On June 30, 2009 BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) and Cell Genesys (NASDAQ:CEGE), reported that they have entered into a definitive merger agreement by which the companies will merge in an all-stock transaction, with BioSante as the surviving company (Press release, BioSante, JUN 30, 2009, View Source [SID1234531733]).

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Under the terms of the merger agreement, Cell Genesys stockholders will receive 0.1615 of a share of BioSante common stock for each share of Cell Genesys common stock they own. Based on the companies’ closing stock prices on June 29, 2009, this represents $0.347 per share of consideration to be received by the Cell Genesys stockholders, or a total consideration of approximately $38 million, and a premium of 12 percent to the closing sale price of Cell Genesys’ common stock on that date. Upon completion of the transaction, BioSante stockholders prior to the merger are expected to own approximately 60.4 percent of the outstanding shares of the combined company and the former Cell Genesys stockholders are expected to own 39.6 percent.

Stephen M. Simes, president and CEO of BioSante, and Phillip B. Donenberg, CFO of BioSante, will continue to serve in those positions in the merged company. Dr. Louis W. Sullivan, chairman of the board of BioSante, will continue in that position. It is anticipated that Stephen A. Sherwin, M.D., chairman and CEO of Cell Genesys, and John T. Potts, Jr., M.D., a current member of the Cell Genesys board, will join the board of the merged company upon completion of the merger.

The merged company will focus primarily on LibiGel, BioSante’s testosterone gel in Phase III clinical development under a U.S. Food and Drug Administration (FDA) agreed Special Protocol Assessment (SPA) for the treatment of female sexual dysfunction (FSD). The merged company also will seek future development opportunities for GVAX Immunotherapies including potential combination with BioVant, BioSante’s vaccine adjuvant, as well as possible external collaborations, and also will seek to outlicense other Cell Genesys technologies. In addition, the merged company will acquire a 16 percent equity ownership position in Ceregene, Inc., a former subsidiary of Cell Genesys which is developing gene therapies for neurodegenerative disorders.

"This merger allows BioSante to secure additional funding required for the continued Phase III development of LibiGel for FSD and offers the potential to expand our product development portfolio with the addition of GVAX Immunotherapies," said Stephen M. Simes, BioSante’s president and CEO. "LibiGel remains the only pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for the common and unmet medical need of FSD with the completion of Phase III studies targeted for mid-to-late 2010. In addition, our company has had a long-standing interest in immunotherapy based on our proprietary vaccine adjuvant, BioVant, and we look forward to future value-creating opportunities for our stockholders based on Cell Genesys’ technologies and other assets."

"Over the past several months, we have had the opportunity to evaluate a wide range of strategic alternatives for our company including several merger opportunities. After reviewing various strategic alternatives, engaging in discussions with a number of other potential merger candidates and conducting extensive due diligence on BioSante’s product development and business activities, our board of directors has voted to recommend a merger with BioSante," stated Stephen A. Sherwin, M.D., chairman and CEO of Cell Genesys. "We believe that BioSante’s lead product, LibiGel, represents a compelling near term product opportunity with significant upside potential. We also are impressed with BioSante’s record of achievement including the recent launch of Elestrin (estradiol gel) as well as their CaP nanotechnology platform which includes BioVant, a novel vaccine adjuvant with potential in immunotherapy."

The merger agreement has been approved unanimously by the boards of directors of both BioSante and Cell Genesys and will need to be approved by both BioSante’s and Cell Genesys’ stockholders. The merger is subject to customary closing conditions as well as a condition requiring Cell Genesys’ net cash, less certain expenses and liabilities, to be a specified minimum amount as of 10 calendar days prior to the anticipated closing date of the merger.

As of June 23, 2009, Cell Genesys’ cash balance was approximately $36 million and BioSante’s cash and cash equivalents balance was approximately $6.2 million. As a result of Cell Genesys’ recently completed exchange offer, Cell Genesys has outstanding approximately $20.8 million of new 3.125% Convertible Senior Notes due in 2013 and $1 million of the original 3.125% Convertible Senior Notes due in 2011.

The transaction is expected to be completed in the late third quarter or early fourth quarter of 2009. BioSante was advised in this transaction by Oppenheimer & Co. Inc. and Cell Genesys was advised by Lazard.

About BioVant

An adjuvant is a substance that, when added to a vaccine, enhances the vaccine’s effectiveness by enhancing the body’s immune response. In multiple studies, BioVant has been shown to be safe and cause minimal dose-dependent inflammation at the injection site, and has been shown both to prevent the manifestation of allergic response, and, to effectively ‘switch off’ established Th2-T-cell-associated allergic reactions. BioVant also may permit a reduction in the needed dosage of vaccine, thereby potentially improving the safety profile of the vaccine.

About GVAX Immunotherapies

GVAX cancer immunotherapies are non patient-specific therapies comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety. GVAX is administered via intradermal injections on an outpatient basis. To date, over 1000 patients have been treated in clinical trials with different GVAX cancer immunotherapies for various types of cancer. Although phase III trials in prostate cancer were discontinued in 2008, phase II trials under physician investigator sponsored-INDs are ongoing at the Sidney Kimmel Cancer Center at Johns Hopkins Hospital in pancreatic cancer, leukemia and breast cancer.

On June 22, 2009 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, reported initiation of global Phase III clinical study by Merck KGaA of the therapeutic cancer vaccine Stimuvax (BLP25 liposome vaccine, L-BLP25) in patients with advanced, inoperable breast cancer (Press release, Cancer Research Technology, JUN 22, 2009, View Source [SID1234523352]). The STRIDE(a) study will determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.

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Stimuvax is a liposomal peptide vaccine against the tumour-associated protein MUC1. The vaccine was developed by Oncothyreon (formerly Biomira) under a portfolio of patents licensed by CRT, following Cancer Research UK-funded investigations led by Prof Joyce Taylor-Papadimitriou at Guy’s Hospital, London. Stimuvax was the first investigational cancer vaccine to enter Phase III clinical testing in NSCLC with the February 2007 launch of the STARTb study, which will involve more than 1,300 patients with unresectable stage III NSCLC, who were stable or responding after chemoradiotherapy.

You can find out more about this new study by reading Merck KGaA announcement here.

On May 26, 2009 Investigators at Cancer Research UK’s Cambridge Research Institute (CRI) in conjunction with Cancer Research Technology (CRT) reported that they have agreed major support from the pharmaceutical company GlaxoSmithKline (GSK) to investigate a promising new treatment in kidney, bowel and pancreatic cancer (Press release, Cancer Research Technology, MAY 26, 2009, View Source [SID1234523354]).

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CRT, the Cancer Research UK owned commercialisation and development company, has secured a deal with GSK which will make use of the charity’s expertise to carry out two projects. The first project seeks to understand how the compound GSK2136773 containing the active portion of an antibody, works in laboratory models of pancreatic cancer*. The second project will use sophisticated imaging techniques** to compare the antibody’s effectiveness against current therapies in treating bowel and kidney cancer. Financial details were not disclosed.

The scientists at the Cambridge Research Institute are experienced at running high quality translational studies using the Institute’s state of the art facilities and highly developed tumour models.

Collaborations such as these with GSK’s Academic Discovery Performance Unit allow CRI researchers to study the latest therapeutics in development and make use of the charity’s expertise in progressing potential new treatments towards clinical use.

Dr David Tuveson, head of the Tumour Modelling and Experimental Medicine laboratory at Cancer Research UK’s Cambridge Research Institute – who will lead the first project – said: "We are delighted to be working with GSK and making the most of our medical and scientific expertise to push forward this project. It will enable us to determine if the domain antibody will help target pancreatic cancer – a cancer that poses some of the toughest questions for scientists because it has proven so difficult to treat."

GSK2136773 was developed by GSK. It is a domain-based biopharmaceutical that binds to and inhibits the action of the protein VEGF. VEGF drives the development of an efficient blood supply to tumours and by blocking the blood supply, a tumour’s growth can be inhibited. Domain antibodies are the smallest active part of an antibody. They can be as small as a 12th of the size of a complete antibody and it is thought that the small size means they will be able to penetrate deeper into the tumour tissue, and therefore be more effective than traditional antibody therapies.

Dr Phil L’Huillier, director of business development at Cancer Research Technology said: "This collaboration offers an opportunity for our scientists to apply their world-leading expertise in cancer to help progress potential treatments. Taking a treatment from the laboratory to the patient is one of the most challenging steps in drug development and such collaborations can make an important contribution to this process."

On May 20, 2009 Cancer Research UK and Cancer Research Technology (CRT) reported they will begin a phase I clinical trial of an anti-cancer drug from GlaxoSmithKline (GSK) (Press release, Cancer Research Technology, MAY 20, 2009, View Source [SID1234523355]).

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GSK’s 1070916A, an aurora kinase inhibitor*, is the third drug to enter Cancer Research UK’s Clinical Development Partnerships (CDP) programme**, but the first that is ready to be used in patients.

Cancer Research UK will sponsor the phase I trial, at the Institute of Oncology at St James’s University Hospital in Leeds and Barts and The London’s Experimental Cancer Medicine Centre in London. The trial will be managed by the charity’s highly experienced drug development office and will start within the next year.

The phase I trial will be carried out on around 30 to 40 patients with advanced solid tumours who have had all the treatments currently available. Cancer Research UK will have the opportunity to carry out a further phase II trial if the trial is successful.

Dr Victoria John, head of clinical partnerships at Cancer Research UK, said: "We’re delighted to be working with GSK on this promising new molecule under our CDP initiative.

"This deal brings our CDP portfolio to three and the total number of new drugs in our early preclinical and clinical pipeline to over 40, something we believe is testament to the specialist skills and capability of our drug development team."

CDP offers companies an alternative model to traditional out licensing, which enables them to retain rights to the compound throughout the development programme. The programme launched in 2006 to increase the number of new treatments for cancer patients by taking deprioritised anti-cancer agents from industry and putting them into clinical trials.

Under the terms of the partnership deal with GSK, Cancer Research UK will fund the study through early clinical development. GSK will have an option to further develop and commercialise the molecule in exchange for future payments to Cancer Research UK. Financial terms have not been disclosed.

If GSK elects not to take the programme forward, the rights to the molecule will be given to CRT to secure an alternative partner.

Dr Keith Blundy, chief executive of CRT, said: "Pharmaceutical and biotechnology companies have always had to prioritise which agents they take into clinical development, but even more so in the current economic climate.

"This deal with GSK demonstrates how Cancer Research UK and CRT can work with industry to speed up the development of anti-cancer drugs that might otherwise remain on companies’ shelves."

Professor Chris Twelves, head of Cancer Research UK’s Experimental Cancer Medicine Centre*** at the University of Leeds and St James’s Institute of Oncology, who will lead the phase I study, said: "This exciting arrangement between Cancer Research UK and GlaxoSmithKline is good news for patients. It opens up a new avenue of drug development, allowing us to investigate a compound that is almost ready for the clinic but otherwise wouldn’t be tested in patients. We look forward to beginning the trial as soon as possible."

On May 15, 2009 Cancer Research Technology Limited (CRT) reported that it has licensed the rights to its DNA-dependent protein kinase (DNA-PK)* inhibitor programme to collaboration partner KuDOS Pharmaceuticals Ltd (KuDOS) – a wholly owned subsidiary of AstraZeneca (Press release, Cancer Research Technology, MAY 15, 2009, View Source [SID1234523356]). The deal will see significant extra investment into the Newcastle University programme for further development of drugs that inhibit DNA-PK.

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DNA-PK plays a key role in the cellular repair-response to DNA damage caused by chemotherapy and radiotherapy treatments. This response often means treatments are less effective, so finding drugs that inhibit DNA repair could lead to a better outcome for patients. Results from earlier work at Newcastle University, funded by the charity Cancer Research UK, and KuDOS show that in laboratory studies the use of DNA-PK inhibitors could increase the efficacy of current chemotherapy and radiotherapy regimes.

The research is a key component of Cancer Research UK’s Drug Discovery Programme at Newcastle University directed by Professors Roger Griffin and Herbie Newell. Professor Nicola Curtin and Dr Celine Cano will head-up this study in collaboration with KuDOS. Professor Curtin said: "This exciting project will enable us to continue our work with KuDOS to rapidly progress DNA-PK inhibitors from this programme into clinical development."

As part of the two year collaboration agreement announced today, KuDOS has exercised an earlier option to a portfolio of intellectual property. The company will also receive an exclusive worldwide licence to develop the intellectual property arising from the continued programme. Both will be in return for upfront, milestone and royalty payments that will be shared between CRT and Newcastle University.

Dr Niall Martin, head of KuDOS, said: "This agreement builds on a very effective research collaboration we have had for a number of years with the Newcastle group, helping us identify and prepare exciting new drugs for clinical trials in the future. As part of this agreement, we will invest in three more full-time posts in Newcastle which will be dedicated to the project, and see further backing from Cancer Research UK and Newcastle University in addition to ongoing work in KuDOS and AstraZeneca – ensuring significant expansion of the research."

Dr Phil L’Huillier, CRT’s director of business management, said: "It’s very exciting to combine efforts with commercial partners to progress early stage scientific discoveries such as DNA-PK, which have the potential to improve cancer treatments of the future. Today’s agreement provides a very strong commitment to the development of this extremely encouraging work."