Biofrontera enters into license and supply agreement with Medac for the marketing of Ameluz® in Poland
July 23 2021 - 3:15AM
Biofrontera Pharma GmbH, a wholly owned subsidiary of Biofrontera
AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F), and Medac
Gesellschaft für klinische Spezialpräparate mbH. (Medac), signed an
exclusive license and supply agreement for the marketing of both
Ameluz® and BF-RhodoLED® in Poland. The agreement has a term of 5
years commencing with the start of sales in Poland.
Under the terms of the agreement, Medac will
make an immediate one-time upfront payment of EUR 50,000 to the
Company, plus an additional one-time payment of EUR 150,000
following receipt of the drug's reimbursement eligibility from the
Polish health insurance providers. According to the agreement,
Medac receives exclusive distribution rights for Poland. Once
reimbursement eligibility has been granted in Poland, Biofrontera
will supply Ameluz® to Medac at a fixed transfer price based on the
expected net revenues.
As with all of the company's other licensing
agreements, Biofrontera will be responsible for regulatory affairs
as well as manufacturing and quality control, while Medac will
handle all aspects of commercialization and local regulatory and
reimbursement in Poland.
Prof. Dr. Hermann Lübbert, CEO of Biofrontera
AG, commented, "We are pleased to have a strong partner on our side
to offer photodynamic therapy for the treatment of actinic
keratosis and basal cell carcinoma by using Ameluz® and the
BF-RhodoLED® in Poland."
Medac Gesellschaft für klinische
Spezialpräparate mbH is a global pharmaceutical company based in
Germany, which has been specializing in the treatment and diagnosis
of oncological, urological and autoimmune diseases. In Poland,
Medac operates a leading sales structure in dermatology and, with
this agreement, expands its dermatology portfolio with the addition
of Ameluz®.
Background:
In 2011, the prescription drug Ameluz® received
a centralized EU marketing authorization from the European
Commission, which since then has repeatedly been expanded. Ameluz®
is approved for use in photodynamic therapy (PDT) of mild to
moderate actinic keratoses, field cancerization, and superficial
and nodular basal cell carcinomas. Ameluz® is approved for the use
in conventional PDT with our special red-light lamp BF-RhodoLED® as
well as for daylight PDT.
-End-
Biofrontera AGPamela Keck, Head of Investor
Relationsir@biofrontera.com+49-214-87632-0
About Biofrontera: Biofrontera
AG is a biopharmaceutical company specializing in the development
and sale of dermatological drugs and medical cosmetics.
The Germany-based company, with over 150
employees worldwide, develops and markets innovative products for
the care, protection and treatment of the skin. The company’s lead
product is the combination of Ameluz®, a topical prescription drug,
and medical device BF-RhodoLED® for the photodynamic therapy of
certain superficial skin cancers and their precursors. Ameluz® has
been marketed in the EU since 2012 and in the United States since
May 2016. In addition, the company markets the prescription
medication Xepi® for the treatment of impetigo in the United
States. In the EU, the company also sells the dermocosmetics series
Belixos®, which offers specialized care for damaged or diseased
skin.
Biofrontera is the first German founder-led
pharmaceutical company to receive a centralized European and a US
approval for a drug developed in-house. The Biofrontera Group was
founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is
listed on the Frankfurt Stock Exchange (Prime Standard) and on the
US NASDAQ.www.biofrontera.com.
Forward-Looking Statements: Certain statements
in this press release are forward-looking within the meaning of the
Private Securities Litigation Reform Act of 1995 regarding the
public offering and the intended use of proceeds from the
offering.
These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimate" and "intend," among others. Such forward-looking
statements are based on the currently held beliefs and assumptions
of the management of Biofrontera AG, which are expressed in good
faith and, in their opinion, reasonable. Forward-looking statements
involve known and unknown risks, uncertainties and other factors,
which may cause the actual results, financial condition,
performance, or achievements of the Company, or industry results,
to differ materially from the results, financial condition,
performance or achievements expressed or implied by such
forward-looking statements. These risks, uncertainties and other
factors are set forth in the annual report on Form 20-F filed with
the SEC, including Item 3.D. "Key Information - Risk Factors," and
in future reports filed with the SEC. Given these risks,
uncertainties and other factors, prospective investors are
cautioned not to place undue reliance on these forward-looking
statements. The Company does not undertake an obligation to update
or revise any forward-looking statement.
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