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MailMovetis advances business plan while controlling expenditure
Market introduction of Resolor highlight of first quarter
Turnhout (Belgium) – 3 May 2010 (7:30 AM CET) – Movetis NV (MOVE), the European gastrointestinal (GI) speciality pharmaceutical company, provides a trading update on the first quarter of 2010, ahead of its General Shareholder Meeting that is being held at 11:00 AM CET today.
- Resolor® (prucalopride) welcomed with enthusiasm at GI medical congresses, as well as by GI specialists in the field. Patient uptake according to plan.
- Cash position of €99.6 million; Resolor 1st Quarter sales of €0.4 million as anticipated, based on 2 months of sales in Germany and, initial sales to wholesalers in UK.
- Movetis preparations to roll-out Resolor to its other European countries on schedule. Partnering discussions to support Resolor’s launch in the remainder of Movetis’ European territory progressing well.
- Johnson & Johnson Pharmaceutical Research & Development in Asia has initiated a Resolor Phase III trial in Asian patients with chronic constipation.
Dirk Reyn, CEO of Movetis commented on today’s trading update, ”We continue to make good progress in delivering our business plan which is focused on the successful roll out of Resolor and the further development of our attractive clinical pipeline. Resolor is already available in Germany and the UK, and our preparations for its introduction in additional markets are going to plan. Initial feedback indicates that the medical community is very receptive to Resolor. “Endlich” is the usual spontaneous reaction from German GI specialists when introduced to the product. It is already clear that GI specialists see Resolor as a novel treatment option in a therapeutic area that has been deprived of innovation for many years. We look forward to delivering further important value creating commercial and development milestones during the remainder of 2010.”
Financial highlights
Strong cash position; well-controlled spend rate
As of 31 March 2010, Movetis had €99.6 million in cash and investments, compared to €105.7 million at 31 December 2009.
Cash utilisation in the first quarter of 2010 was mainly related to strategic marketing (€2.0 million), outsourced R&D activities (€1.6 million) and personnel expenses (€2.3 million), reflecting the set-up of local marketing organisations in Germany and the UK where Resolor is now available on the market.
Business highlights
Running start for Resolor market build-up activities in Germany and UK
In the first quarter of 2010, Movetis introduced its lead product, Resolor, in Germany (January 27) and the UK (March 24). The two months of Resolor sales in Germany and the initial sales to wholesalers in the UK represent a turnover of €0.4 million, which is in-line with internal forecasts. In the market introduction phase, Movetis supplies samples to GI-specialists in line with industry practice in each country. Total patient uptake corresponds with the company’s expectations for the launch phase.
The market introduction of Resolor in Germany and the UK has been supported by the creation of Movetis subsidiaries in both countries.
In Germany, the team consists of 14 representatives who target GI specialists, 4 Market Access managers, and local staff in Medical Affairs and Marketing, led by a country manager. Following an initial sales visit programme over the past months, Movetis has now introduced Resolor to almost all key GI specialists in Germany and the team will start the second wave of calling as well as preparing to extend coverage to other specialists who are involved in the treatment of patients with chronic constipation.
In the UK, the team consists of 4 Market Access managers, 4 Medical Science Liaison officers and local staff in Medical Affairs and Marketing, led by a managing director. Movetis has submitted an application for a Single Technology Assessment by the National Institute of Clinical Excellence (NICE) and is currently engaged in a constructive dialogue with payors, key opinion leaders and decision makers. In parallel, Movetis has started to build its UK sales team and envisages having at least 7 representatives in the field by the third quarter of 2010. Resolor is available to wholesalers in the UK since March, enabling patient uptake as of April.
Movetis continues to prepare for launching Resolor in Belgium/Luxemburg, France and the Netherlands according to plan, and for partnering in other countries.
Development highlights:
2010 clinical trial programme on schedule; Phase III trial with Resolor in Asia initiated
In the first quarter of 2010, Movetis continued specific development activities for Resolor, as part of the EMA post marketing commitments, including the conduct of a trial to assess potential drug interaction of Resolor with oral contraceptives.
Furthermore, Movetis has been informed that, earlier this month, Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) in Asia has the first patient consented in its pan-Asia Phase III clinical trial with prucalopride in patients with chronic constipation. The study will be used for registration purposes in some markets in Asia per local regulatory requirements. Epidemiologic data suggest that, out of a total of 245 million patients in Asia who suffer from chronic constipation, 20 million currently seek medical advice, of whom 6 million are dissatisfied with their current treatment. *
Movetis continues to cooperate with Janssen Pharmaceutica NV (JPNV) on regulatory affairs related to Resolor for various non-European regions. Under the existing Movetis/JPNV licensing agreement, Movetis holds marketing rights for Resolor (prucalopride) in 31 European countries (EU27, Switzerland, Norway, Iceland, Liechtenstein), and JPNV holds rights in the rest of the world. Under this agreement, Movetis ‘is eligible to receive’ royalties from JPNV on Resolor sales beyond the aforementioned 31 European countries
Movetis is also on track with its programme of clinical trials that will be conducted to support broadening the potential uses of prucalopride in indications other than currently approved. In addition, preparations are on-going for clinical trials with M0003 (PPI-refractory GORD) as well as for M0002 (ascites).
About Movetis
Movetis is a European specialty GI company that is focused on improving the lives of millions of patients – both adults and children – by discovering, developing and commercialising innovative treatments targeting GI conditions with a high unmet medical need. Movetis NV was founded in Belgium in November 2006 as a spin-off of Johnson & Johnson.
Movetis has a broad portfolio of GI products: Resolor® (prucalopride) is approved in the European Economic Area for the indication “symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief”. The marketing authorisation application is currently under review in Switzerland. Two products are in Phase II development and Movetis has two prioritised compounds in preclinical development, all addressing important GI areas including ascites, paediatric reflux, refractory GORD (gastroesophageal reflux disease) and severe forms of irritable bowel syndrome.
In addition, Movetis has rights to a large library of qualified lead compounds with potential for development in different GI indications and access to know how for compounds in secretory diarrhoea.
The current portfolio is licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc., two Johnson & Johnson companies.
Movetis shares are listed on Euronext Brussels under the ticker MOVE.
Notes
- This trading update is prepared by the Executive Management Committee of Movetis.
- Beside the press releases announcing the market introduction of Resolor in Germany and the UK, Movetis also issued a press release in the first quarter of 2010 announcing that the company has been granted a positive ruling, enabling it to benefit from the Belgian patent income deduction regime for IP-related Resolor revenues.
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Disclaimer: This release may contain forward-looking statements, including, without limitation, statements containing the words “believes,” “anticipates,” “expects,” “intends,” “plans,” “seeks,” “estimates,” “may,” “will,” “could,” “stands to,” and “continues,” as well as similar expressions. Such forward looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Movetis, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward looking statements. These forward-looking statements speak only as of the date of publication of this document. Movetis expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.
Upcoming events for shareholders
- 3 May 2010 (11:00 AM CET) General Shareholder Meeting
- 27 August 2010 Publication Half Year 2010 Results
- 9 November 2010 Trading Update Third Quarter 2010
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