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.

On December 16, 2010 3M Drug Delivery Systems has signed an exclusive licensing agreement with Spirig Pharma AG, a Swiss manufacturer of dermatological and dermocosmetic products. Spirig Pharma AG will utilize one of 3M’s immune response modifier (IRM) molecules to further its development of treatment for sun damaged skin (Press release, 3M Pharmaceuticals, DEC 16, 2010, View Source [SID:1234511966]). Spirig is known internationally for brands like its Daylong actinica, a medical device for the prevention of certain forms of non-melanoma skin cancer in at risk patients, and Excipial moisturizer.

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Mark Tomai, PhD, vaccine business development director for 3M Drug Delivery Systems, explains the promise of the company’s technology: "The molecule offers potential for treating patients that suffer from a variety of dermatologic conditions. 3M is very proud of the many IRMs we have been developing for a variety of uses."

In addition, 3M has IRMs available for license in the areas of cancer, asthma/allergy and as vaccine adjuvants.

Jim Vaughan, vice president and general manager of 3M Drug Delivery Systems Division, stated that, "3M is pleased to align with a leading European dermatology company to further develop our IRMs. In addition to its Swiss headquarters, Spirig’s seven subsidiary locations, mainly in the EU, give us even more international reach."

"We are excited to expand our franchise of dermatology offerings in the prevention and treatment of sun damage-related skin conditions," said Dr. Silvio Inderbitzin, CEO of Spirig Pharma AG. "With 3M’s IRM molecule, we can enhance our portfolio with the help of an experienced partner in drug delivery technologies."

On December 14, 2010 TESARO, Inc. and OPKO Health, Inc. (NYSE Amex:OPK) reported that they have signed a definitive agreement granting TESARO exclusive rights for the development, manufacture, commercialization and distribution of rolapitant and a related compound (Press release, TESARO, DEC 14, 2010, View Source [SID1234533193]). Rolapitant, a Phase III-ready, oncology supportive-care product candidate, is a potent and selective neurokinin-1 (NK-1) receptor antagonist with an extended plasma half-life that has the potential to improve the management of nausea and vomiting experienced by cancer patients undergoing treatment with emetogenic chemotherapy. Phase II clinical testing of rolapitant for the prevention of nausea and vomiting in cancer patients treated with highly emetogenic chemotherapy demonstrated promising five-day activity following the administration of a single dose.

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Under the terms of the agreement OPKO is eligible for payments of up to $121 million, including an up-front payment and additional payments based upon achievement of specified regulatory and commercialization milestones; and will receive double digit tiered-royalties on sales. TESARO and OPKO will share future profits from the commercialization of licensed products in Japan and OPKO will have an option to market the products in Latin America. In addition, OPKO will acquire a 10% equity position in TESARO.

"TESARO is very pleased to announce this agreement with OPKO and to advance the development of rolapitant, an important supportive care product candidate," said Lonnie Moulder, Chief Executive Officer of TESARO. "Having successfully commercialized the present market-leading therapy in the U.S. for CINV prevention while building MGI PHARMA, our leadership team has a deep understanding of the unmet patient needs and market dynamics that exist in this area of oncology supportive care. We believe that rolapitant may be differentiated from other agents in this class and has great potential to help cancer patients undergoing chemotherapy. In addition, this first transaction will greatly accelerate our plans to build a leading oncology-focused biopharma company."
TESARO was co-founded by former executives of MGI PHARMA, an oncology and acute-care focused biopharmaceutical company that Eisai Co., Ltd. acquired in 2008 for $3.9 billion. While at MGI PHARMA, TESARO executives led the development and commercialization of numerous oncology products, including the successful U.S. commercialization of Aloxi (palonosetron HCl), the leading product in the 5-HT3 receptor antagonist class for prevention of CINV.

"We are pleased to complete this important transaction and look forward to seeing rolapitant progress towards registration in key markets throughout the world," said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. "The TESARO team’s special expertise and successful experience with the development and commercialization of oncology products will be of enormous benefit in making rolapitant a meaningful product for cancer patients and a commercial success."

"There is a continued need for unique agents to prevent nausea and vomiting associated with emetogenic chemotherapy regimens," said Steven Grunberg, M.D., Professor of Medicine and Pharmacology, University of Vermont. "The successful results of the randomized, controlled Phase II clinical trial of rolapitant in patients receiving an anticancer regimen with high potential to produce nausea and vomiting are encouraging for this potentially differentiated agent."

On November 17, 2010 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), reported it sold to Cold Genesys, Inc. exclusive, worldwide rights to develop and commercialize its oncolytic virus technology (Press release, BioSante, NOV 17, 2010, View Source [SID1234531732]). The technology includes CG0070, a replication-competent adenovirus that has completed a Phase I clinical trial for treatment of superficial bladder cancer. In exchange for the technology, BioSante received a 19.9 percent ownership position in Cold Genesys and a $95,000 upfront cash payment and is eligible to receive future milestone and royalty payments.

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Oncolytic (cancer cell killing) virus therapy is novel therapy that utilizes adenoviruses, a cause of the common cold, which are engineered to selectively replicate in targeted cancer cells, thereby killing these cells while leaving healthy cells largely unharmed. The virus is designed to replicate in cancer cells producing large amounts of oncolytic virus until the cancer cell can no longer contain the virus and bursts. The tumor cell is destroyed and the newly created oncolytic virus spreads to neighboring cancer cells to continue the cycle of viral replication and tumor cell destruction.

Stephen M. Simes, president and CEO of BioSante, said, "This is an important step in maximizing the value of technologies acquired late last year. This transaction allows us to transfer our oncolytic virus technology to a company with the expertise and ability to move it along the development path. By maintaining an ownership position in Cold Genesys, Inc. as well as the potential for future milestone and royalty payments, we have maintained important ‘upside’ in this exciting technology."

Paul A. DeRidder, MD, urologist and COO of Cold Genesys states, "CG0070 has demonstrated that tumor cell destruction may be achieved through direct adenovirus-mediated oncolysis and GM-CSF induced anti-tumor cell immune activation. Given the significant toxicity and limited efficacy of current treatment options, additional therapies for superficial and invasive bladder cancer are needed in order to increase bladder preservation and improve long term outcomes. Therefore, we are very excited to move this technology including CG0070 forward as an effective cancer treatment."

BioSante acquired rights to the oncolytic virus technology through its 2009 merger with Cell Genesys, Inc. BioSante also acquired other technologies and a full portfolio of cancer vaccines which may represent the widest portfolio of cancer vaccines in clinical development for a wide variety of cancers.

Advanced Life Sciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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