Semiannual Report at p.6
"Biotechnology firm Biogen Idec, a developer of drugs that treat neurodegenerative diseases exceeded sales expectations for its new multiple sclerosis drug (MS) Techfidera which was also recently approved by the European Commission as a first-line treatment for the most common type of MS. Biogen Idec also benefitted from growing sales of another MS medication, Tysabri, bossted by the company's acquisition of full rights from Perrigo.".......
Mathew J Mohberg, CPA
Rupert H Johson, Jr. Portofolio Manager
Franklin DynaTech Fund
contact Leon Mulgrew 650-312-4958
Leon Charles Mulgrew - Financial Advisor - FindTheBest
financial-advisors.findthebest.com › Personal Finance › Financial Advisors
Leon Charles Mulgrew - Franklin/Templeton Distributors, Inc. Financial Advisor. View assets managed, advisory activities, and more.I submit that BCG is a better treatmant, a safer treatment and a more effective treatment.
I am also willing to demonstrate via time lapse video on You Tube of parts of me that BCG works well for the treatment of plaque psoriasis et al.
BCG provides you with some degree of protection from multi-drug resistant TB and TB in general
see also pubmed.org faustman dl and faustmanlab.org
brought to you by Hot Lead Healthcare in conjunction with the Hiram Maxim and Sam Stone Fan clubs.
Who can I call if I have further questions?
Biogen Idec’s investor relations department is happy to provide shareholders with a toll-free number to answer their questions. That number is (877) 420-BIIB (2442). If your question is merger-transaction specific (e.g. you lost your Biogen shares), please call Computershare at (781) 575-4593.
Result Filters
Neurology. 2014 Jan 7;82(1):41-8. doi: 10.1212/01.wnl.0000438216.93319.ab. Epub 2013 Dec 4.
Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.
Ristori G1, Romano S, Cannoni S, Visconti A, Tinelli E, Mendozzi L, Cecconi P, Lanzillo R, Quarantelli M, Buttinelli C, Gasperini C, Frontoni M, Coarelli G, Caputo D, Bresciamorra V, Vanacore N, Pozzilli C, Salvetti M.
Abstract
OBJECTIVE:
To evaluate Bacille Calmette-Guérin (BCG) effects after clinically isolated syndromes (CIS).METHODS:
In a double-blind, placebo-controlled trial, participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI (6 scans). Both groups then entered a preplanned phase with IM interferon-β-1a for 12 months. From month 18 onward, the patients took the disease-modifying therapies (DMTs) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months.RESULTS:
Of 82 randomized subjects, 73 completed the study (33 vaccinated and 40 placebo). During the initial 6 months, the number of cumulative lesions was significantly lower in vaccinated people. The relative risks were 0.541 (95% confidence interval [CI] 0.308-0.956; p = 0.03) for gadolinium-enhancing lesions (the primary endpoint), 0.364 (95% CI 0.207-0.639; p = 0.001) for new and enlarging T2-hyperintense lesions, and 0.149 (95% CI 0.046-0.416; p = 0.001) for new T1-hypointense lesions. The number of total T1-hypointense lesions was lower in the BCG group at months 6, 12, and 18: mean changes from baseline were -0.09 ± 0.72 vs 0.75 ± 1.81 (p = 0.01), 0.0 ± 0.83 vs 0.88 ± 2.21 (p = 0.08), and -0.21 ± 1.03 vs 1.00 ± 2.49 (p = 0.02). After 60 months, the cumulative probability of clinically definite multiple sclerosis was lower in the BCG + DMT arm (hazard ratio = 0.52, 95% CI 0.27-0.99; p < 0.05), and more vaccinated people remained DMT-free (odds ratio = 0.20, 95% CI 0.04-0.93; p = 0.04).CONCLUSIONS:
Early BCG may benefit CIS and affect its long-term course.CLASSIFICATION OF EVIDENCE:
BCG, as compared to placebo, was associated with significantly reduced development of gadolinium-enhancing lesions in people with CIS for a 6-month period before starting immunomodulating therapy (Class I evidence).Comment in
- BCG vaccine for clinically isolated syndrome and MS: infections and protective immunity. [Neurology. 2014]
- Multiple sclerosis: disease activity is reduced in CIS after BCG vaccination. [Nat Rev Neurol. 2014]
- PMID:
- 24306002
- [PubMed - indexed for MEDLINE]
- PMCID:
- PMC3873620
- [Available on 2015/1/7]
Mutual Series Funds - franklintempleton.com
Adwww.franklintempleton.com/mutualseriesLearn about our unique approach to deep value investing.Franklin Templeton has 553 followers on Google+Search Results
- [PDF]
The following portfolio data for the Franklin Templeton funds ...
https://www.franklintempleton.com/.../4...$11,271,540. 21,000. N/A. N/A. 2.64%. 037833100. BALLY TECHNOLOGIES. $2,186,910. 33,000. N/A. N/A. 0.51%. 01859P609. BIOGEN IDEC INC. $6,576,205.
Franklin Templeton Investments - [PDF]
Franklin Growth Fund - Franklin Templeton
https://www.franklintempleton.com/.../1...BIOGEN IDEC INC. Pharmaceuticals, Biotechnology & Life Sciences. 1.56. 4. ALASKA .... Biogen Idec. Conversely, Haemonetics and Celgene, detracted from
Franklin Templeton Investments... - [PDF]
The following portfolio data for the Franklin Templeton funds ...
https://www.franklintempleton.com/.../4...2.60%. 037833100. BALLY TECHNOLOGIES. $17,892,900. 270,000. N/A. N/A. 0.53%. 01859P609. BIOGEN IDEC INC. $51,997,900. 170,000. N/A. N/A. 1.53%.
Franklin Templeton Investments - [PDF]
Franklin DynaTech Fund - Franklin Templeton
https://www.franklintempleton.com/.../1...BIOGEN IDEC INC. Pharmaceuticals ..... of online medical practice management and electronic medical record/billing services; Biogen Idec, a specialist in drugs ...
Franklin Templeton Investments
Data from Biogen Idec's Portfolio of Multiple Sclerosis Therapies and Pipeline Featured at Medical Congresses
-Scientific Presentations Showcase Innovative MS Medicines and Experimental Therapies-
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 30, 2014--
Biogen Idec (NASDAQ: BIIB) today announced that more than 60 company-sponsored presentations highlighting key data from its industry-leading portfolio of marketed and investigational multiple sclerosis (MS) therapies are being featured during two neurology conferences, further demonstrating its commitment to meeting the individual needs of MS patients and improving outcomes with research that addresses important efficacy and safety questions.
Data are being presented during the annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Sixth Cooperative Meeting with Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS; May 28 -- May 31 in Dallas, Texas); and the Joint Congress of the European Federation of Neurological Societies (EFNS) and European Neurological Society (ENS; May 31 -- June 3 in Istanbul, Turkey).
"Our research and development efforts over the past 30 years have positioned Biogen Idec at the forefront of MS innovation, and the scope of data we are presenting at CMSC/ACTRIMS and EFNS/ENS underscores our commitment to improving the lives of people living with MS," said Katherine Dawson, M.D., vice president, global medical neurology at Biogen Idec. "Beyond discovering new treatments, we are also focused on innovating across the spectrum of MS care, investigating different approaches to advancing disease management."
The data at CMSC/ACTRIMS and EFNS/ENS include results from studies of Biogen Idec's currently marketed products - TECFIDERA(R) (dimethyl fumarate), TYSABRI(R) (natalizumab), AVONEX(R) (interferon beta-1a) and FAMPYRA(R) (prolonged-release fampridine tablets) in markets outside of the U.S. - as well as findings from the clinical programs of its MS pipeline candidates PLEGRIDY(TM) (peginterferon beta-1a), daclizumab high-yield process ([DAC HYP], EFNS/ENS presentation only) and Anti-LINGO-1 ([BIIB033], EFNS/ENS presentation only).
Details and Biogen Idec data presentations listings for the 2014 annual CMSC/ACTRIMS Meeting and 2014 Joint Congress of the EFNS and ENS can be found by visiting:
-- CMSC/ACTRIMS: http://annualmeeting.mscare.org/ -- Joint Congress of the EFNS and ENS: http://www.sessionplan.com/istanbul2014/About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies. For product labeling, press releases and additional information about the Company, please visit www.biogenidec.com.
About TECFIDERA
TECFIDERA is an oral therapy for relapsing forms of MS, including relapsing-remitting MS, the most common form of MS. TECFIDERA is currently approved in the United States, the European Union, Canada and Australia. Through a robust clinical trial program and commercial launches starting with the United States in March 2013, greater than 65,000 patients have been treated with TECFIDERA worldwide(1) .
TECFIDERA has been proven to reduce MS relapses, progression of disability and MS brain lesions, while demonstrating a favorable safety and tolerability profile. In clinical trials, the most common adverse events associated with TECFIDERA were flushing and gastrointestinal (GI) events. Other side effects included a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued. The efficacy and safety of TECFIDERA has been studied in a large, global clinical program, which includes an ongoing long-term extension study. It is believed that TECFIDERA provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.
For additional important safety information, and the United States full prescribing information, please visit www.tecfidera.com
About TYSABRI
TYSABRI is approved in 75 countries. In the United States, TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML). When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. In the European Union, it is indicated as a single disease modifying therapy in highly active relapsing-remitting MS (RRMS) for adult patients who have high disease activity despite treatment with a beta interferon or glatiramer acetate or patients with rapidly evolving severe RRMS.
TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in The New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001).
TYSABRI increases the risk of PML, an opportunistic viral infection of the brain which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses. Serious, life-threatening, and sometimes fatal cases have been reported in the post-marketing setting in multiple sclerosis patients receiving TYSABRI. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting. A list of adverse events can be found in the full TYSABRI product labeling for each country where it is approved.
For additional important safety information, and the United States full prescribing information, please visit www.TYSABRI.com
About AVONEX
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. AVONEX is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with MS in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with MS.
Symptoms of depression, suicidal ideation, or psychosis, and cases of suicide, have been reported with increased frequency with patients receiving AVONEX. Severe hepatic injury, including cases of hepatic failure has been reported rarely in patients. Rare cases of anaphylaxis have been reported. While beta interferons do not have any known direct cardiac toxicity, cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition. Decreased peripheral blood counts have been reported from post-marketing experience. Seizures have been reported in patients using AVONEX, including patients with no prior history of seizure. Autoimmune disorders of multiple target organs have been reported. Routine periodic blood chemistry, hematology, liver function, and thyroid function tests are recommended. AVONEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The most common side effects associated with AVONEX treatment are flu-like symptoms, including chills, fever, myalgia, and asthenia.
For additional important safety information, and the United States full prescribing information, please visit www.AVONEX.com.
About FAMPYRA
FAMPYRA is a prolonged-release (sustained release) tablet formulation of the drug fampridine (4-aminopyridine, 4-AP or dalfampridine). FAMPYRA has been developed to improve walking in adult patients with MS. In MS, damaged myelin exposes channels in the membrane of axons allowing potassium ions to leak, weakening the electrical current sent through nerves. Studies have shown that fampridine can increase conduction along damaged nerves, which may result in improved walking ability.
In clinical trials, the highest incidence of adverse reactions identified with FAMPYRA given at the recommended dose was urinary tract infection, although infection was often not proven by culture. Other adverse drug reactions identified were mainly divided between neurological disorders, such as insomnia, balance disorder, dizziness, paraesthesia, headache and gastrointestinal disorders including nausea, dyspepsia and constipation. In post-marketing experience, there have been reports of seizure. Confounding factors may have contributed to the occurrence of seizure in some patients.
This prolonged-release formulation was developed and is being commercialized in the United States by Acorda Therapeutics, Inc. (NASDAQ: ACOR) under the trade name AMPYRA(R) (dalfampridine) Extended Release Tablets, 10 mg. Biogen Idec licensed rights from Acorda to develop and commercialize fampridine in all markets outside the United States. Biogen Idec commercializes fampridine in these markets under the trade name FAMPYRA(R) .
About PLEGRIDY
PLEGRIDY is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body. PLEGRIDY, an investigational candidate, is a member of the interferon class of treatments, which is often used as a first-line treatment for MS.
Regulatory authorities in the United States and the European Union accepted the marketing applications for the review of PLEGRIDY in relapsing forms of MS in 2013.
About Daclizumab High-Yield Process
Daclizumab high-yield process (DAC HYP) is in late-stage clinical development for the treatment of RRMS, the most common form of MS. DAC HYP is a humanized monoclonal antibody that binds to CD25, a receptor subunit that is expressed at high levels on T cells that are thought to become abnormally activated in autoimmune conditions, such as MS. Data from previous clinical trials showed that DAC HYP increases CD56(bright) Natural Killer (NK) cells, which target the activated immune cells that can play a key role in MS without causing general immune cell depletion.
DAC HYP is currently being studied in the DECIDE Phase 3 clinical trial, which is evaluating the efficacy and safety of once-monthly subcutaneous DAC HYP as a monotherapy compared to interferon beta-1a therapy.
Biogen Idec is developing DAC HYP in collaboration with AbbVie, Inc.
(1) Biogen Idec data on file
CONTACT: Biogen Idec
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MEDIA CONTACTS:
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public.affairs@biogenidec.com
or
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or
INVESTOR CONTACT:
Carlo Tanzi, Ph.D., +1-781-464-2442
IR@biogenidec.com
or
If you are a member of NYSHIP and suffer from an autoimmune disease you are being raped by your insurer who has done nothing to see that BCG is available to you through the State of New York. It is cheap, safe, and effective. Stocks are for dead people and life is for living.
Why should you suffer needlessly when MA, Boston, Ristori and Faustman et al have put the New York Gangster Governor Andrew Cuomo to shame. Shoot BCG and vote for me as a write in candidate for Governor. Dump Cuomo.
NYSHIP_Online - Civil Service - New York State
www.cs.ny.gov/ebd/Welcome to NYSHIP Online, where you will find information on the New York State Health Insurance Program for State and Local Government for active ...
New York
Universa Investments L.P.
www.universa.net/Universa Investments L.P. is an investment management firm that specializes in protecting its clients' portfolios against extreme risks – i.e. universal fat tail risks ...
Mark Spitznagel considers having Detroit Drug Addicts be paid to vaccinate Type 1 Detroit Diabeticsand others in Detroit with autoimmune diseases with BCG while he shorts Biogen Idec?
Fund Manager Sets Goats Grazing in Blighted Detroit
Fabrizio Costantini for The New York TimesAn “urban farming experiment” by the financier Mark Spitznagel uses goats to groom the city’s vacant spaces.To most of the world, the solution to debt-ridden Detroit is money. But for one hedge fund manager, it’s goats.Mark Spitznagel, the founder of the $6 billion hedge fund Universa Investments, on Thursday brought 20 goats to graze among abandoned homes and general detritus in Brightmoor, one of Detroit’s most blighted neighborhoods.Not to be outdone by JPMorgan Chase, the country’s biggest bank, which recently pledged to invest $100 million to help Detroit over the next five years, Mr. Spitznagel says he is contributing directly to the community.“It’s an urban farming experiment,” he said of his plan to leave his goats to roam and munch on overgrown grass. “Goats are an effective way to do landscaping,” he added.
Fabrizio Costantini for The New York TimesThe
investor Mark Spitznagel says that at summer’s end, he will sell the
goats to butchers and give the proceeds to the community.The goats, which will number as many as 60 this summer, have come from Mr. Spitznagel’s farmstead, Idyll Farms, in Northport, Mich. When Mr. Spitznagel is not busy managing investments for his 15 or so clients, which include institutions and sovereign wealth funds, he tends to a business rearing goats and making cheese.Mr. Spitznagel will enlist the help of the community — paying previously unemployed adults and enlisting the help of local youths to herd the baby goats — and he plans to build portable housing for the goats in addition to pens and electric fencing. At the end of the summer, Mr. Spitznagel said, he will sell the goats to Detroit butchers and give the proceeds back to the community.If the goats are allowed to stay, that is.“I have never heard of such a thing,” Linda Vinyard, a spokeswoman for Mayor Mike Duggan, said on Thursday afternoon, adding that Mr. Duggan’s office was unaware of the goats grazing.Mr. Spitznagel “will have to deal with the authorities,” she said. “There are ordinances in our charter that prohibit grazing by goats on public property.”If this all sounds a little unusual, Mr. Spitznagel has never been one to bend to convention. He began his career in a trading pit at the Chicago Board of Trade, where he first toyed with the idea of learning to “invest in loss.” Ever the fearmonger, Mr. Spitznagel says the stock market is in for a great shock that will set off devastating across-the-board losses. Until then, he is paying for the option to short the market, losing money each time he does so. The last boon he received was during the financial crisis: In 2008 his fund returned 115 percent amid wide market carnage.But his goat experiment — called the Idyll Farms Detroit project — also appears to have a bigger objective. Mr. Spitznagel has a vested interest in seeing Detroit make a comeback. He has personally invested millions of dollars in commercial real estate, something he says has no bearing on the Brightmoor project.Residents of the neighborhood may hope that Mr. Spitznagel’s mantra to “invest in loss” will pan out better for Detroit than it has for his hedge fund recently. Mr. Spitznagel is still waiting for the next financial disaster to cash in; so far this year his firm has lost 1 percent.
Fabrizio Costantini for The New York TimesThe hedge fund manager Mark Spitznagel watched as some goats got to work in the Brightmoor neighborhood of Detroit.
Claudine Prowse, Ph.D., +1-781-464-2442
IR@biogenidec.com
Biogen Idec
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