Fri, Nov. 20, 6:51 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Samsung Bioepis' Benepali, a biosimilar version of Amgen's (NASDAQ:AMGN) Enbrel (etanercept), for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.
- This is the first time CHMP has backed an etanercept biosimilar. A final decision by the European Commission usually takes ~60 days.
- Samsung Bioepis is a joint venture between Samsung Biologics and Biogen (NASDAQ:BIIB).
Tue, Nov. 10, 7:58 AM
- Isis Pharmaceuticals (NASDAQ:ISIS) earns a $2.8M milestone payment from strategic alliance partner Biogen (NASDAQ:BIIB) for the advancement of the ongoing Phase 1/2a study of ISIS-DMPK-2.5rx in patients with myotonic dystrophy type 1 (DM1). To date, Isis has earned almost $27M from Biogen related to the product candidate.
- DM1 is a debilitating rare inherited neuromuscular disorder characterized by progressive muscle atrophy, painful muscle spasms, cataracts, heart conduction defects, endocrine abnormalities and myotonia (inability to relax voluntary muscle after effort). It affects ~150K people in the U.S., Europe and Japan. It is caused by defects in the dystrophia myotonica-protein kinase (DMPK) gene.
- ISIS-DMPK-2.5rx is designed to reduce the production of DMPK RNA in cells, including muscle cells, which reduces the accumulation of abnormally long toxic RNA in the nucleus of cells. The accumulation prevents the production of proteins needed for normal cellular function.
Thu, Oct. 29, 7:37 AM
- Based on discussions with the FDA, Alkermes (NASDAQ:ALKS) intends to file its New Drug Application (NDA) for ALKS 8700 for the treatment of multiple sclerosis (MS) in 2018 via the streamlined 505(b)(2) pathway which will allow the company to use pharmacokinetic bridging data from studies comparing ALKS 8700 to Biogen's (NASDAQ:BIIB) TECFIDERA (dimethyl fumarate) in addition to a two-year Phase 3 safety study of ALKS 8700 in ~600 MS patients. Alkermes will not be required to run a separate Phase 3 efficacy trial in MS patients.
- The company plans to initiate a 420-subject, randomized, head-to-head study comparing the gastrointestinal tolerability of ALKS 8700 and TECFIDERA in mid-2016. It expects to complete the studies and file the NDA in 2018.
- Alkermes recently completed a Phase 1 trial that showed ALKS 8700's bioequivalence to TECFIDERA based on pharmacokinetic criteria.
- ALKS 8700 is an oral proprietary monomethyl fumarate molecule in development for the treatment of MS. It is designed to offer unique features compared to TECFIDERA, Biogen's top seller at almost $3.6B per year.
Wed, Oct. 28, 9:32 AM
- Regulus Therapeutics (NASDAQ:RGLS) earns its fourth (and apparently final) milestone payment from Biogen (NASDAQ:BIIB) related to their research collaboration to identify microRNAs as biomarkers for multiple sclerosis (MS). It earned the milestone by analyzing the treatment effects of a Biogen MS drug on circulating microRNA profiles previously identified by Regulus.
- The companies started their collaboration in August 2012 and expanded their research in August 2014 to identify potential microRNA biomarkers in MS. Regulus earned $3.7M in payments from Biogen under the agreement, which is now concluded.
Wed, Oct. 21, 1:22 PM
Wed, Oct. 21, 9:20 AM
- Biogen's (NASDAQ:BIIB) Phase 3 clinical trial, ASCEND, evaluating Tysabri (natalizumab) for the treatment of secondary progressive multiple sclerosis (SPMS) failed to achieve its primary and secondary endpoints.
- The primary endpoint was a composite measure that assessed the proportion of patients whose disability had progressed on one or more of three metrics comprising the endpoint. Tysabri did show a statistically significant effect on one of the three, upper limb function, though. The results will be presented at a future medical conference.
- Tysabri is currently cleared in the U.S. for the treatment of relapsing forms of MS to slow the worsening of symptoms and to decrease the number of flare-ups.
- SPMS is an advanced form of MS that follows the relapsing remitting stage (RRMS). About 85% of RRMS patients progress to SPMS.
Wed, Oct. 21, 9:15 AM
Wed, Oct. 21, 8:09 AM
- Biogen (NASDAQ:BIIB) Q3 results ($M): Total Revenues: 2,777.9 (+10.6%); Net Product Sales: 2,391.7 (+13.0%).
- Net Income: 965.6 (+12.7%); EPS: 4.15 (+14.6%); Non-GAAP EPS: 4.48 (+17.9%).
- Key Product Sales: Tecfidera: 937.4 (+2.3%); Avonex: 685.1 (-7.6%); Tysabri: 497.7 (-0.7%); Plegridy: 99.7 (+999%); Eloctate: 90.6 (+319.4%).
- 2015 Guidance: Revenue Growth: 8 - 9% from 6 - 8%; EPS: $14.65 - 14.95 from $14.25 - 14.70; Non-GAAP EPS: $16.20 - 16.50 from $15.50 - 15.95.
- The company announces a corporate restructuring that includes the termination of certain pipeline programs, an 11% reduction in workforce and a $250M reduction in annual operating expenses. The savings will be reinvested to support commercial activities related to Tecfidera and the advancement of high potential pipeline candidates in Alzheimer's disease, multiple sclerosis (MS) and spinal muscular dystrophy. The reduction in headcount will be completed this quarter. Development programs cut include the Phase 3 program for Tecfidera in secondary progressive MS, anti-TWEAK in lupus nephritis and others in immunology and fibrosis.
- Shares are up 6% premarket on increased volume.
Wed, Oct. 21, 7:32 AM
Tue, Oct. 20, 5:30 PM
Tue, Oct. 20, 9:57 AM
Fri, Oct. 16, 10:24 AM
- Isis Pharmaceuticals (ISIS +1.1%) commences an open-label extension study, called SHINE, that will provide ISIS-SMNrx to infants and children with spinal muscular atrophy (SMA) who completed their participation in the Phase 3 ENDEAR and CHERISH studies. ENDEAR graduates will receive a 12 mg dose of ISIS-SMNrx every four months while CHERISH graduates will receive a 12 mg dose every six months.
- The initiation of SHINE triggers an $11M milestone payment from co-developer Biogen (BIIB +0.4%).
- Isis intends to report data from both CHERISH and ENDEAR in late 2016/early 2017.
- SMA is a severe inherited disorder characterized by the lost of control of muscle movement that affects ~35K people in the U.S., Europe and Japan. It is caused by the absence of or mutations in a gene called survival motor neuron 1, which plays a critical role in the health and survival of nerve cells in the spinal cord.
- Fast Track- and Orphan Drug-tagged ISIS-SMNrx is an antisense drug designed to correct the splicing defect that causes SMA by increasing the production of fully functional SMN protein.
Tue, Oct. 13, 3:49 PM
- Getting out in front of what should be more bashing of their business models at the Democratic debate tonight, the healthcare names (XLV -1.3%) have about doubled the decline in the S&P 500. Within healthcare, it's the biotechs (IBB -3.1%) and pharmaceuticals (XPH -3.2%) leading the way south.
- Celgene (CELG -3.3%), Biogen (BIIB -3.6%), Amgen (AMGN -3.5%), Allergan (AGN -4.1%), Mylan (MYL -3.6%)
- The biotech heavy Russell 2000 (IWM -1.4%) is feeling the pain as well.
- ETFs: IBB, IYH, XLV, XBI, VHT, PJP, BBH, FBT, HQH, CURE, XPH, HQL, PBE, FXH, RXL, IHE, FHLC, SBIO, PPH, RYH, BBC, THQ, BBP, RXD, LABU, LABD, UBIO, ZBIO
Fri, Oct. 9, 7:54 AM
- Tony Kingsley, Biogen's (NASDAQ:BIIB) EVP, Global Commercial Operations, decides to leave the company. The reason for his departure is not disclosed. John Cox, EVP, Pharmaceutical Operations & Technology will assume his duties until a replacement is named.
- Mr. Kingsley joined the firm in January 2010 as SVP, U.S. Commercial Operations.
Thu, Oct. 8, 12:57 PM
- Final results from the Phase 3 DECIDE study just published in the New England Journal of Medicine showed the superiority of ZINBRYTA (daclizumab high-yield process [HYP]) to interferon beta-1a 30 mcg IM injection in patients with relapsing-remitting multiple sclerosis (RRMS). The post-hoc analyses showed that more patients treatment with ZINBRYTA, co-developed by Biogen (BIIB -1.9%) and AbbVie (ABBV -1%), achieved significantly better outcomes across a range of measurements at two years compared to interferon beta-1a (Biogen's Avonex). The results were presented today at the 31st Congress of the European Committee for Treatment and Research in MS in Barcelona.
- 24.6% of patients receiving ZINBRYTA showed no evidence of disease activity at two years compared to 14.2% for interferon beta-1a (p<0.0001).
- The ZINBRYTA cohort showed greater improvement in cognitive processing speed and prevention of clinically meaningful cognitive decline as measured by the Symbol Digit Modalities Test (SDMT): (+4.08[12.4] vs. +2.89[12.7]; p=0.0274). Higher proportions of ZINBRYTA patients achieved at least a three-point gain (60.0% vs. 54.1%; p=0.0153) or a four-point gain (55.4% vs. 50.1%; p=0.0366) in SDMT scores at Week 96.
- 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.
- ZINBRYTA's New Drug Application (NDA) and Marketing Authorization Application (MAA) are currently under review at the FDA and EMA, respectively.
- Avonex is administered once per week via subcutaneous injection while daclizumab is administered once per month via the same route. Another Biogen offering for MS, Plegridy (peginterferon beta-1a), is administered once every two weeks.
Wed, Sep. 30, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
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