Genmab — Regulatory Filings 2017

Aug 29, 2017

Company Announcement

-- Seattle Genetics exercises option to co-develop & co-commercialize
tisotumab vedotin
-- Costs and profits to be shared 50:50 going forward
-- Lead indication in recurrent cervical cancer; additional potential in other
solid tumors

Copenhagen, Denmark and Bothell, Washington; August 29, 2017 – Genmab A/S
(Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN) announced
today that Seattle Genetics, Inc. has exercised its option to co-develop
tisotumab vedotin. The companies originally entered into a commercial license
and collaboration agreement in October 2011 under which Seattle Genetics had
the right to exercise a co-development option for tisotumab vedotin at the end
of Phase I clinical development. Tisotumab vedotin, an antibody-drug conjugate
(ADC) targeting tissue factor, is currently being evaluated in Phase I/II
clinical studies in solid tumors. Going forward, Genmab and Seattle Genetics
will co-develop and share all future costs and profits for tisotumab vedotin on
a 50:50 basis.

“The combination of Genmab’s differentiated HuMax®-TF antibody and Seattle
Genetics’ clinically-validated antibody-drug conjugate (ADC) technology has
resulted in encouraging preliminary data for tisotumab vedotin in selected
solid tumors. We very much look forward to working with Seattle Genetics to
further develop this exciting first-in-class ADC product,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.

“Our ADC partnership with Genmab has generated promising Phase I/II data for
tisotumab vedotin in patients with recurrent cervical cancer. As Seattle
Genetics opts into co-development of this clinical program, we add another
potential product to our strong pipeline,” said Clay Siegall, Ph.D., President
and Chief Executive Officer of Seattle Genetics. “Together with Genmab, we look
forward to advancing tisotumab vedotin for the treatment of solid tumors.”

Preliminary data from the ongoing Phase I/II study of tisotumab vedotin in
solid tumors (GEN701) were announced in June 2017, demonstrating antitumor
activity and manageable safety in recurrent cervical cancer patients. This
announcement can be found here. Updated preliminary data from the Phase I/II
study will be presented in an oral presentation at the European Society for
Medical Oncology (ESMO) 2017 Congress in Madrid (Spain), September 8-12, 2017.

Today’s news does not impact the 2017 financial guidance issued by Genmab on
May 10, 2017.

About the collaboration
In October 2011, Genmab and Seattle Genetics, Inc. entered into a commercial
license and collaboration agreement for ADCs. Under the agreement, Genmab was
granted rights to utilize Seattle Genetics ADC technology with its HuMax®-TF
antibody. Seattle Genetics was granted rights to exercise a co-development and
co-commercialization option at the end of Phase I clinical development for
tisotumab vedotin. With today’s news Seattle Genetics exercises its option to
co-develop tisotumab vedotin and the companies will share all future costs and
profits for the product on a 50:50 basis. Seattle Genetics will be responsible
for commercialization activities in the US, Canada, and Mexico, while Genmab
will be responsible for commercialization activities in all other territories.
Each party has the option to co-promote by employing up to 40 percent of the
sales effort in the other party’s territories.

About tisotumab vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of a human
antibody that binds to tissue factor (TF) and Seattle Genetics’ ADC technology
that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E
(MMAE). TF is a protein involved in tumor signaling and angiogenesis. Based on
its high expression on many solid tumors and its rapid internalization, TF was
selected as a target for an ADC approach. Tisotumab vedotin is in Phase I/II
clinical studies for solid tumors.

About Genmab
Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company has two approved antibodies,
DARZALEX® (daratumumab) for the treatment of certain multiple myeloma
indications, and Arzerra® (ofatumumab) for the treatment of certain chronic
lymphocytic leukemia indications. Daratumumab is in clinical development for
additional multiple myeloma indications, other blood cancers, and solid tumors.
A subcutaneous formulation of ofatumumab is in development for relapsing
multiple sclerosis. Genmab also has a broad clinical and pre-clinical product
pipeline. Genmab's technology base consists of validated and proprietary next
generation antibody technologies - the DuoBody® platform for generation of
bispecific antibodies, and the HexaBody® platform which creates effector
function enhanced antibodies. The company intends to leverage these
technologies to create opportunities for full or co-ownership of future
products. Genmab has alliances with top tier pharmaceutical and biotechnology
companies. For more information visit www.genmab.com.

About Seattle Genetics
Seattle Genetics is an innovative biotechnology company that develops and
commercializes novel antibody-based therapies for the treatment of cancer. The
company’s industry-leading antibody-drug conjugate (ADC) technology harnesses
the targeting ability of antibodies to deliver cell-killing agents directly to
cancer cells. ADCETRIS® (brentuximab vedotin), the company’s lead product, in
collaboration with Takeda Pharmaceutical Company Limited, is the first in a new
class of ADCs commercially available globally in 67 countries for relapsed
classical Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma
(sALCL). Seattle Genetics is also advancing enfortumab vedotin, an ADC for
metastatic urothelial cancer, in a planned pivotal trial in collaboration with
Astellas. Headquartered in Bothell, Washington, Seattle Genetics has a strong
pipeline of innovative therapies for blood-related cancers and solid tumors
designed to address significant unmet medical needs and improve treatment
outcomes for patients. The company has collaborations for its proprietary ADC
technology with a number of companies including AbbVie, Astellas, Bayer,
Celldex, Genentech, GlaxoSmithKline and Pfizer. More information can be found
at www.seattlegenetics.com

Forward Looking Statement for Genmab
This Company Announcement contains forward looking statements. The words
“believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions
identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with
pre-clinical and clinical development of products, uncertainties related to the
outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market acceptance
of our products, our inability to manage growth, the competitive environment in
relation to our business area and markets, our inability to attract and retain
suitably qualified personnel, the unenforceability or lack of protection of our
patents and proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our products obsolete,
and other factors. For a further discussion of these risks, please refer to the
risk management sections in Genmab’s most recent financial reports, which are
available on www.genmab.com. Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement nor to
confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the
Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™;
the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody®
and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates.
DARZALEX® is a trademark of Janssen Biotech, Inc.

Forward Looking Statement for Seattle Genetics
Certain of the statements made in this press release are forward looking, such
as those, among others, relating to the therapeutic potential of tisotumab
vedotin and its possible benefits and uses, and planned development activities
including future clinical trials. Actual results or developments may differ
materially from those projected or implied in these forward-looking statements.
Factors that may cause such a difference include the inability to show
sufficient activity and the risk of adverse events as tisotumab vedotin
advances in clinical trials and regulatory actions. More information about the
risks and uncertainties faced by Seattle Genetics is contained under the
caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q
for the quarter ended June 30, 2017 filed with the Securities and Exchange
Commission. Seattle Genetics disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.

Genmab Contact:

Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications

T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

Seattle Genetics Contacts:

Investors: Peggy Pinkston, Vice President, Investor Relations

(425) 527-4160; ppinkston@seagen.com

Media: Kavita V. Shah, Ph.D., Associate Director, Corporate Communications

(425) 527-4188; kshah@seagen.com

Company Announcement no. 29
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark