NEWS & EVENTS

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News Release Details

Horizon Therapeutics Secures U.S. FDA Approval for Teprotumumab, for the Treatment of Thyroid Eye Disease (TED)

Jan 23, 2020 at 10:38 AM CET

Media Release


Copenhagen, Denmark, January 23, 2020

      ·Third Genmab-created product approved by the U.S. FDA

Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted approval to Horizon Therapeutics (Nasdaq: HZNP) for the use of teprotumumab, under the trade name TEPEZZA™ (teprotumumab-trbw), for the treatment of Thyroid Eye Disease (TED). TEPEZZA, the first and only U.S. FDA-approved medicine for the treatment of TED, was developed by and is manufactured by Horizon, completing a long development program that began when Genmab created the molecule nearly two decades ago.
Horizon submitted the Biologics License Application for teprotumumab, which received Priority Review, Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA. Teprotumumab was created by Genmab under a collaboration with Roche and development of the product is now being conducted by Horizon under a license from Roche. Under the terms of Genmab’s agreement with Roche, Genmab will receive mid-single digit royalties on sales of TEPEZZA.

“We would like to congratulate Horizon on this exciting approval, and we are very pleased that patients in the United States living with thyroid eye disease, a vision-threatening autoimmune condition, will now have this important new treatment option,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We also believe that this approval, the third for a Genmab-created product following Arzerra® and DARZALEX®, reflects our company’s proven track record in improving the lives of patients by creating breakthrough innovative antibody products.”   

For more information about TEPEZZA and TED, please see the press release issued by Horizon Therapeutics.

About Thyroid Eye Disease
TED, which is also known as Graves’ orbitopathy, is a rare vision threatening rare autoimmune disease associated with thyroid disease that affects the eyes including the eye muscles, eyelids, tear glands and fatty tissues behind the eye. Common symptoms of TED include proptosis (eye bulging), diplopia (double vision), misalignment of the eyes, blurred vision, irreversible disfigurement and vision loss. The disease causes serious damage as it progresses, and in some cases can lead to blindness.  

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 amyloidosis. 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, the HexaBody® platform, which creates effector function enhanced antibodies, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. 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. Genmab is headquartered in Copenhagen, Denmark with core sites in Utrecht, the
Netherlands and Princeton, New Jersey, U.S.


Contact:          
Marisol Peron, Corporate Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Media Release 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 or technologies 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 and the risk factors included in Genmab’s final prospectus for our U.S. public offering and listing and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

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

 

 

Media Release no. 02
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

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