KOS AND JERINI SIGN EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT FOR DEVELOPMENT, MARKETING AND DISTRIBUTION OF ICATIBANT IN THE UNITED STATES AND CANADA
Exhibit 99.1
KOS AND XXXXXX SIGN EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT
FOR DEVELOPMENT, MARKETING AND DISTRIBUTION OF ICATIBANT IN THE
UNITED STATES AND CANADA
FOR DEVELOPMENT, MARKETING AND DISTRIBUTION OF ICATIBANT IN THE
UNITED STATES AND CANADA
| • | Kos to develop, market and distribute Icatibant in the US and Canada | ||
| • | Icatibant, in final Phase III clinical trials for hereditary angioedema (HAE), represents next potential new product launch for both companies scheduled for the first half of 2007 | ||
| • | US Food and Drug Administration has granted Icatibant fast track designation and orphan drug status | ||
| • | Xxxxxx plans further clinical development for Icatibant for additional indications of angioedema | ||
| • | Kos responsible for Icatibant’s clinical development in asthma (inhalation) and refractory ascites in liver cirrhosis (intravenous) |
CRANBURY, NJ, BERLIN, GERMANY November 7, 2005 – Kos Life Sciences, Inc., a subsidiary of Kos
Pharmaceuticals, Inc. (Nasdaq: KOSP) and Jerini US Inc., a subsidiary of Jerini AG (FSE: JI4),
announced today the signing of an exclusive agreement for the development, marketing and
distribution of Jerini’s compound, Icatibant, a potent and specific peptidomimetic bradykinin B2
receptor antagonist, in the United States and Canada. The strategic partnership includes an
upfront licensing payment of €12 million (approx.$15 million), along with a €10 million (approx.$12
million) equity investment out of a capital increase at the higher of the weighted average of the
closing price of Xxxxxx’s shares during the last four trading days, or €3.20 (approx.$3.84) per
share (IPO price). Undisclosed milestone payments and sales royalties are also specified in the
agreement. Hereditary angioedema (HAE) is the first of several diseases for which Icatibant offers
a potential treatment. The agreement outlines collaboration in the HAE area as well as other forms
of angioedema, asthma, and refractory ascites in liver cirrhosis (RAIL) indications.
Proof-of-concept trials have already been completed in these indications.
HAE is a rare genetic disease which can be debilitating, painful and life-threatening and is
characterized by recurrent local swelling at three main sites: subcutaneous tissue, the
gastrointestinal tract, and the larynx. Laryngeal attacks can lead to upper airway constriction
and to suffocation. HAE is caused by an activation of the kinin system leading to elevated levels
of bradykinin (a naturally occurring peptide hormone). These elevated levels of bradykinin present
in the affected areas that cause the symptomatic swelling attacks. Icatibant reduces the effects
of such elevated levels of bradykinin, and if approved could offer HAE patients a novel treatment
that will allow them the opportunity to self-administer the drug in the event of an attack. There
are approximately 10,000 diagnosed HAE patients in the European Union and the US, but the disease
is believed to be significantly under diagnosed. Experts estimate the HAE patient population could
be as high as 75,000. In addition, Icatibant also offers a potential treatment for drug-induced and
idiopathic angioedema, affecting a significantly larger patient group. RAIL is another potential
indication for this product affecting approximately 300,000 patients.
“We are very pleased with Xxxxx’s clinical development of Icatibant for the angioedema
indication and are excited about this near-term commercial opportunity. Currently there are no
approved treatment options for HAE in the US or most other countries. We are hopeful that
Icatibant may be able to fulfil a serious unmet medical need in this patient population,” commented
Xxxxxx Xxxxx, President and Chief Executive Officer of Kos Pharmaceuticals, Inc. “The product has
received orphan drug and fast track review status by the FDA, and could potentially be launched in
the first half of 2007. This strategic acquisition could provide entry into new specialty markets
that are synergistic with our therapeutic focus in addition to leveraging Kos’ established field
force strengths and customer targets,” he continued. “Our partnership with Xxxxxx is an excellent
example of Kos’ expanded business model that includes making measured investments to build our R&D
pipeline through
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scientific in-licensing and general corporate development. Kos is committed to exploring the
potential of Icatibant in other bradykinin related diseases such as RAIL and asthma, indications
that may provide additional medium-term opportunities for organic sales growth.”
“Kos is the ideal partner for the U.S. and Canadian markets, and this agreement meets all of
our goals. Our strong financial position of approximately $120 million after our recent IPO
enabled us to structure a transaction that includes significant royalty, sales and regulatory
milestone payments, which allows us to participate substantially in the potential long-term success
of Icatibant. Kos is an outstanding specialty pharmaceutical company and its exceptional growth
and performance distinguish it as a market leader. Kos has a strong US infrastructure with a
specialized sales force covering the complete range of medical areas needed to realize the full
potential of Icatibant in the planned 2007 US and Canadian launch,” said Xxxx Xxxxxxxxx-Xxxxxxxx,
Chief Executive Officer of Jerini AG. “In addition, our agreement with Kos expands the therapeutic
potential of Icatibant to even larger indications that may bring considerable upside for us in the
future.”
Xxxxxx will retain the commercial rights to Icatibant outside the US and Canada and continues
to be responsible for Icatibant’s HAE clinical Phase III trials and regulatory approval. Phase III
clinical trials are currently being conducted in the US, Canada, Europe, and several other
countries. Results from these trials are expected to be reported in mid- 2006, with filing for
market approval in the US and Europe also planned in 2006. Kos and Xxxxxx will collaborate on the
global branding and positioning of Icatibant in HAE and other forms of angioedema. Xxxxxx will also
continue to be responsible for the supply of Icatibant.
Icatibant has been shown to be safe and well tolerated in over 1,000 individuals. Phase II
clinical results in HAE demonstrated a 100% response rate to the drug. Currently, Icatibant is in
Phase III clinical trials, supported by a Special Protocol Assessment (SPA) from the FDA. These
trials include the treatment of life-threatening laryngeal attacks as part of an open-label
extension study. After treatment with Icatibant, all these patients experienced rapid onset of
symptom relief, and no further treatment was necessary. Xxxxxx plans additional clinical testing
for idiopathic and drug-induced angioedema with Icatibant in 2006.
About Icatibant
Icatibant is a potent and specific peptidomimetic bradykinin B2 receptor antagonist. It has
exhibited a strong safety profile in over 1,000 individuals. Icatibant is being tested in clinical
trials for treatment of hereditary angioedema and refractory ascites in liver cirrhosis as well as
in preclinical models for severe burn injuries.
About Icatibant and refractory ascites in liver cirrhosis (RAIL)
RAIL is an extremely painful and debilitating disease caused by the massive accumulation of
excess fluid in the intraperitoneal cavity, which often develops during liver decompensation in
chronic liver cirrhosis. Most patients in the decompensated stage die within three years. The most
prevalent causes of liver cirrhosis are alcohol abuse, viral hepatitis (B, C), and autoimmune
chronic active hepatitis
About Kos Pharmaceuticals, Inc.
Kos Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical company engaged in
developing, commercializing, manufacturing and marketing proprietary prescription products for the
treatment of chronic diseases with a particular focus on the cardiovascular, metabolic and
respiratory disease areas. The Company’s principal product development strategy is to reformulate
existing pharmaceutical products with large market potential to improve safety, efficacy, and
patient compliance. Kos’ strategy also includes making increased, measured investments in new
chemical entity research through in-house and sponsored research, scientific in-licensing and
general corporate development activities. The Company currently markets XxxxxxxX and
AdvicorÒ for the treatment of cholesterol disorders, AzmacortÒ for the treatment of
asthma, CardizemÒLA for the treatment of hypertension and angina, and TevetenÒ and
TevetenÒHCT for the treatment of hypertension. Kos has a strong and growing research and
development pipeline including proprietary drug delivery technologies in solid-dose, inhalation and
aerosol metered-dose device administration to help fuel sustained, organic sales growth into the
future.
About Jerini AG
Jerini AG is a pharmaceutical company based in Berlin, Germany focusing on the discovery and
development of peptide-derived peptidomimetic and small molecule therapeutics. Having recognized
the potential of peptides as natural starting molecules for drug discovery, the company has
developed state-of-the-art technologies to identify and transform peptides into drugs. The
company’s lead product, Icatibant, is a peptidomimetic and is currently in Phase III clinical
trials for the treatment of hereditary angioedema.
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Certain statements in this press release, including statements regarding Kos’ expectations of
the market potential for Icatibant products, the potential launch date of the Icatibant HAE product
in 2007, Xxxxxx’s ability to complete Phase III clinical studies for the HAE indication and to
report the results of such studies by mid-2006, Xxxxxx’s ability to obtain regulatory approval for
the HAE indication, patients’ success in self-administering the Icatibant product, if approved for
the HAE or other indications, the Icatibant product’s ability to fulfill an unmet medical need in
patients with HAE, the ability of Kos’ acquisition to provide entry into new specialty markets
that are synergistic and leverage Kos’ established field sales force strengths and capabilities
with appropriate customer segments, Kos’ commitment to exploring the potential of Icatibant in
other bradykinin related diseases such as RAIL and Asthma, the potential of the Icatibant product
for RAIL and Asthma indications to offer new alternatives to patients suffering from RAIL and
Asthma, the expansion of the therapeutic potential of Icatibant to even larger indications possibly
bringing considerable upside for Jerini in the future, the expectation for Jerini to file for
market approval of Icatibant’s HAE indication in the US and Europe in 2006, Xxxxxx’s plans for
additional clinical testing for idiopathic and drug induced angioedema with Icatibant in 2006,
Kos’ ability to receive regulatory approval for and to launch Icatibant products in RAIL and Asthma
indications, and, Kos’ ability to build its research and development pipeline through external
collaborations in scientific in-licensing and general corporate developments, are forward-looking
and are subject to risks and uncertainties. These risks and uncertainties include the market
acceptance of Icatibant based products, the growth in sales of Icatibant products once introduced
to the market, if at all, Kos’ ability to successfully commercialize Icatibant products, the
ability of Kos to establish and maintain a specialty sales force for Icatibant products, Xxxxxx’s
ability to obtain regulatory approval for the launch of Icatibant products for the HAE indication,
Kos’ ability to develop Icatibant products for RAIL and Asthma indications and, in the event such
products are developed, to obtain regulatory approval for such products, Kos’ ability to complete
successful clinical studies for the RAIL and Asthma indications, the ability of Jerini or its third
party suppliers to meet their production requirement and satisfy regulatory requirements and
conditions, the validity, scope and enforceability of the patents licensed by Kos from Jerini, the
protection afforded by patents related to Icatibant, Xxxxxx’s and Kos’ ability to complete their
respective development activities in a timely manner, Kos’ ability to grow sales of Icatibant
products in the future, and its ability to gain commercial entry into and maintain a competitive
advantage in the HAE market and other potential markets, the effect of conditions in the
pharmaceutical industry and the economy in general, as well as certain other risks. Actual results
may differ materially from our projections. A more detailed discussion of risks attendant to the
forward-looking statements included in this press release are set forth in the “Forward-Looking
Information: Certain Cautionary Statements” section of Kos’ Annual Report on Form 10-K for the year
ended December 31, 2004, filed with the Securities and Exchange Commission and in other documents
filed with the SEC.
Contacts:
|
Kos Pharmaceuticals, Inc | |||
| Xxxx X. Xxxxxxx | Xxxxxx Xxxxxx | |||
| Vice President, Investor Relations | Senior Manager, Investor Relations | |||
| & Corporate Affairs | & Corporate Communications | |||
| (000) 000-0000 | (000) 000-0000 | |||
Contact:
|
Jerini AG | |||
| Xxxxx Xxxxxxxxxx | ||||
| Director Investor Relations | ||||
| & Corporate Communications | ||||
| Jerini AG | ||||
| Invalidenstr. 130 | ||||
| 10115 Berlin | ||||
| T + 49-30-97893-285 | ||||
| xxxxxxxxxx@xxxxxx.xxx |
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