Interim Results

 

TIDMNPH 
 
RNS Number : 9887I 
Neuropharm Group PLC 
23 March 2010 
 

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| For immediate release              |                23 March 2010 | 
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                              Neuropharm Group plc 
                        ("Neuropharm" or the "Company") 
 
           Half-year results for the six months ended 31 December 2010 
 
Neuropharm Group plc (AIM: NPH), a speciality pharmaceutical company focused on 
neurodevelopmental disorders, today announces its half-year results for the six 
months ended 31 December 2010. 
 
Key points 
·      The Company does not currently have the financial resources or support to 
carry out a further Phase III study of NPL-2008, therefore, project expenditure 
is on hold 
·      The Board is exploring a return of cash to shareholders through a 
Members' Voluntary Liquidation of the AIM quoted company, Neuropharm Group plc 
·      Discussions in connection with the sale or merger of the Company or its 
assets are ongoing but early stage 
·      In anticipation of a sale of the Company or of Neuropharm Limited or its 
programmes, or a Members' Voluntary Liquidation, it has been decided to give 
notice to all employees including the three Executive Directors 
·      The Company has significantly reduced its cash burn during the half year 
·      Cash, cash equivalents and money market investments at 31 December 2009 
of GBP6.18 million (30 June 2009: GBP7.04 million) 
 
 
For further information please contact: 
 
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| Neuropharm                             | + 44 (0) 1372  | 
|                                        | 371 171        | 
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| Robert Mansfield, Chief Executive      |                | 
| Officer                                |                | 
| Graham Yeatman, Chief Financial        |                | 
| Officer                                |                | 
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|                                        |                | 
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| Piper Jaffray Ltd.                     | + 44 (0) 20    | 
|                                        | 3142 8700      | 
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| Neil Mackison, Rupert Winckler         |                | 
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|                                        |                | 
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| Buchanan Communications                | + 44 (0) 20    | 
|                                        | 7466 5000      | 
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| Mark Court                             |                | 
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Notes to Editors: 
 
About Neuropharm 
Neuropharm is a speciality pharmaceutical company focused on the development of 
products for the treatment and management of neurodevelopmental disorders. 
Please visit www.neuropharm.co.uk for further information. 
Piper Jaffray, which is authorised and regulated by the Financial Services 
Authority, is acting exclusively for Neuropharm and for no-one else in 
connection with the matters referred to in this announcement and will not be 
responsible to anyone other than Neuropharm for providing the protections 
afforded to customers of Piper Jaffray nor for giving advice in relation to the 
matters referred to in this announcement. 
 
Dealing Disclosure Requirements 
Under the provisions of Rule 8.3 of the City Code on Takeovers and Mergers (the 
"Code"), if any person is, or becomes, "interested" (directly or indirectly) in 
1% or more of any class of "relevant securities" of Neuropharm, all "dealings" 
in any " relevant securities" of Neuropharm (including by means of an option in 
respect of, or a derivative referenced to, any such "relevant securities") must 
be publicly disclosed by no later than 3.30 pm (London time) on the London 
business day following the date of the relevant transaction. This requirement 
will continue until the date on which the offer becomes, or is declared, 
unconditional as to acceptances, lapses or is otherwise withdrawn or on which 
the "offer period" otherwise ends. If two or more persons act together pursuant 
to an agreement or understanding, whether formal or informal, to acquire an 
"interest" in "relevant securities" of Neuropharm, they will be deemed to be a 
single person for the purpose of Rule 8.3. 
Under the provisions of Rule 8.1 of the Code, all "dealings" in "relevant 
securities" of Neuropharm by Neuropharm or by any of its "associates", must be 
disclosed by no later than 12.00 noon (London time) on the London business day 
following the date of the relevant transaction. 
A disclosure table, giving details of the companies in whose "relevant 
securities" "dealings" should be disclosed, and the number of such securities in 
issue, can be found on the Takeover Panel's website at 
www.thetakeoverpanel.org.uk. 
"Interests in securities" arise, in summary, when a person has long economic 
exposure, whether conditional or absolute, to changes in the price of 
securities. In particular, a person will be treated as having an "interest" by 
virtue of the ownership or control of securities, or by virtue of any option in 
respect of, or derivative referenced to, securities. 
Terms in quotation marks are defined in the Code, which can also be found on the 
Panel's website. If you are in any doubt as to whether or not you are required 
to disclose a "dealing" under Rule 8, you should consult the Panel. 
 
 
 
Joint statement from the Chairman and Chief Executive Officer 
 
The six months to 31 December 2009 were a period of intense activity during 
which efforts were focused on identifying the most appropriate way to fund and 
realise the value in the Company, taking into account the requirements of all 
stakeholders and prevailing economic conditions. During the period we have 
significantly reduced the cash burn and minimised expenditure in research and 
development with the result that we had cash and cash equivalents of GBP6.18 
million as at 31 December 2009. 
Before providing an update on progress with identifying the most appropriate way 
forward, it would be useful to provide a brief history of Neuropharm since the 
company joined AIM in March 2007 with six programmes in CNS disorders to treat 
conditions including autism, Fragile X syndrome and obsessive compulsive 
disorder (OCD). 
Since flotation we have demonstrated positive Phase IIa results in two 
programmes in Fragile X syndrome and the filing of a patent relating to 
child-onset OCD. The most advanced of our programmes, NPL-2008, is a novel 
formulation of fluoxetine for the treatment of repetitive behaviours in Autistic 
Disorder in children. Phase II work on fluoxetine in this indication had already 
been completed by Mount Sinai School of Medicine in the US. Fluoxetine is 
reported to be widely used off-label in autism. 
Neuropharm raised GBP18.2 million (net) at flotation to fund a Phase III study 
of NPL-2008 and to support the development of the other programmes in the 
Company's pipeline. We began the multi-centre Phase III SOFIA study as a key 
step in the clinical development of NPL-2008, with the ultimate objective of 
registering and commercialising the product as the world's first licensed 
therapy for the treatment of a core symptom of Autistic Disorder. SOFIA was 
conducted in conjunction with Autism Speaks at 19 US sites following FDA review 
of the study design. 
The results from this study, which were announced in February 2009, were both 
surprising and disappointing to all involved but provided valuable insights that 
have informed the design of a further Phase III trial. The SOFIA study showed 
that NPL-2008 reproduced a reduction in repetitive behaviours at a similar level 
to that seen in a previous study in children and adolescents with Autistic 
Disorder.  However, the study did not meet its primary endpoint of demonstrating 
a statistically significant difference between NPL-2008 and placebo. This was 
because patients receiving placebo also showed a reduction in repetitive 
behaviours. 
Such a placebo effect is not uncommon in clinical studies, particularly where 
psychiatric conditions are being studied.  However, a placebo effect had not 
been seen in our previous studies in Autistic Disorder and had therefore not 
been anticipated in SOFIA.  A detailed analysis conducted in consultation with 
leading clinicians, regulatory advisers and experts from the pharmaceutical 
industry was therefore conducted.  This work revealed recent data from large 
datasets in psychiatry research which point to factors increasing the potential 
for a placebo effect when moving from Phase II to Phase III studies.   This 
understanding and a detailed analysis of the SOFIA study data confirm that 
negative conclusions about the efficacy of NPL-2008 may not be justified and 
further study in children and adolescents with Autistic Disorder was warranted. 
 The data also shed light on other recent unexpected negative results in studies 
of Autistic Disorder and how these should be interpreted. 
These analyses have also assisted in the design of a second Phase III study, 
which would aim to address the issue of placebo responses and potentially allow 
completion of the Rolling New Drug Application that Neuropharm filed with the 
FDA in September 2008. 
Given the unexpected result from the SOFIA study, and since Neuropharm did not 
have sufficient funds to complete the on-going development of NPL-2008, it was a 
key requirement to consider all alternatives for the future development of 
NPL-2008 and for the future of the Company. Despite careful cost control and a 
strong balance sheet it was clear that the Company needed to raise further funds