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For patients with incurable conditions, the fight can sometimes feel hopeless.
Amyotrophic lateral sclerosis (ALS) is a devastating—and incurable—disease that affects nerve cells in the brain and spinal cord. People with ALS lose the ability to initiate and control muscle movements—ultimately leading to total paralysis and death within two to five years of diagnosis.
Fortunately, Japanese drugmaker Mitsubishi Tanabe Pharma has made remarkable discoveries and advances in the treatment of ALS. And with the help of Loeb & Loeb, the pharma company has brought these critical treatments to the U.S. market.
Loeb & Loeb has worked hand in hand with Mitsubishi since the company established its U.S. subsidiary, Mitsubishi Tanabe Pharma America (MTPA). For years, Loeb & Loeb’s lawyers have been embedded within the company as U.S. counsel.
Working cross-functionally with MTPA’s sales and marketing, managed markets, commercial operations, and medical affairs teams, we’ve provided legal guidance spanning the entire organization, supporting the commercial infrastructure for each of MTPA’s U.S. drug launches, and helping grow and scale the business to meet U.S. demand.
In 2017, MTPA’s drug RADICAVA® (also known as edaravone) became the first new ALS treatment to be approved by the FDA in more than 20 years. Loeb & Loeb’s lawyers moved quickly to develop and implement the company’s health care compliance program, coordinate nationwide sales force training and promotional review, and handle label negotiations and distribution logistics. Within just three months of FDA approval, RADICAVA was being administered to patients across the country.
In 2021, Loeb & Loeb assisted MTPA in bringing yet another new ALS treatment to market in the U.S., once again within a rapid time frame. In a matter of months, our team helped MTPA operationalize a comprehensive commercialization and supply program that would normally take a year or more to launch, this time for the drug Exservan™ (riluzole), the first oral film treatment for ALS.
Functioning far more like an in-house legal team than traditional outside counsel, Loeb & Loeb has been able to drive incredible efficiencies at MTPA, making these lightning-fast product launches possible. Seamlessly integrated within the organization, we’ve leveraged a uniquely close lawyer-client relationship in order to spot and address issues across business units, facilitate critical information sharing, and add value at every level.
The fight against ALS continues. And with these treatments in the arsenal, there is reason to be hopeful. Loeb & Loeb is honored to join MTPA in this fight.