1stOncology™: Cancer Intelligence Service – Page 9988 – In the Complex World of Cancer Drug Development, We Provide Understanding.

BioSante Pharmaceuticals and Cell Genesys Announce Completion of Merger

On October 14, 2009 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) and Cell Genesys, Inc. (NASDAQ: CEGE), reported the successful completion of their previously announced merger of Cell Genesys with and into BioSante, with BioSante as the surviving company, under which BioSante now has acquired all of the outstanding shares of Cell Genesys common stock (Press release, BioSante, OCT 14, 2009, View Source [SID1234531734]).

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BioSante intends to 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). BioSante also intends to seek future development opportunities for GVAX Immunotherapies including combinations with BioVant, BioSante’s vaccine adjuvant, and possible external collaborations, and also will seek to outlicense other former Cell Genesys technologies. In addition, BioSante now owns a 16 percent equity ownership position in Ceregene, Inc., a former subsidiary of Cell Genesys which is developing gene therapies for neurodegenerative disorders.

"Closing the merger today is a very exciting development for BioSante. We now have accomplished our objective of having enough cash on hand to complete the LibiGel clinical development program to and through submission of a new drug application (NDA) in the first half of 2011," said Stephen M. Simes, president and CEO of BioSante. "The merger follows our successful registered direct financing closed on August 13, 2009 and our recent announcement of continued safety of LibiGel in our Phase III clinical studies. We now will accelerate completion of the LibiGel clinical development program to be in a position to submit the NDA in a timely fashion. We also will work to maximize the value of our newly acquired GVAX immunotherapies."

"The successful closing of our merger with BioSante provides an impressive array of opportunities to create value from the assets of the combined company," said Stephen A. Sherwin, M.D., the former chairman and CEO of Cell Genesys, and as a result of the merger, a new director of BioSante. "I am very pleased to have the opportunity to serve as a director of BioSante and look forward to working with the BioSante team."

The combined company’s ownership composition consists of approximately 62% from BioSante stockholders and 38% from the former Cell Genesys stockholders. BioSante stockholders approved the merger on September 30, 2009, and the former Cell Genesys stockholders approved the merger agreement and the transactions contemplated thereby at a special meeting of stockholders held today. Well over 90 percent of shares voted were voted in favor of the merger. Effective at the close of business today, trading in Cell Genesys common stock will be discontinued. All remaining Cell Genesys employees and management were terminated effective today.

In addition to Dr. Sherwin, John T. Potts, Jr., M.D., a former Cell Genesys director, also now serves as a director of BioSante as a result of the merger. Stephen M. Simes, president and CEO of BioSante, and Phillip B. Donenberg, CFO of BioSante, continue to serve in those positions, and Dr. Louis W. Sullivan, chairman of the board of BioSante, continues in that position.

Pursuant to the merger, the payment obligations of Cell Genesys under its 3.125% convertible senior notes due 2011 and 2013, respectively, were assumed by BioSante. Prior to the merger, the 2011 and 2013 notes were convertible into common stock of Cell Genesys at a conversion price of $9.10 and $0.68, respectively, and upon the merger, pursuant to the indentures governing those notes, the 2011 and 2013 notes became convertible into common stock of BioSante at a conversion price of $49.78 and $3.72, respectively.

About LibiGel

LibiGel is a gel formulation of testosterone designed to be quickly absorbed through the skin after application of a pea-sized dose of gel on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity. According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex. According to IMS data, 2.0 million testosterone prescriptions were written off-label for women by U.S. physicians in 2007. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.

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.

CRT to licence Telomere targeting agents to Pharminox for Drug Development

On October 13, 2009 Cancer Research Technology (CRT) – Cancer Research UK’s development and commercial arm – and the cancer drug discovery company Pharminox Ltd (Pharminox) reported that CRT has granted Pharminox an exclusive worldwide licence over its programme targeting telomeres and telomerase – the enzyme that is responsible for maintaining them (Press release, Cancer Research Technology, OCT 13, 2009, View Source [SID1234523344]).

Today’s announcement comes only a week after three American researchers were awarded this year’s Nobel Prize for Physiology and Medicine* for their pioneering research into the role of telomeres and telomerase.

Telomeres are the repeat sequences of DNA and associated proteins found at the ends of chromosomes, which act as ‘protective shields’ to maintain chromosomal integrity. In normal cells, these shields get smaller each time a cell divides, until they reach a critically short length at which point the cell stops dividing and ultimately dies. In most cancer cells, however, the part of the telomere lost in cell division is restored by the telomerase enzyme, allowing the cells to continue to divide – effectively rendering them immortal.

Telomerase is thought to be expressed in around 90 per cent of tumours, but telomerase activity is barely detectable in normal tissues – making this enzyme an important target for cancer drug development.

Professor Malcolm Stevens OBE, FRS from the University of Nottingham, who led the original research programme, and who will continue to be involved in the project in his role as chief scientific officer at Pharminox, said: "Telomeres act in the same way as the little plastic caps on the ends of our shoelaces, protecting our chromosomes from fraying. The compounds that we have discovered appear to have a dual mechanism of action: they not only prevent telomerase from replacing the telomeric DNA lost in cell division, but they are also able to disrupt the protective cap around the telomere itself, thereby inducing cell damage and exerting a more rapid anti-tumour effect.

"The programme has made considerable progress and we have already seen promising anti-tumour activity in preclinical tests, but there is still some way to go before compounds from the programme could be used as new cancer treatments."

Peter Worrall, chief executive officer of Pharminox, added: "The critical role of telomeres and telomerase in protecting and immortalising cancer cells makes this a fundamentally important area of cancer science to explore. Today’s agreement with CRT is exciting for Pharminox, and will allow us to continue our work to discover and develop potent and selective telomere targeting agents that could one day offer a new approach to the treatment of cancer."

Dr Phil L’Huillier, CRT’s director of business management said: "We are delighted to be entering into this agreement with Pharminox and are confident that these compounds have strong development potential, thanks to the extensive investigation and development work undertaken by several teams of scientists from across the UK and Europe including the contribution of the CRT’s own Discovery Laboratories, and more recently by Pharminox itself. Pharminox is in an excellent position to take forward this research in the hope of finding effective new treatments which have the potential to treat many forms of cancer."

Under the terms of the agreement, CRT will receive an undisclosed upfront payment and will be eligible for milestone payments as well as royalties on net sales of any resulting treatments. Upfront payment, milestones and royalties will be shared between CRT, the University of Nottingham – where the research programme funded by Cancer Research UK originates from – and The Institute of Cancer Research, whose scientists also contributed to the research.

Santhera Reports Closing of Juvantia Acquisition and Final Upfront Payment from Partner Biovail

On October 5, 2009 Santhera Pharmaceuticals (SIX: SANN), a Swiss specialty pharmaceutical company focused on orphan neuromuscular diseases, reported the final closing of the acquisition of Oy Juvantia Pharma Ltd of Turku, Finland (Press release, Santhera Pharmaceuticals, OCT 5, 2009, View Source;id=196741 [SID1234523622]). Santhera issued 105,973 previously reserved shares from its authorized share capital to Juvantia investors, as announced when exercising its option to acquire Juvantia on August 17, 2009. The closing of the transaction triggers a final upfront payment of USD 4 million from Biovail Laboratories International SRL , a sububsidiary of Biovail Corporation, Santhera’s licensing partner for the further development and marketing of JP-1730/fipamezole to treat Dyskinesia in Parkinson’s Disease in the United States and Canada.

The new shares issued to the former Juvantia shareholders as a consideration for their sale of Juvantia to Santhera will be listed on the SIX Swiss Exchange today. Upon this transaction, the share capital of Santhera Pharmaceuticals Holding AG will consist of 3,629,266 listed shares with a nominal value of CHF 1 each. The available amount of authorized share capital will be reduced accordingly by CHF 105,973 to CHF 323,945.

In August 2009, Biovail acquired the US and Canadian rights to develop and commercialize JP1730/fiapmezole for the treatment of levodopa -induced Dyskinesia in Parkinson’s Disease. Under the terms of the agreement Santhera received a partial upfront payment of USD 8 million and is entitled to up to USD 180 million in development and commercialization milestones and royalties of 8 to 15% on future net sales. Following the closing of the acquisition of Juvantia, Santhera is now entitled to a final upfront payment from Biovail in the amount of USD 4 million.

Upon application by Santhera Pharmaceuticals Holding AG, the Regulatory Board of the SIX Swiss Exchange granted an exemption from the obligation to produce a prospectus in connection with the listing of 105,973 newly issued shares

Exemption from the obligation to produce a listing prospectus was granted upon analysis of the overall situation of the listing of new shares in connection with the acquisition of Juvantia. In particular, the Regulatory Board decided to grant this exemption due to the fact that the collaboration with Juvantia and the option agreement with former shareholders of Juvantia defining the terms and conditions for the potential acquisition of Juvantia were already fully disclosed in the offering memorandum and listing prospectus of the IPO of Santhera back in 2006.

Also, importantly, in order to comply with requirements regarding ad-hoc publicity, contractual arrangements between Santhera and Juvantia required Santhera to disclose important activities and developments of Juvantia. In addition and in contrast to other capital increases in connection with acquisitions, due to the fact that the target company Juvantia has been known for several years, the need for information of investors and market participants was less.

Moreover, since Santhera’s IPO, all annual reports contained relevant information about the potential acquisition of Juvantia. In particular also the maximum number of the newly to be issued shares from authorized capital upon exercising the option for the acquisition were disclosed.

The Regulatory Board appreciated in its analysis the small size of the capital increase of approximately 3% as well as the fact that the acquisition does not lead to a structural change requiring publication of additional financial information in a listing prospectus (financial information on Juvantia and pro-forma consolidated financial information) and also that the shares were placed with the former shareholders of Juvantia. The Regulatory Board notes however that these last-mentioned facts alone would not have lead to an exemption from the obligation to produce a listing prospectus.

Cancer Research UK and AstraZeneca to accelerate biomarker research

On October 5, 2009 AstraZeneca reported that it has to double its investment in Cancer Research UK’s biomarker research in an effort to better understand how drugs behave in early stage clinical trials (Press release, Cancer Research Technology, OCT 5, 2009, View Source [SID1234523346]).

This announcement coincides with a presentation at the NCRI Cancer Conference in Birmingham by Professor Caroline Dive from Cancer Research UK’s Paterson Institute for Cancer Research at the University of Manchester*, who will lead this biomarker** research programme.

The programme will enable the charity to step-up its capacity to undertake both biomarker discovery research and evaluate biomarkers in a range of AstraZeneca clinical trials through a commitment to process up to 30,000 biomarker assays a year over the next 3 years. This will rise from the 14,000 a year currently undertaken.

The biomarkers studied in this programme help to determine whether new AstraZeneca drugs kill tumour cells and/or prevent angiogenesis – the growth of new blood vessels to supply tumour cells with nutrients and oxygen.

This partnership between Cancer Research UK, the Paterson Institute and AstraZeneca is based on the development of ‘proof of concept’ biomarkers***. It has been facilitated by Cancer Research Technology (CRT) – Cancer Research UK’s development and commercialisation arm – after AstraZeneca completed a scoping exercise to decide where to base their collaborative biomarker research efforts.

Cancer Research UK and AstraZeneca will also boost their scientific expertise to make use of biomarker technologies by creating additional Clinical Pharmacology Fellowship awards and a new Radiation Fellowship post. These follow the success of the Cancer Research UK/AstraZeneca Clinical Pharmacology Programme to date, under which six Clinical Pharmacology Fellowships have been supported since it began in 2006. These scientists will support the research programme already underway and explore further the use of biomarkers in radiotherapy and/or chemotherapy clinical trials.

It is expected the programme will help doctors conducting clinical trials to establish the right dose to give patients and to predict the effect the drug could have. It will also set the parameters of how to measure a drug’s effectiveness.

Professor Dive will present new biomarker data at the NCRI Cancer Conference revealing that circulating tumour cells (CTCs) can be used to measure the effects of cancer drugs currently used to treat lung cancer. Her team measured the number of CTCs in blood samples taken from patients with lung cancer and showed that their frequency was higher among the patients whose cancer had spread. The number of CTCs dropped following chemotherapy treatment, suggesting that CTCs could be used as a biomarker in clinical trials of new drugs to help doctors treat patients with this type of cancer more effectively.

Professor Caroline Dive, clinical and experimental pharmacology group leader at the Paterson Institute, said: "Most people in the cancer field have bought into the notion that biomarker research is key to the successful development of new treatments, but very few have really followed through with the thorough investigations and investment necessary for biomarkers to pay off. This deal will enable us to advance our understanding of how biomarker research contributes to drug development and patient care whilst building on the know-how we have gained so far. Everyone stands to gain."

Professor Andrew Hughes, AstraZeneca’s early phase clinical development head, said: "We are continually investing in potential new treatments and are delighted to be expanding this collaboration with Cancer Research UK to develop biomarkers. Before starting a clinical trial, it’s crucial that we understand as much as possible about how the drug will behave so we can decide which patients are most likely to gain from it, and how strong to make the dose in order for it to have the most beneficial effect – this research aims deliver just that."

Dr Phil L’Huillier, CRT’s director of business management, said: "This increased investment is a significant step forward in our commitment to develop this research and improve cancer treatments. By working collaboratively with academia and our commercial partners we are continuing to ensure that we progress these important advances and develop new drugs to treat cancer patients in the fastest possible time."

Dr Peter Sneddon, Cancer Research UK’s executive director of clinical and translational research funding, added: "Biomarkers are fundamental to the development of more targeted medicines and Cancer Research UK has strongly supported this area of research, so we are delighted that AstraZeneca have chosen to invest in our programme in Manchester. It has taken a lot of work to get to a point where biomarkers can reliably be used in clinical trials and as today’s presentation illustrates, new evidence is increasingly showing their worth.

"Today’s presentation about a new biomarker for lung cancer is very welcome because it is vitally important that we improve treatment for this disease – a form of cancer that has not seen the same progress as many others in terms of survival rates."

CRT facilitates collaboration between Duke University and Cancer Therapeutics CRC

On October 5, 2009 Cancer Therapeutics CRC Pty Ltd, Melbourne, Australia (CTx) reported a collaboration with Duke University, North Carolina, USA (Duke) to discover and develop new drugs for the treatment of many forms of cancer, based on research undertaken by the laboratory of Duke Professor Patrick Casey (Press release, Cancer Research Technology, OCT 5, 2009, View Source [SID1234523345]). Professor Casey and his team at Duke have been investigating lipid signaling pathways and the role of lipid metabolising enzymes in cancer for many years and have developed a series of promising new inhibitors of these enzymes. CTx has taken an exclusive license to these inhibitors and will initiate a drug development program to bring these early stage compounds toward the clinic.

This adds to CTx’s international collaborations and was greatly facilitated by CTx’s commercial partner, Cancer Research Technology Ltd of the UK and its US subsidiary, Cancer Research Technology Inc.

CTx’s CEO, Tony Evans commented that collaborating with an academic medical center of Duke’s caliber is a major expansion of CTx’s capabilities in partnering with overseas cancer researchers in order to source the most promising novel targets for CTx’s drug discovery projects.