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PledPharma receives European approval of the composition of matter patent for PledOx® and Aladote®

March 28, 2018

PledPharma AB
Company Announcement

PledPharma receives European approval of the composition of matter patent for
PledOx® and Aladote®

PledPharma AB has received an approval* letter from European Patent Office
(EPO) regarding composition of matter patent for the active ingredient in
PledOx® and Aladote®. 

The decision from EPO is based on PledPharma’s application for calmangafodipir
with the title ”Calmangafodipir, a New Chemical Entity, and Other Mixed Metal
Complexes, Methods of Preparation, Compositions, and Methods of Treatment”. The
expiry date for the patent is December, 2032. 

“An approval of a composition of matter patent for PledOx® and Aladote® gives
us a strong intellectual property protection in Europe and is of a great value
for PledPharma. This composition of matter patent is central in our deep and
strong intellectual property portfolio”, said Nicklas Westerholm, CEO,

The composition of matter patent has previously been approved in the US, Japan,
China and Russia with December, 2032 as the expiry date. 

At the beginning of March, 2018, PledPharma did receive an EPO approval for an
additional patent (which covers the use of pharmaceuticals in combination with
manganese and non-manganese containing PLED-complexes to minimize the risk for
accumulation of manganese in the brain), embodies both PledOx® and Aladote®.
The patent is entitled ”Pharmaceutical Compositions and Therapeutic Methods
Employing a Combination of a Manganese Complex Compound and a Non-Manganese
Complex Form of the Compound” and expires in 2030. 

*Pending patentfee registration

For more information, please contact:

Nicklas Westerholm, CEO, phone: +46 73 354 20 62

Yilmaz Mahshid, CFO, phone: +46 72 231 68 00

About PledOx®
PledOx® is a “first in class” drug candidate developed to provide patients,
that are treated adjuvantly or for metastatic colorectal cancer, prevention
against the nerve damage that can occur in conjunction with chemotherapy
treatment. The results from a completed Phase IIb trial (PLIANT), where
patients with metastatic colorectal cancer were treated with the chemotherapy
combination FOLFOX and PledOx®, indicates that the patients who received
PledOx® had a lower risk than the placebo group to suffer from nerve damage
during the chemotherapy. The presence of the investigator reported sensory
nerve damage, the primary endpoint, was after treatment 38% lower in the group
of patients treated with PledOx® compared with the placebo group (p = 0.16).
This was not statistically significant, but a difference of this magnitude is
considered to be clinically relevant. After completion of chemotherapy, the
patient-reported incidence of moderate and severe neuropathy was 77% lower in
patients treated with PledOx® compared to the placebo group (exploratory
analysis; p = 0.014). This is considered valuable for the success of the
forthcoming POLAR studies, where patient-reported symptoms after completion of
treatment will be the primary efficacy parameter. No apparent negative effect
on the efficacy of the cancer treatment was observed. 

About chemotherapy induced peripheral neuropathy (CIPN)
Peripheral neuropathy symptoms are caused by damages to sensory nerves, most
commonly in hands and feet. Certain chemotherapies, including oxaliplatin, can
cause such damages, which is then called chemotherapy induced peripheral
neuropathy (CIPN). This can be a debilitating adverse reaction of the cancer
treatment and may occur at any time after the initiation of chemotherapy. The
symptoms often increase as the chemotherapy treatment continues and may often
causes discontinuation of the chemotherapy. In many patients, the symptoms are
resolved after discontinuing the chemotherapy, but up to 20-30% of the patients
have sustained symptoms such as numbness, tingling and pain in hands and feet.
Patients with CIPN may have difficulties with fine motor skill, such as
buttoning buttons, challenges using a computer key board and become
hypersensitive to cold. The sensory loss in the feet’s may increase the risk of
falls. There is currently no approved drug to prevent or treat CIPN. 

About PledPharma
PledPharma develops new drugs that protect the body against oxidative stress –
a potentially debilitating and sometimes life-threatening condition that can be
caused by chemotherapy treatment and following acetaminophen (paracetamol)
overdose. The company's most advanced project PledOx® is being developed to
reduce nerve damage associated with chemotherapy. A phase IIb study has been
conducted and will serve as the basis for the continued development. The drug
candidate Aladote® is being developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. PledPharma (STO: PLED) is listed on
Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (tel
+46 8 463 80 00). For more information, see 

This information is information that PledPharma AB (publ) is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person set out
above, at 08:00 CET on Mar 28, 2018.



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