Benuvia Operations, LLC Enters into Licensing and Supply Agreements with Medra Brasil Medicamentos LTDA

Medra Brasil to become exclusive supplier of Benuvia’s SYNDROS® (dronabinol) in Brazil following Anvisa approval

Supply agreement will support the development of new Medra Brasil CBD products

ROUND ROCK, Texas, Nov. 21, 2024 /PRNewswire/ — Benuvia Operations, LLC, a global contract development and manufacturing organization, today announced the company has entered into licensing and supply agreements with Medra Brasil Medicamentos LTDA, a distributor of pharmaceutical medicinal cannabis products.

Under the terms of the licensing agreement, Medra Brasil will become the exclusive supplier for SYNDROS® (dronabinol), oral solution, CII in the country of Brazil following approval by the Brazilian Health Regulatory Agency (Anvisa). SYNDROS® (dronabinol) is the first and only FDA-approved CII tetrahydrocannabinol (THC) liquid cannabinoid used in adults to treat Chemotherapy Induced Nausea and Vomiting (CINV) and Anorexia Associated Weight Loss and Aids (AAWLA). (Please see important safety information below.)

“We are thrilled to announce our first out-licensing partnership with Medra Brasil to bring SYNDROS® to the people of Brazil,” commented Terry Novak, CEO of Benuvia. “This is an important milestone for Benuvia as we expand our global partnerships to further commercialize SYNDROS® and all our cannabinoid and psychedelic products and services.”

For Amanda Sá, CEO of Medra Brasil, the licensing agreement will be a milestone in the use of medicinal cannabis in conditions associated with cancer and AIDS. “More and more people are becoming aware that cannabis medications bring numerous benefits to patients. It is a path of no return.”

Benuvia has also signed a supply agreement with Medra Brasil to support the development of new Medra Brasil CBD products. Under the terms of the agreement, Benuvia will become a key Medra supplier.

Edegar Epaminondas, CEO of Medra USA, emphasizes that the partnership with Benuvia is another significant step in the company’s history, which has been building a strong foundation in the Brazilian market. “Our priority is to bring more new technologies, research development, and contribute to the debureaucratization of access to treatment in Brazil.”

About Benuvia Operations, LLC

Benuvia Operations, LLC is a global Contract Development and Manufacturing Organization (CDMO) that helps pharmaceutical and biotech companies deliver life-changing therapies to patients in need. The company provides end-to-end development and manufacturing services for Active Pharmaceutical Ingredients (APIs) and finished dosage products and has extensive experience with cannabinoids, psychedelics, and other controlled substances. Benuvia operates an 83,000 square foot best-in-class manufacturing facility in Round Rock, Texas that can produce Schedule I-V compounds, offering comprehensive solutions for companies throughout the entire drug development lifecycle—from API synthesis and clinical trial supply to commercial production. Learn more at www.benuvia.com.

About Medra Brasil Medicamentos LTDA

Medra Brasil Medicamentos is an importer and distributor of pharmaceuticals, cosmetics, and health products, with a special focus on medicinal cannabis. With one of the largest portfolios of medicinal cannabis in the country, the company offers a variety of products, from medications to cosmetics, all carefully selected to meet consumers’ needs.

The pillars of Medra Brasil include investment in research, education of healthcare professionals, and care in customer service. The company is dedicated to bringing innovative and effective solutions to the Brazilian market, aiming to improve the health and well-being of its clients. In addition to its operations in Brazil, Medra also operates in the United States through Medra USA, expanding its reach and strengthening its presence in the international market. Its commitment to quality and innovation is evident in its meticulous approach and continuous investment in new products and quality partnerships. For more information, visit medrabrasil.com.br.

About SYNDROS^® (dronabinol), oral solution, CII

SYNDROS® (dronabinol) is a prescription medicine approved by the FDA to help improve nausea and vomiting caused by anti-cancer medicine (chemotherapy) in adults whose nausea and vomiting have not improved with usual anti-nausea medicines and loss of appetite (anorexia) in adults with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.

Complete prescribing information is available at https://syndros.com/full-prescription-information/. For additional information on SYNDROS®, please see www.syndros.com.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SYNDROS® is contraindicated in patients:

with a history of a hypersensitivity reaction to dronabinol. Reported hypersensitivity reactions to dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, ﬂushing, throat tightness [see Adverse Reactions (6.2)].
with a history of a hypersensitivity reaction to alcohol.
who are receiving, or have recently received, disulﬁram- or metronidazole-containing products within 14 days [see Warning and Precautions (5.3)]. SYNDROS® contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol.

SYNDROS® can cause serious side effects, including:

Worsening mental (psychiatric) symptoms. Psychiatric symptoms can worsen in people who have mania, depression, or schizophrenia and who take SYNDROS®. SYNDROS® taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take SYNDROS® may have a greater risk of having psychiatric symptoms. Tell your doctor if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia.
Problems thinking clearly. Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly.
Changes in your blood pressure. SYNDROS® may increase or decrease your blood pressure, especially when you start taking SYNDROS® or when your dose is changed. Tell your doctor if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling lightheaded, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls.
Interactions with disulﬁram or metronidazole. SYNDROS® contains alcohol, which can cause you to have a reaction to medicines that contain disulﬁram or metronidazole. You should not use any medicine that contains disulﬁram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) if you take SYNDROS®. You should not use a medicine that contains disulﬁram or metronidazole for at least 14 days before you start taking SYNDROS® and within 7 days after your last dose of SYNDROS®. Tell your doctor if you have signs or symptoms of a reaction to disulﬁram or metronidazole including: stomach-area (abdominal) cramping, nausea, vomiting, headache, and ﬂushing.

SYNDROS® is a controlled substance (CII) because it contains dronabinol which can be a target for people who abuse prescription medicines or street drugs. Keep your SYNDROS® in a safe place to protect it from theft. Never give your SYNDROS® to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.

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

Do not take SYNDROS® if you:

had an allergic reaction to dronabinol. Signs and symptoms of an allergic reaction to dronabinol include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, ﬂushing, and throat tightness.
had an allergic reaction to alcohol.
are using a medicine that contains disulﬁram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) or have taken or received a medicine that contains disulﬁram or metronidazole in the last 14 days.

You are encouraged to report adverse events related to SYNDROS®, please contact Benuvia Operations, LLC at 1-844-558-8289. You may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

Forward-Looking Statements

This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. These forward-looking statements should be considered together with the risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

Contact

KWM Communications

Kellie Walsh

(914) 315-6072

[email protected]

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