expiration or termination of the agreement, each party will have a
non-exclusive
license to use for internal research purposes all research results,
including joint intellectual property. If Rockefeller or joint intellectual property develops from these programs, we will have the
right-of-first
refusal to negotiate
to acquire a royalty-bearing license to utilize such intellectual property for commercial purposes.
Competition
The pharmaceutical and biotechnology industries are intensely competitive. While we believe that our technology and scientific knowledge
provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies and academic and research organizations in developing therapies
to treat diseases.
CF-301
is a
first-in-class
drug candidate and we believe it is the first lysin to enter human clinical trials in the U.S. We believe there is currently no clinical competitor to
CF-301
as it was designed with at least six attributes that no single antibiotic possesses, including: (1) a novel mechanism of action, (2) specificity for a target bacteria (only
Staph aureus
),
(3) rapid speed of action, (4) activity across all drug-sensitive and drug-resistant strains of the target bacteria (including MRSA, VRSA and DRSA), (5) the ability to eradicate biofilms, and (6) synergy with antibiotics.
Staph aureus
bacteremia is typically treated with oxacillin, or for MRSA strains, daptomycin or vancomycin. We do not see market
competition with these drugs, as our strategy is to combine
CF-301
with these drugs to aim for superiority over any one of those drugs alone. We are aware of several other clinical trials currently being
conducted or recently concluded in patients with
Staph aureus
bacteremia. Depending on the outcomes of those and future trials,
CF-301
may compete with products in development from Genentech, Inc.,
iNtRon Biotechnology, Inc., and XBiotech, Inc. We believe that
CF-301
will be synergistic with other known agents, such as televancin from Theravance, Inc. or ceftobiprole from Basilea Pharmaceutica Ltd., and
therefore not competitive with these agents.
We are not aware of any other lysins in clinical development under an IND in the United
States. iNtRon Biotechnology Inc., a biotechnology company located in South Korea, is currently conducting a human clinical trial for
SAL-200,
an endolysin-based drug candidate to evaluate it as a treatment
for
Staph aureus
bacteremia. We will continue to monitor the advancements of
SAL-200
as data become available.
CF-404
is intended for the treatment of potentially life-threatening seasonal and pandemic influenza
infections. We believe
CF-404
has competitive advantages in that it potentially addresses the short-comings of currently marketed products (Tamiflu, Relenza and Rapivab) and other products in development for
the following reasons: (1) it may not be prone to drug-resistance due to targeting conserved regions of the influenza virus, (2) it may provide for an increased
time-to-treat
window compared to Tamiflu, Relenza and Rapivab, which are indicated to be used within 48 hours of symptom onset, and (3) it may provide
complete coverage against all seasonal and most potential pandemic strains of human influenza without the need for annual reformulation, including influenza B.
CF-404
may directly or indirectly compete with other products already in development from F.
Hoffmann-La
Roche Ltd., Genentech, Inc., Johnson & Johnson, Inc., Theraclone Sciences, Inc., Toyama Chemical Co., Ltd., Romark Laboratories, L.C., Aviragen, Inc., Vectura Group plc, Far East
Bio-Tec
Co. Ltd, Visterra Inc., MedImmune LLC, Ansun Biopharma, Inc. and others with early stage product candidates.
Many of our competitors may have significantly greater financial resources and expertise in research and development, manufacturing,
preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved medicines than we do. We compete with companies that have products on the market or in development for the same indications as our product
candidates. Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller
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