Benuvia Operations, LLC Enters into Licensing Agreement with Avernus Pharma for SYNDROS® CII (dronabinol) in the Gulf Cooperation Council Region

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Dec 10, 2024, 09:00 ET

Avernus to become exclusive supplier of SYNDROS^®following approval by the Gulf Central Committee for Drug Registration

ROUND ROCK, Texas, Dec. 10, 2024 /PRNewswire/ -- Benuvia Operations, LLC, a global contract development and manufacturing organization, today announced the company has entered into a licensing agreement with Avernus Pharma, a leading provider and distributor of global pharmaceutical products throughout the Middle East.

Under the terms of the licensing agreement, Avernus will become the exclusive supplier for SYNDROS^®(dronabinol), oral solution, CII in the Gulf Cooperation Council (G.C.C.) Region including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates, following approval by the Gulf Central Committee for Drug Registration (GCC-DR). SYNDROS® (dronabinol) is the first and only FDA-approved CII tetrahydrocannabinol (THC) liquid cannabinoid used in adults to treat cancer Chemotherapy Induced Nausea and Vomiting (CINV) in patients who have failed to respond adequately to conventional antiemetic treatments, and Anorexia Associated Weight Loss in patients with AIDS (AAWLA). (Please see important safety information below.)

"This partnership with Avernus represents a significant milestone in our mission to make SYNDROS® available to more patients worldwide. Avernus has a strong reputation in the local pharmaceutical distribution market, and we believe they are the ideal partner to help us commercialize the product in the Gulf region," said Terry Novak, CEO of Benuvia.

"The signing of SYNDROS® marks a groundbreaking moment for chemotherapy patients across the GCC, symbolizing a new era of hope and innovation in oncology care," said Dr. Ziad Amir Saleh, CEO of Avernus Pharma & Al Ain Medical Store. Echoing this sentiment Dr. Malath Jamous, Director of Avernus Pharma, added, "This is more than a licensing agreement—it's a monumental step forward in our mission to transform the lives of patients battling the harsh side effects of chemotherapy. By adding SYNDROS® (dronabinol), the first and only FDA-approved Schedule II liquid THC, to our oncology portfolio, we are not only expanding our capabilities but also redefining what's possible in patient care. Our partnership with Benuvia paves the way for local approval of SYNDROS®, a beacon of relief and innovation, and we are honored to bring this important medication to those who need it most."

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 Avernus Pharma, LLC
Avernus Pharma is a leading provider of pharmaceutical products across the Middle East, dedicated to delivering innovative healthcare solutions to patients in need. By partnering with global pharmaceutical and biotech companies, Avernus brings the latest advancements in pharmaceuticals, biologics, and other cutting-edge treatments to the region. Serving as a one-stop solution for its partners, Avernus offers multi-country access across a dynamic region with rapidly growing economies. Committed to excellence in patient care and access. For more information visit https://avernuspharma.com/.

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 chemotherapy in adults whose nausea and vomiting have not improved adequately with usual anti-nausea medicines and loss of appetite and weight (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]

SOURCE Benuvia Operations, LLC