressure from payers to other diabetes product makers.
- He cites the recent launches of Boehringer Ingelheim's Jardiance (empagliflozin) tablets and Eli Lilly's (LLY -1%) Trulicity (dulaglutide injection) that came in 75% below his Q4 estimates. Afrezza's launch trajectory based on script data, albeit early stage, is also falling short of expectations.
- Mr. Olson has lowered his 2025 sales projection 50% for Afrezza to $1B from $2B and reduced EPS estimates from 2017 onward. He believes that MannKind will achieve the sales targets required to capture $925M in milestones from commercial partner Sanofi (SNY -0.1%), however.
- His $3 price target leaves a 50% downside from the current price.
- Previously: MannKind off 10% premarket on Goldman downgrade (March 3)
Fri, Feb. 27, 9:01 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) amend their long -standing collaboration agreement to transition the sole responsibility for the development and commercialization of Zaltrap (ziv-aflibercept) Injection for Intravenous Infusion for cancer indications worldwide to Sanofi.
- Sanofi will now bear all development and commercialization costs and will reimburse Regeneron for its costs related to such activities. It will also pay Regeneron 15 - 30% of aggregate net sales of Zaltrap each year. Regeneron will no longer be required to reimburse Sanofi for 50% of the development expenses pertaining to Zaltrap per the original agreement.
- Zaltrap generated €69M in sales for Sanofi last year. Regeneron booked a total of $541.3M in 2014 from its overall collaboration with Sanofi.
Thu, Feb. 26, 10:23 AM
- The European Commission approves Xadago (safinamide) for the treatment of idiopathic Parkinson's disease (PD). The drug was developed by Newron Pharmaceuticals S.p.A. and will be commercialized by privately-held Zambon S.p.A., both based in Italy.
- Xadago's specific indication is for the treatment of mid-to-late stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicines.
- Safinamide is a new chemical entity, the first approved in Europe in 10 years for PD, with a unique mode of action including selective and reversible MAO-B (monoamine oxidase) inhibition, use-dependent Na (sodium) channels blockade and Ca (calcium) channels modulation which enables it to modulate abnormal glutamate release. Glutamate is an important neurotransmitter that plays a key role in neural activation.
- PD-related tickers: (SNY -2.9%)(ABBV -0.2%)(IPXL -0.5%)(NDRM +1.2%)(XNPT)(OTCPK:BIOZF)(ACOR -1.6%)(OTCQX:RHHBY -0.4%)(PRTA -3.4%)(ADMS -2.5%)(TEVA)(OTCQX:CYNAF -0.9%)(OTCQB:TTNP +2.9%)
Thu, Feb. 26, 7:30 AM
- The FDA approves Sanofi's (NYSE:SNY) Toujeo (insulin glargine [rDNA origin] injection, 300 U/ml), a once-daily long-acting basal insulin, to improve glycemic control in adults with type 1 and type 2 diabetes. The company expects Toujeo to be available in the U.S. at the beginning of Q2.
- Sanofi's intent is to transition patients from its current once-daily basal insulin, Lantus (insulin glargine [rDNA origin] injection, 100 U/ml), which faces competition from generics, to the premium-priced Toujeo, although the company has yet to disclose the specific price.
- Toujeo will be available in a disposable prefilled pen that contains 450 units of insulin and requires only one third of the injection volume to deliver the same number of insulin units as Lantus. The maximum single injection of 80 IU meets the needs to the vast majority of diabetics on basal insulin.
- Lantus is the top-selling insulin in the world, pulling in $7.2B for Sanofi last year. Analysts say the conversion to Toujeo is far from certain, however. Payers may lack enthusiasm for paying more for the new product which is not that differentiated from the old.
- Toujeo's approval in Europe is pending.
- Related tickers: (NYSE:LLY) (NYSE:MRK)
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