News room

Egetis is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment

PledPharma reports constructive meeting with the European Medicines Agency (EMA)

June 7, 2016

PledPharma AB
Company Announcement

PledPharma reports constructive meeting with the European Medicines Agency (EMA)

Stockholm, 2016-06-07 13:28 CEST (GLOBE NEWSWIRE) -- 

PledPharma AB (publ) today announced that the company has completed a
constructive meeting with the European Medicines Agency (EMA) for the remaining
development and potential market introduction of PledOx® - a drug candidate
that reduces the incidence of chemotherapy induced nerve damage. The meeting
was also attended by representatives from NICE in the UK and NOMA in Norway,
two national authorities who are responsible for health economic evaluations of
new drugs. 

The meeting was held within the framework of the pan-European cooperation HTA
Parallel Scientific Advice, where the EMA along with selected national
authorities, responsible for health economic evaluations, support
pharmaceutical companies in the development of new therapies. At the meeting
the design of the remaining part of the development program for PledOx®
(calmangafodipir) was discussed. 

In addition, the types of health economic evaluations that should be conducted
to facilitate future decisions on inclusion in the national pharmaceutical
reimbursement systems were discussed. The authorities' assessment of PledOx®
potential role in the future treatment of cancer patients and their suggestions
are in line with PledPharma’s own opinion. 

The meeting was attended by representatives of the British NICE (National
Institute for Health and Care Excellence) and the Norwegian NOMA (Norwegian
Medicines Agency). 

"It is with great comfort that we note that the European Medicines Agency
shares our view regarding the structure and scope of the final clinical
development of PledOx®. The comments received from national authorities,
commissioned to evaluate new drug therapies, strengthens our view that PledOx®
can play a valuable role in the future treatment of cancer patients, "says
Jacques Näsström, CEO, PledPharma.” 

PledPharma has previously completed a so-called end-of-Phase II/pre-Phase III
meeting with the FDA. This meeting was also held in a constructive and positive
spirit and altogether has the contact with the authorities established a clear
regulatory strategy for the two largest markets, the US and Europe and a good
basis for the continued development. PledPharma’s view is that these meetings
have created an attractive foundation for the way forward towards a market

A large proportion of patients undergoing chemotherapy suffers from symptoms
(tingling, numbness and pain) caused by nerve damage that have occurred in
connection with the chemotherapy. After completing the treatment, it is common
that these symptoms linger and that, in many cases, they become more severe.
The results from the phase IIb study PLIANT shows that PledOx® reduce the
incidence and intensity of chemotherapy induced nerve damage in a statistically
significant and clinically meaningful way without negatively interfering with
the anticancer effect of chemotherapy on colorectal cancer. 

For more information, please contact:

Jacques Näsström, CEO, phone: +46 737 130 979

Michaela Gertz, CFO, phone: +46 709 26 17 75

About PledPharma

PledPharma develop new drugs that protect the body against oxidative stress - a
potentially disabling and sometimes life-threatening condition that can be
caused by chemotherapy and acetaminophen poisoning. The company's most advanced
project PledOx® reduces nerve damage associated with chemotherapy. Positive
results from phase IIb study PLIANT were presented in the spring of 2015. The
drug candidate Aladote® is developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. The project PP-099 aims to limit the
damage that occurs to the heart muscle during a heart attack. PledPharma
(STO:PLED) is listed on Nasdaq First North. Erik Penser Bank is the Certified
Adviser. For further information, please visit



Contact us

Address: Klara Norra Kyrkogata 26, SE 111 22 Stockholm, Sweden

Phone: +46 8 679 72 10