BASEL, SWITZERLAND--(Marketwire - June 11, 2012) - Basilea Pharmaceutica AG /
Basilea enters into global agreement with Stiefel, a GSK company, for
(alitretinoin). Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
* Stiefel gains exclusive worldwide rights to Toctino®
(alitretinoin) and assumes Toctino® distribution agreements
* Basilea receives GBP 146 million (approximately CHF 216 million)
upfront payment and is eligible for additional milestones of up to
GBP 50 million (approximately CHF 74 million) and double-digit
participation in U.S. sales
* Basilea realizes the significant value of Toctino®, secures
development funding and strengthens focus on anti-infectives and
Basel, Switzerland, June 11, 2012 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that Basilea Pharmaceutica International Ltd. ("Basilea")
entered into an exclusive worldwide agreement with Stiefel for
Toctino® was developed by Basilea. It is commercially available in
countries and approved in an additional fifteen countries for the treatment
adults with severe chronic hand eczema that is refractory to treatment with
potent topical corticosteroids. In the U.S., oral alitretinoin is an
investigational drug in a phase III trial.
Stiefel will assume responsibility for the development, manufacturing,
commercialization, and distribution of the product. Existing Toctino®
distribution agreements in Europe, Canada, Mexico, Israel and the Republic
Korea will be assigned to Stiefel.
Basilea will receive a GBP 146 million upfront payment and is eligible for
additional milestone payments of between GBP 30 to GBP 50 million related
regulatory milestone of alitretinoin in the U.S. Basilea will also receive
double-digit participation in U.S. sales starting three years after launch.
Dr. Anthony Man, Chief Executive Officer of Basilea, stated, "Through this
transaction, we are immediately accessing the value of Toctino and we will
able to further focus our strategy on solving the massive health care
resistance in the areas of anti-infectives and oncology. This transaction
provides us with non-dilutive capital to achieve our clinical milestones
are key to optimizing shareholder value. It also gives us the flexibility
selectively add products or product portfolios that address resistance to
current therapies in our focus areas of anti-infectives and oncology."
He added, "Specifically, we will use the proceeds from this transaction to
support the regulatory filing of ceftobiprole for the treatment of
the hospital in Europe this year and subsequently in the U.S., as well as
completing the isavuconazole phase III program to bring this important drug
the market. Furthermore, we aim to advance our innovative phase I compounds
addressing resistant Gram-negative bacterial infections and drug resistance
current anti-tumor therapies."
Employees at Basilea's European affiliates and Swiss headquarters who are
actively involved in the commercialization and distribution of
have the right to transfer to Stiefel upon completion of the transaction.
The agreement is subject to antitrust approval and other customary
Basilea will confirm the accounting treatment of the transaction and update
financial guidance for 2012 in due course.
Antibiotic resistance has become a major health threat as the arsenal of
effective antibiotics is deteriorating. Health authorities and lawmakers
currently addressing how to create new incentives for antibiotic
Specifically the U.S. congress and the FDA are currently considering
exclusivity for innovative antibiotics tackling multidrug-resistance and
allowing eligibility for priority review and fast-track approval of
Ceftobiprole addresses the critical healthcare challenge of empiric therapy
resistant Gram-positive infections such as Methicillin-resistant
aureus (MRSA) while BAL30072 addresses resistant Gram-negative infections
as Pseudomonas and Acinetobacter. Basilea's innovative drug portfolio in
addition addresses life-threatening fungal infections with isavuconazole
with BAL101553 tumor resistance and non-response to standard cancer
Ceftobiprole is a novel antibiotic for the potential first-line empiric
treatment of severe multidrug-resistant bacterial infections. Available
demonstrate activity against a wide range of Gram-positive bacteria,
the methicillin-resistant Staphylococcus aureus (MRSA) 'superbug' as well
clinically important Gram-negative bacteria such as Pseudomonas spp. and
Acinetobacter spp. No other single antibiotic can currently provide such a
spectrum of coverage. Broad bacterial coverage is important as
initial antimicrobial therapy is associated with excess mortality in
with serious infections, including severe pneumonia treated in the
Empiric treatment of severe infections such as pneumonia should include
antibiotics covering MRSA and Pseudomonas aeruginosa.
BAL30072 is a novel sulfactam antibiotic that in in-vitro and in-vivo
demonstrated potent bactericidal activity against a broad range of
resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter
BAL30072 has the potential to play an essential role in the therapy of
and life-threatening infections treated in the hospital. It overcomes
resistance caused by extended-spectrum beta-lactamases (ESBLs),
and the recently characterized New Delhi metallo-beta-lactamase 1 (NDM-1).
BAL30072 has also demonstrated synergistic effects in combination with
antibiotics from the penem class expanding its spectrum of activity to
all clinically important multidrug-resistant Gram-negative pathogens.
Isavuconazole is a novel broad-spectrum antifungal with the potential to
the best-in-class azole for the treatment of severe invasive life-
fungal infections. Invasive yeast or mold infections are potentially life-
threatening in immunocompromised patients such as transplant or cancer
Current treatment options are often limited due to lack of broad-spectrum
coverage, unreliable dosing and toxicity issues. Invasive fungal infections
associated with a significant increase in mortality, particularly among
with serious underlying diseases. Isavuconazole has excellent in-vitro and
vivo coverage of a broad range of yeasts and molds as well as less common
clinically important molds such as Zygomycetes spp. Isavuconazole is
in two dosage forms: an injectable and a highly bioavailable oral form that
importantly provide for predictable dosing to ensure adequate effective
levels in the body. This allows for a seamless intravenous-oral switch,
a significant advantage for potentially allowing patients to be treated
of the intensive care unit or the hospital setting.
BAL101553 is a novel small-molecule anti-cancer drug that has shown potent
activity in many tumor cell lines that are insensitive or resistant to
or other microtubule-targeting agents. BAL101553 disrupts this
microtubule network in a unique way and is as well interfering with the
supply of the tumor resulting in cancer cell death. Unlike all registered
microtubule-targeting agents derived from structurally complex natural
BAL101553 is a simpler synthetic molecule that bypasses some of the
mechanisms associated with existing drugs. BAL101553 is being developed as
highly water-soluble prodrug of Basilea's BAL27862 with anticipated good
bioavailability and an injectable formulation without potentially harmful
Basilea Pharmaceutica Ltd. invites you to participate in a conference call
June 12, 2012,
4 p.m. (CEST), during which the company will discuss today's press release.
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+1 (1) 866 291 4166 (USA)
+44 (0) 203 059 5862 (UK)
A playback will be available 1 hour after the conference call until June
14, 2012, 6 p.m. (CEST). Participants requesting a digital playback may
+41 (0) 91 612 4330 (Europe and ROW)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 16236 followed by the # sign.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd. the company focuses on innovative pharmaceutical
the therapeutic areas of bacterial infections, fungal infections and
targeting the medical challenge of resistance and non-response to current
treatment options in the hospital and specialty care setting.
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition,
or achievements of Basilea Pharmaceutica Ltd. to be materially different
any future, anticipated results, performance or achievements expressed or
implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is
providing this communication as of this date and does not undertake to
any forward-looking statements contained herein as a result of new
future events or otherwise.
This press release can be downloaded from www.basilea.com.
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE