On February 2, 2010 TopoTarget and Spectrum Pharmaceuticals reported an agreement to co-develop and commercialise belinostat, TopoTarget’s lead anticancer drug for cancer in North America and India (Press release TopoTarget, FEB 2, 2010, View Source;messageId=459613 [SID:1234500428]). Belinostat, an HDAC inhibitor, is in registrational clinical trial in Peripheral T-Cell Lymphoma (PTCL) as monotherapy and in a randomized phase 2 clinical trial for cancer of unknown primary site (CUP) in combination with carboplatinum and paclitaxel (BelCaP). Belinostat is currently being investigated in 20 clinical trials in aematological and solid cancers in monotherapy as well as in combination therapies.
Under the terms of the agreement, TopoTarget will receive an upfront payment of USD 30 million in cash. The total potential value of up-front and milestones (for both development and sales) of the agreement, in the event of full commercial success could exceed USD 350. In addition, TopoTarget will receive a double digit royalty on sales of belinostat as well as one million Spectrum shares. Spectrum commits to fund 100% of the costs for the ongoing PTCL study; TopoTarget will fund 100% of the ongoing CUP study. Spectrum and TopoTarget will split the development costs in a 70 to 30 ratio for future development of belinostat.
Under the agreement it is now expected that the BELIEF trial will be finalised and NDA filed with the FDA in 2011 the previous timeline announced by TopoTarget was December 2010. The CUP trial will be fully recruited in 2010 – the previous timeline announced by TopoTarget was H1 2010. In addition other randomised clinical trials in indications such as in lungcancer (NSCLC) are expected to be initiated.
Taking into account the 70:30 cost sharing arrangement under the collaboration, the sign on fee and existing cash resources excluding any other partnerships TopoTarget will, as a result of entering into the Agreement with Spectrum, have sufficient cash resources for at least two to three years. The agreement also includes diligence provisions on development and commercialisation as well as an option to co-promote under certain conditions.

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On January 7, 2010 Astrazeneca reported a Protein Kinase B inhibitor to be taken into clinical development, following a successful collaboration with the biotechnology company Astex Therapeutics (Press release, Cancer Research Technology, JAN 7, 2010, View Source [SID1234523341]). The PKB programme, from which the clinical candidate was selected, stemmed from collaborative research originally carried out by The Institute of Cancer Research, CRT and Astex. Click here to find out more about the deal.

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On January 4, 2010 CANCER RESEARCH UK and Cancer Research Technology (CRT), the charity’s development and commercialisation arm, reported to undertake a phase I clinical trial of an investigational monoclonal antibody * drug from Merck KGaA, Darmstadt, Germany, called DI-B4 (Press release, Cancer Research Technology, JAN 4, 2010, View Source [SID1234523342]).

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DI-B4 is the fourth anti-cancer drug to enter Cancer Research UK’s Clinical Development Partnerships (CDP) programme** – an initiative which allows companies to retain the rights to a treatment whilst enabling the charity to take on its early development work. DI-B4 is the first monoclonal antibody to join the scheme.

DI-B4 binds to the CD19 protein, found on B-cells, and is thought to recruit cells from the immune system to attack the tumour. It is hoped that it may one day help patients with leukaemia and lymphoma who do not respond to existing therapies. Currently, the standard treatment for B-cell lymphoma targets the CD20 protein.

DI-B4 will be one of the first drugs to be manufactured at Cancer Research UK’s new state-of-the-art, £20 million Biotherapeutic Development Unit***. After pre-clinical work on it has been completed, it will be taken into a phase I trial in around 20-40 patients with advanced B-cell lymphoma – a cancer of the white blood cell.

The trial will be managed by Cancer Research UK’s Drug Development Office and will take place at up to five**** hospitals across the UK.

Under the terms of the partnership, Cancer Research UK will fund the study through early clinical development. Merck KGaA will then have an option to take forward and commercialise the drug in exchange for future payments to the charity. If Merck KGaA elects not to progress the programme, the rights to the molecule will be given to CRT to secure an alternative development partner.

Dr Nigel Blackburn, director of Cancer Research UK’s Drug Development Office, said: "We’re very excited to be entering this venture with Merck KGaA. Equipped with the knowledge they have gained from creating the antibody, we will use our brand new manufacturing facility to develop it into a potential new treatment for cancer patients."

Dr Keith Blundy, chief executive of CRT said: "In an increasingly competitive market place, pharmaceutical and biotechnology companies have to focus strategically on certain areas of research and hold back on others. This deal demonstrates how we can work together to progress cancer drugs."

Dr Andrew Davies, Cancer Research UK senior lecturer in medical oncology at University of Southampton, who will run the phase I trial at Southampton General Hospital, added: "Existing treatments which target cancerous cells and draw in the body’s immune system can be extremely helpful. But we still need to search for alternative approaches for patients with B-cell cancers which have not responded to existing treatments. We hope that DI-B4 will have the same effects in patients as it has shown in the lab."

On December 23, 2009 Cancer Research Technology (CRT) – Cancer Research UK’s commercialisation and development arm – reported it has granted Aura Biosciences Inc. worldwide licence to use its cancer-targeting peptides in delivering cancer treatments directly to the tumour (Press release, Cancer Research Technology, DEC 23, 2009, View Source [SID1234523343]).

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These peptides bind to a protein on the surface of the cell called integrin αγβ6, a protein complex that is found at high levels on many tumour cells but is absent in most normal tissues. By seeking out this protein and binding to it, the peptides are able to deliver cancer treatments directly to the site with increased precision and reduced side effects. One of the cancers this could have particular benefit in targeting is pancreatic cancer as these tumours express high levels of integrin αγβ6. Pancreatic cancer is currently very difficult to treat with only around 2 to 3 per cent of patients surviving the disease for five years or more. Recent pre-clinical studies have also shown that these peptides may improve imaging in pancreatic cancer by binding to the αγβ6 *.

This deal strengthens Aura’s investment in the technology and builds on an evaluation agreement between Aura and CRT announced earlier this year**. The peptides were originally developed at Queen Mary, University of London with support from Cancer Research UK and DebRA – who work on behalf of people in the UK with the genetic skin blistering condition Epidermolysis Bullosa (EB).

Under the terms of the agreement, Aura Biosciences will make an upfront payment to CRT as well as providing clinical development milestones and royalties on future sales. Aura will exclusively fund the development work, and have sub-licensing rights on agreed terms.

Dr Elisabet de los Pinos, chief executive of Aura Biosciences said: "This partnership with CRT enables us to make use of their peptide technology as way to deliver our innovative NanosmartTM treatment particles – which are hollow particles made of nano-sized protein shells – to the tumour with increased accuracy. We are delighted with the progress we have already made in developing the technology and are looking forward to progressing it into potential new treatments for cancer."

Dr Phil L’Huillier, CRT’s director of business management said: "These peptides – combined with Aura’s award winning nanotechnology – have the potential to seek out and destroy cancer cells, leaving the surrounding areas unharmed. We believe this technology could have particular strengths in delivering treatments for cancers that have limited treatment options such as pancreatic and head and neck cancer. Crucially this targeted treatment could also reduce the side effects that are commonly associated with standard therapies. We look forward to the results of the programme with great interest."

On November 18, 2009 Cosmo Pharmaceuticals S.p.A. (SIX Swiss Exchange: COPN) reported its intention to launch a public tender offer to acquire all outstanding shares of BioXell S.p.A. (SIX Swiss Exchange: BXLN) (Press release, Cosmo Pharmaceuticals, NOV 18, 2009, View Source [SID:1234510964]). Simultaneously with this announcement, Cosmo has published a pre-announcement stipulating in detail the terms and conditions of its offer, the principal elements of which are as follows:

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A total purchase price of up to CHF 41.3 million (€ 27.4 million), for 100% of BioXell’s outstanding share capital, consisting of

CHF 15.1 million in cash;
1’132’500 of newly issued Cosmo shares each with a par-value of EUR 0.25 each; and

1’132’500 options each giving the holder the right to put the Cosmo shares to Cosmo at a strike price of CHF 21.00 between July 1, 2011 and 31 December 2011.

Based upon 5’381’577 registered BioXell shares outstanding, Cosmo’s offer is equivalent to CHF 7.68 per BioXell share, equalling:

CHF 2.8059 in cash,

CHF 3.64 equivalent to 0.21044 newly issued, freely exchangeable Cosmo shares (using Cosmo’s 60-day volume-weighted average closing price), and

CHF 1.23 equivalent to 0.21044 in newly issued put options for Cosmo shares, using typical valuation methods for option pricing.

A premium of 17.1% over BioXell’s volume-weighted average closing share price over the last 60 trading days.

The cash component of the offer will be increased, subject to certain conditions, based on the collection by BioXell of certain receivables or sales (if any should occur) of BioXell’s technology assets to third parties prior to closing of the Offer.

Closing of the offer will be subject to Cosmo having received acceptances representing 60% of BioXell’s outstanding share capital and to Cosmo and to certain other conditions. Cosmo’s majority shareholder, Cosmo Holding SpA, has already given its support for the offer and committed to vote in favour of the required capital increase at a shareholders meeting to be convened in December 2009.

More details of Cosmo’s proposal can be found in the pre-announcement published today. Cosmo expects to launch the offer in December. Closing of the offer is expected by the end of March 2010.

Mauro Ajani, CEO of Cosmo, commented: "Our offer represents an opportunity to increase our free float and our cash reserves faster and at competitive terms. If 100% of BioXell shares are tendered, our free float will increase by 22% to 32% improving the liquidity of our shares. Whilst we have a comfortable cash position and are profitable, the additional cash will enable us to accelerate a number of our clinical programs and put us in a stronger position to negotiate favourable terms for our un-partnered pipeline products. We look forward welcoming BioXell’s shareholders and are very pleased to offer them the opportunity to participate in the future growth of our company."

BioXell’s board of directors has simultaneously announced today their unanimous support in favour of the proposed transaction with Cosmo and will recommend to its shareholders to accept the tender offer by Cosmo. In addition, Index Ventures and TVM Capital, who together own 19.7% in BioXell, have given undertakings to tender their shares into Cosmo’s offer.