Download Non-Confidential Summary for VOLT01

VOLT01
Reformulated Zoledronic Acid
Targeted to be the first DiseaseModifying Drug in Osteoarthritis
Levolta reformulates approved products to
enhance their customer value, such as efficacy,
safety and convenience.
VOLT01, a reformulated zoledronic acid, has
demonstrated superior efficacy and safety in
patients with knee osteoarthritis vs Novartis’
Reclast®
VOLT01 has advanced to phase III in Australia and
is targeting a global placebo-controlled phase III
trial in 1H 2016.
VOLT01 has broad patent protection in the U.S.
and in International markets.
Levolta is currently focused on the
development of its lead product, VOLT01,
which will be the first approved therapy
that treats osteoarthritis disease.
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VOLT01
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ACR Poster Presentation
Post-dose
Cohort
Change Change in Mean Visual
in Bone
Analogue Score
Syndrome
Marrow (pain measurement)
(Main Side effect) Density
Reclast®
9/16 (56%)
0
-10 mm
VOLT01
2/16 (13%)
0
-35 mm
EFFICACY: VOLT01 was statistically significantly superior to ZA
(measured by VAS) with p<0.05*.
SAFETY: VOLT01 was superior to ZA in safety (measured by PDS).
SUSTAINED EFFECT: Patients in these cohorts were followed for 6
months with a significant reduction in pain still being reported.
DISEASE MODIFICATION: The sustained effect suggests that disease is
being modified, as was also suggested by the ZAP** study.
• Statistical analysis was done by an independent contractor (Percept Pharma Services, NJ).
• A phase 2 randomized controlled trial of ZA in OA of knee in Australia (ZAP study, Zoledronic Acid for Knee Pain) showed
efficacy at six months of ZA in decreasing bone marrow lesions in OA by MRI.
Estimated Global Sales in 2010 = $20.6B
Knee OA
$2.7B
$0.5B
$1.5B
$4.5B
$14B
Rheumatoid arthritis
Osteoarthritis
Psoriatic arthritis
Ankylosing spondylitis
The market is expected to grow at a Compound
Annual Growth Rate (CAGR) of 7.2% between 2010
and 2018 to $38 billion.
VOLT01 (zoledronic acid)
There are no approved therapies that treat
osteoarthritis disease, only the associated
signs and symptoms. VOLT01 is the only
DMAOD currently in development.
Indirect competition may exist from pain and
anti-inflammatory mediations, as well as
surgeons with practice economic concerns.
2014-15
1
Phase III trial in Australia
(cost effective trial with Menzies Group
provides differentiation vs Reclast. Results will drive global reimbursement).
2
Enter Phase III trial in Russia (will serve as a supportive trial for
2016
FDA / EMA approval. Independent regulatory body and cost efficiencies make
Russia an attractive space). Leverage interim analysis data from AU
into FDA / EMA meeting
Begin Global Phase III trial of VOLT01
3
2016
4
File New Drug Application (NDA) with
2016
Therapeutic Goods Administration in Australia
5
File NDA with FDA, EMA & Ministry of Health (RUS)
2017
6
Approvals in AU, NZ & some Asia Pacific countries
2017
7 Approvals in USA & Russia
2018
8 Approvals in Europe & rest of world
7
• First line in treatment of osteoarthritis
• Pharmacoeconomic benefit
• Enhanced Patient Compliance
• Superior safety profile
United States Patent # 8,859,530 issued on 10/14/14
Claims methods for treating OA by intravenously administering a
combination of Zoledronic acid and steroids in a single
infusion. Covers a method for providing long-term relief to OA.
United States Patent # 9,012,432 issued on 04/21/15
Much broader claims ….
Treatment of osteoarthritis with ZA and any steroid (not just
prednisolone), but to any mode of administration (not just IV), and
not just a single infusion. The application also includes various
composition claims.
03/11/15 - Patent Cooperation Treaty Application No:
PCT/US14/22169
International Preliminary Examination Report (“IPRP”) concluded that
all of the pending claims have been indicated as being novel,
inventive, and having industrial applicability.
• Levolta is seeking a partner for
development, sales and registration.
• Levolta is interested in global, regional
and local partnering opportunities.
• VOLT01 is projected to be commercialized
in 3 years.
After reviewing this Presentation Deck please
feel free to contact Mr. Richard Becker with
any questions you may have.
Richard Becker, CEO
Levolta Pharmaceuticals
[email protected]
848.702.0682