Regeneron Pharmaceuticals, Inc.NASDAQ
Regeneron - A Review: Strong Returns Look Likely For 2016 And Beyond
DoctoRx • 55 Comments
DoctoRx • 55 Comments
Wed, Nov. 23, 2:40 PM
- In a note to investors, Leerink analyst Geoff Porges says the list of deficiencies at Sanofi's (SNY -1.3%) "fill and finish" Le Trait facility cited by FDA inspectors in July is "longer and somewhat more concerning" than anticipated and could risk delaying the market introduction of dupilumab, a systemic therapy for the treatment of atopic dermatitis (AD), being co-developed with Regeneron Pharmaceuticals (REGN).
- Leerink obtained a copy of the Form 483 under a Freedom of Information Act request. The document is used by FDA inspectors to record deficiencies observed during an on-site inspection.
- On the plus side, there were apparently no observations related to product quality.
- If, for some reason, Sanofi is unable to resolve the deficiencies in a timely manner, an alternative fill and finish facility may need to be used.
- Dupilumab, a fully human monoclonal antibody, works by binding to (inhibiting) interleukin-4 (IL-4) and interleukin-13 (IL-13), two cytokines that play key roles in the pathogenesis of AD.
- The FDA's action (PDUFA) date is March 29, 2017.
Thu, Nov. 17, 7:59 AM
- The large-scale Phase 3 study investigating the effect of PCSK9 inhibitor Praluent (alirocumab) on cardiovascular outcomes in at-risk patients will continue as planned based on the recommendation from the independent Data Monitoring Committee after it completed its second pre-specified interim analysis. The study involves more than 18K patients from 57 countries.
- Relevant tickers: (NASDAQ:REGN)(NYSE:SNY)
- Regeneron is down 4% premarket on modest volume. Sanofi is up a fraction.
Wed, Nov. 16, 9:13 AM
- Results from a Phase 3 clinical trial, SARIL-RA-MONARCH, assessing Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) sarilumab compared to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab) in adult patients with rheumatoid arthritis (RA) showed sarilumab to be superior in improving RA symptoms. The data will be presented today at the American College of Rheumatology Annual Meeting in Washington, D.C.
- SARIL-RA-MONARCH enrolled 369 adults with active RA who failed to respond adequately or were intolerant of or were inappropriate candidates for methotrexate. They were randomized to receive either sarilumab monotherapy (200 mg every two weeks subcutaneously) or adalimumab (40 mg every two weeks subcutaneously). The primary endpoint was the change from baseline to week 24 in a scale called DAS28-ESR, a measure of RA activity via the evaluation of 28 joints for tenderness and swelling, a general health assessment and ESR (erythrocyte sedimentation rate), a simple laboratory test for inflammation.
- Sarilumab demonstrated superiority to adalimumab as measured by DAS28-ESR (-3.28 vs. -2.20; p<0.0001). The rates of DAS28-ESR remission also favored sarilumab (26% vs. 7%; p<0.0001).
- It also beat adalimumab in terms of the proportion of patients who achieved ACR20 (20% improvement in RA symtoms) (72% vs. 58%; p<0.01), ACR50 (45% vs. 29%; p=0.0017) and ACR70 (23% vs. 11%; p=0.0036).
- The incidence of adverse events were 64% for both groups. Serious adverse events were observed in 5% of the sarilumab subjects and 7% in the adalimumab subjects. The incidence of infections were similar (29% for sarilumab vs. 28% for adalimumab). Neutropenia (low level of a type of white blood cell called neutrophils) was more common with sarilumab (14%) than adalimumab (1%).
- Sarilumab in a human monoclonal antibody that inhibits the inflammatory activity of RA by binding to the interleukin-6 (IL-6) receptor. IL-6 is the most abundant cytokine in the serum and synovial fluid of RA sufferers and is correlated with disease activity and joint destruction.
- Sanofi's U.S. marketing application is currently under review. The FDA issued a CRL last month citing manufacturing deficiencies at the Sanofi site that will "fill and finish" the product. Sanofi has responded to the agency and is working with the regulator to promptly address the issues.
Wed, Nov. 9, 8:08 AM
- Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
- Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN) +3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
Wed, Nov. 9, 3:03 AM
- Healthcare stocks, the weakest sector this year, may become winners, as Obamacare reforms are set to be "repealed and replaced" and major legislation Clinton proposed is unlikely to be imposed on drugmakers.
- While Trump hasn't set out a comprehensive alternative to the Affordable Care Act (which may see 22M Americans lose current coverage), he said he'll encourage competition between markets in different states.
- Insurance stocks: UNH, AET, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY
- Drugmakers premarket: MYL +5.8%, NVS +3.4%, SNY +2.9%, AZN +2.4%, GSK +1.9%, PFE +1.8%, CELG +1%, ABBV, MRK, BMY, LLY, JNJ, ABT, ACET, ZTS, BIIB, REGN
Fri, Nov. 4, 7:12 AM
- Regeneron (NASDAQ:REGN) Q3 results ($M): Total Revenues: 1,220.1 (+7.3%); Net Product Sales: 857.5 (+16.3%); Sanofi Collaboration Revenue: 144.4 (-35.7%); Bayer Collaboration Revenue: 191.3 (+21.4%).
- Key Product Sales: Eylea: 854 (+16.3%); Praluent: 38 (+850.0%).
- Net Income: 264.8 (+25.9%); Non-GAAP Net Income: 365.0 (+32.1%); EPS: 2.27 (+24.7%); Non-GAAP EPS: 3.13 (+31.5%).
- Reimbursement of Regeneron Commercialization-Related Expenses: 65.7 (+23.4%).
- Consensus view was non-GAAP EPS of $2.71 on revenues of $1.3B.
- 2016 Guidance: Eylea Net Sales Growth: 23 - 25% from 20 - 25%; Sanofi Reimbursement of Regeneron Commercialization-Related Expenses: $310M - 335M from $310M - 340M.
- Shares are down 3% premarket on light volume.
Fri, Nov. 4, 6:31 AM
Thu, Nov. 3, 5:30 PM
Tue, Nov. 1, 7:43 AM
- Pfizer (NYSE:PFE) eases 1% premarket on light volume in response to its Q3 earnings and to the news that it has terminated development of cholesterol lowering candidate bococizumab, an inhibitor of Proprotein Convertase Subtilisin Kexin type 9 (PCSK9).
- The company says that after completing six studies, an emerging clinical profile of the drug has emerged that includes an unanticipated attenuation of LDL-C-lowering over time (it doesn't go down as much as expected) and a higher level of immunogenicity and injection site reactions versus other PCSK9 inhibitors. It adds that lowering cholesterol must be durable to have a long-term effect on reducing the risk of cardiovascular events like heart attack and stroke.
- The data will be made available to study leaders for independent analysis with the aim of maximizing the clinical and scientific knowledge gained from the halted trials.
- Pfizer will record a $0.04 charge against GAAP and non-GAAP EPS this quarter.
- There are two PCSK9 inhibitors commercially available in the U.S.; Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab). Both have been slow to gain traction in the marketplace.
Fri, Oct. 28, 3:22 PM
- Regeneron Pharmaceuticals (REGN -3.2%) has resumed trading after the pause for the news about the U.S. delay in approving its marketing application for sarilumab due to manufacturing deficiencies at the Sanofi (SNY +4.1%) site that will put the finishing touches on the product. The company received a Complete Response Letter (CRL) today.
- Sanofi has responded to the FDA about the deficiencies and is working with the agency to promptly resolve the issues. Once this is done, a new action date will be announced.
Fri, Oct. 28, 2:56 PM
- Citing manufacturing issues (disclosed earlier today by Regeneron), the FDA issues a CRL to Regeneron (NASDAQ:REGN) to Sanofi (NYSE:SNY) over Sarilumab for the treatment of rheumatoid arthritis.
- REGN is set to reopen for trade at 3:05 ET. Shares were down 2.5% ahead of being halted. SNY is off earlier highs, but still up 2.6% on the session.
- The two companies say they remain committed to the development of the drug.
- Previously: Regeneron halted with news pending (Oct. 28)
Fri, Oct. 28, 2:17 PM
- The company has a PDUFA date on Oct. 30 for its Sanilumab treatment for rheumatoid arthritis. REGN -2.5% ahead of the halt.
Fri, Oct. 28, 7:53 AM
- In a regulatory filing, Regeneron Pharmaceuticals (NASDAQ:REGN) reports that deficiencies observed by the FDA during a routine on-site inspection at a Sanofi (NYSE:SNY) "fill and finish" manufacturing facility could potentially delay the expected October 30 U.S. approval of sarilumab, an IL-6 inhibitor currently under review for the treatment of rheumatoid arthritis co-developed by the two companies. The site will be responsible for producing the finished product.
- Sanofi has submitted comprehensive responses to the FDA and has been in discussions with the agency on the matter. No Form 483 was issued in connection with the inspection.
- Since the October 30 PDUFA date is Sunday, the actual FDA notification date could be today.
Mon, Oct. 17, 8:07 AM
- The FDA has placed a clinical hold on a Phase 2b clinical trial assessing Regeneron Pharmaceuticals (NASDAQ:REGN) and Teva Pharmaceutical Industries' (NASDAQ:TEVA) fasinumab for the treatment of chronic low back pain. The agency has also requested an amendment to the study protocol after observing a case of confirmed arthropathy (joint disease) in a patient with advanced osteoarthritis who was receiving high dose fasinumab. Regeneron has stopped dosing in the study after completing an unplanned interim review of the data which showed clear evidence of efficacy over placebo at the eight- and 12-week time points. Patients will continue to be followed for up to 36 weeks.
- There are three fasinumab dose cohorts in the study: 6 mg and 9 mg subcutaneously once/month and 9 mg intravenously every two months. Enrollment was 70% completed (target: 800). Updated results will be presented at an upcoming medical conference.
- Based upon the data, the companies intend to design a Phase 3 trial in chronic low back pain that excludes patients with advanced osteoarthritis.
- Results from a previously reported Phase 2/3 study in osteoarthritis pain, a potential dose-dependent rate of arthropathy was observed. Consequently, only the lower doses will be advanced in Phase 3 studies.
- Fasinumab is a fully human monoclonal antibody that targets Nerve Growth Factor, a protein that plays a key role in the regulation of pain signaling.
- Regeneron and Teva are co-developing and co-commercializing fasinumab under an agreement inked last month.
- Regeneron is down 1% premarket on light volume. Teva is up a fraction.
- Previously: Regeneron's fasinumab successful in mid-stage study in treatment-resistant arthritis (May 2)
Thu, Oct. 13, 8:41 AM
- Micro cap Ocular Therapeutix (NASDAQ:OCUL) is up 28% premarket on robust volume in response to its announcement of a strategic collaboration with Regeneron Pharmaceuticals (NASDAQ:REGN) to develop a sustained-release formulation of aflibercept, marketed in the U.S. under the brand name EYLEA, for the treatment of wet age-related macular degeneration (wet AMD) and other retinal disorders.
- Under the terms of the agreement, Regeneron has the option to secure an exclusive license to Ocular's hydrogel-based technology for a sustained-release formulation of aflibercept and other biologics targeting VEGF for ophthalmic indications. Ocular retains the rights to its platform for all other non-VEGF-targeting compounds in addition to small molecule drugs for other retinal diseases. If Regeneron exercises its option, Ocular will receive a $10M payment and will be responsible for Phase 1 development. Regeneron will be responsible for further development and commercialization. Ocular will be eligible to receive up to $305M in milestones and tiered royalties on net sales from high-single-digit to low-to-mid-teens.
Fri, Sep. 30, 9:08 AM
- Ophthotech (NASDAQ:OPHT) slumps 13% premarket on robust volume in apparent response to Regeneron Pharmaceuticals' (NASDAQ:REGN) unsuccessful Phase 2 study of a co-formulated therapy of EYLEA (aflibercept) and rinucumab, an anti-platelet-derived growth factor receptor beta monoclonal antibody (anti-PDGFR-beta), for the treatment of wet AMD. The combo therapy failed to show a treatment benefit over EYLEA alone.
- Ophthotech is also investigating a combination therapy for wet AMD: Fovista, targeting platelet-derived growth factor (PDGF), administered with Roche's (OTCQX:RHHBY) Lucentis (ranibizumab), an anti-VEGF therapy. Unlike Regeneron, though, results from a Phase 2b study showed statistical superiority of the combo compared to Lucentis alone. Phase 3 development is underway.
- Previously: Regeneron's Eylea combo no better than Eylea alone in mid-stage study in wet AMD (Sept. 30)