Navigation Links
EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States

ROCKLAND, Mass., Sept. 30 /PRNewswire/ -- EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Cladribine Tablets has the potential to be the first orally administered disease-modifying therapy available for people living with relapsing MS, as all disease-modifying therapies currently approved for the treatment of MS are parenteral therapies.

"As a leader in the area of neurodegenerative diseases, we continue to focus on making a positive difference in the lives of people living with MS, and their families," said Fereydoun Firouz, President and CEO of EMD Serono, Inc. "If approved, short-course therapy with Cladribine Tablets could transform the way people approach their treatment options, and meet an unmet need as an oral, disease modifying drug available for MS. We look forward to working with the FDA during the course of the regulatory process."

The NDA submission is supported by results from the CLARITY(a) study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in people with relapsing-remitting MS. The NDA also shows that all primary and secondary endpoints of the CLARITY trial were met. The CLARITY data were presented at the 61st Annual Meeting of the American Academy of Neurology (AAN) in April 2009 and at other recent international scientific meetings.

(a) CLARITY: CLAdRIbine Tablets Treating MS OrallY

About the CLARITY study

The CLARITY study was a two-year (96-week), randomized, double-blind, placebo-controlled, international trial. It randomized 1,326 patients with relapsing-remitting MS according to the revised McDonald criteria. Study participants were randomized to one of three different treatment groups consisting of two different dose regimens of cladribine tablets or matching placebo tablets (1:1:1 ratio). Cladribine tablets were given in two or four treatment courses in the first year, with each course consisting of once daily administration for four to five consecutive days, which means study patients took Cladribine tablets for 8 to 20 days during the year. In the second year, two treatment courses were administered to all patient groups. The primary endpoint of the CLARITY study was the qualifying relapse rate at 96 weeks. Secondary endpoints included MRI endpoints, and proportion of subjects qualifying relapse-free and disability progression at 96 weeks. Out of the 1,326 randomized patients, 90% of patients treated with Cladribine tablets completed the study (92% in the lower total dose group and 89% in the higher total dose group) compared to 87% in the placebo group.

About Cladribine Tablets

EMD Serono's oral formulation of cladribine (cladribine tablets) 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.

The clinical development program for cladribine tablets includes:

  • The CLARITY (CLAdRIbine Tablets Treating MS OrallY) extension study: a two-year placebo-controlled extension of the CLARITY study, designed to provide data on the long-term safety and efficacy of extended administration of cladribine tablets for up to four years.
  • The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS). This trial was announced in September 2008.
  • The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled trial designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy. This trial was announced in January 2007.

Cladribine tablets have been granted a fast track designation by the US Food and Drug Administration based on the need for an oral therapy in a subset of patients with relapsing forms of multiple sclerosis.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that more than 2.5 million people have 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 EMD Serono, Inc.

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, with Rebif® (interferon beta-1a), as well as in endocrinology, with Saizen® (somatropin (rDNA origin) for injection) and Serostim® (somatropin (rDNA origin) for injection). EMD Serono is a leader in reproductive health, with Gonal-f® (follitropin alfa for injection), Luveris® (lutropin alfa for injection) and Ovidrel® Prefilled Syringe (choriogonadotropin alfa injection). With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

For more information, please visit

About Merck KGaA

Merck KGaA is a global pharmaceutical and chemical company with total revenues of euro 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,800 employees in 59 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 or

SOURCE EMD Serono, Inc.

SOURCE EMD Serono, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. MJFF and Merck Serono (EMD Serono in North America) Join Forces on $2-Million Initiative to Drive Treatments for PD-Related Cognitive Dysfunction and Mood Disorders
2. Merck Serono Completes Enrollment in the REFLEX Trial of Rebif(R) in Patients at Risk of Developing Multiple Sclerosis
3. Merck Serono Announces Initiation of the ORACLE MS Trial to Evaluate Cladribine Tablets in Patients at Risk of Developing Multiple Sclerosis
4. Merck Seronos Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinsons Disease in a Phase III Pivotal Trial
5. Ambrx and Merck Serono Expand Collaboration Through ARX424 Multiple Sclerosis Drug Development Alliance
6. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
7. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
8. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
9. Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
10. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
11. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
Post Your Comments:
(Date:11/25/2015)... Nov. 26, 2015  The total global healthcare industry is ... 2015-2016. Latin America has the highest ... (excluding Japan ), is second with growth ... to face increased healthcare expenditure. In 2013-2014, total government funded ... 43.5% in 2008-2009 to 41.2% in 2013-2014. In real terms, ...
(Date:11/25/2015)... Nov. 25, 2015  The American Academy of ... (ACOG), and the March of Dimes cheered today,s ... Our Infants Act of 2015 (S.799), which ... newborns born exposed to drugs, such as opioids, ... introduction, all three organizations have worked together leading ...
(Date:11/25/2015)... Nov. 25, 2015 AAIPharma Services Corp./Cambridge ... of at least $15.8  Million to expand its ... NC . The expansion will provide additional ... the growing demands of the pharmaceutical and biotechnology ... expansion will provide up to 40,000 square feet ...
Breaking Medicine Technology:
(Date:11/26/2015)... Omaha, NE (PRWEB) , ... November 26, 2015 , ... ... careers searched by healthcare professionals and offered by healthcare staffing agency Aureus Medical ... top during the month of October 2015 among those searching for healthcare jobs through ...
(Date:11/26/2015)... CA (PRWEB) , ... November 26, 2015 , ... ... a new set of retro-fused, self-animating trailer titles with ProTrailer: Vintage. This newly ... options. These classically-influenced trailer titles work with any font, giving users limitless opportunities ...
(Date:11/25/2015)... ... 25, 2015 , ... Additional breast cancers found with MRI ... to a study published online in the journal Radiology. Researchers said that in ... a change in treatment. , Breast MRI is the most sensitive technique for ...
(Date:11/25/2015)... ... November 25, 2015 , ... Finnleo, a leader in the traditional and far-infrared ... traditional and far-infrared saunas. , For traditional saunas, Finnleo is offering ... sauna wood, and Finnleo uses only European Grade A Nordic White Spruce from sustainably ...
(Date:11/25/2015)... ... 2015 , ... Dr. John Pierce, Medical Director at the Ageless Forever clinic ... the Capillus272™ Pro laser therapy cap. FDA cleared for safety and efficacy, the Capillus272 ... need for surgery, prescription pills, or topical foams. , “Capillus272™ Pro is a ...
Breaking Medicine News(10 mins):