Biogen Idec Has BG-12, But What Excites Investors Next?
Stephen Simpson, CFA
Stephen Simpson, CFA
Thu, Jul. 21, 9:15 AM
Thu, Jul. 21, 7:44 AM
- Biogen (NASDAQ:BIIB) Q2 results ($M): Total Revenues: 2,894.2 (+11.7%); Net Product Sales: 2,466.0 (+12.2%).
- Net Income: 1,049.8 (+13.2%); Non-GAAP Net Income: 1,142.4 (+14.8%); EPS: 4.79 (+21.9%); Non-GAAP EPS: 5.21 (+23.5%).
- Key Product Sales: Tecfidera: 986.5 (+5.2%); Interferon: 728.3 (+18.4%); Tysabri: 497.4 (+7.4%); Eloctate: 124.7 (+67.8%); Alprolix: 80.3 (+47.3%).
- 2016 Guidance: Revenue: $11.2B - 11.4B; EPS: $18.10-18.40; Non-GAAP EPS: $19.70-20.00.
- Note: CEO George Scangos, Ph.D., will step down after a successor is named.
Thu, Jul. 21, 7:04 AM
Wed, Jul. 20, 5:30 PM| Wed, Jul. 20, 5:30 PM | 13 Comments
Mon, Jul. 18, 7:18 AM
- The European Medicines Agency accepts for review Samsung Bioepis' Marketing Authorization Application (MAA) seeking approval of SB5, its biosimilar candidate to AbbVie's (NYSE:ABBV) Humira (adalimumab).
- SB5 is the third anti-TNF-alpha biosimilar candidate submitted for review by Samsung Bioepis. Benepali (etanercept) was approved in January and Flixabi (infliximab) was approved in May. If the MAA for SB5 is approved, Biogen (NASDAQ:BIIB) will be responsible for commercialization.
- Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. It has 13 biosimilar candidates in its pipeline, including six in its first wave. It is responsible for development and manufacturing of all immunology and oncology biosimilar candidates as well as global clinical trials and regulatory submissions. Following approval, Biogen and Merck (NYSE:MRK) are responsible for marketing and distribution.
Mon, Jul. 18, 7:04 AM
- A Phase 3 clinical trial, GOYA, assessing Roche's (OTCQX:RHHBY) Gazyva/Gazyvaro (obinutuzumab) plus CHOP chemotherapy in treatment-naive patients with diffuse large B-cell lymphoma (DLBCL) failed to meet its primary endpoint of a statistically valid increase in progression-free survival (PFS) compared to MabThera/Rituxan (rituximab) plus CHOP chemo.
- Full results from GOYA will be presented at a future medical conference.
- Gazyva (branded as Gazyvaro ex-U.S.), developed with collaboration partner Biogen (NASDAQ:BIIB), is an engineered monoclonal antibody that binds to CD20, a protein expressed on certain types of B cells. It is believed to work by attacking targeted cells both directly and together with the immune system.
- It is currently approved in the U.S. for the treatment of chronic lymphocytic leukemia and follicular lymphoma, both in combination with certain types of chemo.
Thu, Jul. 14, 4:32 PM
- Juno Therapeutics (NASDAQ:JUNO) acquires privately held Boston, MA-based RedoxTherapies. Juno's primary aim of the deal was to secure an exclusive license to vipadenant, a small molecule adenosine A2a receptor antagonist that may disrupt key immunosuppressive pathways in the tumor microenvironment in certain cancers.
- Redox licensed vipadenant from London-based Vernalis in October 2014. It was under development for the treatment of Parkinson's disease by Biogen (NASDAQ:BIIB) but safety concerns scuppered the effort in 2010 despite encouraging efficacy in mid-stage studies. Biogen returned the rights to Vernalis in 2011.
- Under the terms of the transaction, Juno will pay $10M in upfront cash plus undisclosed milestones.
Tue, Jul. 5, 9:20 AM
- Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV) announces that the European Commission (EC) has granted marketing authorization for ZINBRYTA (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). ZINBRYTA is a once-monthly, self-administered, subcutaneous injection.
- ZINBRYTA has an immunomodulatory mechanism of action that regulates inflammation without broadly depleting the immune system and immune cell effects are reversible within six months. It offers an alternative approach to treating multiple sclerosis (MS) and is an important consideration when deciding how to sequence therapies throughout the course of a patient’s disease.
- The EC approval of ZINBRYTA is supported by results from two studies, Phase 3 DECIDE and Phase 2b SELECT involving 2,400 subjects.
- 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. One negative is a boxed warning that daclizumab can cause liver injury. Patients are required to have liver function tests performed prior to starting therapy, before each monthly dose and up to six months after the last dose.
- Previously: Europe Ad Comm backs AbbVie and Biogen's MS drug Zinbryta (April 29)
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. 27, 7:17 AM
- Switzerland's healthcare regulator Swissmedic approves Swedish Orphan Biovitrum AB's (OTC:BIOVF) hemophilia A treatment, Elocta (efmoroctocog alfa), a recombinant factor VIII Fc fusion protein with an extended half-life which enables prolonged protection against bleeding episodes with injections every three to five days. It is indicated for both on-demand and prophylaxis treatment of hemophilia A patients of all ages.
- Elocta is being co-developed and co-commercialized with Biogen (NASDAQ:BIIB). Swedish Orphan has final development and commercialization rights in Europe, North Africa and most Middle Eastern countries. Biogen leads development and manufacturing and has commercialization rights in North America (branded as Eloctate) and other regions worldwide not covered by Swedish Orphan.
Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Wed, Jun. 15, 5:32 PM
Tue, Jun. 14, 7:54 AM
- Micro cap Infinity Pharmaceuticals (NASDAQ:INFI) is down 67% premarket on increased volume in response to its announcement that will close down its discovery research organization and lay off 46 employees (21% of its workforce) prompted by less-than-expected results in a mid-stage study assessing lead product candidate duvelisib for the treatment of refractory indolent non-Hodgkin lymphoma (iNHL), a slow-growing blood cancer. In addition, the company and development partner AbbVie (NYSE:ABBV) have agreed to pause AbbVie's Phase 1b/2 trial evaluating the combination of duvelisib and venetoclax while Infinity evaluates its options with duvelisib.
- The Phase 2 clinical trial, DYNAMO, assessed duvelisib as monotherapy in 129 patients with follicular lymphoma (n=83), small lymphocytic lymphoma (n=28) or marginal zone lymphoma (n=18) whose disease progressed or did not respond to treatment with Biogen's (NASDAQ:BIIB) Rituxan (rituximab) and either chemotherapy or radiotherapy. The primary endpoint was overall response rate (ORR).
- Results showed an ORR of 46%, all partial responders and below expectations. The ORR in the three lymphoma types listed above were 41%, 68% and 33%, respectively. The data will be submitted to presentation at a future medical conference.
- The most common serious adverse events (Grade 3 or higher) were neutropenia (low neutrophils) (28%), diarrhea (15%), thrombocytopenia (low blood platelets) (13%) and anemia (12%). 20% of participants experienced an infection of least Grade 3 (serious).
- CEO Adelene Perkins says, "While DYNAMO met its primary endpoint, we hoped that treatment with duvelisib as monotherapy would have provided a larger clinical benefit....We plan to seek feedback from the FDA to determine our next steps with respect to duvelisib in iNHL."
- Duvelisib is an investigational inhibitor of Class 1 phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma being jointly developed by Infinity and AbbVie. The PI3K pathway plays a key role in regulating the growth and survival of certain blood cancers. Inhibiting PI3K-delta and PI3K-gamma signaling blocks the growth and survival of tumor cells.
- Infinity will release updated guidance after all these activities have been completed. Management will host a conference call at 8:30 am to discuss the situation.
Tue, Jun. 7, 12:50 PM
Tue, Jun. 7, 11:00 AM
Tue, Jun. 7, 9:13 AM
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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