Proventus

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Treat the Disease - Treat the Person

UK Charity No 1131517

Time Waits for Nobody

Working Together to Make a Difference

 

Working Together to Make a Difference

UK Charity No 1131517

Oral cladribine is a proprietary oral tablet formulation of Cladribine that is being studied in an effort to demonstrate possible benefits as a treatment for patients with relapsing forms of MS. Cladribine is a purine nucleoside analogue that interferes with the behaviour and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of MS.

 

U.S. regulators rejected as incomplete Merck KGaA's application to sell the oral treatment for multiple sclerosis.

 

“Merck, the  German based drug maker will seek a meeting with the U.S. Food and Drug Administration after the agency refused to accept its application for the medicine, cladribine,” spokesman Gangolf Schrimpf said.

 

“Our next step is to request a meeting with the FDA,” Schrimpf said in a telephone interview. “We’re not in a position to discuss the details of the FDA letter.”

 

Merck, which is vying with Novartis AG to market the first oral MS drug, asked the FDA in September to approve cladribine.

 

“This will certainly delay market entry, the amount of time depending on the full nature of the required actions,” DZ Bank AG analysts Elmar Kraus and Thomas Maul said in a research note today. Merck’s lead over Novartis “should now be gone.”

 

A refusal to file indicates “important information” was missing from the application, according to regulations dated 1993 that are posted on the FDA’s Web site. Minor omissions that wouldn’t significantly delay an application shouldn’t be grounds for refusal, according to the FDA rules.

 

 

Unlike existing injected medicines for multiple sclerosis, the Merck drug, approved more than a decade ago to fight leukemia, is taken for a few weeks out of the year in pill form. The drug works by suppressing the immune system, blunting its attack on nerve cells. Merck’s pill could compete with Novartis’s experimental multiple sclerosis pill FTY720, which disrupts the movement of immune cells into the bloodstream.

 

Cases of cancer in people who took cladribine during a clinical trial appear “relatively non-threatening,” and the drug is likely to be adopted gradually by patients with severe forms of multiple sclerosis, Sanford C. Bernstein Ltd. analysts concluded after data was presented at the European Committee for Treatment and Research in Multiple Sclerosis congress in Dusseldorf, Germany, in September.

 

In January, Merck said four patients were diagnosed with cancer during a final-stage trial of cladribine. An independent monitoring board was aware of the cases but didn’t consider them a safety concern, Merck said at the time.

 

Cancer

 

Each of the four cancer cases in the trial affected a different organ. Patients were diagnosed with early stage cervical cancer, melanoma, ovarian cancer and pancreatic cancer. Another patient developed choriocarcinoma, a cancer of the placenta, after becoming pregnant six months after she finished the study. No malignancies were reported in the placebo group.

 

Merck asked EU regulators to approve cladribine in July. Sales of the medicine could reach 700 million euros ($1.05 billion) a year, according to an estimate by DZ Bank.

 

Novartis has said it would ask U.S. and European regulators to approve its MS pill at the end of this year. The Swiss drugmaker has said it aims for at least $1 billion in sales for its multiple sclerosis franchise.

 

Source: Bloomberg © 2009 Bloomberg LP (30/11/09)

 

Side effects may occur:

• Headaches.
• Lymphopenia (an abnormally low level of lymphocytes in the blood. Lymphocytes are a white blood cell with important functions in the immune system).
• Nasopharyngitis (Inflammation of the nasal passages and of the upper part of the pharynx.).

 

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Notes.

Bone Marrow

• There are two types of bone marrow, red marrow and yellow marrow.
• Red blood cells, platelets and most white blood cells arise in red marrow; some white blood cells develop in yellow marrow.
• Both types of bone marrow contain numerous blood vessels and capillaries.
• Red marrow is found mainly in the flat bones, such as the hip bone, breast bone, skull, ribs, vertebrae and shoulder blades, and in the cancellous ("spongy") material at the proximal ends of the long bones femur and humerus.
• Yellow marrow is found in the hollow interior of the middle portion of long bones.
• In cases of severe blood loss, the body can convert yellow marrow back to red marrow in order to increase blood cell production.

 

 

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Leustat® - Cladribine