GENEVA, SWITZERLAND -- (MARKET WIRE) -- 12/02/09 -- Allosteric modulation company Addex Pharmaceuticals (SWISS: ADXN) announced today the extension of its research collaboration with Merck & Co., Inc., through an affiliate, for an additional year. The collaboration is focused on developing positive allosteric modulators (PAM) of the metabotropic glutamate receptor 4 (mGluR4) for the treatment of Parkinson's disease and other undisclosed indications.
Addex will receive research funding from Merck in addition to the original financial terms, which include milestones and royalties.
Earlier this year Addex disclosed that a preclinical study had shown that the collaboration had yielded orally available mGluR4 PAM with efficacy in an animal model of Parkinson's disease.
"We are delighted that Merck values the contribution of our allosteric modulator discovery platform and wishes to include us in building further upon the excellent progress this program has made to date," said Emmanuel Le Poul, head of the CNS Business Unit at Addex.
"Developing innovative non-dopaminergic drugs for Parkinson's disease is an increasingly important part of our work at Addex," said Vincent Mutel, CEO of Addex. "We are proud to be advancing mGluR4 PAMs with our collaborators at Merck."
Under the terms of the exclusive collaboration and license agreement, first announced in December 2007, Addex received $3 million upfront and has received two preclinical milestones of $250,000 and $500,000, to date. Addex is eligible to receive up to $106.5 million in research, development and regulatory milestones for the first product developed for multiple indications. Additional milestones of up to $61 million would be payable if a second and third product is developed. Addex is eligible to receive undisclosed royalties on sales of any products resulting from this collaboration. Merck is responsible for clinical development. Extension of the research collaboration allows Addex to recognize $1.8 million in research funding over 12 months beginning on December 1, 2009.
Glutamate, like dopamine and serotonin, is a key neurotransmitter in the human brain, an important signaling molecule involved in control of multiple brain functions ranging from motor control to mood. In Parkinson's disease, the death of dopamine producing neurons leads to excess glutamate signaling.
Parkinson's disease is a degenerative disease of the brain that often impairs motor skills, speech, and other functions. It is estimated that 60,000 new cases are diagnosed each year in the U.S., where more than 1.5 million people currently have PD. While the condition usually develops after the age of 65, 15% of those diagnosed are under 50. PD affects both men and women in almost equal numbers.
mGluR4 may play an important role in Parkinson's disease. Current treatments focus on dopamine-replacement strategies, however most patients reach a stage where dopaminergic treatments are no longer effective. There can also be debilitating side effects with dopaminergic treatments, especially levodopa induced dyskinesia, and many patients are encouraged to limit doses so their side effects will appear later and be less cumbersome. The recent success of surgical approaches suggests that bypassing the dopamine system may provide a more effective treatment strategy. It is believed that selective activation of mGluR4 is one way to do this and could correct the circuitry that modulates motor excitability via a non-dopaminergic mechanism.
Published research* shows that mGluR4 activators, like those in development by Addex and Merck, could work via two distinct mechanisms to alleviate symptoms of Parkinson's disease and, potentially, even slow the progression of the disease: 1) mGluR4 activation triggers a compensatory mechanism that may spare or potentiate the use of dopamine receptor activators; 2) mGluR4 activation may have a neuroprotective effect that helps to preserve the brain's dopaminergic neurons. Thus, this approach has the potential to provide significant benefit in Parkinson's disease.
*Nature Reviews Neuroscience, Vol 6, Oct. 2005, pp 787-798
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops allosteric modulators for human health. Allosteric modulators are a different kind of orally available small molecule therapeutic agent, which we believe will offer a competitive advantage over classical drugs. Our lead allosteric modulator product, ADX10059, an mGluR5 NAM, has achieved clinical proof of concept and is in Phase IIb testing for the treatment of GERD and, separately, migraine prevention. ADX48621, an mGluR5 NAM, has completed Phase I testing and will enter Phase II for PD-LID in 2010. Addex partner Ortho-McNeil-Janssen Pharmaceuticals, a Johnson & Johnson company, is performing Phase I testing of ADX71149, an mGluR2 PAM, which has potential for anxiety and schizophrenia.
Disclaimer: The foregoing release contains forward-looking statements that can be identified by terminology such as "not approvable", "continue", "believes", "believe", "will", "remained open to exploring", "would", "could", or similar expressions, or by express or implied discussions regarding Addex Pharmaceuticals Ltd, its business, the potential approval of its products by regulatory authorities, or regarding potential future revenues from such products. Such forward-looking statements reflect the current views of Addex Pharmaceuticals Ltd regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with allosteric modulators of mGluR4, mGluR2 or mGluR5 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that allosteric modulators of mGluR4, mGluR2 or mGluR5 will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGluR4, mGluR2 or mGluR5 will achieve any particular levels of revenue (if any) in the future. In particular, management's expectations regarding allosteric modulators of mGluR4, mGluR2 or mGluR5 could be affected by, among other things, unexpected actions by our partners, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Addex Pharmaceuticals is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Chris Maggos Head of IR & Communications Addex Pharmaceuticals +41 22 884 15 11 chris.maggos@addexpharma.com
LEUVEN, BELGIUM -- (MARKET WIRE) -- 12/02/09 -- Option N.V. (Euronext: OPTI; OTC: OPNVY), the wireless technology company, today announced that revenues for the fourth quarter of fiscal year 2009 are expected to be in the range of EUR 20-25 million. These revenues combined with EUR 128 million for the first three quarters of 2009 will generate full year revenue in the range of EUR 148-153 million which is approximately 44% less than the full year 2008.
During the quarter a number of factors affected the indicated revenue. The key issues faced by the Company included continuing competitive pricing, continued weakness in the US dollar reducing the Euro value of that revenue and deeply discounted sales of products entering their end of life cycle.
Option anticipated that the fourth quarter of 2009 would continue to prove difficult as the company continues to transition its product portfolio and organization to an integrated software, services and hardware platform.
Option continues to believe that it is well positioned for 2010 due to:
* The significant cost savings identified and implemented during
2009
* The recently announced additional planned cost savings of EUR 20
million, the implementation of which has started including the
recent closing of the Kamp-Lintfort facility as planned
* The launch of its embedded module in the Plastic Logic e-book
reader announced earlier this month as an indication of new
opportunities in the consumer electronics market
* The continued investment and customer interest in the Company's
uCAN software platform combined with the supply chain optimized
and yet highly customizable USB devices to provide an integrated
solution to operators
* The anticipated strengthening of the balance sheet through the
recently announced rights offering
Audited figures for the fourth quarter and the full year 2009 will be published on March 2, 2010.
For the PDF version of the press release in English or in Dutch, please click on the link below:
Option indicates preliminary Q4 and full year 2009 results: http://hugin.info/133962/R/1358564/330839.pdf
Option geeft voorlopig resultaat voor vierde kwartaal en volledig jaar 2009: http://hugin.info/133962/R/1358564/330840.pdf
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
CONTACT JP Ziegler, CFO Gaston Geenslaan 14 B-3001 Leuven, Belgium TEL: +32 (0) 16 31 74 11 FAX: +32 (0) 16 31 74 90 E-mail: investor@option.com
Copyright © Hugin AS 2009. All rights reserved.
GENEVA, SWITZERLAND -- (MARKET WIRE) -- 12/02/09 -- Allosteric modulation company Addex Pharmaceuticals (SWISS: ADXN) announced today the extension of its research collaboration with Merck & Co., Inc., through an affiliate, for an additional year. The collaboration is focused on developing positive allosteric modulators (PAM) of the metabotropic glutamate receptor 4 (mGluR4) for the treatment of Parkinson's disease and other undisclosed indications.
Addex will receive research funding from Merck in addition to the original financial terms, which include milestones and royalties.
Earlier this year Addex disclosed that a preclinical study had shown that the collaboration had yielded orally available mGluR4 PAM with efficacy in an animal model of Parkinson's disease.
"We are delighted that Merck values the contribution of our allosteric modulator discovery platform and wishes to include us in building further upon the excellent progress this program has made to date," said Emmanuel Le Poul, head of the CNS Business Unit at Addex.
"Developing innovative non-dopaminergic drugs for Parkinson's disease is an increasingly important part of our work at Addex," said Vincent Mutel, CEO of Addex. "We are proud to be advancing mGluR4 PAMs with our collaborators at Merck."
Under the terms of the exclusive collaboration and license agreement, first announced in December 2007, Addex received $3 million upfront and has received two preclinical milestones of $250,000 and $500,000, to date. Addex is eligible to receive up to $106.5 million in research, development and regulatory milestones for the first product developed for multiple indications. Additional milestones of up to $61 million would be payable if a second and third product is developed. Addex is eligible to receive undisclosed royalties on sales of any products resulting from this collaboration. Merck is responsible for clinical development. Extension of the research collaboration allows Addex to recognize $1.8 million in research funding over 12 months beginning on December 1, 2009.
Glutamate, like dopamine and serotonin, is a key neurotransmitter in the human brain, an important signaling molecule involved in control of multiple brain functions ranging from motor control to mood. In Parkinson's disease, the death of dopamine producing neurons leads to excess glutamate signaling.
Parkinson's disease is a degenerative disease of the brain that often impairs motor skills, speech, and other functions. It is estimated that 60,000 new cases are diagnosed each year in the U.S., where more than 1.5 million people currently have PD. While the condition usually develops after the age of 65, 15% of those diagnosed are under 50. PD affects both men and women in almost equal numbers.
mGluR4 may play an important role in Parkinson's disease. Current treatments focus on dopamine-replacement strategies, however most patients reach a stage where dopaminergic treatments are no longer effective. There can also be debilitating side effects with dopaminergic treatments, especially levodopa induced dyskinesia, and many patients are encouraged to limit doses so their side effects will appear later and be less cumbersome. The recent success of surgical approaches suggests that bypassing the dopamine system may provide a more effective treatment strategy. It is believed that selective activation of mGluR4 is one way to do this and could correct the circuitry that modulates motor excitability via a non-dopaminergic mechanism.
Published research* shows that mGluR4 activators, like those in development by Addex and Merck, could work via two distinct mechanisms to alleviate symptoms of Parkinson's disease and, potentially, even slow the progression of the disease: 1) mGluR4 activation triggers a compensatory mechanism that may spare or potentiate the use of dopamine receptor activators; 2) mGluR4 activation may have a neuroprotective effect that helps to preserve the brain's dopaminergic neurons. Thus, this approach has the potential to provide significant benefit in Parkinson's disease.
*Nature Reviews Neuroscience, Vol 6, Oct. 2005, pp 787-798
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops allosteric modulators for human health. Allosteric modulators are a different kind of orally available small molecule therapeutic agent, which we believe will offer a competitive advantage over classical drugs. Our lead allosteric modulator product, ADX10059, an mGluR5 NAM, has achieved clinical proof of concept and is in Phase IIb testing for the treatment of GERD and, separately, migraine prevention. ADX48621, an mGluR5 NAM, has completed Phase I testing and will enter Phase II for PD-LID in 2010. Addex partner Ortho-McNeil-Janssen Pharmaceuticals, a Johnson & Johnson company, is performing Phase I testing of ADX71149, an mGluR2 PAM, which has potential for anxiety and schizophrenia.
Chris Maggos Head of IR & Communications Addex Pharmaceuticals +41 22 884 15 11 chris.maggos@addexpharma.com
Disclaimer: The foregoing release contains forward-looking statements that can be identified by terminology such as "not approvable", "continue", "believes", "believe", "will", "remained open to exploring", "would", "could", or similar expressions, or by express or implied discussions regarding Addex Pharmaceuticals Ltd, its business, the potential approval of its products by regulatory authorities, or regarding potential future revenues from such products. Such forward-looking statements reflect the current views of Addex Pharmaceuticals Ltd regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with allosteric modulators of mGluR4, mGluR2 or mGluR5 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that allosteric modulators of mGluR4, mGluR2 or mGluR5 will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGluR4, mGluR2 or mGluR5 will achieve any particular levels of revenue (if any) in the future. In particular, management's expectations regarding allosteric modulators of mGluR4, mGluR2 or mGluR5 could be affected by, among other things, unexpected actions by our partners, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Addex Pharmaceuticals is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Copyright © Hugin AS 2009. All rights reserved.
TOKYO--(BUSINESS WIRE)-- Elpida Memory, Inc. (TOKYO: 6665), Japan's leading global supplier of Dynamic Random Access Memory (DRAM), today announced that its primary chip manufacturing fab, the Hiroshima Plant, was named one of the recipients of the "2009 Global Warming Prevention Activity Award" bestowed by Japan's Ministry of the Environment.
The award has been given annually since 1998 in recognition of individuals and organizations in Japan that have made outstanding contributions to the prevention of global warming.
Elpida's Hiroshima Plant has made it a top priority to institute environmental measures that can reduce the production of greenhouse gas emissions that cause global warming. The plant uses Japan's largest-scale cogeneration system to reduce CO2 emissions and has installed PFC combustion abatement systems to reduce greenhouse gas emissions. Also, since 2003 the plant has introduced an extensive range of energy conservation measures and plant employees have gone through environmental awareness training. As a result of these efforts the Hiroshima Plant has cut annual CO2-equivalent emissions by 862 kilotons (a 56% reduction). The Environment Ministry's 2009 award honors this accomplishment by recognizing the plant's "facility-wide activities to lessen greenhouse gas emissions."
The Elpida Group intends to promote greater environmental awareness among its employees and to implement additional "green" measures in its semiconductor manufacturing facilities.
About Elpida
Elpida Memory, Inc. (TOKYO: 6665) is a leading manufacturer of Dynamic Random Access Memory (DRAM) integrated circuits. The company's design, manufacturing and sales operations are backed by world class technological expertise. Its 300mm manufacturing facilities, consisting of its Hiroshima Plant and a Taiwan-based joint venture, Rexchip Electronics, utilize the most advanced manufacturing technologies available. Elpida's portfolio features such characteristics as high-density, high-speed, low power and small packaging profiles. The company provides DRAM solutions across a wide range of applications, including high-end servers, mobile phones and digital consumer electronics. More information can be found at http://www.elpida.com.
Information in this news release is current as of the timing of the release, but may be revised later without notice.
Source: Elpida Memory, Inc.
Taspoglutide provides potent and durable glycemic control with superiority versus Januvia(R)
PARIS--(BUSINESS WIRE)-- Regulatory News:
Ipsen (Euronext: FR0010259150; IPN), an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of the second and third of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen's research and developed by Roche. T-emerge 1 (subcutaneous weekly taspoglutide versus placebo in treatment-naive patients) and T-emerge 4 (subcutaneous weekly taspoglutide versus sitagliptin versus placebo) both met their respective primary endpoints of change in HbA1c. In both studies taspoglutide was generally well tolerated. The most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting.
This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation. GLP-1 analogues, which stimulate insulin secretion and suppress glucagon secretion, are true innovations in the diabetes field.
About T-emerge 1
T-emerge 1 is a double-blind, randomized, placebo-controlled, 24 week study, to demonstrate superiority of taspoglutide versus placebo in 373 treatment-naive type 2 diabetic patients. The results of T-emerge 1 showed that taspoglutide demonstrated superior HbA1c reduction versus placebo. The study analysis included 373 patients, enrolled into three arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly titrated up to 20mg once weekly after 4 weeks, and placebo).
About T-emerge 4
T-emerge 4 is a head to head comparison study versus sitagliptin (Januvia(R)) as an add-on to metformin. It is a double blind, active and placebo controlled, 24 week study to demonstrate the non-inferiority of taspoglutide to sitagliptin with a statistical test for superiority to placebo, involving 636 patients who have failed to reach their treatment targets with metformin. T-emerge 4 showed that taspoglutide demonstrated superior HbA1c reduction versus sitagliptin. The study analysis included 636 patients, enrolled into four arms (taspoglutide at doses of 10 mg and 20 mg, sitagliptin 100 mg and placebo) in a ratio of 2:2:2:1.
About the T-EMERGE Program
Roche's T-EMERGE Phase III clinical trial programme is designed as multicenter, multi-country, randomized, controlled (active or placebo), double-blind and open studies. Over 6,000 patients will be enrolled in the eight studies that comprise the T-EMERGE programme. Studies include two parallel taspoglutide arms including 10 mg once weekly and 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks. Four of the eight studies have active comparators, including exenatide, sitagliptin, insulin glargine and pioglitazone.
About Taspoglutide (R1583)
Taspoglutide was selected from a family of human once-weekly long-acting glucagon-like peptide-1 (GLP-1) analogues with structural modifications which confer intrinsic controlled release properties. Ipsen is the originator of the concept of matrix free sustained release formulation applied to therapeutic peptides and proteins. Taspoglutide is being developed, by Roche, as a novel and innovative treatment for patients with type 2 diabetes mellitus, the fourth leading cause of death in most developed countries. The structure of the molecule is similar to that of the natural human hormone GLP-1, and has the potential for intervals of up to two weeks in between administration without the use of a matrix.
About Diabetes
Diabetes is a disease characterized by excess blood glucose due to a deficiency in insulin availability and/or resistance to its action. Type 2 diabetes accounts for 90% to 95% of all diabetes cases worldwide and occurs almost entirely in adults. Complications from diabetes, such as coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness, are resulting in increasing disability, reduced life expectancy and enormous health cost for virtually every society. According to current estimates by the World Health Organization, the number of people with diabetes is set to more than double in the next 20 years to over 300 million by the year 2025.
About the agreement
Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market taspoglutide, except in Japan where these rights are shared with Teijin and in France where Ipsen may elect to retain co-marketing rights.
About Ipsen
Ipsen (Paris: IPN) is an innovation-driven global specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,200. Its development strategy is based on a combination of specialty medicine, which is Ipsen's growth driver, in targeted therapeutic areas (oncology, endocrinology, neurology and haematology), and primary care products which contribute significantly to its research financing. The location of its four Research & Development centres (Paris, Boston, Barcelona, London) and its peptide and protein engineering platform give the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. More than 800 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. This strategy is also supported by an active policy of partnerships. In 2008, Research and Development expenditure was about EUR183 million, close to 19% of consolidated sales, which amounted to EUR971 million while total revenues exceeded EUR1 billion. Ipsen's shares are traded on Segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150). Ipsen's shares are eligible to the "Service de Reglement Differe" ("SRD") and the Group is part of the SBF 120 index. For more information on Ipsen, visit our website at www.ipsen.com.
Ipsen Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Notably, future currency fluctuations may negatively impact the profitability of the Group and its ability to reach its objectives. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favourable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group's activities and financial results. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group's business is subject to the risk factors outlined in its registration documents filed with the French Autorite des Marches Financiers.
Source: Ipsen
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