Making progress: A roundup of recent pharma/biotech milestones

News from AiCuris, Organovo, Catalyst Biosciences and Zosano Pharma

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Prevymis approval in Japan triggers milestone payment for AiCuris
WUPPERTAL, Germany—AiCuris Anti-infective Cures GmbH, a company focused on the discovery and development of drugs targeting infectious diseases, announced in late April that the Japanese Ministry of Health, Labor and Welfare had granted marketing authorization to Merck & Co. for Prevymis (letermovir) for the prevention of cytomegalovirus (CMV) infections in allogeneic hematopoietic stem cell transplant patients.
Prevymis is a first-in-class non-nucleoside CMV inhibitor acting via a novel mechanism of action that was successfully developed by AiCuris up to clinical Phase 2b and afterwards subsequently licensed to Merck & Co. in 2012.
Under the terms of the agreement with Merck, AiCuris receives milestone payments as well as royalties on net sales. Marketing approval in Japan triggered a milestone payment in the amount of nearly $18 million, bringing the total amount of upfront and milestone payments AiCuris has received from Merck to $311.7 million.
Organovo achieves key milestones for liver disease and intestinal tissue models
SAN DIEGO—Organovo Holdings Inc. recently announced that along with its collaborators, it has achieved several breakthrough capabilities for its 3D bioprinted tissues. At the recent International Liver Congress, two posters were presented illustrating the company’s ability to create functional human liver tissue, produce a spectrum of non-alcoholic steatohepatitis (NASH) disease conditions and then treat that disease successfully with a client’s development stage NASH drug.  These posters highlighted the performance of Organovo’s human liver model in the generation of a robust non-alcoholic fatty liver disease (NAFLD) and NASH phenotype, including the presence of ‘gold standard’ histopathologic features.
“No other in-vitro modeling system allows drug researchers to explore the evolution of NASH and related treatment strategies using histology, the only accepted measurement for efficacy, based on visual confirmation of the cellular disease process under a microscope,” said Taylor J. Crouch, CEO of Organovo. “We are particularly excited that we can work with clients to explore their clinical stage drug candidates, allowing them to address the patient specific needs of their drugs.”
Organovo continues to map out a range of relevant conditions for creating NASH, including all components of the disease (fat accumulation, inflammation and fibrosis).  In addition to assessing donor-specific susceptibility to NAFLD/NASH conditions, the company is also systematically testing major reference classes of compounds targeting NASH to inform treatment strategies.
Catalyst receives pair of milestone payments for NNR asset
SOUTH SAN FRANCISCO, Calif.—Late March saw Catalyst Biosciences Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, announce that it had received $1.5 million in milestone payments following the completion of two triggering events for its neuronal nicotinic receptor (NNR) asset TC-6499, sold in Oct. 2016. The first milestone payment of $500,000 was received following dosing of the first patient in a clinical trial for TC-6499, and a second milestone payment of $1 million was received for the dosing of the first patient in a Phase 2 clinical trial with TC-6499.
“We are very pleased with the continued clinical development of the TC-6499 NNR program,” said Dr. Nassim Usman, president and CEO of Catalyst. “Although not central to our mission of developing hematology treatments, the continued development of these NNR programs may provide Catalyst with further non-dilutive financing to make additional investments in our non-clinical pipeline programs, specifically our next generation Factor Xa for hemostasis and our anti-C3 protease for dry AMD.”
Zosano passes the hundred-patient mark in M207 study
FREMONT, Calif.—In mid-March, Zosano Pharma Corp., a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (ADAM) technology, announced that 103 patients have enrolled and received M207 in the long-term safety study for the acute treatment of migraine. M207 is Zosano’s lead development candidate, and M207-ADAM is an open-label study evaluating the safety of the 3.8 mg dose of zolmitriptan in migraine patients who have historically experienced at least two migraines per month.
The study will evaluate at least 150 patients for six months and 50 patients for a year at 31 sites in the United States.

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