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FORM 10-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 [FEE REQUIRED]
For the fiscal year ended December 31, 1995
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 [NO FEE REQUIRED]
Commission file number: 0-12042
BIOGEN, INC.
(Exact name of Registrant as specified in its charter)
Massachusetts 04-3002117
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification No.)
14 Cambridge Center, Cambridge, Massachusetts 02142
(Address of principal executive offices)(zip code)
Registrant's telephone number, including area code: (617) 679-2000
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 par value
(Title of class)
Indicate by check mark whether the Registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the Registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days.
Yes X No
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of Regulation S-K is not contained herein, and
will not be contained, to the best of Registrant's knowledge, in
definitive proxy or information statements incorporated by
reference in Part III of this Form 10-K or any amendment to this
Form 10-K. [ ]
Aggregate market value of Common Stock held by nonaffiliates
of the Registrant at January 18, 1996: $2,204,009,310 (excludes
shares held by directors). Exclusion of shares held by any person
should not be construed to indicate that such person possesses the
power, direct or indirect, to direct or cause the direction of
management or policies of the Registrant, or that such person is
controlled by or under common control with the Registrant. Common
Stock outstanding at January 18, 1996: 35,513,951 shares.
Documents Incorporated by Reference
Portions of the Registrant's definitive Proxy Statement for
its 1996 Annual Meeting of Stockholders are incorporated by
reference into Part III of this Report, and portions of the
Registrant's 1995 Annual Report to Shareholders are incorporated by
reference into Parts II and IV of this Report.
PART I
Item 1 - Business
Overview
Biogen, Inc. ("Biogen" or the "Company") is a biopharmaceutical
company principally engaged in the business of developing and
manufacturing drugs for human healthcare through genetic engineering.
Biogen currently derives revenues from a number of products sold by
its licensees around the world. During 1995, Biogen's licensees
generated total sales of approximately $1.8 billion from these
products. In the future, Biogen expects to derive additional revenues
from sales of proprietary products which Biogen will market. Biogen
intends to market as its first product its recombinant beta
interferon, AVONEX TM interferon beta 1a, as a therapy for relapsing
forms of multiple sclerosis. In December 1995, an Advisory Committee
of the United States Food and Drug Administration ("FDA") recommended
that the FDA approve AVONEX TM as a treatment for relapsing forms of
multiple sclerosis. Biogen anticipates that it will receive FDA
approval to market and sell AVONEX TM in the United States in the
first half of 1996 after conclusion of labeling discussions with the
FDA and completion of the FDA's inspection of the manufacturing
facilities used to produce AVONEX TM. In 1995, Biogen also applied
for marketing approval for AVONEX TM in several other jurisdictions,
including Canada and the European Union. The Company is in the
process of building the commercial infrastructure necessary to support
marketing and sales of AVONEX TM.
Biogen continues to devote significant resources to its ongoing
research and development efforts. Biogen focuses its research and
development efforts on areas where it has particular scientific and
competitive strengths: inflammatory diseases, respiratory diseases and
certain cancers and viruses. In 1995, Biogen began Phase I clinical
trials of LFA3TIP, one of the product candidates from its T-cell
activation, T-cell/B-cell interaction and cell adhesion programs.
Biogen is conducting preclinical tests on two other anti-inflammatory
product candidates from these programs. Biogen's anti-inflammatory
product candidates are being tested for therapeutic uses in a broad
range of acute and chronic inflammatory and autoimmune diseases.
Biogen is also conducting preclinical tests on an antimucolytic agent
for treatment in cystic fibrosis and several other pulmonary diseases.
In addition, Biogen has earlier-stage research programs directed
toward finding therapies for renal failure and restenosis and, through
a collaboration with Genovo, Inc., toward developing products for
human gene therapy.
AVONEX TM Interferon Beta 1a
Natural beta interferon is a protein produced by fibroblast cells
in response to viral infection. Biogen has developed a recombinant
form of beta interferon for use as a therapy in multiple sclerosis.
Multiple sclerosis is a progressive neurological disease in which the
body loses the ability to transmit messages among nerve cells, leading
to a loss of muscle control, paralysis and, in some cases, death.
Patients with active relapsing multiple sclerosis experience an uneven
pattern of disease progression characterized by periods of stability
interrupted by flareups of the disease after which the patient returns
to a new baseline of functioning. In December 1995, the Central
Nervous System Advisory Committee of the FDA recommended that the FDA
approve Biogen's AVONEX TM interferon beta 1a for treatment of
relapsing forms of multiple sclerosis. The Advisory Committee's
recommendation was based on data from a Phase III clinical trial in
which approximately 37% fewer patients receiving AVONEX TM progressed
one or more units on the Expanded Disability Status Scale (EDSS) than
patients receiving placebo. The EDSS is the standard measure of
disease progression in multiple sclerosis. Patients receiving AVONEX
TM in the trial also experienced approximately 32% fewer exacerbations
of the disease than patients receiving placebo. Additional studies
of AVONEX TM are underway or planned, including an open-label study
to gather additional safety data which began in late 1995, a
monosymptomatic study of AVONEX TM in patients who have had only one
confirmed exacerbation which is scheduled to begin in 1996 and a dose
comparison study which is also scheduled to begin in 1996.
Biogen anticipates that it will receive FDA approval of AVONEX
for the treatment of relapsing forms of multiple sclerosis in the
first half of 1996 after conclusion of labeling discussions with the
FDA and completion of the FDA's inspection of the Company's
manufacturing facility in Cambridge, Massachusetts and the facilities
used by the Company's contract manufacturers in finishing, filling and
packaging the final product. See "Item 2- Properties." Biogen is in
the process of building the commercial infrastructure necessary to
support the marketing and sale of AVONEX TM. The Company plans to
begin marketing AVONEX TM in the United States shortly after receipt
of FDA approval. The Company has also applied for marketing approval
for AVONEX TM in several other jurisdictions, including Canada and the
European Union. See "Patents and Other Proprietary Rights."
Major Research Programs
Biogen's research is focused on biological systems and processes
where its scientific expertise in molecular biology, cell biology,
immunology and protein chemistry can lead to a greater understanding
of disease processes and, as a result, to the creation of new
pharmaceuticals. Biogen selects product candidates from its research
programs to test in clinical trials, focusing its efforts on those
agents which it believes have the greatest potential competitive
advantages and large commercial markets. Described below are Biogen's
major research programs:
Inflammation Program
Biogen scientists have been working to understand the activities
of white blood cells involved in the inflammation process. Biogen has
focused on two events central to inflammation: (1) the activation of
T-cells, specialized white blood cells which initiate and control the
immune response; and (2) the adhesion of white blood cells to the
endothelium (blood vessel walls) and their migration through the
endothelium into surrounding tissues where they cause inflammation.
Activation and adhesion of white blood cells depend upon the binding
of pairs of receptor molecules which appear on the surface of white
blood cells and endothelial cells. When these pairs of receptors bind
together, their interactions create cellular "pathways" for activation
and adhesion events. Biogen has investigated several of these
cellular pathways and identified new receptors in certain of these
pathways.
Based on its research, Biogen has selected three cellular
pathways as the promising points of therapeutic intervention to
prevent inflammation: (1) the LFA-3/CD2 pathway, which activates
T-cells, (2) the VCAM-1/VLA-4 pathway, which is necessary for the
adhesion of several types of white blood cells to endothelial cells,
and (3) the CD40L/CD40 pathway, which activates B-cells which produce
antibodies. Biogen believes that products which interrupt these
pathways will block the inflammation process at an early stage, thus
preventing tissue damage more effectively than currently available
therapies. Moreover, such products should result in selective
inhibition of the immune system, rather than the broad suppression
associated with many therapies currently available or under
development. In in vitro and in vivo experiments the product
candidates from the inflammation program have shown promising
inhibitory effects. In 1995, the Company began a Phase I clinical
trial of one of the product candidates, LFA3TIP, in healthy human
volunteers. LFA3TIP is a recombinant protein that has been designed
to modulate immune responses through interaction with the CD2
receptor. Biogen plans to investigate the use of LFA3TIP initially
as a treatment for severe psoriasis. Biogen is conducting preclinical
tests on two other anti-inflammatory product candidates.
Gelsolin
Thick viscid secretions in the airways of cystic fibrosis ("CF")
patients and patients with other respiratory diseases are believed to
cause progressive pulmonary destruction. A major contributor to the
viscosity of mucus secretions is the release of a large amount of
filamentous actin by degenerating inflammatory cells which migrate in
large numbers to the airways of patients with these diseases. Biogen
and its collaborators believe that severing actin filaments
contaminating the airway mucus may lead to clinical improvement.
Biogen is developing a recombinant form of the actin severing agent,
gelsolin, for reducing airway mucous viscosity in patients with CF,
chronic bronchitis and several other pulmonary diseases. The Company
is presently conducting preclinical studies of gelsolin product
candidates.
Gene Therapy
In 1995, the Company entered into a collaborative research
agreement with Genovo, Inc. ("Genovo") for the development of certain
human gene therapy treatments. Under the agreement, Biogen will pay
more than $35 million to Genovo over a five-year period to fund
research at Genovo and at the Institute for Human Gene Therapy at the
University of Pennsylvania. Under its agreement with Genovo, Biogen
has received a minority equity interest in Genovo and certain
licensing rights related to diseases of the liver and lung with the
first disease targets to be in the areas of cystic fibrosis and
familial hypercholesterolemia.
Other Research Programs
As part of its further research efforts, Biogen is investigating
methods of preventing restenosis and exploring the use of growth
factors to prevent or treat the degeneration of the kidney which
results from renal failure. The Company is also investigating new ways
to modify immune responses more specifically in order to treat
diseases of the immune system.
Research and Development Costs
During 1995, 1994 and 1993, Biogen's research and development
costs were approximately $87.4 million, $91.2 million and $79.3
million, respectively.
Risks Associated with Drug Development
Certain of the statements set forth above regarding the Company's
drug development programs, such as the statement regarding the
anticipated receipt and timing of regulatory approval by the FDA for
the marketing of AVONEX TM, are forward-looking and based upon the
Company's current belief as to the outcome and timing of such future
events. Many important factors affect the Company's ability to
achieve the stated outcomes and to successfully develop and
commercialize drugs, including the ability to obtain and maintain all
necessary patents or licenses, to demonstrate the safety and efficacy
of drug candidates at each stage of the clinical trial process, to
meet applicable regulatory standards and receive required regulatory
approvals, to be capable of producing drug candidates in commercial
quantities at reasonable costs, to compete successfully against other
products, and to market products successfully. For example, to
receive final marketing approval from the FDA for AVONEX TM in the
first half of 1996, the Company must successfully complete the FDA's
inspection of the facilities used to produce AVONEX TM and conclude
labelling discussions with the FDA. There can be no assurance that
any of the products described above or resulting from Biogen's
research programs will be successfully developed, prove to be safe and
efficacious at each stage of clinical trials, meet applicable
regulatory standards, be capable of being produced in commercial
quantities at reasonable costs or be successfully marketed.
Principal Products Being Marketed or Developed by Biogen's Licensees
Intron (R) A Alpha Interferon
Alpha interferon is a naturally occurring protein produced by
normal white blood cells. Biogen has been granted patents in the
United States and in Europe covering the production of alpha
interferons through recombinant DNA techniques and has applications
pending in numerous other countries. See "Patents and Other
Proprietary Rights." Biogen's worldwide licensee for recombinant
alpha interferon, Schering-Plough Corporation ("Schering-Plough"),
first began commercial sales of its Intron (R) A brand of alpha
interferon in the United States in 1986 for hairy-cell leukemia.
Schering-Plough now sells Intron (R) A in 72 countries for as many as
16 indications, including hepatitis B, hepatitis C, genital warts and
Kaposi's sarcoma.
Royalties from Schering-Plough on sales of Intron (R) A accounted
for approximately 40% of Biogen's revenues (excluding interest) in
1995. The majority of sales of Intron (R) A were generated outside the
United States. Currently the largest market for Intron (R) A is in Japan
for the treatment of hepatitis C. The FDA has approved Intron R A for
the treatment of chronic hepatitis B and hepatitis C, hairy cell
leukemia, AIDS-related Kaposi's sarcoma and condylomata acuminata.
In December 1995, the FDA approved the use of Intron (R) A for injection
as an adjuvant treatment to surgery in patients at high risk for
systemic recurrence of malignant melanoma. Schering-Plough has
undertaken studies using Intron (R) A for a number of additional
indications.
Hepatitis B Vaccines and Diagnostics
Hepatitis B is a blood-borne disease which causes a serious
infection of the liver and substantially increases the risk of liver
cancer. More than 250 million people worldwide have chronic hepatitis
B virus infections. Biogen holds several important patents related
to hepatitis B antigens produced by genetic engineering techniques.
See "Patents and Other Proprietary Rights." These antigens are used
in recombinant hepatitis B vaccines and in diagnostic test kits used
to detect hepatitis B infection. In total, sales of hepatitis B
vaccines and diagnostic products by Biogen licensees exceeded $1.1
billion in 1995.
Hepatitis B Vaccines
At least 20 countries around the world, including the United
States, recommend vaccination against hepatitis B for all infants.
The United States Centers for Disease Control and the American Academy
of Pediatrics have also recommended universal immunization of ten-
year-old children and at-risk adolescents. The United States
Occupational Safety and Health Administration has recommended that all
persons with an occupational exposure to blood and other infectious
material receive the hepatitis B vaccine.
SmithKline Beecham Biologicals s.a. ("SmithKline") and Merck &
Co., Inc. ("Merck") are the two major worldwide marketers of hepatitis
B vaccines. Biogen has licensed to SmithKline exclusive rights under
Biogen's hepatitis B patents to market hepatitis B vaccines in the
major countries of the world, excluding Japan. SmithKline's vaccine
is approved in the United States and in over 60 other countries. In
1990, SmithKline and Biogen entered into a sublicense arrangement with
Merck under which Biogen currently receives royalties. Royalties from
SmithKline and Merck together accounted for approximately 48% of
Biogen's revenues (excluding interest) in 1995. Biogen has also
licensed rights under its hepatitis B patents to Merck and The Green
Cross Corporation on a non-exclusive basis in Japan.
In 1993, SmithKline initiated arbitration in the United States
regarding the rate of royalties payable on sales of hepatitis B
vaccines by SmithKline in the United States. In April 1995, an
arbitration panel ruled in Biogen's favor in the arbitration. In June
1995, SmithKline made a motion in the Federal District Court for the
Southern District of New York to vacate the arbitration panel award.
The Company believes that the Federal District Court will uphold the
arbitration decision in favor of Biogen.
Hepatitis B Diagnostics
Biogen has licensed its proprietary hepatitis B rights, on an
antigen-by-antigen and nonexclusive basis, to diagnostic kit
manufacturers. Biogen currently has hepatitis B license or license
and supply agreements for diagnostic use with more than a dozen
companies, including Abbott Laboratories, the major worldwide marketer
of hepatitis B diagnostic kits, Ortho Diagnostic Systems, Inc., Roche
Diagnostic Systems, Inc. and Organon Teknika B.V.
Other Products
Under a license agreement with Eli Lilly and Company ("Lilly"),
Biogen has granted Lilly rights under certain of Biogen's patents
related to gene expression. Lilly uses the patented vectors and
methods in several products that are on the market or in development.
Under the license agreement Biogen receives royalties on sales of
these products.
Hirulog (R) Thrombin Inhibitor
In October 1994, Biogen decided to discontinue its major
activities associated with development of its Hirulog(R) thrombin
inhibitor, based on the results of a Phase III trial of Hirulog(R) in
angioplasty. In the overall patient population, the trial results did
not demonstrate a significant positive effect, compared to the heparin
control, on the primary efficacy end-point. In a prospectively-
defined subset of high risk patients, Hirulog(R) was more effective than
heparin. An important safety advantage was also observed in patients
treated with Hirulog(R) who as a group had a more than 50% lower
incidence of major bleeding complications than the control group. In
December 1995, Biogen completed enrollment of patients in a blinded
Phase II/III trial of Hirulog(R) as an adjunctive to streptokinase in
myocardial infarction which had begun prior to Biogen's decision to
terminate Hirulog development. Analysis of data from the trial is
ongoing. Biogen continues to seek a marketing partner for Hirulog(R) .
Patents and Other Proprietary Rights
Biogen has filed numerous patent applications in the United
States and various other countries seeking protection of a number of
its processes and products, and patents have issued on a number of
these applications. Issues remain as to the ultimate degree of
protection that will be afforded to Biogen by such patents. There is
no certainty that these patents or others, if obtained, will be of
substantial protection or commercial benefit to Biogen. Furthermore,
it is not known to what extent Biogen's other pending patent
applications will ultimately be granted as patents or whether those
patents that have been issued will prevail if they are challenged in
litigation.
Trade secrets and confidential know-how are important to Biogen's
scientific and commercial success. Although Biogen seeks to protect
its proprietary information, there can be no assurance that others
will not either develop independently the same or similar information
or obtain access to Biogen's proprietary information.
Recombinant Alpha Interferon
Biogen has more than 50 patents in countries around the world,
including the United States and countries of the European Patent
Office, covering the production of recombinant alpha interferons.
Biogen continues to seek related patents in the United States and
other countries.
Four infringement suits have been filed in Biogen's name to
enforce its non-US alpha interferon patents. The first suit was filed
in Vienna, Austria against Boehringer Ingelheim Zentrale GmbH ("BI")
and two of its subsidiaries. The Austrian Court has stayed Biogen's
infringement case pending a decision by the Austrian Patent Office on
BI's petition to revoke Biogen's European (Austrian) patent on grounds
peculiar to Austrian law. In April 1995, Biogen received a favorable
decision from the Austrian Patent Office from which BI appealed. A
hearing on the appeal is expected in mid-1996. The second suit was
filed in Dusseldorf, Germany against Dr. Karl Thomae GmbH and two
other BI companies. The German trial and appeal courts ruled in favor
of Biogen and have enjoined Thomae from the further manufacture, use
or sale of recombinant alpha-2(c) interferon. The third suit was filed
in Warsaw, Poland against Boehringer Ingelheim Pharma GmbH ("BI
Pharma"). The trial is scheduled for January 1996 in Poland. The
fourth suit was filed in June 1994 in Tokyo, Japan against Amgen
Limited. The suit seeks to enjoin Amgen from its clinical testing and
planned commercialization of consensus interferon. Biogen does not
expect a decision in this case before 1997. In the United States, a
Biogen patent application claiming recombinant mature human alpha
interferon was involved in an interference to determine who was the
first to invent that specific form of alpha interferon. In December
1995, priority of invention was awarded to the applicants of a patent
application owned by Genentech Inc. and Hoffman La Roche Inc.
("Roche"). Appeal or other review of the decision may be sought. The
U.S. patent under which Biogen has licensed Schering Plough for alpha
interferon was not involved in the interference. Since Roche has
granted certain non-exclusive rights under its patent application to
Schering Plough, the decision will not affect Schering Plough's
ability to market Intron(R) A alpha interferon. See "Principal Products
Being Marketed or Developed by Biogen's Licensees".
Recombinant Hepatitis B Antigens
Biogen has more than 75 patents in countries around the world,
including three in the United States and two in countries of the
European Patent Office, and several patent applications, covering the
recombinant production of hepatitis B surface, core and "e" antigens.
Biogen continues to seek related patents in the United States and
other countries.
Biogen's first European hepatitis B patent was opposed by five
companies. The Opposition Division of the European Patent Office
maintained the patent over those oppositions. Two of the opponents
appealed the Opposition Division's decision to the Technical Board of
Appeal, which is the final arbiter of European oppositions. In June
1994, the Technical Board maintained Biogen's patent in amended form.
Biogen's second European hepatitis B patent was opposed by four
companies. In 1992, the Opposition Division held that Biogen's second
European hepatitis B patent lacked inventive step. Biogen appealed
this decision to the Technical Board of Appeal. In July 1994, the
Technical Board reversed the Opposition Division and maintained the
Biogen patent.
Biogen has filed three infringement suits to enforce its
hepatitis B patents, in England against Medeva plc ("Medeva"), in
Israel against Bio-Technology General (Israel) Ltd. ("BTG"), and in
Singapore against Scitech Medical Products Pte Ltd. and Scitech
Genetics Pte Ltd. The action against Medeva seeks to enjoin Medeva's
planned production and distribution of a hepatitis B vaccine. In
November 1993, the United Kingdom High Court of Justice ruled in favor
of Biogen and enjoined Medeva from infringement of one of Biogen's
European (UK) patents. The Court then stayed the injunction pending
Medeva's appeal. In October 1994, the United Kingdom Court of Appeal
reversed the High Court and held the Biogen patent to be invalid. In
1995, Biogen received leave from the United Kingdom House of Lords to
appeal this decision and filed its petition in June 1995. A hearing
in the House of Lords is scheduled for April 1996. If the House of
Lords does not reverse the decision of the Court of Appeal and hold
the Biogen patent valid and infringed, the Biogen hepatitis B patent
will no longer be enforceable in the United Kingdom or in any of the
various United Kingdom patent registration countries. In 1992, BTG
brought an action against Biogen seeking a compulsory license under
Biogen's Israeli hepatitis B patent and Biogen filed an infringement
suit against BTG, seeking to enjoin BTG's planned production, sale and
distribution of hepatitis B vaccine. In September 1995, the Israeli
Registrar of Patents, Designs and Trademarks decided that it was
lawful and just to grant to BTG a compulsory license. The proceeding
for setting compulsory license terms by the Registrar is scheduled for
the first half of 1996. Biogen may appeal a final decision by the
Registrar to the Israeli District Court. The infringement suit
continues. In 1993, Biogen sued Scitech Products and Scitech Genetics
in Singapore. Since Singapore is a United Kingdom patent registration
country, Biogen's continued prosecution of this case depends on a
favorable outcome in the United Kingdom House of Lords on Biogen's
appeal of the decision holding Biogen's European (UK) patent invalid.
In September 16, 1994, Biogen filed suit against SmithKline
before the President of the Commercial Court of Nivelles, Belgium
alleging unfair trade practices by SmithKline in refusing to provide
to Biogen copies of SmithKline's marketing authorizations for
hepatitis B vaccines in various European countries to enable Biogen
to obtain supplementary protection certificates for its hepatitis B
patents in those countries. In a June 2, 1995 preliminary judgment,
the President of the Commercial Court referred questions on the
subject to the European Court of Justice where the matter is pending.
Recombinant Beta Interferon
The European Patent Office and certain countries have granted
patents to Biogen covering the recombinant production of beta
interferon. In other countries, including the United States, Biogen
has filed patent applications and continues to seek patents covering
the recombinant production of beta interferon and related technology.
Biogen's European patent was opposed by one company. In December
1993, the European Patent Office's Opposition Division dismissed the
opposition and maintained Biogen's patent. The opponent appealed this
decision to the Technical Board of Appeal. Biogen expects a decision
on the appeal in mid 1996. In the United States, Biogen's claims to
key intermediates in the recombinant production of beta interferon
were involved in an interference to determine who was the first to
invent those intermediates in the United States. Priority of
invention was awarded to another party in the interference. Biogen's
pending United States claims to the production of recombinant beta
interferon were not part of that interference. Prosecution of these
claims continues.
Other parties have also filed patent applications in various
countries covering the recombinant production of beta interferon, and,
in particular, key intermediates in that production, as well as beta
interferon itself. One such party has been granted several patents
in the European Patent Office and in certain countries on these key
intermediates. The same party was awarded priority to those
intermediates in the United States interference. Biogen has obtained
non-exclusive rights to manufacture, use and sell recombinant beta
interferon under these patents in various countries of the world,
including the United States, Japan and most European countries.
Another party has been granted various patents in the United States
and in other countries on beta interferon itself. Biogen has obtained
worldwide, non-exclusive rights under these patents to make, use and
sell recombinant beta interferon. Two other patents issued in 1994
to competitors of Biogen with claims related to beta interferon; one
in the United States and one in the European Patent Office. With
respect to the United States patent, Biogen believes there are
substantial issues of validity, enforceability and scope of claims.
With respect to the European patent, Biogen has been aware of it for
many years and believes that it has no applicability to Biogen's
recombinant beta interferon product. Biogen has filed an opposition
to the European patent in the European Patent Office seeking a
revocation of the entire patent on grounds of lack of inventive step
and lack of novelty. Biogen does not believe that either patent will
prevent Biogen's commercialization of AVONEX TM interferon beta 1a for
the treatment of multiple sclerosis.
Other Patents
In January 1994, Biogen filed suit in Osaka, Japan, against
Sumitomo Pharmaceutical Co., Ltd. ("Sumitomo"). The suit seeks to
enjoin Sumitomo from importing and selling its recombinant human
growth hormone products in Japan. Biogen believes that these products
are made by a process that infringes certain of its licensed patents
relating to the secretion of proteins. Biogen does not expect a
decision in the case until 1997.
Biogen has granted Eli Lilly and Company ("Lilly") a non-
exclusive license under certain of Biogen's patents for gene
expression. Lilly uses the patented vectors and methods in several
products that are on the market or in development.
In March 1995, Biogen filed suit in the U.S. District Court for
the District of Massachusetts against Amgen Inc. ("Amgen"). The suit
seeks to enjoin Amgen from manufacturing and selling its Neupogen R
human granulocyte colony stimulating factor in the United States and
asks for damages for infringing activities. Biogen believes that to
make Neupogen R, Amgen uses technology claimed in certain of Biogen's
licensed patents for gene expression. Biogen does not expect a trial
in the case prior to 1997.
In September 1995, Biogen filed suit in the U.S. District Court
for the District of Massachusetts against Pharmacia Inc.
("Pharmacia"). The suit seeks to enjoin Pharmacia from importing and
selling its Genotropin R recombinant human growth hormone in the
United States. Biogen believes that Genotropin R is made by a process
that infringes certain of Biogen's licensed patents relating to the
secretion of proteins. Biogen does not expect a trial in the case
prior to 1997.
Biogen's European patent relating to gene expression was opposed
by Biotechnology General Corp. in December 1993. In August 1995, the
Opposition Division of the European Patent Office sent an interim
communication with a preliminary and non-binding opinion that, at the
present stage of the proceedings, the patent would be maintained. A
hearing is scheduled for March 1996.
Third Party Patents
Biogen is aware that others, including various universities and
companies working in biotechnology, have also filed patent
applications and have been granted patents in the United States and
in other countries claiming subject matter potentially useful or
necessary to Biogen's business. Some of those patents and
applications claim only specific products or methods of making such
products, while others claim more general processes or techniques
useful or now used in the biotechnology industry. Genentech has been
granted patents and is prosecuting other patent applications in the
United States and certain other countries which it may allege are
currently used by Biogen and the rest of the biotechnology industry
to produce recombinant proteins in microbial hosts. Genentech has
offered to Biogen and others in the industry non-exclusive licenses
under those patents and patent applications for various proteins and
in various fields of use, but not for others. Schering-Plough,
Biogen's exclusive licensee for recombinant alpha interferon, is
licensed under certain of these patents for the manufacture, use and
sale of recombinant alpha interferon. The ultimate scope and validity
of Genentech's patents, of other existing patents, or of patents which
may be granted to third parties in the future, the extent to which
Biogen may wish or be required to acquire rights under such patents,
and the availability and cost of acquiring such rights currently
cannot be determined by Biogen.
There has been, and Biogen expects that there may continue to be,
significant litigation in the industry regarding patents and other
intellectual property rights. Such litigation could create
uncertainty and consume substantial resources.
Competition and Marketing
In General
Competition in the biotechnology and pharmaceutical industries
is intense and comes from many and varied sources. Biogen does not
believe that it or any of the other industry leaders can be considered
dominant in view of the rapid technological change in the industry.
Biogen experiences significant competition from specialized
biotechnology firms in the United States, Europe and elsewhere and
from many large pharmaceutical, chemical and other companies. Certain
of these companies have substantially greater financial, marketing and
human resources than Biogen. The pharmaceutical companies have
considerable experience in undertaking clinical trials and in
obtaining regulatory approval to market pharmaceutical products. In
addition, certain of Biogen's products may be subject to competition
from products developed using alternatives to biotechnology
techniques.
Much competition is directed towards establishing proprietary
positions through research and development. A key aspect of such
competition is recruiting and retaining qualified scientists and
technicians. Biogen believes that it has been successful in
attracting skilled and experienced scientific personnel. Biogen
believes that leadership in the industry will be based on managerial
and technological superiority and may be influenced significantly by
patents and other forms of protection of proprietary information. See
"Patents and Other Proprietary Rights". The achievement of such a
position depends upon Biogen's ability to attract and retain skilled
and experienced personnel, its ability to identify and exploit
commercially the products resulting from biotechnology and the
availability of adequate financial resources to fund facilities,
equipment, personnel, clinical testing, manufacturing and marketing.
Many of Biogen's competitors are working to develop products
similar to those under development by Biogen. The timing of the entry
of a new pharmaceutical product into the market can be an important
factor in determining the product's eventual success and
profitability. Early entry may have important advantages in gaining
product acceptance and market share. Moreover, for certain diseases
with limited patient populations, the FDA is prevented under the
Orphan Drug Act, for a period of seven years, from approving more than
one application for the "same" product for a single orphan drug
designation, unless a later product is considered clinically superior.
Accordingly, the relative speed with which Biogen can develop
products, complete the testing and approval process and supply
commercial quantities of the product to the market is expected to have
an important impact on Biogen's competitive position. In addition,
competition among products approved for sale may be based, among other
things, on patent position, product efficacy, safety, reliability,
availability and price.
AVONEX TM
As a treatment for multiple sclerosis, AVONEX TM will compete
with interferon beta 1b which is sold in the United States under the
brandname Betaseron(R) by Berlex Laboratories, Inc., a United States
affiliate of Schering AG, Germany ("Schering AG"), and sold in Europe
under the brandname Betaferon TM by Schering AG. In Italy and Spain,
AVONEX TM will also compete with an extracted form of beta interferon
sold by Ares Serono S.A. Biogen may also face competition from Teva
Pharmaceuticals which has filed a New Drug Application with the FDA
and applications for marketing approvals in other countries for
Copolymer 1 as a treatment for multiple sclerosis. In addition, a
number of other companies are working to develop products to treat
multiple sclerosis which may in the future compete with AVONEX TM.
Biogen believes that competition among treatments for multiple
sclerosis will be based on product performance, service and price.
Regulation
Biogen's current and contemplated activities and the products and
processes that will result from such activities are and will be
subject to substantial government regulation.
Before new pharmaceutical products may be sold in the United
States and other countries, clinical trials of the products must be
conducted and the results submitted to appropriate regulatory agencies
for approval. These clinical trial programs generally involve a
three-phase process. Typically, in Phase I, trials are conducted in
volunteers or patients to determine the early side effect profile and,
perhaps, the pattern of drug distribution and metabolism. In Phase
II, trials are conducted in groups of patients with a specific disease
in order to determine appropriate dosages, expand evidence of the
safety profile and, perhaps, determine preliminary efficacy. In Phase
III, large scale, comparative trials are conducted on patients with
a target disease in order to generate enough data to provide the
statistical proof of efficacy and safety required by national
regulatory agencies. The receipt of regulatory approvals often takes
a number of years, involving the expenditure of substantial resources
and depends on a number of factors, including the severity of the
disease in question, the availability of alternative treatments and
the risks and benefits demonstrated in clinical trials. On occasion,
regulatory authorities may require larger or additional studies,
leading to unanticipated delay or expense.
In connection with the commercialization of products resulting
from Biogen's projects, it is necessary, in a number of countries, to
comply with certain regulations relating to the manufacturing and
marketing of such products and to the products themselves. For
example, the commercial manufacturing, marketing and exporting of
pharmaceutical products require the approval of the FDA in the United
States and of comparable agencies in other countries. The FDA has
established mandatory procedures and safety standards which apply to
the manufacture, clinical testing and marketing of pharmaceutical
products in the United States. The process of seeking and obtaining
FDA approval for a new product and the facilities in which it can be
produced is likely to take a number of years and involve the
expenditure of substantial resources. In addition, the regulatory
approval processes for products in the United States, Canada and
Europe are undergoing or may undergo changes. Biogen cannot determine
what effect any changes in regulatory approval processes may have on
its business.
In the United States, the federal government regularly considers
reforming health care coverage and costs. Resulting legislation or
regulatory actions may have a significant effect on the Company's
business. Biogen's ability to commercialize successfully human
pharmaceutical products also may depend in part on the extent to which
reimbursement for the costs of such products and related treatments
will be available from government health administration authorities,
private health insurers and other organizations. Currently,
substantial uncertainty exists as to the reimbursement status of newly
approved health care products by third-party payors.
Biogen's policy is to conduct relevant research in compliance
with the current United States National Institutes of Health
Guidelines for Research Involving Recombinant DNA Molecules (the "NIH
Guidelines") and all other federal and state regulations. By local
ordinance, Biogen is required, among other things, to comply with the
NIH Guidelines in relation to its facilities in Cambridge,
Massachusetts, and is required to operate pursuant to certain permits.
Various laws, regulations and recommendations relating to safe working
conditions, laboratory practices, the experimental use of animals and
the purchase, storage, movement, import and export and use and
disposal of hazardous or potentially hazardous substances, including
radioactive compounds and infectious disease agents, used in
connection with Biogen's research work are or may be applicable to its
activities. These include, among others, the United States Atomic
Energy Act, the Clean Air Act, the Clean Water Act, the Occupational
Safety and Health Act, the National Environmental Policy Act, the
Toxic Substances Control Act and the Resource Conservation and
Recovery Act, national restrictions on technology transfer and import,
export and customs regulations. The extent of government regulation
which might result from future legislation or administrative action
cannot accurately be predicted. Certain agreements entered into by
Biogen involving exclusive license rights may be subject to national
or supranational antitrust regulatory control, the effect of which
also cannot be predicted.
Employees
At December 31, 1995, Biogen employed 503 full-time employees, of whom
88 held Ph.D. and/or M.D. degrees. Of the 503 employees,
approximately 186 were engaged in, or directly supported, research and
development and approximately 137 were involved in, or directly
supported, manufacturing, quality assurance/quality control,
regulatory, medical operations and preclinical and clinical
development. Biogen maintains consulting arrangements with a number
of scientists at various universities and other research institutions
in Europe and the United States, including the eight outside members
of its Scientific Board.
Item 2 - Properties
Substantially all of Biogen's facilities are located in Cambridge
Massachusetts. In 1995, the Company completed construction of a
150,000 square foot building in Cambridge which houses laboratories
and office space. The Company also leases a total of approximately
269,000 square feet of additional office and research and development
space in all or part of five other buildings in Cambridge, consisting
of a 67,000 square foot building housing manufacturing facilities,
plant, laboratories and office space, a building with 64,000 square
feet of space containing laboratories, purification and aseptic
bottling facilities and office space, a multitenant building where the
Company occupies approximately 95,000 square feet of office space, a
17,000 square foot building housing office space and a 26,000 square
foot building designed for specialized research laboratories. The
leases for the leased sites terminate in 2003, 2004, 2000, 2004 and
1996, respectively, each with the right to renew.
The Company's European headquarters consists of 1,450 square
meters of office space in a multitenant building in Nanterre, France.
The lease for this space terminates in 2003. The Company also has
small offices in England and Germany.
In the second quarter of 1995, the Company began construction of
a biologics manufacturing facility in Research Triangle Park, North
Carolina. The estimated cost of construction, including land, is $57
million. The Company anticipates construction to be completed in
1997. The Company believes that its production plant in Cambridge,
Massachusetts and existing outside sources will allow it to meet its
production needs for clinical trials and its initial production needs
for AVONEX TM until completion and FDA licensing of the North Carolina
facility. Biogen believes that its existing facilities are in
compliance with appropriate regulatory standards. The Company expects
that additional facilities and outside sources will be required to
meet the Company's future research and production needs.
Item 3 - Legal Proceedings
During the fourth quarter of 1994, a total of six class action
lawsuits were initiated against the Company and several of its
directors and officers. On March 3, 1995, these cases were
consolidated into a single proceeding in the United States District
Court for the District of Massachusetts. The lawsuits generally
allege that the Company and the named directors and officers violated
federal securities laws in connection with the Company's public
disclosures, including disclosures relating to its Hirulog R thrombin
inhibitor and other disclosures made in connection with patent matters
related to AVONEX TM. The plaintiffs seek damages in unspecified
amounts. On January 23, 1996, in response to motions to dismiss the
entire case filed by Biogen and the named officer and director
defendants, the District Court issued a Memorandum and Order (dated
January 22, 1996) dismissing most of the claims asserted in the
plaintiffs' Second Amended Complaint, including all claims against the
Company's outside directors and all claims based upon statements
concerning patent matters related to AVONEX TM. The Court also
dismissed most of the claims brought by the plaintiffs relating to
statements concerning the Company's Hirulog(R) thrombin inhibitor,
including all claims relating to the Hirulog(R) Phase II clinical
trials. The only two claims remaining in the case pertain to
statements concerning the results of the Hirulog(R) TIMI-7 clinical
trials on unstable angina. The Court did not reach a decision on the
merits of these claims. The Company will continue to defend
vigorously the claims that remain in the case.
For a description of legal proceedings relating to patent rights,
see Item 1, "Business-Patents and Other Proprietary Rights."
Item 4 - Submission of Matters to a Vote of Security Holders
None
Executive Officers
The following is a list of the executive officers of the Company
and their principal positions with the Company. Each individual
officer serves at the pleasure of the Board of Directors.
Name Age Positions
James L. Vincent . . . 56 Chairman of the Board of Directors,
Chief Executive Officer
James R. Tobin . . . . . 51 President and Chief Operating Officer
Michael J. Astrue . . . 39 Vice President - General Counsel,
Secretary and Clerk
Kenneth M. Bate. . . . 45 Vice President - Marketing and Sales
Frank A. Burke, Jr.. . 52 Vice President - Human Resources
Lawrence S. Daniels. . 53 Vice President - Strategic Planning
Joseph M. Davie. . . . 56 Vice President - Research
Irving H. Fox. . . . . 52 Vice President - Medical Affairs
Timothy M. Kish . . . 44 Vice President - Finance, Chief
Financial Officer and Treasurer
James C. Mullen. . . . 37 Vice President - Operations
Irvin D. Smith . . . . . 63 Vice President - Development
Operations
The background of these officers is as follows:
James L. Vincent joined the Company as its Chief Executive Officer in
October 1985. He also served as Chief Operating Officer and President
from April 1988 until February 1994. He is also Chairman of the Board
of Directors of the Company. Before joining Biogen, Mr. Vincent
served as Group Vice President, Allied Corporation and as President,
Allied Health & Scientific Products Company, a subsidiary of Allied
Corporation. Before joining Allied Corporation, Mr. Vincent was with
Abbott Laboratories, Inc. where he served in various capacities,
including Executive Vice President, Chief Operating Officer and
Director of the parent corporation.
James R. Tobin joined the Company as its President and Chief
Operating Officer in February 1994. Prior to joining the Company,
Mr. Tobin served in various capacities at Baxter International,
including Executive Vice President from 1988 until 1992 and President
and Chief Operating Officer from 1992 until 1993. Mr. Tobin is a
director of Creative BioMolecules, Inc., Medisense Inc. and Genovo,
Inc.
Michael J. Astrue was appointed Vice President - General Counsel,
Secretary and Clerk of the Company in June 1993. Prior to joining the
Company, Mr. Astrue was a partner in the Boston law firm of Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C. and a managing director
of its wholly-owned consulting firm, ML Strategies, from November 1992
to June 1993. From June 1989 through November 1992, Mr. Astrue served
as General Counsel of the United States Department of Health and Human
Services. From April 1988 through June 1989, Mr. Astrue served as
Associate Counsel to the President of the United States.
Kenneth M. Bate was appointed Vice President - Marketing and Sales in
August 1993 after serving as Vice President - Finance and Chief
Financial Officer since August 1990 and as Treasurer of the Company
since December 1991. From 1978 until 1990, Mr. Bate was employed by
Peter Kiewit & Sons, Inc. and its subsidiaries in various financial
capacities, most recently as Vice President - Treasurer.
Frank A. Burke, Jr., was appointed Vice
President - Human Resources in May 1986 after serving for 12 years in
various human resource management positions at Allied-Signal, Inc.,
most recently as Director of Compensation and Employee Benefits of the
Engineered Materials Sector.
Lawrence S. Daniels was appointed Vice
President - Strategic Planning of the Company in August 1993 after
serving as Vice President - Marketing and Business Development since
November 1991. Prior to joining the Company, Mr. Daniels served for
nine years in planning and administrative functions for Allied-Signal,
Inc., most recently as Vice President, Corporate Strategy Development.
Joseph M. Davie, M.D., Ph.D. was appointed Vice President -
Research of the Company in April 1993. Prior to joining the Company,
Dr. Davie was employed by Searle Corporation where he served as Senior
Vice President - Science and Technology from January 1993 to April
1993, President - Research and Development from July 1987 to January
1993 and Senior Vice President - Discovery Research from January 1987
to July 1987. Dr. Davie is a director of Genovo, Inc.
Irving H. Fox, M.D. was appointed Vice
President - Medical Affairs in February 1990. Dr. Fox joined Biogen
following a 14-year career at the University of Michigan, where he
held professorships in internal medicine and biological chemistry, and
from 1978 to 1990, was program director of the Clinical Research
Center at the University of Michigan Hospital.
Timothy M. Kish was appointed Vice President - Finance, Treasurer
and Chief Financial Officer of the Company in August 1993 after
serving as Corporate Controller of the Company since 1986. Prior to
joining Biogen, Mr. Kish was Director of Finance for Allied Health &
Scientific Products Company, a subsidiary of Allied Corporation.
Before joining Allied, Mr. Kish served in various capacities at Bendix
Corp., most recently as Executive Assistant to the President.
James C. Mullen became Biogen's Vice President
- - Operations in December 1991 after serving as Senior Director -
Operations since February 1991. Mr. Mullen joined the Company in 1989
as Director - Facilities and Engineering and then served as Acting
Director - Manufacturing and Engineering. Before coming to Biogen,
Mr. Mullen held various positions of responsibility from 1984 through
1988 at SmithKline-Beckman Corporation, most recently as Director,
Engineering - SmithKline and French Laboratories, Worldwide.
Irvin D. Smith, Ph.D. was appointed Vice President - Quality
Assurance/Quality Control and Drug Development in August 1993 after
serving as General Manager of Bioferon, Biogen's former joint venture
in Germany, since July 1991. The name of his position was changed to
Vice President-Development Operations in 1994. Dr. Smith was a
private consultant from March 1990 to July 1991 and President and
Chief Executive Officer of Applied BioSystems from October 1987 to
March 1990.
PART II
Item 5 - Market for Registrant's Common Equity and Related Stockholder
Matters
The section entitled "Market for Securities" in the Company's 1995
Annual Report to Shareholders is hereby incorporated by reference.
Item 6 - Selected Financial Data
The section entitled "Selected Financial Data"
in the Company's 1995 Annual Report to Shareholders is hereby
incorporated by reference.
Item 7 - Management's Discussion and Analysis of Financial Condition
and Results of Operations
The section entitled "Management's Discussion and Analysis of
Financial Condition and Results of Operations" in the Company's 1995
Annual Report to Shareholders is hereby incorporated by reference.
Item 8 - Financial Statements and Supplementary Data
The sections entitled "Consolidated Balance Sheets," "Consolidated
Statements of Income," "Consolidated Statements of Cash Flows,"
"Consolidated Statements of Shareholders' Equity," "Notes to
Consolidated Financial Statements" and "Report of Independent
Accountants" in the Company's 1995 Annual Report to Shareholders are
hereby incorporated by reference.
Item 9 - Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure
Not Applicable
PART III
Item 10 - Directors and Executive Officers of the Registrant
Directors
The sections entitled "Election of Directors" and "Trading Reports"
in the Company's definitive proxy statement for its 1996 Annual
Meeting of Stockholders, which the Company intends to file with the
Commission no later than April 30, 1996, are hereby incorporated by
reference.
Executive Officers
Information concerning the Company's Executive Officers is set
forth in Part I of this Annual Report on Form 10-K.
Item 11 - Executive Compensation
The sections entitled "Election of Directors", "Executive
Compensation", "Joint Report on Compensation Philosophy" and
"Performance Graph" in the Company's definitive proxy statement for
its 1996 Annual Meeting of Stockholders, which the Company intends to
file with the Commission no later than April 30, 1996, are hereby
incorporated by reference.
Item 12 - Security Ownership of Certain Beneficial Owners and
Management
The section entitled "Share Ownership" in the Company's definitive
proxy statement for its 1996 Annual Meeting of Stockholders, which the
Company intends to file with the Commission no later than April 30,
1996, is hereby incorporated by reference.
Item 13 - Certain Relationships and Related Transactions
The section entitled "Employment Arrangements with the Company and
Certain Transactions" in the Company's definitive proxy statement for
its 1996 Annual Meeting of Stockholders, which the Company intends to
file with the Commission no later than April 30, 1996, is hereby
incorporated by reference.
PART IV
Item 14 - Exhibits, Financial Statement Schedules and Reports on Form
8-K.
(a) Financial Statements and Financial Statement Schedules.
The following documents are filed as a part of this report:
1. Financial Statements, as required by Item 8 of this Form,
incorporated by reference herein from the 1995 Annual Report to
Shareholders attached hereto as Exhibit 13:
Item Location
Consolidated Balance Sheets Annual Report under the caption
"Biogen, Inc. and Subsidiaries
Consolidated Balance Sheets."
Consolidated Statements
of Income Annual Report under the caption
"Biogen, Inc. and Subsidiaries
Consolidated Statements of Income."
Consolidated Statements
of Cash Flows Annual Report under the caption
"Biogen, Inc. and Subsidiaries
Consolidated Statements of Cash
Flows."
Consolidated Statements
of Shareholders' Equity Annual Report under the caption
"Biogen, Inc. and Subsidiaries
Consolidated Statements of
Shareholders' Equity."
Notes to Consolidated
Financial Statements Annual Report under the caption
"Biogen, Inc. and Subsidiaries Notes
to Consolidated Financial
Statements."
Reports of
Independent Accountants Annual Report under the caption
"Report of Independent
Accountants."
With the exception of the portions of the 1995 Annual Report to
Shareholders specifically incorporated herein by reference, such
report shall not be deemed filed as part of this Annual Report on Form
10-K.
(2) Financial Statement Schedules: None
(3) Exhibits
Exhibit No. Description
(3.1) Articles of Organization, as amended (g)
(3.2) By-Laws, as amended (k)
(4.1) Form of Common Stock Share Certificate (m)
(4.2) Certificate of Designation of Series A Junior
Participating Preferred Stock (f)
(4.3) Rights Agreement dated as of May 8, 1989 between
Registrant and The First National Bank of Boston,
as Rights Agent (f)
(10.1) Independent Consulting and Project Agreement dated
as of June 29, 1979 between Registrant and Kenneth
Murray (a)**
(10.2) Letter Agreement dated September 23, 1995 with Sir
Kenneth Murray relating to renewal of Independent
Consulting Agreement *,**
(10.3) Minute of Agreement dated February 5, 1981 among
Registrant, The University Court of the University
of Edinburgh and Kenneth Murray (a)**
(10.4) Independent Consulting Agreement dated as of June
29, 1979 between Registrant and Phillip A. Sharp
(a)**
(10.5) Letter Agreement dated December 15, 1995 with
Phillip Sharp relating to chairmanship of
Scientific Board and renewal of Independent
Consulting Agreement *,**
(10.6) Project Agreement dated as of December 14, 1979
between Registrant and Phillip A. Sharp (a)**
(10.7) Share Restriction and Repurchase Agreement dated as
of December 15, 1979 between Registrant and
Phillip A. Sharp (a)**
(10.8) Consulting Agreement dated as of April 1, 1991, as
amended, between Registrant and Alexander G. Bearn
(i)**
(10.9) Letter Agreement dated April 14, 1995 with Dr.
Alexander Bearn relating to renewal of Independent
Consulting Agreement *,**
(10.10) Form of Amendment dated July 1, 1988 to Independent
Consulting Agreement between Registrant and
Scientific Board Members (e)**
(10.11) Form of Share Purchase Agreement between Registrant
and Scientific Board Members (a)**
(10.12) Form of Stock Option Agreement between Registrant
and each of Alan Belzer, Harold W. Buirkle, James
W. Stevens and Roger H. Morley (c)**
(10.13) Letter regarding employment of James L. Vincent
dated September 23, 1985 (b)**
(10.14) Form of Stock Option Agreement with James L.
Vincent under 1985 Non-Qualified Stock Option Plan
(k)**
(10.15) Form of Stock Option Agreement with James L.
Vincent under 1985 Non-Qualified Stock Option Plan
(1995) *,**
(10.16) Letter dated December 13, 1989 regarding employment
of Dr. Irving H. Fox (h)**
(10.17) Letter dated August 13, 1990 regarding employment
of Mr. Kenneth M. Bate (i)**
(10.18) Letter dated April 7, 1993 regarding employment of
Dr. Joseph M. Davie (l)**
(10.19) Letter dated January 12, 1994 regarding employment
of James R. Tobin (n)**
(10.20) Letter dated August 30, 1993 regarding employment
of Irvin D. Smith, Ph.D. (n)**
(10.21) Form of Indemnification Agreement between
Registrant and each Director and Executive Officer
(e)**
(10.22) Second Amended and Restated Agreement and
Certificate of Limited Partnership dated as of May
15, 1984 among Biogen Medical Products, Inc. as
General Partner and certain limited partners (g)
(10.23) First Amendment dated December 22, 1986 to
Agreement and Certificate of Limited Partnership
(c)
(10.24) Technology License Agreement dated May 15, 1984
between Biogen B.V. and Biogen Medical Products
Limited Partnership (g)
(10.25) Development Contract dated May 15, 1984 between
Biogen B.V. and Biogen Medical Products Limited
Partnership (g)
(10.26) Amendment dated December 22, 1986 to Development
Contract (c)
(10.27) Amendment dated January 1, 1987 to Development
Contract (d)
(10.28) Extension Agreement dated October 10, 1989 relating
to Development Contract (g)
(10.29) Extension Agreement dated December 31, 1993
relating to Development Contract (n)
(10.30) Extension Agreement dated December 31, 1995
relating to Development Contract *
(10.31) Joint Venture Option Agreement dated May 15, 1984
between Biogen, Inc. and Biogen Medical Products
Limited Partnership (g)
(10.32) Purchase Option Agreement dated May 15, 1984
between Biogen B.V. and the limited partners of
Biogen Medical Products Limited Partnership (g)
(10.33) Guaranty dated May 15, 1984 to Biogen Medical
Products Limited Partnership by Registrant
guaranteeing certain obligations of Biogen Medical
Products, Inc., Biogen B.V. and Biogen, Inc. to the
Partnership (g)
(10.34) Demand Loan Agreement dated October 1, 1989 between
Biogen Medical Products Limited Partnership and
Biogen Medical Products, Inc. (g)
(10.35) Standard Form Commercial Lease dated January 29,
1981 between Ira C. Foss and Ira C. Foss, Jr., as
Trustees of Eastern Realty Trust, and B. Leasing,
Inc. (g)
(10.36) Letter of May 24, 1989 exercising option under
Standard Form Commercial Lease dated January 29,
1981 (g)
(10.37) Lease Extension Agreement dated February 20, 1990
between Eastern Realty Trust and Registrant (g)
(10.38) Standard Form Commercial Lease dated June 1, 1989
between Eastern Realty Trust and Registrant (g)
(10.39) Cambridge Center Lease dated October 4, 1982
between Mortimer Zuckerman, Edward H. Linde and
David Barrett, as Trustees of Fourteen Cambridge
Center Trust, and B. Leasing, Inc. (a)
(10.40) First Amendment to Lease dated January 19, 1989
amending Cambridge Center Lease dated October 4,
1982 (k)
(10.41) Second Amendment to Lease dated March 8, 1990
amending Cambridge Center Lease dated October 4,
1982 (k)
(10.42) Third Amendment to Lease dated September 25, 1991
amending Cambridge Center Lease dated October 4,
1982 (k)
(10.43) Lease dated October 6, 1993 between North Parcel
Limited Partnership and Biogen Realty Limited
Partnership (n)
(10.44) 1983 Employee Stock Purchase Plan, as amended and
restated through September 22, 1995 (*,**)
(10.45) 1982 Incentive Stock Option Plan as amended through
April 25, 1995 and restated with form of Option
Agreement (q)**
(10.46) 1985 Non-Qualified Stock Option Plan as amended
through April 25, 1995 and restated with form of
Option Agreement (q) **
(10.47) 1987 Scientific Board Stock Option Plan as amended
through April 3, 1992 and restated with form of
Option Agreement (j)**
(10.48) Voluntary Executive Supplemental Savings Plan (p)**
(10.49) Supplemental Executive Retirement Plan (p)**
(10.50) Voluntary Board of Directors Savings Plan (p)**
(10.51) Exclusive License and Development Agreement dated
December 8, 1979 between Registrant and Schering
Corporation (a)
(10.52) Amendatory Agreement dated May 14, 1985 to
Exclusive License and Development Agreement dated
December 8, 1979 (b)
(10.53) Amendment and Settlement Agreement dated September
29, 1988 to Exclusive License and Development
Agreement dated December 8, 1979 (k)
(10.54) Amendment dated March 20, 1989 to Exclusive License
and Development Agreement dated December 8, 1979
(k)
(10.55) License Agreement (United States) dated March 28,
1988 between Registrant and SmithKline Beecham
Biologicals, s.a. (as successor to Smith Kline-
R.I.T, s.a.) (k)
(10.56) License Agreement (International) dated March 28,
1988 between Registrant and SmithKline Beecham
Biologicals, s.a. (as successor to Smith Kline-
R.I.T., s.a.) (k)
(10.57) Sublicense Agreement dated as of February 15, 1990
among Registrant, SmithKline Beecham Biologicals,
s.a (as successor to SmithKline Biologicals, s.a.)
and Merck and Co., Inc. (k)
(10.58) Supplemental Amendment and Agreement dated as of
March 1, 1994 between the Registrant and Schering
Corporation (o)
(11) Computation of Earnings per Share *
(12) None
(13) Incorporated portions from Biogen, Inc. 1995 Annual
Report to Shareholders *
(22) Subsidiaries of the Registrant *
(24.1) Consent of Price Waterhouse LLP (Included in Part
IV hereof)
(29) None
(a) Previously filed with the Commission as an exhibit
to Registration Statement on Form S-1, File No.
2-81689 and incorporated herein by reference.
(b) Previously filed with the Commission as an exhibit
to Registrant's Annual Report on Form 10-K for the
year ended December 31, 1985, as amended, File No.
0-12042 and incorporated herein by reference.
(c) Previously filed with the Commission as an exhibit
to Registrant's Annual Report on Form 10-K for the
year ended December 31, 1986, as amended, File No.
0-12042 and incorporated herein by reference.
(d) Previously filed with the Commission as an exhibit
to Registrant's Annual Report on Form 10-K for the
year ended December 31, 1987, File No. 0-12042 and
incorporated herein by reference.
(e) Previously filed with the Commission as an exhibit
to Registrant's Annual Report on Form 10-K for the
year ended December 31, 1988, File No. 0-12042 and
incorporated herein by reference.
(f) Previously filed with the Commission as an exhibit
to Registration Statement on Form 8-A, File No.
0-12042, filed May 26, 1989 and incorporated herein
by reference.
(g) Previously filed with the Commission as an exhibit
to Registrant's Annual Report on Form 10-K for the
year ended December 31, 1989, File No. 0-12042, and
incorporated herein by reference.
(h) Previously filed with the Commission as an exhibit
to Registrant's Annual Report on Form 10-K for the
year ended December 31, 1990, File No. 0-12042, and
incorporated herein by reference.
(i) Previously filed with the Commission as an exhibit
to Registrant's Annual Report on Form 10-K for the
year ended December 31, 1991, File No. 0-12042, and
incorporated herein by reference.
(j) Previously filed with the Commission as an exhibit
to Registrant's Quarterly Report on Form 10-Q for
the quarter ended June 30, 1992, File No. 0-12042,
and incorporated herein by reference.
(k) Previously filed with the Commission as an exhibit
to the Registrant's Annual Report on Form 10-K for
the fiscal year ended December 31, 1993, File No.
0-12042, and incorporated herein by reference.
(l) Previously filed with the Commission as an exhibit
to the Registrant's Quarterly Report on Form 10-Q
for the quarter ended June 30, 1993, File No. 0-
12042, and incorporated herein by reference.
(m) Previously filed with the Commission as an exhibit
to Registration Statement on Form S-3, File No. 33-
51639, and incorporated herein by reference.
(n) Previously filed with the Commission as an exhibit
to Registrant's Annual Report on Form 10-K for the
year ended December 31, 1994, File No. 0-12042, and
incorporated herein by reference.
(o) Previously filed with the Commission as an exhibit
to the Registrant's Quarterly Report on Form 10-Q
for the quarter ended March 31, 1994, File No. 0-
12042, and incorporated herein by reference.
(p) Previously filed with the Commission as an exhibit
to the Registrant's Annual Report on Form 10-K for
the fiscal year ended December 31, 1994, File No.
0-12042, and incorporated herein by reference.
(q) Previously filed with the Commission as an exhibit
to the Registrant's Quarterly Report on Form 10-Q
for the quarter ended June 30, 1995, File No. 0-
12042, and incorporated herein by reference.
* Filed herewith
** Management contract or compensatory plan or
arrangement
(b) Reports on Form 8-K
None.
Signatures
Pursuant to the requirements of Section 13 or 15(d) of
the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
BIOGEN, INC.
By:/s/ James L. Vincent
James L. Vincent, Chairman of the Board
and Chief Executive Officer
Dated January 26, 1996
Pursuant to the requirements of the Securities Exchange
Act of 1934, this report has been signed below by the following
persons on behalf of the Registrant and in the capacities and on the
dates indicated.
Signatures Title Date
/s/ James L. Vincent Chairman of the Board January 26, 1996
James L. Vincent and Chief Executive Officer
(principal executive officer)
/s/ Timothy M. Kish Vice President - Finance,January 26, 1996
Timothy M. Kish Chief Financial Officer
and Treasurer (Principal
financial and accounting officer)
/s/ Alexander Bearn Director January 26, 1996
Alexander Bearn
/s/ Harold W. Buirkle Director January 26, 1996
Harold W. Buirkle
/s/ Alan Belzer Director January 26, 1996
Alan Belzer
/s/ Roger H. Morley Director January 26, 1996
Roger H. Morley
/s/ Kenneth Murray Director January 26, 1996
Kenneth Murray
/s/ Phillip A. Sharp Director January 26, 1996
Phillip A. Sharp
/s/ James W. Stevens Director January 26, 1996
James W. Stevens
/s/ James R. Tobin Director January 26, 1996
James R. Tobin
EXHIBIT INDEX
Exhibit No. Description
(10.2) Letter Agreement dated September 23, 1995 with Sir
Kenneth Murray relating to renewal of Independent
Consulting Agreement
(10.5) Letter Agreement dated December 15, 1995 with
Phillip Sharp relating to chairmanship of
Scientific Board and renewal of Independent
Consulting Agreement
(10.9) Letter Agreement dated April 14, 1995 with Dr.
Alexander Bearn relating to renewal of Independent
Consulting Agreement
(10.15) Form of Stock Option Agreement with James L.
Vincent under 1985 Non-Qualified Stock Option Plan
(1995)
(10.30) Extension Agreement dated December 31, 1995
relating to Development Contract.
(10.44) 1983 Employee Stock Purchase Plan, as amended and
restated through September 22, 1995
(11) Computation of Earnings per Share
(13) Incorporated portions from Biogen, Inc. 1995 Annual
Report to Shareholders
(22) Subsidiaries of the Registrant
(24.1) Consent of Price Waterhouse LLP