On December 16, 2010 Gedeon Richter Plc A ( "Richter") and Watson Pharmaceuticals, Inc. (NYSE: WPI). ( "Watson")reported that its 100% Richter – os owned subsidiary in the PregLem SA ( "PregLem") and Watson’s subsidiary, Watson Laboratories, Inc. license agreement with EsmyaTM (ulipristal acetate) for the exclusive development and marketing in the US and Canada (Press release, Gedeon Richter, DEC 16, 2010, View Source [SID:SID1234515555]). The European tests have shown that EsmyaTM in the final stages of development provides an effective and safe treatment for uterine fibroids affect millions of women. The product is currently in the final stages of development in Europe, Watson said the Phase III. Clinical trials are expected to commence in the United States of 2011.
Under the agreement, Watson PregLem’s US $ 17 million license fee, and after the turnover in the United States and Canada will pay royalty. Watson completed the additional payments to comply with certain regulatory compliance.
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The two companies share EsmyaTM other indications related to development costs.
"I am delighted with the agreement concluded with Watson, as special expertise and marketing network is expected to facilitate the North American EsmyaTM development and market introduction. I am convinced that the acquisition of PregLem and EsmyaTM marketing will increase shareholder value for our investors, " said Erik Bogsch, CEO of Gedeon Richter Plc..
"The EsmyaTM successfully concluded a European clinical trials, significant expertise we have thus gained in recent times and we are confident that the final stage of clinical development in the United States and Canada we will meet the standards," said Ernest Loumaye, PregLem CEO and Founder .
"The EsmyaTM as strategically important product complements the existing female healthcare portfolio, as it is the first product for 20 years, that can provide the first effective treatment of uterine fibroids," said Paul Bísaro, Watson CEO. "The contract allows you to continuously improve our knowledge developing products for the treatment of gynecological diseases in a registration and sale. However, the agreement establishes a fibroid tumor in other potential indications and products development. We look forward to deepening the relations developed both the Richter as the PregLemmel and we are confident that we have the opportunity to further develop cooperation in the establishment. "
Fibroid tumors of the uterus, fibroids grow in medicine are the most common benign, solid tumors that women of childbearing age about 20-25% of the affected. resulting in increased uterine bleeding disease, anemia, pain, frequent urination or incontinence, sometimes characterized by fertility disorders. Annually about 300,000 surgical procedures are performed in connection with the miómákkal, and approximately 230,000 involves removing the uterus. medicinal drugs in the treatment of fibroids associated anemia has accepted the only on the gonadotropin-realising hormone (GnRH) agonists, however, are limited by their side effects that are estrogen practically to zero (occurring after removal of both sides ovarian syndrome) displacement as follows (hot flushes, depression, mood swings, loss of libido, vaginitis and bone mineral density decrease).
The EsmyaTM
The unique mechanism of action of ulipristal acetate, a selective orally active progesterone receptor modulator which creates a reversible blocking progesterone receptors in target tissues. PregLem successfully concluded clinical trials in Europe, the European marketing authorization application was submitted. PregLem will be sold in Europe in the EsmyaTM.