BTG ...Profitabel + Monster Pipeline - 500 Beiträge pro Seite

[BrauchGeld]

BTG ist nach der Übernahme von Protherics das größte Britische Biotech-Unternehmen .
Was BTG von den meisten Biotechs unterscheidet ist das die bereits Profitabel sind und eine kaum schlagbare Pipeline besitzen .
Zu den Partnern gehören erstklassige Unternehmen wie z.b Wyeth,Genzyme ,Onyx Pharma und Astra-Zeneca .
Wer sich mit Biotech auskennt wird schnell merken welch gigantisches Potential hier vorhanden ist .


BTG PLC (BGC.L)

MarktKap : 355 Million GBP ( 406 Million € )
Cash : 57,6 Million GBP ( 65,9 Million € )
Kurs : 141p ( 1,62 € )


Pipeline Teil 1 (Zugelassene Produkte)
http://www.btgplc.com/Products/199/MarketedProducts.html

Pipeline Teil 2 (Produkte mit Vermarktungspartner)
http://www.btgplc.com/Products/198/PartneredProgrammes.html

Pipeline Teil 3 (Produkte noch ohne Vermarktungspartner)
http://www.btgplc.com/Products/197/BTGPipeline.html

Präsentation 2008
http://www.btgplc.com/PubContent/Docs/Analyst%20presentation…


Ein paar Produkte von BTG mit Blockbuster Potential ..

Campath® (Genzyme Corporation) Multiple Sclerosis Phase III

CB7630 (abiraterone) (Cougar Biotechnology, Inc) Prostate cancer Phase III

TRX4 (Tolerx, Inc) Type 1 diabetes Phase III

Varisolve® Varicose veins Phase III

CytoFab™(AstraZeneca) Severe sepsis Phase IIb

[Popeye82]

[BrauchGeld]

Es gibt kaum eine Aktie die mir wirklich so gut gefällt wie BTG .

BTG plc: Interim Management Statement

London, UK, 22 January 2009: BTG plc (LSE: BGC), the specialty pharmaceuticals company, today publishes an interim management statement for the period from 1 October 2008 to 21 January 2009.



On 12 November 2008, prior to the acquisition of Protherics PLC, BTG reported strong interim results for the six months ended 30 September 2008. Net recurring revenues increased by 25% to £15.1m, the profit after tax was £3.2m and cash reserves were £57.5m. The Company has made good progress during the second half of the year and trading is in line with expectations.



Integration update

BTG completed the acquisition of Protherics on 4 December 2008, providing the platform to create a self-sustaining specialty pharmaceuticals business. Key initial activities include rationalising operations to achieve planned cost savings and synergies, and reviewing the development pipeline to prioritise future investment.



Significant progress has been made in integrating operations and achieving the planned cost savings and synergies.

*
The former Protherics sites in London and Runcorn will close in Q1 09 and mid-2009 respectively, and notice has been served on BTG’s current office at 10 Fleet Place, London, following a break point having been reached in the lease. All London-based employees will relocate to a new office in Q1 09, resulting in significantly reduced annual rental costs.

*
The main US office and centre for North American sales and marketing operations will be located in the Philadelphia area.

*
Integration of the development teams and of corporate functions including finance, business development, HR and communications is advanced.

*
Rationalisation of the manufacturing facilities in Wales and Australia is on track.

With the restructuring decisions made to date and additional savings anticipated from the ongoing pipeline and site reviews, the Company is on track to deliver expected total annual savings of £10m in general and administrative costs and to reduce research and development costs by £10m per annum by the 2010/11 financial year.



The pipeline review is expected to be completed during the first quarter of 2009. An update will be provided in a close period statement planned for 2 April 2009, ahead of publication of the preliminary results for the year ending 31 March 2008, anticipated on 14 May 2009.



Operating and development highlights



* In early November 2008, BTG licensed BGC 945, a novel anti-tumour compound, to Onyx Pharmaceuticals, Inc in return for an upfront payment of $13m (£7.3m net), potential development and sales milestones of up to $307m and a royalty on product sales.

* Final data from the Phase II safety study of Varisolve®, under development for the treatment of varicose veins, were presented at the American College of Phlebology symposium in November. The results showed no evidence of adverse subclinical effects following treatment with Varisolve® in patients with a right-to-left cardiac shunt. Varisolve® is progressing through a preparatory phase III study in the US towards the pivotal phase III trials, which are anticipated to commence around mid-2009.

* An Investigational New Drug application has been submitted to the US Food & Drug Administration (FDA) for BGC20-0166, a proprietary combination of two serotonin-modulating agents under development as a treatment for obstructive sleep apnoea.

* The US FDA has granted orphan drug status to OncoGel™ (paclitaxel) for the treatment of brain cancer.

* BGC20-1531 completed Phase I single and multiple ascending dose studies and was well tolerated at all doses. In addition, BGC20-1531 demonstrated significant analgesic-like activity, similar to that of NSAIDs, in an experimental medicine model of pain.

* Analysis of the data from a completed Phase I study of BGC20-0134, a novel structured lipid targeting the treatment of multiple sclerosis, showed anticipated effects on plasma cytokine levels, including an increase in levels of the anti-inflammatory cytokine TGFβ.

* Progress continued in several clinical studies:

o A Phase IIb study of OncoGel™, a slow release formulation of paclitaxel for direct tumour injection, continued enrolment of a planned 124 patients with oesophageal cancer, and a phase I/II study continued to recruit patients with primary brain cancer.

o Following successful dosing of the first 12 patients, recruitment continued into a Phase IIa clinical study of the angiotensin therapeutic vaccine (ATV), designed to reduce blood pressure.

o Recruitment of patients continued into a Phase IIa clinical proof of concept study of Prolarix™, a targeted prodrug-based treatment for primary liver cancer.

o The Phase I/II study of Acadra™ continued to recruit patients with refractory B-cell chronic lymphocytic leukaemia.

Louise Makin, BTG’s CEO, commented: “We are pleased with the progress made in integrating our businesses following the acquisition of Protherics in December, and are on track to deliver the significant planned cost savings and synergies. We have also had a strong start to the second half of the year, with overall progress in line with expectations, good momentum in the development pipeline and the licensing of BGC 945 to Onyx Pharmaceuticals.”

[BrauchGeld]

Campath gilt als aussichtsreichster Kandidat gegen Multiple Sklerosis und BTG wird kräftig mitverdienen .

http://www.businessweek.com/technology/content/oct2008/tc200…
Genzyme's Campath May Slow MS

A new study finds that Genzyme's drug Campath may be an effective treatment for multiple sclerosis

By Catherine Arnst

Campath, a Genzyme (GENZ) drug already approved for leukemia, may turn out to be one of the most effective treatments for multiple sclerosis, and it's the first medication to show potential for reversing the disease, according to a study reported Oct. 22 in The New England Journal of Medicine. In a three-year trial involving 334 patients in early stages of the nerve disease, Campath reduced the number of relapses by 74% when compared with Rebif, a form of interferon that's commonly used to treat MS. Campath also lowered the risk of sustained disability by 71% over Rebif, which is co-marketed by EMD Serono and Pfizer (PFE).

The researchers also noted that patients on Campath showed some recovery of lost motor functions and were less disabled after three years than at the beginning of the trial, while those on interferon worsened. Those results, researchers say, suggest Campath may allow damaged nerve tissue to repair, a first for a disease that afflicts about 400,000 people in the U.S. and several million worldwide.
Side Effects

As encouraging as the results may be, Campath can cause very serious side effects, in particular a rare blood condition called immune thrombocytopenic purpura (ITP) that can lead to abnormal bleeding and even death. Six patients on Campath developed ITP during the trial, and one died. Genzyme temporarily stopped the trial after the death and started closely monitoring all patients on Campath for ITP, which can be reversed if treated promptly. The trial was sponsored by Genzyme and Bayer Schering Pharma, which holds marketing rights to Campath.

Despite the danger of ITP, MS specialists welcomed the results. "These outcomes are really pretty remarkable," says Patricia O'Looney, vice-president for biomedical research at the National Multiple Sclerosis Society. "They still have to be confirmed by further trials, but I think it is a very, very promising drug."

Campath is also appealing because it only needs to be administered once a year, intravenously, while Rebif must be given by injection three times a week, O'Looney says. Interferon can also produce severe flu-like symptoms. "There are a lot of patients who cannot tolerate interferon or do not like the shots, so this drug would be an appealing alternative," O'Looney says.
Hope for MS Sufferers

The Campath results provided some rare good news to the MS community. In April, Rituxan, a promising MS drug made by Genentech (DNA) and Biogen-Idec (BIIB), failed in a clinical trial against a particularly tough form of MS. This summer, two more cases of a rare and sometimes deadly brain disorder were reported in patients on Tysabri, an MS drug marketed by Biogen-Idec and Elan (ELN). Sales growth of the drug slowed in the third quarter as a result. Because of reports of a few deaths from the brain disease, Tysabri was taken off the market in 2005, just months after it won Food & Drug Administration approval. The FDA allowed it back on in 2006 on the condition that patients be closely monitored.

Both Tysabri and Campath are antibodies that manipulate the immune system, making it almost a given that serious side effects will arise. But many MS patients are so desperate for better treatments that they are often willing to take risks that would be unacceptable in drugs for less serious diseases.

In cases of MS, an autoimmune disease, the body's immune system attacks myelin, the protective coating around the nerves. The nerves are then destroyed, resulting in physical and mental impairments that can become crippling as the disease progresses.
Further Trials Planned

Campath, first developed at the University of Cambridge in England, works by inhibiting a portion of the immune system that attacks the myelin. Dr. Alasdair Coles of the University of Cambridge, lead investigator of the study, says he was particularly excited by the drug's ability to promote brain repair. "We are witnessing a drug which, if given early enough, might effectively stop the advancement of the disease and also restore lost function," he says. That would be unprecedented, he adds.

Genzyme is now recruiting patients for two additional trials of Campath, and it will likely be three years or so before the company can seek an additional approval for the drug for the treatment of MS.

[BrauchGeld]

http://biz.yahoo.com/bw/090210/20090210005516.html?.v=1

Cougar Biotechnology Announces Agreement with FDA on Special Protocol Assessment for Phase III Trial of CB7630 (Abiraterone Acetate) in Chemotherapy Naïve Castration Resistant Prostate Cancer Patients

Tuesday February 10, 8:05 am ET

LOS ANGELES--(BUSINESS WIRE)--Cougar Biotechnology, Inc. (NASDAQ: CGRB - News) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase III clinical trial of the Company's lead drug candidate CB7630 (abiraterone acetate) in patients with chemotherapy naïve castration resistant prostate cancer. The SPA is a written agreement between the Company, as the trial's sponsor, and the FDA regarding the design, endpoints, and planned statistical analysis approach of the Phase III trial to be used in support of a New Drug Application (NDA). The European Medicines Agency (EMEA) has also provided protocol advice consistent with that of the FDA regarding the Company's Phase III trial design and ability to support the submission of an EU Market Authorization Application (MAA).

Pursuant to the SPA, the Phase III trial will be a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic castration resistant prostate cancer who have not yet received treatment with chemotherapy. The trial is expected to enroll approximately 1,000 patients who will be randomized (1:1) to receive either CB7630 plus prednisone or placebo plus prednisone. The trial will be conducted at approximately 150 sites in North America, Europe and Australia. The agreed upon co-primary endpoints of the trial are progression free survival and overall survival. The Company plans to use the progression free survival data from the trial as the basis for submission of an NDA/MAA for Accelerated or Conditional Approval from the regulatory agencies. Cougar anticipates that it will begin patient enrollment in this Phase III trial later this quarter.

Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, said, "Obtaining FDA agreement on the overall Phase III trial design, and more specifically patient population and primary endpoints, represents an important milestone in the global development of CB7630 and for Cougar as a company."

Arturo Molina, M.D., M.S., FACP, Chief Medical Officer and Executive Vice President of Clinical Research and Development of Cougar, added, "We are pleased to be able to reach agreement with the FDA on our Phase III trial design for patients with chemotherapy naïve castration resistant prostate cancer. We look forward to commencing patient enrollment in this Phase III trial shortly."

[BrauchGeld]

[BrauchGeld]

Prostate Cancer Drugs Get Street's Attention
* On Friday April 24, 2009, 6:28 pm EDT

http://finance.yahoo.com/news/Prostate-Cancer-Drugs-Get-ibd-…

[glaubehoffnung]

Hallo, mag mich jetzt nicht umständlich einlesen und dann womöglich doch nicht alles begreifen.
Meine Frage, da ich auf eher kurzfristige Biotechs frequentiert bin: Wann wirds bei BTG spannend, gibts Termine???

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.244.468 von glaubehoffnung am 25.05.09 12:31:20

BTG ist eines der besten Biotechs das die Briten zu bieten haben und News gibts auch reichlich in den nächsten 6-12 Monate .

Das Cougar von Johnson&Johnson übernommen wurde ist auch eine gute nachricht für BTG !



http://www.btgplc.com/PubContent/Docs/BTG%20Preliminary%20Re…

Operating review Following the acquisition of Protherics, we completed a detailed review of the enlarged portfolio, assessing programmes in relation to the development pathway and associated investment, technical risks, time to market, competitive landscape, potential returns and strategic fit. Our pipeline currently comprises eight clinical development programmes.

Voraxaze™ is an investigational new drug that is not approved in any indication but is currently available in the US under a Treatment Protocol and cost recovery programme for patients receiving high dose methotrexate (≥1g/m2) who are experiencing, or at risk of, methotrexate toxicity. Voraxaze™ is progressing through a rolling Biologics Licence Application in the US, and we plan to market Voraxaze™ in the US ourselves if the product is approved.

Varisolve®, the investigational endovenous microfoam therapy for varicose veins, successfully completed a Phase II safety study and is progressing towards pivotal Phase III trials in the US. In parallel, discussions are progressing with potential commercial partners. These discussions, and the requirements and costs of the Phase III trials, product registration and launch, will inform BTG’s decisions on the future technical and commercial development of the programme.

OncoGel™, a sustained release formulation of the chemotherapy agent paclitaxel, is progressing through a Phase IIb study in patients with oesophageal cancer. Preliminary data are anticipated in H2 2010 and survival data by H1 2011.

Prolarix™, the prodrug tretazicar co-administered with the co-substrate caricotamide, is being studied in 20 patients with inoperable liver cancer in a Phase IIa study, which is anticipated to report in 2010.

Acadra™ (acadesine) is progressing through a Phase I/II study of in patients with B-cell chronic lymphocytic leukaemia, with results anticipated in H1 2011.

BGC20-1531, an EP4 receptor antagonist targeting the treatment of migraine headaches, showed promising analgesic-like activity in an experimental pain study and is expected to commence a Phase IIa study early in H2 2009 with data anticipated in H2 2010.

BGC20-0134, a novel structured lipid, is anticipated to start a Phase IIa study in H2 2009 as an oral treatment for patients with relapsing-remitting multiple sclerosis. The study is expected to finish in 2011.

ATV, the angiotensin therapeutic vaccine, was progressing through a Phase IIa study but dosing was suspended in April 2009 as a precaution following several injection site reactions and ‘flu-like’ symptoms in patients. Data were reviewed from all patients dosed, and preliminary safety conclusions are that there were no differences between the treatment and control groups. The adverse events were therefore most likely related to the adjuvant rather than the vaccine. Although the sample size was low and statistical significance was not achieved in some measurements, the preliminary data were encouraging in relation to differences observed between ATV and control groups in respect of antibody response and other measures. BTG plans to initiate a new Phase IIa study which will explore different doses of adjuvant and vaccine. As a result of the portfolio review, we decided not to conduct further in-house development of a number of programmes including Digoxin Immune Fab for severe pre-eclampsia,

BGC20-1259 for Alzheimer’s disease,
BGC20-0582 for head lice infestation and BGC20-0166 for obstructive sleep apnoea. Where possible we will seek partners to continue development of these and other programmes not under active development. If partners cannot be found, or where we believe the technical or commercial barriers are too high to make programmes attractive to potential partners, we will seek to return the assets to the originators.

Partnered programmes There has been very good progress in programmes partnered with other pharmaceutical and biotechnology companies. Enrolment of patients with active relapsing-remitting multiple sclerosis has completed in a Phase III trial of Campath® (alemtuzumab), which is under development by Genzyme Corporation. Enrolment into a second Phase III trial is expected to finish by the end of 2009. Data from the trials are expected in 2011, with approval potentially in 2012.

Cougar Biotechnology, Inc. commenced a second Phase III trial of CB7630 (abiraterone acetate) in patients with chemotherapy-naïve castration-resistant prostate cancer (CRPC). The co-primary endpoints of the trial are progression-free survival and overall survival. Cougar plans to use the progression-free survival data as the basis for submission of a New Drug Application and a Marketing Authorisation Application for Accelerated and Conditional Approval from regulatory agencies.

Tolerx, Inc. initiated a Phase III trial of TRX4 in patients with autoimmune new-onset type 1 diabetes. Recruitment of European patients commenced in March 2009, and the study is now actively recruiting patients in the US, Canada, Sweden, Finland, Italy, Germany and the UK. Tolerx has a worldwide collaboration with GlaxoSmithKline to develop and commercialise TRX4 in a range of autoimmune disorders.

A Phase II study of CytoFab™, a polyclonal antibody that neutralises TNF-α and is under development by AstraZeneca for severe sepsis, has made good progress and is expected to finish around mid-2009.

A Phase I safety study commenced in April 2009 of Nexvax 2, a novel vaccine under development by Nexpep Pty Ltd for coeliac disease.

[glaubehoffnung]

Der Chart schläft aber seit Jahren auf etwa gleichem Niveau!?

[glaubehoffnung]

Antwort auf Beitrag Nr.: 37.260.583 von glaubehoffnung am 27.05.09 11:12:11

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