Healthcare Industry News:  Sosei 


 News Release - June 22, 2006

Sosei Business Strategy Update and Portfolio Review

TOKYO, June 22 (HSMN NewsFeed) -- Sosei Co. Ltd ("Sosei"; TSE Mothers Index: 4565), the biopharmaceutical company, today releases the Chairman's statement to be made at Sosei's General Meeting of Shareholders on 23 June 2006.

"The year has been marked by significant change for Sosei. The strategic acquisition of Arakis last year enhanced Sosei's pipeline, spread development risk and added a sustainable product discovery engine. More recently, the withdrawal of SOU-001 from our development pipeline and the withdrawal of the application for approval of Eligard as a generic, along with continuing uncertainty surrounding the Eligard regulatory approval process, have been disappointments.

Strategic Review

The Board has conducted a strategic review of our pipeline and initiated a review of our capabilities and cost base worldwide. We have implemented initial reductions in headcount and by focusing expenditure on a smaller number of core products in our pipeline and reviewing our capabilities and costs we intend to bring the overall cost base of the Company down so that we currently have 2 years planned cash requirements.

Product Development Pipeline

The discussions with the Japanese PMDA concerning any future path towards registration for Eligard have been continued, but after a review of the Eligard programme the Board has confirmed that there is no short or medium term prospect of developing Eligard (SOT-375) for the Japanese market within costs and timescales compatible with creating value for shareholders.

Following the strategic review of the pipeline we have concluded that in addition to our lead product NVA237 and its combination products (for chronic obstructive pulmonary disease) that are funded by our partner Novartis, the prioritised pipeline will focus expenditure on AD 923 (for cancer breakthrough pain), SOU-003 (for nocturia), AD 452 (for rheumatoid arthritis), SOT-075 (for emergency contraception) and AD 337 (for fibromyalgia). In addition, we will continue to fund development work led by the operations in the UK to ensure we continue to have a rich resource to enhance and broaden the pipeline in the future. Product candidates SOT-375, SOT-107, AD 529 and SD 726 are no longer in the prioritised pipeline. The financial impact of the completed portfolio review is minimal in FY2006 although cost reductions will occur in the next financial year.

Despite the recent setbacks we strongly believe that Sosei's pipeline has the necessary quality and breadth to drive real value for shareholders as it matures and we will focus our investment to develop the core portfolio though major value enhancing stages. A number of these stages are expected during the current financial year, including the completion of Phase IIb trials for NVA 237 and AD 452 and the initiation of a Phase I trial for NorLevo (SOH-075) in Japan.

We are confident that the long term future of Sosei as a global biopharmaceutical company is very attractive for the shareholders. This future will be built upon the strong pharmaceutical development pipeline of the Company and our professional and dedicated staff."

Notes to Editors:

About Sosei

Sosei Co. Ltd. is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.

For further information about Sosei, please visit


This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend", "plan", "seeks", "estimates", "will" and "may" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. These factors include, without limitation, those discussed in our public reports filed with the Tokyo Stock Exchange. Further, certain forward looking statements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this presentation and the company does not assume any obligations to update or revise any of these forward statements, even if new information becomes available in the future.

Source: Sosei

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