Vical Expands Infectious Disease Portfolio With Novel Antifungal From Astellas
March 25 2015 - 4:15PM
- Development and potential commercial synergies with existing
CMV program
- Targeting Phase 1 initiation in first half of 2016
- 2015 cash burn guidance remains unchanged
Vical Incorporated (Nasdaq:VICL) today announced that it has
expanded its infectious disease portfolio with the addition of a
novel antifungal, ASP2397, in-licensed from Astellas Pharma Inc.
(TOKYO:4503) ("Astellas"). ASP2397 represents a potential new class
of antifungal compounds to address invasive Aspergillus infections,
which are major causes of morbidity and mortality in
immunocompromised patients, including transplant recipients.
ASP2397 is differentiated by a new mechanism of action and has a
low propensity for P450 drug-drug interactions. In preclinical
studies to date, it has demonstrated faster fungicidal activity
than marketed drugs and activity against azole-resistant fungal
pathogens. As part of the agreement, Astellas, which is also
Vical's partner for the ASP0113 CMV vaccine program in transplant
recipients, will become a shareholder in Vical.
"It is exciting to see a novel antifungal with preclinical data
showing potent and rapid fungicidal activity, and low potential for
drug-drug interactions. Such a drug could become a treatment of
choice for front-line therapy of invasive fungal infections," said
John R. Perfect, M.D., Chief of Division of Infectious Diseases at
Duke University Medical Center.
Under the terms and conditions of the license agreement,
Astellas granted Vical an exclusive worldwide license to develop
and commercialize ASP2397. Astellas will receive Vical common stock
equivalent to approximately 1% of outstanding shares and $250
thousand in cash. Astellas will also be eligible for up to $100
million in aggregate milestone payments, the vast majority of which
are commercial and sales milestones, and single-digit royalties on
net sales. The above agreement does not impact Vical's cash burn
guidance, which remains at between $12 million and $15 million for
2015.
"ASP2397 is an exciting opportunity that has arisen out of the
relationship we have built with Astellas," said Vijay B. Samant,
Vical's President and CEO. "While advancing our CMV and HSV-2
programs remains the top priority at Vical, this novel candidate
adds depth to our pipeline and strengthens Vical's position as an
infectious disease company."
"ASP2397 is a unique antifungal discovered at Astellas, and we
are pleased to partner it with Vical, who we believe has the right
capabilities to develop this compound and bring it to market," said
Naoki Okamura, Corporate Vice President and Global Head of Business
Development at Astellas.
ASP2397 is a novel natural product discovered by Astellas from
leaf litter fungus collected in a Malaysian national park. In vitro
and in vivo data were featured in two posters presented during the
ICAAC 2014 meeting last September. Most of the IND-enabling
preclinical studies have been completed by Astellas, and Vical is
targeting initiation of a Phase 1 trial in the first half of
2016.
Vical consulted an expert team of advisors during the evaluation
of ASP2397 and is forming a Clinical Advisory Board (CAB) to help
direct the development program. Initial members of the CAB
include:
- John R. Perfect, M.D., Chief of Division of Infectious
Diseases, Duke University Medical Center
- Dennis Schmatz, Ph.D., consultant, 30-year veteran of Merck and
team leader for Cancidas (caspofungin)
- Michael R. Hodges, M.D., consultant, 17-year veteran of Pfizer
and team leader for Vfend (voriconazole)
Vical intends to develop ASP2397 as a front-line therapy for
invasive aspergillosis and as part of combination regimen for
preemptive treatment of fungal infections, which may represent a
meaningful commercial opportunity within the $4 billion global
market for systemic antifungals. Current treatment options have
limited efficacy, as approximately 50-60% of allogeneic
hematopoietic stem cell transplant recipients with invasive
aspergillosis infections die within 12 weeks. Over the past 30
years, only one new class of antifungal drugs (echinocandins) has
been introduced.
Conference Call
Vical will conduct a conference call and webcast tomorrow, March
26, at 8:30 a.m. Eastern Time. Listeners may access the
accompanying slide presentation through the webcast at
www.vical.com. The call and webcast will be open on a listen-only
basis to any interested parties. To listen to the conference call,
dial in approximately ten minutes before the scheduled call to
(719) 325-2308 (preferred), or (888) 312-3048 (toll-free), and
reference confirmation code 2695093. A replay of the call will be
available for 48 hours beginning about two hours after the call. To
listen to the replay, dial (719) 457-0820 (preferred) or (888)
203-1112 (toll-free) and enter replay passcode 2695093. The webcast
portion of the call will be available live and archived through the
events page at www.vical.com. For further information, contact
Vical's Investor Relations department by phone at (858) 646-1127 or
by e-mail at ir@vical.com.
About Vical
Vical develops biopharmaceutical products for the prevention and
treatment of chronic or life-threatening infectious diseases, based
on its patented DNA delivery technologies and other therapeutic
approaches. Additional information on Vical is available at
www.vical.com.
Forward-Looking Statements
This press release contains forward-looking statements subject
to risks and uncertainties that could cause actual results to
differ materially from those projected. Forward-looking statements
include cash burn guidance, the potential benefits of ASP2397,
Vical's capabilities to develop ASP2397, Vical's development plans
and timelines for ASP2397, the potential market opportunity for
ASP2397, and potential payments under the license agreement with
Astellas. Risks and uncertainties include whether Vical or others
will continue development of ASP2397, whether planned clinical
development of ASP2397 will begin when expected, or at all, whether
the results of future preclinical or clinical studies will be
consistent with prior preclinical studies or will otherwise merit
further development; whether Vical will achieve levels of revenues
and control expenses to meet its financial projections; whether
Vical or its collaborative partners will seek or gain approval to
market any product candidates, including ASP2397; whether pending
legislation related to the development or drug candidates such as
ASP2397 will be enacted in its current form or at all, and the
ultimate impact of any such legislation; and additional risks set
forth in the company's filings with the Securities and Exchange
Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company
disclaims, however, any intent or obligation to update these
forward-looking statements.
CONTACT: Andrew Hopkins
(858) 646-1127
Website: www.vical.com
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