Regeneron - A Review: Strong Returns Look Likely For 2016 And Beyond
DoctoRx • 55 Comments
DoctoRx • 55 Comments
Regeneron Jumps Ahead In $10 Billion Race For Next Generation Cardio Drugs
Cheryl Swanson • 14 Comments
Cheryl Swanson • 14 Comments
Mon, Jul. 11, 9:40 AM
- The FDA approves a new monthly dosing option for Amgen's (AMGN +0.2%) cholesterol fighter Repatha (evolocumab), the first for a PCSK9 inhibitor. Patients can now self-administer a single subcutaneous dose of 420 mg of evolocumab using the hands-free Pushtronex device (on-body infusor with prefilled cartridge). The original dosing regimen, which remains in place, is 140 mg every two weeks.
- Regeneron Pharmaceuticals (REGN +0.7%) and Sanofi's (SNY +1%) Praluent (alirocumab) is dosed every two weeks up to a maximum of 150 mg per dose.
- Evolocumab is a monoclonal antibody that inhibits convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood.
Tue, Jul. 5, 11:16 AM
- Thinly traded micro cap pSivida (PSDV +5.4%) bucks the market's bearishness. Shares are up on average volume (only ~23K shares so far) in response to its announcement of positive results from preclinical animal studies assessing the effectiveness of a sustained-release insert based on its Durasert technology to deliver a tyrosine kinase inhibitor (TKI) for the treatment of wet age-related macular degeneration (wet AMD).
- The data showed the TKI insert was similar in efficacy to an injection of an FDA-approved AMD biologic in preventing choroidal neovascularization (formation of new blood vessels) and reducing vascular leakage.
- Based on the encouraging results, the company intends to advance the Durasert TKI insert into clinical development.
- TKIs are currently used to treat cancer, but some inhibit a growth factor called PDGF (platelet-derived growth factor) which plays a key role in blood vessel formation. The TKI used by pSivida inhibits both PDGF and VEGF (vascular endothelial growth factor). AMD meds Lucentis (ranibizumab) and Eylea (aflibercept) are both VEGF inhibitors. In cancer, TKIs are taken orally because systemic administration is too toxic. PSivida's approach aims to deliver a TKI dose directly to the retina that is 1,000 times less that the dose used to treat cancer.
- Related tickers: (OTCQX:RHHBY -1.5%)(REGN -0.5%)
Tue, Jul. 5, 6:44 AM
- The Japanese Ministry of Health, Labor and Welfare approves Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab) for the treatment of uncontrolled low-density lipoprotein (LDL) cholesterol in certain adult patients with hypercholesterolemia at high cardiovascular risk.
- Amgen's (NASDAQ:AMGN) Repatha (evolocumab) was approved in Japan in January.
- Both products are monoclonal antibodies that inhibit convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood.
Fri, Jul. 1, 10:08 AM
- Invitae (NYSE:NVTA) initiated with Hold rating with an $8.50 (18% upside) price target by Benchmark.
- Jazz Pharmaceuticals (NASDAQ:JAZZ) initiated with Outperform rating and $190 (33% upside) price target by BMO.
- Pacira Pharmaceuticals (NASDAQ:PCRX) initiated with Underperform rating and $36 (4% upside) price target by BMO.
- Mallinckrodt (NYSE:MNK) initiated with Outperform rating and $84 (35% upside) price target by BMO.
- Horizon Pharma plc (NASDAQ:HZNP) initiated with Outperform rating and $29 (71% upside) price target by BMO.
- Regeneron Pharmaceuticals (NASDAQ:REGN) initiated with an Outperform rating and $400 (13% upside) price target by Bernstein.
- Biogen (NASDAQ:BIIB) initiated with an Outperform rating and $282 (15% upside) price target by Bernstein.
- Amgen (NASDAQ:AMGN) initiated with Market Perform rating and $161 (5% upside) price target by Bernstein.
- Lannett Company (NYSE:LCI) initiated with Hold rating and $26 (5% upside) price target by Deutsche Bank.
- OpGen (NASDAQ:OPGN) initiated with Buy rating and $2.50 (66% upside) price target by Rodman & Renshaw.
- Valeant Pharmaceuticals (NYSE:VRX) initiated with Market Perform rating and $26 (22% upside) price target by BMO.
- Neurocrine Biosciences (NASDAQ:NBIX) initiated with Outperform rating and $80 (75% upside) price target by H.C. Wainwright.
- Healthstream (NASDAQ:HSTM) initiated with Outperform rating and $30 (12% upside) price target by Barrington Research.
- Neurometrix (NASDAQ:NURO) initiated with Buy rating and $4.50 (165% upside) price target by Rodman & Renshaw.
- Vascular Biogenics (NASDAQ:VBLT) initiated with Buy rating and $11 (139% upside) price target by H.C. Wainwright.
Mon, Jun. 20, 8:21 AM
- Ophthotech (NASDAQ:OPHT) hits its enrollment target in a Phase 3 clinical trial assessing lead product candidate, Fast Track-tagged Fovista (pegleranib), in combination with Regeneron Pharmaceuticals (NASDAQ:REGN) and Bayer's (OTCPK:BAYRY) Eylea (aflibercept) or Roche's (OTCQX:RHHBY) Avastin (bevacizumab) for the treatment of patients with wet age-related macular degeneration (wet AMD). According to ClinicalTrials.gov, the estimated study completion date is July.
- The event triggers a $30M milestone payment from ex-U.S. commercialization partner Novartis Pharma AG (NYSE:NVS). The company has earned $330M in upfront fees and milestones from Novartis to date. Going forward, it can earn an additional $300M in regulatory milestones and up to $400M in sales-base milestones plus royalties on ex-U.S. Fovista sales.
- The Fovista Phase 3 program consists of three clinical trials. Results from the first two, evaluating Fovista with Roche's Lucentis (ranibizumab), are expected in Q4.
- Fovista is an anti-platelet-derived growth factor (anti-PDGF) agent
- Previously: Ophthotech moving ahead with Fovista studies (May 11, 2015)
Mon, Jun. 6, 4:11 PM
- A Phase 3 clinical trial, LIBERTY AD CHRONOS, assessing dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13 signaling, for the treatment of adults with moderate-to-severe atopic dermatitis (AD) met its primary and key secondary endpoints. The 740-subject study compared the safety and efficacy of dupilumab together with topical corticosteroids (TCS) to TCS alone in adult patients with AD who were inadequately controlled with TCS with or without calcineurin inhibitors.
- 39% of patients who received either 300 mg of dupilumab once weekly or every two weeks with TCS achieved clearing or near-clearing of skin lesions compared to 12% for placebo plus TCS (p<0.0001) as measured by a metric called Investigator's Global Assessment (IGA).
- 64% of the patients treated with 300 mg of dupilumab weekly achieved a 75% reduction in eczema severity while 69% of the patients on the two-week interval achieved it. Both handily beat placebo + TCS's 23% (p<0.0001).
- The rate of adverse events (AEs) was comparable between the test and control groups. The most common dupilumab-related AEs were injection site reactions.
- Breakthrough Therapy-tagged dupilumab is being co-developed by Regeneron Pharmaceuticals (REGN +0.7%) and Sanofi (SNY). They expect it to be a big winner.
Thu, Jun. 2, 7:54 AM
- The Medicines Company (NASDAQ:MDCO) completes the enrollment of 501 subjects in its Phase 2 study, called ORION-1, assessing its RNA interference therapeutic targeting PCSK9 (PCSK9si) in patients with high cardiovascular risk and elevated LDL-C ("bad cholesterol") despite receiving the maximum tolerated doses of LDL-C-lowering therapies. The study will compare the effect of different doses of PCSK9si and will evaluate the potential for quarterly or biannual dosing. The primary endpoint is the change in LDL-C from baseline to day 180.
- Interim three-month and six-month data should be available by year end. If all goes well, Phase 3 studies will commence in early 2017.
- PCSK9si is an investigational GalNAc-conjugated RNAi therapeutic targeting PSCK9, a protein regulator of LDL receptor metabolism. In contrast to PSCK9 inhibitors, PCSK9si works by turning off PCSK9 synthesis in the liver. The company is collaborating with Alnylam (NASDAQ:ALNY) on its development.
- Related tickers: (NASDAQ:AMGN)(NASDAQ:REGN)(NYSE:SNY)
Tue, May 31, 10:05 AM
- Interim data from four patients with Homozygous Familial Hypercholesterolemia (HoFH) treated with Regeneron Pharmaceuticals' (REGN +0.4%) evinacumab (REGN1500) experienced significant reductions in low-density lipoprotein cholesterol (LDL-C) levels. The results were presented at the 84th European Atherosclerosis Society Congress in Innsbruck, Austria.
- The patients achieved a mean reduction of 55% of LDL-C versus baseline (range: 25 - 90%) after a single 250 mg subcutaneous injection at baseline followed by a 15mg/kg IV infusion at week 2. All patients were receiving maximum doses of statin plus ezetimibe [Merck's (MRK) Zetia]. Evinacumab was generally well-tolerated with no adverse events leading to discontinuation. The most common drug-related adverse events were injection site reactions.
- The ongoing single-arm, open-label study will enroll up to eight HoFH patients.
- HoFH is the most severe form of hypercholesterolemia. It's rare, affecting less than 1,000 Americans, but sufferers have levels of "bad cholesterol" up to 1,000 mg/dL, ten times the optimal amount.
- Evinacumab, created with the company's VelocImmune technology platform, is a human monoclonal antibody that binds to a protein called angiopoietin-like 3 (ANGPTL3), a natural inhibitor of an enzyme that plays a key role in the breakdown of triglycerides and other lipids.
Wed, May 11, 9:12 AM
- Health insurer Cigna (NYSE:CI) enters into new value-based agreements with Amgen (NASDAQ:AMGN) and Sanofi (NYSE:SNY)/Regeneron Pharmaceuticals (NASDAQ:REGN) covering their cholesterol-lowering medications, Repatha (evolocumab) and Praluent (alirocumab), respectively. The contracts modify the cost of the pricey meds based on how well patients respond to the drugs. If they meet or exceed the expected reduction in LDL-C (the "bad" cholesterol) the original negotiated price remains as is. If they fall short of the expected LDL-C reduction, the discount increases.
- Repatha lists for $14,000 per year while Praluent lists for $14,600. Cigna will also determine whether there are cardiovascular improvements related to treatment by analyzing medical and pharmacy claim data.
- Cigna is the first payer to close this type of agreement with the drug makers covering their PCSK9 inhibitors. It also has value-based contracts in place covering drugs for heart failure, diabetes, multiple sclerosis and hepatitis C.
Thu, May 5, 12:07 PM
- The anticipated rapid ramp of Regeneron Pharmaceuticals (REGN +5.3%) and Sanofi's (SNY -3%) cholesterol fighter Praluent (alirocumab) and Amgen's (AMGN +0.2%) Repatha (evolocumab) remains elusive in the face of headwinds from insurers over the high costs of the PCSK9 inhibitors. The companies and bullish analysts have touted both meds as blockbusters that will eventually generate well over $1B a year in sales. When is anyone's guess considering Repatha's Q1 sales of $16M and Praluent's $13M, both shy of expectations.
- Regeneron says that 74% of U.S. commercially insured lives and 91% of Medicare insured lives have access to its drug (as of April 1). The premium list price of $14,600 per year, significantly more expensive that other therapies like statins, has prompted insurers to restrict access via specific utilization criteria and burdensome paperwork. The company expects payers to loosen the strings a bit when when upcoming data are released on Praluent's cardiovascular benefits.
- Amgen is in the same boat. Repatha is priced at $14,000 per annum before discounts.
- Another cloud hanging over Praluent's prospects is a patent dispute versus Repatha, currently under appeal after Amgen prevailed in March.
Thu, May 5, 9:12 AM
- Gainers: SYNC +143%. LGCY +31%. AAWW +27%. EPE +21%. FCEL +19%. WTW +15%. DNR +14%. ZNGA +14%. CHK +13%. BCEI +12%. UNXL +12%. ARRS +10%. CRC +10%. CLMT +9%. ORIG +9%. QRVO +8%. GSV +8%. HMY +8%. VNR +7%. MEET +7%. SDRL 7%. CLR 6%. SGYP 6%. OAS 5%. REGN 5%. BABA 5%. AUY 5%.
- Losers: PTX -37%. FRSH -27%. SQNM -19%. FIT -13%. EBIO -11%. LB -10%. WFT -9%. SEAS -8%. ABC -8%. CTL -5%.
Thu, May 5, 7:35 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) Q1 results ($M): Total Revenues: 1,201 (+38.0%); EYLEA U.S. Sales: 781 (+44.4%); EYLEA Ex. U.S. Sales: 419 (+43.5%); Sanofi Collaboration Revenue: 219.7 (+26.7%); Bayer Collaboration Revenue: 179.6 (+45.1%); Praluent Sales: 13.0.
- Net Income: 165.7 (+118.0%); Non-GAAP Net Income: 292.8 (-12.7%); EPS: 1.45 (+119.7%); Non-GAAP EPS: 2.57 (-10.8%). Q1 Consensus: EPS of $2.58 on revenues of $1.18B.
- 2016 Guidance: EYLEA U.S. Sales Growth: 20 - 25%; Sanofi reimbursement of commercialization-related expenses: $320M - 370M.
- Q2 Consensus: EPS of $2.73 on revenues of $1.24B.
- Shares are up 4% premarket but only on 76 shares.
Thu, May 5, 6:31 AM
Wed, May 4, 5:30 PM
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Mon, May 2, 7:55 AM
- Regeneron Pharmaceuticals' (NASDAQ:REGN) investigational Nerve Growth Factor (NGF) antibody, fasinumab, met its primary endpoint in the Phase 2 portion of a Phase 2/3 clinical trial in patients with moderate-to-severe osteoarthritis of the hip or knee who had a history of inadequate pain relief or intolerance to current analgesic therapies. At week 16, patients treated with fasinumab showed a statistically valid improvement in pain relief, the primary endpoint of the study, in addition to improvements in physical function. The results will be presented at an upcoming medical conference. The study will proceed to Phase 3.
- The U.S.-based trial enrolled 421 adults with the above mentioned arthritis and history of inadequate pain relief or intolerance to acetaminophen, at least one oral nonsteroidal anti-inflammatory drug (NSAID) and an opioid. At enrollment, the average pain score was 6.3 on a 10-point scale. Participants were randomized 1:1:1:1:1 to receive either 1 mg, 3 mg, 6 mg or 9 mg of fasinumab or placebo (n=85, n=84, n=85, n=84, n=83, respectively), administered via subcutaneous injection every four weeks for 12 weeks, with primary efficacy measured at week 16. Patients are being followed for an additional 20 weeks off treatment (past week 16).
- At week 16, the reductions in pain scores, measured by the WOMAC subscale for pain, were statistically significant for all doses of fasinumab compared to placebo.
- The incidence of adverse events for fasinumab was 17% compared to 6% for placebo, which included joint pain, parathesia (tingling sensation), hypoaesthesia (numbness) and peripheral edema. Anti-NGF therapies carry a risk of joint damage so the study included extensive imaging and analyses at baseline to assess the negative impact, if any, of fasinumab on subchondral insufficiency fractures (SIF), osteonecrosis (ON) and rapidly progressive osteoarthritis (RPOA). ~2% of subjects were excluded from the trial based on the presence of SIF or ON at baseline. During the study period, there were no cases of ON, one case of SIF in placebo, 2 in the 3 mg cohort and 4 in the 9 mg cohort and one case of RPOA in each of the 3 mg, 6 mg and 9 mg fasinumab groups. A modest increase in a biomarker of osteoblast activity, bone-specific alkaline phosphatase, was observed in fasinumab-treated patients.
Mon, Apr. 11, 4:57 PM
- Following Bayer's lead, Regeneron Pharmaceuticals (NASDAQ:REGN) enters into a licensing and collaboration agreement with privately held Cambridge, MA-based Intellia Therapeutics to advance CRISPR/Cas9 gene-editing technology for the development of new therapeutics in addition to advancing the technology itself.
- Under the terms of the six-year deal, Regeneron has exclusive rights to discover and develop CRISPR-based products against as many as 10 targets, focused primarily a range of diseases that can be potentially treated by editing genes in the liver, although it may select up to five non-liver targets out of the 10. Intellia will receive an upfront payment of $75M, undisclosed milestones and royalties and a $50M equity investment from Regeneron in its next round of financing. The first target will be transthyretin amyloidosis, a slowly progressive inherited disorder characterized by the buildup of a protein called amyloid in the body's organs and tissues.
- CRISPR-Cas9 is the "next big thing" in biotech because of its unprecedented precision in editing DNA. CRISPR, the acronym for "clustered, regularly interspaced short palindromic repeats," uses RNA to guide the molecular scissors, the Cas9 enzyme, to a specific DNA sequence where it makes a specific cut in the DNA and triggers the cell's DNA repair machinery to address the genetic defect.
- Previously: Bayer claims a stake in CRISPR-based drug discovery race (Jan. 29)
- Read now Regeneron Pharmaceuticals Is My Top Pick In The Biotech Space
Regeneron Pharmaceuticals, Inc. operates as a biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer and a rare inflammatory condition... More
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