TIDMDEST
Destiny Pharma PLC
14 June 2018
Destiny Pharma plc
("Destiny Pharma" or "the Company")
Destiny Pharma notes FDA statement on their focus to enable new
approaches to fight AMR
Brighton, United Kingdom - 14 June 2018 - Destiny Pharma (AIM:
DEST), a clinical stage biotechnology company focused on the
development of novel anti-microbial drugs, which address the global
problem of anti-microbial resistance (AMR), notes the FDA
Commissioner, Scott Gottlieb M.D.'s further announcements this week
outlining the regulator's support of new incentives for companies
developing novel anti-infectives through both financial
reimbursement and further streamlined clinical trial
requirements.
Neil Clark, Chief Executive Officer of Destiny Pharma
commented:
"We welcome the FDA's continued support for companies investing
in the development of much needed novel anti-infectives to address
the global issue of antimicrobial resistance. Destiny Pharma is
well positioned to benefit from such initiatives as it continues
the clinical development of its lead drug candidate, XF-73, for the
prevention of post-surgical infections."
The full FDA press release is below
June 12(th) 2018 Statement from FDA Commissioner Scott Gottlieb,
M.D., on FDA's efforts to foster discovery and development of new
tools to fight antimicrobial-resistant infections
The increase in serious antimicrobial drug resistant infections
is a critical public health concern and a growing threat to
patients. According to our colleagues at the Centers for Disease
Control and Prevention, each year in the U.S. at least 2 million
people become infected with bacteria that are resistant to
antibiotics and 23,000 people die each year as a direct result of
these infections.
As more and more bacteria grow resistant to currently available
antibiotics, we must tackle the issue on all fronts and seek new
approaches to this persistent and potentially deadly problem. This
means helping to ensure good antibiotic stewardship and use in
appropriate clinical scenarios. It also means spurring the
development of new antibiotics, for instance, by pursuing novel
incentive models for developers that take into consideration the
challenging economic and usage dynamics of these products.
Despite the growing incidence of these resistant strains of
bacteria, there has unfortunately been an overall decline in
antibiotic drug research driven largely by the significant
obstacles to developing innovations in this category. This is
especially true when it comes to developing new antibiotics that
work through novel mechanisms that can evade existing patterns of
resistance.
Consider patients who are hospitalized with life-threatening
infections and need immediate treatment, but the severity and
symptoms of the acute illness, such as delirium, may make obtaining
informed consent from patients and performing other trial
enrollment procedures difficult. This is just one example of the
many challenges to conducting effective clinical trials in patients
with serious bacterial diseases.
Complicating matters further, many patients with serious
infections may have already tried several currently available
antibiotics before a clinical trial is considered. If patients have
already received substantial treatment for their infection before
enrolling in a clinical trial, this exposure to other treatments
can make it more difficult to isolate the effects of an
investigational drug.
These are some of the scientific challenges. But there are also
economic impediments.
Developing new drugs is a costly endeavor. But the current
reimbursement model, where drugs are reimbursed based on each
episode of their use, presents incentives that run contrary to
effective stewardship over new antibiotics that might be highly
effective against very rare and dangerous pathogens. When such
drugs become available, we try to use them sparingly, lest
pathogens become over-exposed to a new mechanism of attack and
develop resistance to it. So, providers have imposed understandable
restrictions on the use of such drugs. While this represents
responsible stewardship, it also means that a novel antibiotic may
have a very limited market. If product developers know that they
will not be able to recoup their investments, there may be reduced
incentive to invest the significant money needed to discover and
develop such a drug.
The global effort to educate patients and providers about the
importance of reducing the unnecessary and over-use of antibiotics
is a crucially important means to slowing the rate of resistance.
However, we must acknowledge that these essential antimicrobial
stewardship programs do have an impact - as they should and aim to
do - on the use of antibiotics and thus the amount of product sold.
And as consequence, we must find ways to spur development and
incentivize innovators. The FDA and other federal agencies are
taking new steps to address each of these challenges, including new
efforts to address the need for better economic incentives.
One of those steps is implementing the set of special incentives
that Congress created for antibacterial and antifungal drugs that
treat serious or life-threatening infections. This includes the
qualified infectious disease product (QIDP) designation. Under this
program, new drug applications that are designated as QIDP can
receive fast track designation, priority review designation and a
possible five-year extension of any exclusivity that the
application qualifies for upon approval.
Even with these incentives, we recognize that challenges remain.
As such, we continue to work with Congress, our partners at other
agencies and the scientific community to find additional ways to
create incentives for the development of novel antimicrobial drugs
and strengthen the research and development pipeline.
One idea that we're currently discussing with other agencies
such as the Centers for Medicare and Medicaid Services (CMS) would
involve changing the model for reimbursement of certain new,
anti-microbial drugs that meet critical, public health needs -
principally their ability to effectively target dangerous,
multi-drug resistant infections.
Under such an approach, instead of paying for drugs that meet a
narrow set of critical, public health criteria on a per use basis -
for each prescription that's written, as is done now - one might
move instead to a licensing model. Under such a model, the acute
care institutions that are most likely to prescribe these medicines
would pay a fixed licensing fee for access to the drug, which would
offer them the right to use a certain number of annual doses. This
is similar to the way that software often gets reimbursed, where
institutions pay a licensing fee for a fixed number of
installations. We have been speaking with our counterparts at CMS
as to whether such an approach is feasible, whether it can be
formulated as a demonstration, and as a demonstration, whether it
would have the intended public health benefits.
These concepts are still being developed and we look forward to
greater public engagement around these ideas. Adapting this
licensing payment model to drugs that target dangerous,
antimicrobial resistant organisms can help achieve two important
public heath goals. First, such a model would create a natural
market for drugs that meet certain public health criteria, by
providing a predictable return on investment and revenue stream
through more foreseeable licensing fees. Second, it would put the
institutions fully in charge of stewardship of these important
medicines. Once they purchase the ability to access a drug, they
would be stewards of its use up to a certain number of annual
doses, which could be tied to the number of beds an institution has
or its likelihood of encountering certain organisms.
This reimbursement model would address some of the investment
challenges associated with the market for potent antimicrobials
that target multidrug resistant organisms. These are drugs that we
want to have available to us, but that we should keep in reserve
and hope that we seldom have to use them. It is my belief that a
licensing model might offer an effective "pull incentive" that
attempts to create a predictable market for antimicrobial drugs
that would meet a narrow set of critical, public health
criteria.
We are currently discussing these ideas as part of the FDA's
broader policy work in this area. We plan to release more
information soon. Such an approach potentially de-links the return
on investment on an important antimicrobial drug from the volume of
that drug that's used. This would achieve an important public
health purpose since these are drugs that we would want to hold in
reserve.
We're also taking other new steps to help advance development of
improved antimicrobial drugs, through measures that make the
development process more predictable and efficient.
Towards these ends, another new program is the Limited
Population Pathway for Antibacterial and Antifungal Drugs, or LPAD
pathway; established by Congress under the 21st Century Cures Act.
The FDA believes this program will advance development and approval
of antibacterial drugs to treat serious or life-threatening
infections in limited populations of patients with unmet needs.
Today FDA issued a draft guidance to assist in the development of
drugs using this additional, important pathway.
This draft guidance, when finalized, will support drug
development by describing the criteria, processes and other general
considerations for drugs approved under the LPAD pathway. In
reviewing an application submitted under the LPAD pathway, the FDA
will consider the severity, rarity or prevalence of the infection
that the drug is intended to treat. The agency will also consider
the availability or lack of alternative treatment in the limited
population.
The guidance will also assist companies in developing labeling,
including prescribing information, patient labeling and
carton/container labeling, to inform the medical community that the
drug was approved under the LPAD pathway based on a benefit-risk
assessment in a limited population.
We've already had meaningful, early interest by innovators in
potentially developing drugs under this new pathway. We expect that
development programs for drugs eligible for approval under the LPAD
pathway will follow streamlined approaches to clinical development.
This may involve smaller, shorter or fewer clinical trials.
However, the LPAD pathway still requires these drug products meet
the FDA's approval standard for safety and effectiveness. Early and
frequent communications between the FDA and drug companies
interested in pursuing approval under the LPAD pathway for their
products can help reduce overall product development times.
While we hope our work will help advance the development of new
antibacterial and antifungal drugs, this isn't a problem that can
be addressed by our agency alone. We're collaborating with agency
partners, the broader scientific and policy community, and medical
product sponsors to address scientific challenges. Bacteria will
continue to evolve. They will continue to chip away at the
usefulness of available treatments - including the medicines that
we have relied on for years.
Many of the existing antibiotics are simply old. They were
screened out of nature where they resided in soil for centuries,
engaging in a natural battle with various bugs.
More judicious use of antibiotics in health care and agriculture
settings can help slow the rate at which bacteria become resistant
to antibiotics. But even with prudent use, we will need to
continuously encourage the development of new therapeutic options
to keep pace with these challenges. The steps we're taking,
including the issuance of today's draft guidance on the LPAD
pathway and the discussion of new incentive models with our
partners at other agencies, are some of the additional steps we're
taking towards strengthening the fragile antibacterial drug
pipeline, as part of the larger effort to combat
antibiotic-resistant bacteria.
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The
agency is also responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Simon Sacerdoti, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440
FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000
Cantor Fitzgerald Europe (Nominated Adviser and Joint
Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000
finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500
About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative
biotechnology company focused on the development of novel medicines
that represent a new approach to the treatment of infectious
disease. These potential new medicines are being developed to
address the need for new drugs for the prevention and treatment of
life-threatening infections caused by antibiotic-resistant
bacteria, often referred to as "superbugs". Tackling anti-microbial
resistance has become a global imperative recognised by the World
Health Organisation (WHO) and the United Nations, as well as the G7
and the G20 countries. For further information, please visit
https://www.destinypharma.com
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END
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