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PledPharma and Solasia enter license agreement to develop and commercialize PledOx® in Asia

November 20, 2017

PledPharma AB
Company Announcement

PledPharma and Solasia enter license agreement to develop and commercialize
PledOx® in Asia

Stockholm, 2017-11-20 07:30 CET (GLOBE NEWSWIRE) -- 
Stockholm, Sweden / Tokyo, Japan, November 20th 2017 - PledPharma AB
(“PledPharma”) (STO: PLED) and Solasia Pharma K.K. (“Solasia”) (TSE: 4597)
today jointly announce that they have entered a license agreement pertaining to
the clinical development and commercialization of PledOx® in Japan, China, Hong
Kong, Macau, South Korea and Taiwan. 

Under the terms of this agreement, PledPharma grants exclusive development and
commercialization rights to PledOx® in the territories mentioned and Solasia
will pay upfront, development, regulatory and sales milestones of up to ~USD 83
million (SEK 700 million)*. In addition, Solasia will pay industry standard
royalty rates on sales applicable for a deal pertaining to an in-licensed asset
in Phase III development. Solasia will also fully finance an expansion of the
Phase III program to include Asian patients subject to regulatory

The license agreement is initially focused on the use of PledOx® as prevention
of chemotherapy induced peripheral neuropathy in colorectal cancer patients.
The agreement with Solasia facilitates an expansion of the recently announced
global Phase III-program for PledOx® with Asian patients, subject to regulatory
consultations, aiming to gain sufficient documentation for regulatory approvals
in the major Asian markets. In addition, a Phase I study in Japanese and
Caucasian Healthy Volunteers with focus on safety, tolerability and
pharmacokinetics will be conducted. Following potential regulatory approvals,
Solasia will be responsible for the commercialization of PledOx® in Japan,
China, Hong Kong, Macau, South Korea, and Taiwan. 

“We are very excited to announce our partnership with Solasia – an ideal
partner during the development, regulatory process and commercialization of
PledOx in this very important region. The collaboration will ensure an
optimized expansion of the Phase III program to include Asian patients, aiming
at further realising the global commercial potential of our drug candidate,”
said Nicklas Westerholm, Chief Executive Officer and President, PledPharma. 

“We are convinced that PledOx, as a novel first in class therapy, will play an
important role in fulfilling the significant unmet medical need of preventing
chemotherapy induced peripheral neuropathy. Solasia is ideally equipped to
support PledPharma during the remaining clinical development and local
regulatory processes in Japan, and to effectively launch the product in key
Asian markets,” said Yoshihiro Arai, President and Chief Executive Officer,

As PledPharma announced earlier in November, following interactions with the
regulatory authorities, EMA and FDA, the company has finalized the design of
the global Phase III program for the drug candidate PledOx®. The Phase III
studies are anticipated to be initiated at the end of 2017 with top line
results expected during 2020. 

* The total value of upfront and milestone payments is up to JPY 9.3 billion.
The amount given in USD and SEK is subject to exchange rate. 

Invitation to corporate presentation
PledPharma will attend the Redeye Life Science Seminar on November 24 at 11:00
CET where PledPharma will provide a company update and an overview of the
license agreement with Solasia. The event will be live streamed from Redeyes
website After the event, the presentation will be available on
PledPharma's website. 

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 side-effects of chemotherapy can lead to a reduction of the
planned dose or, in worst case, treatment discontinuation. Unfortunately, it
appears that the chemotherapy can induce permanent nerve damage. Patients may,
for example, experience discomfort and numbness in the hands and feet,
difficulty with balance with risk of falling and problems with sensation that
can last for the rest of their lives. 

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 Solasia
Solasia is a specialty pharmaceutical company based in Asia, with a mission of
"Better Medicine for a Brighter Tomorrow". In order to address the unmet
medical needs within the oncology area, we develop innovative medicines to
contribute to the patient's healthy living and to provide treatment options for
the healthcare providers. Additional information is available at 

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 

For further information, please contact:

Nicklas Westerholm, Chief Executive Officer, PledPharma AB
Tel. +46 73 354 20 62

Rie Toyoda, Investor Relations, Solasia Pharma K.K.
Tel. +81 3 6721 8332

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 07:30 CET on November 20, 2017



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