Receptos Continues To Reward
Stephen Simpson, CFA
Stephen Simpson, CFA
Multiple Observations On Celgene's Latest Licensing Deals, And Its Valuation
DoctoRx • 75 Comments
DoctoRx • 75 Comments
Yesterday, 4:08 PM
- Celgene (CELG -1.1%) inks an agreement to acquire privately held Acetylon Pharmaceuticals for an undisclosed sum. The Boston, MA-based biopharma firm is developing next-generation small molecule histone deacetylase (HDAC) inhibitors that allow for the epigenetic regulation of gene and protein function.
- One of its lead product candidates is ricolinostat (ACY-1215), an HDAC6 inhibitor in development for the treatment of blood cancers and solid tumors. Another is citarinostat (ACY-241), a candidate to treat solid tumors.
- Prior to the deal close, Acetylon will spin out a new company called Regenacy Pharmaceuticals, LLC, that will focus on developing novel drug candidates that selectively regenerate intracellular transport and upregulate gene expression to modify the course of disease. Regenacy will have exclusive global rights to ricolinostat for the treatment of certain non-cancer disorders including neuropathies. It will also have exclusive global rights to HDAC1,2 inhibitor candidates and intellectual property for all indications including sickle cell disease and beta thalassemia.
- Regenacy will be owned by Acetylon shareholders, excluding Celgene, which will fund operations.
Tue, Nov. 29, 1:08 PM
- Oppenheimer initiates coverage on Celgene (CELG +2.1%) with an Outperform rating and $141 (15% upside) price target.
- The company expects revenues as high as $13B next year with Revlimid pitching in more than $8B. Crohn's candidate GED-0301 is one of its promising pipeline candidates along with blood disorder candidate luspatercept.
Fri, Nov. 18, 4:01 PM
- An affiliate of Celgene (CELG -0.1%) inks a deal with privately held Triphase Accelerator Corp. for the rights to marizomib, a brain-penetrant proteasome inhibitor in development for the treatment of glioblastoma and relapsed/refractory multiple myeloma.
- Under the terms of the agreement, Celgene will make an upfront payment and regulatory, approval and sales milestone payments. Specific financial terms are not disclosed.
Fri, Nov. 18, 7:48 AM
- San Diego, CA-based biopharmaceutical outfit PharmAkea expands its strategic collaboration with Celgene (NASDAQ:CELG) focused on discovering small molecule drugs to treat fibrotic diseases. The original three-year partnership was inked in October 2013.
- Under the terms of the new agreement, PharmAkea will receive $9M to extend the collaboration for nine months. It is currently currently conducting early-stage studies of a small molecule LOXL2 inhibitor and is preparing to enter Phase 1 development with an Autotaxin inhibitor.
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
Mon, Nov. 7, 5:15 PM
- Mizhuo initiates Celgene (NASDAQ:CELG) at Buy with $130 PT. Implied upside 21%.
- Firm says Ozanimod (MS, UC...) and GED-301 (Chron's) has 2/3 chances of working in their lead indications.
- Notes a series of singles/doubles in near to medium term - added "call options" on CELG.
- Active buyer of its own shares. Seems to believe its guidance is conservative.
Tue, Nov. 1, 12:07 PM
- The European Medicines Agency (EMA) signs off on the design of a Phase 3 clinical trial assessing Can-Fite BioPharma's (CANF) lead product candidate CF101 (Piclidenoson) for the treatment of psoriasis. The study should commence in the latter half of next year.
- The randomized, double-blind, placebo-controlled trial will enroll ~400 patients with moderate-to-severe plaque psoriasis. Oral medication will be administered twice daily for 32 weeks. Piclidenoson will be compared to Celgene's (CELG +1.1%) Otezla (apremilast) in addition to placebo. The primary endpoint will be the proportion of subjects who achieve a 75% improvement in psoriasis symptoms at Week 16. Secondary endpoints include non-inferiority to apremilast.
- Piclidenoson is an anti-inflammatory oral small molecule drug. Its mechanism of action is mediating A3 adenosine receptors, key signalling proteins which play key roles in the production of inflammatory cytokines.
Thu, Oct. 27, 8:01 AM
- Celgene (NASDAQ:CELG) Q3 results ($M): Total Revenues: 2,982.8 (+27.8%); Net Product Sales: 2,968.6 (+28.4%).
- Net Income: 171.4 (+602.6%); Non-GAAP Net Income: 1,263.5 (+25.0%); EPS: 0.21 (+625.0%); Non-GAAP EPS: 1.58 (+28.5%).
- Key Product Sales: Revlimid: 1,891.1 (+30.1); Pomalyst/Imnovid: 341.1 (+33.0%); Otezla: 274.6 (+98.0%); Abraxane: 233.3 (+1.5%); Vidaza: 154.7 (+4.8%).
- 2016 Guidance: Total Product Sales: ~$11.2B from ~$11.0B; Revlimid Sales: ~$7.0B from ~$6.8B; EPS: $3.12 - 3.29 from $3.82 - 4.05; Non-GAAP EPS: $5.88 - 5.92 from $5.70 - 5.75.
- 2017 Guidance: Total Product Sales: high end of $12.7B - 13.0B; Revlimid: more than $8.0B; Non-GAAP EPS: high end of $6.75 - 7.00.
- Consensus Q3 view was EPS of $1.48 on revenues of $2.8B.
- Shares are up 3% premarket on light volume.
Thu, Oct. 27, 7:32 AM
Wed, Oct. 26, 5:30 PM
- ABB, ABMD, ACOR, AET, ALLE, ALV, ALXN, AMT, APD, ASPS, AUO, AVT, AXTA, BBW, BC, BCOR, BGCP, BMS, BMY, BWA, BX, CBG, CCMP, CELG, CFX, CHH, CL, CLF, CMC, CME, CMS, COLB, COP, COR, CRI, CRR, CRS, CVE, CVI, CVRR, CWT, CYS, DFT, DLX, DOW, DPS, EME, EPD, EQGP, EQM, EQT, EXLS, F, FCFS, FCN, FMS, GCI, GLOP, GNC, GOV, GTLS, HCA, HEES, I, IDA, IDCC, IP, IPGP, IRDM, IVZ, LANC, LAZ, LKQ, LLL, MD, MDP, MDXG, MHO, MJN, MO, MPC, MPLX, MSCI, MTH, MTRN, NEWM, NMR, NOK, NOV, NTCT, ODFL, ORI, PATK, PENN, PF, PJC, POT, PRLB, PTEN, PX, QSII, RDN, RGS, ROCK, RTN, SCG, SEE, SFE, SILC, SIRI, SMP, SQNS, SRPT, STM, SUP, SWK, TCK, TDC, TFX, THRM, TKR, TMO, TPH, TPX, TREE, TROW, TUES, TWTR, TZOO, UAN, UFS, UPS, UTHR, VC, VLP, WCC, WEX, WST, WWE, XEL, XRS, YNDX
Thu, Oct. 20, 7:15 AM
- England's National Institute for Health and Care Excellence (NICE), an advisory group to the National Health Service (NHS) on costs and quality, issues a positive final appraisal determination providing patient access to Celgene's (NASDAQ:CELG) OTEZLA (apremilast) for the treatment of chronic plaque psoriasis.
- Patients in England and Wales will now have access to OTEZLA, joining those in Scotland who have had access since June 2015.
Tue, Oct. 18, 12:20 PM
- Galapagos NV (GLPG +5%) is up on modestly higher volume in early trading. The bullish action is being stoked by increased optimism with Crohn's disease (CD) candidate filgotinib after Celgene (CELG +0.8%) released early-stage data on its CD candidate GED-0301.
- Yesterday, Celgene announced Phase 1b data which showed a 67% clinical response rate and 48% remission rate in patients treated with GED-0301 for 12 weeks. Clinical response was defined as at least a 100 point drop in a CD symptom scale called Crohn's Disease Activity Index (CDAI) while clinical remission was defined as a CDAI score less than 150. Patients with active CD have CDAI scores of 220 - 450. A Phase 3 study is currently recruiting patients. According to ClinicalTrials.gov, the estimated completion date is April 2022.
- A Phase 2 study, FITZROY, showed a statistically valid proportion of patients receiving filgotinib for 10 weeks achieved clinical remission compared to placebo (48% vs. 23%; p=0.0067). The proportion of clinical responders (60% vs. 41%; p=0.0386) also favored filgotinib. Both endpoints were based on the same CDAI metrics as Celgene. A Phase 3 study in adults with moderately to severely active Crohn's should commence shortly. According to ClinicalTrials.gov, the estimated study completion date is December 2019. It is being developed with collaboration partner Gilead Sciences (GILD +1.4%).
Tue, Oct. 18, 10:29 AM
- Biotech industry offers "attractive buying opportunities" given pre-election weakness, Jefferies says.
- Valuation multiples are near-historic lows; policy concerns are likely overstated.
- Firm recommends using weak sentiment to buy attractive names. Likes: Gilead (NASDAQ:GILD) and Celgene (NASDAQ:CELG) in large-caps, The Medicines Co. (NASDAQ:MDCO), Alkermes (NASDAQ:ALKS) and Vertex (NASDAQ:VRTX) in mid-caps. Alder Biopharmaceuticals (NASDAQ:ALDR), Cempra (NASDAQ:CEMP), Ultragenyx (NASDAQ:RARE) and Immunomedics (NASDAQ:IMMU) in small-caps.
Mon, Oct. 17, 7:28 AM
- Results from a Phase 1b study assessing Celgene's (NASDAQ:CELG) GED-0301 in patients with active Crohn's disease (CD) showed a clinical response rate of 67% and a remission rate of 48%. The data are being presented at the United European Gastroenterology Week in Vienna, Austria.
- A total of 63 subjects were enrolled in the trial, called CD-001. Active CD was defined by scores of 220 - 450 in a scale called Crohn's disease activity index (CDAI). They were also categorized according to a simple endoscopic score for CD (SES-CD at least seven) or ileal disease (SES-CD at least four). Patients were randomized to receive one of three treatment regimens: four, eight or 12 weeks of once-daily GED-0301 160 mg, followed by an observation period off treatment.
- Clinical response was defined as a decrease in CDAI score of at least 100 while remission was defined by a CDAI score of less than 150. The 12-week cohort experienced the results cited above, which was the best of the three. The average reduction from baseline in CDAI score in this group was 133 points.
- Of the patients with evaluable endoscopies at week 12 (n=52), 37% (n=19/52) showed an endoscopic response (defined as at least a 25% reduction in SES-CD score from baseline). There was no meaningful difference across treatment groups. In patients with the highest endoscopic disease activity at baseline (SES-CD score >12; n=16), 63% (n=10/16) experienced at least a 25% reduction in SES-CS score while 31% (n=5/16) experienced at least a 50% reduction.
- The rates of adverse events and serious adverse events were low and similar across treatment groups. No new safety signals were reported.
- GED-0301, licensed from Dublin, Ireland-based Nogra Pharma, is an oral antisense therapy designed to target the messenger RNA for a protein called Smad7 which is overexpressed in patients with Crohn's. Abnormally high levels of Smad7 interfere with anti-inflammatory pathways in the gut. GED-0301 reduces inflammation by reducing the level of Smad7.
- Previously: Celgene's Crohn's disease candidate GED-0301 shows encouraging action in early-stage study (Sept. 12)
Wed, Oct. 12, 7:49 AM
- Celgene (NASDAQ:CELG) and Agios Pharmaceuticals (NASDAQ:AGIO) ink collaboration agreements with Abbott (NYSE:ABT) to develop and commercialize companion diagnostic tests to identify isocitrate dehydrogenase (IDH) mutations in patients with acute myeloid leukemia (AML). The tests will be performed on Abbott's m2000 RealTime System, an automated polymerase chain reaction (PCR) instrument.
- Celgene is currently developing an IDH2 inhibitor, enasidenib, for the treatment of IDH2-positive AML. Agios is developing an IDH1 inhibitor, AG-120, for AML patients positive for that mutation. IDH1 and IDH2 occur in ~20% of AML cases.