13th January 2012
Julia Kagan
Principal Adviser, Issuers (Melbourne) ASX Compliance
Level 4, North Tower Rialto
525 Collins Street
Melbourne VIC 3000
By email: julia.kagan@asx.com.au
Re: Response to Price Query for Clinuvel Pharmaceuticals Ltd (the "Company")
Dear Ms Kagan,
In reply to your letter dated 12th January 2012 regarding an increase in the price of the Company's securities, we respond as follows:
1. The Company is not aware of any information related to the business that has not been announced which, if known, could be an explanation for recent trading in the securities of the Company.
2. In light of 1.above, not applicable.
3. We note two recent Company announcements made to the ASX on 3rd November 2011 and December
20th 2011 announcing positive results from its Phase II USA clinical trial and its pivotal Phase III European clinical trial. Both studies related to the Company's lead indication (erythropoietic protoporphyria) for its first-in-class drug SCENESSE® (afamelanotide). In the 20th December 2011 announcement it was stated that the Company is finalising a Marketing Authorisation Application (MAA) for SCENESSE® for submission to the European Medicines Agency within the next few weeks. An approved MAA would allow the Company to market SCENESSE® across the European Union.
Subject to these announcements, the Company does not have an explanation for the change in price of its securities.
4. The Company is in compliance with the Listing Rules and, in particular, Listing Rule 3.1. If you require further explanation, please let me know.
Yours Sincerely,
Darren Keamy
Chief Financial Officer and Company Secretary
Clinuvel Pharmaceuticals Ltd
Melbourne Office | Level 14, 190 Queen Street Melbourne Victoria 3000 Australia | T +61 3 9660 4900 F +61 3 9660 4999 |
European Office | Neuhofstrasse 3D, 6340 Baar | T +41 41 767 4545 |
Switzerland | F +41 41 767 4546 | |
US Office | 30 Broad Street Suite 1407 & 1408, Floor 14 New York, NY 10004 | T +1 646 480 4810 F +1 646 480 4811 clinuvel.com |
ASX Compliance Pty Limited
ABN 26 087 780 489
Level 4
Rialto North Tower
525 Collins Street
Melbourne VIC 3000
GPO Box 1784
Melbourne VIC 3001
12 January 2012
Darren Keamy
Chief Financial Officer and Company Secretary
Clinuvel Pharmaceuticals Limited
Melbourne
By email only
Dear Mr Keamy
Telephone 61 3 9617 8648
Facsimile 61 3 9614 0303
www.asx.com.au
We have noted a change in the price of the Company's
securities from $1.58 at the close of trading on Friday 6
January 2012 to $1.92 at the time of writing.
In light of the price change, please respond to each of the
following questions.
1. Is the Company aware of any information concerning it that
has not been announced which, if known, could be an
explanation for recent trading in the securities of the
Company?
Please note that as recent trading in the Company's
securities could indicate that information has ceased to be
confidential, the Company is unable to rely on the exceptions
to listing rule 3.1 contained in listing rule 3.1A when
answering this question.
2. If the answer to question 1 is yes, can an announcement be
made immediately? If not, why not and when is it expected
that an announcement will be made?
Please note, if the answer to question 1 is yes and an
announcement cannot be made immediately, you need to contact
us to discuss this and you need to consider a trading halt
(see below).
3. Is there any other explanation that the Company may have
for the price change and increase in volume in the securities
of the Company?
4. Please confirm that the Company is in compliance with the
listing rules and, in particular, listing rule
3.1.
Your response should be sent to me by return e-mail. It
should not be sent to the Company Announcements
Office.
Unless the information is required immediately under listing
rule 3.1, a response is requested as soon as possible and, in
any event, not later than half an hour before the start of
trading (ie before 9.30 a.m. Melbourne time) on Friday, 13
January 2012.
Under listing rule 18.7A, a copy of this query and your
response will be released to the market, so your response
should be in a suitable form and separately address each of
the questions asked. If you have any queries or concerns,
please contact me immediately.
Listing rule 3.1 requires an entity to give ASX immediately
any information concerning it that a reasonable person would
expect to have a material effect on the price or value of the
entity's securities. The exceptions to this requirement are
set out in listing rule 3.1A.
In responding to this letter you should consult listing rule
3.1 and Guidance Note 8 - Continuous Disclosure:
listing rule 3.1.
If the information requested by this letter is information
required to be given to ASX under listing rule 3.1 your
obligation is to disclose the information immediately.
Your responsibility under listing rule 3.1 is not confined
to, or necessarily satisfied by, answering the questions set
out in this letter.
If you are unable to respond by the time requested, or if the
answer to question 1 is yes and an announcement cannot be
made immediately, you should consider a request for a trading
halt in the Company's securities. As set out in listing rule
17.1 and Guidance Note 16 - Trading Halts we may grant a
trading halt at your request. We may require the request to
be in writing. We are not required to act on your request.
You must tell us each of the following.
• The reasons for the trading halt.
• How long you want the trading halt to last.
• The event you expect to happen that will end the trading
halt.
• That you are not aware of any reason why the trading halt
should not be granted.
• Any other information necessary to inform the market about
the trading halt, or that we ask for.
The trading halt cannot extend past the commencement of
normal trading on the second day after the day on which it is
granted. If a trading halt is requested and granted and you
are still unable to reply to this letter before the
commencement of trading, suspension from quotation would
normally be imposed by us from the commencement of trading if
not previously requested by you. The same applies if you have
requested a trading halt because you are unable to release
information to the market, and are still unable to do so
before the commencement of trading.
If you have any queries regarding any of the above, please
let me know.
Yours sincerely
[Sent electronically without signature]
Principal Adviser, Listings (Melbourne)
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Response to Price Query |