PRESS RELEASES

MORRISTOWN, NJ - November 14, 2018

Averitas Pharma, a recently acquired Grünenthal Group company, announced that it has taken over the US commercialization of Qutenza® (capsaicin) 8% patch on October 30, after the acquisition of the product by Grünenthal on the same day. Qutenza® is approved in the US for the management of neuropathic pain associated with postherpetic neuralgia. A single, 1-hour, localized treatment with Qutenza® may provide 3 months of relief from post-shingles nerve pain.

"We're happy to establish Grünenthal's commercial footprint in the largest pharma market in the world," says Douglas Stefanelli, President of Averitas Pharma. "With Qutenza®, we have an exciting opportunity in front of us. There's still a high unmet medical need in pain management, especially for non-opioid treatments. Our plans include changing the commercial distribution model for Qutenza® to provide patients and health care providers with improved access to the product."

To support the Qutenza® commercialization, Averitas Pharma expects to add new positions in New Jersey and across the country.

"As a leader in pain research and management, we're dedicated to bringing solutions for patients with high unmet medical needs. Qutenza® has a broad neuropathic pain label in Europe and Averitas Pharma is actively pursuing the regulatory approvals necessary to support expanding the US label," adds Mark Fladrich, Grünenthal's Chief Commercial Officer.

About Averitas Pharma - Averitas Pharma aims to be more than just another pharmaceutical company. We focus on bringing non-opioid pain relief products to market, keeping treatment prices reasonable, and making the use of our products efficient for both patients and physicians. We are located in Morristown, NJ.

About Grünenthal - Grünenthal is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation. Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a € 2 bn company. We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.

Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in approx. 30 countries with affiliates in Europe, Latin America and the US. Our products are sold in more than 100 countries with approximately 5,200 employees worldwide. In 2017, Grünenthal achieved revenues of approx. € 1.3 bn.

More information: www.grunenthal.com

About Qutenza®

Qutenza® is indicated for the management of neuropathic pain associated with postherpetic neuralgia.

IMPORTANT SAFETY INFORMATION

Treatment with Qutenza® must be performed only by a healthcare provider. You should never apply or remove Qutenza® yourself.

Warnings and Precautions:

Qutenza® is not for use near eyes or mucous membranes. Do not sniff or inhale near the Qutenza® patch as this may cause you to cough or sneeze Do not touch the Qutenza® patch with your hands. If you touch the patch, it may cause burning and stinging; if this occurs, tell your healthcare provider Even though a numbing medicine is used on the skin before applying Qutenza®, some patients may still experience substantial pain during the treatment. Tell your healthcare provider if you are experiencing pain; a cool compress or medicine for the pain can be provided to help lessen your discomfort
Qutenza® can cause serious side effects including pain and increases in blood pressure during or right after treatment
Your healthcare provider should check your blood pressure during treatment with Qutenza® Patients who have high blood pressure that is not well controlled by medicine, or who have had recent heart problems, stroke, or other vascular problems, may be at increased risk and should discuss with their doctor whether Qutenza® is right for them If opioids are used to treat pain associated with the application procedure, please note that opioid treatment may affect the patient's ability to perform potentially hazardous activities such as driving or operating heavy machinery

Side Effects:

In clinical studies, the most common drug-related side effects of Qutenza®, which occurred in 5% or more of patients, included redness, pain, itching, or small bumps where Qutenza® was applied, and nausea
You should tell your doctor if any side effects bother you or do not go away
These are not all the side effects of Qutenza®. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088. For more information, ask your healthcare provider or pharmacist.

For the full Prescribing Information, please visit www.qutenza.com

Qutenza® is a registered US trademark of Averitas Pharma, Inc.

72512-QZ-10

For further information, please contact:
Douglas Stefanelli, President Averitas Pharma, Inc.
Phone: +1-908-745-2271
dstefanelli@averitaspharma.com
Averitas Pharma, Inc. 360 Mt. Kemble Avenue, Morristown, NJ 07960

SOURCE Averitas Pharma

AACHEN, GERMANY & MORRISTOWN, NJ - November 14, 2018

Grünenthal announced today that it has acquired the US-based pharmaceutical company Averitas Pharma, thereby extending its commercial footprint to the United States. Averitas Pharma will be commercialising the pain patch Qutenza® (8 % capsaicin) for Grünenthal in the US. Grünenthal had only recently acquired the remaining global rights, including the US rights, for the product from Acorda Therapeutics.

"I am proud to say that we are now establishing our own commercial presence in the world's biggest pharma market, the US, for the first time," says Gabriel Baertschi, Grünenthal's Chief Executive Officer. "This acquisition is another important milestone in executing our growth strategy and expanding our business across multiple pain related therapeutic categories and geographies. Averitas Pharma is a perfect match due to its significant specialty pharma expertise in the US market and experience in different commercial models also beyond the typical 'reach and frequency' approach".

Averitas Pharma will be enhancing the commercial distribution model for Qutenza® towards a specialty pharmacy and hub services model that makes it easier for patients to access the product and support health care professionals in prescribing and applying it. "This will help us transitioning and ramping up the Qutenza® US business, bringing the product back on the growth path in the US," explains Gabriel Baertschi.

Qutenza® is a local analgesic and an alternative to the current standard of care, as there is still a high unmet medical need in pain management, particularly for non-opioid and non-systemic treatments. In Europe, it is approved for a broad peripheral neuropathic pain indication in adults, e.g. post-surgical neuropathic pain, cancer-related neuropathic pain and painful diabetic peripheral neuropathy. In the US, Qutenza® is currently only approved for the treatment of postherpetic neuralgia (PHN). Averitas Pharma will work towards a broader neuropathic pain label from the US Food & Drug Administration (FDA).

Grünenthal continues executing its growth strategy and has been expanding its pain portfolio by a series of acquisitions including European rights to Nexium®, the global (ex US and Japan) rights to Vimovo®, the global rights to Qutenza® and global (ex Japan) rights to Zomig®. The company has signed deals with a total value of more than US$ 1.3 billion since 2016.

About Qutenza®

Qutenza® (capsaicin) 8% patch is approved in the US for the management of neuropathic pain associated with postherpetic neuralgia. A single, 1-hour, localized treatment with Qutenza® may provide 3 months of relief from post-shingles nerve pain (PHN). In Europe, Qutenza® is approved by the European Medicines Agency for the treatment of peripheral neuropathic pain in adults, including post-surgical neuropathic pain, cancer-related neuropathic pain and painful diabetic peripheral neuropathy, either alone or in combination with other pain medicines. The 8% capsaicin patch delivers a high dose of capsaicin directly to the damaged nerves in the skin that are the source of neuropathic pain. Applied to the area of pain, the capsaicin reduces the spontaneous activity and consequently reduces the neuropathic pain intensity. Important safety information can be found here: http://www.qutenza.com and http://www.ema.europa.eu/documents/product-information/qutenza-epar-product-information_en.pdf

About Grünenthal

Grünenthal is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation. Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a € 2 bn company. We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.

Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in approx. 30 countries with affiliates in Europe, Latin America and the US. Our products are sold in more than 100 countries and approx. 5,200 employees are working for Grünenthal worldwide. In 2017, Grünenthal achieved revenues of approx. € 1.3 bn.

More information: www.grunenthal.com


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For further information, please contact:
Štěpán Kráčala
Head Global Communications
Tel.: +49-241-569-1335
Stepan.Kracala@grunenthal.com
Grünenthal GmbH, 52099 Aachen, Germany

Kerstin Nacken
Head Editorial Management and Media Relations
Tel.: +49-241-569-2710
Kerstin.Nacken@grunenthal.com
Grünenthal GmbH, 52099 Aachen, Germany

SOURCE Grünenthal Group