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  • 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.
    | Thu, Oct. 20, 7:15 AM | 2 Comments
  • 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, 12:20 PM | 3 Comments
  • 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.
    | Tue, Oct. 18, 10:29 AM | 49 Comments
  • 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)
    | Mon, Oct. 17, 7:28 AM | 3 Comments
  • 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.
    | Wed, Oct. 12, 7:49 AM | 2 Comments
  • Thu, Oct. 6, 3:32 PM
    • Biotech investors are sitting on the sell button today. The iShares Nasdaq Biotechnology ETF (IBB -2.4%) is down on increased volume. Shares have retraced over 5% since the recent close of 300 on September 22.
    • Alnylam (ALNY -48%) is leading the rout after it announced that it was dropping development of RNAi candidate revusiran.
    • Representative tickers: (AMGN -0.3%)(BIIB -1.3%)(GILD -1.9%)(CELG -1.4%)(BMY)(MRK -0.7%)(PFE -1.2%)(VRTX -3%)(ALXN -2.2%)
    | Thu, Oct. 6, 3:32 PM | 25 Comments
  • Tue, Oct. 4, 12:27 PM
    • Dynavax (DVAX -9.7%) bulls are feeling a bit "penned in" this morning on the heels of an article just published by TheStreet's Adam Feuerstein delving into the prospects for FDA approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] after it canceled the Advisory Committee meeting to review the company's Biologics License Application (BLA). Normally, Ad Comm reviews are done ~45 - 60 days before the agency's action date (PDUFA). A positive vote by the majority of Committee members typically portends approval. The PDUFA date for the HEPLISAV-B BLA is December 15.
    • On occasion, Ad Comm meetings are canceled, normally a bearish development, but there have been strong opinions on both sides of the aisle in this case. Mr. Feuerstein wondered if a historical look at previous cancellations would be informative on HEPLISAV'B's potential fate. An unnamed investor did just that.
    • Going back to 2008, the FDA has canceled 15 previously scheduled Ad Comm meetings, 13 of which were eventual rejections. In the two cases where drugs were approved, Bristol-Myers Squibb's (BMY +1.2%) Yervoy (ipilimumab) and Celgene's (CELG +0.9%) Pomalyst (pomalidomide), the agency stated in its announcements that "...the issues for which the FDA was seeking scientific input of the committee have been resolved." Clear language implying that the agency had no lingering questions that needed answering before giving its nod to the products.
    • The FDA's wording is a bit different for the rejections, mentioning the need to "review and resolve outstanding issues." Investors may feel like "China watchers" as they try to decipher the agency's intentions, but even the most ardent of bulls may want to put a hedge in place before mid-December.
    | Tue, Oct. 4, 12:27 PM | 113 Comments
  • Mon, Sep. 12, 8:39 AM
    • Interim top-line data from an exploratory Phase 1b study assessing the effects of Celgene's (NASDAQ:CELG) GED-0301 (mongersen) on endoscopic and clinical outcomes in Crohn's disease patients showed positive effects after a 12-week treatment period.
    • The 63-subject study, called CD-001, evaluated three three different treatment regimens of GED-0301 followed by an observation phase of up to one year (off treatment). The primary endpoint was an assessment of GED-0301 on endoscopic outcomes as measured by the change from baseline in a scale called SES-CD (Simplified Endoscopic Activity Score for Crohn's disease) at Week 12. The results showed endoscopic improvement (at least a 25% improvement from baseline) in a proportion of patients and clinical response and remission across all treatment groups at Week 12.
    • Safety and tolerability were consistent with earlier studies.
    • Complete data from the 12-week treatment period will be presented at a scientific meeting later this year. Data from the observation phase are expected in 2017. Current Phase 3 studies are ongoing.
    • 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.
    | Mon, Sep. 12, 8:39 AM | 5 Comments
  • Wed, Sep. 7, 9:02 AM
    • Agios Pharmaceuticals (NASDAQ:AGIO) is up 15% premarket on increased volume in response to the announcement that collaboration partner Celgene (NASDAQ:CELG) plans to file a New Drug Application (NDA) with the FDA by year end seeking approval of Agios' AG-221 for the treatment of patients with advanced blood cancers who have a mutation in a protein called isocitrate dehydrogenase-2 (IDH2). Celgene will be discussing its plans for the NDA today at the Citi 11th Annual Biotech Conference in Boston.
    • The data supporting the NDA was generated in a Phase 1/2 study in patients with IDH2 mutation-positive acute myeloid leukemia (AML). AG-221 (enasidenib) inhibits IDH2.
    • In May, Agios and Celgene announced a collaboration to discover, develop and commercialize novel immuno-oncology therapies based on Agios' cellular metabolism research platform. The new partnership followed the expiration of the discovery phase of their 2010 agreement, which includes AG-221.
    • Previously: Celgene and Agios Pharma team up in immuno-oncology; Agios up 4% after hours (May 17)
    | Wed, Sep. 7, 9:02 AM | 3 Comments
  • Fri, Sep. 2, 1:19 PM
    • In a factsheet just published on Presidential candidate Hillary Clinton's website, she outlines her plan to reign in rogue drug companies who aggressively increase the prices of their medicines.
    • Her plan features three methods for containing runaway drug costs: make alternatives available and increase competition; enable emergency importation of safe treatments and fine drug firms for unjustified price increases.
    • Her first action, as President, will be to create a dedicated group of representatives from Federal agencies that oversee health and safety and fair competition that will be charged with protecting consumers from "outlier" price increases. The group will establish criteria for determining if a price increase is justified for a long-available treatment and investigate and consider enforcement in certain situations.
    • In cases where the level of competition is light, her plan will enable the emergency purchases of alternative versions and make them available to patients in need while encouraging competition from additional suppliers.
    • She also calls for legislation to safely and securely import drugs from foreign nations whose regulatory regimes are as robust as the FDA, with the proviso of a "careful review" by the agency (more temporary than permanent).
    • In cases where miscreant drug firms are fined, the funds will be used to support new programs to make lower-cost alternatives available and speed up approvals in order to beef up competition (specifics are not provided).
    • In her broader plan to lower prescription drug costs for all Americans, she proposes a cap on out-of-pocket costs, additional funding to support the clearing of the FDA's backlog of generic drug applications, prohibit "pay for delay" deals (long overdue), a moratorium on direct-to-consumer advertising and allowing Medicare to negotiate drug and biologic prices.
    | Fri, Sep. 2, 1:19 PM | 454 Comments
  • Thu, Sep. 1, 11:22 AM
    • OncoMed Pharmaceuticals (OMED +0.2%) completes the enrollment of 207 subjects in its Phase 2 clinical trial, YOSEMITE, assessing demcizumab as first-line treatment of metastatic pancreatic cancer. Top-line data should be available in the first half of next year, probably near June.
    • YOSEMITE is comparing the safety and efficacy of demcizumab, in combination with standard-of-care (SOC) therapy [Celgene's (CELG -0.5%) Abraxane (paclitaxel protein-bound particles for injectable suspension) plus gemcitabine], to SOC alone. Participants have been randomized into one of three arms: SOC + one course of demcizumab; SOC + demcizumab followed by a second course of demcizumab after a 98-day wash-out period and SOC + placebo.
    • The primary endpoint is progression-free survival. Secondary endpoints include overall survival, response rate and biomarker analyses.
    • Demcizumab is a humanized monoclonal antibody that binds to a protein called Delta-like Ligand 4 (DLL4) which plays a key role in a cellular signaling pathway called Notch. It appears to have a multi-faceted mechanism of action: halting cancer stem cell growth and reducing cancer stem cell frequency, disrupting tumor angiogenesis (formation of new blood vessels) and increasing anti-tumor immune responses by decreasing tumor myeloid-derived suppressor cells.
    | Thu, Sep. 1, 11:22 AM | 2 Comments
  • Tue, Aug. 23, 7:35 AM
    • Janssen-Cilag International NV (NYSE:JNJ) submits a Type II variation application to the European Medicines Agency (EMA) seeking approval of DARZALEX (daratumumab), in combination with lenalidomide [Celgene's (NASDAQ:CELG) REVLIMID] and dexamethasone or bortezomib [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYYVELCADE] and dexamethasone, for the treatment of adult patients with relapsed multiple myeloma (MM) who have received at least one prior line of therapy.
    • DARZALEX is currently approved in the EU as monotherapy in adult patients with relapsed/refractory MM whose prior therapy included a proteasome inhibitor (i.e., VELCADE) and an immunomodulatory agent (i.e., REVLIMID) and experienced disease progression on the last therapy.
    • In two Phase 3 studies, CASTOR and POLLUX, supporting the application MM patients who had received one or more prior lines of therapy who were treated with one of the combinations experienced greater than a 60% reduction in the risk of disease progression or death (hazard ratio less than 0.40).
    | Tue, Aug. 23, 7:35 AM
  • Sun, Aug. 21, 6:39 PM
    • Pfizer (NYSE:PFE) is close to a $14B deal to acquire cancer drugmaker Medivation (NASDAQ:MDVN), FT says.
    • The price is about 1/3 higher than Medivation's closing price on Friday.
    • Pfizer would be beating out rivals including Celgene (NASDAQ:CELG), Gilead (NASDAQ:GILD), Sanofi (NYSE:SNY), Merck (NYSE:MRK) and AstraZeneca (NYSE:AZN), who have been pursuing Medivation for months.
    • Medivation has already rejected two "inadequate" bids from Sanofi, the last for $11B ($58/share).
    • Shares of Medivation have more than doubled in the last six months.
    • Medivation makes the leading prostate cancer drug, Xtandi, which is expected to generate $5.7B in annual revenue by 2020.It is also developing an experimental drug called Talazoparib, which is designed to stop tumor cells from multiplying by damaging their DNA.
    • Update: It's official. Pfizer will acquire Medivation for $81.50 a share (~$14B). The deal will be immediately accretive to Pfizer's non-GAAP EPS, adding ~$0.05 in the first full year after the transaction closes, expected by Q4. Its 2016 guidance will be unaffected. The deal will be financed with existing cash. Pfizer will host a conference call this morning at 9:00 am ET to discuss the acquisition.
    | Sun, Aug. 21, 6:39 PM | 92 Comments
  • Wed, Aug. 17, 4:08 PM
    • Janssen Biotech (NYSE:JNJ) submits a supplemental Biologics License Application (sBLA) to the FDA seeking approval of the use of DARZALEX (daratumumab), in combination with lenalidomide [Celgene's (NASDAQ:CELG) Revlimid] and dexamethasone or bortezomib [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE] and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
    • The FDA granted Breakthrough Therapy status for DARZALEX for this indication last month. Janssen has requested Priority Review of the filing.
    • The FDA approved DARZALEX in November 2015 as monotherapy for MM patients who have received at least three prior lines of therapy.
    | Wed, Aug. 17, 4:08 PM | 9 Comments
  • Wed, Aug. 17, 1:30 PM
    • In-play Medivation (MDVN +2.1%) perks up on modestly higher volume on the news that Merck (MRK -0.3%) has joined Sanofi (SNY -0.5%), Celgene (CELG +0.3%), Gilead Sciences (GILD +1.7%), Pfizer (PFE +0.6%) and AstraZeneca (AZN -0.2%) as potential acquirers.
    • Medivation has already rejected two "inadequate" bids from Sanofi, the last for $11B ($58/share).
    | Wed, Aug. 17, 1:30 PM | 36 Comments
  • Mon, Aug. 15, 2:57 PM
    • Sorrento Therapeutics (SRNE +6.8%) appoints Jerome Zeldis, M.D., Ph.D., as Chief Medical Officer and President of Clinical Development. He joins the firm from Celgene (CELG +1.1%) where he was CMO and CEO of Celgene Global Health.
    | Mon, Aug. 15, 2:57 PM