Clinigen Group plc Clinigen agreement with Humanigen - Lenzilumab MAP
08 Octubre 2021 - 1:00AM
RNS Non-Regulatory
TIDMCLIN
Clinigen Group plc
08 October 2021
8th October 2021
Clinigen signs agreement with Humanigen for
Lenzilumab Managed Access Program
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical Services and Products company, announces it has
signed an exclusive agreement with Humanigen, Inc. ('Humanigen') to
implement a Managed Access Program for lenzilumab.
Once set up the program will enable access to lenzilumab on a
case-by-case basis for hospitalized patients with COVID-19 where
the treating physician deems there to be no suitable alternatives
and where regulations allow. The program will be available in the
following 16 European countries: Austria, Bulgaria, Croatia,
Cyprus, Denmark, Estonia, France, Greece, Ireland, Lithuania,
Luxembourg, Netherlands, Portugal, Spain, Sweden, and Switzerland.
Lenzilumab is an investigational product and is not currently
authorized or approved in any country.
Under the terms of the agreement, Clinigen will manage key
elements of the program including regulatory oversight, logistics
and access management.
Pete Belden, Executive Vice President Services Division,
Clinigen, said:
"We are pleased to partner with Humanigen to offer this
important treatment option to help address a significant unmet need
for hospitalized patients across Europe. This agreement underlines
Clinigen's strength in partnering with biotechnology companies to
provide services that enable quicker and broader access to critical
medicines ."
Timothy E. Morris Chief Operating Officer and Chief Financial
Officer, Humanigen, said:
"While we complete a Marketing Authorization Application for
lenzilumab and await the associated review by the European
Medicines Agency, as well as a decision regarding conditional
marketing authorization, the Managed Access Program will enable
Humanigen to respond positively to requests for access from
healthcare professionals to treat hospitalized patients where
allowed by the local competent authorities. We look forward to
working with Clinigen."
Patients seeking information should contact their physician.
- Ends -
Contact details
Clinigen Group plc +44 (0) 1283 495010
Pete Belden, EVP Services Division investors@clinigengroup.com
Rob Fox, VP Investor Relations and Corporate
Development
Consilium Strategic Communications
Mary-Jane Elliott / Matthew Cole / Jessica Tel: +44 (0) 20 3709 5700
Hodgson Clinigen@consilium-comms.com
Humanigen
Ken Trbovich, SVP Investor Relations Tel: +1 (650) 410-3206
trbo@ humanigen.com
Notes to Editors
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global, specialist
pharmaceutical services and products company focused on providing
ethical access to medicines. Its' mission is to deliver the right
medicine to the right patient at the right time. The Group operates
from sites in North America, Europe, Africa and the Asia
Pacific.
Clinigen has more than 1,000 employees across five continents in
14 countries, with supply and distribution hubs and operational
centres of excellence in key long-term growth regions. The Group
works with 34 of the top 50 pharmaceutical companies; interacting
with over 20,000 healthcare professionals across more than 120
countries.
For more information on Clinigen, please visit
http://www.clinigen.com
About Humanigen
Humanigen is a clinical-stage biopharmaceutical company focused
on preventing and treating an immune hyper-response called
'cytokine storm'. Humanigen has submitted lenzilumab to Medicines
and Health Regulatory Agency in the United Kingdom for a rolling
review towards potential Marketing Authorization. Humanigen is
developing lenzilumab as a treatment for cytokine storm associated
with COVID-19 and CD19-targeted CAR-T cell therapies and is also
exploring the effectiveness of lenzilumab in other inflammatory
conditions such as acute Graft versus Host Disease in patients
undergoing allogeneic hematopoietic stem cell transplantation,
eosinophilic asthma, and rheumatoid arthritis. For more
information, visit www.humanigen.com and follow Humanigen on
LinkedIn, Twitter, and Facebook.
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