Terran Biosciences Granted US Patent for the World’s First New Forms of MDMA, Potentially Clearing the Path to a Future 505(b)(2) Approval

In a huge win for patients, we're ecstatic to share that today Valhalla Ventures portfolio company Terran Biosciences was issued a patent covering the world's first new salts and polymorphs of MDMA (MDMA hemifumarate) as well as the method of use for treating post-traumatic stress disorder. This means that Terran now holds the only granted composition of matter patent on the first new form of MDMA in history while also opening the door for Terran to pursue a rapid 505(b)(2) FDA approval in order to bring the drug to market which could result in commercialization 5 years following the first approval of MDMA.

Ultimately the more groups in the market with MDMA-based drugs and therapies, the greater the benefit to patients who will be able to take advantage of these treatments at more competitive price points. Terran is committed to ensuring that patients have access to the best and most cutting-edge treatments for mental health conditions at affordable price points in order to maximize their social impact.

For the full press release please see below:

https://finance.yahoo.com/news/terran-biosciences-granted-us-patent-120000091.html

Terran Biosciences , Inc. ("Terran"), a biotech platform company developing therapeutics and technologies for patients with neuropsychiatric illnesses, has been awarded patent US 11,958,821 from the United States Patent and Trademark Office (USPTO) covering the world’s first new salts and polymorphs of MDMA (MDMA hemifumarate), pharmaceutical compositions using these forms, and the method of use for treating post-traumatic stress disorder (PTSD). Terran now holds the only granted composition of matter patent on a new form of MDMA. MDMA was originally invented by Merck in 1912 and the clinical trials of MDMA to date have been limited to using the older forms of MDMA hydrochloride (MDMA HCl) described in the historical literature.

“With this new breakthrough, we are committed to bringing affordable and accessible MDMA treatment options to patients with PTSD” - Dr. Sam Clark, MD/PhD, Founder and CEO of Terran

MDMA HCl has been submitted to the FDA for approval on the 505(b)(1) path and is currently undergoing FDA review, with a decision expected by August this year. If the FDA approves MDMA HCl, Terran plans to use its new form of MDMA hemifumarate to pursue a rapid 505(b)(2) FDA approval pathway. This regulatory pathway could potentially enable Terran to use pharmacokinetic bridging studies and leverage existing safety and efficacy data from completed trials to bring a Terran MDMA product to market approximately five years after the first MDMA approval, regardless of any listing in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for the older MDMA HCl. Terran’s novel approach is designed to help broaden access for patients and increase affordability. To realize this goal, Terran has already developed a new GMP manufacturing process and is making MDMA available to researchers and clinics worldwide.

“With this new breakthrough, we are committed to bringing affordable and accessible MDMA treatment options to patients with PTSD,” said Sam Clark, MD, PhD, inventor of the patent and Terran’s founder and CEO. “We believe this new form of MDMA will enable us to bypass any potential future Orange Book listing, eliminating the potential for a 30-month stay that could otherwise delay the entry of generic MDMA HCl. MDMA-assisted psychotherapy could revolutionize the treatment of PTSD and Terran will ensure that affordable MDMA is not delayed.”