Galapagos NV (PK) (GLPGF) 銘柄情報

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Galapagos acquires structure-based drug discovery from Sareum


Mechelen, Belgium and Cambridge, UK; 26 August 2008 – Galapagos NV (Euronext: GLPG) and Sareum Holdings plc (AIM: SAR) announce today that Galapagos has acquired Sareum’s assets in drug discovery services, for a total cash consideration of €695,000 (£553,000). These assets will position Galapagos’ service division BioFocus DPI strongly in the growing field of structure-based drug discovery.

A key step in drug discovery research is the identification of small molecules that bind to a drug target. In structure-based drug design, the three-dimensional structure of a drug target is used to guide the discovery of such small molecules. It is a rapidly growing segment of the drug discovery market, having generated molecules for approved drugs and numerous candidate drugs in clinical development. Sareum’s structure-based approach specifically makes use of x-ray crystallography to discover chemical fragments for recombination into lead compounds. This approach has proven to accelerate drug discovery in many programs, both in its internal R&D and in services contracts with top pharma clients.

Under the agreement, Galapagos has acquired all of Sareum’s ongoing services contracts relating to structure-based drug discovery, the Crystal Bank (a set of protein target structures), a fragment screening library and the specialized equipment needed to perform structure-based drug discovery. This technology fits very well and will be incorporated within BioFocus DPI’s capabilities in screening and medicinal chemistry, and will complement its services offering. A team of five Sareum employees will join BioFocus DPI (Chesterford Park, Saffron Walden, UK) and continue to operate the platform, securing a smooth transition of the business.

“We are pleased to have acquired Sareum’s structure-based drug discovery assets and welcome their team and their clients to BioFocus DPI,” said Dr Chris Newton, Senior Vice President BioFocus DPI. “The assets and expertise acquired from Sareum strengthen our drug discovery, adding a novel technology that our customers are expressing interest in. We look forward to extending and expanding this business within the BioFocus DPI client base.”

“I am confident that the acquisition of Sareum’s expertise in structure-based drug discovery services will further enhance BioFocus DPI’s leading position in global drug discovery service provision”, added Dr Tim Mitchell, CEO, Sareum Holdings plc.

The structure based offering will contribute marginally to BioFocus DPI revenue target for 2008 and Galapagos reiterates it full year guidance of revenues between €75-80 million and a year-end cash position of around €25 million.

About structure-based drug discovery
Structure-based drug discovery has been in use within the pharmaceutical industry for over twenty-five years. It plays an important role in drug discovery, design and optimization. The technology relies on knowledge of the three-dimensional structure of drug targets. Once the structure is known, potential drugs are designed to ‘lock-in’ to the drug target, facilitating the development of high-quality drug candidates.

About Sareum
Sareum Holdings plc is a structure-based drug discovery business headquartered in Cambridge, UK. The Company was formed in August 2003 to discover new drugs for the treatment of cancer. Sareum’s unique approach aims to halve the time it takes to discover new drug candidates. Sareum’s approach to structure determination utilises its proprietary protein expression platform in order to produce multiple recombinant proteins that accelerate structure determination. Sareum aims to successfully deliver drug candidates for licensing to larger pharmaceutical companies at the pre-clinical or early clinical trials stage. Sareum joined the AIM market of the London Stock Exchange in October 2004 under the symbol SAR. For further information, please visit www.sareum.co.uk

About Galapagos and BioFocus DPI
Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical programs in bone and joint diseases and bone metastasis. Its division BioFocus DPI offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. BioFocus DPI also provides adenoviral reagents for rapid identification and validation of novel drug targets, compound libraries for drug screening as well as ADMET products to select compounds. Galapagos currently employs 500 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More information about Galapagos and BioFocus DPI can be found at www.glpg.com and www.biofocusdpi.com.

UCB transfers UK-based medicinal chemistry program to BioFocus DPI

Mechelen, Belgium; 12 August 2008 – Galapagos NV (Euronext: GLPG) announced today that its service division BioFocus DPI and UCB have signed a contract for the provision of chemistry services in the UK by BioFocus DPI, for one of UCB’s medicinal chemistry programs. The total contract value for Galapagos could potentially exceed €4 M. Additionally, Galapagos is eligible to receive up to €500,000 in success payments subject to fulfillment of certain conditions.

UCB will transfer a team of chemists to BioFocus DPI from UCB’s recently closed Cambridge (UK) research site and BioFocus DPI will continue the chemistry work for the program that was running at UCB, towards candidate selection stage. Under the contract, UCB will provide biology support for the program.

“This agreement with UCB demonstrates BioFocus DPI’s flexibility in meeting client needs,” said Chris Newton, Senior Vice President of BioFocus DPI. “This innovative deal structure allows UCB to progress their program externally while applying the specific project expertise that UCB has already built internally.”

“UCB is delighted to be able to work with BioFocus DPI in this way, combining our expertise to advance this programme towards development,” said Dr Neil Weir, Senior Vice President Research, UCB.


About Galapagos and BioFocus DPI
Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical programs in bone and joint diseases and bone metastasis. Its division BioFocus DPI offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. BioFocus DPI also provides adenoviral reagents for rapid identification and validation of novel drug targets, compound libraries for drug screening as well as ADMET products to select compounds. Galapagos currently employs 490 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More information about Galapagos and BioFocus DPI can be found at www.glpg.com and www.biofocusdpi.com.
http://www.glpg.com/press/2008/26.htm

Galapagos announces milestone payment of EUR 0.8 million in osteoarthritis alliance with GlaxoSmithKline
Monday June 16, 2:08 am ET

MECHELEN, BELGIUM--(MARKET WIRE)--Jun 16, 2008 --
Mechelen, Belgium; 16 June 2008 - Galapagos NV (Euronext: GLPG) announced today that it has reached two new milestones in its multi-year drug discovery alliance with GlaxoSmithKline in osteoarthritis, triggering a payment of EUR 0.8 million from GSK.

In June 2006, GSK's Center of Excellence for External Drug Discovery (CEEDD) and Galapagos initiated a program to deliver disease-modifying drugs with clinical Proof of Concept to GSK's global research and development organization. The aim of this agreement is for Galapagos to expand its portfolio of novel targets in the field of osteoarthritis, to conduct compound screening, identify tractable hits, pursue a number of hit-to-lead programs, and develop the resulting leads into candidate selection compounds through to a successful Proof of Concept in clinical research Phase IIa. GSK has exclusive options to further develop and commercialize these compounds on a worldwide basis. Galapagos will have the right to further develop and commercialize compounds for which GSK does not exercise its option. In July 2007, GSK made a EUR 4.4 million equity investment in Galapagos and the alliance was expanded to include up to two selected GSK targets. Now part of GSK's Immunoinflammation Center of Excellence for Drug Discovery alliance portfolio, the expanded alliance is worth up to EUR 186 million in milestones for two marketable products to Galapagos, plus royalties on global product sales.

Today's announcement marks the fifth milestone payment made to Galapagos since the start of the osteoarthritis alliance. To date, Galapagos has received a total of EUR 15.9 million in access fees and milestone payments from GSK under the alliance.

"We are pleased that the osteoarthritis alliance with GSK is progressing as planned, in line with our expectation to deliver a pre-clinical candidate this year," said Onno van de Stolpe, Chief Executive Officer of Galapagos. "Our successful track record in risk-sharing alliances demonstrates that this model is a viable strategy to progress a number of drug discovery programs while retaining the upside."

Commenting on the collaboration, Jose Carlos Gutierrez-Ramos, Ph.D., Senior Vice President and head of the Immuno-Inflammation Center of Excellence for Drug Discovery at GSK noted "Galapagos is proving to be a partner which consistently delivers results. We are confident that our alliance will continue to advance GSK's pipeline in osteoarthritis."

About osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis, typically affecting people aged 45 and older. It is a degenerative disease characterized by joint destruction and loss of articular cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint. Healthy cartilage allows bones to glide over one another. It also absorbs energy from the shock of physical movement. In OA, the surface layer of cartilage breaks down and wears away. This allows bones under the cartilage to rub together, causing pain, swelling, and loss of motion of the joint. Over time, the joint may lose its normal shape. Also, bone spurs - small growths called osteophytes - may grow on the edges of the joint. Bits of bone or cartilage can break off and float inside the joint space. This causes more pain and damage. No currently available treatments prevent OA or even reverse or block the disease process. Treatment of OA involves pain control, weight control, and exercise. Many OA patients have pain that persists despite these measures. Most of these patients use non-steroidal anti-inflammatory drugs (NSAIDs) that relieve the symptoms without changing the course of the underlying disease. Healthcare providers are concerned about long-term NSAID use due to serious possible side effects. It is expected that with the ageing of the population, more individuals will be prone to develop OA. As mobility of seniors is of high importance to maintaining a high quality of life, preventing the severity of OA is seen as an immense clinical need over the next decade. The market potential of a disease-modifying drug could exceed $8 billion annually[1], based on the current market and the absence of disease-modifying treatment.

Galapagos signs research agreement with UCL
Monday May 19, 2:08 am ET

MECHELEN, BELGIUM--(MARKET WIRE)--May 19, 2008 --
Mechelen, Belgium, 19 May 2008 - Galapagos NV (Euronext: GLPG) announced today that is has signed a drug discovery research agreement with UCL (University College London). Galapagos' BioFocus DPI service division will perform medicinal chemistry services for a UCL research project. It is also intended that BioFocus DPI will offer UCL ADME[1] screening facilities during the appropriate stages of the work. Total contract value for Galapagos is expected to reach more than EUR 1.8 million over the course of the two-year agreement.

UCL has an ongoing drug discovery program for the treatment of vascular collapse during sepsis (collapsing of blood vessels due to systemic infection by a pathogen). BioFocus DPI will provide medicinal chemistry services to progress UCL's lead series through to pre-clinical testing. In addition UCL will also have the opportunity to utilize BioFocus DPI ADME screening services and will receive access to a selection of compounds in BioFocus DPI's SoftFocus collection to facilitate the identification of new chemical starting points for this drug discovery program.

"We are pleased to add UCL to BioFocus DPI's considerable list of academic partners," said Onno van de Stolpe, CEO of Galapagos. "BioFocus DPI's leading medicinal chemistry and ADME expertise, such as the newly launched ADME/PK Laboratory, give us a strong edge in winning highly competitive deals."

Bausch & Lomb and Galapagos sign agreement to collaborate on ophthalmic disease research
Thursday April 10, 2:08 am ET

MECHELEN, BELGIUM--(MARKET WIRE)--Apr 10, 2008 --
Rochester, New York, USA and Mechelen, Belgium; 10 April 2008 - Bausch & Lomb, the eye health company, and Galapagos NV (Euronext: GLPG), a drug discovery company, announced today that they have entered into a collaborative research agreement. Bausch & Lomb will have the exclusive option to license select Galapagos compounds as development candidates for therapeutic uses in ophthalmic diseases.

"The agreement provides access to a group of compounds that may have excellent development candidate potential," said Praveen Tyle, Ph.D., Chief Scientific Officer, Bausch & Lomb. "The small molecule compounds under evaluation have very attractive in vitro and in vivo profiles. Our intent is to develop these compounds as unique therapies, tapping our research expertise in ophthalmic diseases."

"We are pleased to partner with Bausch & Lomb, a leader in the development of treatments for eye diseases. Our collaboration with Bausch & Lomb gives us the opportunity to leverage select compounds in a therapeutic area that we would not otherwise pursue," said Onno van de Stolpe, Chief Executive Officer of Galapagos.

Bausch & Lomb is responsible for the preclinical and clinical development of the select compounds for use in ophthalmic diseases. Under the terms of the collaboration, Galapagos will receive an upfront payment of US$400,000 and may receive research funding to support Bausch & Lomb's further development of the compounds for ophthalmic uses, plus future milestone payments. Pending successful development and commercialization under the license, potential total value of the payments exceeds US$50 million, plus royalties on the commercial sale of licensed products.

Contact
Mike McDougall, APR
Director, Corporate Communications, Bausch & Lomb
Tel: +1 585 338 5469
mmcdougall@bausch.com

Onno van de Stolpe
CEO, Galapagos NV
Tel: +31 6 2909 8028
ir@glpg.com

About Bausch & Lomb

Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is headquartered in Rochester, N.Y., and employs approximately 13,000 people worldwide. Its products are available in more than 100 countries. More information about the Company can be found at www.bausch.com.


About Galapagos

Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical programs in bone and joint diseases and bone metastasis. Its BioFocus DPI division offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. BioFocus DPI also provides adenoviral reagents for rapid identification and validation of novel drug targets, compound libraries for drug screening as well as chemogenomics and ADMET database products to select targets and compounds. Galapagos currently employs 450 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More information about Galapagos and BioFocus DPI can be found at www.glpg.com and www.biofocusdpi.com.

Galapagos announces 2007 full year results
• Revenues increased 87% to €65.9 million, exceeding guidance
• Year-end cash position of €49.3 million
• BioFocus DPI reported segment loss of €3.9 million
• Net loss per share increased to €1.06 from €0.84 in 2006
• Guidance for 2008 revenues €75-80 million, year end cash position of approximately €25 million

Webcast audio conference presentation today on www.glpg.com
14.00 CET/8:00 AM EST, call number +32 2290 1608

Mechelen, Belgium; 7 March 2008 – Galapagos NV (Euronext: GLPG) announces its 2007 full year results and provides market guidance for 2008.

In 2007 Galapagos grew revenues by 87% and made sound progress toward entering the clinic with its bone and joint programs. In a year of restructuring and consolidation following the acquisitions made in 2006, the BioFocus DPI service division reported year-on-year growth in segment revenues of 39% to €48.4 M. The Drug Discovery division showed outstanding results across all therapeutic areas, attracting big pharma partners for alliances in the rheumatoid arthritis and osteoporosis programs as well as for anti-infectives, the first alliance outside the Company’s bone & joint diseases core area. By executing this partnering strategy, Galapagos can expand its internal drug discovery, while reducing the impact to cash burn in the years to come.

“In our third year as a public company we have made major steps towards building a European leader in drug discovery. We have delivered on our discovery research, secured long-term alliance partners for our therapeutic programs, and established BioFocus DPI as a leader in discovery services. We are proud of the results reached in 2007, showing a substantial growth in revenues and maintaining a healthy cash balance. Galapagos will continue to build on this momentum in 2008, with the anticipated entry into the clinic of our bone metastasis program and IND submission for rheumatoid arthritis,” said Onno van de Stolpe, Chief Executive Officer of Galapagos.

“Galapagos has demonstrated that it can deliver its R&D milestones, with €22.9 million in external revenues in its Drug Discovery division. Through its alliance strategy, Galapagos has established a model for financing expansion of R&D activities without incurring a corresponding impact to cash burn. Despite BioFocus DPI’s segment loss, we believe the restructuring in 2007 will strengthen its leading position and bring the division back to profitability,” said Leo Steenbergen, Chief Financial Officer of Galapagos.

Key figures 2007 (consolidated)
(€ millions, except net loss per share)


Financial Highlights

Operational overview

Drug Discovery division
The Drug Discovery division delivered exciting results across all core programs. The Company announced that its rheumatoid arthritis candidate drug demonstrates significant bone protection and reduced inflammation in the industry standard mouse model. The effect of this oral compound was at least equivalent to Enbrel® (etanercept), the injectable anti-TNF treatment for rheumatoid arthritis. In bone metastasis, Galapagos’ candidate drug has shown reduction of bone metastasis and bone degeneration comparable to Zometa® (zolendronate), and superior prevention of metastases to other organs. Based on these encouraging results, Galapagos announced the initiation of pre-clinical development of both compounds, with the aim to file Investigational New Drug (IND) applications for each and begin with dosing the bone metastasis compound in humans in a Phase I clinical trial before the end of 2008. Galapagos aims to initiate a clinical Phase I trial in rheumatoid arthritis shortly thereafter.

Galapagos announced achievement of Proof of Concept (reduction of targeted symptoms) in pre-clinical models in its osteoarthritis program. Galapagos’ osteoarthritis program has progressed from validated targets to a Proof of Concept in 18 months. The data generated thus far encourage the Company to aim for delivery of a pre-clinical candidate in osteoarthritis by end 2008.

In June 2007, Galapagos announced the expansion of the scope of the osteoarthritis alliance with GlaxoSmithKline (GSK) to include up to two drug discovery programs on selected GSK targets. Additionally, GSK made a €4.4 million equity investment in Galapagos by way of a share issue. Galapagos also attracted world-leading partners for its remaining core programs, in addition to signing a first major alliance outside its core areas. In October 2007, Galapagos entered a major alliance with Janssen Pharmaceutica (a Johnson & Johnson company) to develop novel oral therapeutics in rheumatoid arthritis. In December 2007, Galapagos announced major alliances in osteoporosis with Eli Lilly and in infectious diseases with GSK.

Through its alliance strategy, Galapagos is eligible to receive in excess of €1.7 billion in success-dependent downstream milestone revenues plus up to double-digit royalties on commercial products. Galapagos will be progressing over 40 target-based programs in R&D, the majority of which are partnered with leading pharmaceutical companies.

BioFocus DPI service division
BioFocus DPI has long-standing relationships with more than 35 partners, including most of the large pharma and biotech companies. BioFocus DPI continued to win new business from existing partners and developed several new relationships in 2007 in a highly competitive market. To establish a cost structure for future profitability, the division consolidated operations in 2007 by integrating sites in Cambridge, moving the Heidelberg operations into the Basel site and moving into new facilities in Leiden.

Details of the financial results

Revenue
Galapagos' revenues for the full year 2007 grew 87% to €65.9 million (2006: €35.2 million). Of these revenues, €48.4 million were generated by BioFocus DPI, including €5.4 million inter-company revenues that were eliminated in the consolidation. The Drug Discovery division contributed €22.9 million to Group external revenues.

Results
The Group net loss for the full year 2007 was €21.9 million, or €1.06 per share, compared to €11.3 million, or €0.84 per share for 2006. The main contributing factor to the increase of the net loss was an increase in research and development costs from €15.9 million to €30.6 million. The BioFocus DPI segment result, before restructuring and one-off costs, was a loss of €3.9 million, mainly due to lower than expected sales in biology services and compound libraries as well as to the effect of site consolidations. Medicinal chemistry services exceeded expectations. The order book for biology services has since shown improvement, with the recent €7.6 million collaboration with Janssen Pharmaceutica as an illustration. General and administrative costs amounted to €19.4 million, including €1.4 million for stock-based compensation and other IFRS adjustments. As a percentage of revenue, general and administrative costs were reduced from 34% in 2006 to 29% in 2007. Restructuring costs and impairment amounted to €6.6 million, including costs related to the restructuring and consolidation of operations in Romainville and Chesterford Park, the consolidation of Heidelberg into Basel, and a €1.6 million write-off of intangible assets related to ProSkelia.

Cash flow and cash position
Galapagos’ cash and cash equivalents amounted to €49.3 million on 31 December 2007, compared to €51.5 million at the end of 2006. In 2007, €4.8 million in cash was received through capital increases. Strong cash flow in the second half of the year was related to upfront and milestone payments received from Galapagos’ alliance partners Janssen Pharmaceutica, GSK and Eli Lilly.

Outlook 2008
Galapagos anticipates continued growth in revenues from milestones in its Drug Discovery division and an increase in sales from BioFocus DPI, resulting in a full-year revenue guidance of between €75–80 million in 2008. Management is confident that the restructuring and consolidation efforts in BioFocus DPI will start to pay off in 2008 and will contribute to bringing the division back into profitability. R&D expenditure is expected to increase to approximately €50 million as a result of progressing its drug candidates towards the clinic, delivering a pre-clinical candidate in osteoarthritis and advancing its other R&D programs. The R&D expenditure is expected to be substantially offset by anticipated milestones from its alliance partners. Full year cash burn in 2008 should be limited to around €25 million, leading to a year end cash position of approximately €25 million.

Annual Financial Report 2007
Galapagos is currently finalizing its financial statements for the year ended 31 December 2007. The auditor has confirmed that his audit procedures, which are substantially completed, have not revealed any material corrections that are required to be made to the financial information included in this press release. Should any material changes arise during the audit finalization, an additional press release will be issued. We expect to be able to publish our fully audited Annual Financial Report for the year 2007 before the end of April 2008.

Conference call and webcast presentation
Galapagos will conduct a conference call open to the public today at 14.00 Central European Time (CET)/8:00 AM US Eastern Standard Time (EST), which will also be webcast. To participate in the conference call, please call +32 2290 1608, or toll free in the US +1 866 225 8754, ten minutes prior to commencement. A question and answer session will follow the presentation of the results. The live audio webcast can be accessed via Galapagos’ website at www.glpg.com. The archived webcast also will be available for replay shortly after the close of the call.

About Galapagos
Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical programs in bone and joint diseases and bone metastasis. Its division BioFocus DPI offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. BioFocus DPI also provides adenoviral reagents for rapid identification and validation of novel drug targets, compound libraries for drug screening as well as chemogenomics and ADMET database products to select targets and compounds. Galapagos currently employs 450 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More information about Galapagos and BioFocus DPI can be found at www.glpg.com and www.biofocusdpi.com.


CONTACTS

Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@glpg.com


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 Galapagos, 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. Nothing in this disclaimer is intended to nor does it affect the obligations and responsibilities of Galapagos pursuant to the rules of the exchanges on which Galapagos' shares are admitted for trading, including the AIM Rules for Companies.

http://www.glpg.com/press/2008/9.htm