TIDMFUM
RNS Number : 9779M
Futura Medical PLC
27 September 2021
27 September 2021
Futura Medical Announces Collaboration with Labatec Pharma to
Commercialise MED3000 in the Gulf and Middle East Region
Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a
pharmaceutical company developing a portfolio of innovative
products based on its proprietary, transdermal DermaSys(R) drug
delivery technology and currently focused on sexual health and
pain, today announces it has entered into a licensing agreement
with Labatec Pharma ("Labatec"), a Swiss-based specialty pharma
Company focused on commercialisation in Europe and the Middle East
and North Africa ("MENA") regions, for the rights to exclusively
commercialise the Company's topical, gel-based Erectile Dysfunction
("ED") treatment MED3000, in the Gulf Co-operation Council ("GCC")
region as well as Jordan, Lebanon and Iraq.
Commercial Highlights:
-- Futura eligible to receive initial upfront payments, as well as undisclosed milestone payments based on
regulatory approval
-- Labatec to pay an agreed price to Futura for the manufacture and supply of MED3000 by Futura's Contract
Manufacturing Organisation ("CMO"), plus royalties on all sales
-- Labatec is responsible for all local MED3000 development and regulatory costs in GCC and Levant as well as all
launch and marketing expenses
-- Initial licence agreement term of 8 years with the ability to extend for successive two-year terms by mutual
consent
Based in Switzerland and privately-owned, Labatec is a
pharmaceutical company with a successful track record of delivering
high quality pharmaceutical products to European and MENA markets.
Labatec has a presence in both hospital and retail sectors, with
prescription and OTC ranges and delivers a trusted brand of
medicines manufactured in Europe and Canada.
Labatec Licensing Agreement
Under the terms of the agreement, which is for an initial 8-year
period, Futura and Labatec will work together to gain marketing
authorisation and commercialise MED3000 as a clinically proven
treatment for ED in Jordan, Lebanon, Iraq and the GCC region of
Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Oman and
Bahrain.
Labatec will be responsible for all costs related to the
regulatory approval and marketing of the product in the region.
Labatec and Futura believe the EU (inclusive of the UK) approval of
MED3000 will facilitate approval in GCC and other countries within
the Middle East without the need for further clinical development.
Futura will provide reasonable technical support for product
development and commercialisation, will receive upfront and
milestone payments, manufactured product from Futura's CMO and a
royalty rate on all sales.
James Barder, Chief Executive of Futura Medical commented: "This
is our third commercial agreement for MED3000, and we are excited
to be working with Labatec to expand the product's market reach
into Middle Eastern countries as we continue MED3000's regulatory
and commercial rollout worldwide. Labatec is a trusted medicines
supplier in the region that is ideally placed to market both
prescription and retail products, and its local teams have deep
understanding of regional markets and experience in rapidly
registering and launching new products. We look forward to working
closely with them."
Faisal Darwazeh, Chief Executive Officer of Labatec commented :
"We are delighted to license Futura's MED3000 for the GCC and other
Middle Eastern countries. We feel that there is significant market
potential in the region for MED3000 as a trusted, branded medicine
for enhancing erectile performance, optimally through pharmacy
sales and are confident of generating significant value and long
term sustainable growth for both Futura and Labatec with this
innovative, clinically proven product."
Commercial Transaction Advisors
JSB Partners served as an adviser to Futura Medical in this
transaction
www.jsb-partners.com
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulation (EU) No. 596/2014 as amended by The
Market Abuse (Amendment) (EU Exit) Regulations 2019. Upon the
publication of this announcement via the Regulatory Information
Service, this inside information is now considered to be in the
public domain.
-ENDS-
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
www.futuramedical.com
Nominated Adviser and Sole Broker:
Liberum
Richard Lindley/ Euan Brown/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 922 0900
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company
developing a portfolio of innovative products based on its
proprietary, transdermal DermaSys(R) technology. Each DermaSys(R)
formulation is separately patented and specifically tailored for
the selected indication and application, as well as being optimised
for clinical efficacy, safety, administration and patient
convenience. The products are developed for the prescription and
consumer healthcare markets as appropriate. Current therapeutic
areas are sexual health, including erectile dysfunction, and pain
relief. Development and commercialisation strategies are designed
to maximise product differentiation and value creation whilst
minimising risk.
MED3000 is Futura's topical gel formulation that is a
breakthrough treatment for erectile dysfunction (ED) through a
unique evaporative mode of action. Futura has conducted a Phase 3
study using MED3000 in ED, referred to as "FM57". This was a 1,000
patient, dose-ranging, multi-centre, randomised, double blind,
placebo-controlled, home use, parallel group study delivering
highly statistically significant results compared to pre-treatment
baseline, consistently meeting all co-primary endpoints of IIEF,
SEP2 and SEP3 (internationally accepted clinical trial endpoints in
ED) with over 60% of patients experiencing a clinically meaningful
improvement in their ED. MED3000 also begins to work immediately in
some patients, with 60% of patients seeing onset of their erection
within 10 minutes of application. MED3000 is CE marked in Europe
and the UK as a clinically proven topical treatment for adult men
with erectile dysfunction.
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange.
www.futuramedical.com
About Labatec
A Swiss based privately owned pharmaceutical company, based in
Meyrin (Geneva) since 1957, Labatec develops and markets medicines
that contribute to improving patients' quality of life. Our
portfolio includes more than 85 high quality products, manufactured
in Europe and Canada and marketed in 10+ countries across MENA
markets, Switzerland and neighbouring EU countries. Labatec is a
recognised partner choice for Swiss and MENA hospitals and has an
established retail presence, including an OTC range, in the
therapeutic categories of musculo-skeletal, urology, and
reproductive health. www.labatecpharma.com
In case Labatec contacts are needed:
Viktoria Stepanova, COO
Email: bd@labatec.com
Tel: +41 22 785 95 00 (Head Office)
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCPPURCBUPGGPA
(END) Dow Jones Newswires
September 27, 2021 02:00 ET (06:00 GMT)
Futura Medical (LSE:FUM)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Futura Medical (LSE:FUM)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024
