A few days ago, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) filed for approval of a new version of its multiple sclerosis drug, Copaxone, which can be injected once every two days, instead of daily. The product is important for Teva, and should consolidate Copaxone's status and help it deal with generic versions, which will reach market in the coming years, as well has help Teva deal with oral treatments for multiple sclerosis.
Today, Mapi Pharma Ltd. announced that it plans to develop a longer-acting version of Copaxone, which can be taken once a month, a massive improvement even over Teva's new version of the drug. Mapi will soon begin clinical trials of its drug, which should reach market when Teva's Copaxone patents expire. If the clinical trials are successful and the drug is approved, it could compete directly against Copaxone.
Mapi was founded by chairman and CEO Ehud Marom, a former Teva COO at its active pharmaceutical ingredients (APIs) and Copaxone group. He also served as CEO of Gamida Cell Ltd. and executive at Makhteshim Agan Industries Ltd. "Teva should be encouraged by the existence of this product, because we have patented it," he said. "But I am not sure that they know how much progress we have made."
Marom added, "Mapi Pharma, which has kept media quiet until now, is a company with laboratories in Rehovot, China, and Germany. We're now building a plant to produce industrial APIs at Ramat Hovav. We have also developed a new technique for delayed release."
Marom said that Mapi has two products in preclinical trials and which were ready to begin human trials: an injectable longer-acting version of Risperidone (Risperdal) for the treatment of schizophrenia, which can be delivered once a month; and long acting formulation of glatiramer acetate, the API in Copaxone, which is also delivered monthly.
Marom predicts that the glatiramer acetate product will undergo the US Food and Drug Administration (FDA) b2505 procedure (an abbreviated clinical trial, because the molecule's safety profile is already known from brand Copaxone). He estimates the cost of the approval process at $20-30 million.
Marom is also the founder and chairman of Pharma Two B Ltd., which is also developing drug combinations, including for the treatment of Parkinson's and pancreatic, lung and breast cancer, under the FDA b2505 procedure. He said that Mapi and Pharma Two B have raised $40 million, but declined to break down the amount by company.
Published by Globes [online], Israel business news - www.globes-online.com - on May 6, 2013
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