Biogen Idec Has BG-12, But What Excites Investors Next?
Stephen Simpson, CFA
Stephen Simpson, CFA
Fri, Apr. 29, 12:35 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions recommending approval of new indications for Roche's (OTCQX:RHHBY -0.4%) Gazyvaro (obinutuzumab) and Avastin (bevacizumab).
- The thumbs up for Gazyvaro is the treatment of follicular lymphoma, in combination with bendamustine chemo, followed by maintenance therapy with Gazyvaro in patients who failed to respond to or progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen, an indication already approved in the U.S.
- CHMP's positive recommendation was based on results from the Phase 3 GADOLIN study which showed treatment with Gazyvaro reduced the risk of cancer worsening or death by 52%.
- Gayzvaro/Gazyva, a CD20-directed monoclonal antibody, is currently approved for the treatment of chronic lymphocytic leukemia.
- The thumbs up for Avastin is the first-line treatment, in combination with Tarceva (erlotinib), of adults with EGFR-positive, unresectable, advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). A mid-stage study, JO25567, showed treatment with Avastin extended progression-free survival by a median of 6.3 months. Avastin is currently approved for a range of cancers, including non-squamous NSCLC (in combination with carboplatin and paclitaxel).
- Final decisions by the European Commission usually take ~60 days.
- Related ticker: (BIIB -2.5%)
Fri, Apr. 29, 11:29 AM
Fri, Apr. 29, 8:01 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of AbbVie (NYSE:ABBV) and co-developer Biogen's (NASDAQ:BIIB) ZINBRYTA (daclizumab) for the treatment of relapsing forms of multiple sclerosis (MS). A final decision from the European Commission usually takes ~60 days.
- Daclizumab is a new form of humanized monoclonal antibody that selectively binds to interleukin-2 (IL-2) receptor subunit CD25, a protein that is over-expressed on T cells that become abnormally activated in MS. It modulates IL-2 signaling without causing general immune cell depletion. It is administered once per month via subcutaneous injection.
- Their marketing application is currently under review in the U.S.
- AbbVie secured the rights to daclizumab via its $450M acquisition of Facet Biotech in March 2010.
Wed, Apr. 27, 9:51 AM
Thu, Apr. 21, 7:47 AM
- Biogen (NASDAQ:BIIB) Q1 results ($M): Total Revenues: 2,726.8 (+6.7%); Net Product Sales: 2,309.4 (+6.3%).
- Net Income: 970.9 (+18.0%); Non-GAAP Net Income: 1,049.4 (+16.6%); EPS: 4.43 (+26.9%); Non-GAAP EPS: 4.79 (+25.4%).
- Key Product Sales: Tecfidera: 945.9 (+7.1%); Total Interferon (Avonex + Plegridy): 670.4 (-11.1%); Tysabri: 477.0 (+3.1%); Eloctate: 107.7 (+100.9%).
Thu, Apr. 21, 7:16 AM
Wed, Apr. 20, 5:30 PM
- ADS, ALK, AZZ, BANC, BBT, BHE, BIIB, BK, BX, CFG, CLS, COL, DAN, DGX, DHI, DHR, DOV, DST, ERIC, FAF, FCS, FITB, GM, GMT, HOMB, IMAX, JAKK, JCI, KCG, KEY, LAD, LAZ, LUV, MAN, MDSO, MDWD, NUE, NVR, NVS, PBCT, PHM, PII, POOL, PPG, PVTB, RS, SHW, SILC, SNA, SON, STC, SWK, SYNT, TCB, TRV, UA, UNP, USG, UTEK, VZ
Wed, Apr. 20, 11:18 AM
- According to Leerink's Geoff Porges, drug makers appear to be taking little heed to politicians' outcries over high prices. In a research note, he says, "The price increases for established brands across our coverage have been substantial indeed. To the surprise of many investors, it now appears these price increases are likely to flow through to actual sales growth, with such growth more than offsetting any volume weakness in Q1 and resulting in significant positive revenue surprises for those companies when they report Q1 results."
- He cites Johnson & Johnson's (JNJ +0.8%) Q1 results released yesterday. Its total business was flat (+0.6%) but its pharmaceuticals unit was up 12.9%. His analysis showed as much as 90% of the list price increases are flowing through to reported sales, some as high as 100%.
- Over the past year, Amgen (AMGN +0.7%) increased its drug prices 8 - 28%, Gilead Sciences (GILD +0.9%) 10 - 18% for its HIV drugs and Biogen (BIIB -1.6%) 10 - 18%, according to Mr. Porges.
- Biogen reports tomorrow. Eli Lilly (LLY -0.3%), Baxalta (BXLT -1.4%), AbbVie (ABBV +0.9%), Celgene (CELG +0.4%), Bristol-Myers Sqibb (BMY +0.3%) and Shire (SHPG -1.6%) report next week. Pfizer (PFE +1%) and Merck (MRK -0.2%) report the week after. Amgen (AMGN +0.7%) is due to report shortly as is Gilead.
Fri, Apr. 1, 3:45 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of FLIXABI (infliximab), a biosimilar to Johnson & Johnson's (JNJ +0.9%) Remicade (infliximab), developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen (BIIB).
- If approved, it will be the second biosimilar developed by Samsung Bioepis to be cleared in the EU. BENEPALI, a biosimilar to Amgen's (AMGN +2.8%) Enbrel (etanercept), was approved in January.
- A final decision from the European Commission usually takes ~60 days.
- Previously: First Enbrel biosimilar cleared in Europe (Jan. 17)
- Read now Samsung Bioepis And Biogen: A Profitable Case For SB2 and Enbrel
- Update: On May 30, Biogen announced that FLIXABI was approved by the European Commission.
Thu, Mar. 31, 9:07 AM
- Interim results after the completion of the 24-week treatment period in RedHill Biopharma's (NASDAQ:RDHL) Phase 2a clinical trial, CEASE-MS, assessing RHB-104 as add-on therapy to interferon beta-1a for in 18 patients with relapsing-remitting multiple sclerosis (MS) showed promising results compared to interferon beta-1a alone.
- RHB-104 demonstrated an annualized relapse rate (ARR) at week 24 of 0.288 per patient-year in the modified intent-to-treat (mITT) population and 0.0 in the per-protocol (PP) population. This beat published relapse rates for interferon beta-1a alone [Biogen's (NASDAQ:BIIB) Avonex; (0.67 per patient-year) and EMD Serono's Rebif; (0.87 - 0.91 per patient-year)].
- 88% of the mTT patient population and 100% of the PP patient population were relapse-free at week 24. This, again, compared favorably with Avonex (63%) and Rebif (75%) as reported in previous studies.
- RHB-104 was safe and well-tolerated with no drug-related serious adverse event reported.
- A full analysis and final Clinical Study Report should be completed in Q2.
- RHB-104, an antibiotic combination therapy, is currently in Phase 3 development for Crohn's disease.
- Shares are up 2% premarket on light volume.
- Now read RedHill Biopharma - 9 Late Stage Clinical Assets»
Wed, Mar. 30, 11:19 AM
- "What concerns us most is the continued extreme overweight in lower quality stocks," says BAML's Savita Subramanian. A strategy of buying the ten most underweight stocks and selling the ten most overowned stocks has generated an average alpha of 15 percentage points per year, she says.
- This chart from the BAML report shows the 11 most overowned stocks based on percentage of funds holding vs. their weighting in the S&P 500. At the top is PCLN, followed by MA, BIIB, V, MDT, TWX, ESRX, BA, AMGN, CELG, AMZN.
- Among those underowned are: AGL Resources (NYSE:GAS) and Diamond Offshore (NYSE:DO).
- via Scott Barlow
Wed, Mar. 30, 10:33 AM
Mon, Mar. 28, 6:57 AM
- Following through on its October 2015 announcement that it would seek a development partner, XenoPort (NASDAQ:XNPT) enters into a license agreement with Dr. Reddy's Laboratories (NYSE:RDY) for exclusive U.S. rights to Phase 3-stage XP23829, its candidate for plaque psoriasis and, potentially, relapsing forms of multiple sclerosis (MS).
- Under the terms of the deal, Dr. Reddy's will receive exclusive rights in the U.S. to develop and commercialize XP23829 for all indications. XenoPort will receive an upfront payment of $47.5M, $2.5M for the transfer of certain clinical trial materials to Dr. Reddy's, up to $190M in regulatory milestones, up to $250M in commercial milestones and mid-teens royalties on net U.S. sales.
- In October 2015, the company announced that it would focus on maximizing the value of HORIZANT (gabapentin enacarbil), its one commercial product, and discontinue its sole development of XP23829.
- XP23829 is an orally available fumaric acid ester compound that is a prodrug of monomethyl fumarate (MMF). Once absorbed in the body, it is rapidly converted to MMF which has shown immuno-modulatory effects and neuroprotective effects in preclinical testing. Another MMF prodrug is Biogen's (NASDAQ:BIIB) Tecfidera (dimethyl fumarate), approved by the FDA in March 2013 for the treatment of MS.
- A Phase 2 study assessing XP23829 in moderate-to-severe plaque psoriasis was successful.
- Previously: XenoPort's XP23829 successful in mid-stage psoriasis study; shares up 16% premarket (Sept. 15, 2015)
- Previously: XenoPort to focus on HORIZANT; new CEO named (Oct. 1, 2015)
Thu, Mar. 17, 6:27 AM
- The FDA approves Bayer's (OTCPK:BAYRY) KOVALTRY Antihemophilic Factor (Recombinant), an unmodified full-length factor VIII compound for the treatment of children and adults with hemophilia A. KOVALTRY can be used two to three times per week in adolescents and adults and up to every other day in children.
- Hemophilia A, or factor VIII deficiency, affects 16,000 Americans.
- KOVALTRY was cleared in the EU and Canada in February.
- Related tickers: (NYSE:BXLT)(NYSE:BAX)(OTCQX:RHHBY)(NASDAQ:DMTX)(NYSE:SNY)(NASDAQ:ALNY)(NASDAQ:BIIB)(NYSE:OPK)(NASDAQ:SGMO)
Mon, Mar. 7, 7:05 AM
- The FDA approves CSL Behring's IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] for the routine prophylaxis of hemophilia B in children and adults to prevent or reduce the frequency of bleeding episodes, on-demand control and prevention of bleeding episodes and the perioperative (around the time of surgery) management of bleeding.
- IDELVION's principal value proposition is 14-day dosing. This is achieved via the maintaining of high levels of factor activity, above 5% over 14 days at 75 IU/kg.
- IDELVION will be available later this month.
- Related tickers: (NASDAQ:BIIB)(NYSE:NVO)(NASDAQ:DMTX)(NASDAQ:QURE)(NASDAQ:SGMO)(NYSE:BAX)
Fri, Feb. 26, 1:53 PM
- GlaxoSmithKline (GSK -0.9%) initiated with Hold rating and 1400p price target (-0.7% downside risk) by Cantor Fitzgerald.
- Shire plc (SHPG -0.6%) initiated with Buy rating by Cantor Fitzgerald.
- Insulet (PODD +8.7%) initiated with Sell rating and $15 (53% downside risk) price target by Empire Asset Management.
- MacroGenics (MGNX +2.2%) initiated with Equal Weight rating and $20 (29% upside) price target by Morgan Stanley.
- Biogen (BIIB +0.8%) initiated with Buy rating and $345 (30% upside) price target by Citigroup.
- Boston Scientific (BSX -0.3%) initiated with Buy rating and $21 (22% upside) price target by SunTrust Robinson Humphrey.
- Other initiations by Citigroup: Amgen (AMGN +1.1%) Neutral rating and $165 (11% upside) price target; Celgene (CELG +1.4%) Buy rating and $130 (25% upside) price target; Regeneron Pharmaceuticals (REGN) Buy rating and $480 (22% upside) price target; Alexion Pharmaceuticals (ALXN +0.1%) Neutral rating and $165 (18% upside) price target.
- IMS Health Holdings (IMS +0.2%) initiated with Outperform rating and $31 (19% upside) price target by Leerink Swann.
- Ocera Therapeutics (OCRX +5.7%) initiated with Buy rating and $10 (229% upside) price target by Brean Capital.
- Repligen (RGEN +3.8%) initiated with Buy rating and $36 (35% upside) price target by Craig-Hallum.
- Mesoblast (MESO -2.2%) initiated with Neutral rating and $5.50 (12% downside risk) price target by Chardan Capital.
- Ultragenyx Pharmaceutical (RARE +1.2%) initiated with Buy rating and $80 (29% upside) price target by Leerink Swann.
- Teva Pharmaceutical Industries (TEVA -0.2%) initiated with Outperform rating with $68-71 (21% upside from midpoint) price target by Wells Fargo.
- Medivation (MDVN +9.8%) initiated with Buy rating and $46 (28% upside) price target by Bank of America.
- Collegium Pharmaceutical (COLL -0.1%) initiated with Outperform rating and $35 (83% upside) price target by William Blair.
Biogen, Inc. is a global biotechnology company, which develops markets and manufactures therapies for people living with neurological, autoimmune and hematologic disorders. Its products include AVONEX, PLEGRIDY, TECFIDERA, TYSABRI, and FAMPYRA for multiple sclerosis, ALPROLIX for hemophilia B... More
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