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Will Antibiotic Industry Rise Up to the Challenge of Tackling Growing Antibiotic Resistance?

27 Jan Will Antibiotic Industry Rise Up to the Challenge of Tackling Growing Antibiotic Resistance?

Melinta Therapeutics (NASDAQ: MLNT), a commercial-stage pharmaceutical Company, engaged in developing therapeutic options for treatment of bacterial infectious diseases, filed for Chapter 11 bankruptcy in January 2020.  The Company had concerns about its financial prospects and warned the investors that it would be difficult to continue as a going concern. Melinta will now be controlled by Deerfield and receive 100% of the equity issued by the new company, in lieu of the $140 million loan it extended to Melinta. Deerfield will help the Company in its reorganization, which will include lay off of nearly 60 people.

Achaogen (OTCPINK: AKAOQ), another promising biotech, whose antibiotic was once predicted to bring in $500 million a year in peak sales, sold most of its clinical assets to buyers around the globe including worldwide rights for its plazomicin for multidrug-resistant, gram-negative pathogens along with its lab equipment to Zemdri, for $16 million. In addition it sold the global rights to Zemdri outside of China to Cipla USA and royalty-free China rights to QiLu Antibiotics Pharmaceutical. The catalyst for its fall was the rejection of its antibiotic against bloodstream infections by the FDA; however, it allowed the Company to use its antibiotic for the treatment of drug-resistant urinary tract, with the addition of a black box safety warning. The Company soon realized that hospitals were less than receptive to newer antibiotics on the market and it was not easy to wrestle market space from well-established big pharma as well as generics.

In January 2019, Aradigm (OTCPINK: ARDMQ) withdrew its application for an approval for Linhaliq intended for the treatment and prevention of flares in non-cystic fibrosis bronchiectasis patients with chronic lung infections linked to Pseudomonas aeruginosa bacteria. This move was prompted by EMA concern that the data from two studies submitted by the Company were insufficient to establish its benefits and consistency. This was a big blow to the Company which had already received a rejection from the U.S. Food and Drug Administration (FDA) for the oral antibiotic treatment, to be known as Apulmiq in the U.S. The Company did not have the financial means to carry out additional studies requested by both the regulatory bodies and decided to discontinue the clinical development.

These three different Companies reflect the state of affairs of the Global Antibiotic Industry, which is on the cusp of an impending crisis, due to lack of innovative development approaches and the absence of sufficient returns for their investment, leading to a mass exodus by the big pharmaceutical companies and struggle for funding by the remaining small and medium-stage companies.

An Industry Grappling with Uncertainty
The Global Antibiotics Market is expected to be worth over $40.78 billion by 2025, growing at a CAGR of 4.4% according to a report by Adroit Market Research. The rising prevalence of infectious disease is propelling the growth in the market; however the rise of antimicrobial resistance or AMR is proving to be challenging for the industry as it undermines the effectiveness of antibiotics, reducing their demand and usage.

The growth of treatment resistant strains owing to rampant and indiscriminate use of antibiotics has seen a decline in antibiotic usage, which are now prescribed and used sparingly with extreme caution. This has resulted in a decline in investment and research and development activities by major players in the pharmaceutical industry, as it does not give expected returns and is a risky proposition owing to stringent regulatory control. While the big pharma stays away from the antibiotic industry, the smaller companies are struggling to find investments to develop their pipeline.

Antibiotic Resistance – A catastrophe in the making?
The lack of innovation and further research is likely to have severe repercussions in the fight against drug-resistant infection according to a report by WHO. Companies do not see enough returns from their investment in the antibiotic industry, leading to a clear lack of effort and innovation in the field.

The pipeline for antibiotics is a cause for concern as there are about 60 products in clinical development, as they hardly offer any substantial benefit over conventional treatment options and those that are promising are still at a nascent stage of development.

Dr Tedros Adhanom Ghebreyesus, Director-General of WHO stated,

“Never has the threat of antimicrobial resistance been more immediate and the need for solutions more urgent. Numerous initiatives are underway to reduce resistance, but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines.”

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Another interesting aspect is that the industry pipeline is predominantly being led by relatively small or medium clinical – stage companies, but are constrained in their ability to raise funds for development activity. A report points out that out of the 50 antibiotics in the pipeline 32 target WHO priority pathogens, a list that was published by the organization in association with independent experts to encourage the development of treatments for these resistant bacteria. Out of these a majority do not offer any significant improvement over existing antibiotics. Only two from the list are active against the multi-drug resistant Gram-negative bacteria such as Klebsiella pneumoniae and Escherichia coli, which spread fast and have devastating effects on people whose immunities are compromised.

Another grave concern is that there are only three antibiotics in the pipeline that aim to potentially target the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), which are highly potent and cannot be treated in spite of using antibiotics from the carbapenem family, which are considered the last resort against antibiotic-resistant bacterial infections.

A Wake Up Call for the Industry
The need of the hour is a concerted effort from pharmaceutical Companies, Government and Public health organizations to come up with alternatives to effectively tackle treatment resistant bacteria. Sufficient Funding and Regulatory Impetus will go a long way in achieving this objective. WHO is undertaking numerous initiatives to this end, for instance, it has established a partnership with  the Drugs for Neglected Diseases Initiative (DNDi) to create Global Antibiotic Research and Development Partnership (GARDP), a non-profit research and development organization, to focus solely on developing new age antibiotics that can tackle drug-resistant infections. The organization is working with over 50 public and private sector entities in 20 countries to not only create five new treatments by 2025, but also to provide sustainable access to treatments, promoting responsible use and affordability to all in need as per a statement by WHO.

The World Health Organization’s (WHO) third annual review of the clinical antibacterial pipeline highlights the fact that the antibiotic drug pipeline is extremely weak and incapable of tackling the emergence and spread of antimicrobial resistance. The report states that eight new antibacterial agents have been approved since 1 July 2017; however, they are limited in their ability to provide any substantial clinical benefits. There is a definite need for innovative approaches in this area, which is being hampered due to scientific and economic challenges. In fact the out of the 10 antibiotics in Phase I against critical resistant Gramnegative bacteria, only one will make it to the market in the next 10 years, accounting for an attrition rate of 14 percent for antibiotics.

These numbers are alarming, as experts fear that it will prove to be insufficient defense against evolving bacterial infections, which are challenging the conventional therapeutics available in the market. The industry will hopefully reassess their strategies and chalk out a mutually beneficial agreement with regulatory bodies to unitedly fight this impending menace.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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