apple
- 25 Mar 2004 20:47
tabasco
- 15 Dec 2009 07:15
- 1269 of 1451
RNS Number : 1072E
Oxford Biomedica PLC
14 December 2009
?
+---------------------------------------------------+--------------------------+
| | 2009/OB/23 |
+---------------------------------------------------+--------------------------+
| EMBARGOED UNTIL 7.00AM, 15 DECEMBER 2009 | 15 DECEMBER 2009 |
+---------------------------------------------------+--------------------------+
OXFORD BIOMEDICA'S STARGEN(TM) FOR STARGARDT DISEASE RECEIVES EUROPEAN ORPHAN
DRUG DESIGNATION
Oxford, UK - 15 December 2009: Oxford BioMedica (LSE: OXB), a leading gene
therapy company,
announced today that StarGen, the Company's gene-based
therapy for Stargardt disease, has received orphan designation from the
Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA).
Stargardt disease is a hereditary disorder of the eye that is caused by
abnormalities in a gene called ABCA4 in the retina. StarGen is designed to
deliver a corrected version of the ABCA4 gene into the cells of the retina using
the Company's LentiVector technology. In collaboration with sanofi-aventis,
clinical development is expected to start in 2010. The US charity, Foundation
Fighting Blindness, is also supporting the programme and previously funded the
preclinical development.
The EMEA grants orphan drug designation to products that may provide a
significant advantage over current treatments, if any
exist, for life-threatening or chronically debilitating conditions affecting up
to five in 10,000 people in the European Union. Companies with European orphan
drug designation benefit from incentives, including ten years of marketing
exclusivity and reduced regulatory fees.
Oxford BioMedica's Chief Executive Officer, John Dawson, commented: "There is a
real and urgent need
for an effective treatment of Stargardt disease. Gene
correction offers the only means of addressing the root cause of this
debilitating, sight-robbing disorder. The EMEA's decision to grant orphan
designation to StarGen adds significant value by providing development,
regulatory and commercial advantages. StarGen is one of the four gene-based
therapies for ocular diseases that we are developing in collaboration with
sanofi-aventis and it also benefits from the Foundation Fighting Blindness'
valuable assistance. Both StarGen and our other lead ocular programme,
RetinoStat for wet age-related macular degeneration, are on track to enter
clinical development in 2010."
-Ends-
tabasco
- 05 Jan 2010 07:41
- 1270 of 1451
Oxford strengthen the Board and Management team..
RNS Number : 0095F
Oxford Biomedica PLC
05 January 2010
OXFORD BIOMEDICA PLC
MANAGEMENT AND BOARD CHANGES
Oxford, UK - 5 January 2010: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, today announces the appointments of Dr Paul Blake and Dr Andrew Heath
as independent Non-Executive Directors, and the retirement from the Board of
Mark Berninger. These changes became effective on 1 January 2010. In addition,
the management team was strengthened by the appointment in November 2009 of Dr
Adam Love as Senior Director, Commercial Activities and Strategic Planning.
........................
tabasco
- 13 Jan 2010 13:16
- 1271 of 1451
SADIF Analytics releases new summary due diligence report for Oxford BioMedica plc
2010-01-13 12:37:19 - SADIF-Investment Analytics has applied its StockMarks stock-rating system to Oxford BioMedica plc and produced a report, rating the company's attractiveness to long-term investors.
Ilhavo, Portugal 13/01/2010 SADIF Investment Analytics, announces a new summary due diligence report covering Oxford BioMedica plc (OXB). The report uses SADIF's powerful StockMarks stock rating system and contains important analysis for any current or potential Oxford BioMedica plc investor.
Report Summary: Oxford BioMedica plc is an above average quality company with a neutral outlook. Oxford BioMedica plc has strong business growth and is run by passable management. When compared to its closest peer, Vectura Group PLC, Oxford BioMedica plc shows greater overvaluation and is more likely to outperform the market.
The 8-page report breaks down the Total StockMark into its three components business, management and price, performing an in-depth analysis of Oxford BioMedica plc for long-term investors.
The report has been distributed to Reuters, and forwarded to Yahoo Finance and FT.com. It is available under 'Analyst Reports' from these websites, from multiple professional platforms including Reuters Knowledge, TheMarkets.com, Thomson Research and Capital IQ or directly from SADIF-Investment Analytics at:
www.sadifanalytics.com/stockmarks/company.php?tickerr=OXB&cod_co ..
tabasco
- 20 Jan 2010 08:03
- 1272 of 1451
Very good newsbut for SP movementa prosavin deal is the news we all wont>
RNS Number : 8079F
Oxford Biomedica PLC
20 January 2010
?
+---------------------------------------------------+--------------------------+
| For Immediate Release | 20 JANUARY 2010 |
+---------------------------------------------------+--------------------------+
OXFORD BIOMEDICA'S USHSTAT(TM) FOR USHER SYNDROME RECEIVES
EUROPEAN ORPHAN
DRUG DESIGNATION
Oxford, UK - 20 January 2010: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, announced today that UshStat, the Company's gene therapy for
the treatment of Usher syndrome 1B, has received orphan designation from the
Committee for Orphan Medicinal Products of the European Medicines Agency.
Usher syndrome 1B is an inherited condition that results in hearing loss and
progressive loss of vision from retinitis pigmentosa. It is caused by
abnormalities in a gene called Myosin VIIA (MYO7A). UshStat is designed to
deliver a corrected version of the MYO7A gene into the cells of the retina using
the Company's LentiVector gene delivery technology. In collaboration with
sanofi-aventis, clinical development is expected to start in 2011.
The European Medicines Agency grants orphan drug designation to products that
may provide a significant advantage over current treatments, if any
exist, for life-threatening or chronically debilitating conditions affecting up
to five in 10,000 people in the European Union. Companies with European orphan
drug designation benefit from incentives, including ten years of marketing
exclusivity and reduced regulatory fees.
Oxford BioMedica's Chief Executive Officer, John Dawson, commented: "We are
delighted to have received orphan designation from the European Medicines
Agency for another of our innovative LentiVector-based candidates targeting
debilitating and progressive ocular diseases. This designation is an important
step towards the start of clinical trials of UshStat for Usher syndrome 1B as
part of our landmark collaboration with sanofi-aventis to develop gene
therapies in the field of ophthalmology."
-Ends-
neil777
- 20 Jan 2010 08:05
- 1273 of 1451
RNS Number : 8079F
Oxford Biomedica PLC
20 January 2010
For Immediate Release
20 JANUARY 2010
OXFORD BIOMEDICA'S USHSTAT FOR USHER SYNDROME RECEIVES
EUROPEAN ORPHAN DRUG DESIGNATION
Oxford, UK - 20 January 2010: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that UshStat, the Company's gene therapy for the treatment of Usher syndrome 1B, has received orphan designation from the Committee for Orphan Medicinal Products of the European Medicines Agency.
Usher syndrome 1B is an inherited condition that results in hearing loss and progressive loss of vision from retinitis pigmentosa. It is caused by abnormalities in a gene called Myosin VIIA (MYO7A). UshStat is designed to deliver a corrected version of the MYO7A gene into the cells of the retina using the Company's LentiVector gene delivery technology. In collaboration with sanofi-aventis, clinical development is expected to start in 2011.
The European Medicines Agency grants orphan drug designation to products that may provide a significant advantage over current treatments, if any exist, for life-threatening or chronically debilitating conditions affecting up to five in 10,000 people in the European Union. Companies with European orphan drug designation benefit from incentives, including ten years of marketing exclusivity and reduced regulatory fees.
Oxford BioMedica's Chief Executive Officer, John Dawson, commented: "We are delighted to have received orphan designation from the European Medicines Agency for another of our innovative LentiVector-based candidates targeting debilitating and progressive ocular diseases. This designation is an important step towards the start of clinical trials of UshStat for Usher syndrome 1B as part of our landmark collaboration with sanofi-aventis to develop gene therapies in the field of ophthalmology."
-Ends-
hangon
- 25 Jan 2010 17:52
- 1274 of 1451
Anyone here got a handle on the recent Patent-deal? -
I've read the RNS, 22Jan2010.
- Really, it seems to me OXB is strengthening its grip on profits by emboldening their Patent-holding - and - the US researchers have securred a commercial partner = = = = = yet as I read it, both parties have paid very little; the transaction in Cash being covered by buying Shares (=my interpretation, not in the RNS).
Looks like a smart move.
...A small dilution is worth it; if it avoids opportunistic Patent woes later...
I hold a few, most from about 40p so I'm "waiting".
halifax
- 25 Jan 2010 18:04
- 1275 of 1451
looks like you have a long wait.
tabasco
- 26 Jan 2010 09:03
- 1276 of 1451
Not necessarily halifax The ocular products could become a nice little earner for oxbwith possibilities of sub-licensing the licence I would believe is World wideand having secured exclusive rights to intellectual property that supports its gene-based ocular products RetinoStat and Encorstat for the issue of a few shares and a small upfront payment looks a very good deal?the sp has maintained a range of around 11-12p since Trovax came back from the deada deal with this or prosavin would achieve hangons 40p and start momentum imooxb have plenty of cashso it aint got to happen tomorrowI would say a good investmentnot so good for impatient traders
tabasco
- 27 Jan 2010 07:55
- 1277 of 1451
Whatever strength of position oxb were in with Bavarian Nordic it is good to see a litigation issue cleared with this compromiseit appears to be slightly favourable to oxbinteresting to view sp reaction today?
BIOMEDICA AND BAVARIAN NORDIC ANNOUNCE SETTLEMENT OF MVA-BN LITIGATION
AND CROSS LICENSE OF PATENTS
Oxford, UK - 27 January 2010: Oxford BioMedica (LSE: OXB) and Bavarian Nordic
(OMX: BAVA) announced today that they have reached a global settlement ending
the legal disputes between the two companies.
The settlement and cross-license agreement resolve the patent litigation by
Bavarian Nordic before the US District Court for the Southern District of
California, and Oxford BioMedica's oppositions to Bavarian Nordic's European
MVA-BN patents.
Under the settlement and cross-license agreement Bavarian Nordic will grant a
license to its MVA-BN patents in return for Oxford BioMedica granting a license
to its heterologous prime-boost patents and a sub-license under poxvirus patents
licensed to Oxford BioMedica by sanofi-aventis. Both Bavarian Nordic and Oxford
BioMedica will make undisclosed milestone and royalty payments on the future
development of their respective products.
tabasco
- 28 Jan 2010 16:22
- 1278 of 1451
A Second Viral Vector for Gene Therapy in Parkinson's Disease
January 27, 2010
Analysis by: GLG Expert Contributor
Analysis of: Oxford BioMedica Announces Update on ProSavin Phase I/II Trial in Parkinsons Disease And Publication of Preclinical Results
Published at: www.pipelinereview.com
Summary
Oxford Biomedica announces the clinical use of a Lentiviral-based retroviral vector that packages and delivers the enzymatic machinery to produce three distinct dopamine-producing enzymes within neurons of the human striatum afflicted by Parkinson's disease (PD). The Lentivirus is of nonhuman origin and follows advances in human gene therapy for PD primarily using the human, nonpathogenic adeno-associated virus (AAV), which has been safely used in three previous clinical trials for PD.
Analysis
While the genome packaging and delivery capabilities of the Lentivirus are significantly more than that of the AAV, it remains unclear as to whether the clinical effects of the triple enzyme delivery (TH, AADC, and GCH1) is significantly better than the delivery of AAV-AADC alone in humans. Early and late published clinical results of AAV-AADC suggest excellent clinical improvement, and AADC gene expression within the treated striatum, visualized with FMT-PET uptake, especially at higher vector doses, which correlates in nonhuman primates with histological gene expression.
As important as the vector is to the packaging and delivery of the gene construct to the neuronal cells within the striatum, the delivery method used for the gene infusion appears to make a difference as well. Nonhuman primate data and early clinical evidence suggest that convection-enhanced delivery (CED) is the most efficient delivery method for viral vectors and other therapeutics due to the extensive, homogenous coverage of the target brain region. Injection techniques deliver localized therapeutics which typically fail to cover a large target region like the putamen. Together with intraoperative MRI imaging to visualize the therapeutic infusion in real-time, treating clinicians are able to tailor their infusions to provide more consistent coverage of the target, alter cannula position for improve target coverage, and stop the infusion once the limits of the target are reached by the therapeutic.
Oxford Biomedica's exciting new approach paves the way for packaging additional therapeutics within a larger viral vector, as long as the safety and efficacy mirrors or improves upon what has been achieved with AAV.
tabasco
- 02 Feb 2010 11:00
- 1279 of 1451
Chief business officer Nick Woolf seems very confident in oxb futurean interesting 60 seconds
http://biobusiness.tv/videos/250
tabasco
- 10 Mar 2010 07:19
- 1280 of 1451
Preliminary Results
TIDMOXB
RNS Number : 3388I
Oxford Biomedica PLC
10 March 2010
?
+--------------------------------------------+----------------------+
| For Immediate Release | 10 MARCH 2010 |
+--------------------------------------------+----------------------+
OXFORD BIOMEDICA PLC
PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2009
Oxford, UK - 10 March 2010: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, today announces its preliminary results for the year ended 31 December
2009.
Operational highlights:
ProSavin : Parkinson's disease
First dose level in Phase I/II trial showed sustained efficacy at 12
months
Enhanced administration has potential to accelerate development
Regulatory approval to evaluate higher dose level
Ground-breaking preclinical results published in journal
Ocular gene therapies
Landmark partnership with sanofi-aventis in ophthalmology
Received US$26 million upfront payment
Committed funding for three years to develop four gene therapies
RetinoStat and StarGen on track to enter clinical development in 2010
TroVax : cancer
Further analysis of Phase III TRIST study confirmed subset efficacy
Received US$17.4 million regarding termination from sanofi-aventis
Support from FDA for further trials in multiple cancers
Phase II trial in prostate cancer expected to start in 2010
Financial highlights1:
Revenue of GBP19.1 million (2008: GBP18.4 million)
Research & development costs of GBP18.3 million (2008: GBP27.0 million)
Net loss before exceptional items of GBP9.5 million (2008: GBP5.5 million)
Net loss after exceptional items of GBP3.5 million (2008: GBP10.0 million)
Net cash generated2 of GBP3.0 million (2008: net cash burn2 of GBP16.9
million)
Net cash3 of GBP25.3 million (2008: GBP21.9 million)
1. Audited financial results
2. Net cash generated by/used in operating activities plus sales and
purchases of non-current assets
3. Cash, cash equivalents and current financial assets
Commenting on the 2009 annual results, Oxford BioMedica's Chief Executive
Officer, John Dawson said: "I am very pleased with our achievements during 2009.
Our strategic decision to focus our internal development efforts and to expand
our partnering activities is delivering results. The scope and potential value
of our ocular collaboration with sanofi-aventis is testament to this strategy.
We are building the value of our lead product candidates, ProSavin and TroVax,
by advancing their development while pursuing partnership opportunities for both
programmes. Furthermore, we are on track to start clinical development of our
first two ocular gene therapies during 2010. Our vision is to create a
sustainable, highly profitable biopharmaceutical company and we are well
positioned to achieve this goal."
-Ends-
----------------------------------------------------
All sounds great to me.partners and deal for this yeartrovax still looking goodProvSavin heading in the right directionthe SP must move several % today?
tabasco
- 10 Mar 2010 12:06
- 1281 of 1451
Ark/Oxford BioMedica merger touted as Cerepro file is pulled
09 March 2010
Ark Therapeutics is in talks about a possible sale of the company after European regulators informed the UK firm that an expensive additional clinical trial is needed before its brain cancer drug Cerepro could be given the green light.
tabasco
- 12 Mar 2010 14:08
- 1282 of 1451
Edison Investment Research Limited
Mar 12
2010 No surprises in results
Oxford BioMedica remains an attractive recovery play: its current market cap implies little value is attributed to TroVax and the upside potential in the stock. With a solid cash position of 25.3m, the company has a good chance of partnering ProSavin on attractive economic terms (and re-partnering TroVax) in 2010. The year should also bring clinical catalysts, including further ProSavin Phase I/II data and the initiation of new trials Phase IIb for TroVax in prostate cancer, Phase I/IIa for two ocular assets.
tabasco
- 29 Mar 2010 12:30
- 1283 of 1451
Interesting post that answers a few questions>
Tuco 1 - 29 Mar'10
All,
I have spoken with someone at OXB this morning and can confirm that the amount of stock on loan (borrowed to support a short position ) has gone from 1% to over 3% in the last month
OXB confirm that no institution have been selling.
tabasco
- 21 Apr 2010 07:42
- 1284 of 1451
RNS Number : 5026K Oxford Biomedica PLC 21 April 2010
Nick Woolf leaving to go and live down underby all accounts a good guy and one that oxb did not want to loose
I did like his personal comment:- Nick Woolf commented: "It has been a difficult personal decision to leave Oxford BioMedica, particularly at a time when the Company is pursuing multiple collaborations and exploring other opportunities to build the business.
---------------
Mind youif the wife says we are going.you go!!!
jeffmack
- 21 Apr 2010 11:31
- 1285 of 1451
Maybe he is joining Trevillion on a joint venture. I understand Trevillion has a good few bob hidden away.
hangon
- 22 Apr 2010 17:56
- 1286 of 1451
I'm not seeing this as a significant loss, rather he's gone for career improvement maybe headhunted who knows? - OR it may be family reasons and he's not saying, etc.
I doubt this creates a big-hole in the forward plans of OXB, rather it's a shame, a small glitch etc.....
OXB has plenty of cash, so maybe they should buy into another prospect to bring something to market, to prove they can, etc. I know they are keen to use the money to secvure good terms with a suitable partner, so the chang in direction by Sanoffi was a bitter pill...
tabasco
- 26 Apr 2010 09:10
- 1287 of 1451
OXB plc also announces that its Annual General Meeting ("AGM") will be held on Tuesday 27 April 2010. The meeting will be held at the offices of Morrison & Foerster (UK) LLP, 7th Floor, CityPoint, One Ropemaker Street, London EC2Y 9AW, commencing at 11.00 a.m.
tabasco
- 28 Apr 2010 13:24
- 1288 of 1451
An investors take on yesterdays the AGM :-
In order:-
"The AGM
Was run through quickly. The only issue being that whilst approval was given (on proxies) for the company to increase the share capital by up to 2/3rds WITH pre-emption rights, but the resolution 12 was withdrawn after pressure from big investors. It would have given them the right to allot 10% of share capital on a sale WITHOUT pre-emption rights.
Instead they will have to call a shareholder meeting if they need to do this.
PRESENTATIONS
1. John Dawson - "Headlines"
A run through of Ocular, Trovax, and Prosavin... highlight comment "We HAVE Trovax proof of efficacy...."
2. Stuart Naylor - detail progress
Slide by slide review of the whole product set.
Lentivector.... regulators now have 2 complete years of safe, well tolerated, no side effects
experience in man. Every subsequent application to the regulators for a gene delivery comes with this increasing body of evidence. The Prosavin programme has been slower than they would have liked but "at French regulator pace". They are adding a British centre (in Cambridge)to the French one, which will help broaden the capacity. However, he says, we need to realise just how conservative the regulators are regarding the risk of introducing a gene
into a human brain.
Very confident, lots of added "anecdotal" information which he believes cannot be released to the market, but helps to explain why their confidence is SO high. e.g. ALL Prosavin patients were at the end of their L-dopa and suffering swings between dyskinesia and off states. There are golfers now doing a full round, patients living normal lives and even one who has "taken up DIY"! "UDPRS scores tell something but not the quality of life story."
The animal model has shown that the new infusion method has a much more significant improvement at lower dose levels. If repeated in human trial they may not need to escalate further two levels (which they have permission to do).
Prosavin P3 expected to commence in 2011.
Ocular progress as planned, two of these into clinical trial in man in Q4 2010.
"We have clarity on Trovax and the evidence to support efficacy."
Trovax would/will pass a restructured phase 3 now, with what has been learned about blood state.
Their view is that a partner is required to fund a large trial and they don't plan to fund one themselves. Instead they are funding at low levels a series of P2 trial with randomisation and placebo arms.
3. John Dawson - Strategy
He is keen on Mergers and acquisitions and has restructured the company so as to be capable of delivering deals and handling M & A. Gave a "personal success CV" to support these assertions.
Prosavin deal is potentially near. He HAS a term sheet but is still not happy about "one or two of the terms offered". "Will not accept any deal, only the right deal".
Trovax. A number of "suitors" at "early discussions".
M & A - "ongoing evaluation of opportunities."
Sees the financial potential for lead products as follows (in ANNUAL revenues):-
Prosavin $850m peak sales in EU and US
Retinostat $850m
Trovax >$1Bn ("many indications")
4. Q & A
Agreed Prosavin not as well known as they would like. Now have a couple of USA luminaries on the DSMB which should help. But problem IS understood.
What happened to QASAR? - "We missed the boat. At the time that the funding became actually available the TRIST issues were not at all clear."
How long would a Prosavin P3 trial be, given they (the authorities) would have 3 years safe dosage and efficacy knowledge by the time it starts? Probably only one confirmatory trial, 1 year.
So would that mean 2012 approval? "Probably too optimistic".
"However, if the infusion method should deliver results like the pre-clinical, there is the potential for significant acceleration."
5. "INFORMAL" Discussion
I asked Dawson if he speaks to the corporate investors, or are OXB too small an investment?
"I speak to all of them. Especially M & G, who I speak to very often".
Asked Prof Kingsman "you once famously said you wouldn't accept less than 1 per share? Big grin... "Things have changed I guess but I am guessing that your corporate investors are on averages around 25p to 30p, wouldn't you think?" AK: "Probably slightly less, but around that, yes."
AK still considers Prosavin "as good as a cure" and is confident in Trovax efficacy."