BerGenBio

Regulatory Filings • Oct 22, 2019

BerGenBio Receives FDA Approval of Fast Track Designation for Bemcentinib

BerGenBio Receives FDA Approval of Fast Track Designation for Bemcentinib

Bergen, Norway 22nd October 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

multiple cancer indications, today announces that the U.S. Food and Drug

Administration (FDA) has approved Fast Track Designation for bemcentinib for the

treatment of elderly patients with acute myeloid leukaemia (AML) whose disease

has relapsed. There are currently no marketed drugs specifically approved for

all relapsed AML patients, representing a significant unmet medical need.

BerGenBio has ongoing phase 2 trials in this indication and plans to seek

regulatory advice from the FDA and European Medicines Agency (EMA) to determine

the optimal regulatory path for bemcentinib in relapsed AML.

Fast Track is a process designed to facilitate the development and expedite the

review of drugs to treat serious conditions and fill an unmet medical need. The

purpose is to get important new drugs to the patient earlier. Fast Track

addresses a broad range of serious conditions. Filling an unmet medical need is

defined as providing a therapy where none exists or providing a therapy which

may be potentially better than available therapy. A drug that receives Fast

Track designation is eligible for the following:

· More frequent meetings with FDA to discuss the drug's development plan and

ensure collection of appropriate data needed to support drug approval

· More frequent communication from FDA about such things as the design of the

proposed clinical trials and use of biomarkers

· Eligibility for Accelerated Approval and Priority Review, if relevant

criteria are met

· Rolling Review, which means that a drug company can submit completed

sections of its Biologic License Application (BLA) or New Drug Application (NDA)

for review by FDA, rather than waiting until every section of the NDA is

completed before the entire application can be reviewed. BLA or NDA review

usually does not begin until the drug company has submitted the entire

application to the FDA

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are

thrilled that bemcentinib has been granted Fast Track Designation. Not only does

this make us eligible for accelerated approval and priority review, but it

serves as an important validation of bemcentinib in this significant unmet

medical need we are trying to address. Currently, bemcentinib is in expanded

Phase II trials in the U.S. and Europe for the treatment of AML and the Company

has recently announced positive interim top line data."

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About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the

biological mechanisms underlying life-threatening diseases. In cancer, AXL

suppresses the body's immune response to tumours and drives cancer treatment

failure across many indications. AXL inhibitors, therefore, have potential high

value at the centre of cancer combination therapy, addressing significant unmet

medical needs and multiple high-value market opportunities. Research has also

shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class

selective AXL inhibitor in a broad phase II clinical development programme.

Ongoing clinical trials are investigating bemcentinib in multiple solid and

haematological tumours, as monotherapy and in combination with current and

emerging therapies (including immunotherapies, targeted therapies and

chemotherapy). Bemcentinib targets and binds to the intracellular catalytic

kinase domain of AXL receptor tyrosine kinase and inhibits its activity.

Increase in AXL function has been linked to key mechanisms of drug resistance

and immune escape by tumour cells, leading to aggressive metastatic cancers.

About AML

Acute myeloid leukemia (AML) is the most common type of aggressive leukemia in

adults, which has the lowest survival rate for all types of leukemia. In 2018,

it is estimated there will be nearly 20,000 new cases of AML diagnosed in the

United States. Many AML patients older than age 60 are unable to tolerate

intensive induction chemotherapy treatment.

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing

transformative drugs targeting AXL as a potential cornerstone of therapy for

aggressive diseases, including immune-evasive, therapy resistant cancers. The

company's proprietary lead candidate, bemcentinib, is a potentially first-in

-class selective AXL inhibitor in a broad phase II oncology clinical development

programme focused on combination and single agent therapy in lung cancer and

leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL

-ADC (ADCT-601) are undergoing phase I clinical testing. In parallel, BerGenBio

is developing a companion diagnostic test to identify those patient populations

most likely to benefit from bemcentinib: this is expected to facilitate more

efficient registration trials supporting a precision medicine-based

commercialisation strategy.

BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The

company is listed on the Oslo Stock Exchange (ticker: BGBIO). www.bergenbio.com

Contacts

Richard Godfrey CEO, BerGenBio ASA

+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Carina Jurs, Consilium Strategic

Communications

bergenbio@consilium-comms.com

+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

stiff@crux.no

+47 995 13 891

Forward looking statements

This announcement may contain forward-looking statements, which as such are not

historical facts, but are based upon various assumptions, many of which are

based, in turn, upon further assumptions. These assumptions are inherently

subject to significant known and unknown risks, uncertainties and other

important factors. Such risks, uncertainties, contingencies and other important

factors could cause actual events to differ materially from the expectations

expressed or implied in this announcement by such forward-looking statements.

This information is subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Trading Act.