TIDMVER
RNS Number : 2975Z
Vernalis PLC
14 December 2017
14 December 2017
LSE: VER
AGM Statement
Tuzistra(R) XR prescriptions continue to grow steadily, despite
a reduction in narcotic prescribing
Vernalis plc ("Vernalis" or the "Company") provides an update
ahead of its Annual General Meeting ("AGM") being held today at
10.30 am at the offices of Covington & Burling, 265 Strand,
London WC2R 1BH.
Highlights
-- Tuzistra(R) XR prescriptions continue to grow steadily, up
85% on prior year (1 July to 1 Dec)
o With c.70% of 2017/18 cough cold season remaining, Tuzistra(R)
XR needs to see an acceleration in prescription growth to achieve
the annual guidance of 105,000-115,000 prescriptions
o Next update: end of Q1 2018 - in conjunction with interim
results release
-- CCP-06, our non-narcotic cough cold product candidate, continues to progress
-- CCP-07 and CCP-08 NDAs remain on track for approval during 2018/19 financial year
-- Research business continues to perform well
Ian Garland, CEO of Vernalis commented: "We are encouraged by
the steady growth in Tuzistra(R) XR prescriptions, despite the
general negativity, in the US, surrounding the use of
narcotic-based drugs. Whilst we need to see acceleration in
prescription growth to achieve our total prescription market
guidance of a threefold increase in prescription volume, we are
early in the cough cold season and the US commercial team is
executing a disciplined plan to accelerate growth over the coming
months."
Tuzistra(R) XR and the cough cold franchise
Tuzistra(R) XR scripts grow 85%
Tuzistra(R) XR prescriptions for the 22 weeks from 1 July 2017
to 1 December 2017, the latest weekly data available, are up
approximately 85% on the equivalent 22 week period of the prior
year. Although we have seen steady growth, this growth will need to
accelerate in the four months to March 2018, when typically almost
half of the annual cough cold prescriptions are written (2016/17
approximately 49% of annual total), if we are to achieve our target
growth of 200% over the prior year. We will provide a further
update at the end of Q1 2018 when we announce our interim results
for the six months to 31 December 2017.
Total cough cold market opportunity remains intact, however
narcotic segment continues to decline
The growth in Tuzistra(R) XR prescriptions seen in the first 22
weeks of 2017/18 is against a background of a continuing decline in
the narcotic portion of the prescription cough cold market.
Year-to-date, the combined prescribing of codeine and
hydrocodone-based cough cold products is down 13% compared to the
same period in the prior year, which itself was down 14% compared
to 2015/16. Over the past two years, the combined prescribing of
codeine and hydrocodone cough products has fallen by 25%. This
decline in prescribing reflects continued public focus on the level
of usage of opiate based products that are prescribed to treat
pain. Although the use of opiates in a short term acute setting to
treat cough cold is not the principal area of concern, we are still
seeing a significant impact on prescribing.
In addition to this decline in the level of narcotic
prescribing, restrictions on the size of narcotic prescriptions
have also been introduced by some US States, health insurance plans
and physicians. This has resulted in a decline in the average size
of a Tuzistra(R) XR prescription from approximately 160 mL in the
prior year to approximately 145-150 mL in the current year-to-date.
This decline in prescription size will have an impact on the net
sales value of each Tuzistra(R) XR prescription.
CCP-06, our non-narcotic cough cold product continues to
progress and will allow us to fully exploit potential of
franchise
The prescription cough cold market comprises both narcotic and
non-narcotic based products and the dynamics highlighted above only
impact the narcotic portion. This is important because of the mix
of cough cold products in our portfolio. We have one non-narcotic
product in development (CCP-06) and our two most advanced pipeline
products (CCP-07 and CCP-08), like Tuzistra(R) XR, are both
targeting the narcotic portion of the market but include additional
active ingredients that can extend their market reach.
CCP-07/08 NDAs still on track for approval during 2018/19
financial year
In April 2017 and August 2017, we announced that we had received
Complete Response Letters (CRLs) for CCP-07 and CCP-08 respectively
and would provide further information related to the issues raised
by the FDA and the implications on the timing of their
re-submissions and potential approvals. We are now able to provide
updated information regarding these CRLs.
In early 2017, FDA undertook an inspection at Tris and
identified certain non-product related issues needed to be
addressed. Given the issues identified, FDA determined that it was
unable to approve CCP-07 on its 20 April 2017 PDUFA date and
instead issued a CRL, indicating that these issues needed to be
addressed before re-submission of the NDA could occur. On 4 August
2017, although Tris had made good progress in addressing the
issues, FDA was unable to approve the CCP-08 NDA and issued a CRL
for that product. The CRL for CCP-08 indicated that the FDA wanted
evidence that the issues identified in its inspection at Tris did
not impact the CCP-08 NDA. This evidence includes manufacturing new
batches of CCP-08 and could require repeating the pivotal
bio-equivalence studies on which approval was sought.
Tris is working diligently to address the issues raised by FDA
and specifically as they relate to the NDAs for CCP-07 and CCP-08.
This includes the support of external expert consultants and
regular discussions with FDA. We continue to believe that both NDAs
are approvable and could potentially be resubmitted and
subsequently approved during our 2018/19 financial year.
Moxatag(R)
We continue to progress qualification of a new supplier of
Moxatag(R) and expect to be back in supply during 2018. We continue
to focus on increasing pharmacy stocking since its re-launch in
September and will provide a more detailed update when we announce
our interim results at the end of Q1 2018.
Research Business continues to perform well
The research business continues to perform to plan having
secured a EUR1m milestone from the third collaboration with Servier
(as recently announced) as well as two new collaborations,
including one recently announced with Daiichi Sankyo.
Cash position is in line with expectations
The Company's unaudited cash position (including cash and cash
equivalents and held to maturity assets), remains strong and at 11
December 2017, was GBP48.9 million. The cash position has been
negatively impacted by the weakening of the US dollar since 30 June
2017, with a significant proportion of our cash denominated in that
currency.
No additional material information or updates on trading will be
given at Vernalis' AGM today. The presentation to be given will be
available on the company website after the AGM.
-- ends --
The information contained within this announcement is deemed to
constitute inside information as stipulated under the Market Abuse
Regulations (EU) No. 596/2014. Upon the publication of this
announcement this inside information is now considered to be in the
public domain.
Enquiries
Vernalis plc: +44 (0) 118 938 0015
Ian Garland, Chief Executive Officer
David Mackney, Chief Financial Officer
Canaccord Genuity Limited (Nominated
Adviser and Joint Broker): +44 (0) 20 7523 8000
Henry Fitzgerald-O'Connor
Emma Gabriel
Shore Capital (Joint Broker): +44 (0) 20 7408 4090
Mark Percy
Toby Gibbs
FTI Consulting: +44 (0) 20 3727 1000
Ben Atwell
Simon Conway
Stephanie Cuthbert
Stern Investor Relations, Inc: + 1 212 362 1200
Stephanie Ascher
Jane Urheim
Notes to Editors
About Vernalis
Vernalis is a revenue generating, commercial stage
pharmaceutical company with significant expertise in drug
development. The Group has three approved products: Tuzistra(R) XR
targeting the US prescription cough-cold market; Moxatag(R) , a
once-daily formulation of the antibiotic, amoxicillin, indicated
for the treatment of tonsillitis and/or pharyngitis secondary to
Streptococcus pyogenes in adults and pediatric patients 12 years
and older; and frovatriptan for the acute treatment of migraine. It
has an exclusive licensing agreement to develop and commercialise
multiple novel products focused on the US prescription cough-cold
market as well as eight programmes in its NCE development pipeline.
Vernalis has also significant expertise in fragment and structure
based drug discovery which it leverages to enter into
collaborations with larger pharmaceutical companies. The Company's
technologies, capabilities and products have been endorsed over the
last five years by collaborations with leading pharmaceutical
companies, including Asahi Kasei Pharma, Biogen Idec, Endo, GSK,
Genentech, Lundbeck, Menarini, Novartis, Servier, and Tris.
For further information about Vernalis, please visit
www.vernalis.com.
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that
reflect the Company's current expectations regarding future events
including the clinical development and regulatory clearance of the
Company's products, the Company's ability to find partners for the
development and commercialisation of its NCE pipeline, the
Company's ability to successfully commercialise its cough-cold
products and Moxatag(R) through its own sales force, as well as the
Company's future capital raising activities. Forward-looking
statements involve risks and uncertainties. Actual events could
differ materially from those projected herein and depend on a
number of factors including the success of the Company's research
strategies, the applicability of the discoveries made therein, the
successful and timely completion of clinical studies, the
uncertainties related to the regulatory process, the ability of the
Company to identify and agree beneficial terms with suitable
partners for the commercialisation and/or development of its
products, as well as the achievement of expected synergies from
such transactions, the acceptance of Tuzistra(R) XR, Moxatag(R) ,
frovatriptan and other products by consumers and medical
professionals, the successful integration of completed mergers and
acquisitions and achievement of expected synergies from such
transactions, and the ability of the Company to identify and
consummate suitable strategic and business combination
transactions.
This information is provided by RNS
The company news service from the London Stock Exchange
END
AGMBXLLFDLFFFBL
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December 14, 2017 02:00 ET (07:00 GMT)
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