WOODBRIDGE, ON, Jan. 22, 2015 /PRNewswire/ - Pivotal
Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the
"Company"), a specialty pharmaceutical company with a focus on
Omega-3 therapies for cardiovascular disease and overall health is
pleased to provide you with a summary of the Company's
accomplishments in 2014 and its outlook for 2015 from the CEO, Mr.
Eugene Bortoluzzi.
Dear Fellow Shareholders,
We would like to take this opportunity to share with you the
Company's achievements over the past year. In March 2014, the Company completed a series of
equity and debt financings with US-based institutional investors
led by Crossover Healthcare Fund, LLC which took approximately 20
months from start to finish to complete. Specifically, Pivotal
raised approximately $1.5 million in
2012, $3.1 million in 2013 and
$5.8 million in 2014. In addition to
keeping the business and operations going during the long raise
period, these funds have allowed the Company to initiate and
further expand the following activities:
1. Intellectual Property - Patents
On
May 7, 2014 the Company announced the
issuance of U.S. Patent 8,715,648 for its unique 6:1 EPA:DHA
formulation. The issuance of this patent represents an important
step in further protecting and advancing the commercial potential
of VASCAZEN®'s formulation. This patent covers
Pivotal's unique formulation in conjunction with anti-obesity
agents for the reduction of body weight in patients with
cardiovascular disease ("CVD") and diabetics.
On October 7, 2014 the Company
received notification of patent allowance for U.S. Patent
Application serial number 13/584,480 related to a combination
product of VASCAZEN® and statin therapy. The
Company received another notification of allowance for U.S. Patent
Application serial number 13/584,403 on October 8, 2014 related to a combination product
of VASCAZEN® and a cholesterol absorption
inhibitor.
These applications are part of Pivotal's expanding patent
portfolio that protects its unique formulation. The Company has a
total of eight (8) patent applications, of which one has been
issued and two allowed in the United
States. The Company is also pursuing patent applications
related to VASCAZEN®'s formulation in multiple
jurisdictions outside the United
States. The Company has patents pending on the formulation,
composition and combinations with existing cardiovascular drugs
around the world. The Company expects the issuance of the above two
allowed patents and the allowance of several more patents in
2015.
2. Publication of
VASCAZEN®-REVEAL TRIAL
The publication
of the VASCAZEN®-REVEAL Trial in 2014 has added
credence to the concept that an Omega-3 deficiency plays a vital
role in cardiovascular disease and that VASCAZEN®
is an effective medical food that can correct this deficiency.
According to the study, correcting an Omega-3 deficiency with
VASCAZEN® can increase blood flow, reduce
inflammation, promote normal triglyceride levels and have positive
effects on blood lipid profile.
The randomized, double blinded, placebo-controlled
VASCAZEN®-REVEAL Trial found that of the 655 CVD
patients screened, 89% were Omega-3 deficient. The results of the
trial were significant. The
VASCAZEN®-REVEAL Trial was the first to determine
levels of Omega-3 in plasma and in red blood cells using the
Omega-Score and Omega-Index diagnostics. Omega-Score measures whole
blood levels of EPA, DHA and DPA and Omega-Index measures EPA and
DHA in red blood cells. VASCAZEN® was
demonstrated to be highly effective in correcting an Omega-3
deficiency in CVD patients with normal and high triglycerides: in
eight weeks of treatment with four (4) capsules/day of
VASCAZEN® there was a 121% improvement in the
Omega-Score and 112% improvement in Omega-Index in CVD patients
with hypertriglyceridemia (200-500 mg/dL). According to the results
of the VASCAZEN®-REVEAL Trial, Omega-3 deficiency
was corrected within eight weeks of treatment, and treatment
resulted in a 48% reduction of triglycerides, a 30% reduction of
very-low-density lipoprotein cholesterol and a 9% increase of HDL
(good cholesterol), without adversely affecting LDL (bad
cholesterol), in CVD patients with normal and high triglyceride
levels. The VASCAZEN®-REVEAL Trial has been
published in the peer-reviewed journal, Molecular and Cellular
Biochemistry, with open public access at
http://link.springer.com/article/10.1007/s11010-014-2132-1/fulltext.html,
and was presented at various American Heart Association scientific
meetings in 2014.
3. US Product Sales
The last quarter of
2014 set a record high for the Company with a 47% increase in sales
versus the last quarter of 2013. This demonstrates that healthcare
practitioners and patients across the country are acknowledging the
Company's medical food strategy and messaging.
VASCAZEN® is selling in 37 states across the U.S.
even though sales efforts to date have predominately concentrated
on only three states, which further demostrates the growing
awareness, acceptance and adoption of VASCAZEN®
and the concept of Omega-3 deficiency. This is a very positive
experience for Pivotal and validates the decision to seek
additional financing to expand the in-house sale force and find a
co-marketing partner so that the Company can implement the next
phase of its commercialization strategy.
4. Point-of-Care (POC) Diagnostic
Capitalizing on its extensive experience in developing innovative
POC diagnostics tests, the Company established an in-house research
facility to develop a POC diagnostic test to assist healthcare
practitioners to easily identify patients that are Omega-3
deficient in their offices, clinics and pharmacies. The POC
diagnostic will simplify the current technology to determine
Omega-Score and Omega-Index tests which measure the amount of
Omega-3 fatty acids in blood. Current practice involves collecting
blood samples and sending them to a laboratory for analysis and
reporting, which can be a costly and time-consuming process. The
POC test will also act as a companion diagnostic to assist with
VASCAZEN® treatment monitoring and patient
compliance. During the year, the Company focused its efforts and
resources on the development of reagents for the rapid format (POC)
test. The Company is targeting a 510(k) submission to the FDA in
the latter part of 2015 or early part of 2016.
5. Expansion of Product Pipeline
In 2014
the Company continued to build on its product pipeline that is
backed by clinical research that supports the performance of its
products. In Canada the commercial
development strategy includes the over-the-counter (OTC)
professional and direct to retail supplement markets.
- OMAZEN®: In 2014, the indication of
OMAZEN® was expanded to include a
product specifically for heart health and another product for the
lowering of triglycerides. OMAZEN® is Pivotal's second product to market for the
maintenance of good health, contains greater than 90% pure,
pharmaceutical grade Omega-3 with the optimal 6:1 ratio of EPA to
DHA. OMAZEN®'s dosage is three softgel
capsules per day, delivering 2.7 grams of total Omega-3.
OMAZEN® is available for sale and
distribution in Canada only and is
positioned for the professional OTC market.
- BeneFishial™ was created as the
cornerstone of our new nutraceutical product line, which will
include prenatal, children and heart health orientated products. It
is specifically designed to be sold as a nutraceutical in the OTC
direct to retail or direct to consumer markets in both the U.S. and
in Canada. BeneFishial™ contains the highest content of Omega-3 fatty
acids of any other OTC product on the market. It is specifically
formulated to give the highest purity, highest anti-inflammatory
properties and the best therapeutic effect for a healthy body and
mind. It contains the optimal purity, ratio and dose of Omega-3 and
is a simple solution to a number of health risk factors.
Another key differentiating benefit of our products is that unlike
our OTC counterparts, Pivotal is one of the only companies whose
products are backed by clinical data and scientific support.
- Drug Candidate – PVT-100: Pivotal introduced
PVT-100 as its first drug candidate. PVT-100
indication is for the stabilization of vulnerable plaque in
patients undergoing carotid endarterectomy. Also during 2014 the
Company began the first steps in establishing a Phase IIa clinical
trial to be conducted in France.
On December 16, 2014, the French FDA
in Paris (ANSM: Agence Nationale
de la Sécurité du Médicament - French National Agency for Drug
Safety) officially cleared the clinical evaluation part of the
VASCAZEN® POMEGA Phase IIa trial protocol.
The VASCAZEN® POMEGA Phase IIa clinical
trial is a double-blinded placebo controlled study in over 100
patients scheduled to undergo vascular invasive surgery for carotid
endarterectomy at the University Hospital of Strasbourg, France. Patients shall be
randomized to receive either Pivotal's uniquely formulated drug
candidate PVT-100 or placebo for six consecutive weeks. The
composite primary endpoint of the trial consists of
histomorphological, biochemical and immunological status of the
vascular plaque. The Company looks forward to reporting in 2015 on
initiating this Phase IIa trial with its lead drug candidate
PVT-100 in patients with vulnerable plaque.
Looking Ahead
We look forward to building on the
momentum we gained in 2014 and to carrying out the objectives we
have planned for 2015, including finding the right partners to help
achieve some of the objectives we have laid out as well as to help
further capitalize the Company.
We would like to take this opportunity to thank all of our
shareholders, business partners and employees and to express our
gratitude for their continued support and loyalty. We have great
programs that were initiated in 2014 and new ones planned for 2015
and we look forward to sharing them with you as they come to
fruition and translate into increased shareholder value.
Sincerely,
"Eugene Bortoluzzi"
Chief Executive Officer
Pivotal Therapeutics Inc.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded (OTCQX:PVTTF;
CSE:PVO), specialty pharmaceutical company with a focus on
cardiovascular disease and overall health. Pivotal Therapeutics'
lead product VASCAZEN® is a prescription only
medical food formulated to meet the dietary Omega-3 deficient needs
of patients with cardiovascular disease through elevating
Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) to
levels associated with reduced risk of cardiovascular
complications. OMAZEN® is a pharmaceutical
grade Omega-3 providing over 90% pure Omega-3 in each capsule for
the maintenance of good health. OMAZEN® is a
patented product available for sale and distribution in
Canada. BeneFishial™ is the
first product in Pivotal's new nutraceutical product line, which
has been specifically designed to be sold in the OTC direct to
retail or direct to consumer markets.
Disclosure Notice
The information contained in this document is as January 22, 2015. This press release contains
forward-looking statements. Such forward-looking statements are
subject to a number of risks, assumptions and uncertainties that
could cause Pivotal's actual results to differ materially from
those projected in such forward-looking statements. These
statements can be identified by the use of words such as "will",
"anticipate", "estimate", "expect", "project", "forecast",
"intend", "plan", "believe", "project", "potential", and similar
expressions with any discussion of future operating or financial
performance or events. In particular, factors that could cause
actual results to differ materially from those in forward looking
statements include the following: Pivotal's inability to obtain
additional financing on acceptable terms; growth in costs and
expenses; inability to compete with others who provide comparable
products; risk that the Company's products will not gain widespread
market acceptance; risks relating to the Company's ability to
maintain its CSE listing. Forward-looking statements speak only as
of the date made and are not guarantees of future performance.
The Company undertakes no obligation to publicly update or
revise any forward-looking statements contained in this document as
a result of new information or future events or developments. The
CSE has not reviewed and does not accept responsibility for the
adequacy or accuracy of this information.
SOURCE Pivotal Therapeutics Inc.
