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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Filing, 10-Q, Zalicus, NOV 10, 2010, View Source [SID:1234504422])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On October 26, 2010 4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, reported the presentation of Phase II data from Hodgkin Lymphoma patients treated in the 1st Simon Stage cohort of the ongoing SAPHIRE study with resminostat (4SC-201), an oral pan-histone deacetylase (HDAC) inhibitor, at the 8th International Symposium on Hodgkin Lymphoma in Cologne, Germany (Press release, 4SC, OCT 26, 2010, View Source [SID1234533469]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The oral presentation will be given by the lead investigator of the SAPHIRE study, Prof Dr Jan Walewski of the Marie-Skłodowska-Curie Memorial Institute in Warsaw, Poland. It highlights initial safety and tolerability as well as efficacy data from the first 18 patients with relapsed or refractory Hodgkin Lymphoma in this study.

Daily oral application of 600 mg resminostat for 5 consecutive days per 2-week treatment cycle was well tolerated with the majority being mild to moderate gastrointestinal and haematological side effects. In addition, a number of anaemia cases were observed, however these were judged as being primarily related to the underlying disease. Pharmacokinetic data indicate good bioavailability of this HDAC inhibitor and plasma exposure levels yielded significant pharmacodynamic activity as exemplified by time dependent HDAC enzyme inhibition after dosing.

In this first patient cohort, the average treatment duration with resminostat reached approximately nine weeks. Anti-tumour activity of the drug was assessed every six weeks by combination of computer tomography (CT) and positron-emission tomography (PET), a technique which allows the simultaneous evaluation of changes in the metabolic activity and the size of a tumour lesion. Based on established PET/CT evaluation criteria, 10 patients out of 18 benefited from treatment with resminostat with two patients being assessed as partial responders (PR) (i.e. more than 50% reduction in size of tumour lesions) and a further eight patients with stabilization of disease (SD). Based on PET analysis almost all of these patients showed a diminished metabolic activity of their lesions with the majority being evaluated as partial metabolic responders (more than 25% decrease in PET activity). These results are based on intermediate analysis of the data and are therefore subject to final review.

According to the statistical design of the SAPHIRE study (Simon two-stage design), a minimum number of five responders were required in this reported 1st Simon stage in order to extend the study to a second enrolment phase of an additional 15 patients (the 2nd Simon stage). After reaching this threshold the study has recently proceeded into the 2nd Simon stage recruitment phase. Due to the good tolerability and side effect profile observed in this relatively young HL patient population an optional increase of the daily dose of resminostat from 600 mg to 800 mg has been implemented.

Prof Walewski of the Marie-Skłodowska-Curie Memorial Institute in Warsaw, Poland, the lead investigator of the SAPHIRE study, commented: ‘Despite the fact that patients with Hodgkin Lymphoma often respond well to first-line treatment with chemotherapy, there is an urgent medical need for new therapeutic approaches for patients relapsing or becoming refractory to standard therapy. For patients not responding to second line high-dose chemotherapy the 5-year progression-free survival rate is as low as 17%. Hodgkin Lymphoma patients are often very young and the repeated use of chemotherapy can lead to secondary tumour developments in addition to the primary lymphatic cancer. Based on the initial data presented on the 1st Simon stage of the trial, we are hopeful that resminostat may provide a new therapy option to relapsed or refractory HL patients.’

Dr Bernd Hentsch, Chief Development Officer at 4SC, commented: ‘We were very pleased with these initial results and are hopeful of the potential of our oral, pan-HDAC Inhibitor resminostat as a monotherapy treatment for advanced Hodgkin Lymphoma patients. We feel that this indication could provide a clinical proof-of-concept for resminostat, which is currently also being evaluated as a combination treatment in solid tumour indications.’