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Delcath Systems Announces Move to a Direct Sales & Marketing Model for CHEMOSAT®

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Delcath Systems, Inc. (Nasdaq: DCTH) announced its decision to resume direct responsibility for the sales, marketing, and distribution of the CHEMOSAT® Hepatic Delivery System in Europe effective March 1, 2022. This move comes after medac GmbH held the license for the product since December 2018. Delcath aims for a smooth transition to ensure patient access to CHEMOSAT, a proprietary device that delivers high-dose chemotherapy to the liver while managing systemic exposure. The product has been used in major medical centers for treating liver cancers since its EU launch in 2012.

Positive
  • Resuming direct sales and distribution may enhance DCTH's market presence in Europe.
  • CHEMOSAT has been successfully used in major medical centers since its launch, indicating strong demand.
Negative
  • Transitioning back to direct responsibility may pose operational challenges.
  • Reliance on the previous licensee (medac) for four years could hinder immediate sales ramp-up.

NEW YORK, Feb. 22, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today that effective March 1, 2022, it will resume direct responsibility for sales, marketing and distribution activities relating to the CHEMOSAT® Hepatic Delivery System in Europe (EU, United Kingdom, Norway, Liechtenstein, Switzerland). Since December 2018, medac GmbH, a privately held, multi-national pharmaceutical company based in Germany, has been the licensee for CHEMOSAT in Europe. Delcath and medac are working closely together on an orderly transition of activities.

CHEMOSAT is the European trade name for Delcath’s proprietary percutaneous hepatic perfusion (PHP) device, which administers a high-dose chemotherapeutic agent (melphalan hydrochloride) to the liver, while controlling systemic exposure. Delcath launched CHEMOSAT in the EU in 2012 and sold the product through its own dedicated sales force up until the 2018 licensing agreement.

“Delcath is eager to resume direct sales and distribution in Europe and will work closely with medac during the transfer process to ensure patients continue to receive access to CHEMOSAT treatment,” said Gerard Michel, CEO of Delcath.

About Delcath Systems, Inc.

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary percutaneous hepatic perfusion (PHP) system is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In the United States, the PHP system is being developed under the tradename HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO, and is considered a combination drug and device product regulated by the United States Food and Drug Administration (FDA).

In Europe, the PHP system is regulated as a Class IIb medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used at major medical centers to treat a wide range of cancers of the liver.

Contact:

Delcath Investor Relations

Email: investorrelations@delcath.com

Hayden IR

James Carbonara (646)-755-7412
james@haydenir.com

Source: Delcath Systems, Inc.


FAQ

What is the significance of Delcath Systems resuming direct sales of CHEMOSAT?

Delcath's resumption of direct sales may improve control over marketing strategies and increase revenue potential.

When will Delcath Systems take over sales and marketing for CHEMOSAT in Europe?

Delcath will resume direct responsibility for CHEMOSAT sales and marketing in Europe effective March 1, 2022.

What is the CHEMOSAT system used for?

CHEMOSAT is used to treat primary and metastatic liver cancers by administering high-dose chemotherapy directly to the liver.

How long has CHEMOSAT been on the market in Europe?

CHEMOSAT was launched in Europe in 2012 and has been utilized in major medical centers for liver cancer treatment.

Who was responsible for CHEMOSAT sales prior to Delcath's takeover?

Medac GmbH was the licensee for CHEMOSAT in Europe since December 2018.

Delcath Systems Inc

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