ckmtang
- 13 Nov 2003 15:50
Antisoma (LSE: ASM.L - news) shares could double if the ovarian cancer drug, R1549, is successful, and halve if it is not says the Independent. Given the probability of success, reckoned to be about 65%, that looks a gamble worth taking says the paper.
driver
- 22 Apr 2007 16:26
- 98 of 143
Independent
Antisoma soars on Novartis deal to develop cancer drug
By Karen Attwood
Published: 20 April 2007
Biotechnology company Antisoma closed a deal worth up to $890m (445m) with Swiss drug giant Novartis yesterday to develop its lead product, an anti cancer drug which is to enter final stage trials for lung cancer next year.
Shares initially jumped 19 per cent, before settled back to finish the day 10 per cent ahead at 57.75p, giving the company a market capitalisation of 257m.
Antisoma will receive $75m upfront and an additional $25m when its compound AS1404 enters into phase three trials in lung cancer at the beginning of next year. The drug is designed to be used alongside traditional chemotherapy, and clinical studies have shown it extends patient survival by five months.
The deal comes as welcome news for the company after Swiss firm Roche, which has a drug discovery alliance with Antisoma, dropped the compound last year, saying it had failed to live up to early expectations.
Future milestone payments are dependent on the successful development and marketing of the treatment for other types of cancer. The London-based company will also receive royalties on sales of the drug and will have an option to commercialise the drug in the US. Novartis will assume the management and all costs of the future development of AS1404.
Glyn Edwards, Antisoma's chief executive, said he was "very confident this would be a blockbuster product with the potential for strong sales". However, part of the attraction of the deal was that it would also provide extra resources for Antisoma to develop as a standalone company, he said. "We plan to use it as a springboard to further expand our pipeline and to exploit the value in our present portfolio."
Antisoma has six compounds in early stage development. Chief operating officer Dr Ursual Ney added: "We have a healthy pipeline but the deal with Novartis is allowing us to strengthen the pipeline and to buy more products for us to develop."
Samir Devani, analyst at Nomura Code, said that while expectations in the market were high the company has more than delivered. "The Novartis deal substantially strengthens Antisoma's cash position and the company has indicated that it will now look to in-license further oncology candidates and that this may include company acquisitions," he added.
Sam Fazeli, an analyst at Piper Jaffray, said he expects a series of value-driving news from Antisoma over the next year, including data from trials from other cancer drugs.
driver
- 05 May 2007 18:13
- 101 of 143
London, UK: 2 May 2007 - Cancer drug developer Antisoma plc (LSE:
ASM; USOTC: ATSMY) today announces that it will convene an
Extraordinary General Meeting
http://www.antisoma.com/admin/data/datFiles/pdf/EGMNoM.pdf
driver
- 09 May 2007 15:34
- 102 of 143
From Therapeutics Daily:
Antisoma's $100M Novartis Deal Puts VDA Approach In Spotlight
BioWorld Financial Watch - May. 07, 2007
Though more than 10 years old, the concept of "disruptive technology" holds strong appeal, and in biotech vascular disrupting agents (VDAs) occupy a rising-star approach first discovered even longer ago.
Last month's licensing deal, which gives Antisoma plc $75 million up front from Novartis AG for rights to AS1404 and $25 million more when Phase II lung-cancer trials with the compound start early next year, brought fresh attention to the VDA space - and a renewed licking of chops by investors.
Antisoma's backers might have felt disillusioned less than a year ago, when longtime partner F. Hoffmann-LaRoche Inc. bowed out of its plan to usher AS1404 into Phase III trial, blaming "commercial reasons" for the move. (The composition-of-matter patent for AS1404 expires in 2011.) But Antisoma promised a juicy deal on the way, and Novartis stepped up.
The deal could provide as much as $890 million in milestone payments to Antisoma plus royalties, and Novartis will fund all future development as well as Phase II trials now under way.
Included in the milestone payments are approvals in four oncology indications. Novartis has shown its marketing muscle through Gleevec (imatinib), its compound for chronic myeloid leukemia. Also in the milestones package is an undisclosed non-oncology condition, most likely in ophthalmology, as Novartis outside the U.S. markets Lucentis (ranibizumab), Genentech Inc.'s therapy for age-related macular degeneration, and VDAs are being actively explored in that disease. Antisoma is retaining rights to co-commercialize the flavonoid AS1404.
Plans for the compound entail the Phase III study in front-line, squamous non-small cell lung cancer and supporting studies in lung and other cancers. The NSCLC bid goes after the sector of the market not covered by the label for the VEGF inhibitor Avastin (bevacizumab), from Genentech Inc.,cleared for NSCLC in the fall of last year. If AS1404's Phase II data merit, the compound will move into Phase III trials in prostate and ovarian tumors as well.
VDAs might be regarded as the (so far) quieter counterpart to headline-making anti-angiogenesis drugs. Whereas the latter block formation of tumor blood vessels, VDAs target vessels already established, collapsing the endothelial cells in place.
Kobi Sethna, president and CEO of the much earlier-stage VDA player Nereus Pharmaceuticals Inc. likened the scans of VDA-attacked tumors to "donut holes," and told BioWorld Financial Watch that cardiotoxicity hampered the first generation VDAs' ability to chew tumors from within. AstraZeneca plc, for example, discontinued work on its VDA known as ZD6126.
The picture has changed in recent years. AS1404's profile looks clean, as does the profile for NPI-2358, one of about 200 synthetic analogues made by Nereus from a marine fungal extract. A Phase I trial against solid tumors launched last summer.
Antisoma is doing well. Behind AS1404 is a novel aptamer dubbed AS1411, seized in the early 2005 buyout of Aptamera Inc. in an all-share deal that valued the privately held firm at 11.5 million (then US$21.5 million). Early data suggest activity in renal cancer and acute myeloid leukemia. Phase II trials are expected to start late this year and early next. UK-based Antisoma ended the second half of this year with about 33.6 million (US$67 million) in cash and equivalents, not counting the upfront payment from Novartis, with a loss for the period of 6.4 million.
Others with VDAs include Myriad Genetics Inc., which started the first Phase II trial with its compound called Azixa for brain cancer in March. Like Nereus' drug, Azixa seems to work as a cytotoxin as well. The first stage of the Azixa study will include about 16 patients.
MediciNova Inc. has the VDA known as MN-029 ready to start Phase II/III studies in ovarian and NSCLC by the end of this year. The compound came from Angiogene Pharmaceuticals Ltd., which holds a worldwide license. Abbott also has a VDA, the sulfonamide ABT-751, in Phase II trials for lung, colon, breast and kidney cancers, and Bionomics Ltd. is doing preclinical work with the VDA tagged BNC105.
A higher-profile VDA force to reckon with is Oxigene Inc., which has CA4P (combretastatin A4 phosphate). The drug proved its mettle last year in Phase II trials against thyroid cancer, with chemotherapy and without. In February, CA4P yielded positive top-line Phase II data against myopic AMD, too. Full results were due for unveiling at the Association for Research In Vision and Ophthalmology meeting, which started over the weekend.
Oxigene is finalizing a Phase III study with CA4P in anaplastic thyroid cancer (ATC), with first dosing expected in the second quarter of this year. The firm is expected to test CA4P when combined with chemo agents, as compared to chemo alone, in 100 to 200 patients. After Avastin's clearance in NSCLC, Oxigene backed away from that indication as the first Phase III trial, and went with ATC instead.
Amgen Inc. is working in thyroid cancer, too - and during the conference call on first quarter earnings last month, officials said they had decided not to file for approval of AMG-706 for thyroid cancer after Phase II trial with the compound in about 180 patients with locally advanced or metastatic disease who are not candidates for radioactive iodine or local therapies.
ATC patients were left out of the Amgen study (expected to report data at the American Society of Clinical Oncology meeting in June) but some Oxigene/CA4P watchers might have taken pause when Amgen decided to wait on a filing for its drug, until the FDA offers more guidance about the regulatory path. Amgen's trial, though, was an open-label, single-arm study; Oxigene already is talking with the FDA about a randomized, controlled study.
Data from a Phase Ib trial with CA4P plus Avastin should become public in the third quarter of this year, though, and positive results would spur a Phase II study testing a quadruplet combination regimen against non-squamous NSCLC in the second half. CA4P's Phase II ovarian cancer trial is still enrolling patients. Sanofi-Aventis Group also has a combretastatin derivative, AVE8062, but it's lagging behind the Oxigene compound in Phase I trials.
While Novartis' interest in AS1404 could bring pharma sniffing around CA4P (which works by a different mechanism of action), Antisoma boasts the benefit of efficacy data from several randomized, controlled Phase II trials. Oxigene lacks randomized results with its compound, and likely will need more results before signing a partner. Either way, the Antisoma deal has drawn eyes to the space, which is likely to mature even more in the months ahead.
driver
- 14 May 2007 15:23
- 104 of 143
Bluelady
- 25 May 2007 11:59
- 106 of 143
Resolutions passed
All resolutions at today's EGM were passed (details below). The
Directors now have additional flexibility to pursue new opportunities
to grow and develop the business.
If the Company makes a non-pre-emptive offer of shares for cash
pursuant to the authority granted at today's EGM to disapply
pre-emption rights, then shareholders who have disclosed to the
Company a beneficial interest of 3% or more will be given a
reasonable opportunity to participate, on the agreed terms, to a
level at least proportionate to their shareholding at the time of the
offering.
There are no current plans either to issue new shares for cash or as
consideration for an acquisition.
Important AS1404 data ahead
We can now refine our guidance on the expected timing of further data
from our programme of phase II trials with AS1404, the vascular
disrupting agent that we recently partnered with Novartis AG.
* Additional data on PSA response in the phase II prostate cancer
study will be presented at ASCO in Chicago on 3 June (poster
#5115 by Roberto Pili & Mark Rosenthal, 2pm-6pm, Genitourinary
Cancer session)
* Between ASCO and the end of October we expect headline data on
time to tumour progression and 1-year survival from our phase II
studies in ovarian and prostate cancers and from our confirmatory
phase II study in lung cancer. Further details from these studies
will be presented at conferences in Q3 and Q4
* In late 2007 and/or 2008 we expect additional, longer-term
survival data from the ovarian and prostate cancer phase II
studies
Following the licensing of AS1404 to Novartis, the drug has now been
redesignated ASA404.
Positive outlook for Antisoma
We now have a strong partner for ASA404/AS1404. The drug has
demonstrated a five month survival advantage in a phase II lung
cancer trial. Novartis will start enrolling patients into a phase III
trial in lung cancer early next year. Before then, we expect
additional phase II data in ovarian and prostate cancers, which could
add significantly to the drug's value. We will also soon be
recruiting the first patients into a thorough programme of randomised
trials on AS1411, building on highly promising early clinical and
laboratory data. Developments in these and our other programmes will
ensure a continuing run of new data from Antisoma through next year
and beyond.
driver
- 08 Jun 2007 14:13
- 109 of 143
Antisoma to present at Needham & Company Si...
8 June 2007,
London, UK - Antisoma plc (LSE: ASM; USOTC: ATSMY) today
announces that its Chief Executive Officer, Glyn Edwards, will be
presenting at the Needham & Company Sixth Annual Biotechnology and
Medical Technology Conference in New York, USA.
Mr Edwards's presentation is scheduled for 11am EST on Wednesday,
June 13, followed by a 30 minute breakout session. A webcast of the
presentation will be available to all on Antisoma's website
http://moneyam.uk-wire.com/cgi-bin/articles/20070608120000H1814.html
driver
- 22 Jun 2007 11:23
- 111 of 143
Cheers from Mike111D on the other side.
If you have not already done so, you may want to listen to the web cast of Glyn Edwards presenting today at the Piper Jaffray Health Care Conference, in London:
http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=ATSMY.PK&item_id=1573805
Everything remains very much on track further to the plans articulated as a result of the company transforming deal recently announced with Novartis.
I will leave you to listen to the web cast but thought that I would just share a few things with you, some of which will not be that evident to you unless you have been following matters closely:
Aside from the conference today, a number of one on one presentations with institutional investors were undertaken and the feedback from which continues to be positive, based both upon the strength of the Novartis deal and the overall prospects for other aspects of the pipeline; for which the required funds are now firmly in place
There are no known issues of larger shareholders selling etc despite the recent pullback in the price. Given the move in the price from 15p last year, an element of profit taking was to be expected
What has been observed is that there continues to be an increase in holdings within the specialist healthcare funds both in Europe (outside of the UK) and specifically in the US. Due to the way in which these shares are being held i.e. frequently in nominee accounts and due to the UK disclosure requirements not applying, it is difficult for this to be quantified and reported on in the normal way
With circa 80m of cash available, there are certainly no plans to raise further funds and nor at this time to move ahead with the NASDAQ listing. This will be considered at a later stage should funds be sought to progress in-licensing or acquisitions
As per the presentation today, further ASA404 1 year survival data for Ovarian and Prostrate cancer will be released by October 2007
A key point to note but not communicated via RNS to date, is that on the strength of the phase II data that they have seen so far, Novartis are already now prepared to move ahead with ASA404 in Prostrate cancer prior to seeing the data in October. With prostrate cancer being a key indication with blockbuster potential ($1bn plus annualised revenues)
Novartis have already started with patient recruitment for the phase III ASA404 trials which will commence early in 2008
With AS1411, the same randomised trial model will be applied as it was with AS1404. This model is expected to de-risk the project at an earlier stage and consequently add more value at a later stage when compared with the less robust uncontrolled studies often undertaken by other companies
Despite the fact that ASM would in all likelihood have little difficulty in out licensing AS1411, they still have no intention of doing so but instead plan on leveraging the sales and marketing infrastructure that Novartis will be establishing and paying for on their behalf in the US
Trials in AML for AS1411 will be commencing shortly (over the summer) with data being reported in 2008. Trials for Renal cancer will follow on with data expected in 2009
As per the presentation today, reporting through the balance of 2007 will be focussed on ASA404
Finally, dont forget that of the $890m deal agreed with Novartis, $355m is being released in relation to development milestones, so the data being reported is key in more ways than one. Understandably, the actual milestones and associated payments remain commercially confidential and not even key industry analysts have been able to determine these and I have heard some of them try in vain to do so
So IMHO, investing in ASM remains a very sound bet, given the scale and fully funded nature of the deal with Novartis for ASA404 and the strategic significance of how this will allow ASM to press ahead with what for me is a very exciting prospect in AS1411.