RNS Number : 9275Y
Oxford Biomedica PLC
11 December 2017
Oxford BioMedica notes the primary analysis results from the pivotal JULIET trial demonstrating that Kymriah (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer
Oxford, UK - 11 December 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis on the updated results from the JULIET clinical trial demonstrating sustained responses with Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.
The data from this pivotal trial, led by researchers from the University of Pennsylvania (Penn), show an overall response rate (ORR) of 53% (95% confidence interval [CI], 42% - 64%; p<0.0001), with 40% achieving a complete response (CR) and 14% achieving a partial response (PR) among 81 infused patients with three or more months of follow-up or earlier discontinuation. At six months from infusion, the ORR was 37% with a CR rate of 30%. The median duration of response was not reached.
Results from this study of Kymriah, the first-ever FDA-approved chimeric antigen receptor T cell (CAR-T) therapy, were included in the US and EU regulatory filings for Kymriah in r/r DLBCL and will be presented in an oral presentation at the 59th American Society of Hematology (ASH) annual meeting (Abstract #577; Monday, December 11, 7:00 AM EST)1.
Results of a cost-effectiveness analysis of Kymriah for the treatment of r/r B-cell ALL in the US will be presented in an oral presentation at the meeting (Abstract #609; Monday, December 11, 7:30 AM EST). The analysis showed that, based on the current US list price of $475,000, Kymriah is cost-effective compared to standard of care2.
In addition, results of another analysis to determine the potential societal value of Kymriah to patients with r/r ALL in the United Kingdom were presented in a poster presentation at the meeting (Abstract #1330; Saturday, December 9, 5:30 PM EST). Results show that therapies such as Kymriah have the potential to provide benefit to patients and society, particularly through gains in survival, contributing to productivity3.
In April 2017, the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to CTL019 based on data from the JULIET study. In October 2017, Novartis submitted an application to the FDA for CTL019 for the treatment of adult patients with r/r DLBCL who are ineligible for or relapse after ASCT. Novartis is also seeking approval from the European Medicines Agency (EMA) for CTL019 in pediatric and young adult patients with r/r B-cell ALL and adult patients with r/r DLBCL who are ineligible for or relapse after ASCT. Additional filings beyond the US and EU are anticipated in 2018.
Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes CTL019. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.
Novartis have issued an update on CTL109 or Kymriah and it is very positive
Novartis presents data at ASH for patients with serious blood disorders like lymphoma, leukemia and sickle cell disease
Primary results of pivotal KymriahTM Phase II JULIET study in relapsed/refractory DLBCL
Post-hoc sub-analysis of crizanlizumab (SEG101, formerly SelG1) SUSTAIN trial evaluating time to first sickle cell pain crisis
Outcomes from matched analysis of Molecular Recurrence-free Survival from EURO-SKI and ENESTfreedom trials following Tasigna® vs. imatinib in patients with CML-CP eligible for Treatment-free Remission (TFR)
Additional data on Rydapt®, Revolade®/Promacta®, Exjade®/Jadenu® and Jakavi® underscore breadth of Novartis Oncology hematology portfolio
Basel, November 1, 2017 - Novartis will present new data from across its hematology portfolio at the upcoming 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Atlanta, December 9-12. More than 75 abstracts will be presented, highlighting the robust Novartis development program for serious blood diseases.
"This is an exceptionally productive time in hematology, and the breadth of our Novartis Oncology data and presence at ASH underscore our commitment to this space," said Vas Narasimhan, Global Head Drug Development and Chief Medical Officer, Novartis. "Following the launch of Kymriah, the first FDA-approved CAR-T therapy, we are particularly excited about presenting additional data on this new approach to cancer treatment, as well as a new analysis for crizanlizumab, an investigational treatment for patients with sickle cell disease."
KymriahTM* (tisagenlecleucel) suspension for intravenous infusion is a CD19-directed genetically modified autologous T cell immunotherapy, indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Additional results evaluating Kymriah in pediatric ALL and in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) will be presented.
Data for Kymriah include results from the primary analysis of the JULIET study in adult patients with relapsed or refractory DLBCL, demonstrating sustained complete response rates based on extended follow up, and efficacy and safety findings from additional treated patients compared to a previously presented interim analysis. Additionally, results of a cost-effectiveness analysis of Kymriah for the treatment of relapsed or refractory ALL in the United States will be presented in an oral presentation.
Primary Analysis of JULIET: A Global, Pivotal, Phase 2 Trial of CTL019 in Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma [Abstract #577; Monday, December 11, 7:00 AM EST]
Cost-Effectiveness Analysis of CTL019 for the Treatment of Pediatric and Young Adult Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in the United States [Abstract #609; Monday, December 11, 7:30 AM EST]
Patient-Reported Quality of Life (QoL) Following CTL019 Infusion in Adult Patients with Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) [Abstract #5215; publication only]
Expert Elicitation of Long-Term Survival for Pediatric Acute Lymphoblastic Leukemia Patients Receiving CTL019 in ELIANA Phase II Study [Abstract #3377; Sunday, December 10, 6:00 PM EST]
Outcomes for chimeric antigen receptor T cell (CAR-T) pipeline therapies in other malignant blood cancers will also be shared at ASH:
Updated Safety and Efficacy of B-cell Maturation Antigen (BCMA)-specific Chimeric Antigen Receptor T Cells (CART-BCMA) for Refractory Multiple Myeloma (MM) [Abstract #505; Sunday, December 10, 4:30 PM EST]
Durable Remissions with Humanized CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells in Children and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia, Includ
This could be just what OXB needs if the details are correct regarding the news regarding Sanofi not exercising its option on Voyager's VY-AADC gene therapy product for Parkinsons,
Boost for Oxford Biomedica as Novartis files for further blood cancer indication
Tue 31 Oct 2017
(ShareCast News) - Oxford Biomedica received a boost as Novartis announced that it has filed for approval of its Kymriah drug for a second blood cancer indication.
Kymriah is the main potential driver of revenues and profits for Oxford Biomedica through its deal as the sole manufacturer of the lentiviral vectors used to generate Kymriah.
Novartis said on Tuesday it had applied to the US Food & Drug Administration for Kymriah in adult patients suffering from a relapsed or refractory diffuse large B-cell lymphoma who are ineligible for an autologous stem cell transplant.
Kymriah was approved by the FDA in August in the smaller indication of paediatric acute lymphoblastic leukemia, which was the first-ever chimeric antigen receptor T cell (CAR-T) therapy approved by the US regulator.
Novartis also plans to apply to European authorities to market DLBCL this year.
Novartis noted that DLBCL is a significantly larger patient pool with US & EU relapsed/refractory DLBCL incidence of around 50,000 per year versus 2,200 for ALL.
Elsewhere, Oxford Biomedica got a second piece of good news as Sanofi chose not to exercise its option on Voyager's VY-AADC gene therapy product for Parkinsons, which is a potential competitor to OXB-102, Oxford BioMedica's own gene therapy pipeline candidate for Parkinsons.
According to reports, Sanofi's decision was due to the fact that its existing deal with Voyager did not include US rights.
Sanofi has a number of other existing gene therapy projects with Oxford BioMedica, noted analysts at Peel Hunt, also suggesting that further deals, whether for lentiviral vector supply and/or gene therapy partnerships, "are important potential catalysts for Oxford BioMedica and we await further updates with interest".
Novertis has now submitted CTL109 for marketing approval in the US and Europe ,they have also given CTL109 a new name, its now called KymriahTM . This is very good news for the stockholders, and OXB , as marketing clearance for this product should give our S/P a well earned bounce .
Novartis submits application to FDA for KymriahTM (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy
Submission based on updated analyses from global, multi-center Phase II JULIET study, which met primary endpoint, including 6-month data to be presented at ASH 2017
Kymriah has demonstrated durable response rates in r/r DLBCL, a highly aggressive and difficult-to-treat non-Hodgkin lymphoma that is fatal in nearly 40% of patients due to relapsed or refractory disease
Novartis plans to submit an application for marketing authorization with the European Medicines Agency (EMA) in both DLBCL and pediatric ALL later this year
Basel, October 31, 2017 - Novartis today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). In April 2017, Novartis received Breakthrough Therapy designation for r/r DLBCL which, if approved, would be the second indication for Kymriah. In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval five weeks prior to its PDUFA date and was launched for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.
"Kymriah represents a historic breakthrough in the evolution of individualized immunotherapy and we are committed to bringing this innovation to as many patients who may benefit as possible," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "The response rates we've seen in the JULIET trial show that Kymriah has the potential to transform treatment for these patients and we look forward to collaborating with the FDA to make it available to patients for this second indication."
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), a cancer of the lymphatic system, accounting for up to 40% of all NHL cases globally. Roughly 50-60% of patients with DLBCL achieve and maintain complete remission after first-line therapy; however, roughly one-third of patients relapse after receiving first-line treatment,. Only about 25% of patients with r/r DLBCL are eligible for ASCT, the mainstay of secondary treatment. If left untreated, r/r DLBCL has a life expectancy of three to four months.
"The approval of tisagenlecleucel in the treatment of children and young adults with second relapse or refractory B-cell ALL was a watershed moment in the journey for researchers to develop immunocellular therapies," said Stephen Schuster, MD, director of the Lymphoma Program and Lymphoma Translational Research, University of Pennsylvania Perelman School of Medicine. "The data show this therapy could change the treatment paradigm for patients with r/r DLBCL as we've seen durable complete responses in patients who previously relapsed or were refractory to prior therapies, and this second filing is a significant step toward realizing its potential for even more patients who are currently battling fatal blood cancers."
Kymriah is an innovative immunocellular therapy that is a one-time treatment. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enha
It appears that yet another director has purchased shares on the open market ,this can only be good news and shows at least the BOD believe they have a good chance of making good money from OXB in the future. This gives me confidence of good things to come , so I to will be joining them, and will be adding more OXB shares to my portfolio
Director Dealings / Market Share Purchase
Oxford, UK - 26 September 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), a leading gene and cell therapy group, was informed that on 26 September 2017 Andrew Heath, Deputy Chairman and Senior Independent Director, acquired ordinary shares of 1p each ("Ordinary Shares") in the Company for his wife as follows:
Interest after purchase
Price per share (p)
Number of Ordinary Shares acquired 110,511;price paid 9.05p total holding 1,607,086 total
issued share capital 0.05%
The issued share capital of the Group is 3,106,253,317 1p ordinary shares.
To clarify. If there had been an immediate sell off following the announcements I could have understood that; buy on rumour sell on news. What bamboozles me is that there wasn't an immeidate sell off. There was real, if but too briefly, demand until the MMs stepped in and shut the market down (the MMs tied up the market in auctions until they'd rested back control and were able to move the price down). I can't ever recollect seeing that before.
They will eventually; a share offer out of the blue would probably turn your charts upside down.
But, back in the real world, you do appear to have called it right this time.
I know they say buy on rumour sell on news but I am still perplexed by the share price action on the day of both announcements (the recommendation and the approval). Most bizarre; generally PI enthusiasm is allowed to run its course before the MMs step in but the way they stepped in and killed any momentum was brutal. Was it simply because there was a large seller or something more to it.
I'm sticking for the time being. It will probably cost me but I'm irked!
pharmaspecialist I thought I should just let you know OXB all ready has a US Nasdaq listing, it goes' under Oxford Biomedica (NASDAQ:OXBDF)
So any listing by Nightstar Therapeutics wouldn't help OXB , unless of course a deal could be done prior to them listing ,in which case, they would lose out on the £65m they are raising via that I.P.O.
As we know from our own experience that cash won't get them to their end stage 4, especially if they don't have FDA approval for their AAV2 vector and manufacturing facilities, and would also need to get same clearance for the recombinant human complementary DNA they use before the FDA would give them a licence .Where as Novartis, Sanofi Aventis , Pfizer , and GSK and our self's all ready have a licence for production of the vector ,and DNA products,so why would OXB want to give a potential rival access to their technology for free?.
Remember it will take years before Nightstar get any thing to market, by which time, most of the big Bio 4 companies will have got their own retinal disease products to market, as there is a big race going on right now to see who can capture that this massif market,especially for the wet &Dry Macular disease, and for retinitis pigmentosa market.
Personally I don't see any incentives for OXB or Novartis, or any other company come to that, who are all ready involved in this science to buy out nightstar, unless of course they have some excellent intellectual property, or other science that others don't have, and if that is the case, then it's normal practice for such companies' to licence out that technology as it would generate their only means of income ,which in nightstars case, would be crucial to their survival over the next 5-10 years I would of thought, just as it has been for OXB over the last 20 years .
Maybe one of the big boys might take them out in order to obtain the cash ,but I don't see how OXB could amalgamate with them, unless they formed a new company with new stock ,or OXB reversed in to Nighthawk ,and then cancel OXB 3billion plus shares they have, and then re rate Night hawk shares prorate .
just my personal thoughts on this subject so .P.D.Y.H
That's the trouble with this share. Too few buyers understand the science and the long lead time from initial research, to discovery, careful testing, further development with other companies, to production, to selling enough to make a profit.
All the talk of charts and MMs is fine, but the fundamental issue is how well all the above can be managed along with the cash burn until substantial and reliable revenues can flow in. Almost 20 years ago I wrote of taking a 10 year view and was told I was too pessimistic. I warned that speculators would make, and lose along the way, but the MMs would always ensure they won. Dead right I've been. I still think we may need to look beyond a year or two, and 5 years is a more reasonable timescale before we'll know which way this is going.
In 5 years we could have failed entirely, been taken over, or the SP may be 5, 10 or 50 times higher. I wrote off such hopes many years ago, but wouldn't mind if that did eventually happen - although 50x won't! In all probability we'll be tottering along, hand to mouth, still looking forward to jam tomorow.
In the meantime I'm happy that OXB is developing science that may one day lead to treatments to benefit future generations.
Just because we have FDA approval it doesn't mean we can start production and the market knows this ,it can take another 6 months be fore Novartis will gain marketing approval ,and this includes pre production testing to ensure the product is safe once the manufacturing lines start.
It could take another 3 months from that date before the product is offered to the likes of N.I.C.E ,or the U.S.A or European agencies' ,or any other countries agencies, the product will go through scrutiny and price negotiations before they can even think about selling it ,in all, it could be another year to eighteen months before any country agree to use it ,but there again, they could accept the product with in 6 months if the price is right, and they can prove the procedure will help them make savings but even then they would have to train the doctors on how to use it ..This time gap is probably why the price is now falling back again, what happens next lie's with the individual countries health authorities,and how quick this procedure is taken up and marketed .
This news is not helping the Novartis or OXB share prices, it should because it lengthens the time where we have the market, but I guess investors do not know the difference between our CAR-T treatment and an allogeneic CAR-T.
Since the "good news" this share has gone from 11p to 8.8p. SP support around 6p.
Maybe I should stay away from shares that I don't understand (i.e. HEALTH). If I look at the performance of this share since the "good news", then I am really confused and lost faith (even with 25 years of trading).
Am I being too optimistic or could there be a chance of creating one of the world's leading gene therapy companies by merging OXB with another Oxford University spin-off, Nightstar Therapeutics? Nightstar is undergoing an IPO on Nasdaq hoping to raising £65m for further clinical development , having raised £34M privately in July 2017. A merger would reduce risk by adding diversity to the resulting company as Nightstar uses a different viral vector system to OXB. I am sure OXB's regulatory experience and bioprocessing expertise would come in useful for Nightstar which, like OXB, includes two products in clinical trials for eye disorders. There surely must be some synergy there. Nightstar would also gain a ready made marketing partner (Novartis) and funding raised for a potential merger would enable OXB to develop its wholly owned product candidates a bit further to the point where it could get decent royalties through partnership deals. This would also fit in with the philosophy of Nightstar's major shareholder, Syncona, of it reaping the full rewards of biotechnology developed in the UK academic sector. You may ask why Nightstar hasn't already merged with OXB, well I am sure the US is the right place for OXB to list so Nightstar's ability to raise funds and get a US listing before a takeover/merger with OXB is not necessarily silly. Following Gileads' takeover of Kite and the approval of Kymriah, interest in CAR-T & gene therapy companies has soared in the US and I am sure Nightstar is right in taking advantage of this for an IPO as soon as possible. Of course, as with all biotech mergers, the egos would have to fit in with the transaction but, on the surface at least, it would seem to make sense. Does anyone agree?
Trouble -Two in answer to your question a seller or a buyer cane sell into the market at an agreed price with an M/M ,but in order to keep the share price steady, the M/M can then sell those the shares back into the market over a period of time , this is done in order not to spook the market in that stock.
The M/M would then report the sell once the holding had been released in full .The problem here I believe, may lay in the fact it was a non executive member of the board wanting to sell at that particular time leading up to financial dates and could be construed as bad timing .
Obviously there are rules relating to such a sale which are set by the London Stock exchange, so the date of that sale may have some thing to do with that, especially as the sale was close to OXB half year accounts ,and the date of the FDA decision on the CTL109,what ever the reason, it will have been above board, as the M/M would have been in control of such a large sale of OXB stock .
What I found interesting about the 3 transactions ,was the fact he brought back 320,000 shares at a reduced price against the sell, after he had sold 300,000, doe's that indicate that Martin had to take a profit for personal reason which is allowed, but then after selling, he realised he had sold to many shares so reinvested the excess cash back into OXB again ,if that's so, then it shows Martin and Vulpe's still have confidence in the stock in the future to make them more money through OXB growth potential .
I'm back in at 9.07; so now watch this baby drop like a lead balloon! You say this is, has been, a speculator's share but somebody has most definitely decided to deflate OXB's balloon the last couple of months. Both recent RNS created significant initial buying interest, which was immediately snuffed out. Nobody seems to be shorting OXB that I can tell, so I am rather won over to Dave's suggestion that the MMs are trying to fill a purchase order (this appears to be supported by recent after hours sales above 10p). If Dave is right then the order should eventually be filled and normality allowed to return. There is also the added upside that if there is large order being filled at over 10p then the purchaser will not want the share price to continue languishing below 10p for too long once the order has been filled. If all else fails, I just blame Dave (only joking).
Yes I'm afraid you are right S17, OXB's share price tends to respond to short term speculative interest as there is poor visibility over the company's long term future. It does not have sufficient financial resources for additional worthwhile therapeutic development so perhaps the remaining interests in these will be sold off to Novartis so OXB can concentrate on its bioprocessing activities. Whilst this may represent a less exciting future, it may well be more profitable in the longer term as it is clear that the expansion of gene therapy products may present plenty of opportunties for OXB to license its technologies or provide development or production services.
RNS re Connected person Director/PDMR Shareholding
Notification relates to the following connected persons:
Vulpes Testudo Fund
This Notification relates to following connected persons:
Vulpes Testudo Fund has sold through his Vulpes Testudo Fund 2,377,600 shares @ £0.1009 on 31 Aug 2017
This might exsplain why the price has fallen
It's still basically a penny share, subject to the whims of speculators more than long term holders with real understanding of both the science and financial implications for its long term exploitation.
It's been the same since the beginning, and will continue that way unless and until a steady income stream is guaranteed, with sustainable profits rather than frequent cash calls, and the need to arrange high cost loans.
I say this as a holder for 20 years! As others have pointed out, it's one thing to make a discovery, it's another to make it into something saleable, and something else to make profit from selling it.
There was speculation in the press etc. before the 13 July RNS that the FDA's decision would be delivered in September. I know this for a fact because I decided to put OXB on my watch list with a view to buying some shares in early September and was therefore caught off guard by the 13 July RNS (at which time I made my first purchase at 10.63p during the 5 minute window permitted by the MMs before they snuffed out the share price surge). I subsequently bought additional tranches of shares as the share price dropped (my cheapest tranche was bough at 8.15p towards the end of July).
Subsequently, OXB announced in their interim results RNS in mid-August that the FDA's decision was expected to be announced by October at the latest (the RNS did not say in October) and if you look at the last message I post on 24 August you will note that I was speculating then that the FDA's announcement might actually be made a lot sooner (I suggested early September after the holidays).
As I say, I have seen the FDA fast track their decisions before (and I'm not a seasoned pharma investor by any means) and, given the 10-0 recommendation, the chances of a fast track approval seemed odds on to me and I very much doubt that any seasoned, large pharma investor would have been caught off guards by the "early" announcement (they would have realised that there was a good possibility).
I'm not arguing against your assertion (indeed I think it has a lot of merit and it does help to explain what I couldn't understand); I'm only suggesting that, if there is a buyer who's order is being filled, that the MMs have been trying to fill the order from before 13 July and that it might not be an institution (it would seem to me that it would make strategic sense for Novartis to buy an interest in OXB) and would speculate that they have been buying, at least, a couple of million shares each and every day for the last couple of months (so must surely be approaching a threshold if they've not already done so). I guess it could be more than one institution buying but wouldn't there then be a risk of them being seen as acting as a concert party i.e. their interests would, in effect, be combined for any threshold disclosure purposes.
I haven't been counting the shares transacted but I am looking at a period starting before the 13 July RNS and running to date; that's over 50 days. The share price reaction on 13 July was exactly the same as last weeks. I'm not suggesting that Dave is wrong; I'm just wondering if there is a bigger fish buying up shares and, if so, how long this can go on for (given that IMHO they been buting since before 13 July).
I note that there were two transactions recorded after close today which were dealt at over 10p today which would seem to support Dave's theory.
Max I have just been looking at the RNS and there is no date on that notice I can see (see below) .You can also see from the chart, there was a lot of activity after that announcement and the price moved very quickly to a high of 10.75p ,over the next few days , it then slowly headed south again. There was further buying after the half year results but again the price headed south soon after ,but that trend did not appear after the announcement of last week see below .If somebody wanted to buy more shares than normal, they could instruct several MM to buy on their behalf, and provided they kept below 3% ,this way ,they can accumulate several holdings without giving notice ,but must give notice if their combined holding goes' above 15 % across all their holdings,as institutions have several subsidiaries, and each one could hold 2.99%) ,but that would be difficult to achieve here I suspect ,unless of course they joined forces with another shareholder who already holds a large stake in OXB . This is known as connected concert party, see page 45 of the takeover code see link . www.slaughterandmay.com/media/39320/a-guide-to-takeovers-in-the-united-kingdom.pdf
I would also point out that the RNS you refer to says nothing about a date the FDA would give clearance .see below .also if you look at the chart their was buying after the announcement of the 10.-0 ,and again after the accounts ,but nothing after the FDA notice .
13 Jul 2017 07:00:03
Oxford Biomedica PLC
RNS Number : 9230K
Oxford Biomedica PLC
13 July 2017
FDA Advisory Committee Unanimously Recommends CTL019 (tisagenlecleucel) for Approval
London, UK - 13 July 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, today notes that the US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee voted unanimously 10 to 0 in favour of approval of Novartis investigational therapy CTL019 (tisagenlecleucel) for the treatment of relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).
Novartis announced in March that the FDA accepted its BLA filing and granted priority review for CTL019 in paediatric and young adult patients with B-cell ALL. The BLA review is ongoing and is under FDA priority review.
Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes CTL019. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products. Oxford BioMedica recently signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years.
John Dawson, Chief Executive Officer of Oxford BioMedica, commented: "The positive vote by 10 to 0 provides further support for CTL019, a novel immunocellular therapy, and we are proud to be a part of this important development. We continue to work closely with Novartis in delivering the lentiviral vector that encodes CTL019, a product the company described earlier this year as having "blockbuster" potential."
- Ends -
Are you aware that 3% of issued capital is 93 million shares?
With several big buyers in the market it will take quite some time to reach the 3% level despite the very large turnover recently.
If each serious buyer has established a reasonable stake alteady, I would expect them to be happy to pick up the rest of their requirement without pushing the market too high
This goes right back to the announcement of the 10-0 recommendation. Exactly the same thing happened when that announcement was made and, after that announcement, the share price actually dropped below 8p for a while.
I really don't know what to make of it. If the MMs have been filling the order since before the 10-0 recommendation was announced then surely they'd have had to have made some sort of announcement before now (because surely they must have crossed 3%, 5% etc. by now).
Something makes me think that this is not a normal institutional order being filled. It's been too prolonged. If, for example, Novartis was buying a strategic stake would they be allowed to do this? How long before they'd have to make an announcement?
PS. As regards nobody expecting this announcement before October; I thought there was a good chance of an early September announcement, as I said in an earlier post, and I have very limited knowledge of how the FDA works. I've seen the FDA fast track decisions before and the 10-0 recommendation seemed to make it an odds-on chance that they would fast track this decision (and I think any buyer worth their salt would have realised that there was a reasonable chance that the approval might get fast tracked).
MaX ProfOrdiS as you say the demand was there when the announcement was made ,but it dropped away quickly. That normally indicates the M/M have got large institutional buyers on their books, who want to fill buy orders at a set price ,they do that ,by dropping the S/P to entice sellers and then scoop up the OXB sells ,and then transfer them internally to those buyers. If the buyers are looking for a stake of over 3%, then it could take a good week or so before we start seeing the R.N.S coming through ,and only then, will we see the S/P move north. but if they are not buying above the 3% notifiable point, then the S/P could change over night once the institutional buys are filled .
Remember.Nobody expected this announcement for another month or two ,so it caught every one by surprise, in normal circumstances, the Institutions would have made there purchases prior to the announcement, by leaving a buy notice with the M/M, the M/M would then have walked the price down in order to get the sellers, and then fill the buy orders ,but on this occasion that didn't happen .
Obviously this is just my take on what happened, so please don.t invest on my hunch .
Note the chart over the past month below ,it shows both the 50 and 200 SMA are still moving north .and that following the announcement the sells doubled /trebled on some days .
I too closed my spread bets this morning and took a £500 profit.
Disappointed. Not sure what was going on; there was share demand when both announcements were made but somebody chose to snuff in out. Will keep a watching brief and may look to try and buy back in at a lower price if this downwards price pressure continues.
MaX - I had a 'subscription' to IC for a year, and while they do get somethings right, they got quite a lot wrong, so I cancelled my subscription. Its interesting to see what they have to say, as they do have a 'value' based approach, but I prefer to follow sentiment as my main guide.... I survive anyway, so I hope you do well with your investments. AR
Tip Update: Sell at 8.9p
Our Previous Tip: We said sell at 3.8p on 10 Nov 2016
With that sort of "success" it's a wonder anybody still buys the mag! That said, FDA aprroval has come in two months earlier than they were expecting and one of their main concerns (non-approval) has gone by the wayside.
Important message from the Financial Conduct Authority:
Posting inside information that is not public knowledge, or information that is false or misleading, may constitute market abuse.
This could lead to an unlimited fine and up to seven years in prison.
If you have any information, concerns or queries about market abuse, click here.
The content of the messages posted represents the opinions of the author, and does not represent the opinions of Interactive Investor Trading Limited or its affiliates and has not been approved or issued by Interactive Investor Trading Limited.
You should be aware that the other participants of the above discussion group are strangers to you and may make statements which may be misleading, deceptive or wrong.
Please remember that the value of investments or income from them may go down as well as up and that the past performance of an investment is not a guide to its performance in the future.
The discussion boards on this site are intended to be an information sharing forum and is not intended to address your particular requirements.
Whilst information provided on them can help with your investment research you need to consider carefully whether you should make (or refraining from making) investment or other decisions based on what you see without doing further research on investments you are interested in.
Participating in this forum cannot be a substitute for obtaining advice from an appropriate expert independent adviser who takes into account your circumstances and specific investment needs in selected investments that are appropriate for you.