Ad-hoc | 20 November 2017 07:31
PledPharma AB
PledPharma and Solasia enter license agreement to develop and commercialize
PledOx(r) in Asia
20-Nov-2017 / 07:31 CET/CEST
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Stockholm, 2017-11-20 07:30 CET (GLOBE NEWSWIRE) --
Stockholm, Sweden / Tokyo, Japan, November 20^th 2017 -
PledPharma AB (âPledPharmaâ) (STO: PLED) and Solasia Pharma K.K.
(âSolasiaâ) (TSE: 4597) today jointly announce that they have
entered a license agreement pertaining to the clinical
development and commercialization of PledOx^Â(R) 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^Â(R) 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 consultations.
The license agreement is initially focused on the use of PledOx^Â(R)
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^Â(R) 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^Â(R) in Japan,
China, Hong Kong, Macau, South Korea, and Taiwan.
âWe are very excited to announce our partnership with Solasia â
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,â said
Nicklas Westerholm, Chief Executive Officer and President,
PledPharma.
âWe 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,â said Yoshihiro Arai, President and Chief
Executive Officer, Solasia.
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^Â(R). 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
[1]www.redeye.se. After the event, the presentation will be
available on PledPharma's website.
About PledOx^Â(R)
PledOx^Â(R) is a âfirst in classâ 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 feetâs 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
[2]http://www.solasia.co.jp/en/
About PledPharma
PledPharma develops new drugs that protect the body against
oxidative stress â 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^Â(R) 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^Â(R) 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 companyâs Certified
Adviser (tel +46 8 463 80 00). For more information, see
[3]http://[4]www.pledpharma.se[5]/
For further information, please contact:
Nicklas Westerholm, Chief Executive Officer, PledPharma AB
Tel. +46 73 354 20 62
[6]nicklas.westerholm@pledpharma.se
Rie Toyoda, Investor Relations, Solasia Pharma K.K.
Tel. +81 3 6721 8332
[7]info@solasia.co.jp
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
Click on, or paste the following link into your web browser, to
view the associated documents
https://cns.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=653705
References
1. http://www.redeye.se/
2. http://www.solasia.co.jp/en/
3. http://www.pledpharma.se/
4. http://www.pledpharma.se/
5. http://www.pledpharma.se/
6. mailto:nicklas.westerholm@pledpharma.se
7. mailto:info@solasia.co.jp
News Source: NASDAQ OMX
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Language: English
Company: PledPharma AB
Sweden
ISIN: SE0003815604
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