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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.

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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.

(Press release, Innate Pharma, SEP 14, 2009, View Source [SID:1234505994])

IMBiotechnologies Ltd completes purchase of ‘Tumor Starvation Technology’ from Paladin Labs Inc.

On August 13, 2009 IMBiotechnologies reported that the company has completed purchase of all assets related to the Occlusin tumor starvation technology from Paladin Labs (Press release, IMBiotechnologies, AUG 13, 2009, View Source [SID:1234502249]). In addition to the cash payment provided to purchase the technology, Paladin will receive a one time milestone payment on first sale of product and a royalty with a capped payment. IMBio will focus its efforts on obtaining regulatory approval for its lead product candidate, Occlusin 500 Artificial Embolization Device ("OCL 500 AED"), which is a medical device.

"All pre-clinical testing of the OCL 500 AED medical device is complete and we are in the process of assembling the pre-market notification (510(k)) submission to the FDA," commented Michael Stewart, President & CEO of IMBio. "The OCL 500 AED embolic agent cuts off the blood supply to tumors and demonstrates equivalent safety and effectiveness in comparison to currently approved embolic agents. One of the significant advantages of OCL 500 AED is that it is biodegradable and is slowly broken down by the body until it ultimately disappears. Competitor’s products are permanent implants and stay in the body for the life of the patient."

OCL 500 AED is designed for the treatment of malignant and non-malignant vascularised tumors. Examples of vascularised tumors include heptocellular carcinoma (HCC; liver cancer), renal cell carcinoma (RCC; kidney cancer) and uterine fibroids. Over 2 million women in the USA alone suffer from debilitating effects of uterine fibroids.