Wed, Apr. 22, 4:04 PM
- Hedge fund investor Kyle Bass, head of Dallas, TX-based Hayman Capital Management L.P., files a challenge to a key patent covering Biogen's (BIIB +0.6%) $2.9B Tecifera (dimethyl fumarate). Specifically, he is challenging the validity of U.S. Patent No. 8,759,393 entitled, "Utilization of Dialkylfumarates."
- Mr. Bass founded the group, Coalition for Affordable Drugs, which is targeting the '393 patent via a process called inter partes review, a type of patent challenge allowed by the 2012 American Invents Act. It was designed as a way to curtail the ballooning number of lawsuits by patent trolls. According to him, the group's raison d'etre is to stop companies from over-pricing drugs based on evergreening patents.
- Other companies in the crosshairs of the Coalition for Affordable Drugs include Shire (NASDAQ:SHPG) and Acorda Therapeutics (NASDAQ:ACOR).
Tue, Apr. 21, 12:38 PM
- Interim results from the first year of a two-year extension study (ATTAIN) of a Phase 3 trial (ADVANCE) evaluating Biogen's (BIIB) Plegridy (peginterferon beta-1a) in patients with relapsing-remitting multiple sclerosis (RRMS) show that continuous, fixed-dose treatment with Plegridy delivered robust long term efficacy. The results were consistent with those achieved in the ADVANCE trial.
- Patients with RRMS were administered Plegridy subcutaneously every two weeks for three years. In ADVANCE, the percentage of patients in the intent-to-treat population who achieved NEDA (no evidence of disease activity) was 34.8% in year one and 54.3% in year 2. In year one of ATTAIN, the proportion was 48.7%.
- The data were presented at the 67th American Academy of Neurology Annual Meeting in Washington, DC.
- Plegridy is a long-acting form of the company's top selling Avonex, which generated over $2.3B in sales the past four quarters. The FDA approved Plegridy in August 2014. It logged $41.1M in sales in Q4.
Tue, Apr. 21, 7:53 AM
- A new analysis of two Phase 3 trials shows that previously-treated patients with highly-active relapsing multiple sclerosis (RMS) who were treated with Novartis' Gilenya (fingolimod) had a 6x greater likelihood of achieving "no evidence of disease activity" across four key measures of disease activity compared to placebo over two years (p<0.0001). The disease status, called NEDA4, is achieved when an RMS patient has no relapses, no new MRI lesions, no MS-related brain shrinkage and no disability progression. It provides physicians with a more complete picture of an RMS patient's disease and response to therapy.
- A separate analysis of the data also confirmed that, after one year of treatment, RMS patients on Gilenya were 2x as likely to achieve NEDA4 as patients on Biogen's (NASDAQ:BIIB) Avonex (interferon beta-1a).
- The data were presented at the 67th American Academy of Neurology Annual Meeting in Washington, D.C.
- Gilenya is approved in the U.S. for the first-line treatment of RMS in adults and in Europe for adult patients with highly-active RMS.
Tue, Apr. 14, 12:05 PM
- The USPTO's Patent Trial and Appeal Board (PTAB) declares an interference between Forward Pharma's (FWP -1.3%) patent application 11/576,871 and Biogen's (BIIB -0.6%) issued patent No. 8,399,514. Both contain claims to methods of treating multiple sclerosis with 480 mg of dimethyl fumarate per day. Biogen's pertains to Tecfidera, which generated $2.9B in sales the past four quarters while Forward's pertains to its lead product candidate, FP187.
- The PTAB has designated Forward Pharma as the "Senior Party" in light of its earlier patent application filing date. This means that Biogen, as the "Junior Party," must prove that it is the first inventor. Should Forward prevail in the yet-to-be-scheduled hearing, its patent application will issue and Biogen's will be canceled, which obviously does not bode well for the fat margins it earns on Tecfidera. Biogen filed its patent application on February 13, 2012 while Aditech Pharma AG filed its application on October 7, 2005.
- An interference proceeding, also known as a priority contest, basically determines which party was first. It is a unique feature of U.S. patent law.
- Forward Pharma was created to exploit the patent family acquired from privately-held Swedish firm Aditech Pharma AG in 2010, which includes '871.
Wed, Apr. 1, 9:57 AM
- Receptos (RCPT -3.7%) completes patient enrollment in its RADIANCE Phase 3 study evaluating ozanimod (RPC1063) in patients with relapsing multiple sclerosis (RMS). The randomized, double-blind trial will assess whether ozanimod is superior to Biogen's (BIIB -2.7%) Avonex (interferon beta-1a) in reducing the annualized relapse rate in patients after two years of therapy.
- Ozanimod is an oral, once-daily selective sphingosine 1-phosphate 1 and 5 receptor modulator being developed for the treatment of autoimmune diseases. It diminishes the activity of autoreactive lymphocytes (white blood cells) which is the cause of many types of autoimmune disorders.
- In a Phase 2 RMS trial, it achieved its primary endpoint of reduction in MRI brain lesion activity.
Mon, Mar. 30, 8:00 AM
- The European Medicines Agency (EMA) validates (accepts for review) the Marketing Authorization Application (MAA) for SB2, Biogen's (NASDAQ:BIIB) biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). The MAA was submitted by the firm's joint venture partner, Samsung Bioepis. This is the second MAA accepted for review by the European regulator. It validated the MAA for SB4, a biosimilar to Amgen's (NASDAQ:AMGN) Enbrel (etanercept), earlier this year.
- Both SB2 and SB4 will be manufactured at Biogen's Hillerod, Denmark facility, once approved.
Fri, Mar. 27, 7:30 AM
- The European Medicines Agency (EMA) validates the Marketing Authorization Application for Zinbryta (declizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS). The regulator's confirmation that the application is complete signals the start of the review process.
- Zinbryta is a new form of humanized monoclonal antibody that selectively binds to interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become abnormally activated in MS. It modulates IL-2 signaling without causing general immune cell depletion. It is believed to work by decreasing abnormally-activated T-cells and pro-inflammatory lymphoid tissue inducer cells and increasing CD56bright natural killer cells, which help regulate the immune system.
- Zinbryta is being jointly developed by Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV).
- Previously: Zinbryta trumps Avonex in MS trial (Sept. 12, 2014)
Tue, Mar. 24, 7:14 AM
- Stifel Analyst Thomas Shrader downgrades Biogen (NASDAQ:BIIB) from Buy to Hold based on valuation. He agrees that the company is in driver's seat in neurological drug development, but notes that definitive data on BIIB037 is years away, as are revenues, while its safety could be an issue.
- Another significant risk is the Tecfidera patent fight with Forward Pharma, far from a certain win.
- His revenue model suggests the stock is worth $466 compared to yesterday's close of $463.73.
Mon, Mar. 23, 7:30 AM
- With a shortened name and new logo, Biogen (NASDAQ:BIIB) is entering a high risk-high return phase of its corporate life. CEO George Scangos, on board since 2010, is leading the firm into several difficult-to-treat areas in neurodegenerative diseases like Alzheimer's (AD), ALS and spinal muscular dystrophy. It won't take but one or two successes for the payoff to be huge.
- Shares jumped on Friday after the company announced positive Phase 1b results for its Alzheimer's candidate, BIIB037 (aducanumab). If the Phase 3, due to start later this year, is successful it could be the largest selling drug in history. As many as 75M people could be living with AD by 2030.
- Mr. Scangos says, "The future looks pretty exciting for us. If the Alzheimer's thing works, then we're not just an MS (multiple sclerosis) company. We are broadly focused on neurodegenerative diseases. Five years down the road, with some luck, we'll have an Alzheimer's drug that's getting approved. I hope we can transform the treatment of MS. By that time, we will have made substantial progress on ALS and nerve degenerative diseases, spinal muscular dystrophy in kids. All that stuff is on our plate. I am sure of two things, not all it is going to work, but some of it will."
- The company is also working on biosimilars to Amgen's (NASDAQ:AMGN) Enbrel (etanercept) and J&J's (NYSE:JNJ) Remicade (infliximab).
Fri, Mar. 20, 10:37 AM
- Biogen Idec (BIIB +6.3%) jumps of double normal volume in response to its announcement of positive interim results of a Phase 1b study evaluating BIIB037 (aducanumab) for the treatment of patients with early-stage Alzheimer's disease (AD). Treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque in the brain, the buildup of which is believed to play a key role in the development of AD symptoms.
- The interim analysis involved 166 patients up to Week 54 in four dosage cohorts: placebo, 1 mg/kg, 3 mg/kg and 10 mg/kg. A fifth arm, 6 mg/kg, involved 30-week data. The placebo arm was virtually unchanged at 26 and 54 weeks but there were statistically significant reductions in amyloid plaques in all dosage arms except 1 mg/kg at 26 weeks. At Week 54, greater reductions were observed in the 3 and 10 mg/kg arms (data from the 6 mg/kg arm was not available yet).
- Biogen group SVP and Chief Medical Officer Alfred Sandrock, M.D., Ph.D., says, "This is the first time an investigational drug for [AD] has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease. Based on these results, we are advancing the aducanumab clinical program to Phase 3 with plans to initiate enrollment later this year."
- An estimated 25M people live with AD worldwide. Drug candidates that target amyloid plaque have not been successful in clinical studies to date.
Fri, Mar. 20, 9:23 AM
Fri, Mar. 6, 9:28 AM
- Isis Pharmaceuticals (NASDAQ:ISIS) earns a $9M milestone payment from Biogen Idec (NASDAQ:BIIB) for advancing the ongoing Phase 3 trial evaluating ISIS-SMNrx for the treatment of infants with spinal muscular atrophy (SMA).
- The study is a randomized, double-blind, sham-procedure-controlled 13-month trial in ~110 infants diagnosed with SMA. The primary endpoint is survival or time to permanent ventilation.
Fri, Feb. 27, 9:59 AM
- Biogen Idec (BIIB -0.5%) and collaboration partner Swedish Orphan Biovitrum AB announce positive top-line results from a Phase 3 trial evaluating Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) in children under age 12 with severe hemophilia B.
- Medical professionals recommend prophylactic treatment in children with severe hemophilia in order to manage and/or prevent bleeding episodes, but frequent administration schedules can be burdensome for patients and caregivers. Alprolix is administered once every 7 - 10 days for routine prophylaxis (prevention).
- In the study, children treated with Alprolix experienced an overall median annualized bleeding rate (ABR) of 1.97, while the median ABR for spontaneous joint bleeds was zero. About one third of the participants had no bleeding episodes at all. Overall, 91.7% of bleeding episodes were controlled by one or two infusions of Alprolix. None of the patients produced inhibitors (antibodies) to Alprolix in the study, which was the most significant potential complication of treatment.
- The European Medicines Agency requires the inclusion of pediatric study data in the initial Marketing Authorization Application (MAA) for a new hemophilia treatment. Interim data were used in the U.S. New Drug Application (NDA).
- Alprolix is the only approved hemophilia B therapy with prolonged circulation in the body. The FDA cleared it in March of last year. It generated $25.3M and $40.3M in sales for Biogen in Q3 and Q4, respectively.
- Related tickers: (BAX +0.3%)(OPK -0.8%)(SGMO -1.9%)(ALNY -1.9%)(ONCE +3%)(PFE -0.2%)(SHPG -1.6%)
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Mon, Feb. 9, 12:21 PM
- The following are healthcare companies whose after-tax margins have expanded the past three quarters and trade at least 500K shares per day:
- (ACOR -0.7%)(BCR -1.5%)(BIIB -0.2%)(CAH -1.2%)(CPHD +1.3%)(EVHC -1.6%)(ILMN +0.7%)(JAZZ -1.7%)(LCI +7.3%)(MNK -0.5%)(SHPG -2.9%)(SYK -0.2%)(TMO -0.7%)(UTHR +1.4%)(VRX).
- This is not a list of "Buy" recommendations, but rather a targeted list of firms that may be suitable for more in-depth research.
Fri, Jan. 30, 12:31 PM
- Opko Health (OPK +3.5%) submits an Investigational New Drug Application (IND) to the FDA for clearance to commence a Phase 2a study evaluating its long-acting Orphan Drug-designated coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VII or Factor IX.
- Currently, Factor VIIa therapy is administered intravenously which requires multiple infusions, due to its short half-life, to treat a bleeding episode.
- The longer duration of action of Opko's Factor VIIa-CTP is based on the naturally occurring peptide, C-terminal peptide, of the beta chain of human chorionic gonadotropin (hCG).
- Opko acquired the rights to the product when it bought Prolor Biotech.
- Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
- Related tickers: (BAX +0.4%)(SGMO +0.6%)(ALNY +0.5%)(BIIB +11.4%)(OTCPK:BAYRY -1.4%)
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