Novartis gains exclusive worldwide rights to PTK 0796, in Phase III
study as potential first-in-class IV and oral broad-spectrum
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* PTK 0796 potentially the first broad-spectrum antibiotic given by
once-daily infusion or tablet to treat infections caused by
drug-resistant bacteria such as MRSA
* Oral form of PTK 0796 could offer a convenient way for patients
to continue outpatient antibiotic treatment after leaving
* New antibiotics needed in fight against bacterial resistance,
with an estimated 150,000 deaths a year from hospital-acquired
infections across US and EU
* Novartis to make upfront payment to Paratek Pharmaceuticals;
Paratek eligible for milestones and royalties on future sales
Basel, October 8, 2009 - Novartis has gained exclusive worldwide
rights to market PTK 0796, potentially the first once-daily
broad-spectrum antibiotic that can be given by intravenous (IV)
infusion or oral tablet to treat a wide variety of life-threatening
infections, including those caused by highly resistant bacteria such
as methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug
resistant Streptococcus pneumoniae (MDRSP).
Under the agreement with Paratek Pharmaceuticals, a privately held
company based in Boston, Massachusetts, the companies will share
responsibility for developing PTK 0796. A Phase III study is already
under way in complicated skin and skin structure infections (cSSSI),
and clinical trials are planned in a number of other potential
Because PTK 0796 may be given as a once-daily 30-minute IV infusion
or daily oral tablet, it could offer patients a convenient way to
continue antibiotic treatment after they have been discharged from
hospital. Its broad spectrum of activity means it could be used as a
single agent against a range of bacteria, unlike other antibiotics
which may have to be used in combination.
"As the first in a new class of antibiotics, PTK 0796 is being
developed to address the growing problem of bacterial resistance to
currently available antibiotics," said Joe Jimenez, CEO of the
Novartis Pharmaceuticals Division. "It will potentially benefit
patients by offering a flexible and highly effective approach to the
treatment of a number of critical infections, and should form an
important addition to our growing portfolio of antibiotic medicines."
The in-licensing of PTK 0796 represents a further expansion of the
Novartis infectious diseases portfolio following the acquisition of
Protez Pharmaceuticals in June 2008. The Protez transaction covered
the North American and European rights to PTZ601 (razupenem),
currently in Phase II development as the first injectable
broad-spectrum antibiotic in the carbapenem class to cover MRSA.
PTK 0796, a first-in-class aminomethylcycline, has shown
broad-spectrum activity against a wide range of bacteria, including
both Gram-positive and Gram-negative strains - a basic classification
derived from the staining process used to analyze the cell wall - as
well as atypical and anaerobic bacteria, which grow with little or no
In addition, PTK 0796 has shown activity against multi-drug resistant
bacteria such as MRSA, vancomycin-resistant enterococci (VRE) and
Gram-negatives producing ESBL (extended-spectrum beta-lactamase).
These bacteria have developed resistance during decades of antibiotic
use, so many of the standard therapies are no longer effective.
Studies have estimated there were nearly 100,000 deaths from
hospital-acquired infections in the US in 2002, and around 50,000
deaths a year in the EU.
Clinical studies involving a total of more than 500 patients have
shown that PTK 0796 has a favorable safety and tolerability profile.
A Phase II study in cSSSI found that clinical success rates among
evaluable patients (n=188) were 98% for PTK 0796 and 93% for
linezolid (Zyvox®*). In this study PTK 0796 was used as a single
agent, whereas Zyvox was used for Gram-positive infections only and
an additional antibiotic had to be given for Gram-negative cases. The
study met its primary safety and tolerability endpoints by showing no
relevant difference between PTK 0796 and linezolid in terms of
adverse events. In this study, approximately 50% of the infecting
bacteria were MRSA.
The Novartis portfolio of medicines for hospital-based infections
includes Cubicin® (daptomycin), marketed by Novartis in the EU and
other countries for treating complicated skin and soft tissue
infections (cSSTI), right-sided infective endocarditis (RIE) due to
Staphylococcus aureus (S. aureus), and S. aureus bacteremia (SAB)
when associated with RIE or cSSTI. Cubicin is the first of a new
class of antibiotics called cyclic lipopeptides.
Terms of the agreement
The agreement states that Novartis will make an upfront payment to
Paratek in return for the exclusive rights to commercialize PTK 0796
worldwide. Both companies will share responsibility and costs for
developing PTK 0796. Paratek will be eligible to receive future
milestone payments, and will also receive a royalty on net sales of
PTK 0796 around the world.
* Zyvox is a registered trademark of Pfizer Inc.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "potential," "potentially,"
"could," "eligible," "future," "can," "will," "planned," "may,"
"should," or similar expressions, or by express or implied
discussions regarding potential future regulatory filings or
marketing approvals for PTK 0796, or the timing of any such potential
filings or approvals, or regarding potential future revenues from PTK
0796, PTZ601 or Cubicin. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current views
of the Company regarding future events, and involve known and unknown
risks, uncertainties and other factors that may cause actual results
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that PTK 0796 will be submitted or approved for sale in any
market, or that any such approvals will occur at any particular time.
Nor can there be any guarantee that PTK 0796, PTZ601 or Cubicin will
achieve any particular levels of revenue in the future. In
particular, management's expectations regarding these drugs could be
affected by, among other things, unexpected clinical trial results,
including unexpected new clinical data and unexpected additional
analysis of existing clinical data; unexpected regulatory actions or
delays or government regulation generally; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; competition in general; government, industry and general
public pricing pressures; the impact that the foregoing factors could
have on the values attributed to the Group's assets and liabilities
as recorded in the Group's consolidated balance sheet, and other
risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. Should one or
more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected.
Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
Novartis provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in each of these areas. In
2008, the Group's continuing operations achieved net sales of USD
41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 99,000 full-time-equivalent associates and operate in
more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
 Klevens RM, et al. Estimating Health Care-Associated Infections
and Deaths in U.S. Hospitals, 2002. Public Health Reports Mar-Apr
2007 Vol. 122 p.160-166.
 Surveillance of Nosocomial Infections in Europe Analysis Results
- HELICS European Database, including 2005 data.
 Paratek Pharmaceuticals. Data on file.
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