New Interferon Formulations Promise to Eliminate Injections in Multiple Sclerosis Treatment

SAN DIEGO, CA January 12, 2009/MarketWire/-- Nerveda Inc. and Aegis Therapeutics
LLC today announced preclinical results from their joint collaboration aimed at
developing non-injectable formulations of the beta-interferons. The beta interferons,
beta-1a (tradename Rebif®), and beta 1b (tradenames Betaseron® and Betaferon®) are
closely related injectable protein drugs in the interferon family that are used to treat both the relapsing-remitting and secondary-progressive forms of multiple sclerosis (MS). The beta interferons are currently administered by subcutaneous injection and have been proven clinically to slow the advance of multiple sclerosis and reduce the frequency of attacks. Current worldwide combined annual sales of Rebif®, Betaseron® and Betaferon® are approximately $4 Billion.

Because proteins are large and fragile molecules, they cannot be administered orally
and are typically administered by injection. They are often subject to instability due to aggregation of the protein molecules – particularly upon storage and handling at nonrefrigerated temperatures. The resulting protein aggregates are more poorly absorbed
into the blood stream upon injection due to their increased size, and induce development of circulating antibodies to interferon in patients that reduce the effectiveness of the drug over time.

Leading medical scientists at Johns Hopkins University, expert in the treatment of
neurological diseases, in collaboration with Nerveda and Aegis have applied Aegis’
Intravail® transmucosal absorption enhancement, and ProTek® protein stabilization
technologies to address these problems and have demonstrated for the first time that the beta interferons can be administered intranasally to prevent nerve damage in preclinical animal models of multiple sclerosis. In addition, the new formulations were shown to reduce or eliminate the immunogenicity of Betaseron® and Rebif®, administered either by injection or intranasally, while substantially increasing stability in a stress test involving constant agitation at elevated temperatures for extended periods of time.

Dr. Edward Maggio, Ph.D., CEO of Aegis Therapeutics, who participated in the
research, said, “since interferons will continue to be the foundation of MS therapy, it is critical that non-invasive delivery options for patients be developed.” Maggio also indicated, “the reduction in immunogenicity and the increase in stability also address a significant unmet need of the currently available beta-interferon therapies.”
Nerveda plans to begin testing the new formulation in clinical trials in early 2009 in
collaboration with clinicians and scientists at John Hopkins University Medical Center
and other sites.

* Rebif® is a registered trademark of Pfizer, Inc.
* Betaseron® is a registered trademark of Bayer Healthcare Pharmaceuticals
* Betaferon® is a registered trademark of Bayer Schering Pharma AG
* Intravail® and ProTek® are registered trademarks of Aegis Therapeutics, LLC

About Nerveda Inc.

Nerveda is a privately funded specialty pharmaceutical and diagnostic company focused
on improving the quality of life for patients suffering from neurodegenerative diseases
and their caregivers. Nerveda supports the clinical development of products licensed
from Johns Hopkins University, including neuroprotective compounds and stem cell
therapeutics that show promise in treating auto-immune disorders.

About Aegis Therapeutics

Aegis Therapeutics LLC is a drug delivery technology company commercializing its
patented or proprietary drug delivery and drug formulation technologies through productspecific licenses. Our patented Intravail® drug delivery technology enables the noninvasive delivery of a broad range of protein, peptide and non-peptide macromolecular therapeutics that can currently only be administered by injection. Aegis’ Intravail® absorption enhancement agents provide exceptionally high and unmatched bioavailability performance, comparable in efficiency to subcutaneous injection, via the intranasal administration route. Intravail® has also been successfully applied to buccal, oral, and rectal administration of small molecule, peptide, and nucleotide-analog type drugs. Our patented ProTek® technology allows creation of proprietary, easily manufacturable, and stable aqueous or lyophilized dosage forms that maintain the integrity and physiological activity of many protein and peptide therapeutics. ProTek® technology is applicable to injectable, intranasal, and other dosage forms of peptide or protein therapeutics.

For more information about Aegis, please visit the Aegis website at: htpp://www.aegisthera.com.

Contact:
Aegis Therapeutics LLC
Ralph Barry, Chief Business Officer
1-858-618-1400 Ext. 102
Email: rbarry@aegisthera.com

Contact:
Nerveda Inc.
Cam Gallagher, CEO
1-(858) 705-2365
Email: CGallagher@NervedaBio.com

Study Results: Multiple Sclerosis Patients Have Significant and Sustained Reduction in Disability and Risk Of Relapse On Alemtuzumab Versus Approved T

Date: October 22, 2008

Final Phase 2 Data Published in New England Journal of Medicine
International Phase 3 Alemtuzumab Studies Enrolling

Genzyme Corporation (Nasdaq: GENZ) and Bayer HealthCare Pharmaceuticals Inc. today announced study results showing that patients with early relapsing-remitting multiple sclerosis (RRMS) taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 74 percent and the risk of sustained accumulation of disability by 71 percent compared to patients treated with the active comparator Rebif® (high-dose interferon beta-1a). Importantly, the mean disability of patients on alemtuzumab improved from baseline, whereas the mean disability of those on Rebif worsened. The treatment benefits of alemtuzumab were sustained for at least three years, even though the majority of alemtuzumab-treated patients were last dosed two years earlier. These results come from the final three-year analysis of a Phase 2 clinical study (CAMMS223) reported in the Oct. 23 issue of the New England Journal of Medicine. The study involved 334 patients who had not previously been treated for their disease.

“The alemtuzumab trial data continue to suggest a potentially new and exciting treatment for patients with early, active multiple sclerosis,” says Alastair Compston, Professor of Neurology and the head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom, and the study’s principal investigator. “This randomized study confirms findings from prior studies demonstrating that treatment with alemtuzumab can have a profound and durable impact on patients with relapsing-remitting multiple sclerosis, including restoring some lost function in many patients.”

“Symptoms of multiple sclerosis result from an immune system attack on the protective insulation surrounding nerve fibers of the central nervous system. We believe alemtuzumab shuts down this immune system attack, treating the disease at its root cause,” says Alasdair Coles, Senior Lecturer, Department of Clinical Neurosciences, University of Cambridge and a lead investigator in the study.

Common non-serious adverse events in the trial included infusion-associated reactions in the alemtuzumab patients and flu-like symptoms in patients using Rebif. Alemtuzumab-treated patients were more likely than Rebif patients to experience infections, which were predominantly mild to moderate in severity, as well as autoimmune thyroid disease. Three percent of alemtuzumab-treated patients developed the potentially serious autoimmune adverse event immune thrombocytopenic purpura (ITP), a disorder characterized by a low platelet count and corresponding increased risk of uncontrolled bleeding. Additional study and trial safety information is below.

“The trial was larger and follow-up was longer than the typical Phase 2 trial in multiple sclerosis. It is important to note that we compared the investigative drug directly against a widely used therapy rather than against placebo. The trial did not show an increased risk of life-threatening or opportunistic infections, but a proportion of alemtuzumab patients experienced new autoimmune disease. We have been able to create a robust patient monitoring program that allows us to proceed into our two international Phase 3 trials with greater assurance on safety associated with patient management,” says Dr. Richard Moscicki, chief medical officer for Genzyme.

According to the National Multiple Sclerosis Society, approximately 400,000 Americans acknowledge having MS, and every week about 200 people are diagnosed. Worldwide, multiple sclerosis may affect 2.5 million individuals. The disease causes a wide range of symptoms including difficulty with walking, numbness, fatigue and impairment of vision, and progresses to permanent, severe disability in the majority of patients. Relapsing-remitting MS is the most common presenting form of the disease.

“We are pleased to see potential new treatment options move positively through the MS pipeline,” says Dr. John Richert, executive vice president for research and clinical programs at the National Multiple Sclerosis Society, “and as alemtuzumab is moved into Phase 3 studies, we hope that individuals with MS will consult with their physicians to assess whether they are appropriate patients and if so will consider the pros and cons of participating in these important clinical trials.”

Additional New Top-Line Data

New and previously unreported top-line data from secondary analyses of the CAMMS223 Phase 2 clinical trial, presented last month at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRIMS), revealed that the proportion of clinically disease-free patients was significantly higher in the alemtuzumab group than in the Rebif group at year one (86 percent vs. 63 percent), year two (81 percent vs. 48 percent), and year three (71 percent vs. 39 percent, p-values <0.0001). “Clinically disease-free” was defined as the absence of both relapses and sustained accumulation of disability during the time-period assessed.

The top-line data from WCTRIMS also showed that the proportion of patients free of sustained accumulation of disability over a six-month period was also significantly greater in the alemtuzumab group than in the Rebif group at year one (97.2 percent vs. 87.0 percent), year two (94.3 percent vs. 82.4 percent), and year three (91.0 percent vs. 73.8 percent, p-values <0.005).

Further, the proportion of relapse-free patients over time was significantly greater in the alemtuzumab group than in the Rebif group at year one (91.1 percent vs. 69.3 percent), year two (88.2 percent vs. 58.5), and year three (80.2 percent vs. 51.6 percent, p-values <0.0001).

Phase 2 Extension Trial

Genzyme with Bayer support has launched an extension of the CAMMS223 trial to examine safety and efficacy outcomes beyond three years, and to compare two distinct retreatment strategies. The results should provide an understanding of the long-term effects of prior alemtuzumab treatment as well as the safety and sustained efficacy of additional alemtuzumab retreatment delivered in fixed annual cycles or as needed for resumed MS disease activity. In the fixed arm, patients will receive two annual cycles of alemtuzumab (12 mg/day for three consecutive days/cycle). In the as-needed arm, retreatment is deferred until a patient relapses or develops two or more new/active brain lesions on MRI.

Phase 3 Trials

Genzyme with Bayer support is sponsoring two Phase 3 trials in which patients are now enrolling. The CARE-MS I Phase 3 study (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), is a randomized, rater-blinded study that will again compare alemtuzumab to Rebif in patients with relapsing-remitting MS who have not been previously treated for their disease. The CARE-MS II trial is studying patients who have continued to relapse while using approved MS therapies.

Physicians or patients in the United States seeking additional information about the CARE-MS Phase 3 trials should go to www.care-ms.com or call Genzyme Medical Information at 800-745-4447.

About Study CAMMS223

In the Phase 2 trial, 334 patients with active relapsing-remitting multiple sclerosis were enrolled at 49 medical centers in Europe and the United States. Patients in the trial were randomized to treatment with alemtuzumab at one of two dose levels (12 or 24 mg per day intravenously) for five days during the first cycle and three days 12 months later during the second cycle of therapy, or Rebif (44 mcg administered by subcutaneous injection three times per week, as indicated in its product label). A third cycle of alemtuzumab therapy was received by 46 patients at month 24.

The trial compared the efficacy of alemtuzumab with Rebif using two primary outcome measures: the Relapse Rate and the time to Sustained Accumulation of Disability as evidenced by an increase in the Expanded Disability Status Scale (EDSS) score for six consecutive months. Efficacy assessments were made by independent neurologists blinded to patients’ treatment assignments. The EDSS is a 10-point scale in which every 0.5-point step marks a notable deterioration in neurological capabilities.

The mean disability score of patients after alemtuzumab actually improved (by 0.39 EDSS points) indicating a recovery of neurologic functions. The median disability score improved to a similar extent after alemtuzumab. In contrast, mean disability worsened in the Rebif group (by 0.38 EDSS points) resulting in a difference of nearly a full EDSS point (0.77 difference, p<0.0001) at three years.

Safety Data

A total of six alemtuzumab-treated patients, and one Rebif-treated patient, in this study developed a serious adverse event, immune thrombocytopenic purpura (ITP). ITP is a disorder characterized by a low platelet count and corresponding increased risk of uncontrolled bleeding. The Rebif patient with ITP was asymptomatic but ITP persisted at the time of study completion. In the previously reported alemtuzumab-related fatal case, symptoms of ITP were experienced but were not recognized in time, thus delaying medical attention. Of the remaining alemtuzumab cases, four patients were diagnosed promptly, responded well to medical treatment, and have been stable without a need for ongoing treatment. The other alemtuzumab-treated case experienced spontaneous remission of ITP. A patient monitoring program was instituted in the trial, and there have been no new cases of ITP reported in CAMMS223 in approximately two years.

Common non-serious adverse events in the trial included infusion-associated reactions in the alemtuzumab patients and flu-like symptoms in patients using Rebif. Alemtuzumab-treated patients were more likely than Rebif patients to experience infections, particularly of the upper respiratory tract; infections were predominantly mild to moderate in severity and there were no life-threatening or fatal infections. Though alemtuzumab transiently lowers white blood cell counts, the trial did not show an increased risk of opportunistic infections. Serious infections were infrequent in the alemtuzumab-treated patients. Approximately 23 percent of alemtuzumab-treated patients developed autoimmune thyroid-related adverse events, including Graves’ disease, and were managed using conventional therapies.

Alemtuzumab is an investigational drug for the treatment of MS and must not be used in MS patients outside of a formal, regulated clinical trial setting in which appropriate patient monitoring measures are in place.

About Alemtuzumab

Alemtuzumab is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside of the U.S. for the treatment of B-CLL in patients who have been treated with alkylating agents and for whom fludarabine combination therapy is not appropriate. The product was launched in its oncology indication in 2001 in the US, where it is marketed by Bayer HealthCare Pharmaceuticals Inc. as Campath®, and in Europe, where it is named MabCampath®.

Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces and directs the body’s immune system to destroy those cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-CLL.

Genzyme and Bayer are co-developing alemtuzumab in oncology and multiple sclerosis. Bayer holds exclusive worldwide marketing and distribution rights to alemtuzumab.

Campath for B-CLL has a boxed warning that includes information on cytopenias, infusion reactions, and infections. The most commonly reported adverse reactions in patients with B-CLL were infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

This press release contains forward-looking statements regarding Genzyme’s future plans and business strategies, including: its expectations for the success of alemtuzumab to treat MS, and its expectations regarding the information to be gained from the phase 2 extension trial. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements, including: that the phase 3 trials are not successful; that the phase 2 extension trial fails to produce the anticipated results regarding longer-term effects; and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in Genzyme’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2008. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Genzyme®, Campath®, and MabCampath® are registered trademarks of Genzyme Corporation. All rights reserved. Rebif® is a registered trademark of EMD Serono, Inc.

Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.

Bayer HealthCare Pharmaceuticals Inc. press releases and other information are available at www.bayerus.com.

Editor’s Note: This study appears in the October 23, 2008 issue of the New England Journal of Medicine. The citation is N Engl J Med 2008;359:1786-1801.

Terms and Conditions of Use | Privacy Policy | © 2002-2008 Genzyme Corporation. All rights reserved.

Results from IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif® at 16 Weeks in Patients with Multiple Sclerosis

• Study meets primary endpoint by demonstrating significant effect of new formulation of Rebif® on disease activity as measured by MRI after 16 weeks of treatment

• Data presented at late-breaking session of the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada

Geneva, Switzerland, September 22, 2008 - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the ongoing IMPROVE (Investigating MRI Parameters with Rebif imprOVEd formulation) study met its primary endpoint. The primary objective of the study was to evaluate the efficacy of the new formulation of Rebif®, compared to placebo, in patients with relapsing-remitting multiple sclerosis (RRMS) and active disease by means of magnetic resonance imaging (MRI) at the end of 16 weeks of treatment. The 16-week study results show that the mean number of combined unique active brain MRI lesions per patient was reduced by 69% in patients treated with the new formulation of Rebif® compared with those receiving placebo, a statistically significant result (p<0.001). These data were presented at the late-breaking session of the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada.

"Patients who received Rebif® experienced far fewer new active brain MRI lesions than the placebo group after 16 weeks of treatment,” said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa, Director of the MS Research Clinic at the Ottawa Hospital, and an investigator of the IMPROVE trial. “These data demonstrate a
significant effect of the new formulation of Rebif® on disease activity and provide further evidence of its benefit in treating patients with relapsing-remitting multiple sclerosis.”

The IMPROVE study is a two-arm, randomized, double-blind, controlled, multicenter, international Phase IIIb study to evaluate the efficacy, safety and tolerability of the new formulation of Rebif® in patients with RRMS according to the revised McDonald criteria and evidence of active disease. A total of 180 patients were randomized in a 2:1 ratio to receive either the new formulation of Rebif® 44 micrograms three times a week subcutaneously, or placebo for an initial period of 16 weeks. At the end of this initial 16-week treatment period, patients from the placebo group have been switched in a single-blinded fashion to treatment with the new formulation of Rebif® 44 micrograms three times a week subcutaneously for a period of 24 weeks (the physician assessing treatment response and side effects is blinded). Patients who were initially assigned to the new formulation of Rebif® group continue to receive active treatment for an additional period of 24 weeks. The duration of the whole treatment period is 40 weeks.

The primary endpoint of the study is the difference between the number of combined unique active MRI lesions at week 16 in the group treated with the new formulation of Rebif® versus the placebo group. Combined unique active MRI lesions are defined as an active lesion on T1 sequence with gadolinium or T2 sequence, or both, avoiding double counting. The primary endpoint mainly reflects inflammatory activity (gadolinium-enhancing T1 lesions), but also reflects disease progression (T2 lesions).

The primary efficacy analysis showed that, at week 16, the number of combined unique active brain lesions was significantly lower in patients treated with the new formulation of Rebif® than in patients who received a placebo (p<0.001). The mean number of combined unique active brain lesions per patient was reduced by 69% in patients treated with the new formulation of Rebif® compared with those receiving placebo (0.7 versus 2.2). The median number of combined unique active brain lesions at week 16 was 0.0 in the group treated with the new formulation of Rebif® and 1.0 in the placebo group. Over half (53%) of patients treated with the new formulation of Rebif® had zero combined unique active brain lesions at week 16, compared to only 16.7% in the placebo group.

Results for the secondary and tertiary endpoints of the IMPROVE study will be available at the end of the 40-week treatment period.

The safety profile of the new formulation of Rebif® reported in this study is consistent with the known safety profile of Rebif®. No unexpected safety concerns were identified in this study.

The new formulation of Rebif® was approved in the European Union in August 2007 and in Canada in September 2007. It is now marketed in all EU countries and in Canada. The new formulation of Rebif® is not available in the United States.

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. Interferons are thought to help modulate the body’s immune system and reduce inflammation. The exact mechanism is unknown.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area.* Rebif® is available in a 22 micrograms and 44 micrograms ready-to-use pre-filled syringe and a titration pack (8.8 micrograms).

Rebif® should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors. For more information about Rebif®, please visit www.mslifelines.com for prescribing information.

* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. Full prescribing information for Rebif® can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including oral cladribine, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, disabling, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Euthyrox®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).
With an annual R&D expenditure of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.net or www.merck.de

Merck Serono Announces Initiation of the ORACLE MS Trial to Evaluate Cladribine Tablets in Patients at Risk of Developing Multiple Sclerosis

• ORACLE MS Phase III trial will assess effectiveness of cladribine tablets in preventing conversion to definite multiple sclerosis in addition to the fully enrolled Phase III pivotal trial – the CLARITY study – for treatment of relapsing forms of multiple sclerosis

Geneva, Switzerland, September 18, 2008 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the initiation of a Phase III trial to evaluate the therapeutic effects of its proprietary oral formulation of cladribine (cladribine tablets) in patients at risk of developing multiple sclerosis (MS).

The trial, called ORACLE MS (ORAl CLadribine in Early MS) will evaluate the safety and efficacy of two dosage regimens of cladribine tablets versus placebo in the treatment of patients who have experienced a first clinical event suggestive of MS. Cladribine tablets are currently also being evaluated in a fully enrolled Phase III pivotal trial – the CLARITY1 study – for treatment of relapsing forms of MS. As announced in January 2007, CLARITY was the first pivotal trial among all Phase III oral compounds in development for MS to complete enrollment. Cladribine tablets have been granted a fast track designation by the US Food and Drug Administration.

“There is increasing evidence supporting the initiation of treatment with a disease-modifying drug in patients who have experienced a first clinical event suggestive of multiple sclerosis, an initial stage of the disease when clinical manifestations are not necessarily pronounced but where the potential exists for irreversible neurological damage to take place,” said Dr. Thomas Leist, Associate Professor of Neurology and Director of the Comprehensive MS Center at Thomas Jefferson University, Philadelphia, PA, and an investigator in the ORACLE MS study. “The ORACLE MS study will evaluate the effectiveness and safety of cladribine tablets in preventing conversion to definite multiple sclerosis.”

“As a leader in multiple sclerosis treatments, we are committed to providing new options that can further improve the course of the disease and the quality of life for people living with this disease,” said Dr. Richard Douge, Executive Vice President, Global Marketing, Merck Serono. “The initiation of the ORACLE MS study further demonstrates our commitment to continue to build a solid portfolio of products for use in a broad multiple sclerosis patient population. We believe that our proprietary oral formulation of cladribine has the potential to address an important unmet medical need at a critical time of disease development.”

The ORACLE MS study is a randomized, double-blind, placebo-controlled, international trial. It will involve more than 600 patients considered at risk of developing MS due to a recently experienced isolated demyelinating event (e.g. optic neuritis, myelopathy or brainstem syndrome) and having MRI brain scans consistent with early signs of MS. Study participants will be randomized in one of the three arms of the study to receive one of two different dosage regimens of cladribine tablets or matching placebo tablets (1:1:1 ratio).

Patients will be treated for a period of two years (96 weeks), or up to the time when they experience a second attack leading to a diagnosis of clinically definite MS, in which case they would be offered open-label treatment with Rebif® 44 mcg three times a week for a 96-week maintenance treatment period. Patients who do not convert to clinically definite MS within the initial 96-week period of the study will be eligible to enroll in a 96-week long-term follow-up treatment period. These maintenance and long-term follow-up periods of the study are intended to assess the effect of early treatment with cladribine tablets on relapses and subsequent treatment response to disease-modifying therapy for relapsing-remitting MS and to evaluate the sustained effect of cladribine tablets in delaying the development of definite MS.

In the study, cladribine tablets are given in two or four treatment cycles in the first year, with each cycle consisting of once daily administration for four to five consecutive days, which means study patients take cladribine tablets for only 8 to 20 days during that year. In the second year, two treatment cycles are administered to all patient groups.

The primary endpoint of the ORACLE MS trial is time to conversion to MS, according to the McDonald criteria. Other endpoints include time to conversion to clinically definite MS according to the Poser criteria (the main secondary endpoint), assessments of MRI brain scans, and disability progression.

Approximately 200 medical centers globally are expected to participate in this trial.
1 CLARITY: CLAdRIbine Tablets Treating MS OrallY

About cladribine tablets

Merck Serono’s proprietary oral formulation of cladribine is currently being evaluated in Phase III as a treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. Interferons are thought to help modulate the body’s immune system and reduce inflammation. The exact mechanism is unknown.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*. Rebif® is available in a 22 microgram and 44 microgram ready-to-use pre-filled syringe and a titration pack (8.8 micrograms).

Rebif® should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors. For more information about Rebif®, please visit www.mslifelines.com for prescribing information.

* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. Full prescribing information for this product can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including cladribine tablets, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.
About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Euthyrox®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).
With an annual R&D expenditure of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.net or www.merck.de

Merck Serono Announces Initiation of Phase II Clinical Trial of Atacicept in Relapsing Multiple Sclerosis

Geneva, Switzerland, April 30, 2008 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its partner ZymoGenetics, Inc. (NASDAQ: ZGEN) today announced the initiation of a Phase II clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (RMS).

“This trial with atacicept underlines Merck Serono’s long-term commitment to patients with multiple sclerosis,” said Dr. Anton Hoos, Head of Global Development at Merck Serono. “Atacicept has the potential to complement existing MS drugs by offering a novel mode of action and convenient administration.”

“Patients with multiple sclerosis need more treatment options,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Our preclinical models have shown biological activity of atacicept in multiple sclerosis and, because of the growing body of supporting data in the literature indicating the importance of B cells and antibodies in the pathology of multiple sclerosis, we believe there is strong rationale for the clinical testing of atacicept in patients with RMS.”
The four-arm randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety and efficacy of atacicept in patients with RMS over 36 weeks of treatment. The primary objective of the study is to evaluate the efficacy of atacicept in reducing central nervous system inflammation in subjects with RMS as assessed by frequent MRI measures.

Approximately 300 RMS patients meeting the eligibility criteria will be randomly assigned to receive one of three subcutaneous doses of atacicept or placebo for 36 weeks. Patients will be followed up until week 48.

About atacicept

Merck Serono and ZymoGenetics are developing atacicept (formerly referred to as TACI-Ig) as a potential treatment of autoimmune diseases, such as systemic lupus erythematosus (SLE), lupus nephritis (LN), rheumatoid arthritis and multiple sclerosis, as well as B-cell malignancies.

Atacicept contains the soluble TACI receptor that binds to the cytokines BLyS and APRIL. These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases such as systemic lupus erythematosus. Current data indicates that levels of BLyS and APRIL are elevated in patients with rheumatoid arthritis, lupus erythematosus, B-cell malignancies and multiple sclerosis. Atacicept has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies.

About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. In addition to Rebif®, the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone® (mitoxantrone for injection concentrate) for worsening forms of MS. Full prescribing information for these products can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including oral cladribine, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).
With an annual R&D investment of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,681 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.net or www.merck.de

Teva Pharmaceutical's Altered Peptide Ligand Copaxone Boasts the Greatest Patient Share Among First- and Second-Line Therapies for the Treatment of Mu

WALTHAM, Mass., March 11 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Teva Pharmaceutical's Copaxone has the greatest patient share among first- and second-line therapies, and falls short of Merck Serono/Pfizer's Rebif (by 0.2 percent) in third-line treatment. However, in all three lines of therapy, the interferon-beta drug class (Biogen Idec's Avonex, Rebif, and Berlex's Betaseron) outpaces the altered peptide ligand drug class (consisting only of Copaxone) in patient share. Competition between the two drug classes is fiercest in first-line therapy.

"The low volume of patient share attributed to Avonex or Rebif compared with Copaxone in first- and second-line treatment illustrates a significant delay on the part of physicians and/or patients to engage in an interferon- beta therapy within a year of a patient's initial diagnosis for multiple sclerosis," said Madhuri Borde, analyst at Decision Resources. "However, the magnitudes of Rebif's first- and second-line patient shares suggest that some physicians are treating the disease more aggressively than might be expected, as this high-dose, high-frequency agent reaches patient shares close to and surpassing Avonex in first- and second-line treatment, respectively."

According to the new report entitled Treatment Algorithms in Multiple Sclerosis, neurologists note that Copaxone's better short-term and long-term side-effect/safety profile, together with its lower rate of induction of neutralizing antibodies, are critical reasons for choosing Copaxone instead of Avonex, Rebif and Betaseron. Although Copaxone is administered daily, 23-28 percent of neurologists we surveyed indicate that a key reason to prescribe the drug over any of the interferon-beta therapies is the drug's ability to foster greater patient compliance, an attribute that is closely tied to the Copaxone's lower incidence of flulike side effects.

About Treatment Algorithm Insight Series
Decision Resources combines in-depth primary research with the most extensive claims-based longitudinal patient-level data from PharMetrics(R) to provide exceptional insight into physicians' prescribing trends and the factors that drive therapy product choice, from diagnosis through multiple courses of treatment, for a specific disease.

For each disease examined, Decision Resources' Treatment Algorithm Insight Series provide the following:

-- Summary of U.S. medical practice based on interviews with leading experts in the field. -- Qualitative diagnosis/referral/treatment algorithm for the United States. -- Drug usage by lines of therapy (1st, 2nd, 3rd line). -- Discussion of key freeform combinations by lines of therapy. -- Product share (class and specific compound level) within each line of therapy (1st, 2nd, 3rd line). -- Progression of therapy from key 1st line products. -- Pathway to key therapies from previous therapies. -- Qualitative analysis of two-year forecast incorporating upcoming launches, changes in reimbursement, etc.

About Decision Resources
Decision Resources, Inc., (http://www.decisionresources.com/) is a world leader in healthcare market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact: Elizabeth Marshall Decision Resources, Inc. 781-296-2563 emarshall@dresources.com
Decision Resources

Interferon Beta-1a Offers A Near 3-fold Improvement In Injection Tolerability Compared With The Original Formulation - 2-Year Phase IIIb Data

Merck Serono, a division of Merck KGaA, announced today new results of a two year (96 week) Phase IIIb study in 260 patients which has shown that the new formulation of Rebif® (interferon beta-1a) offers a near three-fold improvement in injection tolerability for patients with relapsing remitting multiple sclerosis (RRMS). These results are compared with historical data for the previous formulation of Rebif® (30.8% versus 85.8%) (1).

These study results will be presented today at a satellite symposium and tomorrow at a poster session at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.

"Rebif is an established first-line disease modifying treatment for relapsing types of MS" said Professor Gavin Giovannoni from The Royal London Hospital. "Injection site reactions can lead to withdrawal from treatment. The reduction in these reactions with the new formulation should improve treatment benefit to patients."

Rebif® has a favourable benefit-to-risk profile (2) and has a proven efficacy and safety profile, which has been demonstrated consistently across numerous phase III clinical trials and clinical practice (1, 3-5). The new study results have also confirmed consistent efficacy of the new formulation of Rebif® compared with previous experience (1). At 96 weeks, 53.3% of patients remained relapse-free and overall the expanded disability status scale (EDSS) score remained stable throughout the study.

The new formulation of Rebif® was approved on August 10, 2007, by the European Commission and is due to be launched in the UK in early 2008. The new formulation of Rebif® is the first and only therapy for multiple sclerosis that is serum free, both from animal and human-derived components (HSA-free and FBS-free) and is the latest product development from Merck Serono. Other recent enhancements have included the launch of a new initiation pack designed to make starting Rebif® therapy easier and more convenient.

References

1. Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE trial. Neurology 2002; 59: 1496-506.
2. Francis GS. Importance of benefit-to-risk assessment for disease-modifying drugs used to treat MS. J Neurol 2004; 251 (Suppl 5): v42-9.
3. Li D, Paty D, UBC MS/MRI Analysis Research Group, PRISMS Study Group. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo controlled study of interferon-b1a in relapsing-remintting multiple sclerosis. Ann Neurol 1999; 46: 197-206
4. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcultaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-504, Erratum inLancet 1999; 353; 678.
5. PRISMS Study Group, University of British Columbia MS/MRI Analysis Group. PRISMS-4: Long-term efficacy of interferon-β-1a in relapsing MS. Neurology 2001; 56: 1628-36.

About the Study

The study was a two-year (96 weeks) Phase IIIb, international, multicenter, single-arm, open-label study with historical controls, evaluating the safety and immunogenicity of the new formulation of Rebif® (interferon beta-1a) 44 micrograms (mcg) subcutaneously (sc) three times weekly (tiw) in 260 patients with relapsing forms of multiple sclerosis (MS).

No unexpected adverse events were reported with the new formulation of Rebif®. Safety outcomes were consistent with the known profile of Rebif®. The majority of adverse events were mild or moderate in severity. The most frequent side effect was flu-like symptoms (71.5%), which is typical of interferon therapy; most were mild in severity. Flu-like symptoms are transient. Prophylactic antipyretic treatment is recommended.

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system and reduce inflammation.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity compared to placebo*. Rebif® is not approved for treatment of chronic progressive MS. Rebif® is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and a titration pack (8.8 mcg and 22mcg).

Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.

* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

About Merck Serono and Multiple Sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. In addition to Rebif®, the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone® (mitoxantrone for injection concentrate). Product information can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including cladribine, currently in Phase III, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Merck Serono

Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.

Merck Serono has leading brands serving patients with cancer, metabolic and cardiometabolic disorders, as well as psoriasis. With an annual R&D investment of EUR 1bn, we are committed to growing our business in specialist-focused therapeutic areas such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

-- http://www.merckserono.net
-- http://www.merck.de

Merck KGaA's Rebif, Teva's Copaxone similar-study

Wed Oct 10, 2007 5:01am EDT

FRANKFURT, Oct 10 (Reuters) - Merck KGaA's (MRCG.DE: Quote, Profile, Research) Rebif multiple-sclerosis drug is not superior to rival Teva's (TEVA.O: Quote, Profile, Research) Copaxone, a study obtained by Reuters on Wednesday showed.

"The number of events (relapses) was insufficient to establish a statistically significant difference between the two products, despite a trend advantage for Rebif," the report said.

The 96-week Phase IV study involving almost 800 patients will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague.

Merck inherited Rebif through its recent 10.2 billion-euro

($14 billion) acquisition of Swiss biotech company Serono.

Serono had hoped to gain market share from Copaxone in the case of a positive outcome from the head-to-head study.

Merck shares were 1.6 percent lower at 88.20 euros at 0908 GMT, compared with a flat blue-chip DAX index (.GDAXI: Quote, Profile, Research).

((Reporting by Mantik Kusjanto; Reuters Messaging: mantik.kusjanto.reuters.com@reuters.net; E-mail: mantik.kusjanto@reuters.com; +49 69 7565 1203))

© Reuters2007All rights reserved

Bayer Schering Pharma AG, Germany, and Genzyme Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis

Berlin, September 26, 2007 – Bayer Schering Pharma AG, Germany, and Genzyme Corporation, USA, today announced that the first patient has been treated in the first of two planned Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).

The CARE-MS SM I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomized, rater-blinded study, will compare alemtuzumab to Rebif® (interferon beta-1a) in patients with relapsing-remitting MS. Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but have not yet begun treatment with any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.

Initiation of this Phase 3 program follows the successful completion of the initial treatment period in the Phase 2 trial. Interim results from the Phase 2 trial indicated that alemtuzumab-treated patients experienced a statistically significant reduction in the risk for sustained accumulation of disability and the risk for relapse for 24 months compared with Rebif-treated patients. Results of the primary outcomes from this trial at 36 months are expected to be presented on Oct. 14 by Professor Alastair Compston during the Charcot Award lecture at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis, ECTRIMS, in Prague.

The CARE-MS I study will enroll up to 525 patients at approximately 60 medical centers throughout North America, Australia, Latin America, and Europe, and will again compare alemtuzumab-treated patients to Rebif-treated patients according to two co-primary endpoints: the time to sustained accumulation of disability and the annualized relapse rate. Alemtuzumab will be dosed at 12 mg/day for five days by daily IV infusion, with a second dosing 12 months later of 12 mg/day for three days. All patients will be followed for two years from the date that the last patient is randomized to treatment. Alemtuzumab-treated patients will continue to have safety evaluations for at least three years after the last course of treatment. The companies anticipate filing for marketing approval of alemtuzumab for the treatment of MS in 2011.

About Multiple Sclerosis
Multiple sclerosis is a chronic disease of the central nervous system (CNS) in which the immune system can attack the brain and spinal cord. The disease causes a wide range of symptoms including fatigue, difficulty walking, numbness, and vision problems, and can progress to cause severe disability. Relapsing-remitting MS is the most common form of this disease.

About Alemtuzumab
Alemtuzumab is an investigational drug for the treatment of MS and must not be used outside of a formal clinical trial setting in MS patients. Physicians or patients seeking additional information about the CARE-MS I trial should contact Genzyme Medical Information at 1-800-745-4447, option 2 in the U.S., +31 35 699 1499 in Europe, or visit www.clinicaltrials.gov.

Alemtuzumab is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Outside of the U.S., alemtuzumab has been approved for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The product is marketed outside the United States as MabCampath® by Bayer Schering Pharma AG, Germany, and in the U.S. by the company's U.S. affiliate, Bayer HealthCare Pharmaceuticals, as Campath®.

Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces and directs the body’s immune system to destroy those cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-CLL.

Genzyme and Bayer Schering Pharma AG, Germany, are co-developing alemtuzumab in oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG, Germany, holds exclusive worldwide marketing and distribution rights to alemtuzumab.

About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Genzyme®, Campath® and MabCampath® are registered trademarks of Genzyme Corporation. All rights reserved.

Genzyme’s press releases and other company information are available at www.genzyme.com.

About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.


Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact
Cantor, Maria

New Formulation of Multiple Sclerosis Treatment Rebif Approved in European Union

New formulation of Rebif® designed to improve injection tolerability

GENEVA, Switzerland, August 30, 2007 – Merck Serono, a division of Merck KGaA, announced today that the European Commission has granted a marketing authorization for a new formulation of Rebif® (interferon beta-1a) for the treatment of relapsing multiple sclerosis (MS). The new formulation of Rebif® has been developed to increase treatment benefit by improving injection tolerability while targeting an improved immunogenicity profile. This new formulation originates from an innovative approach, using state-of-the-art technologies.

“The European approval of the new formulation of Rebif® is an important step in our efforts to continuously provide enhanced therapeutic solutions for patients with MS,” said Roberto Gradnik, Head of Merck Serono’s Operations for Europe. “We are pleased to bring this enhanced treatment option to patients throughout Europe.”

The European Commission decision applies to all 27 countries in the European Union1, as well as Iceland, Liechtenstein and Norway. Launches of the new formulation of Rebif® in the various countries of the European Union will start in September 2007. The new formulation of Rebif® will be available in the same strengths and pharmaceutical forms as currently registered, i.e. 8.8, 22 and 44 mcg, as a solution for injection in pre-filled syringes.

“The European approval of the new formulation of Rebif® is good news for patients with MS,” said Professor Per Soelberg Sørensen, Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital. “This new formulation will represent an improvement in the therapy of MS patients being treated with Rebif®.”

Rebif®, which was originally approved in Europe in 1998, has been proven effective on the following three key measures of treatment effectiveness: MRI lesion area and activity, relapse rates, and disability progression. The safety and efficacy of Rebif® are supported by a robust long-term clinical development program including comparative studies and 13 years of patient experience from around the world.

The new formulation of Rebif® is the latest of many product developments from Merck Serono to continuously enhance the convenience and tolerability of Rebif®. Other enhancements have included the Rebiject II auto-injector to facilitate injections; a 29 gauge-5 bevel needle pre-filled syringe, the thinnest needle in a ready-to-use pre-filled syringe for the treatment of MS; and a titration pack designed to make starting on Rebif® therapy easier and more convenient.

1 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, The Republic of Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom


About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body’s immune system, fight disease and reduce inflammation.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area[1]. Rebif® is not approved for treatment of chronic progressive MS. Rebif® is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and a titration pack (8.8 mcg).

Most commonly reported side effects are injection site disorders, flu-like symptoms, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.


About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. In addition to Rebif®, the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone® (mitoxantrone for injection concentrate) for worsening forms of MS. Full prescribing information for these products can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including oral cladribine, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.


About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.


###

Forward-looking statements
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Merck Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Merck Serono’s current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on February 28, 2006. These factors include any failure or delay in Merck Serono’s ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, the outcome of any government investigations and litigation. Merck Serono is providing this information as of the date of this press release, and has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.


###

About Merck Serono

Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), metabolic and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®). With an annual R&D investment of EUR 1bn, we are committed to growing our business in specialist-focused therapeutic areas such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.


About Merck

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.


For more information, please visit www.merckserono.net or www.merck.de

New Rebif (Interferon Beta-1a) Initiation Pack For Patients With Relapsing Remitting Multiple Sclerosis

Merck Serono has announced the launch of a new Rebif initiation pack for patients with relapsing remitting multiple sclerosis (RRMS). It is important when patients begin interferon beta therapy that the dose is gradually increased over a four week period as this helps minimise possible side effects. The new pack consists of 12 pre-filled syringes at the recommended staged dosing to enable easy titration and minimal wastage as a patient begins therapy.

Gradual dose titration when starting treatment may minimise side effects such as flu-like symptoms that can occur with interferon beta therapy1. Flu-like symptoms occur in 40% of patients2 and are typically present within the first few days of commencing treatment. Most patients will also experience injection site reactions, predominantly mild inflammation. Whilst both side effects are in the majority of cases reversible and may alleviate over time, they have been shown to decrease the potential for concordance. In a retrospective study among 281 patients, injection site reactions and flu-like symptoms were cited among the top three reasons for interrupting interferon beta therapy3.

Debbie Quinn, MS Specialist Nurse at Northamptonshire Teaching PCT commented on the new initiation pack. "It is really important when you start a patient on interferon beta therapy that you manage their expectations in terms of the likely side effects, building up to the maintenance dose over an extended period of time limits these symptoms. Delivering the syringes in an easy to use pack simplifies the titration process for patients and is reassuring for them."

Starting treatment for MS can be a stressful experience for patients and their carers and it has been shown that patients who do have a more positive experience during the initial stages of therapy will be more likely to adhere to treatment in the long term. Long term follow up has demonstrated the benefits of interferon beta over a 7-8 year period and supports the importance of initial concordance4, 5.

-- The Rebif initiation pack contains 12 pre-filled syringes (six with 8.8μg and six with 22μg)

-- Rebif should be taken three times a week at approximately the same time each day and the injections should be at least 48 hrs apart

-- A Rebif initiation pack covering a four week course of treatment costs £586.196

-- The titration schedule consists of 2 weeks' treatment at 8.8μg, followed by a further 2 weeks at 22μg, building up to a maintenance dose of 44μg at week 5 and is based on the schedule used during the landmark trials7

About Merck Serono

Merck KGaA of Darmstadt, Germany, is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by about 35,000 employees (including Merck Serono) in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 73% interest and free shareholders own the remaining 27%. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917.

http://www.serono.com

References

1. Wroe SJ. J Int Med Res. 2005;33:309-18
2. Rebif SPC
3. Tremlett and Oger. Neurology 2003;61:551-554
4. Kappos L et al. Neurology 2006;67:944-953
5. World Health Organisation Report 2003; Please click here.
6. Rebif Initiation Pack Prescribing Information, May 2007
7. PRISMS Study Group. Lancet 1998;352:1498-1504

Genzyme and Bayer HealthCare Announce Detailed Interim Two-Year Alemtuzumab in Multiple Sclerosis Data Presented at AAN

Interim analysis of Phase 2 comparative study showed significant results in favor of alemtuzumab versus Rebif®

CAMBRIDGE, Mass. and Wayne, NJ - Genzyme Corporation (Nasdaq: GENZ) and Bayer HealthCare Pharmaceutical today announced detailed interim results from the CAMMS223 Phase 2 study. This interim analysis of all patient data through at least twenty-four months from the start of the study for all patients showed that a once-yearly cycle of alemtuzumab treatment had a statistically significant impact on reducing the frequency of relapses and the sustained accumulation of disability in early active relapsing remitting multiple sclerosis (RRMS) patients compared to Rebif® (interferon beta-1a).

The data were presented yesterday at the 59th Annual Meeting of the American Academy of Neurology (AAN) in Boston by Dr. Alasdair J. Coles, Ph.D., MRCP, Addenbrooke's Hospital, University of Cambridge, United Kingdom. This is the first time that an analysis of the primary and secondary endpoints has been presented in full.

Dr. Coles' presentation showed patients taking alemtuzumab at the high dose experienced an 87 percent reduction in the risk for relapse (p<0.0001) and a 66 percent reduction in the risk for progression of clinically significant disability (p<0.0098) when compared to patients treated with Rebif. At the low dose, patients taking alemtuzumab experienced similar results, with a 72 percent reduction in the risk for relapse (p<0.0001) and an 88 percent reduction in the risk for progression of clinically significant disability (p<0.0008) compared with patients treated with Rebif. Patients in both alemtuzumab arms also achieved a statistically significant reduction in disability compared with their pre-treatment baseline, as measured by their Extended Disability Status Scale (EDSS) scores.

"Although several therapies are already available to treat MS, patients still face an unmet need for more effective treatment that further stabilizes disability," said Principal Investigator Professor D. Alastair S. Compston, MBBS, Ph.D., FRCP, FMedSci, Addenbrooke's Hospital, University of Cambridge, United Kingdom. "The large two-year reductions in the risk of relapse and sustained accumulation of disability seen in these interim results are impressive, and potentially very encouraging for the many people worldwide who currently face an uncertain future with this devastating disease and for their treating physicians."

As previously announced, dosing of alemtuzumab in this study was voluntarily suspended in September 2005 after three cases of immune thrombocytopenic purpura (ITP) were reported, the first of which resulted in a fatality. The U.S. Food and Drug Administration (FDA) subsequently placed the study on clinical hold. To date, six of the 216 (2.8 percent) alemtuzumab-treated patients in the CAMMS223 study have developed ITP. ITP is a disorder characterized by a low platelet count and corresponding increased risk of uncontrolled bleeding. Though potentially serious, ITP can be detected and monitored through blood tests, and is usually treatable.

At the time of the dosing suspension, most patients had received two cycles of therapy with alemtuzumab. Treatment with Rebif in the control arm continued without interruption. Alemtuzumab re-dosing in the trial remains on clinical hold in the United States, and active discussions are underway with regulatory authorities regarding the clinical development program. Significant progress has been made toward the initiation of two planned Phase 3 clinical trials, one that will include previously untreated patients and one that will involve patients receiving an approved therapy whose disease remains active. These Phase 3 studies are expected to begin this year, following FDA clearance. Alemtuzumab is an investigational drug for the treatment of MS. Alemtuzumab should not be used in MS outside of the formal clinical trial setting so that patient safety, including the risk of ITP, can be monitored.

Phase 2 Study Details

The open-label, rater-blinded, randomized study enrolled 334 treatment-naïve patients with early, active, RRMS. The trial compares the safety and efficacy of alemtuzumab to Rebif. This is the first time that a potential new therapy for multiple sclerosis has undergone a prospective, controlled, multi-year, head-to-head comparison to a recommended first-line therapy.

In the trial, patients with RRMS at 49 medical centers in Europe and in the U.S. were treated with alemtuzumab at one of two doses (12 or 24 mg IV per day for five days at initial treatment, and for three days in the subsequent yearly treatments), or Rebif (44 mcg administered subcutaneously three times per week, as indicated in its product label). Although treating physicians were aware of which treatment patients received, independent (blinded) neurologists assessed the disability efficacy endpoint and performed relapse evaluations.

Primary endpoints in the trial were the annualized relapse rate and the time to Sustained Accumulation of Disability as measured by an increase in EDSS scores lasting at least six months. The efficacy and safety data analyses were reviewed by an independent Data and Safety Monitoring Board. The final analysis of the primary endpoints in CAMMS223 will be based on data through three years in all patients.

In addition to the results of the co-primary endpoints outlined above, Dr. Coles presented the interim results of the change from baseline in MRI T2 lesion volume and mean EDSS, which are secondary and tertiary endpoints, respectively. Each of these findings supports the results seen in the primary endpoints.

Safety Results

In the comparison of safety parameters of alemtuzumab vs. Rebif, a greater number of serious adverse events (a subset of total adverse events) were reported in patients receiving Rebif than in the two alemtuzumab dose groups combined. Most of these were associated with patients who were hospitalized for treatment of their MS.

The majority of adverse events (93 percent) in all three arms, including infusion-associated adverse events, were mild-to-moderate in intensity. The total number of adverse events was approximately twice as high in each of the alemtuzumab-treated arms as in the Rebif-treated arm, primarily due to the high number of infusion-associated adverse events. Excluding infusion-associated adverse events (i.e., those occurring within 48 hours of an infusion), the incidence of adverse events was similar across the three arms.

To date, a total of six of 216 (2.8 percent) alemtuzumab-treated patients in the CAMMS223 study have developed ITP. In the initial case, symptoms of ITP were experienced but not recognized in time to seek prompt medical attention. After that case, the sponsor notified investigators and patients of the risk of ITP, and a Patient Monitoring Program for ITP was implemented in CAMMS223. The other five ITP patients were diagnosed promptly, responded well to medical treatment, and have been stable without ongoing treatment for ITP for between five and thirteen months. No new cases of ITP have been reported in the study since September 2006. A presentation of updated ITP information will be made at the AAN conference by Herman Sullivan, MD on Wednesday, May 2, at 4:30PM EDT.

Additionally, the proportion of patients with thyroid-related clinical adverse events after alemtuzumab treatment was 16.2 percent vs. 1.9 percent after Rebif treatment. Thyroid adverse experiences were substantially less common in the two years after alemtuzumab treatment than in prior studies of the product in MS patients. A poster presentation of updated thyroid autoimmunity information will be made by Dr. Coles on Thursday, May 3.

About Multiple Sclerosis

Multiple sclerosis is an immune-mediated disease of the central nervous system (CNS) in which the immune system may attack the brain and spinal cord. MS affects approximately 2.5 million people worldwide and approximately twice as many women as men. The clinical course of MS is highly variable, but is typically characterized by an initial relapsing and remitting phase where episodes of transient neurological compromise are followed by partial to full recovery. Within 10 to 20 years, however, most patients experience progressive disability in which a steady worsening of symptoms may culminate in profound muscle weakness, impaired gait and mobility, bladder and bowel dysfunction, and cognitive and visual impairments. At onset, relapsing-remitting MS is the most common form of this disease.

About Alemtuzumab

Genzyme is conducting the clinical development program of alemtuzumab in multiple sclerosis. Bayer HealthCare holds exclusive worldwide marketing and distribution rights to alemtuzumab and participates with Genzyme in the design of clinical protocols and conduct of activities for the development of alemtuzumab for the treatment of MS.

Alemtuzumab is an investigational drug for the treatment of MS, and should not be used outside of the formal clinical trial setting.

Alemtuzumab was approved in 2001 and is marketed outside the United States as MabCampath®and in the U.S. by Bayer HealthCare Pharmaceuticals Inc., as Campath®. The product is indicated for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Determination of the effectiveness of Campath is based on overall response rates. Comparative, randomized trials demonstrating increased survival or clinical benefit such as improvement in disease-related symptoms have not yet been conducted.

Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on some cells of the immune system, including lymphocytes. When alemtuzumab binds to these cells, it triggers their destruction by the immune system. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-cell Chronic Lymphocytic Leukemia (B-CLL), a malignant disease of B-lymphocytes.

Campath should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Campath has a boxed warning which includes events of hematologic toxicity, infusion reactions, and infections/opportunistic infections.

Campath is contraindicated in patients who have active systemic infections, underlying immunodeficiency (e.g., seropositive for HIV), or known Type 1 hypersensitivity or anaphylactic reactions to Campath or to any one of its components.

The most commonly reported infusion-related adverse events in patients with B-CLL were rigors, drug-related fever, nausea, vomiting, and hypotension. Hematologic toxicities included pancytopenia/marrow hypoplasia, anemia, thrombocytopenia, neutropenia, and profound lymphopenia, and should be monitored. Infections reported included sepsis, pneumonia, and opportunistic infections such as CMV, candidiasis, aspergillosis, and mucormycosis.

Please refer to www.campath.com for complete prescribing information of Campath in CLL.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

About Bayer HealthCare

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the US, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forward-Looking Statements

This press release contains forward-looking statements, including statements about clinical trial results, regulatory plans and expected timelines for alemtuzumab, including the initiation of a Phase 3 trial in MS patients and the timing thereof, and the ability to manage patient safety. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: that final results of the clinical trial demonstrate safety and efficacy comparable to the interim data that have emerged to date, the actual timing and content of submissions to and decisions made by the regulatory authorities, institutional review boards, data safety monitoring boards and treating physicians regarding the continued administration of alemtuzumab to MS patients, Genzyme's ability to develop and obtain approval of a patient safety plan, and the other risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission.

Please see the disclosure under the heading "Risk Factors" in the Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations section of Genzyme's Annual Report on Form 10-K for the year ended December 31, 2006 for a more complete discussion of these and other risks. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Genzyme®, Campath®, and MabCampath® are registered trademarks of Genzyme Corporation. All rights reserved.

Rebif® is a registered trademark of EMD Serono, Inc.

# # #

Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.

Bayer HealthCare press releases and other information are available at pharma.bayer.com or by calling 1-888-84BAYER.