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Catalyst - Fall 2012 - NJ Biotech Company Takes on `Top Terrorist Threat’

It was September 2001. The FBI launched an investigation it has since called "one of the largest and most complex in the history of law enforcement" And, while its source had nothing to do with planes or towers, it had the potential to wreak mass destruction far worse than the devastating events of 9/11.

The 2001 anthrax attacks in the United States occurred over the course of several weeks beginning on Tuesday, Sept. 18, 2001. Letters containing anthrax spores were mailed to several news media offices and two Democratic U.S. senators, killing five people and infecting 17 others. Subsequent attacks ensued, including an anthrax-laden envelope reportedly mailed to New Jersey Congressman Rush Holt’s office.

Anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis. The current course of action, when someone is exposed to anthrax, is a combination vaccine and antibiotic that has the best chance of working when administered early in the course of the disease. However, the truth is, inhaled anthrax is often fatal, despite treatment with antibiotics.

Bioterrorism wasn’t a new concept back then, but the anthrax attacks – especially in the wake of September 11th – were a wake-up call to anyone who wasn’t full-tilt aware of the dangers among us. The U.S. Health and Human Services Department labeled anthrax “a top terrorist threat.” The result was a mandate by the government to stockpile bioterrorism countermeasures.

Right Place, Right Time
Elusys Therapeutics, Inc. of Pine Brook, N.J. had been focused on the development of antibody therapeutics for the treatment of life-threatening diseases, specifically biodefense countermeasures, since 2000. The company was in the right place at the right time to respond to the government’s mandate in late 2001, said Robert Love, chief financial officer. Only problem is that the company was working on the wrong solution.

Elusys started out as a venture capital-backed company focused on the development of a proprietary coupling technology to fight anthrax infection. “The thought process behind the coupling,” explained Love, “is that part of the technology would attach to the bacteria and part would attach to the red blood cell on the receptive site. The company believed it would be a faster mechanism to rid the disease from the body.”

Pfizer and Metamune agreed there was potential with the coupling technology and separately collaborated with Elusys on two research studies. All parties wanted to find out if Elusys’ technology would work with the antibiotics being marketed by either of the two pharma giants.

“The results of those studies were interesting, but not compelling enough to warrant proceeding any further,” Love said, who joined the company as CFO in 2007, with over 30 years of domestic and international experience in the pharmaceutical industry.

That’s when Elusys turned its attention to one of its back-burner compounds, anthim (ETI-204).

“People who are exposed to anthrax are prescribed a 60-day antibiotic regimen. With that long of a regimen, there are drug resistance and patient compliance issues,” explained Love. Anthim, an anti-toxin for the prophylaxis and treatment of anthrax infection, attacks the toxins released by anthrax bacteria – effectively shutting down the process at the root of the problem.

Anthim was granted Fast-Track status and Orphan Drug Designation in 2006 by the FDA and Elusys sought to develop it under the FDA's animal rule, a regulatory structure created in 2002 that permits a drug's effectiveness to be demonstrated in animals when it is unethical or not feasible to conduct controlled clinical trials in humans. To date, anthim has been extensively studied in multiple models of anthrax infection and has consistently prevented death in 70 to 100 percent of animals treated with a single dose of drug.

Elusys recently completed a clinical dose-escalation study of Anthim in 108 human volunteers, as well, in addition to two other dose-escalation safety studies in humans.

Love said that late stage trials are currently underway and, if all activities in the anthim development program are completed to FDA's satisfaction, the federal government could purchase anthim for the Strategic National Stockpile under Project BioShield. Project BioShield was established in 2004 to provide much needed funding to procure important countermeasures to protect the American public in the event of a biowarfare attack.

A Fine Balance Sheet, Indeed…
In early January, 2010, Elusys signed a government contract potentially totaling up to $143 million to complete the final development, commercial manufacturing and licensure of anthim. Funding was provided by the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services.

The company received $16.8 million in the first contract year. Subsequent awards have been received by Elusys, the most recent $14.5 million to support expanded human safety studies announced on Sept. 13, 2012. That brings the company’s government grant receipts to $149 million to date, under two advanced development contracts (that actually hold a potential total value of $211 million) from the BARDA.

“Having governmental support is a validation of the value of our anthim asset,” Love said. “Regardless of the government’s call for countermeasures, there remains a significant hurdle to become a government contractor, The fact that Elusys is a recipient of $211 million of funding is a validation of the effectiveness of our asset.”
 

EisnerAmper's Catalyst: Fall 2012

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