LONDON - Polyclonal antibody specialist Therapeutic Antibodies Inc. (TAb), headquartered in the U.S. but based in the U.K., is expected to hold an offering to raise £20 million in London.
The company is low on funds, with a burn rate of US$19 million per annum in 1997 and a mere US$7 million cash at the end of 1997, according to annual results released last month. Losses for the year rose by more than 30 percent, to US$16.8 million.
CEO Andrew Heath told BioWorld International, “The company will make some form of offering in the next few weeks. We will be using cash at the same rate as last year, giving us enough for the next 18 to 21 months, at which point we expect revenues from CroTAb.“
CroTAb is an emergency antidote to snake bites. It will be commercialized with DigiTAb for digoxin toxicity and TriTAb, a therapy to reverse the effects of tricyclic anti-depressant toxicity, under a US$23 million distribution deal with Altana Inc. signed in 1997. An initial $1 million milestone payment was made when the deal was signed.
Heath said, “We are now preparing to develop these products at an accelerated pace, and believe the Altana alliance lays the foundation for their successful commercialization in the U.S.“
Heath said CroTAb is potentially a $30 million to $50 million market in the U.S., which, he added, TAb “will penetrate very quickly.“
CroTAb will be submitted for FDA approval within the next 12 months. The Phase III trial of DigiTAb began recently and 15 centers currently are screening patients. In February 1998 TAb disclosed the FDA cleared its investigational new drug (IND) application for TriTAb, and a pilot study is scheduled to start “during the coming months,“ Heath said.
TAb also made progress with CytoTAb, an antitumor necrosis factor (TNF) treatment for sepsis. The company revised its development strategy during 1997, changing the clinical endpoint and splitting patients into different treatment groups, following the Phase III failure of a monoclonal antibody treatment for sepsis in a trial run by Bayer AG, of Leverkusen, Germany.
During 1997, TAb completed a Phase I study of CytoTAb in cerebral malaria and launched a Phase II control trial in the disease. The trial, in Thailand, treated 28 patients, none of whom died. There was a reduction in TNF alpha levels, reduced fever and parasite clearance.
The company also concluded a Phase II trial in severe sepsis and launched a Phase IIb trial in the U.S. in 19 centers. It also received an IND for CytoTAb in acute graft-vs.-host disease.
Firm Undaunted By Sepsis Failures Of Others
Despite the many failures to treat sepsis by using antibodies to mop up TNF, Heath said, “In the right patient groups there is a great opportunity for anti-TNF antibodies in treating sepsis.“
He argued that polyclonal antibodies, which bind to more than one epitope on TNF, will be more effective than monoclonal antibodies, which bind to only one. “Our product is the only one to have shown an ability to lower TNF levels.“
Heath, who previously worked for Glaxo Wellcome plc, of London, and Astra AB, of Sodertalje, Sweden, joined TAb last month from Aerogen Inc.
He said that while the company could spend more money on its portfolio, bringing pharmaceutical management into the team would ensure the R&D projects are “purely commercially oriented.“
Heath does not feel threatened by the low level of cash. “The burn rate will stay the same, and we will soon have revenues from CroTAb. At the same time we are very actively looking at partnerships with the pharmaceutical industry,“ he said.
He also is confident investors will put in more money. “This is a great value stock,“ he observed. “You just have to look at where the company is at the moment compared to the time of the public offering 18 months ago. With CroTAb we will have a revenue stream in the relatively near term.“
Heath has some unease about the company's geographical organization, with headquarters in Nashville, Tenn., and most of its operations in London. “The company is not in the U.S. or the U.K. We are sitting in the world's largest pharmaceutical market and I have good relationships with investment bankers in the U.S. It would be folly not to take that opportunity. That said, this is a U.K. company.“ *