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Helsinn Group announces agreement to acquire worldwide rights to Valchlor/Ledaga, an approved and marketed alkylating agent for topical treatment of mycosis fungoides type cutaneous T-cell lymphoma

Helsinn Group announces agreement to acquire worldwide rights to Valchlor®/Ledaga® - an approved and marketed alkylating agent for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma, a rare type of skin cancer

  • Product is approved by the U.S. Food & Drug Administration and the European Commission and launched in the U.S. with global sales of $35 million in 2017

Lugano, Switzerland March 21, 2018 - Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces that yesterday, March 20th, 2018, in Zürich, it entered into a definitive agreement to acquire worldwide rights to Valchlor®/Ledaga®, (mechlorethamine/chlormethine) an alkylating agent for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) from Actelion Pharmaceuticals Ltd. Completion of the acquisition is subject to customary closing conditions, and is expected to close in the second quarter of 2018.

Valchlor® is the first and only FDA-approved topical formulation of mechlorethamine. It was launched in the U.S. at the end of 2013 and sales have grown from $11 million in 2014 to $35 million globally in 2017. In the U.S., approximately 15,000 patients are currently diagnosed with stage IA-IB MF-CTCL, qualifying it as a rare or orphan disease. The U.S. Food and Drug Administration has granted it orphan drug designation. To date, limited treatment choices are available for those patients who can benefit from Valchlor® through the reimbursement by a wide range of public and commercial payers.

The Group's U.S. subsidiary, Helsinn Therapeutics (U.S.), Inc., will draw on its extensive experience in cancer care products' sales to market Valchlor® in the U.S. and build upon the strong sales base it has already developed in the region.

The drug, known as Ledaga® in EU was approved by the European Commission in March 2017, for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma in adult patients for all stages and was granted orphan drug designation in 2012. In France, patients benefit from the drug under a temporary authorization for use ("Autorisation Temporaire Utilisation") program initiated during the second half of 2014.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: "Helsinn is delighted to announce the acquisition of Valchlor®/Ledaga®, for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. This is a discomforting disease which has a significant impact on patients' quality of life. Helsinn is committed to developing and marketing products designed to help people with cancer get the most out of every day and benefit from Valchlor®, which is approved and marketed in the U.S. where limited treatment choices are available. We are excited to be adding this drug to our portfolio of products designed to offer appropriate cancer therapeutic and supportive care treatment options to patients. We are looking forward to bringing the drug to more patients worldwide".

Rothschild S.p.A. acted as the sole financial adviser to Helsinn on the acquisition.

Terms of the acquisition are not being disclosed.

END

About Valchlor®/Ledaga®

Valchlor®/Ledaga® gel is an alkylating drug indicated for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL). Valchlor®/Ledaga® is a gel which is applied topically once a day. The drug has been approved by the U.S. Food & Drug Administration (for MF-CTCL patients in stages IA and IB who have received prior skin-directed therapy) and the European Commission (for MF-CTCL patients in all stages) and received Orphan Drug Designation from both health authorities. It is commercialized in the U.S. market and available in France through an ATU. Ledaga® is also available in Israel.

Important Safety information about Valchlor®
Valchlor® (mechlorethamine) gel is for use on skin only. Do not get Valchlor® near or in your eyes, mouth, or nose as it can cause pain, redness, swelling, burning, and ulcers. It can also cause sensitivity to light, blurred vision, and may also cause blindness or permanent eye injury. If Valchlor® gets in your eyes, rinse your eyes right away for at least 15 minutes with a large amount of water, normal saline, or an eyewash solution. If it gets in your nose or mouth, rinse the affected area right away for at least 15 minutes with a large amount of water. Get medical help right away.

Do not use Valchlor® if you are severely allergic to mechlorethamine. Tell your healthcare provider if you have had an allergic reaction to mechlorethamine.

It is not known if Valchlor® is safe and effective in children.

Before using Valchlor®, tell your healthcare provider about all your medical conditions. In addition, if you are pregnant, or breastfeeding or planning a pregnancy:

  • Valchlor® can harm your unborn baby and you should not become pregnant while using Valchlor®. Tell your healthcare provider if you are planning to get pregnant, are pregnant, or become pregnant while using Valchlor®
  • It is not known if Valchlor® passes into breast milk. You and your healthcare provider should decide if you will use Valchlor® or breastfeed; do not do both


Valchlor® is flammable. Avoid fire, flame, and smoking until Valchlor® has dried.

Serious side effects include:

Risk of secondary exposure to Valchlor® for caregivers who accidentally come into contact with Valchlor® may include risk of skin inflammation (dermatitis); injury to eyes, mouth, or nose; and certain types of cancer. If accidental contact occurs, wash the affected area with soap and water right away for at least 15 minutes and remove any contaminated clothing. Get medical help right away if Valchlor® gets in your eyes, mouth, or nose.

Skin inflammation (dermatitis) is common with Valchlor® and may sometimes be severe. Risk for dermatitis is increased if Valchlor® is applied to your face, genital area, anus, or skin folds. Tell your healthcare provider if you develop skin reactions such as redness, swelling, itching, blisters, ulcers, and skin infections.

Increased risk of certain types of skin cancers. Certain types of skin cancer can develop on treated and non-treated areas with Valchlor®. Your healthcare provider will check your skin for skin cancers during and after treatment. Tell your healthcare provider if you get any new skin lesions.

Most common side effects include redness, swelling, itching, skin ulcers or blisters, skin infection, and darkening of areas of your skin.

These are not all the possible side effects of Valchlor®. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Mycosis Fungoides

Mycosis fungoides (MF) accounts for almost 50% of all primary cutaneous lymphomas, a form of non-Hodgkin's lymphoma. The cause of MF remains unknown and there are no curative treatments. MF has an indolent clinical course, slowly progressing from patches to thicker plaques and eventually to tumours over years or decades. Signs include rash, patch and plaques with severe itch. MF typically affects older adults (median age at diagnosis: 55-60 years) with male predominance. In the U.S., approximately 15,000 patients are affected by stage IA-IB MF-CTCL. Epidemiologic studies based on the Surveillance, Epidemiology, and End Results (SEER) databases have shown a threefold increase in CTCL incidence in the US during the last 25-30 years.

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.

To learn more about Helsinn Group please visit www.helsinn.com

For more information:

Helsinn Group Media Contact:

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

Info-hhc@helsinn.com

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Source:Helsinn Healthcare S.A.