Tuesday, July 24, 2007

Newly Identified Boycott Targets Named

Contact: Life Decisions International, 540-631-0380, ext. 22, media@fightpp.org; General E-Mail: ldi@fightpp.org

WASHINGTON, July 24 /Christian Newswire/ -- Life Decisions International (LDI) will soon release a revised edition of The Boycott List, which identifies corporations that are boycott targets due to their support of Planned Parenthood, the world's leading abortion-advocacy group.

"As a direct result of the commitment, action and prayers of pro-family people, at least 153 corporations have stopped funding Planned Parenthood," said LDI President Douglas R. Scott, Jr. It is estimated that the boycott has cost Planned Parenthood more than $35 million since the Corporate Funding Project (CFP) began some 15 years ago. "This should be a testament to those who believe it is impossible to change corporate philanthropic behavior."

Corporations appearing on The Boycott List for the first time are Allstate (insurance), CCA Global (Carpet One, Flooring America, Flooring Canada, Flooring One, Lighting One, etc.), Chevron (fuel/energy; Xpress Lube, Texaco), Comcast (cable television, Internet, etc.), DuPont (chemicals), eBay (online marketplace; PayPal), Four Seasons Hotels (Regent Hotels), GlaxoSmithKline (over-the-counter medication, prescription drugs, etc.), Marriott (Courtyard Hotels, Fairfield Inn, Grand Residences, Horizons Hotels, JW Marriott Hotels, Renaissance Hotels & Inns, Ritz-Carlton Hotels, SpringHill Suites, TownePlace Suites), OSI Restaurant Partners (Outback Steakhouse, etc.), Sears (Kmart), Sonic (drive-in restaurants), and Wawa (convenience stores), among others.

Corporations continuing as boycott targets from the previously released Boycott List are Basics Office Products, Adobe (software), Wachovia (finance), Nike (shoes/apparel, etc.), Time Warner (Cinemax, HBO, AOL, etc.), Bank of America, CIGNA (insurance), Walt Disney, Johnson & Johnson, Lost Arrow (Patagonia, etc.), Wells Fargo, Whole Foods Market, and Nationwide (insurance), among others.

The new Boycott List includes a revised and significantly expanded "Dishonorable Mention" section, which identifies charitable organizations that are associated with Planned Parenthood and/or its agenda. Among the groups new to this section is the Audubon Society, Alzheimer's Association, American Association of Retired Persons (AARP), American Diabetes Association, Council of Churches (including Church World Service, and CROP Hunger Walks), Glaucoma Research Foundation, Juvenile Diabetes Foundation, Leukemia & Lymphoma Society Muscular Dystrophy Association (MDA), National Education Association (NEA), National Multiple Sclerosis Society, Save the Children, and the Sierra Club, among others.

"The Pro-Life Movement will succeed only to the extent that pro-life people are willing to be inconvenienced," Scott said. "The very lives of children are worth that much effort and a whole lot more."

More information about the CFP, visit www.fightpp.org


Edmonton, Alberta, July 24, 2007 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the first of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with approximately 215 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com .

Ryan Giese
VP Corporate Communications
Phone: 780-413-7152

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152

Childhood Sun Exposure May Lower Multiple Sclerosis Risk

By Judith Groch, Senior Writer, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
July 24, 2007

LOS ANGELES, July 24 -- Exposure to the sun may be a risk factor for skin cancer, but it seems to have a protective effect against multiple sclerosis, according to a twin study.

Action Points
Explain to patients who ask that in this study of genetically identical twins, the twin who spent more time in the sun as a child, had a lower risk of developing multiple sclerosis.

Explain to patients that the cause of multiple sclerosis is unknown, but that this study may provide insight into potential avenues for future research.

In a study of 79 pairs of monozygotic twins, the twin who spent more hours outdoors as a child had a 25% to 57% reduced risk of developing MS, Thomas M. Mack, M.D., M.P.H., of the University of Southern California, and colleagues, reported in the July 24 issue of Neurology.

Despite a strong genetic component, with an approximately 20% concordance among identical twins, environmental effects have been suggested by the role of latitude and of migration within genetically uniform groups, the researchers said.

To eliminate genetic confounding, the researchers sought twins, at least one of whom had MS, by yearly newspaper advertisements throughout North America from 1980 through 1992. Diagnosis was verified by updated medical documentation through 2005.

The analysis was limited to monozygotic twin pairs in which only one of the pair had MS and their childhood exposure to the sun differed. The twins had ranked themselves before 1993 in relation to each of nine childhood sun-exposure activities.

The diagnoses of the twin cases occurred between the ages of 15 and 50, with roughly two-thirds diagnosed from age 20 to 40.

Sun exposure included nine activities, those in the four major seasons, on hot and cold days, and time spent sun tanning, at the beach, or playing team sports. A sun exposure index was calculated as the sum of those exposures for which one twin ranked higher than his or her co-twin.

The odds ratio (OR) for MS ranged from 0.25 to 0.57, depending on the activity and the time of year.

For example, the risk of MS was substantially lower (OR 0.40, 95% CI 0.19 to 0.83, P=0.06) for the twin who spent more time sun tanning than for his or her sibling. For twins who spent more time playing team sports, the OR was 0.44 (CI, 0.19-1.02, P=0.06).

For each unit increase in the sun index, the relative risk of MS decreased by 25%, independent of birthplace and age at diagnosis, the researchers said.

The protective influence was seen among female twins only, they noted, but added that this novel finding must be viewed with caution because only 13 male pairs were involved in the study.

Exposure to sunlight might induce protection against an autoimmune disease by any of several immunosuppressive mechanisms, the researchers said. Ultraviolet radiation may exert its effect directly by producing cytokines, and reducing natural killer cell activity, thus affecting innate immunity.

Ultraviolet radiation can also act indirectly by producing vitamin D and suppressing melatonin secretion, with the resultant effects on Th1-Th2 balance, they speculated.

This effect is probably achieved by activated vitamin D suppressing production of cytokines associated with MS activity, such as IL-2, and tumor necrosis factor alpha, and stimulating opposing cytokines, the researchers said.

Because the researchers used relative exposure within pairs and were unable to directly quantify exposure, they could not estimate the level of exposure that might confer protection, and such estimates would be inaccurate under any circumstances, they said.

Furthermore, estimates of "time spent in the sun" or "in outdoor activities" involve substantial recall bias, given the long interval between sun exposure and diagnosis, the researchers said.

This study, Dr. Mack and his colleagues wrote, reports the importance of sun exposure among individuals with identical genetic risks. "Studies of the pathway by which sun exposure reduces MS risk should receive high priority if we are to unravel the mystery of MS etiology," they concluded.

The authors reported no conflicts of interest. The study was supported by grants from the National Multiple Sclerosis Society, the National Institute of Neurological Disorders and Stroke, the National Cancer Institute, and the National Institute of Environmental Health Sciences.

Additional Multiple Sclerosis Coverage

Primary source: Neurology
Source reference:
Islam T et al "Childhood sun exposure influences risk of multiple sclerosis in monozygotic twins" Neurology 2007; 69: 381-388

Monday, July 23, 2007

Veterans could be key in multiple sclerosis cure

By Stephanie Heinatz - Daily Press
July 22, 2007

NEWPORT NEWS, VA. — The National Multiple Sclerosis Society is keeping an eye on military veterans, especially those who served in the first Persian Gulf war and have since been diagnosed with the debilitating neurological disease.

“There appears to be an increased risk of MS in combat vets,” said Shawn O’Neail, the society’s vice president for federal government relations. “Are Gulf war veterans at an increased risk of developing MS? We have a long way to go to say that comfortably.”

But they want to find out.

The strongest evidence comes from a 2005 European Neurology study showing that from 1993 to 2000, the years following the first Gulf war, the rate of MS among Kuwaitis more than doubled.

“In a geographic area that was previously associated with low prevalence, local environmental factors may be responsible for these dramatic changes,” the study said.

If Gulf war vets do have an increased risk, it could lead researchers to a specific environmental trigger for the currently incurable disease. A trigger could lead to better treatment and “dare I say a cure,” according to O’Neail.

The society, with help from a nationwide grassroots effort, lobbied Congress this year to include MS in the Congressionally Directed Medical Research Program, which is administered by the Defense Department.

While diseases studied in the program don’t necessarily have a connection to military service, the society never pursued getting MS included before because “it never really made sense to us,” O’Neail said. “It makes sense now.”

More than 25,000 veterans from all wars have been diagnosed with MS, O’Neail said. More than 5,000 of those cases have been classified “service connected” by the Department of Veterans Affairs.

The symptoms for Gulf war illness and MS can be very similar, said Julie Mock, a Gulf war veteran with MS who runs Veterans of Modern Warfare.

MHRA stalls cannabis-based MS drug

By Anna Lewcock

23/07/2007 - A UK firm developing cannabis-derived multiple sclerosis (MS) treatments has decided to pull an EU application for its lead candidate Sativex, following demands by UK regulators for additional data in support of the treatment.

Despite the fact that there are no quality or safety issues standing in the way of approval for GW Pharmaceuticals' MS spasticity treatment Sativex, and clinical efficacy data showing promising and statistically significant results, the Medicines and Healthcare products Regulatory Agency (MHRA) has requested an 'enriched design' study be carried out focussing on specific patients who respond to the treatment.

MS specialist Professor Mike Barnes of the University of Newcastle criticised the regulator's "bureaucratic approach," claiming it is "regrettable and unnecessary…that the regulators require GW to generate further data to show what we already know - that Sativex is a safe and efficacious treatment for people with MS."

The stumbling block in the approval process has been caused by the fact that Sativex is intended for patients who have exhausted all other treatment options, which means that some subjects simply lack the ability to respond to the the drug, or any other MS treatment.

"That translates in a clinical trial setting into a situation where…patients who do respond [are] masked by the lack of response in those patients who simply don't have the capacity to respond," explained Stephen Wright, R&D director at GW.

As such, the MHRA has asked GW to carry out confirmatory studies looking only at patients showing a response to Sativex, and to identify the level in response in this set of subjects. Although the company carried out analysis of existing data through which responders were found to be easily identifiable, as well as 62 per cent more likely to achieve a meaningful response than on placebo, the MHRA has put its foot down and demanded more data be generated before the drug can be approved.

"Analyses show we can very reliably identify responders after four weeks of treatment," said Wright.

"From the regulator's point of view that is very encouraging, but from a technical point of view they have a requirement that those analyses be carried out in a prospective way rather than in a 'post-hoc' analysis."

GW had planned to carry this type of study further down the line anyway, and as such is already well-prepared to carry out the confirmatory study. The first patients should be able to enter the trial in October this year, with completion expected in around 12 months time.

The company has two options for resubmission in the EU following the decision to withdraw its application last week. A second pivotal Phase III trial of Sativex for the treatment of MS neuropathic pain is due to complete in early 2008, which could lead to a regulatory filing around that time. As the outstanding issue regarding efficacy in responders relates to an indication of MS spasticity, it should not affect the pain application.

Should GW not submit an application for the neuropathic pain indication, the company's next opportunity is to submit for MS spasticity in the second half of 2008 following completion of the additional study.

"It's quite clear from our discussions with [the MHRA] that this enrichment study, providing it's positive, will result in the approval of Sativex," said Wright.

Sativex is GW Pharmaceutical's first product, and is being developed for approval in four target indications: MS spasticity, MS neuropathic pain, cancer pain and peripheral neuropathic pain.

The treatment is based on extracts taken from the widely-used recreational drug cannabis, and applied as an oro-mucosal spray to the mouth. It is based on a combination of two well-characterised cannabinoids (chemical compounds found only in the cannabis plant), delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD).

THC has been shown to have analgesic, anti-spasmodic, anti-tremor, anti-inflammatory, appetite stimulant and anti-emetic properties, while CBD has shown anti-inflammatory, anti-convulsant, anti-psychotic, anti-oxidant, neuroprotective and immunomodulatory effects.

In April 2005 GW received approval for Sativex in Canada, for use as an adjunctive therapy for the relief of neuropathic pain in patients with MS. The company also expects Canadian approval for the relief of cancer pain in the near future.

In the US, cancer pain is the lead indication for Sativex, with the first patients entering pivotal late stage trials next month.

While the drug is yet to be approved anywhere outside Canada, the company has already licensed Sativex to Bayer Healthcare for the Canadian and UK markets and Almirall Prodesfarma for the rest of Europe, as well as Otsuka for the US market. Together, these agreements have generated $51m (€37m) in signature fees, up to $376m in milestone payments, and 'significant' long term supply price provisions.

Elan Says About 14,000 People Are Taking MS Drug Tsyabri

July 23, 2007 8:37 a.m.

DUBLIN -- Elan Corp. said Monday that about 14,000 commercial patients world-wide were currently taking its multiple-sclerosis drug Tysabri, one year after its launch in Europe and re-launch in the U.S.

Elan and its U.S. partner Biogen Idec Inc. starting rolling out their 50-50 joint venture Tysabri in the U.S. and EU in June 2006 after it was temporarily suspended on safety grounds in 2005.

With 8,600 patients in the U.S., 4,300 in the EU and 1,000 in the rest of the world as of mid-July, this is 8.5% over NCB Stockbrokers' forecast, which says a slower U.S. uptake is being offset elsewhere.

Elan and Biogen in a statement quoted Howard Rossman, medical director, MS Center, Michigan Institute for Neurological Disorders in Farmington Hills, Mich., who said the drug had "compelling efficacy."

Dublin-based Goodbody Stockbrokers said Tysabri could have peak annual sales of $2.1 billion within three to four years, while AAB-001 -- if successful -- could have peak annual sales of up to $2.5 billion by 2015.

Davy Stockbrokers, which has a $21 target on Elan, "remains comfortable with our long-term projections for Tysabri for 2010, with global revenues of approximately $1.6 billion and patient numbers approaching 60,000."

Elan's share price has had a rollercoaster ride over the last five years: falling from its 2002 high of €50.27, leading some analysts to say that it may be significantly undervalued, given its Alzheimer's pipeline and MS drug.

Elan was down 1.4%, or €0.22, at €14.43 in Dublin in a week overall market; shares already fell from €15.55 last week after EU regulators advised against Tysabri's use for Crohn's disease.

The EU regulators cited the risk of serious infection given the relatively modest benefits, while the U.S. Food and Drug Administration's advisory panel is due to discuss Tysabri's use for Crohn's next week.

On the upside, the stock has still risen about 23% since late May on news of the imminent move into Phase III trials of its Alzheimer's treatment AAB-001, which is another 50/50 joint venture with Wyeth.

Write to Quentin Fottrell at quentin.fottrell@dowjones.com

Nuon Therapeutics, Inc. Completes Licensing, Supply and Collaboration Agreement on Tranilast With Kissei Pharmaceutical Co., Ltd.

SAN FRANCISCO--(BUSINESS WIRE)--Jul 23, 2007 - Nuon Therapeutics, Inc., a clinical stage biotechnology company, today announced the completion of a licensing, supply and collaboration agreement on tranilast with Kissei Pharmaceutical Co., Ltd., Matsumoto City, Japan.

The agreement will enable Nuon Therapeutics to advance tranilast, the company's lead compound, through the next phase of clinical development while giving Kissei the exclusive option right for research, development and marketing of tranilast in Japan and Korea for the field of autoimmune diseases, including multiple sclerosis (MS). The terms include provisions for Kissei to supply tranilast to Nuon Therapeutics for clinical trials and license Nuon related intellectual property on tranilast. The agreement also establishes a collaborative relationship between Nuon Therapeutics and Kissei for the development of additional portfolio products.

Nuon Therapeutics has licensed and developed worldwide intellectual property for the use of tranilast to treat MS, rheumatoid arthritis (RA), pain, and other indications.

"Our technology is based on the work of international thought leaders in autoimmune disease," said Rodney Pearlman, PhD, CEO of Nuon Therapeutics. "Nuon Therapeutics has collaborated with Dr. Marc Feldmann, Imperial College, London, to develop this technology in RA and pain and with Dr. Larry Steinman, Stanford University, Palo Alto, to develop tranilast in MS and other indications."

Kissei has marketed tranilast (under the brand name Rizaben(R)) in Japan and Korea for bronchial asthma since 1982. Indications for keloid and hypertrophic scar were added in 1993. In addition, a Rizaben eye drop was launched in 1995 in those countries and is widely used for allergic conjunctivitis. Tranilast is thought to act in these diseases by inhibiting the release of chemical inflammatory mediators from mast cells.

"We are delighted to have established a strategic partnership with Kissei, the originator of tranilast," said Joshua Funder, Chairman of Nuon Therapeutics and investor at GBS Venture Partners. "This collaboration will accelerate our development of new tranilast products as well as provide supply of high quality tranilast material for clinical trials. We are particularly excited to work with Kissei because of their extensive clinical experience with tranilast and deep insight in preclinical research in this field."

About Kissei Pharmaceutical Co., Ltd.

Kissei Pharmaceutical Co., LTD., headquartered in Matsumoto, Nagano prefecture, founded in 1946, is a Japanese pharmaceutical company that develops, manufactures, markets, sells and distributes brand pharmaceutical products. Kissei is primarily focused on three important fields of new drug research: urogenital, endocrinology & metabolism and immunology & allergy.

More: http://www.kissei.co.jp/

About Nuon Therapeutics, Inc.

Nuon Therapeutics, Inc. is a clinical stage biotechnology company that develops innovative small molecule drugs that address critical, unmet needs in autoimmune disease and pain. Nuon Therapeutics' initial programs are focused on repositioning tranilast to treat multiple sclerosis, rheumatoid arthritis and pain. The company's scientific founders are Dr. Larry Steinman at Stanford University, Palo Alto, Dr. Marc Feldmann, Imperial College, London, and Dr. Michael Selley, formerly from the Australian National University. Nuon Therapeutics, Inc. has headquarters in San Francisco, CA and a wholly-owned subsidiary, Nuon Therapeutics Pty. Ltd., in Australia, where additional discovery and development efforts are located.

More: www.nuontherapeutics.com

About GBS Venture Partners

GBS is Australasia's largest specialist life science venture capital investment group. GBS manages specialist funds from seed through to expansion stage in the life sciences sector, and has more than AU$300m under management. The GBS team has been investing in Australasia since 1996 and played founding roles in companies with a combined market capitalization of more than $1 billion.

More: www.gbsventures.com.au


Nuon Therapeutics, Inc.
Rodney Pearlman, 1-650-208-3478
Chief Executive Officer
E-mail: rpearlman@nuontherapeutics.com

Friday, July 20, 2007

GW thwarted again

Porton Down, UK, 20 July 2007: GW Pharmaceuticals plc (AIM: GWP) announces that it has chosen to withdraw its current regulatory application for Sativex in Europe and that it expects to resubmit an application for approval in 2008. This follows constructive and detailed discussions with regulatory authorities in which they have provided a clear path to approval for Sativex in the treatment of MS Spasticity.

MS Spasticity Application
In September 2006, GW filed an application for Sativex under the decentralised procedure in four European countries (UK, Spain, Denmark, Netherlands) for the relief of MS Spasticity. GW has been able to resolve successfully all the major questions raised by the regulators during this process except one, and at a meeting with the UK assessors this week, it became clear that this outstanding issue requires the generation of additional data. As European regulatory rules do not permit the introduction of new data as part of the current process, GW has elected to withdraw and resubmit its application.

The current regulatory application process has confirmed that quality and safety data are already sufficient to support a marketing authorisation of Sativex. The regulators have also confirmed that existing efficacy data provide statistically significant evidence and “could in principle lead to a positive risk benefit conclusion”. In addition, regulators have recognised that a large proportion of otherwise treatment-resistant patients respond to Sativex by obtaining clinically meaningful improvements in spasticity.

Sativex provides benefit to the most high need MS patients who have no further therapeutic options available. The regulator’s outstanding clarification relates to the fact that in a clinical trial context, the benefit obtained by “responders” can be masked by looking at the mean improvement across the whole studied patient population, which comprises both responders and non-responders. The regulators therefore wish to be able to identify Sativex responders in the first 4 weeks of treatment and to confirm that the improvements gained by such responders over a further 12 week period is significantly greater than placebo.

As part of the current regulatory process, GW performed analyses of existing data showing that responders can be reliably identified after 4 weeks and that, after 12 weeks, the difference from placebo is clinically important and highly statistically significant (p=0.015). The regulators view this as acceptable evidence of efficacy in principle but consider these analyses technically to be “post-hoc” since they were performed at the regulator’s request following completion of the trials. They require such data to be produced as part of a prospectively planned analysis and hence GW will undertake an additional study to re-confirm this result prior to resubmitting its regulatory application.

The regulators have given GW clear guidance as to the design of the further study required, which differs from a conventional Phase III design. The study is expected to start recruiting patients in the next few months, with the results due in the second half of 2008. The regulators have specified a novel “enriched design” which first identifies responders over a 4 week period, and then focuses on analysing the effect of Sativex vs placebo on those responders over a further period of time.

GW’s clinical plans for the next twelve months have for some time included a further MS Spasticity trial and the regulator’s specific design requirements will therefore be incorporated into the planned study. This study is already within GW’s budget for 2008, will not result in any increase in rate of R&D expenditure above current levels and will be financed from existing cash resources, which today stand at £19.5m.

Sativex Resubmission
There are two potential opportunities for early re-submission in Europe next year. In the indication of MS Neuropathic Pain, a second pivotal Phase III trial completes in early 2008 which could lead to a regulatory filing in this indication at that time. Since this is a distinct indication from MS Spasticity, the outstanding issue identified as part of this recent application would not be relevant. In the event that GW does not submit for this indication, the second opportunity is to resubmit for MS Spasticity later in 2008 following completion of the new study outlined above.

Dr Stephen Wright, R&D Director, said, “We are encouraged that the regulators see Sativex as providing useful efficacy and that they accept our quality and safety data as sufficient for approval. This regulatory application has provided us with a clear route to approval for Sativex in the relief of MS Spasticity. We have received detailed and constructive guidance from the regulators on how to satisfy their single outstanding requirement and are confident that we can address this.

“We expect to re-submit our application to the regulators in Europe in 2008, either in the indication of MS Neuropathic Pain or MS Spasticity. Elsewhere, we look forward to receiving final regulatory approval in Canada for the Cancer Pain indication in the coming weeks and our first large scale clinical trials in the US are scheduled to commence in the late summer.”

Professor Mike Barnes, President of the World Federation of Neuro-rehabilitation, Professor of Neurological Rehabilitation and Consultant Neurologist, University of Newcastle, said, “The data clearly show that Sativex provides valuable and much needed relief of MS Spasticity. Indeed, this medicine is able to treat some of the highest need MS patients, who currently have no further treatment options available. It is regrettable and unnecessary in my view, and in the view of other prominent members of the MS treatment community, that the regulators require GW to generate further data to show what we already know – that Sativex is a safe and efficacious treatment for people with MS.”

Dr Geoffrey Guy, GW Chairman, said, “We recognise that it is taking longer than we had hoped for Sativex to obtain approval in Europe. Each step, however, has been one of progress towards achieving this goal. Whilst we complete these final steps, we will continue to respond to the needs of people with MS by ensuring Sativex remains available under our named patient prescription programme.”

There will be a conference call for analysts today at 8.30am BST. Analysts should contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. There will be a live audio web cast of this call, which will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com). A recording of this call will be available on the GW website later today.


GW Pharmaceuticals plc Today: +44 20 7831 3113
Dr Geoffrey Guy, Chairman Thereafter: +44 1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR Tel: +44 7885 638810

Financial Dynamics Tel: +44 20 7831 3113
David Yates, Ben Atwell
About Sativex

Sativex is being developed for approval in four target indications (MS Spasticity, MS Neuropathic Pain, Cancer Pain and Peripheral Neuropathic Pain). Each of these indications provides a distinct regulatory opportunity and is supported by a specific clinical development programme.

In Canada, Sativex is approved for the relief of MS Neuropathic Pain and has also received a Qualifying Notice from the Canadian regulators for a further approval in the relief of Cancer Pain. Final approval of the Cancer Pain indication is expected shortly.

In the United States, the lead indication for Sativex is Cancer Pain and, following a series of positive meetings with the Food & Drug Administration (FDA), late stage trials in that country are about to commence.

GW has to date entered into three Sativex license agreements – with Otsuka in the US, with Bayer HealthCare in the UK and Canada, and with Almirall in Europe (ex-UK). These agreements together have yielded financial terms to GW totaling $51m of signature fees, up to $376m of milestone payments as well as significant long term supply price provisions.

About GW

GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products that alleviate pain and other neurological symptoms in patients who suffer from serious ailments. GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field. For further information, please visit www.gwpharm.com

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumer and medical professionals.

Thursday, July 19, 2007

Glenmark purchases rights to two therapeutic antibodies from Chromos

Mumbai, India and Burnaby, British Columbia, Canada July 19, 2007 - Glenmark Pharmaceuticals S.A., the wholly-owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark) and Chromos Molecular Systems Inc. (Chromos) (TSX:CHR) of British Columbia, Canada, announced today that they have completed the purchase by Glenmark of Chromos’ two New Biological Entities (NBE’s) CHR-1103 and CHR-1201. The two NBE’s are humanized monoclonal therapeutic antibodies.

Under the terms of the transaction agreements between Glenmark and Chromos, Glenmark has purchased all rights to the two products as well as rights to use Chromos’ proprietary ACE System technology for cell line development for use with respect to CHR-1103 and CHR- 1201. Glenmark holds the worldwide rights for further development, registration and
commercialization of these products. Financial terms of the transaction are not to be released.

CHR-1103 and CHR-1201 are part of a validated class of drugs known as SAMI’s (selective adhesion molecule inhibitors) that includes such drugs as ReoPro (Centocor/Lilly), Raptiva (Genentech/Xoma) and Tysabri (Biogen/Elan). CHR-1103 is a broad anti inflammatory agent with a novel mechanism of action, being developed initially to treat acute multiple sclerosis, for which there is no treatment approved at present. Glenmark plans to initiate Phase I clinical trials in 2008 and complete Phase 1 on CHR-1103 by March 2009. CHR-1201 is an anti-thrombolytic humanized monoclonal antibody, which Glenmark plans to develop initially to treat acute stroke. Glenmark plans to start Phase I on CHR-1201 by March 2009.

On this occasion, Glenn Saldanha, Managing Director and CEO of Glenmark Pharmaceuticals Ltd., stated, “This is a very important addition to our pipeline of Novel Biological Entities. These two NBE’s would help accelerate our pipeline in the biologics space.” Michael Buschle, President – Biologics at Glenmark Switzerland said, “These therapies hold a lot of promise in areas of high unmet medical need and also fit very well within our areas of focus. We are delighted with the addition of these two highly exciting molecules to our rapidly expanding pipeline”.

"We share Glenmark's enthusiasm for these antibodies, and are pleased that these therapies will be moved forward with the support of Glenmark's outstanding infrastructure and personnel" said Alistair Duncan, President and Chief Executive Officer of Chromos. As part of Chromos’ on-going restructuring proceedings under the Bankruptcy and Insolvency Act, the Supreme Court of British Columbia in Bankruptcy has approved this transaction. The upfront proceeds from this purchase transaction will be used to repay Chromos’ secured creditors.

About Glenmark

Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. The Company has generic formulation and API business interests in over 80 countries across the world including the highly regulated markets of USA and Europe. The formulation
business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT, Diabetes and Oncology. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. The Company’s second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes was out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. A third molecule targeting pain, GRC 6211, is undergoing Phase II clinical trials in Europe. Glenmark has three other programmes across obesity, inflammation and pain management at the pre-clinical stages; all of which should enter the clinics in H1 FY 2008. [www.glenmarkpharma.com]

For Further Information, Please Contact:
Vasudha Jha,
Tel: +91 22 6758 9919 / +919833822406
Email: media@glenmarkpharma.com

About Chromos

Chromos is a biopharmaceutical company focused on the development and commercialization of its proprietary ACE System technology that is used to engineer production quality cell lines to manufacture biopharmaceutical products including monoclonal antibodies and the development of human therapeutic products. As part of its ongoing restructuring efforts, on April 12, 2007 Chromos filed a Notice of Intention to Make a Proposal to its creditors under the Bankruptcy and Insolvency Act.

For more information visit our website at www.chromos.com.

Risks and Uncertainties

Certain of the statements contained in this press release are forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Chromos, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

To the extent possible, management implements strategies to reduce or mitigate the risks and uncertainties associated with Chromos’ operations. Operating risks include (i) the continued availability of capital to finance Chromos’ activities; (ii) Chromos’ limited cash position, (iii) the ability to successfully obtain proof of the effectiveness of Chromos’ technology (iv) the ability to complete and maintain corporate alliances relating to the development and commercialization of Chromos’ technology; (v) the ability to obtain and enforce patent and other intellectual property protection for Chromos’ technology; (vi) market acceptance of Chromos’ technology; (vii) the competitive environment and impact of technological change; (viii) Chromos’ ability to attract and retain employees to carry out its business plans; (ix) the timely development and commercialization of any technology or products that are contingent on the completion and maintenance of corporate alliances with third parties (x) the demand for repayment of the outstanding Notes by the Noteholders; (xi) approval of any proposal to creditors made under the Bankruptcy and Insolvency Act; and (xii) re-emergence from its reorganization proceedings. Further details on Chromos’ operating risks can be found in its most recently filed Annual Information Form and in its Quarterly and Annual Reports to Shareholders.

For Further Information, Please Contact:

Jeff Charpentier, CA
Vice President Finance and CFO
email: jcharpentier@chromos.com

Elan and Biogen Idec Preparing to Appeal Ruling on European Application for Natalizumab for the Treatment of Crohn's Disease

DUBLIN, Ireland & ZUG, Switzerland--(BUSINESS WIRE)--Jul 19, 2007 - Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that they have been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. In accordance with European regulations, Elan and Biogen Idec plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by 1Q 2008.

"Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be offered surgery, with its potential complications, intravenous nutritional therapies or clinical trials with unproven experimental agents, depending upon on the patients' condition," said Professor Jean-Frederick Colombel, University of Lille. "There is a need for new therapies for this very difficult disease."

An application for approval of TYSABRI(R) (natalizumab) for treatment of moderate to severe Crohn's disease was filed in the US on December 15, 2006. The FDA is holding an advisory committee to discuss the application on July 31, 2007.

About Crohn's Disease

Approximately one million people worldwide have Crohn's disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.

The disease usually causes diarrhea and crampy abdominal pain, often associated with fever, and at times rectal bleeding. Loss of appetite and weight loss also may occur. Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), and malnutrition. Most patients eventually require surgery, which has both risks and potential short- and long-term complications.

Crohn's disease can have a devastating impact on the lifestyle of patients, many of whom are young and active. Currently there is no medical or surgical cure for Crohn's disease. Many patients fail to respond to current therapies, including biological therapies such as agents that inhibit tumor necrosis factor alpha (TNF-alpha). Due to this failure of current therapies in CD, therapies that have novel biological targets are required.

About TYSABRI(R) (natalizumab)

TYSABRI is a treatment approved for relapsing forms of multiple sclerosis (MS) in the US and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (pless than0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (pless than0.001).

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.

TYSABRI is approved in the United States, European Union, Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.

For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit: http://www.biogenidec.com

Safe Harbor/Forward Looking Statements

This press release contains forward-looking statements regarding TYSABRI. The commercial potential and regulatory path forward of TYSABRI are subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that concerns may arise from additional data or analysis or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to obtain approval for TYSABRI as a treatment for Crohn's disease. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


Biogen Idec
Jose Juves, +41 41 3921860
Amy Reilly, +1 617-914-6524
Elizabeth Headon, +353 1 498 0300
Matt Dallas, +1 212-850-5664
Biogen Idec
Eric Hoffman, +1 617-679-2812
Chris Burns, +353 1 709 4444/+1 800 252 3526

Wednesday, July 18, 2007

Stem cell trial gets $2M shot in arm


In response to "unexpected" positive results, a local research facility conducting a bone marrow stem cell transplant therapy trial has been awarded additional funding.

The Multiple Sclerosis Society of Canada announced yesterday that the Ottawa Health Research Institute, a University of Ottawa-affiliated arm of the Ottawa Hospital, will receive $2.4 million over five years to continue and further develop the trial begun in October 2000.

The procedure, which early on resulted in one death and carries potentially serious side effects, involves employing a patient's bone marrow cells to replace a diseased immune system with a new, purified one.

A similar procedure has attained positive results in cancer patients, but has rarely been applied to the treatment of autoimmune diseases such as MS, an often-debilitating, chronic condition affecting the brain and spinal cord.

More than two dozen patients with rapidly progressive disease were selected for the initial stages of the trial; 18 have received the transplant therapy.


Another transplant recipient died during the procedure four years ago, effectively bringing further treatment to a halt for more than a year. The transplant program resumed in March 2004, after modifications were made to the procedure.

Most of the patients who have undergone the transplant procedure have seen their condition stabilize or improve, the MS Society reported. Moreover, additional, unexpected improvements to their condition have been witnessed.

"The hope was that treatment would stabilize progression of the disease, but researchers have found that some patients have experienced improved vision and improved walking ability," reported Ottawa Health Research Institute spokeswoman Jennifer Paterson.

"Part of this money will go to finding out what is causing that tissue repair. Additional funds will go to transplants for six more patients."

Monday, July 16, 2007

Pipex Pharmaceuticals' Oral TRIMESTA Initiates Dosing in Phase II/III Clinical Trial for Multiple Sclerosis

ANN ARBOR, MI--(Marketwire - July 16, 2007) - Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has initiated patient dosing of TRIMESTA (oral estriol), its proprietary therapy for multiple sclerosis (MS), in a multi-center Phase II/III clinical trial for the treatment of women with relapsing-remitting MS. This clinical trial has received a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health (NIH).

Dr. Rhonda Voskuhl, professor of neurology at the University of California, Los Angeles and inventor of TRIMESTA, commented, "We are delighted to be enrolling so shortly after recently initiating the Phase II/III clinical trial."

Dr. Charles Bisgaier, Pipex's President, stated, "To our knowledge, this is the first gender-specific, oral, potentially disease-modifying agent that has entered later-stage clinical trials for the treatment of MS."

Dr. Bisgaier went onto say, "Given the convenience of an oral drug therapy, such as TRIMESTA, we have received a lot of positive patient interest in this study and hope to continue enrolling at this positive rate."

The Phase II/III clinical study is a double-blind, placebo-controlled trial that will take place at seven sites in the US and will enroll up to 150 female MS patients. Investigators will administer TRIMESTA along with COPAXONE, an FDA approved therapy for MS to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS.
Previous Phase II Clinical Trial Results in Relapsing Remitting Multiple Sclerosis

TRIMESTA (oral estriol) has completed an initial 22-month, single-agent, crossover Phase II clinical trial in the US for the treatment of MS in relapsing remitting patients, with highly encouraging results. The results showed the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in MS) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79 percent (p=0.02) and the number of lesions decreased by 82 percent (p=0.09) within the first three months of treatment with TRIMESTA.

Following a six-month drug holiday during which the patients weren't on any drug therapies, TRIMESTA therapy was reinitiated during a four-month retreatment phase of this clinical trial. The relapsing-remitting MS patients again demonstrated a decrease in enhancing lesion volumes of 88 percent (p=0.008) and a decrease in the number of lesions by 48 percent (p=0.04) compared with original baseline scores (1),(2).

Improvement in Cognitive Testing Scores

During this Phase II clinical trial, a 14-percent improvement in Paced Auditory Serial Addition Test ("PASAT") cognitive testing scores (p=0.04) was also observed in the MS patients at six months of therapy. PASAT is a routine cognitive test performed in patients with a wide variety of neuropsychological disorders such as MS. The PASAT scores were expressed as a mean percent change from baseline and were significantly improved in the relapsing-remitting group.

About The TRIMESTA Phase II/III Study

TRIMESTA will be given in combination with subcutaneously injected Copaxone®, a standard treatment for MS. The team will evaluate effects of the treatment combination on relapse rates by using several clinical and magnetic resonance imaging measures of disability progression

The study sites include the University of California, Los Angeles (UCLA), Ohio State University (OSU), Rutgers University (UMDNJ), Washington University, St. Louis, University of Chicago, University of Utah, and Wayne State University. For further information on this Phase II/III clinical trial, please visit http://clinicaltrials.gov/ct/show/NCT00451204.


TRIMESTA is an orally active, immunomodulatory and anti-inflammatory molecule which has been approved and marketed throughout Europe and Asia for approximately 40 years for the treatment of post-menopausal hot flashes, but which has never been introduced in North America. Estriol, the active ingredient in TRIMESTA, is a weak estrogenic-based molecule that is produced in the placenta by women during pregnancy. Estriol is considered to play an important role in the immunologic privilege offered to the fetus during pregnancy, and is also thought to be responsible for the spontaneous remission of Th1-mediated autoimmune diseases of women (such as multiple sclerosis and rheumatoid arthritis) during pregnancy, especially during the third trimester. Pipex has an exclusive worldwide license with UCLA (through the Regent of the University of California) to the intellectual property rights surrounding TRIMESTA.

Pregnancy and MS

Doctors have known for decades that women with MS often experience a sharp drop in disease symptoms during the course of pregnancy, specifically in the third trimester when estriol is being produced at its highest level by the placenta. The list of autoimmune diseases that have been shown to improve during pregnancy includes multiple sclerosis, rheumatoid arthritis, thyroiditis, uveitis, juvenile rheumatoid arthritis, ankylosing spondylitis with peripheral arthritis, and psoriatic arthritis.
A landmark clinical study published in the New England Journal of Medicine, known as the PRIMS study (Pregnancy in Multiple Sclerosis), followed 254 women with MS during 269 pregnancies and for up to one year after delivery. The PRIMS study demonstrated that relapse rates were significantly reduced by 71 percent (p < 0.001) from pre-baseline levels through the third trimester of pregnancy, and relapse rates then increased by 120 percent (p < 0.001) during the first three months postpartum before returning to prepregnancy rates (3).

About Multiple Sclerosis (MS)

MS is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and virtually every hour someone is newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times more often than men. Worldwide, MS may affect 2.5 million individuals.

According to the National MS Society, the economic cost of care for MS patients in the United States, including medical and non-medical care, production losses, and informal care, exceeds $23 billion annually, or more than $57,000 per US patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common daily activities. During 2006, combined sales estimates of FDA-approved injectable MS therapies, which include Avonex®, Betaseron®, Copaxone®, and Rebif®, totaled approximately $5.0 billion.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Relapses often lead to increasing disabilities such as walking impairment, muscle weakness, or speech or vision impairments.

About the National MS Society

The National MS Society is committed to building a movement by and for people with MS that will move us closer to a world free of this disease. The Society funds more MS research, provides more services to people with MS, offers more professional education and furthers more advocacy efforts than any other MS organization in the world. The Society has approximately 500,000 members, including more than 300,000 people with MS, and over 460,000 volunteers who carry out the Society's mission. For further information on the National MS Society, please visit www.nationalmssociety.org.

(1) Sicotte NL, Liva SM, Klutch R, Pfeiffer P, Bouvier S, Odesa S, Wu TC, Voskuhl RR. Treatment of multiple sclerosis with pregnancy hormone estriol. Ann Neurol. 2002 Oct. 52(4):421-8.

(2) Soldan SS, Alvarez Retuerto AI, Sicotte NL, Voskuhl RR. Immune modulation in multiple sclerosis patients treated with pregnancy hormone estriol. J Immunol. 2003 Dec 1:171(11):6267-74.

(3) Confavreux, C., Hutchinson, M., Hours, M.M., Cortinovis-Tourniaire, P., and Moreau, T. Rate of pregnancy-related relapse in multiple sclerosis. 1998. Pregnancy in Multiple Sclerosis Group. N Engl J Med 339:285-291.
Copaxone® is a registered trademark of Teva Pharmaceuticals.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals Inc. is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases. Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the US and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information please visit www.pipexpharma.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. (the "Company," "we" or "our" "Pipex") current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use and therapeutic effects of TRIMESTA for the treatment of Multiple Sclerosis. Where possible, the Company has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, including the risks set forth in our most recent filing on Form 10-QSB and Form 10-KSB filed with the Securities and Exchange Commission. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA, TRIMESTA, Anti-CD4 802-2, CORRECTA, EFFIRMA and SOLOVAX particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise.

Friday, July 13, 2007

Cheaper biotech drugs?

Bill would clear way for less-costly similar forms

By Terri Somers
July 13, 2007

It costs $1,500 a month for the biotech drug betaseron, which Joanne Alvarez takes to slow the progression of her multiple sclerosis.

At that price, Alvarez, who is disabled and on Medicare, would quickly exceed her $2,500 drug coverage and have to pay thousands out of pocket. For now, she has found a charity to underwrite her drug costs, so she pays $70 monthly out of pocket. But she never knows when that financial aid might dry up.

“It's hard enough dealing with this disease and having to worry about all this other stuff, like how can I afford to continue taking my medications,” said Alvarez, 59. “A generic form of betaseron would make my life a lot easier because it wouldn't be so expensive.”

The Lakeside woman's hope is shared by several consumer and insurance groups that have been lobbying Congress to give generic drug makers a clear and short pathway for bringing copycat versions of expensive biotechnology drugs to market.

About $40 billion was spent on name-brand biotechnology drugs in the United States last year, and with more biotech drugs coming to market, that number is expected to keep climbing. There is no law dictating the rules for manufacturing generic versions of biotechnology drugs, but that is expected to change this year.

At issue:
Senate Bill 1965

Sponsors: Edward Kennedy, D-Mass., Hillary Clinton, D-NY, Orrin Hatch, R-Utah, and Mike Enzi, R-Wyoming

Would give 12 years market exclusivity to a new biotechnology drug after it is approved by the FDA. The industry wants 14 years exclusivity. Consumer groups want 5 years exclusivity.

Would give the FDA the authority to decide on a case-by-case basis whether clinical trials are required for biosimilar drugs, and the length and scope of those trials.

Would give the FDA the authority to decide whether a biosimilar drug is interchangeable with the original biotechnology drug.

A bipartisan bill that attempts to balance consumer demands for more affordable medicine with the needs of the biotechnology industry – which makes new therapies for diseases ranging from cancer to MS to AIDS and diabetes – has passed a key Senate committee. So far, the measure has not been taken up in the House, but consumer groups are confident that it will.

“There needs to be more competition for the prices to go down, which means access will go up, and that's impossible to do unless we bring generic alternatives to market,” said Mark Merritt, chief executive of the Pharmaceutical Care Management Association, or PCMA, which represents pharmacy benefit managers. “This (bill) would allow for generics to see how they can enter the marketplace. . . . It's unsustainable otherwise.”

The issue has been percolating in Congress for years, because the 1984 law governing generic pharmaceutical drugs cannot be applied to cheaper, copycat versions of biotechnology drugs.

Under what is known as the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, generic versions of pharmaceutical drugs are considered chemically identical to the innovative version of the drug.

The so-called generic versions of biotechnology drugs could never be exact copies. At most, they could be highly similar, which is why the industry avoids the “generic” term and refers to them as “biosimilars” or “follow-on biologics.”

Making biotechnology medicines involves a complicated process of growing cells, which work as factories to make the proteins that are used as the therapies. Change the cells that are used as the factories, and the characteristics of the resulting proteins can be changed and result in a therapy with much different effects, according to the biotechnology industry.

The makers of biosimilars would like to cut costs and the time needed to bring a product to market by relying on all the safety and efficacy data that were collected by the pioneering drug maker during the long and expensive clinical trial process.

But the biotechnology companies that took the risk of investing in a developmental new drug, which had very high chances of failing, want that interest to be protected.

The industry also contends that it is equally important to ensure the safety of the biosimilar drugs – and you cannot ensure safety if the drugs are not exactly the same.

“We are agnostic as to whether or not follow-ons exist commercially. We'll have competitors in every market in which we have a therapy long before we expect follow-ons to come against our current therapies,” said Walter Moore, vice president of government affairs at Genetech. That South San Francisco company manufactures the cancer drug Avastin in Oceanside.

“Our concern has been more about patient safety and making certain that we don't have an episode that calls all genetically engineered therapies into question,” Moore said.

The Senate bill, sponsored by Democrats Ted Kennedy and Hillary Clinton and Republicans Mike Enzi and Orrin Hatch, addresses issues of market exclusivity, clinical trials and safety. And it seems just enough of a compromise that there's something to make people on every side of the debate unhappy.

“We're happy people have been working on this issue and see how important it is, but we are not happy with the result,” said Sandy Dennis, general counsel for regulatory affairs at the national Biotechnology Industry Organization. “We're not comfortable that it gives enough protection to ensure patient safety.”

As an incentive for venture capital and Wall Street to continue investing in the risky field of drug development, the bill guarantees an innovative biotechnology therapy 12 years of market exclusivity after it has been approved by the Food and Drug Administration.

The industry says it needs 14 years of exclusivity to recoup its investment.

Consumer groups want five years of exclusivity.

“Each year of exclusivity will cost billions of dollars for the consumers, unions, employers and government agencies,” said Merritt of PCMA.

“There should be some incentives, but when they are protecting the second, third and fourth generation of the same product for 20 years beyond the patent life, that's got to change,” said Merritt, whose organization has been in the forefront of pushing for follow-on biologic guidelines.

The so-called Kennedy bill allows the FDA to decide when clinical trials should be required of the biosimilars, and just how extensive those trials should be.

That does not sit well with the industry, unless there is funding attached.

“We've already got the FDA operating under some pretty severe stress and now you're saying the agency should figure out how to make it easy for people to bring follow-on biologics to market?” asked Joe Panetta, who heads Biocom, the industry trade group in San Diego.

“It has to be done in a way that ensures safety and efficacy by giving the FDA the resources it needs,” Panetta said.

Consumer groups, however, applaud that element of the bill, saying it's FDA scientists who should be making the call.

The Kennedy bill would also allow the FDA to determine whether a biosimilar product should be considered interchangeable with the original therapy. The industry said that creates the potential for safety problems. and would prefer doctors to have the power to make that determination.

In a letter sent last month to Kennedy, who chairs the Senate's Health, Education, Labor and Pension Committee, Health and Human Services Secretary Mike Leavitt stressed the importance of a doctor determining interchangeability.

Several patient advocacy groups have also sent Kennedy letters supporting doctors as the judge on interchangeability.

No matter what the final legislation looks like, consumers should not expect the same big savings on biosimilars as they received on generic drugs, industry insiders said.

Creating a manufacturing facility is an expensive and complicated investment, said Matthew Croughan, a bioprocessing expert at the Keck Graduate Institute.

All companies have the potential to improve their manufacturing process with time, so that the cost can keep dropping, Croughan said. But companies are not quick to change the manufacturing process because it is part of the FDA approval process to ensure that the drug is consistently the same, he said.

“You're not going to see as much savings in this area as with generic drugs. Maybe you'll ultimately see a follow-on biologics price that is 30 percent lower, but it's not going to be much lower because these are still fairly expensive and complicated things,” Croughan said.

Consumer groups will take the savings wherever they can get them.

“If you're saving 15 percent on a drug that costs $30,000 a year, you're still saving a good bit,” said Drew Nannis, a spokesman for AARP.

“It's good for the entire health care system, including the insurance companies that are picking up the tab, and for the 46 million people who don't have health insurance,” Nannis said.

While there are many issues yet to be worked out with the legislation, some of the smaller biotechnology companies that see generics as a potential pathway to additional revenue are happy that the debate is creating at least a silhouette of policy in this new area.

Favrille, a small San Diego biotechnology company, recently bought the rights to monoclonal antibodies that have the potential to become biosimilar therapies for cancer and other diseases. How the company would go about developing those therapies and what the FDA would want to see before approving them has been a mystery, said John Longenecker, Favrille's chief executive.

The company's biggest issue was what its clinical trials would involve, he said.

“From our point of view, because we are at the starting line, having action taken now by the legislature allows us to plan the most economical way to develop our (molecules),” he said.

Terri Somers: (619) 293-2028; terri.somers@uniontrib.com

Tuesday, July 10, 2007

Scientists Show EGFR Protein’s Role in White Matter Repair

Jul 9 2007, 12:52 PM EST

Scientists at Children’s National Medical Center demonstrated that epidermal growth factor receptor (EGFR) protein and its signaling activity are instrumental in myelination and remyelination. Underdeveloped white matter or white matter injuries are linked to conditions including mental retardation, cerebral palsy, and multiple sclerosis.

The researchers used enhanced EGFR to demonstrate the role that this molecule plays as a catalyst to the natural processes of proliferation and migration of progenitor cells, which are integral to white matter development and repair. Inserting enhanced EGFR protein into mouse models showed enhanced myelination/remyelination. Then, using an EGFR protein with reduced biological activity, the researchers found a decrease in myelination/remyelination.

The study also found that progenitor cells in the peri-ventricular zone of the brain contribute to remyelination of white matter lesions and that these lesions naturally prompt progenitor cells to replicate and migrate to the site of the lesion where they are involved in remyelination and functional repair.

The paper will be published in the August issue of Nature Neuroscience.

Selenium pills may make you sick

Last updated: Tuesday, July 10, 2007

Selenium supplements appear to increase the risk of type 2 diabetes, a new study suggests.

The chances of developing the blood sugar disease was higher in people who had high blood selenium levels, according to the report in the July 10 online edition of the Annals of Internal Medicine.

"The hypothesis was that, because of its antioxidant properties, selenium could be beneficial in diabetes prevention," explained lead researcher Dr Saverio Stranges, from the Warwick Medical School, in Coventry, UK "Actually, long-term selenium supplementation did not have any benefits in diabetes prevention and actually increased the risk for this disease."

Selenium is a mineral found in soil and foods. Selenium is used by the body to aid in metabolism. Selenium supplements have been widely promoted for conditions such as cold sores, shingles, arthritis and multiple sclerosis. These supplements are also sold to prevent ageing, enhance fertility, prevent cancer and get rid of toxic minerals such as mercury, lead and cadmium.

Selenium supplements have shown some promise in preventing cancer, including prostate cancer and lung cancer, Stranges noted. "There are ongoing clinical trials to determine if selenium can be beneficial in cancer prevention," he said.

In the study, Stranges and his colleagues collected data on 1 202 patients who participated in the Nutritional Prevention of Cancer Trial. During the trial, half the patients received a daily 200 microgram selenium supplement or placebo.

50% higher risk
The researchers found that 58 out of 600 people in the selenium group and 39 of the 602 in the placebo group developed type 2 diabetes. During 7.7 years of follow-up, Stranges' team noted that the risk of developing type 2 diabetes was approximately 50 percent higher among those taking selenium compared with those taking a placebo.

"Most people have adequate selenium in their diet," Stranges said. "Taking selenium on top of an adequate dietary intake may cause diabetes."

Many multivitamin pills contain between 33 and 200 micrograms of selenium. The recommended dietary allowance for selenium varies by age. For people aged 14 and over, 55 micrograms per day is recommended.

No conclusive evidence
"Right now, there is no conclusive evidence of the benefits of selenium in chronic disease prevention," Stranges said. "People can get all of the antioxidants they need from the diet."

One expert thinks that, while not proven, the increased risk of developing diabetes by taking selenium supplements is concerning.

"We probably get enough selenium in our diet, and there is no reason to take supplements," said Dr Eliseo Guallar, from Johns Hopkins University Bloomberg School of Public Health and author of an accompanying editorial.

Guallar doesn't think that this single study proves that selenium increases the risk for diabetes. "But it's enough to say this is worrisome. The risk appears high enough that people should be concerned," he said. "Until we know for sure that there are benefits from these supplements, it doesn't make sense to be taking them."

Another expert also thinks there is probably no value in taking supplemental selenium.

"We are so quick to take stuff," said Dr Larry Deeb, president for medicine and science at the American Diabetes Association. "If they put it in a pill, we'll take it. But it doesn't always work for you."

Deeb isn't sure that taking selenium is dangerous. "But why would you take selenium for something to do?" he said. "I don't see a good reason to take selenium. It's certainly not to prevent diabetes - that's for sure." – (HealthDayNews)

Monday, July 09, 2007

Pluristem and Center for Regenerative Therapies at Charite University Hospital of Berlin Enters into Collaborative Research Agreement

Jul 9 2007, 8:00 AM EST

Business Wire

Pluristem Life Systems, Inc. (OTCBB:PLRS) (DAX:PJT), a bio-therapeutics Company dedicated to the commercialization of products for a variety of malignant, degenerative and auto-immune indications, announced today that it has entered into a Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) at Charite - University Medicine Berlin.

Pluristem and BCRT will collaborate on a variety of indications utilizing mesenchymal stem cells (MSCs) derived from the placenta that have been expanded in the Company's proprietary PluriX(TM) 3-D bioreactor. The initial focus of the collaboration will be on neurological indications such as Multiple Sclerosis and Parkinson's disease. The agreement also covers organ transplantation and cardiovascular indications such as inflammatory cardiomyopathy. Pluristem will be the exclusive owner of the technology and any products stemming from the collaboration.

Professor Hans Dieter Volk, MD, Director/ Chairman of BCRT at Charite commented, "The collaboration of BCRT, working with Pluristem and their proprietary PLX cells offers several exciting prospects. We believe Pluristem's cells can potentially result in beneficial therapies for a number of diseases."

The BCRT is a cooperative research institution of the Charite University Hospital in Berlin and Germany's largest research association, the Helmholtz Association. BCRT also receives generous financial support from the BMBF and the states of Berlin and Brandenburg, as well as from the Technology Foundations in Berlin and Brandenburg, the Future Fund Berlin and from various industry partners. More than 15 regional partners from science and industry are active members of the consortium at the BCRT.

"This cooperation is extremely important to us," commented Pluristem Chairman and CEO, Mr. Zami Aberman. "First, it corroborates our approach regarding the use of MSCs from the placenta and our PluriX(TM) technology to develop new therapeutic products for a variety of indications. In addition, the collaboration significantly enhances our approach to develop our pipe line of products."

About BCRT

The Berlin-Brandenburg Center for Regenerative Therapies (BCRT) was founded as a cooperative research institution of the Charite University Hospital in Berlin and Germany's largest research association, the Helmholtz Association. BCRT also receives generous financial support from the BMBF and the states of Berlin and Brandenburg, as well as from the Technology Foundations in Berlin and Brandenburg, the Future Fund Berlin and from various industry partners. The mission of the BCRT is to develop a translational platform for Regenerative Therapies from bench-to-bedside. The five clinical platforms -- Immune, muskuloskleletal, hepatic, neuronal, and cardiovascular system -- are cross-linked by technology platforms (basic science, bio-engineering, translational technologies). First clinical trials with cell therapy have been started.


About Pluristem

Pluristem Life Systems, Inc. is a Company dedicated to the commercialization of non-personalized (allogeneic) stem cell therapy products for the treatment of numerous severe degenerative, malignant and autoimmune disorders. The Company's first planned product, PLX-I, targets a $2 billion market and is intended to resolve the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood (CB).

Pluristem's products are derived from mesenchymal stem cells (MSCs) obtained from the placenta and expanded in the Company's proprietary PluriX(TM) 3D bioreactor that imitates the natural microstructure of bone marrow and does not require supplemental growth factors, cytokines or other exogenous materials. Pluristem believes the resultant expanded cells, termed PLX cells, are multipotent and able to differentiate into a variety of cell types as well as being immune-privileged to protect the recipient from immunological reactions that often accompanies transplantation. Pluristem believes their future products will participate in the approximate $30 billion therapeutic and regenerative cellular market.

Pluristem has offices and is incorporated in the USA with research and manufacturing facilities in Israel.


Safe Harbor Statement

This press release contains statements, which may constitute "forward-looking statements" regarding our intent, belief or current expectations. Forward-looking statements in this release include that "the Pluristem's cells can potentially result in beneficial therapies for a number of diseases; that the collaboration corroborates our approach regarding the use of MSCs from the placenta and our PluriX(TM) technology to develop therapeutic products for a variety of indication; that the corroborates our approach regarding the use of MSCs from the placenta and our PluriX(TM) technology to develop new therapeutic products for a variety of indications; that the collaboration significantly enhances our approach to develop our pipe line of products. Factors that could prevent our forward looking statements from being achieved include that we may be unable to get regulatory approval for our products; we may be unsuccessful in developing any products; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient to protect essential aspects of our technology; competitors may invent better technology; our products may not work as well as hoped or worse, our products may harm recipients; and we may not be able to raise funds for development or working capital when we require it. As well, our products may never develop into useful products and even if they do, they may not be approved for sale to the public. For further risk factors see the Company's latest 10-KSB filed with the SEC.

Thursday, July 05, 2007

Farmers Can Grow Their Own Marijuana, Says New Mexico's New Law

By Samantha Beck
Published Jul 04, 2007

New Mexico isn't the first state to allow medicinal marijuana to be legally grown on state soil-eleven other states, including Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Rhode Island, Vermont and Washington-have legalized the plant.

Although Maryland doesn't have a law that protects patients using medicinal marijuana from jail, if a judge can be convince that the defendant needed it out of medical necessity, that person will be kept out of jail. A bill regarding medical marijuana was recently vetoed by Connecticut's governor.

In all 50 states, distributing and using marijuana for recreational purposes are illegal.

New Mexico's marijuana law was passed in March and signed by Gov. Richardson, who is currently running under the Democrat ticket for the presidential nomination.

Though marijuana has been legalized for medical purposes in other states, New Mexico is the only state to officially license workers and facilities to grow marijuana.

The state will have to contact its Dept. of Health by Oct. 1 to receive official licensing to give to both marijuana farmers and in-state growing facilities and issues guidelines for a distribution system.

With that in mind, New Mexico's Attorney General Gary King was contacted by the state health department to determine whether state workers could be prosecuted under federal law for running a medicinal marijuana registry and licensing marijuana farmers and facilities.

Proceeding with care, the health department will be taking the whole process step by step as no other state that has legalized medicinal marijuana is involved in the production of it.

The main reason for legalizing the other otherwise illegal drug is to provide a safe way for ill patient to get their supply, one that doesn't involve drug dealers or growing their own.

Until New Mexico has finalized their plans for producing marijuana, patients in need of the drug must get themselves. Also, the state will start collecting applications from patients whose doctors sign off on the marijuana program.

Once approved, the patients or their caretakers will receive a card certifying that they are allowed to carry up to six ounces on their persons and have four mature plants and three immature seedlings. The health department says that's enough for a three-month supply.

The new law allows the use of marijuana to quell symptoms associated with cancer, epilepsy, glaucoma, multiple sclerosis, and HIV-AIDS.

Blood clotting protein may inhibit spinal cord regeneration

Fibrinogen, a blood-clotting protein found in circulating blood, has been found to inhibit the growth of central nervous system neuronal cells, a process that is necessary for the regeneration of the spinal cord after traumatic injury. The findings by researchers at the University of California, San Diego (UCSD) School of Medicine, may explain why the human body is unable to repair itself after most spinal cord injuries.

The study, led by Katerina Akassoglou, Ph.D., assistant professor in UCSD’s Department of Pharmacology, is the first evidence that when blood leaks into the nervous system, the blood protein contributes to the neurons’ inability to repair themselves. The findings, which show the molecular link between vascular and neuronal damage during injury to the central nervous system, was published in the online issue of the Proceedings of the National Academy of Sciences on July 2.

The research team studied three types of spinal cord injuries in mice and rats which resulted in cellular and vascular damage, and leakage of fibrinogen from the blood vessels. Once injured, neurons cannot be repaired because of various inhibitors that are present in the brain and the spinal cord after damage, which results in a patient’s paralysis. The researchers were surprised at the massive deposits of fibrinogen found at the sites of injury. That discovery led them to investigate the protein’s effect on neuronal cells’ ability to regenerate.

“Our study shows that fibrinogen directly affects neurons by inhibiting their ability for repair,” said Akassoglou. Fibrinogen – contained in the blood which leaks at the site of injury – begins the process of inhibiting axonal growth by binding to the beta 3 integrin receptor. This binding, in turn, induces the activation of another receptor on the neuronal cells, called the epidermal growth factor receptor. When the second receptor is activated, it inhibits the axonal growth. Other inhibitors have been identified that use the same epidermal growth factor receptor, but this is the first blood-derived inhibitor that has been found.

The discovery may open the door to a possible strategy to improving recovery after spinal cord injury by discovering a way to block activation of neuronal receptors by fibrinogen. Identifying the specific inhibitors that impede the repair process could provide ways to regenerate and connect the damaged nerves and initiate recovery from paralysis after spinal cord injury.

“Inhibiting the damaging effects of fibrinogen on neurons may potentially facilitate repair in the nervous system after injury” said Akassoglou. A similar mechanism could be at work in other neurological diseases that result in paralysis, such as multiple sclerosis or hemorrhagic stroke, where blood vessels break and bleed into the brain. She added that such a therapeutic approach wouldn’t interfere with fibrinogen’s essential role in coagulation, because its blood-clotting mechanism depends on binding with a different receptor.

Debra Kain | EurekAlert!
Informationen: www.ucsd.edu

Tuesday, July 03, 2007

TYSABRI® Recommended by NICE for Use in Highly Active Relapsing Remitting Multiple Sclerosis in the Final Appraisal Determination

New Hope For People With Highly Active Multiple Sclerosis

ZUG, Switzerland & DUBLIN, Ireland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) and Elan Corporation (NYSE: ELN) welcome today’s announcement by the National Institute for Health and Clinical Excellence (NICE) in the final appraisal determination which recommended use of TYSABRI® (natalizumab) in people with highly active relapsing remitting multiple sclerosis (RRMS). TYSABRI is the first treatment for multiple sclerosis to be recommended for use by NICE.

“This decision offers people with highly active relapsing remitting multiple sclerosis hope of regaining control of their disease,” commented Professor Gavin Giovannoni, The Royal London Hospital. “TYSABRI represents a significant advance in MS treatment, offering real hope of delaying the progression of disability and reducing the frequency of relapses.”

Highly active RRMS (defined as two or more disabling relapses in one year and an active MRI scan) has a devastating effect on the lives of the individual and their families. These patients experience more relapses and will become disabled more quickly than those people with typical RRMS. This inevitably means that they will not be able to enjoy an active life combined with the strong probability that they, and the family members who care for them, will be unable to work. In these patients, MS progresses twice as quickly as those with less active forms of the disease.

TYSABRI is the first treatment to be specifically licensed for highly active RRMS. Over two years, treatment with TYSABRI leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.

Hans Peter Hasler, Head of Biogen Idec International, added, “Multiple sclerosis can be a devastating condition if not treated appropriately, and we are very pleased that NICE has recommended in the final appraisal determination that patients with highly active relapsing remitting multiple sclerosis should have access to treatments like TYSABRI. With successful treatment with TYSABRI, highly active relapsing remitting multiple sclerosis patients are more likely to be able to continue to work, maintain active social lives, and spend quality time with their families.”

“TYSABRI is the first treatment to be recommended for use by NICE, a significant milestone for patients suffering from MS. This final appraisal firmly supports patients and their physicians having access to TYSABRI with its compelling benefits in the treatment of MS,” said Dr. Menghis Bairu, SVP, Head of Elan International.

As of late May, TYSABRI is already offering hope to approximately 12,000 patients on therapy in both commercial use and clinical trials in the US, Germany, France, Ireland and many other countries.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

Safe Harbor/Forward Looking Statements

This press release contains forward looking statements regarding TYSABRI that are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. Important factors that could cause our actual results to differ include the possibility that our competitors may offer treatment options that gain greater acceptance than TYSABRI, regulatory and safety risks of TYSABRI, and the other risks and uncertainties that are described in the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission, including the "Risk Factors" sections of such filings. These forward looking statements speak only as of the date of this press release, and the companies do not undertake any obligation to update any forward looking statements, whether as a result of new information, future events, or otherwise.

Media Contacts:
Biogen Idec
Katja Buller, +41 41 3921792
Amy Reilly, +1 617-914-6524
Matt Dallas, +1 212-850-5664
Elizabeth Headon, +353 1 498 0300
Investor Contacts:
Biogen Idec
Eric Hoffman, +1 617-679-2812
Chris Burns, +353 1 709 4444 or 800-252-3526