On July 30, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) and TerSera Therapeutics LLC reported that they have entered into an asset purchase and sale agreement for the sale to TerSera of Lexicon’s rights, title and interest in XERMELO (telotristat ethyl) (Press release, Lexicon Pharmaceuticals, JUL 30, 2020, View Source;020.htm [SID1234562634]).

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Pursuant to the terms of the agreement, TerSera will pay Lexicon approximately $159 million in cash at closing, which includes a $155 million upfront payment and approximately $4 million for existing inventory. Lexicon may receive additional development, regulatory and sales milestone payments of up to an aggregate of $65 million for the development and commercialization of telotristat ethyl in patients with biliary tract cancer. Additionally, Lexicon will be eligible to receive mid-teens royalties on net sales of XERMELO in biliary tract cancer. As part of the transaction, TerSera has agreed to assume the currently ongoing TELE-ABC Phase 2 clinical study of XERMELO in biliary tract cancer patients and offer employment to at least 20 Lexicon employees currently dedicated to XERMELO. The transaction is expected to close in the third quarter of 2020, subject to customary closing conditions.

"This agreement allows us to focus Lexicon around LX9211 for neuropathic pain and other early-stage research and development programs, enabling efficient use of our resources and substantially reducing our debt," said Lonnel Coats, Lexicon’s president and chief executive officer. "TerSera’s dedicated oncology focus will provide physicians and patients continued access to this important medicine for carcinoid syndrome diarrhea and continue its ongoing development for people suffering with biliary tract cancer."

"XERMELO continues to gain an increasingly important role in carcinoid syndrome diarrhea with a potential future role in other cancers," said Ed Fiorentino, Chairman & CEO of TerSera. "We are very excited to add XERMELO to our existing oncology portfolio."

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

XERMELO (telotristat ethyl) Important Safety Information

•Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking

XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
•Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
•Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.