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Company spotlight: Novacta Biosystems

November 10th, 2008 - Conference:

Harnessing Biological Systems to Generate Novel Antibiotics and Offer a Service Business to Grow Revenues

After five years developing novel agents for hospital-based infections, Novacta Biosystems is now aggressively developing new business opportunities and arrives at BIO-Europe 2008 actively scouting for partners.

Having recently won financing and validation of its science from the Wellcome Trust, Novacta earlier this year reorganized its offering into two bespoke business units for therapeutics and service.
Georg Buchner, the Vice President for Corporate and Business Development is part of a new experienced commercial management team at Novacta that intends to develop an attractive anti-infective company, Novacta Therapeutics, that will address the current unmet needs in the industry, while expecting to double the revenue generated from the service business grouped under the name of Novacta Biosystems.
Buchner told Partnering News his priorities will be meeting with potential partners for an early deal for a new class of gram-positive anti-infectives and to secure financing to hit value enhancing milestones.

“The great strength of Novacta’s scientific team is an ability to harness biological processes of enzymes and microorganism to solve difficult chemical processes and to genetically engineer micro-organisms for the production of novel antibacterial agents,” said Buchner.

Yet he said while Novacta has built this core strengths over the past five years, there was not a parallel focus on business development. The newly created Novacta Therapeutics group focuses on the generation and development of novel anti-infectives agents with clear differentiation against the competition, he said, adding that ‘While most current efforts in the antimicrobial space are Only incremental improvement on well established classes already prone to resistance, Novacta is one of the few companies that developed a new class of antibiotics with a novel mode of action that demonstrated to have an excellent resistance and cross resistance prognosis.

Tackling the antibiotic resistance with a new class of anti-infectives, Novacta exploits the antibiotic proprieties of the lantibiotic family by genetic and chemical lead improvement, resulting in drug-like antibiotics with no resistance nor cross resistance with other antibiotics.

The lead project is a new treatment for Clostridium difficile infections (CDI) now in preclinical development.
Addressing a highly pathogenic family that creates very high costs for hospitals, Novacta’s NVB302 shows improved selectivity against C. difficile that leads to reduced recurrence in vivo. Preliminary preclinical results showed that the novel agent is optimally positioned to address the current needs in the C. difficile space.

“Existing therapies are suboptimal and NVB302 with its novel mode of action and selectivity clearly addresses resistance and recurrence of CDI in a unique manner,” said Buchner.

Cases of infection in the United States have jumped from 82,000 in 1996 to 500,000 in 2007 with an incidence of 61 patients per 100,000 population. There is not consistent data for the European Union, but an estimate of cases is well above 260,000 patients annually and increasing rapidly.
The only available therapies, vancomycin or metronidazole, result in high recurrence rates of up to 25% due to regrowth of surviving spores or re-infection.

“For C. difficile, our lantibiotic candidate NVB302 is showing good in vitro activity with a selectivity better than vancomycin, good in vivo efficacy and with no concerns raised from preliminary toxicology,” said Buchner, adding that development milestones for the program have been formally agreed with Wellcome. “On the other side, our scientists managed to manipulate the properties of our proprietary parent lantibiotic molecules achieving a truly new broad spectrum agent for gram-positive infections. First in-vitro and in-vivo results showed that it is superior to the gold standard vancomycin. Coupled with the excellent resistance and cross resistance prognosis, we believe that this program has huge potential, and strategically we are looking for a partner that can help us to fully develop the chosen molecules for the different indication.”

Another direction for Novacta Therapeutics lies in the field of gram-negative organisms, which account for nearly 50% of the hospital acquired infections resulting in pneumonia, skin infections, intra-abdominal sepsis, urosepsis and bloodstream infections.

Buchner said natural and emerging antibiotic resistance constitutes a threat to established therapies and there simply are no effective new antibiotics being developed in the foreseeable future.

“There is a great unmet need here and we hold the potential to introduce a whole new class of therapeutics into this space soon,” he said. Buchner indicated that a public announcement would be made soon in this area.
Meanwhile the Novacta Biosystems business unit is building up from an existing revenue stream from established relationships that includes more than 10 customers across big pharmaceutical, specialized pharma, biotechs and biofuels companies.

The service offering covers three areas including biotransformation, metabolite factories and pathway engineering.
Novacta sees an especially rich potential in pathway engineering with strain optimization for the biofuel industry through the genetic manipulation of micro-organisms.

“Most Biofuel companies simply have not looked at strain optimization using genetic manipulation and we can play strongly in this space,” said Buchner. He added that an example program for the generation of a thermophile strain for TMO, a leading UK based biofuel company, improved bioethanol yield from 20 to 90%, allowing the client to start the first pilot plant using the bacteria created by Novacta.
To this point, Buchner said pharmaceutical customers have provided the highest success for Novacta but the opportunities for higher revenues per customer in biofuels if driving a shift in strategic focus.


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