Basilea enters into global agreement with Stiefel, a GSK company, for Toctino® (alitretinoin)
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea enters into global agreement with Stiefel, a GSK company, for Toctino®
(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 oncology
Basel, Switzerland, June 11, 2012 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announced today that Basilea Pharmaceutica International Ltd. ("Basilea") has
entered into an exclusive worldwide agreement with Stiefel for Toctino®.
Toctino® was developed by Basilea. It is commercially available in fourteen
countries and approved in an additional fifteen countries for the treatment of
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 of
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 to a
regulatory milestone of alitretinoin in the U.S. Basilea will also receive low
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 be
able to further focus our strategy on solving the massive health care threat of
resistance in the areas of anti-infectives and oncology. This transaction
provides us with non-dilutive capital to achieve our clinical milestones that
are key to optimizing shareholder value. It also gives us the flexibility to
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 pneumonia in
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 to
the market. Furthermore, we aim to advance our innovative phase I compounds
addressing resistant Gram-negative bacterial infections and drug resistance to
current anti-tumor therapies."
Employees at Basilea's European affiliates and Swiss headquarters who are
actively involved in the commercialization and distribution of Toctino® will
have the right to transfer to Stiefel upon completion of the transaction.
The agreement is subject to antitrust approval and other customary provisions.
Basilea will confirm the accounting treatment of the transaction and update the
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 are
currently addressing how to create new incentives for antibiotic development.
Specifically the U.S. congress and the FDA are currently considering extending
exclusivity for innovative antibiotics tackling multidrug-resistance and
allowing eligibility for priority review and fast-track approval of antibiotics.
Ceftobiprole addresses the critical healthcare challenge of empiric therapy of
resistant Gram-positive infections such as Methicillin-resistant staphylococcus
aureus (MRSA) while BAL30072 addresses resistant Gram-negative infections such
as Pseudomonas and Acinetobacter. Basilea's innovative drug portfolio in
addition addresses life-threatening fungal infections with isavuconazole and
with BAL101553 tumor resistance and non-response to standard cancer therapy.
Ceftobiprole is a novel antibiotic for the potential first-line empiric
treatment of severe multidrug-resistant bacterial infections. Available data
demonstrate activity against a wide range of Gram-positive bacteria, including
the methicillin-resistant Staphylococcus aureus (MRSA) 'superbug' as well as
clinically important Gram-negative bacteria such as Pseudomonas spp. and
Acinetobacter spp. No other single antibiotic can currently provide such a broad
spectrum of coverage. Broad bacterial coverage is important as inappropriate
initial antimicrobial therapy is associated with excess mortality in patients
with serious infections, including severe pneumonia treated in the hospital.
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 models
demonstrated potent bactericidal activity against a broad range of multidrug-
resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter species.
BAL30072 has the potential to play an essential role in the therapy of serious
and life-threatening infections treated in the hospital. It overcomes bacterial
resistance caused by extended-spectrum beta-lactamases (ESBLs), carbapenemases
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 almost
all clinically important multidrug-resistant Gram-negative pathogens.
Isavuconazole is a novel broad-spectrum antifungal with the potential to become
the best-in-class azole for the treatment of severe invasive life-threatening
fungal infections. Invasive yeast or mold infections are potentially life-
threatening in immunocompromised patients such as transplant or cancer patients.
Current treatment options are often limited due to lack of broad-spectrum
coverage, unreliable dosing and toxicity issues. Invasive fungal infections are
associated with a significant increase in mortality, particularly among patients
with serious underlying diseases. Isavuconazole has excellent in-vitro and in-
vivo coverage of a broad range of yeasts and molds as well as less common but
clinically important molds such as Zygomycetes spp. Isavuconazole is available
in two dosage forms: an injectable and a highly bioavailable oral form that very
importantly provide for predictable dosing to ensure adequate effective drug
levels in the body. This allows for a seamless intravenous-oral switch, which is
a significant advantage for potentially allowing patients to be treated outside
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 taxanes
or other microtubule-targeting agents. BAL101553 disrupts this intracellular
microtubule network in a unique way and is as well interfering with the blood
supply of the tumor resulting in cancer cell death. Unlike all registered
microtubule-targeting agents derived from structurally complex natural products,
BAL101553 is a simpler synthetic molecule that bypasses some of the resistance
mechanisms associated with existing drugs. BAL101553 is being developed as a
highly water-soluble prodrug of Basilea's BAL27862 with anticipated good oral
bioavailability and an injectable formulation without potentially harmful
solubilizers.
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
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 dial:
+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.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Through the fully integrated research and
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd. the company focuses on innovative pharmaceutical products in
the therapeutic areas of bacterial infections, fungal infections and oncology,
targeting the medical challenge of resistance and non-response to current
treatment options in the hospital and specialty care setting.
Disclaimer
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, performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different from
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 update
any forward-looking statements contained herein as a result of new information,
future events or otherwise.
For further information, please contact:
+-----------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-----------------------------+--------------------------------+
| Peer Nils Schröder, Ph.D. | Barbara Zink, Ph.D., MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com.
Press release (PDF):
http://hugin.info/134390/R/1618919/516985.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1618919]
Unternehmensinformation / Kurzprofil:
Datum: 11.06.2012 - 23:30 Uhr
Sprache: Deutsch
News-ID 155316
Anzahl Zeichen: 12232
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 163 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Basilea enters into global agreement with Stiefel, a GSK company, for Toctino® (alitretinoin)"
steht unter der journalistisch-redaktionellen Verantwortung von
Basilea Pharmaceutica AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
