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
- 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.
driver
- 24 Aug 2007 18:47
- 118 of 143
From the other side.
Piper Jaffrey now has a 83.1p price target........with the Lung Cancer drug alone worth 45/50p!!!!
LONDON (Dow Jones)--Shares in U.K.-based Antisoma PLC (ASM) jumped Wednesday after an experimental cancer drug that it is developing with Novartis AG (NVS) of Switzerland produced good final Phase II results in patients suffering from non-small-cell lung cancer.
Dr. Ursula Ney, Antisoma's chief operating officer, said: "These positive results strongly support our earlier trial findings, which showed that adding ASA404 to chemotherapy improves survival in patients with lung cancer."
Nomura Code analyst Samir Devani said: "It's good news for Antisoma. It's their lead product and a key value driver and gives confidence in the magnitude of benefits at a high dose." Devani has a buy rating on Antisoma, with fair value at 50-52 pence a share.
At 1325 GMT, Antisoma shares were up 21% at 34.5 pence in a higher London market. But Antisoma shares at that level are nonetheless down 19% year-to-date.
Wednesday's good trial results by ASA404 contrasts with the experimental drug's failure, announced July 12, in a mid-stage clinical trial for ovarian cancer - news that sent shares in the British cancer specialist sharply lower.
However, Antisoma is in line to receive a $25 million milestone payment from Novartis when it begins recruiting patients for ASA404's Phase III trials in early 2008.
Daniel Elger, Antisoma's director of communications, told Dow Jones Newswires that the U.K. biotech company will receive the cash as part of its $780 million deal with the Swiss pharmaceuticals giant.
Novartis bought the rights to ASA404 in April and is now gearing up to begin late-stage testing of the experimental drug in lung cancer patients following Wednesday's second set of positive Phase II results. It has already received the first installments of an upfront payment of $75 million.
He added that Novartis is also preparing to initiate Phase III trials of ASA404 in the treatment of prostate cancer - provided the drug produces positive results in its Phase II trial - which is expected to be completed in late October.
" Novartis have said they are very keen to get going," Elger said. "Lung cancer is the lead indication for this drug, but they will also be looking to do other trials. We have had initial positive data on prostate cancer, but we await the final survival data.
"If that is positive, Novartis' plan is to do a Phase III trial in prostate cancer in parallel with lung cancer," he said.
Elger said lung cancer is the single most common cancer in the U.S. and Europe and the potential market opportunity for ASA404 is extremely large. "You are certainly into the blockbuster range in terms of sales that could be achieved," he said.
Phase II trial results for ASA404 released Wednesday show it corroborates data from an earlier Phase II trial, which demonstrated an increase in survival rates of non-small-cell lung cancer patients to 14 months when used with chemotherapy, compared with 8.8 months for those receiving chemotherapy alone, Antisoma said.
Collins Stewart analyst Navid Malik said that although Wednesday's results were good news for the company, he is keen to see how ASA404 performs in Phase III trials.
"The data is encouraging but the gold standard test is Phase III. They need to crack on with Phase III and then we will get the definitive view of what this drug can really do with lung cancer," he said.
Piper Jaffray analyst Sam Fazelli said in a note that he hopes data from ASA404's prostate cancer trial will further support his view that the drug has blockbuster potential. He reiterated his outperform rating on the stock and set a price target 83.1 pence.
"Our valuation suggests the lung cancer indication alone is worth around 45 pence to 50 pence per share," he said.
Elger told Dow Jones Newswires that Antisoma has no plans to license its other products and will instead seek to bring them to market itself.
The company's pipeline includes ASA1411, a biologic, starting Phase II trials for both leukemia and renal cancer; ASA1402, an antibody starting phase II for breast cancer; and ASA1409, still in preclinical development.
"The deal with Novartis only applies to ASA404. We will not be looking for similar deals with the other drugs because one of the strategically important dimensions with the Novartis deal is that we have an option to co-commercialize the drug with Novartis in the U.S.," Elger said.
Elger said Novartis will provide operational and financial support for Antisoma to set up an Antisoma-branded sales force to sell ASA404 alongside them.
"But that sales force will be free to sell any other Antisoma products that we bring through," he added. "So rather than partnering with the other drugs, it's our intention to take them forward through development ourselves. Ultimately, you can earn a bigger share of the drug's value by retaining rights and selling it yourself."
driver
- 05 Sep 2007 11:34
- 119 of 143
UK: 5 September 2007
Cancer drug developer Antisoma plc (LSE: ASM, US OTC: ATSMY) announces that
positive survival data from a recently completed trial of ASA404 are
presented today at the World Conference on Lung Cancer in Seoul,
South Korea.
This single-arm phase II trial evaluated an 1800 mg/m2 dose of ASA404
in combination with carboplatin and paclitaxel chemotherapy in
patients with non-small cell lung cancer. Key findings were as
follows:
* Median survival was 14.9 months
* Median time to tumour progression was 5.5 months
* Tumour response rate was 37.9%
* Addition of ASA404 to chemotherapy was well tolerated
* Safety findings were similar in patients with squamous and
non-squamous lung cancer
These data support the findings from an earlier, randomised phase II
trial in which the addition of ASA404 to chemotherapy produced one of
the largest increases in median survival ever reported in advanced
lung cancer. In that trial, patients who received a 1200 mg/m2 dose
of ASA404 combined with chemotherapy had a median survival of 14.0
months whereas patients who received chemotherapy alone had a median
survival of 8.8 months.
In the earlier trial, tumour response rates were 31.2% with 1200
mg/m2 ASA404 plus chemotherapy and 22.2% with chemotherapy alone.
Time to tumour progression was 5.4 months with ASA404 and 4.4 months
with chemotherapy alone.
Dr Mark McKeage of the University of Auckland, New Zealand, an
investigator in both ASA404 lung cancer trials and the presenter of
the new data in Korea, said: "This is a second set of positive data
on ASA404 in lung cancer. It's particularly encouraging to see more
evidence that patients receiving ASA404 on top of chemotherapy may
live longer than we would expect with chemotherapy alone."
Glyn Edwards, Antisoma's Chief Executive Officer, said: "These data
add considerably to the strength of the evidence supporting ASA404 in
its lead indication and give us extra confidence as the drug proceeds
into phase III testing."
Antisoma's partner, Novartis, plans to start enrollment of patients
into a phase III trial in non-small cell lung cancer in early 2008.
The poster presentation containing the ASA404 data presented at the
World Conference on Lung Cancer is available on Antisoma's website at
www.antisoma.com