GlaxoSmithKline related Press Releases

Disclosure of Shareholdings in Accordance with Stock Market Rules

Calisha Myers — Mon, 29 Sep 2008 12:44:21 -0400

Disclosure of Shareholdings in Accordance with Stock Market Rules

Geneva, Switzerland, 26 September 2008- Addex Pharmaceuticals (SWX:ADXN) announced today that on September 25, 2008, S.R. One Ltd, the investment arm of GlaxoSmithKline plc, has informed of reaching the threshold of 3.0% in the shareholding of Addex Pharmaceuticals Ltd., holding a total of 175,951 registered shares, corresponding to 3.0% of the voting rights.

About Addex

Addex Pharmaceuticals discovers and develops allosteric modulators for human health. Allosteric modulators are an emerging class of orally available small molecule therapeutic agents that we believe will offer patients better results than classical drugs. Most marketed drugs bind receptors where the body's own natural molecular activators (i.e. endogenous ligands) bind, specifically to a key part of each receptor's anatomy called the "active site". In short, most drugs must out-compete endogenous ligands for the active site. By contrast, allosteric modulators are non-competitive because they bind receptors and modify their function even if the endogenous ligand also is binding it. In addition, because of this, allosteric modulators aren't limited to simply turning a receptor on or off, the way most drugs are. Instead, they act more like a dimmer switch, offering control over the degree of activation or deactivation, while offering the body the ability to maintain control over initiating receptor activation. Furthermore, the allosteric approach generally affords freedom to operate - even on well-known, clinically validated targets - because the intellectual property surrounding allosteric chemistry and the allosteric sites on receptors is most often un-exploited.

ADX10059, our most advanced product, is an mGluR5 NAM (metabotropic glutamate receptor 5 negative allosteric modulator). It has demonstrated clinically and statistically significant efficacy in separate Phase IIa clinical trials in gastroesophageal reflux disease (GERD) patients and migraine headache patients and has potential in Parkinson's disease and other indications.

The Addex allosteric modulation discovery and development platform have been additionally validated through three seperatate product license or collaboration agreements with Merck & Co., Inc. and Johnson & Johnson as well as an investment by Roche Ventures.

Contact

Chris Maggos
Head of IR & Communications
Addex Pharmaceuticals
+41 22 884 15 11
chris.maggos(at)addexpharma.com

Disclaimer
The foregoing release may contain 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, future economic performance or prospects, and, by their very nature, involve inherent risks and uncertainties, both general and specific, whether known or unknown, and/or any other factor that may materially differ from the plans, objectives, expectations, estimates and intentions expressed or implied in such forward-looking statements. Such may in particular cause actual results with allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or other therapeutic targets 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 mGluR2, mGluR4, mGluR5, mGluR7 will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or other therapeutic targets will achieve any particular levels of revenue (if any) in the future. In particular, management's expectations regarding allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or other therapeutic targets 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 Ltd 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, except as may be required by applicable laws.

AHF Advocacy Spurs GSK to Suspend Fear-Mongering AIDS Drug Ads

Calisha Myers — Fri, 26 Sep 2008 10:33:56 -0400

AHF Advocacy Spurs GSK to Suspend Fear-Mongering AIDS Drug Ads

AHF Runs Pieces Headlined "GSK: Worst Drug Ads Ever." The Issue Prompts Articles in the Wall Street Journal and Philadelphia Inquirer; Subsequently, Company Pulls Ads

AHF and Others Believe Controversial Ad Campaign Was an Attempt by GSK to Maintain Market Share, to Detriment of Patient Health

LOS ANGELES--(BUSINESS WIRE)--AIDS Healthcare Foundation (AHF), the largest non-profit AIDS healthcare provider in the United States and operator of free AIDS treatment clinics in the US, Africa, Latin America/Caribbean and Asia, acknowledged British multi-national drug giant GlaxoSmithKline (GSK) for wisely suspending publication of its recent series of direct-to-consumer print advertisements that, under the guise of patient education, instead capitalized on patients' fears of HIV treatment. The controversial GSK ad campaign had been running since spring of this year in magazines such as POZ, a monthly national magazine targeting people living with HIV/AIDS. Over the summer, AHF began an aggressive advocacy effort criticizing GSK for the irresponsible marketing tactics it used in this campaign, which AHF and others saw as an attempt by GSK to maintain its dwindling market share for AIDS drugs, disregarding the negative impact such advertising has on patients' health.

AHF's advocacy efforts, which included a "GSK: Worst Drug Ads Ever" print ad campaign directly criticizing the GSK ads, initially publicized the issue. AHF's campaign begin last in late August and featured print ads in publications including the Washington Blade, the Village Voice and Los Angeles' Frontiers. To learn more and view a copy of AHF's "GSK: Worst Drug Ads Ever" ad: http://www.aidshealth.org/news/press-releases/ahf-blasts-gsk-on- advertisement.html. This lead to comprehensive and unflattering news articles in the Wall Street Journal (August 25, 2008) and the Philadelphia Inquirer (August 29, 2008)-both of which cited AHF's criticisms of GSK. The GSK ads are not running in the current October edition of POZ.

The two print advertisements in question did appear in the June and July/August issues of POZ, a national monthly magazine targeting those living with HIV/AIDS. Both ads utilized the same scare tactic to dissuade patients from changing their HIV medications, presumably from GSK's drugs to a competitor's. One ad featured a scenic photo of the sun setting over the ocean with what appear to be sailboats floating calmly in the background. The text, invitingly, reads: "First Impressions...". Upon turning the page, an ominous image greets you. A close-up on the triangular boat sails reveals them to be the fins of sharks lurking just beneath the water's surface. The text on this page: "...Can Be Deceiving. Avoid hidden dangers from changing your HIV medicines." And, opposite the shark fin image: "If you are thinking about switching your HIV medicine, make sure you know what you're getting into." Another similar ad, with the same text, features a scenic view of a placid lake, sand dunes, palm trees and serene fields, that-on the next page-are revealed to be hiding a fierce, menacing-looking lion.

"AIDS drug advertising has a history of distorting the reality of AIDS treatment in order to generate sales. However, the GSK ads sank to a new low, and we are grateful that they have had the good sense to suspend this marketing campaign," said AHF President Michael Weinstein. "These ads resort to blatantly exploiting patient fears in order to sell a product, while remaining unconcerned about the potential harm caused to patients who might be scared off treatment altogether, or going on a better course of treatment because of the threats implied by these ads. Frankly, we were disappointed that Poz magazine-a publication targeted to an HIV-positive population-would even run such inflammatory ads. This kind of underhanded negative advertising creates fear of HIV treatment in general, which could dissuade people from seeking treatment at all."

"Unfortunately, the ads only served to amplify fears and doubts patients may already have about antiretroviral therapy, making it harder for doctors to treat them," said Homayoon Khanlou, M.D., AHF's Chief of Medicine/U.S. "It is important for patients and their providers to work together to make treatment decisions independent of drug industry advertising that might compromise the doctor/patient relationship and potentially the health of the patient."

According to the August 25^th Wall Street Journal news article on the ad controversy: "The ads are part of a larger trend of drug companies taking aim at rival HIV drugs, hinting at side effects and other drawbacks, experts say." The article also noted that: "A development fueling the sharp-elbows advertising: The market for HIV medicines has grown crowded, and companies want to protect their market share."

As part of its ongoing advocacy efforts to ensure drug companies act responsibly with their DTC advertising, AHF will continue to challenge GSK and other pharmaceutical companies over questionable advertising and marketing tactics to ensure that such harmful ads are no longer produced. And to ensure such drug advertising will no longer be permitted, AHF has also contacted the U.S. Department of Health and Human Services (HHS) to express concerns regarding this particular GSK campaign and to ask HHS for better government and regulatory oversight of direct-to-consumer drug advertising in general so that all drug ads are in the best interest of patient health.

(NOTE: Long URLs in this release may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

About AHF

AIDS Healthcare Foundation (AHF) is the nation's largest non-profit HIV/AIDS healthcare provider. AHF currently provides medical care and/or services to more than 80,000 individuals in 22 countries worldwide in the US, Africa, Latin America/Caribbean and Asia. Additional information is available at www.aidshealth.org.

New data for GlaxoSmithKline's pre-pandemic H5N1 influenza vaccine, PrepandrixTM, show administration flexibility for pandemic

Maureen Martino — Thu, 18 Sep 2008 09:07:36 -0400

New data for GlaxoSmithKline's pre-pandemic H5N1 influenza vaccine, Prepandrix^TM, show administration flexibility for pandemic planning

Prepandrix^TM, Europe's only approved pre-pandemic influenza vaccine, confers persistent immune response against a number of H5N1 strains

Issued: 16th September 2008, Third European Influenza Conference (ESWI), Vilamoura, Portugal

Results from two new clinical studies announced at the Third European Influenza Conference (ESWI) demonstrate that Prepandrix^TM, GlaxoSmithKline's (GSK) H5N1 adjuvanted pre-pandemic influenza vaccine, confers broad cross-clade immunity that is maintained when the second dose is given many months after the first dose, and even if the second dose is formulated from a different H5N1 strain. Greater administration flexibility, adaptable to local pre-pandemic vaccination policies, could potentially reduce the impact on vital healthcare resources during the first intensive months of a pandemic.

"When indeed H5N1 would be at the basis of the next influenza pandemic, it is critical that a pre-pandemic H5N1 influenza vaccine provides broad and persistent immunity, also against drifted H5N1 strains." said Professor Albert Osterhaus, Head Department of Virology, Institute of Virology Erasmus Medical Centre Rotterdam. "GSK's pre-pandemic influenza vaccine has repeatedly demonstrated and now confirmed that this level of immunity can be maintained when the second dose is given many months after the first, even with a different H5N1 strain."

The World Health Organization (WHO) considers that the world is now closer to another influenza pandemic than at any time since the last one in 1968,1 with the virus currently threatening to trigger a pandemic (H5N1) having a potential reported case fatality rate above 60%.2 The WHO has highlighted that vaccines are the most important intervention for preventing influenza and reducing its health consequences during a pandemic1.

A pre-pandemic influenza vaccine is the only vaccine which can be produced in advance and stockpiled today, allowing immediate availability in the event of a WHO declared pandemic. In contrast, a pandemic influenza vaccine can only go into production once the exact pandemic influenza strain is determined and declared, with the first doses being available a minimum of four months after the onset of a pandemic.2

The pre-pandemic influenza vaccine concept is based on using a currently circulating avian influenza virus likely to cause a pandemic, such as H5N1, to make a vaccine with the ability to raise immune protection against potential drift H5N1 strains. With experts citing immunisation with stockpiled pre-pandemic influenza vaccine as the most effective strategy for protecting entire populations,3,4 GSK's pre-pandemic vaccine will play a critical role in pandemic preparedness planning.

"These new data show that GSK's pre-pandemic influenza vaccine, is highly adaptable to local pandemic policies. Stockpiling of H5N1 vaccine and use of this vaccine is anticipated to provide the ability to offer protection to vaccinated individuals as well as to slow down the spread of the disease. New developments such as this make it vital for governments to continually evaluate their pandemic preparedness plans," said Jean Stéphenne, President and General Manager GSK Biologicals. "We are actively working with governments and other organisations across the world to ensure the most effective pre-pandemic influenza vaccine is available to help protect against an influenza pandemic."

Study Results from ESWI

AS03 adjuvanted pre-pandemic H5N1 vaccine allows highly flexible prime-boost vaccination strategy
The phase II, open, randomised study (in adults aged 18-60 years) evaluated the impact on the reactogenicity and immunogenicity when the second dose is administered between 21 days and up to six months after the first dose using GSK's adjuvanted pre-pandemic influenza vaccine. A single booster dose of Prepandrix was administered six months after primary vaccination with either one or two dose(s) of the same adjuvanted vaccine. The results show that two vaccination doses, whether given 21 days or six months apart, elicit a comparable immune response against the vaccine strain. This confirms that the timing of administration with the second dose can be flexible and undertaken up to six months after first immunisation while maintaining the quality of the immune response. This highlights the robustness of the immunity achieved with the adjuvanted vaccine.

AS03 adjuvanted pre-pandemic H5N1 vaccine: single dose primary vaccination with clade 1 vaccine strain leads to strong immune responsiveness to clade 2 strain booster vaccination
The phase II, open, randomised study (in adults aged 18-60 years) evaluated the cross-clade* immunity with a two dose vaccination schedule using GSK's adjuvanted pre-pandemic H5N1 influenza vaccine. A single booster dose of the pre-pandemic influenza vaccine containing a clade 2.1 strain (drifted* H5N1 strain) was administered six months after primary vaccination with either one or two dose(s) of the pre-pandemic vaccine containing a clade 1 strain (Prepandrix). The clinical trial results show that a single dose primary vaccination with a clade 1 vaccine strain leads to strong immune responsiveness to the clade 2 strain booster vaccination. In addition, re-vaccination provides rapid and notable cross-clade immune responses against both strains.

*A clade is the name given to groups of viral variants that are closely related from an evolutionary standpoint

*Drift strains are the result of small, gradual changes in the genetic material that occur through point mutations (which are random and unpredictable) resulting in alterations to the main surface proteins, haemagglutinin, and neuraminidase

Notes to Editors

About GSK's Adjuvanted Pre-Pandemic Influenza Vaccine
GSK's H5N1 adjuvanted pre-pandemic influenza vaccine is the first and only pre-pandemic influenza vaccine to be granted marketing authorisation by the European Commission (in 30 European states).The vaccine is an H5N1 adjuvanted pre-pandemic influenza vaccine, designed to be given before or at the onset of a declared influenza pandemic to prevent influenza caused by the H5N1 virus type (avian influenza or ‘bird flu'). GSK's vaccine is formulated with a novel proprietary adjuvant system, which is designed to achieve a high immune response at a low dose of antigen, and to be long-lasting and active against a broad range of H5N1 strains.

GSK is the world leader in pandemic influenza product development as it is the only company to operate a flexible portfolio of licensed pandemic products, including the pre-pandemic influenza vaccine (Prepandrix), a pandemic influenza vaccine (Pandemrix) and an influenza antiviral (Relenza®).

GlaxoSmithKline Supporting Pandemic Preparedness Plans
GSK has previously announced its intention to donate 50 million doses of its H5N1 adjuvanted pre-pandemic influenza vaccine to the WHO in support of its stockpile initiative. The intended donation would help establish a much needed stockpile of pre-pandemic vaccines that can be distributed to the world's poorest countries at short notice by the WHO. Delivered over a three-year period, it would provide enough doses of vaccine for 25 million people at two injections per person. GSK supports this proactive strategy of worldwide stockpiling of H5N1 pre-pandemic vaccine which may be able to save millions of lives by protecting some of the most vulnerable populations in the world at the outbreak of a pandemic.

GSK has already signed contracts with the US and several European countries, such as Switzerland and Finland, for the supply of its pre-pandemic vaccine and bulk antigen.

Prepandrix^TM, Pandemrix^TM andRelenza® are trade marks of the GlaxoSmithKline group of companies.

GlaxoSmithKline (GSK) - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.

GlaxoSmithKline Biologicals (GSK Bio) - one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GSK's activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2007, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world - an average of 3 million doses a day. Of those vaccine doses, more than one in every ten doses delivered were combination vaccines intended to prevent up to six diseases in one vaccine.

Prepandrix^TM, Pandemrix^TM andRelenza® are trade marks of the GlaxoSmithKline group of companies.

***

References

1. WHO. Influenza Pandemic Preparedness and Response. Report by the Secretariat. EB115/44. 20 January 2005. (Accessed Aug 08)

2. Osterhaus Albert. Pre- or post-pandemic influenza vaccine? Editorial. Vaccine 2007; 25: 4983-4984.

3. Gambotto A, Barratt-Boyes SM, de Jong MD, Neumann G, Kawaoka Y. Human infection with highly pathogenic H5N1 influenza virus. Lancet 2008; 371; 1464-75

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.

Antitrust: Commission welcomes Court decision on parallel trade in the pharmaceutical sector

Calisha Myers — Wed, 17 Sep 2008 11:59:53 -0400

Brussels, 16^th September 2008

Antitrust: Commission welcomes Court decision on parallel trade in the pharmaceutical sector

The European Commission welcomes today's ruling of the European Court of Justice (ECJ) on the supply quotas for pharmaceuticals on the Greek wholesale market (Joined Cases C-468/06, C-469/06, C-470/06, C-471/06, C-472/06, C-473/06, C-474/06, C-475/06, C-476/06, C-477/06, C-478/06 Sot. Lélos kai Sia). The ECJ decided that a dominant company's refusal to supply wholesalers with a view to impeding parallel trade constitutes an abuse of a dominant market position under Article 82 of the EC Treaty unless it is justified by objective reasons. The Court confirmed that differences in national price regulations are in themselves not a sufficient justification and that control exercised by Member States over the selling prices or the reimbursement of medicines does not entirely remove the prices of those products from the law of supply and demand. The ruling confirms the Commission's antitrust policy, namely that the protection of parallel trade in the pharmaceutical sector is within the scope of EC competition law.

The ECJ gave a preliminary ruling based on national proceedings between the pharmaceutical company GlaxoSmithKline (GSK) and Greek wholesalers exporting pharmaceutical products to countries where prices for medicines are higher.

In 2000, GSK stopped supplies of three medicines (Lamictal, Imigran and Serevent) to Greek wholesalers, who complained to the Hellenic Competition Commission (HCC). GSK subsequently resumed supplying wholesalers in 2001, but only at volumes to meet national demand, i.e. not enough for exporting.

The case was brought before the ECJ on a request from the Greek Competition Commission for a preliminary ruling asking to clarify whether pharmaceutical supply quotas could constitute an abuse of a dominant position under Article 82 of the EC Treaty and to what extent State interventions that fixe prices for pharmaceuticals must be taken into account to assess the alleged infringement. Advocate-General Jacobs stated in his opinion that supply restrictions can be justified to protect commercial interests, even if they intend to impede parallel trade. However, the ECJ refused the case on procedural grounds.

In November 2006 the Athens Appeal Court re-submitted the same questions. In today's ruling, the European Court of Justice considers, in line with Advocate-General Ruiz-Jarabo Colomer's opinion of 1 April 2008, that where a dominant pharmaceutical company refuses to supply medicines to wholesalers with a view to impede parallel trade, it abuses its dominant position unless it provides objective justifications. In this case, the reasons for the refusal to supply submitted by GSK, in particular, the fact that the State intervenes in fixing prices for pharmaceuticals at national level do not constitute, according to the Court, objective justifications as such. The court considers however, that a producer of pharmaceutical products must be in a position to protect its own commercial interests if it is confronted with orders that are out of the ordinary in terms of quantity. Whether orders are ordinary must be assessed by the national courts in the light of the needs of the national market in question and previous trading relations.

GSK and XenoPort Announce Submission of New Drug Application Requesting FDA Approval of Solzira for Restless Legs Syndrome

Calisha Myers — Tue, 16 Sep 2008 08:54:55 -0400

GSK and XenoPort Announce Submission of New Drug Application Requesting FDA Approval of Solzira for Restless Legs Syndrome

Submission Based on Results from Pivotal Trials Evaluating Efficacy, Safety and Maintenance of Effect in Patients with Moderate-to-Severe Primary RLS

RESEARCH TRIANGLE PARK, N.C. and SANTA CLARA, Calif., September 16, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira(TM) (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the United States and can result in distressing symptoms that disrupt sleep and significantly impact daily activities.

Solzira is a non-dopaminergic new chemical entity that provides improvement in the symptoms of RLS with the convenience of a once-daily formulation.

"GSK is committed to bringing innovative products to patients where there is unmet medical need," said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicine Development Center. "We believe that Solzira may offer a new therapeutic option to treat primary Restless Legs Syndrome, a condition that includes both sensory and motor symptoms."

The NDA submission is based on a comprehensive Phase 3 clinical development program for Solzira in patients with moderate-to-severe primary RLS, including data from two randomized, double-blind, placebo-controlled trials (PIVOT RLS I and PIVOT RLS II), which evaluated the safety and efficacy of Solzira over 12 weeks. The submission also included results from a third pivotal trial (PIVOT RLS Maintenance) evaluating the ability of Solzira to maintain efficacy in treating RLS symptoms over a nine-month period. The most common side effects of Solzira were dizziness and somnolence.

"We are very encouraged by the results that we have seen in the clinical development program for Solzira," said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort. "Solzira is the first non-dopaminergic compound to demonstrate efficacy in large, controlled clinical trials for the treatment of primary RLS, and we believe it will offer patients a beneficial alternative to currently approved therapies."

About SOLZIRA

Solzira is a new chemical entity that is designed to improve upon the pharmacokinetics of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline at www.gsk.com.

About XenoPort

XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. Its development and commercialization efforts are currently focused on potential treatments of central nervous system disorders. Its most advanced product candidate, XP13512, which is known as Solzira in the United States, has been evaluated for the treatment of RLS. As announced today, GlaxoSmithKline, in collaboration with XenoPort, has filed with the FDA the NDA for Solzira(TM) for the treatment of RLS. XenoPort has also successfully completed a Phase 2a clinical trial of XP13512 for the management of post- herpetic neuralgia. XP13512 is currently being evaluated by XenoPort's collaborators, Astellas Pharma Inc. and GlaxoSmithKline, in Phase 2 clinical trials as a potential treatment for neuropathic pain, by Astellas in a Phase 2 clinical trial as a potential treatment for RLS in Japan and by GlaxoSmithKline in a Phase 2b clinical trial as a potential treatment for prophylaxis of migraine headache. XenoPort has reported positive results from a Phase 2a clinical trial of its second product candidate, XP19986, in patients with gastroesophageal reflux disease, or GERD. It is currently conducting a second Phase 2 clinical trial in GERD patients and plans to initiate an exploratory Phase 2 clinical trial of XP19986 in patients with acute back spasms. It is also evaluating XP19986 as a potential treatment of patients with spasticity related to spinal cord injury. XenoPort's third product candidate, XP21279, has been evaluated in a Phase 1 clinical trial that produced positive data regarding its use as a potential treatment for Parkinson's disease. To learn more about XenoPort, please visit the Web site at www.XenoPort.com.

GlaxoSmithKline Forward-Looking Statement

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.

XenoPort Forward-Looking Statement

This press release contains "forward-looking" statements, including, without limitation, all statements related to the therapeutic and commercial potential of Solzira. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes", "plans," "will", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort' s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability of the company to successfully conduct the clinical trials for Solzira, and the results thereof; the uncertainty of the FDA approval process and other regulatory requirements; XenoPort' s dependence on its current and additional collaborative partners; and the therapeutic and commercial value of the company' s compounds. These and other risk factors are discussed under the heading "Risk Factors " in XenoPort' s Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, filed with the Securities and Exchange Commission on August 7, 2008. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company' s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

New cannabis-like drugs could block pain without affecting brain, says study

Calisha Myers — Mon, 15 Sep 2008 13:00:36 -0400

New cannabis-like drugs could block pain without affecting brain, says study

A new type of drug could alleviate pain in a similar way to cannabis without affecting the brain, according to a new study published in the journal Pain on Monday 15 September.

The research demonstrates for the first time that cannabinoid receptors called CB2, which can be activated by cannabis use, are present in human sensory nerves in the peripheral nervous system, but are not present in a normal human brain.

Drugs which activate the CB2 receptors are able to block pain by stopping pain signals being transmitted in human sensory nerves, according to the study, led by researchers from Imperial College London.

Previous studies have mainly focused on the other receptor activated by cannabis use, known as CB1, which was believed to be the primary receptor involved in pain relief. However, as CB1 receptors are found in the brain, taking drugs which activate these receptors can lead to side-effects, such as drowsiness, dependence and psychosis, and also recreational abuse.

The new research indicates that drugs targeting CB2 receptors offer a new way of treating pain in clinical conditions where there are currently few effective or safe treatments, such as chronic pain caused by osteoarthritis and pain from nerve damage. It could also provide an alternative treatment for acute pain, such as that experienced following surgical operations.

The new study showed that CB2 receptors work to block pain with a mechanism similar to the one which opiate receptors use when activated by the powerful painkilling drug morphine. They hope that drugs which target CB2 might provide an alternative to morphine, which can have serious side effects such as dependency, nausea and vomiting.

Praveen Anand, Professor of Clinical Neurology and Principal Investigator of the study from the Division of Neurosciences and Mental Health at Imperial College London, said: "Although cannabis is probably best known as an illegal recreational drug, people have used it for medicinal purposes for centuries. Queen Victoria used it in tea to help with her period pains, and people with a variety of conditions say that it helps alleviate their symptoms.

"Our new study is very promising because it suggests that we could alleviate pain by targeting the cannabinoid receptor CB2 without causing the kinds of side-effects we associate with people using cannabis itself."

The researchers reached their conclusions after studying human sensory nerve cells in culture with CB2 receptor compounds provided by GlaxoSmithKline, and also injured nerves from patients with chronic pain.

The researchers are now planning to conduct clinical trials of drugs which target CB2 in patients with chronic pain at Imperial College Healthcare NHS Trust, which has integrated with Imperial College London to form the UK's first Academic Health Science Centre.

ESMO 2008 - GlaxoSmithKline announces newly integrated 'GSK Oncology' Research and Development unit

Maureen Martino — Fri, 12 Sep 2008 10:34:01 -0400

ESMO 2008 - GlaxoSmithKline to present encouraging new data supporting late stage development programme

- Newly integrated ‘GSK Oncology' Research and Development unit announced

12 Sep 2008 , London, UK : At the 33rd meeting of the European Society of Medical Oncology (ESMO) Stockholm, Sweden, GlaxoSmithKline (GSK) Oncology will present exciting new data for Tyverb® (lapatinib) and pazopanib. These new data form the foundation of Phase III development plans for these molecules across a variety of tumours including Head and Neck, Ovarian, Lung, and Soft Tissue Sarcoma.

GSK will also present data for the anti-emetic neurokinin-1 receptor antagonist, Zunrisa^TM (casopitant); the oxidative stress inducer, elesclomol, for metastatic melanoma and the antigen-specific cancer immunotherapeutic, MAGE-A3 ASCI for non-small cell lung cancer and metastatic melanoma.

These data represent a significant level of growth within GSK's oncology portfolio - demonstrating the Company's commitment to oncology and the strength of its late stage pipeline

Newly Integrated ‘GSK Oncology'
Today, GSK also announced the formation of a newly integrated Oncology Research and Development Organisation. GSK Oncology brings together small discovery units (DPUs) within the existing CEDD, and a highly specialised drug development group to create a dedicated oncology research and development organisation, led by Paolo Paoletti, M.D., Senior Vice President Oncology Research and Development.

"GSK has designed this new organisation to help us increase the breadth and depth of our core oncology knowledge, in order to ultimately deliver more innovative medicines that enhance cancer patients' lives", said Paoletti. "By creating an end-to-end R&D unit we are able to capture the many synergies that exist between discovery and development in oncology. The application of translational medicine will bring about significant enhancements to the R&D group via the ‘bench to bed' connection - the constant loop and flow of information from early to late stage development, and vice-versa."

"The newly formed GSK R&D Oncology Unit is directly aligned with our R&D strategy to deliver more products of value, and will help us increase our efforts towards personalised medicine in oncology," said Moncef Slaoui, Chairman, Research and Development. "This dedicated unit will have the primary goals of identifying new targets and pathways, conducting innovative clinical research and cost-effectively increasing development capacity in order to deliver the unit's large portfolio of medicines."

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

Ellen Strahlman Appointed Chief Medical Officer at GlaxoSmithKline

Maureen Martino — Thu, 11 Sep 2008 10:14:59 -0400

Ellen Strahlman Appointed Chief Medical Officer at GlaxoSmithKline

PHILADELPHIA, Sept 09, 2008 -- Ellen Strahlman, M.D., M.H.Sc., has been appointed Chief Medical Officer (CMO) at GlaxoSmithKline

Ellen joins GSK from Pfizer Inc. where she was Vice President, Licensing, Worldwide Business Development. During her career, Ellen has worked in a variety of roles including Chief Executive Officer of Virogen Limited, a biotechnology company; Chief Medical Officer and Global Head of R&D for Bausch & Lomb, a pharmaceutical company; and as a senior medical officer for the US government at the National Eye Institute at the National Institutes of Health. She also has worked in leadership roles at Merck and Novartis.

An ophthalmologist, Ellen was appointed this year as the industry representative to the Food and Drug Administration/Center for Drug Evaluation and Research (CDER) Dermatologic & Ophthalmic Drug Advisory Committee. She also serves on the Columbia University Medical & Science Technology Council and the Board of the Foundation of the American Academy of Ophthalmology.

She has a Bachelor of Arts degree in biochemistry and mathematics from Harvard University. She earned her medical degree at the Johns Hopkins University School of Medicine, where she completed her internship in general surgery and residency in ophthalmology. She also has a Master of Heath Sciences' degree in epidemiology and statistics from the Bloomberg School of Public Health at Johns Hopkins.

The Chief Medical Officer is the most senior physician leader of the company with primary responsibility for matters of patient safety, general medical governance, ethics and integrity, medical information, and investigation involving human subjects relating to any GSK products (pharmaceutical, biologicals and consumer healthcare medicinal products) in development or on the market.

"This role unquestionably represents one of the most important physician leadership opportunities within the global biopharmaceutical industry," said GSK R&D Chairman Moncef Slaoui. "The depth of Ellen's medical expertise, her general management and business development experience and proven leadership skills make her ideally suited to take on the challenges of this critical role."

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GlaxoSmithKline Signs Up to $1.5 Billion Drug Deal with Cellzome

Maureen Martino — Wed, 10 Sep 2008 09:01:59 -0400

GlaxoSmithKline Signs Up to $1.5 Billion Drug Deal with Cellzome

LONDON and CAMBRIDGE, England and PHILADELPHIA and HEIDELBERG, Germany, September 10 -- Cellzome Inc. and GlaxoSmithKline (LSE & NYSE: GSK) announce the signing of a worldwide strategic alliance to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases.

The alliance gives GSK access to Cellzome's significant expertise in identifying and developing selective kinase inhibitors and its proprietary Kinobeads(TM) technology which, by screening compounds in a physiological setting, is designed to improve the predictability of these drug candidates' performance in clinical testing. Kinases are key molecular switches in cellular signaling events with a central role in many inflammatory responses and selective inhibitors offer a different approach to therapeutic intervention in diseases such as rheumatoid arthritis or multiple sclerosis.

Under the agreement GSK has exclusive options to license drug candidates from Cellzome's kinase programs directed against four identified targets, and three additional targets to be jointly identified by both parties. In the alliance, Cellzome will utilize its proprietary Kinobeads(TM) technology to discover novel small molecule inhibitors of these targets, and then will develop the most promising product candidates through to completion of a clinical proof of concept trial, unless GSK elects to exercise its option earlier. Cellzome is eligible to receive success-based milestones from GSK as product candidates are advanced. Upon Cellzome's achievement of clinical proof of concept for a product candidate for a particular kinase target, GSK would have an exclusive option to license all product candidates from that program. GSK would then assume full responsibility for further clinical development and commercialization on a worldwide basis. Cellzome retains the right to continue the development and commercialization of drug candidates if GSK chooses not to exercise its option to that program.

Under the terms of the agreement, Cellzome will receive upfront payments of GBP14.4 million comprised of both cash and equity. Cellzome is eligible for up to GBP118 million per program in potential development, regulatory and commercial milestones and up to double digit royalties on net sales of products resulting from the alliance.

Jose Carlos Gutierrez-Ramos, Ph.D, Senior Vice President and Head of the Immuno-Inflammation Centre of Excellence for Drug Discovery of GSK said: "GSK is committed to becoming a world leader in immuno-inflammation drug discovery by finding transformative medicines through internal efforts and external collaborations. We are excited to be working with Cellzome to discover and develop improved approaches to existing biologic therapies which cannot access intracellular signaling mechanisms. Cellzome's Kinobeads(TM) technology will provide a distinct advantage because it uses native kinases directly isolated from human cells and tissues."

Tim Edwards, CEO of Cellzome, said: "We are very pleased to begin a strategic alliance with GSK, one of the world's leading pharmaceutical R&D companies. This alliance is a significant endorsement of our leading Kinobeads(TM) technology, programs and people. It is a major event in Cellzome's development, giving us the opportunity to broaden our pipeline and progress several kinase programs towards the clinic, ultimately for the benefit of patients."

About Cellzome Inc.

Cellzome is a privately-owned drug discovery company identifying a new generation of kinase-targeted drugs to treat inflammatory diseases. Its pipeline of small-molecule therapeutics is driven by Kinobeads(TM), a proprietary technology for screening and profiling kinases in relevant cells and tissues.

Cellzome is applying its distinctive Kinobeads(TM) technology to the discovery and development of innovative small-molecule kinase inhibitors targeting key inflammatory mediators such as PI3Kg and d, Zap-70, Jak3 and mTOR, as potential oral therapeutics for rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, psoriasis and asthma.

In addition to the GSK collaboration, Cellzome has an alliance with Johnson & Johnson focused on the discovery of novel medicines for the treatment of Alzheimer's disease. Cellzome's holding company is domiciled in the US and it employs about 90 people at its two operating subsidiaries in Cambridge, UK and Heidelberg, Germany. To learn more about Cellzome, please visit the website: http://www.cellzome.com.

About GlaxoSmithKline (LSE & NYSE: GSK)

Cautionary statement regarding forward-looking statements

About Kinases

Kinases are important enzymes because they are responsible for either activating or inhibiting proteins within cell signaling pathways. As a result of their importance, approximately 30% of current discovery and development spending focuses on kinases, especially in the fields of oncology, inflammation and metabolic diseases. Despite this level of interest and research, only 8 small molecule kinase inhibitors have so far reached the market, all of them targeting oncology indications.

GlaxoSmithKline plc - Directorate change

Maureen Martino — Mon, 08 Sep 2008 11:11:15 -0400

GlaxoSmithKline plc - Directorate change

GlaxoSmithKline plc (GSK) today announced that Chris Viehbacher, Executive Director and President North American Pharmaceuticals, has decided to stand down from the Board on 8th September, and will leave the company with effect from 1st December 2008 to pursue another opportunity.

Andrew Witty, Chief Executive Officer said: I would like to thank Chris for his significant contribution to GSK, he is one of the most talented and respected executives in this industry and we wish him well in his future endeavours."