12th Sep 2006 07:03
Vernalis PLC12 September 2006 12 September 2006 Vernalis Plc: Interim Results for the six months ended 30 June 2006 - Vernalis Delivers on Significant Clinical Milestones and Establishes Commercial Operation - Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced its interim results forthe six months ended 30 June 2006. Highlights • U.S. commercial business fully operational detailing Apokyn(R) and Frova(R) • Strong financial position with closing cash of £50.9 million • Losses reduced at £19.4 million (2005: £20 million) • Frova(R) supplemental New Drug Application (sNDA) submitted to US FDA for the prevention of menstrual migraine (MM) • V1003 (partial opioid agonist) meets primary end point in Phase IIa study for the management of post-operative pain • Significant progress towards initiation of four further clinical trials in H2 2006 o V1512 (methylester of levadopa) Phase III study in Parkinson's disease o V2006 (A2A antagonist) Phase II study in Parkinson's disease o V24343 (CB1 antagonist) Phase I study in obesity o Hsp90 (Hsp90 inhibitor) Phase I study in cancer • Entered into an agreement with Pfizer to sub-lease approximately half of premises at Granta Park, Cambridge Simon Sturge, chief executive officer of Vernalis, commented:"Vernalis is continuing to show substantial progress toward becoming aself-funding, sustainable R&D driven commercial business. Establishing our U.S.operation with the successful launch of Apokyn(R) and completing the Frova(R)clinical trials for the short-term prevention of menstrual migraine weresignificant achievements. The second half of 2006 is expected to havesubstantial news flow as we progress our drug candidates through the clinic andboost our product revenues." U.S. Commercial Operation Fully Operational During the first six months of 2006 Vernalis' North American commercial businessbecame fully operational and is now marketing the Company's Parkinson's diseasedrug, Apokyn(R) (apomorphine hydrochloride injection), as well as co-promotingits migraine drug, Frova(R) (frovatriptan succinate) 2.5 mg tablets alongsideits partner, Endo Pharmaceuticals (Endo). Apokyn(R) Vernalis' U.S. commercial operation has established its credibility through asignificant increase in new prescriptions for Apokyn(R) following its re-launchin January 2006. However, gross sales for the first six months of 2006 of $2.3million are somewhat below initial expectations because of lower levels ofrepeat business due to an under-reporting of patients who had discontinued theirtreatment during the period prior to acquisition by Vernalis. The lower sales inH1 2006 mean that, while we still believe gross sales for the full year will bewithin the guidance initially provided of $6 million - $7.5 million, we wouldnow expect them to be at the lower end of this range. Net sales for the period,after provisions, were $1.8 million. The substantial growth in new business, along with the new marketing initiativesincluding the Nurse Support Programme (The APOKYN(R) Circle of CareTM) and theintroduction of product sampling, gives us considerable confidence in thepotential of Apokyn(R). Frova(R) In May 2006 Vernalis completed the final Phase III pivotal efficacy study in MMpatients who had failed on acute therapy, aimed at obtaining approval for Frova(R) for use as an intermittent, short-term preventative treatment for MM. Thisstudy achieved its primary end point and, together with the Phase III efficacyand safety studies previously conducted, resulted in the submission of the sNDAto the FDA. If the sNDA is successful, Vernalis expects FDA approval inmid-2007. Development Portfolio Update Pain Franchise • V1003 (partial opioid agonist) - Achieved the primary endpoint in a Phase IIa study in acute post-operative pain. Vernalis is now working with its partner, Reckitt Benckiser, to identify the most appropriate development programme for nasal delivery of buprenorphine. • V3381 (dual NMDA antagonist/MAO-A inhibitor) - In August 2006, Vernalis started a Phase IIa trial in patients with neuropathic pain resulting from long-standing diabetes. Neurology Franchise • V1512 (methylester of levadopa) - This potential treatment for Parkinson's disease has completed Phase II studies with a Phase III study expected to begin in H2 2006. • V10153 (thrombolytic) - Phase IIa trial in acute ischaemic stroke is on-going with the aim to determine whether V10153 can be clinically effective in patients up to 9 hours after the occurrence of a stroke. The trial is targeted to complete patient enrolment in H2 2006. • V2006 (A2A antagonist) - A series of Phase I trials has been completed. Vernalis' partner, Biogen Idec, is now responsible for moving forward into Phase II trials which are expected to start in H2 2006. Other Programmes • V24343 (CB1 antagonist) - This potent and selective cannabinoid receptor antagonist is a potential treatment for obesity and related disorders. Vernalis expects to start Phase I testing in overweight and mildly obese volunteers in H2 2006. • Hsp90 (Hsp90 inhibitor) - Vernalis' partner, Novartis, has selected a clinical development candidate in this oncology programme. Phase I testing is expected to start in H2 2006. • MMPI-12 (metalloenzyme inhibitor) - Vernalis' partner, Serono, has completed a Phase I study of this matrix metalloprotease inhibitor looking at its therapeutic potential in inflammatory disorders including multiple sclerosis. Financial Position Revenues increased to £6.6 million in the first six months of 2006 from £5.9million in the same period of 2005. In addition, Vernalis reduced its lossbefore taxes to £19.4 million during the first half of 2006 as compared to £20.0million in the same period of 2005. Following a successful fund raisingcompleted at the end of 2005, Vernalis' cash resources at the end of June 2006totalled £50.9 million. ----ends---- Simon Sturge and Tony Weir, CEO and CFO of Vernalis respectively, will todayhost an analyst / investor presentation and conference call at 9:00 am BST todiscuss the interim results. This may be accessed by dialling: +44(0)1452 541076, and quoting 'Vernalisconference call. A replay facility will be available for 7 days by dialling: +44(0)1452 550000,with the access code: 5493221# Enquiries: Vernalis plc Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial OfficerJulia Wilson, Head of Corporate Communications +44 (0)118 977 3133 Brunswick Group Jon ColesJustine McIlroy +44 (0)20 7404 5959 About VernalisVernalis is a speciality bio-pharmaceutical company focused on products marketedto specialist neurologists. The company has two marketed products, Frova(R) andApokyn(R), and a development pipeline focused on neurology and central nervoussystem disorders. The company has seven products in clinical development anddevelopment collaborations with leading, global pharmaceutical companiesincluding Novartis, Biogen Idec and Serono: -----------------------------------------------------------------------------------Product Indication Phase Phase Phase Registration Market Marketing Rights I II III-----------------------------------------------------------------------------------Apokyn(R) Parkinson's x North Disease America----------------------------------------------------------------------------------- Frova(R) Migraine x US milestones & royalties - Endo (EU - royalties)-----------------------------------------------------------------------------------Frova(R) Menstrual x US Migraine milestones & Prevention royalties - Endo (EU - royalties)-----------------------------------------------------------------------------------V1512 Parkinson's x World Wide Disease (excl. Italy)-----------------------------------------------------------------------------------V10153 Ischaemic x World Wide stroke -----------------------------------------------------------------------------------V1003 Acute Pain x US Profit share Option Reckitt Benckiser-----------------------------------------------------------------------------------V3381 Neuropathic x World Wide Pain -----------------------------------------------------------------------------------V2006 Parkinson's x US Disease Co-promotion Biogen Idec-----------------------------------------------------------------------------------MMPI Multiple x None - Sclerosis royalty (Serono)----------------------------------------------------------------------------------- Vernalis has established a U.S. commercial operation to promote Apokyn(R) andco-promote Frova(R) alongside its North American licensing partner, EndoPharmaceuticals, progressing the company towards its goal of becoming asustainable, self-funding, R&D-driven, speciality bio-pharmaceutical company.For further information about Vernalis, please visit www.vernalis.com. Vernalis Forward-Looking Statement This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events including the clinicaldevelopment and regulatory clearance of the Company's products, the Company'sability to find partners for the development and commercialisation of itsproducts, as well as the Company's future capital raising activities.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the ability of theCompany to identify and agree beneficial terms with suitable partners for thecommercialisation and/or development of its products, as well as the achievementof expected synergies from such transactions, the acceptance of Frova(R) andApokyn(R) and other products by consumers and medical professionals, thesuccessful integration of completed mergers and acquisitions and achievement ofexpected synergies from such transactions, and the ability of the Company toidentify and consummate suitable strategic and business combinationtransactions. 1. Strategy and operational review Vernalis' strategic goal is to become a sustainable, self-funding, R&D drivenspeciality bio-pharmaceutical company primarily focused on drugs for thetreatment of neurology and CNS disorders. The Company has two marketed products,a pipeline of seven clinical drug candidate programmes as well as a strongresearch capability that expects to add two clinical programmes to its portfolioin H2 2006. Vernalis has established a commercial operation in North America tomarket Apokyn(R) and co-promote Frova(R) alongside its partner Endo, as well asto promote other products that it is developing in-house or may acquire. Marketed Products Apokyn(R) - Advanced Parkinson's DiseaseApokyn(R) is the only acute, intermittent therapy available in the U.S. for thetreatment of immobilising "off" episodes associated with advanced Parkinson'sdisease. It is administered, as needed, by means of an injector pen to treatperiods of immobility in people with advanced disease. In April 2004, Apokyn(R)received FDA approval with Orphan Drug designation to treat advanced Parkinson'sdisease patients in the U.S. who experience the severe "on/off" motorfluctuations that are unresponsive to other oral Parkinson's disease therapies.Approximately 112,000 patients with Parkinson's disease experience such "off"episodes despite optimal oral PD therapy. Apokyn(R) was launched in the U.S. inJuly 2004 and Vernalis acquired the North American commercial rights from Mylanin November 2005. Mylan stopped promoting Apokyn(R) in July 2005. When Vernalis re-launched thispromotion-sensitive product in February 2006, new prescriptions had diminishedto almost zero. Apokyn(R) is sensitive to promotion due to patients' requirementfor close medical supervision during the initial administration in order ensurethat each individual patient is individually titrated to their optimal dose andto minimise the risk of first dose side effects. During the first half of 2006, Vernalis established several marketinginitiatives as part of its Apokyn(R) re-launch strategy. Vernalis has workedclosely with physicians to communicate the benefits of Apokyn(R) and reduce thebarriers that prevent patients from starting to use the product. These effortsinclude a nurse support programme (The APOKYN(R) Circle of CareTM) where nursesassist physicians with the initial titration and may also visit patients intheir home to ensure that they are comfortable using the drug and gaining themaximum benefit. In addition, Vernalis has introduced a sampling programmemaking it easier for the physician to initiate a patient and help ensure thepatient will benefit from the drug prior to having incurred any expense. Vernalis expects these types of activities to begin to impact levels of newprescriptions approximately three months after introduction. As a result,prescriptions initially remained at the low levels inherited from Mylan duringthe early part of the year, but have begun to increase substantially in recentmonths. Gross sales in H1 2006 were $2.3 million and are expected to be at thelower end of the initial guidance of $6 million to $7.5 million for the fullyear. Apokyn(R) is indicated for the acute, intermittent treatment of hypomobility or"off" episodes associated with advanced Parkinson's disease. It is used as anadjunct to other PD medications. Apokyn(R) is associated with severe nausea andvomiting and should be given with a concomitant antiemetic (trimethobenzamide). Frova(R) - Acute MigraineFrova(R) is a selective 5-HT1B/1D receptor agonist approved as an acute oraltreatment for migraine headache and its associated symptoms. Frova(R) is atriptan and is distinguished from other triptans by its long half-life. Vernalis has licensed North American rights for Frova(R) to Endo who reportednet sales of the product of $20 million for H1 2006. Vernalis has co-promotedFrova(R) in the U.S. with Endo since February 2006. In Europe, frovatriptan is marketed in twelve countries by Menarini. The drugwas approved throughout the then 15 member states of the European Union via themutual recognition procedure in January 2002. In the first half of 2006 Menarinilaunched frovatriptan in Slovakia (January 2006), Finland (March 2006), CzechRepublic (June 2006) and Slovenia (June 2006). In Germany and Italy market sharehas grown to approximately 10 per cent. and in excess of 12 per cent.,respectively, of the overall triptan market. Frova(R) is approved for the treatment of migraines in adults. The most commonadverse events include dizziness, fatigue, paresthesia, flushing, and headache. Development Portfolio Pain Franchise Frova(R) - Prevention of Menstrual MigraineVernalis has completed a series of studies aimed at obtaining approval for Frova(R) for the intermittent, short-term prevention of MM and Vernalis' partner,Endo filed an sNDA with the FDA in July 2006. Vernalis expects an approximate10-month review for the sNDA with a potential approval in mid-2007. If approvedby the FDA for this new indication, Vernalis will receive a $40 millionmilestone payment from Endo. The Frova(R) sNDA is supported by data from four clinical studies, the final ofwhich, a second efficacy study, reported in May 2006. Patients in the study hadpreviously failed on other acute therapies and were treated for threeperi-menstrual periods (PMPs). The primary endpoint was the number of menstrualmigraine-free PMPs. Both once and twice-daily dose regimens of Frova(R)demonstrated efficacy, with statistical significance compared to placebo (pRelated Shares:
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