Aura Renew Acq Regulatory News (ARA)

20 Sep 2006 07:03

Ardana PLC20 September 2006 Ardana plc20 September 2006 Not for release, publication or distribution, in whole or in part, in, into orfrom the United States, Canada, Australia and Japan Ardana plc ("Ardana") Proposed Placing and Open Offer of 9,585,380 New Ordinary Shares at 115 penceper Share raising £11.0 million Ardana announces today that it is proposing to raise approximately £9.9 million,net of expenses, by the issue of 9,585,380 New Ordinary Shares at a price of 115pence per New Ordinary Share. A Prospectus issued by the Company containing details of the Placing and OpenOffer and convening an EGM for 12 October 2006 is expected to be posted toQualifying Shareholders today. Highlights of the fundraising are as follows: • Placing and Open Offer of 9,585,380 New Ordinary Shares at a price of 115 pence per New Ordinary Share to raise £11.0 million (£9.9 million net of expenses); • Open Offer to Qualifying Shareholders on the basis of 5 New Ordinary Shares for every 29 Existing Ordinary Shares; • Placing and Open Offer has been fully underwritten by Piper Jaffray, other than the Committed Shares; • The Issue Price of 115 pence per New Ordinary Share represents a 9.1 per cent. discount to the closing middle market price on the Business Day prior to announcement of the Placing and Open Offer; • Certain of the Directors have irrevocably undertaken to subscribe for a total of 44,573 New Ordinary Shares (being the Committed Shares) under the terms of the Open Offer; and • 5,493,362 New Ordinary Shares (being the Firm Placed Shares) have been conditionally placed firm by Piper Jaffray with institutional investors which will broaden the Company's institutional investor base. Use of proceeds: • approximately £5.7 million will be used to invest in the clinical development of Ardana's Growth Hormone Secretagogue (GHS) in its first indication as a diagnostic and second indication AIDS lipodystrophy; and • approximately £4.2 million will be used to launch and promote Emselex(R) in the UK, a product developed by Novartis for the treatment of overactive bladder for which Ardana has been granted sole and exclusive rights to launch and promote in the UK for ten years. Dr. Maureen Lindsay, Chief Executive Officer of Ardana, commented: "We have always believed that the GHS programme represented significantpotential value for the Company, and we are pleased to have the support ofinvestors to accelerate this opportunity. We are delighted that Novartis haschosen Ardana to launch Emselex(R) in the UK market which we think is atremendous endorsement of our sales and marketing capabilities. Emselex(R) hasshown favourable efficacy, a low incidence of cardiovascular adverse events andin elderly healthy volunteers did not significantly impair memory function. Webelieve that Emselex(R) will offer health professionals an effective and welltolerated new treatment option for patients who experience overactive bladdersymptoms and is an important addition to Ardana's portfolio." Enquiries: Ardana plc +44 (0)131 226 8558 Dr Maureen Lindsay, Chief Executive Officer Graham Lee, Chief Financial Officer Piper Jaffray Ltd. +44 (0)20 7743 8700 Jamie Adams James Steel Financial Dynamics +44 (0)20 7831 3113 Julia Phillips A presentation for analysts will be held today at 10.45 a.m. for 11.00 a.m. atthe offices of Financial Dynamics, Holborn Gate, 26 Southampton Buildings,London WC2A 1PB. Please call Gemma Cross Brown for further details on +44 (0)207269 7125. Piper Jaffray Ltd., which is authorised and regulated in the United Kingdom bythe Financial Services Authority and is a member of the London Stock Exchange,is acting for the Company and no-one else in connection with the Placing andOpen Offer and will not be responsible to anyone other than the Company forproviding the protections afforded to its customers or for providing advice inrelation to the Placing and Open Offer or any other matter referred to herein. This press announcement has been issued by Ardana plc and is the soleresponsibility of Ardana plc. The Placing and Open Offer is not, subject to certain exceptions, being made,directly or indirectly, in or into the United States. Securities may not beoffered or sold in the United States without registration or an exemption fromregistration. Neither the existing Ordinary Shares, nor the New Ordinary Sharesnor the Open Offer Entitlements have been or will be registered under the USSecurities Act or under the securities laws of any state of the United States,or under the applicable securities laws of Australia, Canada or Japan. Subjectto certain exceptions, the Ordinary Shares made available under the Placing andOpen Offer and the Open Offer Entitlements may not be offered, sold, taken up,delivered or transferred in or into the United States, Australia, Canada orJapan, and, subject to certain exceptions, Application Forms are not beingposted to and no Open Offer Entitlements will be credited to a stock account ofany person with a registered address in the United States, Australia, Canada orJapan. This announcement should not be issued, mailed or otherwise distributedor sent into the United States. All persons (including, without limitation,stockbrokers, banks or other agents) must observe these restrictions. This announcement does not constitute or form part of any offer or invitation tosell or issue, or any solicitation of any offer to purchase or subscribe for,any securities. Any purchase of, or application for, the New Ordinary Sharesshould be made only on the basis of information contained in the Prospectus tobe sent to Qualifying Shareholders shortly. The delivery of this announcement shall not, under any circumstances, create anyimplication that there has been no change in the affairs of the Group since thedate of this announcement nor that the information in it is correct as of anysubsequent time. This announcement may contain forward-looking statements that reflect theGroup's current expectations regarding future events, including the clinicaldevelopment and regulatory clearance of the Group's products, the Group'sability to find partners for the development and commercialisation of itsproducts, the Group's liquidity and results of operations, as well as theGroup's future capital raising activities. Forward-looking statements involverisks and uncertainties. Actual events could differ materially from thoseprojected herein and depend on a number of factors, including the success of theGroup's research strategies, the applicability of the discoveries made therein,the successful and timely completion of clinical studies, the uncertaintiesrelated to the regulatory process, the ability of the Group to identify andagree beneficial terms with suitable partners for the commercialisation and/ordevelopment of its products, the acceptance of the Group's products by consumersand medical professionals, and the ability of the Group to identify andconsummate suitable strategic and business combination transactions. Not for release, publication or distribution, in whole or in part, in, into orfrom the United States, Canada, Australia and Japan Ardana plc Proposed Placing and Open Offer of 9,585,380 New Ordinary Shares at 115 penceper Share Introduction Ardana announces today that it proposes to raise approximately £9.9 million, netof expenses, by way of a Placing and Open Offer of 9,585,380 New Ordinary Sharesat 115 pence per Ordinary Share. The Placing and Open Offer, which isconditional, inter alia, upon the passing by Shareholders of the Resolutions atthe EGM has been fully underwritten by Piper Jaffray (save for the CommittedShares). The New Ordinary Shares (other than the Committed Shares) have beenconditionally placed by Piper Jaffray with institutional investors subject toclaw back to satisfy valid applications from Qualifying Shareholders under theOpen Offer (other than in respect of the Firm Placed Shares). Monies raised by the Placing and Open Offer will be used to develop EP01572(GHS), the Company's oral growth hormone secretagogue and to launch and promoteEmselex(R), a treatment for overactive bladder, in the UK, for which agreementhas been reached with Novartis Pharmaceuticals UK Limited to grant Ardana soleand exclusive rights to launch and promote the product in the UK for a ten yearterm. GHS has for sometime been considered an asset which the Company believes hassignificant near and long term potential. Following a positive pre-IND meetingwith the FDA, the Directors believe that GHS can be developed in a nicheindication as a diagnostic for the diagnosis of growth hormone deficiency. Inaddition, Phase I results have shown that GHS can stimulate growth hormonerelease selectively without affecting other hormone levels. It was also shownto be well tolerated in Phase I clinical trials. Ardana believes that GHS hasthe potential to be the first oral therapy in the growth hormone market andcould capture a significant share of this market currently estimated to be worthUS$3.1 billion, if approved by the relevant authorities. Current therapiesinvolve hormone replacement, principally for children, using daily subcutaneousinjections. Therefore, the Company will invest in a registration trial for GHSas a diagnostic in the indication of growth hormone deficiency which the Companyhas identified as a niche indication with near term potential. Subject to theoutcome of the trial and regulatory approval, the launch of the diagnosticindication could be as early as H1 2008 in the US and H2 2008 in the EU. It isexpected that an early market entry of GHS as a diagnostic would provide Ardanawith a strong platform from which to develop GHS as a therapeutic agent and togenerate near term revenues. The Company also intends to undertake furtherclinical trials for the first potential therapeutic indication (AIDSlipodystrophy). This would allow Ardana to compete in this US$3.1 billiontherapeutic market once approved. Agreement has been reached with Novartis Pharmaceuticals UK Limited for Ardanato be granted the sole and exclusive rights to launch and promote Emselex(R)(Darifenacin) for overactive bladder (OAB) in the UK for a 10 year term.Emselex(R), which has been launched in collaboration with Bayer Vital GmbH inGermany and Procter and Gamble Pharmaceuticals, Inc. in the US (where theproduct is known as Enablex(R)), is a product which fits extremely well withArdana's therapeutic focus of human reproductive health. The product will betargeted to urologists, the same customer group as for InvicorpTM, which isexpected to be launched by the end of 2006. An additional marketed product inthe UK will leverage the current sales force who are currently promoting StriantTM SR to endocrinologists and urologists. This transaction presents anopportunity for the Group to grow its sales and marketing infrastructure in timefor the UK launch of Testosterone Cream and GHS as a diagnostic, both of whichcould enter the market in 2008. Information and background on Ardana Ardana is an emerging pharmaceutical company focused on the discovery,development and marketing of innovative products to improve human reproductivehealth, in order to address areas of considerable unmet need in this US$25.5billion market. Ardana's strategy is to manage risk by continuing to maintain a broad andbalanced pipeline of products and product candidates through relationships withleading research institutions and the acquisition of products and intellectualproperty rights. The Group has already established a targeted sales force inthe UK and intends to establish its own specialist sales and marketinginfrastructure in the Group's five largest European markets to support thefuture launch of additional products as and when commercially appropriate. Itis intended that such infrastructure will be in place in time to support thelaunch of Teverelix LA in Europe. In the interim, commercialisation of theGroup's products will be by a combination of own infrastructure and strategicpartnerships. Currently, Ardana's key customers are endocrinologists andurologists and, as the portfolio expands, the customer profile will includeother reproductive health specialists such as obstetricians and gynaecologists. Ardana has already established a broad, balanced portfolio of productsaddressing a range of diseases and medical conditions within the humanreproductive health market. This portfolio includes one marketed product(StriantTM SR) that was launched in the UK in June 2004 through Ardana's ownsales force and has since been launched in Germany, the Nordic Region and theRepublic of Ireland through partners. Another product (InvicorpTM has receivedmarketing approval in one European territory (Denmark) and is being submittedfor approval in the other European territories. Three other product candidateswith clinical proof-of-concept (in four different indications) are beingdeveloped, two of which are expected to enter the market by H1 2008. Theseproducts are supplemented by a number of other products and technologies invarious stages of development. It is Ardana's intention to continue to advanceand add to the Group's pipeline of products under development. Ardana's leadproducts, each of which has been in-licensed or acquired are summarised below: StriantTM SR - A unique and innovative controlled-release buccal tabletcontaining 30mg of unmodified testosterone indicated for testosteronereplacement therapy in men with confirmed male hypogonadism, the most commonhormone deficiency in men. The StriantTM SR tablet is applied twice a day tothe gum above the incisor tooth, providing a novel method of delivery comparedwith existing testosterone replacement products. In April 2004, marketingauthorisation was granted for this product in the UK, where Ardana commencedcommercial sales in June 2004. StriantTM SR has received a positive opinionunder the Mutual Recognition Procedure for several other European countries.Through its local partners, Ardana commenced rolling-out the sale anddistribution of StriantTM SR across European-licensed territories in 2005,starting with Germany and Ireland, and continued with the appointment of apartner and launch in the Nordic Region in 2006. InvicorpTM - An injectable treatment for erectile dysfunction. Marketingauthorisation for InvicorpTM has already been granted in Denmark. Ardanaintends to initiate mutual recognition proceedings and to commence sales inEurope by the end of 2006. Emselex(R) - Ardana has recently reached agreement with Novartis PharmaceuticalsUK Limited to be granted the sole and exclusive rights to launch and promoteEmselex(R) for OAB in the UK for a ten year term. Emselex(R) was grantedapproval for the treatment of OAB in all 25 EU member states as well as Norwayand Iceland in October 2004. Part of the net proceeds of the Placing and OpenOffer will be used to launch and promote Emselex(R) in the UK. Oral GHS - GHS is a growth hormone secretagogue and is a novel syntheticcompound that is orally active and stimulates the secretion of growth hormonefrom the patient's pituitary gland for the treatment of growth hormonedisorders. Phase I trial results show that GHS stimulates growth hormonerelease in a selective manner without affecting the stimulation of otherhormones. GHS may be able to be formulated in such a way that it can mimic thehuman body's daily growth hormone pulsatility. Part of the net proceeds of thePlacing and Open Offer will go towards progressing clinical development of GHSin the first therapeutic indication. At the same time Ardana intends tocomplete a US registration trial for the use of GHS as a diagnostic fordetection of growth hormone deficiency in adults following agreement of itsplans at a pre-IND meeting with the FDA. Subject to a positive trial outcomeand successful registration, Ardana believes that the diagnostic product couldbe on the US market as early as H1 2008 and in the EU in H2 2008. Testosterone Cream - A transdermal testosterone delivery system based on theCompany's Bi-gel technology, which is in development for the treatment of malehypogonadism. The testosterone cream consists of both oil-based and water-basedsubstances together with the active ingredient, testosterone, to form a smoothcream. The Directors believe that this product potentially offers importantadvantages over existing gel-based testosterone products. Clinicalproof-of-concept has been established in a Phase II study. In December 2005Ardana reached agreement with the FDA on the path forward for development oftestosterone cream. Phase III trials are planned to commence in H2 2006 and thefirst commercial sales are expected to be in the US by H1 2008. Ardana also hasthe opportunity to develop additional compounds to market using the Bi-geltechnology. Teverelix LA - A long-acting formulation of a GnRH (gonadotrophin releasinghormone) antagonist that binds with receptors in the pituitary gland, toprovide dose-dependent control of the release of the sex hormones testosteroneand oestradiol. This mode of action means that Teverelix LA can be used as an ''on/off'' or ''dimmer'' switch for hormone release. Ardana is developingTeverelix LA to treat three initial indications: prostate cancer, benignprostatic hyperplasia (BPH) and endometriosis. In Phase I trials, Teverelix LAwas well tolerated and demonstrated a dose dependent reduction of testosteronein men and oestradiol in women. In two initial Phase II studies in patientswith advanced prostate cancer, the product was well tolerated and testosteronewas reduced in all treated patients to levels equivalent to those achieved bycastration. In a Phase II study in patients with BPH Teverelix demonstrated astatistically significant improvement in symptoms of BPH as measured by theInternational Prostate Symptom Score. Additional Phase II trials in prostatecancer and BPH are currently underway. In 2005 Ardana reached agreement withthe FDA on the path forward for development of Teverelix in prostate cancer andBPH. Progress since the IPO Since the Company successfully completed its listing on the main market of theLondon Stock Exchange in March 2005 the Company has made significant progress inall areas of its business and has utilised the net proceeds from the IPO toachieve many of the objectives that the Directors set out at that time. In terms of key research and development objectives at the time of the IPO theCompany has announced successful results of a second Phase II study of TeverelixLA in patients with advanced prostate cancer, a Phase II study of Teverelix LAin BPH and Phase I data for the proposed indication of endometriosis. TheCompany has also had pre-IND meetings with the FDA to discuss development forthe indications of both prostate cancer and BPH which has resulted in asignificant advance in the expected launch date of Teverelix LA for BPH. Inaddition, the Company has also announced positive results in two Phase IIstudies of its testosterone cream for the treatment of male hypogonadism, apre-IND meeting has also been held with the FDA and agreement has been reachedon the regulatory requirements to obtain a marketing authorisation in the US.Furthermore, positive results were announced from a Phase I study of its oralgrowth hormone secretagogue and, following this, a pre-IND meeting has been heldwith the FDA to discuss the development of this compound as a growth hormonestimulation test for the diagnosis of growth hormone deficiency. Agreement onthe requirements in terms of supporting preclinical and clinical data wasreached such that, subject to a positive study outcome and successfulregistration, the diagnostic product could reach the market as early as H1 2008in the US and in H2 2008 in the EU. At the time of the IPO the Directors also indicated that 25 per cent. of the netproceeds would go towards the commercialisation of the Group's lead products,particularly StriantTM SR and InvicorpTM. To this end, since the IPO Ardana haslaunched StriantTM in Germany, the Republic of Ireland and the Nordic Regionthrough its partners Cytochemia AG, Mode Medical and Pharmacuro ApSrespectively. In addition, sales of InvicorpTM are expected to commence by theend of 2006. Since the IPO, the Company has also made a number of senior appointmentsincluding Carol Ferguson as a Non-executive Director and chair of the Audit Committee, Dr HuwJones as a Non-executive Director, Klaus Falk as VP of Sales and Marketing andJohn Hawkins, as director of Human Resources. Ardana is in discussions with potential partners to collaborate on the futuredevelopment and commercialisation of Teverelix LA. Currently there are a numberof opportunities in terms of indications and territories which the Directorsbelieve will allow Ardana to maximise value. This range of opportunitiescombined with the recent emergence of new potential partners has meant that theCompany wishes to take more time to explore all the options. The Directorsexpect to have agreements in place before the start of the first Phase IIItrials. Current Trading and Prospects Since the year ended 31 March 2006, the Company has continued to incur losses inline with the Directors' expectations and has continued to make good progressacross each of its development programmes. As at 31 July 2006, Ardana had £15.5million in cash and cash equivalents (unaudited). The Directors are confidentof the financial and trading prospects of the Group for the current financialyear. The Directors expect that losses and cash outflows will continue for anumber of years. Use of proceeds of the Placing and Open Offer The Directors intend to use the net proceeds of the Placing and Open Offer,amounting to approximately £9.9 million, for the following purposes: • approximately £5.7 million will be used to invest in the clinical development of GHS in its first indication as a diagnostic and second indication in AIDS lipodystrophy; and • approximately £4.2 million will be used to launch and promote Emselex(R) in the UK. The Directors also believe that the additional financial strength resulting fromthe Placing and Open Offer will enhance the Company's ability to negotiate morefavourable terms in any future partnering agreements or other future corporatetransactions. Principal Terms of the Placing and Open Offer Qualifying Shareholders are being given the opportunity to subscribe for the NewOrdinary Shares pro rata to their existing shareholdings at a price of 115 penceper New Ordinary Share on the basis of: 5 New Ordinary Shares for every 29 Existing Ordinary Shares held by Qualifying Shareholders at the Record Date and so on in proportion forany other number of Ordinary Shares then held. Certain Qualifying Shareholders, being 3i Group plc, ABN AMRO ParticipatiesB.V., Baronsmead VCT 2 Plc, Baronsmead VCT 3 plc, Merlin General Partner II Ltd.as General Partner of the Merlin Biosciences Fund LP, Merlin General Partner IILtd. as Managing Partner of the Merlin Biosciences Fund Gbr, MVM Life SciencePartners LLP ("MVM"), MVM for and on behalf of UK Medical Ventures Fund No.1 LP,MVM for and on behalf of MVM International Life Sciences Fund No.1 LP andcertain executives of MVM, TVM V Life Science Ventures GmbH & Co. KG andWaverley Healthcare Private Equity Limited have entered into irrevocableundertakings to vote in favour of the Resolutions and not to take up any part oftheir respective Open Offer Entitlements which, in aggregate, amount to5,493,362 New Ordinary Shares (being 57.3 per cent. of the New Ordinary Shares). Accordingly, under the terms of the Placing Agreement, such number of NewOrdinary Shares (being the Firm Placed Shares) have been conditionally placedfirm by Piper Jaffray with institutional investors. Certain of the Directors (being Dr Maureen Lindsay, Graham Lee, Dr John Brownand Carol Ferguson) have irrevocably undertaken to take up their entire OpenOffer Entitlements (being the Committed Shares) in respect of their ownbeneficial shareholdings, which together amount to 258,538 Existing OrdinaryShares (being 0.47 per cent. of the Company's current issued ordinary sharecapital). Fractions of New Ordinary Shares will not be allotted and each QualifyingShareholder's entitlement under the Open Offer will be rounded down to thenearest whole number. The fractional entitlements will be aggregated andincluded in the Placing, with the proceeds being retained for the benefit of theCompany. Qualifying Shareholders may apply for any whole number of New Ordinary Shares upto their maximum entitlement which, in the case of Qualifying non-CRESTShareholders, is equal to the number of Open Offer Entitlements as shown ontheir Application Form or, in the case of Qualifying CREST Shareholders, isequal to the number of Open Offer Entitlements standing to the credit of theirstock account in CREST. Qualifying Shareholders with holdings of ExistingOrdinary Shares in both certificated and uncertificated form will be treated ashaving separate holdings for the purpose of calculating their entitlements underthe Open Offer. No application in excess of a Qualifying Shareholder's maximum entitlement willbe met, and any Qualifying Shareholder so applying will be deemed to haveapplied for his maximum entitlement only. The Placing and Open Offer has been fully underwritten by Piper Jaffray (otherthan the Committed Shares), subject to certain conditions set out in the PlacingAgreement. Application has been made for the Open Offer Entitlements to be admitted toCREST. It is expected that the Open Offer Entitlements will be admitted toCREST on 21 September 2006. The Open Offer Entitlements will also be enabledfor settlement in CREST on 21 September 2006. Applications through the means ofthe CREST system may only be made by the Qualifying Shareholder originallyentitled or by a person entitled by virtue of a bona fide market claim. Qualifying non-CREST Shareholders will receive an Application Form with theProspectus which sets out their maximum entitlement to New Ordinary Shares asshown by the number of Open Offer Entitlements allocated to them. Shareholders should note that the Open Offer is not a rights issue. QualifyingCREST Shareholders should note that, although the Open Offer Entitlements willbe admitted to CREST and be enabled for settlement, applications in respect ofentitlements under the Open Offer may only be made by the Qualifying Shareholderoriginally entitled or by a person entitled by virtue of a bona fide marketclaim raised by CRESTCo's claims processing unit. Qualifying non-CRESTShareholders should note that the Application Form is not a negotiable documentand cannot be traded. Qualifying Shareholders should be aware that in the OpenOffer, unlike in a rights issue, any New Ordinary Shares not applied for willnot be sold in the market or placed for the benefit of Qualifying Shareholderswho do not apply under the Open Offer, but will be placed under the Placing forthe benefit of the Company. Pursuant to, and subject to the terms and conditions, of the Placing Agreement,Piper Jaffray has agreed conditionally to place the New Ordinary Shares (otherthan the Committed Shares) with institutional investors. To the extent thatthey fail to do so, Piper Jaffray has agreed to subscribe for the New OrdinaryShares (other than the Committed Shares) at the Issue Price, subject to clawback to satisfy valid applications by Qualifying Shareholders under the OpenOffer. The Placing and Open Offer is conditional, inter alia, upon: (i) the passing of the Resolutions; (ii) Admission becoming effective by not later than 8.00 a.m. on13 October 2006 (or such later time and/or date as Piper Jaffray and the Companymay agree, not being later than 8.00 a.m. on 19 October 2006); and (iii)the Placing Agreement becoming unconditional in allrespects and not having been terminated in accordance with its terms. Accordingly, if any of such conditions are not satisfied, or, if applicable,waived, the Placing and Open Offer will not proceed and any Open OfferEntitlements admitted to CREST will thereafter be disabled. The New OrdinaryShares, when issued and fully paid, will rank in full for all dividends or otherdistributions declared, made or paid after the date of issue of the New OrdinaryShares and otherwise pari passu with the existing Ordinary Shares. No temporarydocuments of title will be issued. Application has been made for the NewOrdinary Shares to be admitted to the Official List and to trading on the LondonStock Exchange's main market for listed securities. It is expected thatAdmission will become effective on 13 October 2006 and that dealings for normalsettlement in the New Ordinary Shares will commence at 8.00 a.m. on the sameday. Documents Available for Inspection Copies of the Prospectus will be available to the public for inspection at theDocument Viewing Facility, 25 The North Colonnade, Canary Wharf, London E14 5HS. Expected Timetable of Principal Events 2006 Record Date for the Open Offer close of business on 18 September Posting of Prospectus, Application Forms and Forms of Proxy for use at 20 Septemberthe EGM Open Offer Entitlements credited to stock accounts in CREST of Qualifying 21 SeptemberCREST Shareholders Latest recommended time for requesting withdrawal of Open Offer 4.30 p.m. on 4 OctoberEntitlements from CREST Latest time for depositing Open Offer Entitlements into CREST 3.00 p.m. on 6 October Latest time and date for splitting Application Forms (to satisfy bona 3.00 p.m. on 9 Octoberfide market claims) Latest time and date for receipt of completed Application Forms and 11.00 a.m. on 11 Octoberpayment in full under the Open Offer or settlement of relevant CRESTinstruction (as appropriate) EGM 12.00 p.m. on 12 October Dealings in the New Ordinary Shares commence 8.00 a.m. on 13 October Expected date for crediting of New Ordinary Shares to CREST stock 13 Octoberaccounts in uncertificated form Expected date of despatch of share certificates in respect of New by 20 OctoberOrdinary Shares in certificated form Placing and Open Offer Statistics Issue Price 115 pence Number of Ordinary Shares in issue as at the Record Date 55,595,209 Number of New Ordinary Shares to be issued pursuant to the Placing and Open Offer 9,585,380 Number of Ordinary Shares in issue immediately following Admission 65,180,589 Market capitalisation of Ardana following the Placing and Open Offer at the Issue Price £74.96 million Gross proceeds of the Placing and Open Offer receivable by the Company £11.0 million Estimated net proceeds of the Placing and Open Offer available to the Company £9.9 million Enquiries: Ardana plc +44 (0)131 226 8558 Dr Maureen Lindsay, Chief Executive Officer Graham Lee, Chief Financial Officer Piper Jaffray Ltd. +44 (0)20 7743 8700 Jamie Adams James Steel Financial Dynamics +44 (0)20 7831 3113 Julia Phillips Piper Jaffray Ltd., which is authorised and regulated in the United Kingdom bythe Financial Services Authority and is a member of the London Stock Exchange,is acting for the Company and no-one else in connection with the Placing andOpen Offer and will not be responsible to anyone other than the Company forproviding the protections afforded to its customers or for providing advice inrelation to the Placing and Open Offer or any other matter referred to herein. This press announcement has been issued by Ardana plc and is the soleresponsibility of Ardana plc. The Placing and Open Offer is not, subject to certain exceptions, being made,directly or indirectly, in or into the United States. Securities may not beoffered or sold in the United States without registration or an exemption fromregistration. Neither the existing Ordinary Shares, nor the New Ordinary Sharesnor the Open Offer Entitlements have been or will be registered under the USSecurities Act or under the securities laws of any state of the United States,or under the applicable securities laws of Australia, Canada or Japan. Subjectto certain exceptions, the Ordinary Shares made available under the Placing andOpen Offer and the Open Offer Entitlements may not be offered, sold, taken up,delivered or transferred in or into the United States, Australia, Canada orJapan, and, subject to certain exceptions, Application Forms are not beingposted to and no Open Offer Entitlements will be credited to a stock account ofany person with a registered address in the United States, Australia, Canada orJapan. Subject to certain exceptions, neither this announcement nor any otherdocument connected with the Placing and Open Offer may be issued, mailed orotherwise distributed or sent, through CREST or otherwise, in or into the UnitedStates. All persons (including, without limitation, stockbrokers, banks orother agents) must observe these restrictions. This announcement does not constitute or form part of any offer or invitation tosell or issue, or any solicitation of any offer to purchase or subscribe for,any securities other than the securities to which it relates or any offer orinvitation to sell or issue, or any solicitation of any offer to purchase orsubscribe for, such securities by any person in any circumstances in which suchoffer or solicitation is unlawful. Neither the delivery of this announcement nor any subscription or sale madeunder it shall, under any circumstances, create any implication that there hasbeen no change in the affairs of the Group since the date of this announcementor that the information in it is correct as of any subsequent time. This announcement may contain forward-looking statements that reflect theGroup's current expectations regarding future events, including the clinicaldevelopment and regulatory clearance of the Group's products, the Group'sability to find partners for the development and commercialisation of itsproducts, the Group's liquidity and results of operations, as well as theGroup's future capital raising activities. Forward-looking statements involverisks and uncertainties. Actual events could differ materially from thoseprojected herein and depend on a number of factors, including the success of theGroup's research strategies, the applicability of the discoveries made therein,the successful and timely completion of clinical studies, the uncertaintiesrelated to the regulatory process, the ability of the Group to identify andagree beneficial terms with suitable partners for the commercialisation and/ordevelopment of its products, the acceptance of the Group's products by consumersand medical professionals, and the ability of the Group to identify andconsummate suitable strategic and business combination transactions. Definitions The following definitions apply throughout this announcement, unless the contextrequires otherwise: Admission the admission of the New Ordinary Shares (i) to the Official List and (ii) to trading on the London Stock Exchange's main market for listed securities becoming effective in accordance with the Listing Rules and the Admission and Disclosure Standards Application Form the personalised application form which will accompany the Prospectus for Qualifying non-CREST Shareholders for use in connection with the Open Offer Board the board of Directors of the Company Business Day a day (excluding Saturdays and Sundays and public holidays in England and Wales) on which banks are generally open for the transaction of normal banking business in the City of London certificated or certificated form in relation to an Ordinary Share, not in uncertificated form Committed Shares the 44,573 New Ordinary Shares that certain Directors, have irrevocably committed to take up under the Open Offer Company or Ardana Ardana plc CREST the relevant system (as defined in the Regulations) for the paperless settlement of trades and the holding of uncertificated securities operated by CRESTCo in accordance with the Regulations CRESTCo CRESTCo Limited, the operator of CREST Directors the directors of the Company EGM the extraordinary general meeting of the Company convened on 12 October 2006 enabled for settlement in relation to Open Offer Entitlements, enabled for the limited purpose of settlement of claim transactions and unmatched stock event transactions (each as described in the CREST Manual issued by CRESTCo) Firm Placed Shares 5,493,362 New Ordinary Shares that certain Qualifying Shareholders have irrevocably undertaken not to apply for pursuant to the Open Offer Group the Company and its subsidiary undertakings at the date of this announcement Issue Price 115 pence per New Ordinary Share Japan Japan, its territories and possessions and any areas subject to its jurisdiction Listing Rules the rules and regulations made by the Financial Services Authority under Part VI of the Financial Services and Markets Act 2000 (as amended from time to time) New Ordinary Shares 9,585,380 new Ordinary Shares to be issued pursuant to the Placing and Open Offer Official List the Official List of the Financial Services Authority Open Offer the conditional invitation to Qualifying Shareholders to subscribe for New Ordinary Shares at the Issue Price on the terms and subject to the conditions set out or referred to in the Prospectus and, where relevant, in the Application Form Open Offer Entitlement an entitlement to apply to subscribe for New Ordinary Shares, allocated to a Qualifying Shareholder pursuant to the Open Offer Ordinary Shares ordinary shares of 1p each in the capital of the Company Overseas Shareholders Shareholders who are resident in, or who are citizens of, or who have registered addresses in, territories other than the United Kingdom and Shareholders who are US persons Piper Jaffray Piper Jaffray Ltd., sole sponsor, broker and financial adviser to the Company Placing the conditional placing by Piper Jaffray on behalf of the Company of the New Ordinary Shares pursuant to the Placing Agreement Placing Agreement the agreement dated today between the Company and Piper Jaffray relating to the Placing and Open Offer Prospectus the Prospectus to be posted to Shareholders in connection with the Placing and Open Offer and Admission Qualifying CREST Shareholders Qualifying Shareholders whose Ordinary Shares on the register of members of the Company on the Record Date are in uncertificated form Qualifying non-CREST Shareholders Qualifying Shareholders whose Ordinary Shares on the register of members of the Company on the Record Date are in certificated form Qualifying Shareholders holders of Ordinary Shares on the Company's register of members at the Record Date (other than certain Overseas Shareholders) Record Date close of business on 18 September 2006 Regulations the Uncertificated Securities Regulations 2001, as amended from time to time Resolutions the resolutions set out in the notice convening the extraordinary general meeting of the Company to be held on 12 October 2006 Shareholders holders of Ordinary Shares stock account an account within a member account in CREST to which a holding of a particular share or other security in CREST is credited uncertificated or uncertificated form recorded on the relevant register or other record of the share or other security concerned as being held in uncertificated form in CREST, and title to which, by virtue of the Regulations, may be transferred by means of CREST United Kingdom or UK the United Kingdom of Great Britain and Northern Ireland United States or US the United States of America, its territories and possessions, any state of the United States of America and the District of Columbia US Securities Act the United States Securities Act of 1933, as amended This information is 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