Kalytera works on definitive arrangement to buy Salzman
2020-06-16 08:33 ET - News Release
Mr. Robert Farrell reports
KALYTERA PROVIDES UPDATE REGARDING ACQUISITION OF SALZMAN GROUP
Kalytera Therapeutics Inc. is working with Salzman Group toward completing definitive agreements for Kalytera's acquisition of Salzman Group. On May 19, 2020, Kalytera announced that it had signed a binding Letter of Intent dated May 12, 2020 to acquire Salzman Group, Inc., a privately held company located in West Tisbury, MA ("Salzman Group").
Salzman Group is the owner of R-107, a proprietary drug with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea. Salzman Group is developing R-107 for treatment of COVID-19 associated lung disease, chlorine inhalation lung injury ("CILI") and pulmonary arterial hypertension ("PAH").
Kalytera is not making any express or implied claims that R-107 has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.
Kalytera and Salzman Group had expected that definitive agreements for the Acquisition would be executed by June 15, 2020. Although the definitive agreements have not yet been executed, both Kalytera and Salzman Group are working to complete the definitive agreements, and anticipate that these agreements will be executed shortly.
In anticipation of the close of the Acquisition, the companies have already begun working together to accelerate development of R-107.
"Given the data demonstrating the antiviral activity of nitric oxide against coronaviruses1, as well as the even greater body of data demonstrating the potential activity of nitric oxide in treatment of viral-associated lung disease2, Kalytera and Salzman Group have already begun working together to advance R-107 into Phase 1 clinical testing," stated Robert Farrell, President and CEO of Kalytera. "We plan to submit an Investigational New Drug Application (IND) to the Australian Therapeutic Goods Administration (TGA) and the U.S Food and Drug Authority (FDA) later this month in support of a first-in-human Phase 1 clinical trial. We are planning to carry out this Phase 1 safety and pharmacokinetic study of intramuscular R-107 using a single dose escalation design in 32 healthy middle-aged volunteers at CMAX, a clinical contract research organization located at Royal Adelaide Hospital in Australia. The study will be initiated during the third quarter, and we expect it to be completed during fourth quarter this year."
About Salzman Group
The Salzman Group is a privately held GMP and GCP compliant pharmaceutical development firm located in West Tisbury, MA. Based on over two decades of drug development experience and a strong track record, Salzman Group continues to generate groundbreaking pharmaceutical opportunities.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. ("Kalytera") is committed to developing new treatments for a variety of diseases and disorders, by discovering, developing, manufacturing and delivering innovative human therapeutics. Kalytera focuses on areas of unmet medical need, and leverages its expertise to find solutions that will improve health outcomes and dramatically improve people's lives.
1 Akerstrom S et. Al. Nitric oxide inhibits the Replication Cycle of Severe Acute Respiratory Syndrome Coronavirus. J Virol 2005; 79(3):1966-9.
2 Nitric Oxide Investigated as COVID-19 Treatment