Telesta Therapeutics Inc. (BNHLF)
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FOR IMMEDIATE RELEASE:
Telesta Therapeutics Submits Biologics Licen
se Application (BLA) to the U.S. FDA
?
BLA for MCNA submitted electronically to the US FDA on June 29
th
, 2015
?
Manufacturing facility upgrades completed
and pre-launch production planning initiated
?
FDA waives US$2.3 million application fee for Telesta
Montreal, Quebec, June 30, 2015.
Telesta Therapeutics Inc.
(TSX:TST; PNK:BNHLF)
announced today
that it has submitted electronically, through its U.S. ag
ent, a Biologics License Application (BLA) to the
United States Food and Drug Administration (FDA) for MCNA
1
. MCNA is Telesta’s novel biologic
immunotherapeutic for the treatment of high-risk non
-muscle invasive bladder cancer patients who have
failed first-line BCG therapy.
Telesta also announced today that they have recei
ved from the FDA a waiver exempting Telesta from the
payment of the $US2.3 million BLA application fee.
The FDA has a 60-day filing review period to determ
ine whether Telesta’s BLA submission for MCNA is
complete and acceptable for filing, whether MCNA will
be designated for priority review or standard
review and whether an advisory committee meeting w
ill be scheduled. Their decisions on these items will
be communicated to Telesta in the FDA’s official
filing communication known as the “Day-74 letter”.
Telesta will communicate the FDA’s filing decisions upon receipt.
Telesta’s BLA submission has been made following
extensive and ongoing dialogue with the US FDA,
including a formal pre-BLA meeting in November, 2014
and a Type C facility meeting in February, 2015.
As part of this process, Telesta has incorporated
the FDA’s recommendations into the current submission
and the Company has also been work
ing with top tier regulatory consultants to ensure that their BLA
submission meets all current regulatory requirements.
Concurrently with this BLA submission, Telesta c
onfirmed the completion of a number of upgrades and
improvements to Telesta’s manufacturing facilit
y and operating procedures, undertaken following
recommendations received from the FDA at the Type C fa
cility meeting held in February. As previously
announced, these improvements were implemented by Telest
a to ensure that their manufacturing facility is
well positioned for the FDA pre-approval inspection that
will take place as part of the FDA’s formal review
process.
“The BLA submission for MCNA marks a major step to
wards our ultimate goal of providing bladder cancer
patients and the medical professionals in the urology co
mmunity, with a therapeutic alternative to radical
cystectomy,” said Dr. Michael Berendt, CEO & Chief Scien
tist of Telesta Therapeutics. “There is an urgent
and unmet medical need to develop new therapies
for bladder cancer patients who have not seen new
therapies approved for almost 20 years. I am incr
edibly proud of Telesta’s dedicated and talented
employees, many of whom have been working for more
than a decade to advance th
is important therapeutic
agent, for their hard wo
rk and professionalism that has permitted
us to achieve this key corporate
milestone.”
Current practice guidelines for the treatment of high
-risk non-muscle invasive bladder cancer patients who
are refractory to or have relapsed from first line BCG
therapy call for radical cystectomy (surgical removal
1
Mycobacterium phlei cell wall-nucleic acid complex
- -
2
of the bladder and adjacent organs). MCNA was de
veloped to provide a much-needed therapeutic
option for these patients. This BLA submission is the
first step towards the potential regulatory approval
and commercialization of MCNA, which could become
the first approved therapeutic alternative for these
high-risk bladder cancer patients since 1998. The appr
oval of MCNA in the U.S. could occur as early as
Q1/2016 should the FDA designate the MC
NA BLA submission for priority review.
About MCNA
Telesta’s MCNA is a biologic therapy derived from the
cell wall fractionation of a non-pathogenic bacteria.
Its activity is believed to be through a dual mechanism
of immune stimula
tion and direct anti-cancer effects.
MCNA was developed to be delivered as a sterile susp
ension for intravesical administration by urologists
and urology nurses, following the same dosing paradigm
as first-line BCG therapy, with the advantage that
it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety
data from MCNA’s pivotal Phase 3 trial were re
cently published in the Journal of Urology
2
. Telesta
continues to prosecute novel composition of matter,
methods of use and manufacturing patents in most
regions of the world and recently announced the granti
ng of the key composition of matter patent in the
United States providing intellectual prope
rty coverage of MCNA to 2031.
A recent commercial assessment, conducted
by Medical Marketing Economics (“MME”),
a global leader
in the development of value-based strategies and market research, employed rigorous
qualitative and
quantitative primary market research with payers
(managed care organizations/decision makers both from
the private and public sector) and over 100 urologists (c
ommunity urologists and key opinion leaders), to
define market size, pricing strategy and market
access context as well as reimbursement potential for
MCNA. This study confirmed a commercial U.S. market
opportunity of more than $400 million and clearly
established that the target product profile of MCNA re
presents an extremely interesting therapeutic option
for practicing urologists.
About Telesta Therapeutics Inc.
Telesta Therapeutics Inc. is a late
stage therapeutics company with n
ear term commercial potential focused
on the manufacturing, marketing and licensing/acquisiti
on of proprietary and innovative therapies for the
global health market. The Company’s primary goal is
to develop and commerciali
ze products that advance
human health and increase shareholder value. For more information, please visit
www.telestatherapeutics.com
Except for historical information, this
news release may contain “for
ward-looking statements” and
“forward-looking information”
within the meaning of applicable
securities laws that
reflect the Company’s cu
rrent expectation regarding future events. Forwar
d-
looking statements and information are necessarily based upon
a number of estimates and assump
tions that, while, considered
reasonable by management, are inherently
subject to significant bus
iness, economic and competitive uncertainties and
contingencies. Readers are
cautioned that any such forward-
looking statements and informa
tion are not guarantees and there can
be no assurance that such statements and information will prove
to be accurate, and actual results and future events could diff
er
materially from those anticipated in such statements and inform
ation. These forward-looking stat
ements and information involve
risk and uncertainties, which may cause, but are not limited
to, changing market conditions, the successful and timely completi
on
of clinical studies, the establishment of corporate alliances
, the impact of competitive pr
oducts and pricing, new product
development, uncertainties related to the re
gulatory approval process, and
other risks detailed from time to time in the Compan
y's
ongoing quarterly and annual reporting. The Company
expressly disclaims any intention or
obligation to update or revise any
forward-looking statements and information whether as a result
of new information, future events or otherwise. All written and
oral forward-looking statements and information attributable to
us or persons acting on our behalf are expressly qualified in t
heir
entirety by the foregoing cautionary statements.
For further information:
Donald Olds, Chief Operating Officer
Telesta Therapeutics Inc.
Telephone: (514) 394-7921
Donald.Olds@telestatherapeutics.com
2
Morales A, Herr H, Steinberg
G, et al. Efficacy and safety of MCNA in
patients with nonmuscle invasive bladder
cancer at high risk for recurrence and progression after fail
ed treatment with bacillus Calmette-Guérin. J Urol. 2015;
193: 1135-1143
