Antibiotic innovation

Helperby Therapeutics and Cadila Pharmaceuticals collaborate on ‘resistance breaker’ R&D agreement

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HELPERBY, U.K.—The United Kingdom’s pioneering Helperby Therapeutics and Indian pharma giant Cadila Pharmaceuticals Ltd. have joined in an antibiotic drug resistance research and development agreement that company officials are describing as “the most important innovation in the discovery of new antibiotics since Alexander Fleming’s original breakthrough more than 80 years ago.”
“The emergence and spread of drug-resistant pathogens has accelerated while the pipeline for new anti-microbial drugs has all but run dry,” said Prof. Anthony Coates, Helperby’s chief scientific officer. “This exciting and timely partnership with Cadila offers us all hope.”
Recently, World Health Organization Director General Margaret Chan warned that a post-antibiotic era means, in effect, an end to modern medicine as we know it, noting that “Things as common as strep throat or a child’s scratched knee could once again kill.”
Helperby Therapeutics has been working for the past 12 years to develop solutions to the global threat of antibiotic resistance, which could “render the world’s dwindling antibiotic armory useless in the not-too-distant future,” according to Coates. The company invented a novel patented screening platform to select numerous small chemical compounds that are active against dormant multidrug resistant bacteria, which are dubbed “resistance breakers.” These compounds can potentially rescue old antibiotics by rendering them active against highly resistant bacteria.
As a drug discovery company, Helperby’s strategy is to find and screen promising compounds, and to date it has been supported by private equity, but it intends to seek partners with whom it can work to take compounds through clinical trials, approvals and commercialization. Its flagship Phase 2 compound, HT61, is the subject of its first licensing deal, which was announced late in 2013.
“In seeking a partner, the sheer scale of antibiotic resistance in Asia made the continent a natural starting point, as clinical trials require large numbers of patients with high levels of resistant bacteria, enabling trials to be statistically significant at 500 patients,” Coates says.
One of the largest privately held pharmaceutical companies in India, Ahmedabad-based Cadila Pharmaceuticals, emerged as the most desirable partner, based on its proven track record in anti-infectives and antibiotics.
“Cadila’s drug development expertise and Helperby’s scientific excellence provide a solid platform for the further development of these novel compounds,” according to Dr. Rajiv I. Modi, Cadila’s chairman and managing director.
“Helperby Therapeutics brings a small team of world-class microbiology researchers to the relationship, highly motivated to address the neglected, but critical, global antibiotic resistance time bomb,” Coates adds. “Importantly, this discovery will fill a major hole in the world’s antibiotic discovery and development pipeline.”
There are 20 different classes of antibiotics, and Helperby has found resistance breakers for five of those classes, out of eleven investigated preclinically so far. One of these compounds, HT61, has been shown to boost the effect of an old antibiotic in a Phase 2 clinical trial. Helperby has 300 small molecules and seven further programs that are all at the preclinical stage, targeted at systemic and topical infection (Gram-positive and Gram-negative) and indicated for a range of conditions including skin and mucosal bacterial and fungal infections and eye and ear infections. It has 49 patent applications in place.
Helperby has been successful in raising equity through a private cohort of investors and some institutional funding to bring the discoveries to this stage. “It is renowned and expert in this niche, and the team is continually innovating and inventing, ensuring that a consistent stream of promising candidates can be brought forward for development,” Coates says.
As well as a proven track record in development, formulation, manufacturing and commercialization, Cadila is capable of recruiting high numbers of clinical trial subjects quickly and effectively. It has developed and commercialized more than 450 branded and generic pharmaceutical products in the past 60 years in more than 45 therapeutic areas and was the first Indian pharmaceutical company to receive U.S. Food and Drug Administration (FDA) IND approval. It is GLP and GMP-approved, and its manufacturing, preproduction and production comply with FDA/GMP standards. Cadila sells and distributes products in more than 90 countries worldwide, supported by 7,000 employees across 49 countries.
Cadila recently launched Mycidac–C for lung cancer, said to be the world’s first active immune therapy in cancer management. The company developed Polycap, a five-in-one formulation combining atenolol, thiazide, ramipril, simvastatin and aspirin for primary prevention of cardiovascular events and stroke. In other milestones, the company developed the world’s first probiotic combined with anti-infective agent (Symbiotic), launched Risorine, the world’s first anti-tuberculosis drug with a bio-enhancer, has built further alliances to combat infections (such as Bactiguard in 2012) and received the Wellcome Trust Award to support a Phase 3 clinical trial of Polycap.
While the deal value was undisclosed, it could contribute to Helperby scaling up in the United Kingdom  to a potential £500 million (about $828 million) operation. Prime Minister David Cameron said, “The life-sciences industry is the jewel in the crown for the U.K. economy, consistently growing and achieving new breakthroughs. The deal has the potential to create up to 1,000 highly skilled jobs in the U.K. by 2019.”

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