BIOGEN
Biotechnology
Company
OVERVIEW
• Biogen is the world oldest
and first global independent
biotechnology companies
• Biogen has 7500 employees
worldwide
• American Multinational
Biotechnology Company
OVERVIEW
• This Company also has a
collaboration agreement with
Genentech, Inc. (Genentech)
• Biogen Inc. develops, manu-
factures, and markets drugs for
human healthcare through
genetic engineering.
Biogen Key Facts
COMPANY TITLE Biogen Inc. (former Biogen Idec)
COMPANY TYPE Public
INDUSTRY Biotechnology
FOUNDING YEAR 1978
FOUNDERS Phillip Allen Sharp
Walter Gilbert
Charles Weissmann
Heinz Schaller
Kenneth Murray
ADDRESS Cambridge, Massachusetts
KEY PEOPLE Stelios Papadopoulos (Chairman)
Michel Vounatsos (CEO)
ANNUAL REVENUE US$ 12.274 billion (2017)
SPECIALIZATION
Specializing in the discovery, development, and deliveries of
therapies for the treatment of neurodegenerative diseases,
hematologic condition, and autoimmune disorders segment.
NEURODEGENERATIVE DISEASES are incurable and
debilitating conditions that result in progressive degeneration
or death of nerve cells. (e.g. Parkinson's, Alzheimer's, and
Huntington's diseases)
HEMATOLOGIC CONDITION disorders of the blood and blood-
forming organs. (e.g. Rare Genetic Disorder, Anemia, conditions
related to HIV, Sickle Cell Disease, and complications from
chemotherapy)
AUTOIMMUNE DISORDER are diseases caused by the immune
system mistaking the body's own tissue and attacking it. This
can happen due to a number of complications within the
immune system. (e.g. rheumatoid arthritis, lupus, and
multiple sclerosis)
HISTORY
1978 - 2019
• BIOGEN is the 1st Biotechnology Company.
• Founded in 1978 by a small group of visionary scientists
Phillip Allen Sharp
Walter Gilbert
Charles Weissmann
Heinz Schaller
Kenneth Murray
• 1979 - Biogen scientist Charles Weissmann, M.D., Ph.D.,
announces that he has successfully cloned biologically active
human leukocyte (alpha) interferon.
• Biogen scientist Kenneth Murray, Ph.D., synthesizes bacteria of
hepatitis B virus protein antigens.
• 1980 - Biogen founder Walter Gilbert, Ph.D., wins the Nobel Prize
in chemistry for his work in DNA sequencing.
• 1982 - The company opens facilities — including its new
headquarters — in Cambridge, Massachusetts
• 1985 - James L. Vincent is hired as CEO and launches a radical
restructuring at Biogen.
• 1986 - Biogen establishes its first manufacturing facilities, located
in Cambridge, Massachusetts
• 1989 - Biogen announces FDA approval of a recombinant hepatitis
B vaccine
• 1993 - Biogen founder Phillip Sharp, Ph.D., receives the Nobel
Prize in medicine for his discovery of split genes.
• 1995 - FDA approves Avonex for the treatment of relapsing forms
of multiple sclerosis.
• 1996 - Biogen begins marketing Avonex in the United States.
• 1997 - European marketing of Avonex begins
• 1999 - Development of Antova, an immune system regulator, is
halted
• 2000 - Biogen introduces MS ActiveSource®, a comprehensive
support service for multiple sclerosis patients and caregivers.
• 2000 - Biogen introduces MS ActiveSource®, a comprehensive
support service for multiple sclerosis patients and caregivers.
• 2002 - Biogen opens its 90,000-liter large-scale manufacturing
plant in Research Triangle Park, North Carolina.
• The company opens its first Community Lab in Cambridge.
• 2003 - Biogen and IDEC merge, creating Biogen Idec
• 2004 - The FDA approves Biogen’s natalizumab, a monotherapy
for the treatment of patients with relapsing forms of multiple
sclerosis.
• Biogen Idec opens its new international headquarters in Zug,
Switzerland.
• 2007 - Biogen Idec acquires Syntonix Pharmaceuticals, which
eventually leads to the development of two hemophilia therapies.
• 2010 - Genentech and Biogen announced a restructuring of their
collaboration on antibodies targeting CD2011
• 2011 - Biogen Idec business development executes deals with
Portola Pharmaceuticals, on oral therapy for autoimmune
diseases.
• 2013 - Biogen Idec moves its company headquarters back to
Cambridge, Massachusetts, after several years in Weston,
Massachusetts.
• 2015 - The company returns to its original name: Biogen.
• 2017 - Biogen announce agreement to jointly develop new MRI
tools for MS.
• 2018 - Biogen celebrates its 40th anniversary.
FACILITIES
Research Triangle Park
(RTP), North Carolina
This facility introduced an
innovative process for early-
stage clinical products. Single-
use technology in a closed
system replaces the traditional
stainless-steel systems. This
increases flexibility and speed
of supplying drugs for clinical
studies, and reduces the
environmental impacts of the
manufacturing process.
Research Triangle Park
(RTP), North Carolina
This facility introduced an
innovative process for early-
stage clinical products. Single-
use technology in a closed
system replaces the traditional
stainless-steel systems. This
increases flexibility and speed
of supplying drugs for clinical
studies, and reduces the
environmental impacts of the
manufacturing process.
NEW
MANUFACTURING FACILITIES
Solothurn, Switzerland
Construction on this next-
generation biologics
manufacturing facility began in
2016 and is expected to be
completed in 2019. The
Solothurn facility will produce
up to ten metric tons of
antibody per year, helping us
provide meaningful therapies to
patients with serious medical
conditions around the globe.
NEW
MANUFACTURING FACILITIES
Solothurn, Switzerland
Construction on this next-
generation biologics
manufacturing facility began in
2016 and is expected to be
completed in 2019. The
Solothurn facility will produce
up to ten metric tons of
antibody per year, helping us
provide meaningful therapies to
patients with serious medical
conditions around the globe.
NEW
MANUFACTURING FACILITIES
Solothurn, Switzerland
Manufacturing Biotech Facility West Block
Manufacturing Biotech Facility
Top Side Buffer Hold
Under Construction
NEW
MANUFACTURING FACILITIES
Solothurn, Switzerland
Manufacturing Biotech Facility Placing
Buffer Hold Modules into Building
Manufacturing Biotech Facility
Structural Frame and Crane
Under Construction
NEW
MANUFACTURING FACILITIES
Solothurn, Switzerland
Manufacturing Biotech Facility Buffer
Prep Piping Module
Manufacturing Biotech Facility
Northeast Warehouse
Under Construction
RESEARCH & LABORATORY
FACILITIES
Biogen’s
Department of
Medical Research
Biogen’s Department of Medical Research
Biogen believe in improving the quality of patient care by supporting
medical research that advances scientific knowledge of disorders relevant
to our therapeutic portfolio and products.
Scientific Objectives
Biogen continuously engage with external researchers in an
effort to maintain the scientific leadership in a number of
therapeutic areas.
Biogen’s established areas of research interest and therapeutic
areas being considered for support.
22
Biogen’s Department of Medical Research
MULTIPLE SCLEROSIS
• Biogen has pioneered the development of
multiple sclerosis (MS) treatments for
more than 25 years.
• Research is focused on potentially
transformative therapies, including the
potential repair of the damage caused by
MS.
• General Multiple Schlerosis
• Prolonged-released fambridine
• Dimethyl fumarate
• Natalizumab 23
• Interferon beta-1a
Biogen’s Department of Medical Research
SPINAL MUSCULAR
ATROPHY
• (SMA) refers to a group of inherited
neurological disorders that begin in
infancy or childhood and lead to the
degeneration of spinal motor neurons, the
neurons that control skeletal muscles.
• Biogen is the first therapy approved for
the treatment of SMA.
• General Spinal Muscular Atrophy
• Nusinersen 24
Biogen’s Department of Medical Research
BIOSIMILARS
• Biogen sees biosimilars as central to
safeguarding future of healthcare
innovation. As biologics go off-patent,
biosimilars – biologics medicines that is
highly similar to an already-approved
biologic – can play an important role in
expanding access to treatments.
• Etanercept (BENEPALI)
• Infliximab (FLIXABI)
25
BIOGEN PHASE
1
PHASE
2
PHASE
3
PHASE
4
RESEARCH DACLIZUMAB
Relaxing remitting MS
PIPELINE ADUCANUMAB
Alzheimer’s disease
Biogen had a strong late-stage ISIS SMNrx
research and development Spinal muscular atrophy
pipeline. Biogen has five
NATALIZUMAB
investigational medicines in Secondary Progressive MS
phase three clinical trial
phase, targeting diseases OBINUTUZUMAB
such as Alzheimer’s, spinal Diffuse large B-cell Lymphoma
muscular atrophy, secondary Biogen Late-Stage Research Pipeline
progressive multiple sclerosis,
and diffuse large B-cell
lymphoma.
POLITICAL ACTION
POLITICAL CONTRIBUTORS POLICY
At Biogen, our mission is clear: we are pioneers in neuroscien
ce. Since our founding in 1978 as one of the world’s first
global biotechnology companies, Biogen has led innovative
scientific research with the goal over the last decade to
defeat devastating neurological diseases. In furtherance of
our objectives, we believe it is important to be an active partici
pant in the political process in the U.S. and that we should s
upport the legislative process by contributing prudently to sta
te and local candidates and political organizations when such
contributions are permitted by applicable law.
BIOGEN FEDERAL POLITICAL ACTION
COMMITTEE (Biogen PAC)
Biogen established the Biogen Federal Political Action
Committee (Biogen PAC), a federally registered political
action committee, to provide eligible employees and members
of our Board of Directors.
FEDERAL INDEPENDENT EXPENDITURES
Although it is permissible in the U.S. to use corporate funds to make
independent expenditures on behalf of federal candidates, Biogen
have not made and do not plan to make any independent
expenditures on behalf of federal candidates.
Trade Associations, Industry Groups
and Other Organizations
• Biogen is a member of several industry and trade groups
which represent the biotechnology, pharmaceutical and
business community at large.
• Their participation as a member of these various industry and
trade groups comes with the understanding that we may not
always agree with the positions of the larger organizations or
other members, and we are committed to voicing our
concerns as appropriate through our colleagues who serve on the
boards and committees of these groups.
Listing of the trade organizations to which we pay more than $25,000
per year in membership dues and other payments. (2018)
CONTROVERSY
and CRITICISM
1980’s Bankruptcy
• The company was a great place to do research, but it had yet to show a profit. Biogen
had racked up a stunning $100 million in losses and was teetering on the edge of
bankruptcy.
• Biogen was using an estimated $100,000 each day in research costs. Furthermore,
royalty revenues had slid to less than $20 million annually because the company had
sold some of its patents.
• 1985 - they hired James L. Vincent.
• Biogen began a radical restructuring and turn around under Vincent's command.
• Vincent succeeded in negotiating with companies to get or buy back most of those
patents.
• 1985–1988 - Biogen lost more than $70 million
Biogen Plunges After Making Changes to
Alzheimer's Drug Trial
• Biogen Chief medical officer, Al Sandrock, shook up investors by saying that
the company had added 510 more patients to its clinical trial of aducanumab
in Alzheimer’s disease.
• Biogen indicates that the option to expand the trial was part of the trial
design, although Brian Skorney, an analyst at Robert W. Baird & Co. thinks
Biogen’s announcement may not have gone over the way it was intended.
• Bloomberg describes the issue: “The problem seems to have been that the
tests were creating too much statistical noise, and not giving researchers a
clear indication of whether or not the drug was helping patients.”
Biogen’s Alzheimer’s disease drug
crashes in Phase III testing
• The news sent Biogen's shares down more than 26 percent pre-market, but
analysts also wrote that it deals a significant blow to amyloid beta as a target
in Alzheimer's disease.
• Biogen together with its development partner, Japanese drugmaker Eisai
said that they were discontinuing the Phase III ENGAGE and EMERGE
studies of aducanumab in mild cognitive impairment and dementia due to
Alzheimer’s. The decision was based on results of an independent data
monitoring committee’s futility analysis, which indicated the trials were not
likely to meet their primary endpoint. Extensions of earlier-stage studies were
also halted.
Biogen scraps two Alzheimer drug trials,
lost $18 billion from market value
• Biogen Inc and partner Eisai Co Ltd are ending two late-stage trials of their
experimental Alzheimer’s disease drug aducanumab.
• Experts had seen aducanumab as one of the last tests of the hypothesis that
removing sticky deposits of amyloid from the brain of patients in earlier
stages of the lethal disease could stave off its ravages, which include loss of
memory and the ability to care for oneself.
• Alzheimer’s drug, (Aducanumab) BAN2401, being co-developed with Biogen.
That drug failed in a 12-month analysis.
• “This disappointing news confirms the complexity of treating Alzheimer’s
disease and the need to further advance knowledge in neuroscience,” Biogen
Chief Executive Officer Michel Vounatsos said.
PRODUCTS/
PRODUCTS TIMELINE
AVONEX® (INTERFERON BETA-1A
INDICATIONS
AVONEX is indicated for the treatment of relapsing forms of
multiple sclerosis (MS), to include clinically isolated
syndrome, relapsing-remitting disease, and active
secondary progressive disease, in adults.
DOSAGE
BENEPALI® (ETANERCEPT)
INDICATIONS
BENEPALI indicated for the treatment of moderate to severe
active rheumatoid arthritis in adults when the response to
disease-modifying antirheumatic drugs
DOSAGE
• 50 mg solution for injection in pre-filled syringe
• Each pre-filled syringe contains 50 mg of etanercept
FLIXABI® (INFLIXIMAB)
INDICATIONS
FLIXABI is indicated for the treatment of adults with
rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis,
ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Additionally, FLIXABI can be used in patients 6 to 17 years
old with severe, active Crohn's disease or severely active
ulcerative colitis
DOSAGE
• One vial contains 100 mg of infliximab*. After reconstitution,
each ml contains 10 mg of infliximab.
• Child - 5 mg/kg given as an intravenous infusion
• Adult - 5 mg/kg given as an intravenous infusion
followed by additional 5 mg/kg infusion doses at 2 and 6
weeks after the first infusion
IMRALDI™ (ADALIMUMAB)
INDICATIONS
IMRALDI is indicated for reducing signs and symptoms,
inhibiting the progression of structural damage, and
improving physical function in adult patients with active
psoriatic arthritis
DOSAGE
PLEGRIDY® (PEGINTERFERON BETA-1A)
INDICATIONS
PLEGRIDY is a prescription medicine used to treat relapsing
forms of multiple sclerosis (MS), to include clinically isolated
syndrome, relapsing-remitting disease, and active secondary
progressive disease MS.
DOSAGE
BENEPALI® (ETANERCEPT)
INDICATIONS
BENEPALI indicated for the treatment of moderate to severe
active rheumatoid arthritis in adults when the response to
disease-modifying antirheumatic drugs
DOSAGE
• 50 mg solution for injection in pre-filled syringe
• Each pre-filled syringe contains 50 mg of etanercept
SPINRAZA® (NUSINERSEN)
INDICATIONS
SPINRAZA is a survival motor neuron-2 (SMN2)-directed
antisense oligonucleotide indicated for the treatment of
spinal muscular atrophy (SMA) in pediatric and adult
patients.
DOSAGE
• Recommended dosage is 12 mg (5 mL) per administration.
• Initiate SPINRAZA treatment with 4 loading doses:
• The first three loading doses should be
administered at 14-day intervals.
• The 4th loading dose should be administered 30
days after the 3rd dose.
BENEPALI® (ETANERCEPT)
INDICATIONS
BENEPALI indicated for the treatment of moderate to severe
active rheumatoid arthritis in adults when the response to
disease-modifying antirheumatic drugs
DOSAGE
• 50 mg solution for injection in pre-filled syringe
• Each pre-filled syringe contains 50 mg of etanercept
TECFIDERA® (DIMETHYL FUMARATE)
INDICATIONS
TECFIDERA is indicated for the treatment of relapsing forms
of multiple sclerosis (MS), include clinically isolated
syndrome, relapsing-remitting disease, and active secondary
progressive disease
DOSAGE
TECFIDERA is 120 mg twice a day orally
TYSABRI® (NATALIZUMAB)
INDICATIONS
TYSABRI is indicated as monotherapy for the treatment of
relapsing forms of multiple sclerosis, to include clinically
isolated syndrome, relapsing-remitting disease, and active
secondary progressive disease.
DOSAGE
Injection: 300 mg/15 mL (20 mg/mL) solution in a
single-dose vial for dilution prior to infusion
PRODUCTS
Partnered Therapies
Partnered Products
Collaboration with
GENENTECH
GAZYVA® (OBINUTUZUMAB)
INDICATIONS
GAZYVA® (obinutuzumab) is a prescription medicine used
with the chemotherapy drug, chlorambucil, to treat chronic
lymphocytic leukemia (CLL) in adults who have not had
previous CLL treatment.
DOSAGE
OCREVUS ® (OCRELIZUMAB)
INDICATIONS
OCREVUS® (ocrelizumab), a prescription medicine used to
treat adults with relapsing or primary progressive forms of
multiple sclerosis.
DOSAGE
PRODUCTS TIMELINE
2018 TOP NEUROLOGY SALES TOP NEUROLOGY PRODUCTS
52
AWARDS &
RECOGNITION
1998, U.S. President Bill Clinton awards Biogen “the
annual National Medal of Technology”. This is the highest
distinction bestowed upon the leading technological
innovators in the U.S.
Prix Galien Netherlands 2018 Pharmaceutical Award
STEMmy Awards
S.Awards is for outstanding work in STEM over the past year
Biogen Scoops Sixth Prix Galien Award with UK
Win for Life-Changing Rare Disease Medicine
Commitment to Diversity Award Winners
Minita Shah-Mara (left)
Kristi Sarno, President Emeritus of Women in Biogen (middle)
Theresa McNeely, Board member, Women in Biogen (right)
Best Card Solution Highly Commended: Biogen
Biogen wins Recycling Business of the Year 2013
Best Biotechnology Product” at the 2017
USA Awards Ceremony
Biogen’s website has scooped awards including
Gold in the flagship “Website” category at the Milton
Keynes Digital Awards 2015.
ONE OF THE
LTEN Excellence Awards
ISPE FACILITY OF THE YEAR AWARDS
Additional
INFORMATION
BIOGEN
Biogen Foundation Awards Citizen Schools $2M Grant
in Support of STEM Education
Biogen Foundation awards the Museum $584,700 grant
At Biogen, every month is pride month ♥
Neuroscience, also
known as Neural
Science, is the study of
how the nervous
system develops, its
structure, and what it
does.
Neuroscientists focus
on the brain and its
impact on behavior and
cognitive functions.
SAYINGS
THANK
YOU!
GROUP 2
GABRIEL, Pamela
PABALAN, Mark Giving
SANTOS, Joy Erica
