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
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/a937b0a3-2943-449a-ad35-689b7e572f6d
