Apricus Biosciences, Inc.
APRI, a biopharmaceutical company advancing innovative medicines in
urology and rheumatology, today reviewed its 2014 corporate progress and its
clinical development and commercialization plans for 2015.
Apricus' 2014 Accomplishments
* Successful European launch of Vitaros^®, Apricus' novel topical treatment
for erectile dysfunction (ED);
* Completion of development of the Vitaros Room Temperature Device
(RTD) required to begin stability testing;
* Diversification and strengthening of Apricus' product pipeline, including
the recent acquisition of US rights to fispemifene for urological
conditions in men, and the initiation of Phase 2a testing of RayVa™ for
Raynaud's phenomenon;
* Enhancement of Apricus' Senior Management Team and Board; and
* Recast the Company's risk profile by modifying its development priorities
and prudently managed funding options to support its strategy.
"2014 has been a transformational year for Apricus. Importantly, we achieved
several key corporate goals that will support our growth strategy in 2015 and
beyond," said Richard Pascoe, Chief Executive Officer. "We expanded and
diversified our drug development pipeline with the in-licensing of
fispemifene, an investigational treatment for urological conditions in men,
that is in Phase 2 development. We initiated a Phase 2a clinical trial for
RayVa, our product candidate for the circulatory disorder Raynaud's
phenomenon. In addition, through our partners, Vitaros, our topical treatment
for erectile dysfunction, was commercially launched in Europe. The Vitaros
launch has been proceeding well, with double-digit growth in monthly
prescription activity and positive trends in repeat usage."
Mr. Pascoe added, "We also assembled a focused and highly experienced senior
management team that is well positioned to execute on our strategy and
operating plans. These new executives joined Apricus because they see the
potential to create substantial value by advancing our pipeline and building a
strategically diversified company. I am confident that this accomplished team
has the drive, incentive and passion to achieve business success and create
shareholder value."
"With this solid base of accomplishments, we enter 2015 with a strong
portfolio of commercial and development-stage assets. Anticipated 2015
milestones across our programs should reinforce and build investor interest
and confidence in Apricus' vision throughout next year," said Mr. Pascoe.
2014 Management Team Enhancements
Neil Morton joined Apricus in March as Vice President, Business Development
from Auxilium Pharmaceuticals, where he helped build a pipeline of men's
health products including the male erectile dysfunction treatment Stendra^™.
Since joining Apricus, Mr. Morton played an instrumental role in the Company's
in-licensing of fispemifene.
Earlier this month, Brian Dorsey was appointed Chief Development Officer
bringing to Apricus over 20 years of direct experience in manufacturing, drug
development and regulatory leadership, which includes securing FDA approval
for the sleep maintenance drug Silenor^®.
Last week, Dr. Barbara Troupin joined Apricus as Chief Medical Officer to lead
the Company's clinical development efforts. Dr. Troupin most recently held
leadership positions in Medical Affairs and Clinical Development at Vivus,
where she was the clinician lead for the Phase 3 program for weight loss drug
Qsymia^®, as well as lead contributor for all medical review of the successful
New Drug Application and the lead medical presenter at the FDA Advisory
Committee Meeting for this product.
Apricus also plans to appoint a new Vice President of Finance in January.
Given Apricus' size, focus on clinical development, and financial reporting
needs, Apricus will focus its financial management and reporting
responsibilities on this incoming position rather than filling the recently
vacated CFO role. The Company's Chief Executive Officer and Chief Medical
Officer will lead all investor-facing activities.
While these executive appointments required the departure of several senior
executives, Apricus has been successful in forging a smaller, more cost
effective and nimble team that possesses the expertise and relevant experience
required to execute its refocused mission.
Product and Pipeline Updates
Vitaros
During 2014 Apricus secured European approval, expanded its European
distribution partnerships, and the Company's partners initiated commercial
launch of Vitaros in four countries: the United Kingdom in June, Germany and
Sweden in August and Belgium in November. During 2015, Vitaros is expected to
launch in six additional European territories, including major markets such as
France, Italy and Spain. The market for ED treatments in Europe represents
approximately $1.3 billion in annual sales. Vitaros represents a compelling
alternative form of treatment for all ED patients but particularly those that
are not using or unable to utilize, for safety reasons, the pill formulations
that make up the bulk of ED treatments. Vitaros also provides a more
patient-friendly treatment option than injectable or catheter-administered ED
medications that generate approximately $100 million in annual sales in
Europe.
Apricus' marketing partners for Vitaros are Abbott Laboratories Limited,
Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati
Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle.
During the fourth quarter of 2014, Apricus completed the development of the
room temperature formulation of Vitaros, which is housed and delivered in a
small, custom developed, disposable dispenser or "room temperature device."
The initial production of Vitaros RTD to generate the required stability data
required for marketing approval has commenced. The Company continues to expect
its commercial partners to launch the Vitaros RTD in 2016.
Fispemifene
During the fourth quarter of 2014, Apricus in-licensed the U.S. rights to
fispemifene from Forendo Pharma. Fispemifene is an exciting new chemical
entity with solid Phase 2 data that builds upon the Company's male urological
focus. The first indication being pursued for fispemifene is for the treatment
of secondary hypogonadism in males. Apricus believes fispemifene targets at
least $1 billion of the total market for current therapies that currently
generate over $2 billion in annual sales. The Company plans to begin a Phase
2b clinical trial with fispemifene in this lead indication in the first half
of 2015, with top-line data expected to be reported by the end of 2015. Since
in-licensing fispemifene, Apricus has transferred the regulatory filings from
Forendo, developed the Phase 2b clinical trial protocol, held a scientific
advisory board meeting with leading experts in the field to refine our
development strategy, initiated the manufacturing process to obtain drug
product, and begun the clinical trial site selection process.
RayVa
Patient enrollment commenced in December 2014 for a 45-patient Phase 2a
clinical trial for RayVa, Apricus' internally developed product candidate for
Raynaud's phenomenon, a circulatory disorder affecting the hands and feet.
Patients are being actively screened and enrolled for this trial, which is
expected to be completed and results announced in the second quarter in 2015.
Apricus believes RayVa's market potential could approach $200 million in
annual sales, as it would be the only FDA approved treatment for this
debilitating condition.
Femprox
In consultation with its clinical and regulatory experts, Apricus decided
earlier this year to put on hold the development of its female sexual interest
/ arousal disorder product candidate Femprox, until such time as the
regulatory pathway becomes more certain and a more robust partnering
environment develops. This decision reflects both the anticipated costs of
development and the current development risks related to such an investment.
Goals and Priorities for 2015 and Beyond
1) Apricus will continue to leverage Vitaros as a cash-generating asset
through growing royalty and milestone payments as the Company's commercial
partners ramp up sales and expand the product's market reach via additional
European launches. Apricus will also continue to pursue out-license
opportunities for Vitaros in Asia Pacific and Latin America and will work to
support the launch of Vitaros by its distribution partner in Canada.
2) Apricus plans to complete Phase 2 clinical trials for RayVa and fispemifene
in 2015 and report RayVa Phase 2a study results by the end of the second
quarter of 2015 and fispemifene Phase 2b study results in the fourth quarter
of 2015. Positive results from these trials, if achieved, would further
demonstrate these drug candidates' therapeutic and commercial potential and
position Apricus to move these assets into Phase 3 clinical trials, when
appropriate.
3) Apricus will seek to fund operations and the continued development of these
projects via cost-effective, shareholder-friendly means. Funding sources
include ongoing cash flows from Vitaros' commercialization, pursuit of
additional out-licensing agreements for Vitaros, RayVa and Femprox, and
accessing equity or debt funding or strategic investments as market conditions
allow, in addition to the prudent management of expenses and existing cash.
Apricus will continue to be disciplined stewards of shareholder capital,
advancing projects only when the Company has determined that the cost of
capital and the potential upside are aligned with shareholders' interests.
Mr. Pascoe concluded, "This year, the Board of Directors and I have made
crucial decisions on our strategic priorities and capital allocation, with a
goal of maximizing the future potential of Apricus while prudently managing
risk. We recognize the challenges our shareholders have faced over the past
year; however, we are confident that progress in our growth plan during 2015
will create the momentum needed to build sustained shareholder value."
"I would like to thank our employees and partners for their hard work and
commitment to execution of key goals for 2014. Through their collective
efforts, I am confident we will succeed in 2015. Finally, I want to thank our
investors for their patience and their efforts to embrace the new strategies
and underlying rationale we have employed to focus Apricus on the most
compelling development opportunities from a return on investment and risk
management standpoint. Their support and persistence is genuinely
appreciated."
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