neil777
- 02 Apr 2007 15:26
BTG's upbeat close period update (imo) further confirms the turnaround.
With recurring royalty revenues expected to be up by about 5% and R&D spend in line, and a product pipeline to die for, i believe they are cheap, and a real growth stock for the future.
Any comments.
hangon
- 01 Aug 2007 21:50
- 14 of 93
95p looks like the rest of the World doesn't think these execs are up to much - I'm holding ( in Hope!), but it's a sure thing I'm thinking of getting out. This is now in negative gain land and I don't like their complacency.
Execs rewarding themselves with more Options is not why I invest. If they can't do their job without additional sweeteners - are they really "fit for purpose?" - surely they can buy shares out of salary, not get a Discount - - My brokers doesn't offer a Discount....is this honest use of Shareholder funds?
No, I just don't get it.
Any more of this and I'm out.
They'll be going to AIM, next!
- Oops don't be too sure.
neil777
- 02 Aug 2007 08:47
- 15 of 93
I know what you mean hangon, news about execs buying tiny amounts of discount shares is not the kind of news we are looking for. But there is just something lurking in the back of my mind (probably a fly) telling me to sit tight, we shall see.
hangon
- 24 Aug 2007 14:04
- 16 of 93
I have re-evaluated and added to my holding recently, since I think the sp drift has been caused by lack of new buyers, rather than a panic-selling as has hapened to other businesses.
Their trials are on-going and FWIW I'm still hopful they will received the recognition for what is ( otherwise) an unpleasant surgical procedure ( Varicose vein removal) - that there are alternatives "doesn't matter" because these are mixed by the surgeon and subject to variability, both in mixing and the ingredients - therefore once Varisolve is approved I suspect insurance Co's and health authorities will insist on an Approved product being used. It represents a minor part of the over-all cost and the Surgeon makes a profit on the price anyway.
My average price was close to 1.50 and now has dropped, so any significant boost to the sp will be most welcome. I think that BTG needs to demonstrate at least one out of the several "blockbuster" pharma-products before folk realise this is a long-term growth business - so let's hope it comes Good!
- I must have changed my position (based on an opportunistic buy).... and the recent sp-rise, as Markets recover their fear of recession - sparked by the sub-prime Mortgage scandal. (er, IMHO). It would help if BTG-Execs were a bit more positive, rather than expecting shareholders to fund their good lifestyles, with little (yet) to show for it and that is why I remain against Options - they are paid enough to buy shares for themselves....
neil777
- 24 Aug 2007 17:18
- 17 of 93
I can't find falt with any part of your post hangon, there should be some news to come over the next few months, let's hope it's good news, and the very best of luck!
Neil
neil777
- 20 Sep 2007 16:10
- 18 of 93
This is more like it! and hopefully more news to come.
BTG PLC
20 September 2007
BTG plc: Campath(R) approved for first-line use in Adult Leukemia
London, UK, 20 September 2007: BTG plc (LSE: BGC), the life sciences company,
today announces that its licensee, Genzyme Corporation, has received approval to
market Campath(R) (alemtuzumab) as a first-line treatment for B-cell chronic
lymphocytic leukaemia (CLL). Campath(R) was previously approved only for
third-line use in CLL.
Louise Makin, BTG's CEO, commented: 'The approval of Campath as a first-line
treatment for CLL provides another effective treatment option for newly
diagnosed patients and should increase product sales and royalties to BTG. We
are also excited by the ongoing development of Campath in multiple sclerosis.'
The text of Genzyme's announcement on the approval follows.
'FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment
for Leading Form of Adult Leukemia
Study Data Demonstrated Improved Progression-free Survival with Campath
Cambridge, MA and Wayne, NJ - Genzyme Corp. (Nasdaq: GENZ) and Bayer HealthCare
Pharmaceuticals Inc. (NYSE: BAY) today announced that the U.S. Food and Drug
Administration (FDA) has approved a supplemental biologics license application
(sBLA) for Campath(R) (alemtuzumab) and granted regular approval for
single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia
(B-CLL). Campath was initially approved in 2001 under accelerated approval
regulations and the FDA has determined that the study results submitted in the
sBLA fulfill the post-marketing commitment to verify clinical benefit. A label
expansion is under consideration in Europe.
'Campath is clearly an important single agent for the first-line treatment of
CLL,' said Peter Hillmen, MB, ChB, of the Leeds General Infirmary, Leeds, United
Kingdom, and the lead investigator of the pivotal study comparing Campath
against chlorambucil. 'We are excited to be entering an era where our improved
understanding of CLL, coupled with more advanced laboratory tests and targeted
therapy options like Campath, have dramatically changed the first-line treatment
approach for this type of leukemia.'
Campath works in an entirely different way than chemotherapy, and is the first
and only monoclonal antibody approved by the FDA for the treatment of B-CLL.
'The data that supported this label expansion add to a growing body of evidence
about the effectiveness of Campath across the entire B-CLL treatment pathway,'
stated Mark Enyedy, president of Genzyme's oncology business unit. 'A broader
range of patients is now eligible for Campath treatment, regardless of whether
they have received prior therapy. The approval also marks an important step in
a long-term development plan that is exploring the full potential of Campath in
high-risk CLL, combination and consolidation therapy.'
Presented at the 48th Annual Meeting of the American Society of Hematology (ASH)
conference last year, data supporting the sBLA were part of an international
Phase III clinical trial comparing Campath with chlorambucil in previously
untreated patients with B-CLL. The study met its primary endpoint by
demonstrating longer progression free survival (PFS) in patients treated with
Campath versus chlorambucil, with Campath reducing the risk of disease
progression or death by 42 percent (p=0.0001).
Patients receiving Campath exhibited higher overall and complete response rates
that were statistically significant in comparison to patients who were treated
with chlorambucil. Campath also demonstrated a manageable safety profile among
study patients.
'We are excited that Campath can now be used to treat patients in the U.S.
earlier in the course of their disease,' said Gunnar Riemann, Ph.D., member of
the Board of Management of Bayer Schering Pharma AG. 'The ability to now
provide Campath as a first-line treatment of the disease will make an important
difference in battling B-CLL. It may help patients by offering a potentially
more effective treatment approach that can extend progression-free survival.'
Campath is marketed in the U.S. by Bayer HealthCare Pharmaceuticals Inc., as
Campath, and outside the United States as MabCampath(R).
About B-Cell Chronic Lymphocytic Leukemia
According to the Leukemia and Lymphoma Society, approximately 15,000 new cases
of B-cell chronic lymphocytic leukemia (B-CLL) are diagnosed in the U.S. each
year. It is the largest subset of chronic lymphocytic leukemia (CLL), the most
common form of adult leukemia in the western world. B-CLL is characterized by
the accumulation of functionally immature cells in the bone marrow, blood, lymph
tissue and other organs. Because these cancerous B cells have a longer than
normal life span, they begin to build up and 'crowd out' normal, healthy blood
cells and can become fatal. Symptoms include fatigue, bone pain, night sweats,
fevers, and decreased appetite and weight loss. Bone marrow infiltration leads
to a lack of healthy blood cells, thus causing susceptibility to bleedings and
weakening of the immune system, exposing the patient to a higher risk of
infection.
About Campath
Campath is indicated as a single agent for the treatment of B-cell chronic
lymphocytic leukemia (B-CLL). Campath has a boxed warning which includes
information on cytopenias, infusion reactions, and infections. The most commonly
reported adverse reactions are infusion reactions (fever,chills, hypotension,
urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia,
lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV
infection, other infections). In clinical trials, the frequency of infusion
reactions was highest in the first week of treatment. Other commonly reported
adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The
most commonly reported serious adverse reactions are cytopenias, infusion
reactions, and immunosuppression/infections.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to
making a major positive impact on the lives of people with serious diseases.
Since 1981, the company has grown from a small start-up to a diversified
enterprise with more than 9,500 employees in locations spanning the globe and
2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the
National Medal of Technology, the highest honor awarded by the President of the
United States for technological innovation. In 2006 and 2007, Genzyme was
selected by FORTUNE as one of the '100 Best Companies to Work for' in the United
States.
With many established products and services helping patients in nearly 90
countries, Genzyme is a leader in the effort to develop and apply the most
advanced technologies in the life sciences. The company's products and services
are focused on rare inherited disorders, kidney disease, orthopaedics, cancer,
transplant, and diagnostic testing. Genzyme's commitment to innovation continues
today with a substantial development program focused on these fields, as well as
immune disease, infectious disease, and other areas of unmet medical need.
Genzyme(R) and Campath(R) are registered trademarks of Genzyme Corporation. All
rights reserved.
About Bayer HealthCare Pharmaceuticals Inc
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of
Bayer HealthCare LLC, a division of Bayer AG. Its research and business
activities are focused on the following areas: Diagnostic Imaging, Hematology/
Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's
Healthcare. The company's aim is to discover and manufacture products that will
improve human health worldwide by diagnosing, preventing and treating diseases.
For more information about Campath, including full prescribing information, call
1-888-84-BAYER (1-888-842-2937) or visit
www.campath.com
.
This press release contains forward-looking statements, including statements
about the regulatory plans and timing for, and the expansion of, the Campath
product label into earlier-line CLL, high-risk CLL, and combination and
consolidation therapy. These statements are subject to risks and uncertainties
that could cause actual results to differ materially from those projected in
these forward-looking statements. These risks and uncertainties include, among
others: the actual efficacy and safety of Campath in these indications; the
actual timing and content of submissions to and decisions made by the U.S. Food
and Drug Administration and other regulatory authorities, and the other risks
and uncertainties described in reports filed by Genzyme with the Securities and
Exchange Commission under the Securities Exchange Act of 1934, as amended,
including without limitation the information under the heading 'Risk Factors' in
the Management's Discussion and Analysis of Financial Condition and Results of
Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter
ending June 30, 2007. Genzyme cautions investors not to place substantial
reliance on the forward-looking statements contained in this press release.
These statements speak only as of the date of this press release, and Genzyme
undertakes no obligation to update or revise the statements.
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in our annual and interim reports to the Frankfurt Stock
Exchange and in our reports filed with the U.S. Securities and Exchange
Commission (including our Form 20-F). The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments'
For further information contact:
BTG Financial Dynamics
Christine Soden, Chief Financial Officer Ben Atwell
+44 (0)20 7575 0000, +44 7710 484199 +44 (0)20 7831 3113
neil777
- 26 Sep 2007 16:43
- 19 of 93
BTG PLC
26 September 2007
BTG plc: Campath(R) commences pivotal phase III trial in multiple sclerosis
London, UK, 26 September 2007: BTG plc (LSE: BGC), the life sciences company,
today announces that its licensee, Genzyme Corporation, and Bayer Schering
Pharma AG have initiated a pivotal phase III trial of Campath(R) (alemtuzumab)
as a treatment for multiple sclerosis. This follows the announcement of 20
September that Campath(R) had been approved as a first-line treatment for B-cell
chronic lymphocytic leukaemia.
Louise Makin, BTG's CEO, commented: 'We are excited by the prospects of Campath
in multiple sclerosis and delighted that the pivotal phase III trials are under
way. If the excellent results from the phase II trials are reproduced, patients
will have a new treatment option that has the potential to be much more
efficacious than any other existing treatment.'
The full text of Genzyme's announcement follows.
'Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program
with Alemtuzumab for Treatment of Multiple Sclerosis
Date: September 26, 2007
Genzyme Corporation (Nasdaq: GENZ) and Bayer Schering Pharma AG, Germany today
announced that the first patient has been treated in the first of two planned
Phase 3 trials examining the safety and efficacy of alemtuzumab for the
treatment of multiple sclerosis (MS).
The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple
Sclerosis), a randomized, rater-blinded study, will compare alemtuzumab to Rebif
(R) (interferon beta-1a) in patients with relapsing-remitting multiple sclerosis
(MS). Alemtuzumab will be given in two annual cycles; Rebif will be administered
three times per week. The CARE-MS I study will include patients who have been
diagnosed with relapsing-remitting MS but who have not yet begun treatment with
any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who
have continued to experience relapse episodes while on currently available
disease-modifying therapies.
Initiation of this Phase 3 program follows the successful completion of the
initial treatment period in the Phase 2 trial. Interim results from the Phase 2
trial indicated that alemtuzumab-treated patients experienced a statistically
significant reduction compared with Rebif-treated patients in the risk for
sustained accumulation of disability and the risk for relapse for 24 months.
Results of the primary outcomes from this trial at 36 months are expected to be
presented on Oct. 14 by Professor Alastair Compston during the Charcot Award
lecture at the annual meeting of the European Committee for Treatment and
Research in Multiple Sclerosis, in Prague.
The CARE-MS I study will enroll up to 525 patients at approximately 60 medical
centers throughout North America, Australia, Latin America, and Europe, and will
again compare alemtuzumab-treated patients to Rebif-treated patients according
to two co-primary endpoints: the time to sustained accumulation of disability,
and the annualized relapse rate. Alemtuzumab will be dosed at 12 mg/day for five
days by daily IV infusion, with a second dosing 12 months later of 12 mg/day for
three days. All patients will be followed from their entry into the trial until
two years from the date that the last patient is randomized to treatment.
Alemtuzumab-treated patients will continue to have safety evaluations for at
least three years after the last course of treatment. The companies anticipate
filing for marketing approval of alemtuzumab for the treatment of MS in 2011.
Alemtuzumab is an investigational drug for the treatment of MS and must not be
used outside of a formal clinical trial setting in MS patients. Physicians or
patients seeking additional information about the CARE-MS I trial should contact
Genzyme Medical Information at 1-800-745-4447, option 2 in the United States, +
31 35 6991499 in Europe, or visit
www.clinicaltrials.gov
.
About Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic disease of the central nervous system (CNS)
in which the immune system can attack the brain and spinal cord. The disease
causes a wide range of symptoms including fatigue, difficulty walking, numbness,
and vision problems, and can progress to cause severe disability.
Relapsing-remitting MS is the most common form of this disease.
About Alemtuzumab
Alemtuzumab is licensed in the United States as a single agent for the treatment
of B-cell chronic lymphocytic leukemia (B-CLL), and outside of the U.S. for the
treatment of B-CLL in patients who have been treated with alkylating agents and
who have failed fludarabine therapy. The product was launched in its oncology
indication in 2001 in the US, where it is marketed by Bayer HealthCare
Pharmaceuticals Inc. as Campath(R), and in Europe, where it is named MabCampath
(R).
Alemtuzumab is a humanized monoclonal antibody that binds to a specific target,
CD52, on cell surfaces and directs the body's immune system to destroy those
cells. It is the first and only monoclonal antibody approved by the FDA for the
treatment of patients with B-CLL.
Genzyme and Bayer Schering Pharma AG, Germany are co-developing alemtuzumab in
oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG,
Germany holds exclusive worldwide marketing and distribution rights to
alemtuzumab.
Campath has a boxed warning which includes information on cytopenias, infusion
reactions, and infections. The most commonly reported adverse reactions in
patients with B-CLL were infusion reactions (fever, chills, hypotension,
urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia,
lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV
infection, other infections). In clinical trials, the frequency of infusion
reactions was highest in the first week of treatment. Other commonly reported
adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The
most commonly reported serious adverse reactions are cytopenias, infusion
reactions, and immunosuppression/infections.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to
making a major positive impact on the lives of people with serious diseases.
Since 1981, the company has grown from a small start-up to a diversified
enterprise with more than 9,500 employees in locations spanning the globe and
2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the
National Medal of Technology, the highest honor awarded by the President of the
United States for technological innovation. In 2006 and 2007, Genzyme was
selected by FORTUNE as one of the '100 Best Companies to Work for' in the United
States.
With many established products and services helping patients in nearly 90
countries, Genzyme is a leader in the effort to develop and apply the most
advanced technologies in the life sciences. The company's products and services
are focused on rare inherited disorders, kidney disease, orthopaedics, cancer,
transplant, and diagnostic testing. Genzyme's commitment to innovation continues
today with a substantial development program focused on these fields, as well as
immune disease, infectious disease, and other areas of unmet medical need.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at
www.bayerhealthcare.com
.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized
Therapeutics and Women's Healthcare. With innovative products, Bayer Schering
Pharma aims for leading positions in specialized markets worldwide. Using new
ideas, Bayer Schering Pharma aims to make a contribution to medical progress and
strives to improve the quality of life. Find more information at
www.bayerscheringpharma.de
.
Forward-Looking Statements
This press release contains forward-looking statements, including statements
about the initiation of clinical trials, regulatory plans and expected timelines
for alemtuzumab, including the initiation of a second Phase 3 trial in MS
patients and the timing thereof, the timing of obtaining clinical trial data,
enrollment in clinical trials and the ability to manage patient safety. These
statements are subject to risks and uncertainties that could cause actual
results to differ materially from those projected in these forward-looking
statements. These risks and uncertainties include, among others: that final
results of the clinical trial demonstrate safety and efficacy comparable to the
interim data that have emerged to date, the actual timing and content of
submissions to and decisions made by the regulatory authorities, institutional
review boards, data safety monitoring boards and treating physicians regarding
the continued administration of alemtuzumab to MS patients, Genzyme's ability to
develop and obtain approval of a patient safety plan, and the other risks and
uncertainties described in reports filed by Genzyme with the Securities and
Exchange Commission under the Securities Exchange Act of 1934, as amended,
including without limitation the information under the heading 'Risk Factors' in
the Management's Discussion and Analysis of Financial Condition and Results of
Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter
ending June 30, 2007. Genzyme cautions investors not to place substantial
reliance on the forward-looking statements contained in this press release.
These statements speak only as of the date of this press release, and Genzyme
undertakes no obligation to update or revise the statements.
Genzyme(R), Campath(R), and MabCampath(R) are registered trademarks of Genzyme
Corporation. All rights reserved. Rebif(R) is a registered trademark of EMD
Serono, Inc.'
neil777
- 26 Sep 2007 16:50
- 20 of 93
The chart is looking a little better, lets hope it continues.
neil777
- 28 Sep 2007 09:11
- 21 of 93
BTG PLC
28 September 2007
BTG plc: Close Period Update
London, UK, 28 September 2007: BTG plc (LSE: BGC), the life sciences company,
today announces the following update ahead of the planned interim results
announcement for the six months to 30 September 2007 which will be released on 7
November 2007.
Trading update
BTG's financial position continued to strengthen during the first half of the
year. Underlying recurring royalty revenues remain strong although, as
anticipated, BTG's reported royalty revenue is expected to be in line with last
year because of the continuing weakness of the US dollar against sterling. In
addition to these royalties, other transactions completed in the period are
expected to contribute around 15m of net profits and gains before withholding
taxes. These include the previously announced semiconductor chip patent licences
and the licensing of AQ4N by KuDOS to Novacea, Inc, and the completion of
additional elements of the RFID patent sale and other fully paid-up royalty
transactions. These sources of income, together with continued cost control,
have generated positive cash flow in the first half of this financial year which
has added to the 43m cash reserves reported at the start of the period.
Research and development costs are expected to be up to 15m for the full year
but will be significantly weighted to the second half, with the planned
acceleration of recruitment in the Varisolve(R) safety study, commencement of
phase I clinical studies of BGC20-1531 (migraine) and BGC20-0134 (multiple
sclerosis), and the progression towards the start of a phase I study of BGC945
(solid tumours) and a phase IIa study of BCG20-1259 (Alzheimer's disease).
Looking forward, the recent approval of Campath(R) as a first-line treatment for
chronic lymphocytic leukaemia is likely to have a small positive impact on BTG's
royalty revenues in the second half of the current financial year and provides
the potential for significantly increased royalties in future years.
BTG is continuing to seek development partners for a number of its
pharmaceutical programmes and to look to licence or sell its remaining non-core
physical science assets. These have the potential to generate both one-off
revenues and future milestones and royalty streams.
Operating update
Good progress has been made with products under development. Varisolve(R), the
varicose veins treatment, continued to progress through the US phase II safety
study as planned. A scheduled meeting of the Drug and Safety Monitoring Board
was held in early September in order to review initial results. Recruitment is
proceeding well and it is expected that the study will complete on schedule
during the first half of 2008.
A phase II trial commenced of BGC20-0582, a novel head lice treatment following
the successful outcome of ex vivo studies. Recruitment is anticipated to finish
by the end of 2007, with the trial results being available around the end of the
financial year.
The proof of concept trial on BGC20-0166, a pharmacological treatment for
obstructive sleep apnoea based on combining two known serotonin modulators, is
fully recruited and the results are expected to be fully analysed by the end of
2007.
BGC20-0134 and BGC20-1531 progressed towards completion of their preclinical
development and are anticipated to enter phase I clinical studies in multiple
sclerosis and migraine respectively during the second half of the financial
year. BGC945, targeting solid tumours, also continued preclinical development
including long-term safety testing ahead of a planned phase I study, anticipated
to commence in the first half of 2008.
BGC20-1259, a multifunctional compound targeting Alzheimer's disease (AD),
continued to progress towards a planned phase IIa study in AD patients in 2008
while completing certain safety studies.
Among licensed programmes, in addition to its approval as a first-line treatment
for B-cell chronic lymphocytic leukaemia, Campath(R) also commenced a pivotal
phase III in multiple sclerosis.
Louise Makin, BTG's Chief Executive, commented:
'We have made good progress during the first half and the significant one-off
transactions have further strengthened our cash position. With a strong
financial platform of growing recurring royalties, we can step up investment in
our development programmes as planned with the confidence that we can continue
to build a valuable pipeline and life sciences business.'
Ends
neil777
- 10 Oct 2007 11:57
- 22 of 93
BTG PLC
10 October 2007
10 October 2007
BTG PLC : NOTIFIABLE INTERESTS IN SHARES
BTG plc (LSE: BGC) has received notification that Schroders plc has a notifiable
interest in 15,158,645 ordinary shares of BTG plc. This increased holding
represents 10.038% of the voting rights of the Company.
The shares are held in portfolios managed by Schroder Investment Management
Limited on a discretionary basis for clients under investment management
agreements.
- ends -
neil777
- 15 Oct 2007 12:37
- 23 of 93
FOCUS BTG's Campath leaves MS patients weighing the risks despite study success
AFX
LONDON (Thomson Financial) - Biotech company BTG will be in focus after analysts highlighted excellent results for its Campath product in a multiple sclerosis (MS) phase III trial, but cautioned that its side-effects may keep it a niche product.
Neurologists may think twice about prescribing Campath because of the risk of developing serious blood disorders, said Bear Stearns.
However, if preliminary evidence is correct, then patients and doctors will need to decide whether the documented risks are worth the improvements in quality of life.
The success of Campath in the MS indication is noteworthy by any measure -- Bear stearns described it as 'outstanding' -- as patients who received small doses of Campath were 73 pct less likely to suffer a relapse of the condition than those prescribed with the market leader Rebif.
According to the initial trial data, Campath can cause side-effects in some patients that can be fatal if not properly managed. The most serious is ITP, a blood disorder that must be detected early and treated with steroids.
BTG said the questions over side-effects are nothing new and there will be a very big debate within the neurological community over the benefits and risks of Campath.
The side-effects for all MS products in development are well known, but this has never affected trial recruitment, the company said
Citigroup analysts predict that Campath will stay a niche product because of its side-effect profile and will pose little threat to sales of Rebif.
Martin Adams at Datamonitor said that Campath's growth may be hampered by strict prescribing rules or an indication limited to late-stage MS patients, but the drug could still achieve global sales of 500 mln usd, in a total market of 4.5 bln usd.
Bear Stearns points out that a high side-effect profile has limited another promising MS product, Biogen and Elan's Tysabri, to 17,000 patients -- although this is because Tysabri caused instances of the fatal blood disorder PML.
The full extent of Campath's risks and benefits will be clearer when the phase III trial reports in full next year.
julian.hofmann@thomson.com
neil777
- 07 Nov 2007 09:19
- 24 of 93
Decent set of results, and if varisolve continues to produce in the phase II US study, then a deal must be on the cards!
BTG PLC
07 November 2007
BTG plc: Interim Results for the Six Months Ended 30 September 2007
London, UK, 7 November 2007: BTG plc (LSE: BGC), the life sciences company,
today announces its interim results for the six months ended 30 September 2007.
Financial highlights
• Revenues of £47.6m (H1 06/07: £20.8m) reflect significant non-recurring
transactions and continued steady receipts from royalty income
o Total net revenues £27.2m (H1 06/07: £12.5m)
o Net recurring royalty revenues £12.1m (H1 06/07: £12.2m)
o Net revenues from non-recurring items £15.1m (H1 06/07: £0.3m)
• Operating and administrative costs stable at £8.9m (H1 06/07: £9.1m)
• Research and development expenditure increased to £4.8m (H1 06/07: £4.5m)
o H2 investment expected to be significantly greater
• Profit before tax of £15.2m (H1 06/07: £1.7m) and profit after tax £13.4m
(H1 06/07: £1.6m)
o £1.8m tax charge relates primarily to unrecoverable withholding tax on
one-off licensing deal
• Cash reserves at £46.6m (31/03/07: £43.0m)
Operating highlights
• Good progress with internal development programmes
o Varisolve(R) Phase II study proceeding as planned, on track to end
in H1 08
o BGC20-0166 (sleep apnoea) clinical study completed, results due Q1 08
o BGC20-0582 (head lice) Phase II study enrolment completed, results due
Q1 08
o BGC20-1259 (Alzheimer's disease) completed Phase I and preparing to
enter Phase IIa study in 2008
o CTAs filed for BGC20-1531 (migraine) and BGC20-0134 (multiple
sclerosis) to commence first clinical studies
• Strong progress in partnered programmes
o Campath(R) approved as 1st-line treatment for chronic lymphocytic
leukaemia and two Phase III trials in multiple sclerosis initiated
o TRX4 to be developed by Tolerx in collaboration with GlaxoSmithKline
for type 1 diabetes and other autoimmune diseases
Louise Makin, BTG's Chief Executive Officer, commented: 'These excellent
financial results are supported by strong progress in our internal and licensed
development programmes. We look forward to an exciting second half-year in which
we anticipate achieving a number of significant development milestones while
continuing to seek to strengthen our pipeline by in-licensing or acquiring new
programmes.'
For further information contact:
BTG Financial Dynamics
Andy Burrows, Director of Investor Relations Ben Atwell
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591
About BTG
BTG in-licenses, develops and commercialises pharmaceuticals principally in the
areas of neuroscience and oncology. The company has a substantial and growing
revenue stream of royalties from out-licensed products and a broad, expanding
internal pipeline of development programmes. BTG operates from offices in
London, Philadelphia and Osaka. For further information, visit:
www.btgplc.com
.
Toya
- 30 Nov 2007 15:19
- 25 of 93
Isn't it great when one goes out and comes home to find things have moved up? I knew I'd read something somewhere, and have just tracked it down - this little snippet from Moneyam's Press Roundup of 27Nov:
"Dealers suggest an upbeat broker note is imminent for BTG" - from the Daily Express.
I've tried to search for more details on the Express site today but not found anything. Anyway: it explains today's rise - could go further next week perhaps?
neil777
- 30 Nov 2007 16:52
- 26 of 93
Thanks Toya, have a good weekend.
Toya
- 30 Nov 2007 17:03
- 27 of 93
You too, Neil.
neil777
- 04 Dec 2007 16:42
- 28 of 93
BTG PLC
04 December 2007
BTG plc Appoints Dr John Brown as Chairman Designate
London, UK, 4 December 2007: BTG plc (LSE: BGC), the life sciences company,
today announces the following Board changes.
Dr John Brown is to join the Board of BTG on 1 January 2008 as a non-executive
director and, upon the retirement of Sir Brian Fender on 3 March 2008, will
become non-executive Chairman of BTG.
Sir Brian Fender commented:
'I am delighted that John Brown will join our board and will succeed me as
Chairman of BTG. I have enjoyed the years I have spent as a director and then
Chairman of this exciting company and wish John every success in moving BTG
forward in the coming years.'
John Brown, PhD MBA FRSE is a non-executive director of a number of public and
private biotech companies including Ardana plc, Protherics plc and Vectura Group
plc, and was a director of Cambridge Antibody Technology plc until its recent
acquisition by AstraZeneca. He currently chairs the Governing Council of the
Roslin Institute in Edinburgh and is chairman of Scottish Biomedical, CXR Ltd
and SingVax Pte Ltd. He sits on the advisory board of the Life Sciences ITI in
Scotland, is a member of the UK Technology Strategy Board and an advisor to
several private equity and venture capital funds.
Until late 2003, Dr Brown was Chief Executive of Acambis plc, a leading producer
of vaccines to treat and prevent infectious disease. John holds a PhD in
neuropharmacology from Edinburgh University and is a Fellow of the Royal Society
of Edinburgh.
There are no further details to be disclosed in relation to paragraph 9.6.13R of
the Financial Services Authority Listing Rules.
Ends
hangon
- 17 Dec 2007 16:46
- 29 of 93
Replacing one expensive-suit with another will make no difference to the business"Pipeline" - or the short-term finances, IMHO.
neil777
- 24 Jan 2008 08:02
- 30 of 93
BTG PLC
24 January 2008
BTG plc: Interim Management Statement
London, UK, 24 January 2008: BTG plc (LSE: BGC), the life sciences company,
today publishes an Interim Management Statement, providing an update on progress
in the business since 1 October 2007. The results for the full year to 31 March
2008 will be reported on 19 May 2008.
The overall performance of the business during the period has been in line with
the Board's expectations. In particular, recruitment of patients in the
Varisolve(R) phase II safety study is on track for the planned finish by June
2008.
Louise Makin, BTG's chief executive officer, commented:
'BTG has made good progress in the first nine months of the year. Momentum in
our own development pipeline has been supplemented by progress in licensed
programmes, including Campath(R) in CLL and MS, TRX4 in type 1 diabetes and
abiraterone in prostate cancer. Over the coming months we expect to report
results from our sleep apnoea and head lice clinical studies, initiate the first
clinical studies for our migraine and MS programmes, and conclude the US safety
study of Varisolve(R).
'We are in a strong financial position with significant revenue streams and cash
reserves, and we are well positioned to create shareholder value by further
developing and strengthening our pipeline.'
Financial update
Sales and growth rates of licensed products underpinning BTG's recurring royalty
revenues for the three months to 31 December 2007 are anticipated to generate
income broadly in line with expectations.
Factors that may influence sales of certain individual products during the
period and for the remainder of the second half of the financial year are:
As previously disclosed, Wyeth's distribution agreement with Baxter
in the EU for BeneFIX(R), the treatment for haemophilia B, has ended and
although the demand for this product remains strong sales may be affected
temporarily;
The label for MabCampath(R) (trademarked as Campath(R) in the US)
was extended in the EU in January 2008 to include treatment of patients with
B-cell chronic lymphocytic leukaemia (CLL) for whom fludarabine combination
therapy is not appropriate. This followed the approval in September 2007 of
Campath(R) in the US as a single agent therapy for B-cell CLL, and together
these approvals are expected to increase product sales over time; and
Sales of the antibody products that underpin BTG's royalties from
the Medical Research Council are expected to continue to increase as the
products become more established.
Research and development expenditure has increased as planned during the period
as programmes have progressed further through preclinical and clinical
development. Full-year expenditure is anticipated to be in the range 12-14m.
Operating and administrative costs are stable and over the full year are
anticipated to be around 18-19m.
Cash and equivalents of over 46m at 1 October 2007 have been augmented by the
receipt of $10m gross/$5m net from Tolerx, Inc. in connection with its agreement
with GlaxoSmithKline on TRX4. The business has otherwise operated on a broadly
cash neutral basis over the three month period, with cash and cash equivalents
of 48.2m at 31 December 2007.
Pipeline update
Varisolve(R) - varicose veins and venous stasis ulcers
The US phase II safety study continues as planned. This study is investigating
whether patients who have right-to-left cardiac shunts experience
microinfarction or other subclinical events following treatment. Six treatment
sites have now been initiated, and it is anticipated that the required 50
patients with detected microbubbles in the middle cerebral artery during
treatment will have been evaluated by the end of H1 2008. To date, treatment
with Varisolve(R) has not been associated with evidence of microinfarction. An
interim report will be presented at a scientific meeting in March 2008
describing the results of the study in patients treated up to early March.
BGC20-1259 - Alzheimer's disease
Approval was granted in Sweden to conduct a positron emission tomography (PET)
study in healthy volunteers to estimate the efficacious dose range of BGC20-1259
to take into Alzheimer's patients in a phase IIa study, which is anticipated to
start in H2 2008. Dosing in the PET study is anticipated to begin during the
current quarter.
BGC20-0166 - sleep apnoea
The 39-patient clinical proof of mechanism study was completed and the results,
which are being analysed and will be discussed with expert advisers, will inform
the future clinical and commercial options for the programme. It is anticipated
that the results and next steps will be published around the end of the current
quarter. Development is continuing of a proprietary formulation to deliver the
most effective dose form of the two serotonin modulators.
BGC20-0582 - head lice
Treatment of 225 subjects in a phase II study of this Generally Regarded As Safe
(GRAS) designated compound was completed in Q4 2007. The results are anticipated
during the current quarter, and in parallel BTG is planning the future clinical
and commercial strategy for this product which promises safe, effective
pediculocidal and ovicidal activity with reduced expectation of resistance
build-up.
BGC20-1531 - migraine
Site initiation was completed for a phase I clinical study of this EP4 receptor
antagonist, which offers a potential new mechanism to treat migraine headaches.
First doses are now scheduled to be administered this quarter rather than before
Christmas 2007.
BGC20-0134 - multiple sclerosis
MHRA and ethics approvals are expected for commencement of a phase I study in
healthy volunteers of BGC20-0134, a novel structured lipid that aims to treat
multiple sclerosis by rebalancing the body's pro- and anti-inflammatory
cytokines during MS episodes. First dosing is anticipated this quarter.
Senexis Limited, a private drug development company in which BTG is an investor,
secured 2.9m of new funding from the Wellcome Trust in January 2008. The funds
will be used to further optimise and progress preclinical development of the
company's small molecule compounds, licensed to Senexis by BTG, as a potential
disease-modifying treatment for Alzheimer's disease. BTG currently owns 48% of
Senexis.
For further information contact:
BTG Financial Dynamics
Andy Burrows, Director of Investor Relations Ben Atwell
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591
About BTG
BTG in-licenses, develops and commercialises pharmaceuticals principally in the
areas of neuroscience and oncology. The company has a substantial and growing
revenue stream of royalties from out-licensed products and a broad, expanding
internal pipeline of development programmes. BTG operates from offices in
London, Philadelphia and Osaka. For further information, visit:
www.btgplc.com
neil777
- 25 Feb 2008 17:46
- 31 of 93
Worth a read!
Mon, 25 Feb, 13:02 GMT
FOCUS Prognosis poor for cash-strapped biotech cos if market problems persist
LONDON (Thomson IM) - Troubled biotech companies Ardana and Vernalis are early casualties of a funding crisis that could leave peers such as Allergy Therapeutics, SkyePharma, Amarin, Medical Marketing International and Proteome needing to make major cuts to survive, according to analysts.
'It's become very apparent that the next six months are going to be very hard for companies that need to raise money,' said Robin Davison, a senior analyst at Edison Investment Research.
He said that any company that is at risk of coming to the market is getting its shares depressed because investors don't want to have to stump up more money.
Ardana announced last week that it was putting itself up for sale, and the following day Vernalis cut its workforce by almost 60 pct and sold most of its profit-making operations in a bid to pay off debt.
Davison said the few companies that aren't in this danger area include Antisoma, BTG, Renovo, Oxford Biomedica, GW Pharmaceuticals and Protherics.
For most other companies in the secto, the funding situation is either quite bad or acute, he said, adding that the only way they can solve their problems is by licensing a product.
'You've got like 20 or 30 companies that are desperate to license,' he said.
He mentioned Allergy Therapeutics as being in a difficult situation, explaining that it has got a borrowing facility but is unlikely to want to use it because 'that just gears up disaster'.
He added that Alizyme also is in a difficult situation unless it can do a licensing deal because it doesn't have a lot of money to fund ongoing development.
Meanwhile SkyePharma has a put option for 69 mln stg convertible bonds due at the earliest in May 2009, and another put option for 20 mln stg due in June 2010 at the earliest, and Davison said that in the current climate refinancing the debt would be very difficult.
He said that in a lot of cases the problem faced by companies is that their overheads limit what they can spend on R&D
'Maybe if you can rationalise that -- you have fewer CEOs paying themselves a lot of money, all the other costs and hangers on, PR advisors and that sort of thing -- it will thin the whole thing out,' he said.
Paul Cuddon at KBC Peel Hunt agreed, adding: 'It all depends on whether people can make some money with what they've got at the moment. I mean that's the key. If they've got some IP (intellectual property) that's worth something then they should be OK; if not then they shouldn't really have the IP in the first place.'
Cuddon identified Proteome, Allergy Therapeutics, Amarin, Alizyme and Acambis as being companies that don't have a lot of cash, but said that in the case of Alizyme and Acambis they have good products to license.
Cuddon agreed with Davison that a key factor that could determine the survival of biotech companies is the extent of their overheads.
'Phytopharm don't spend very much money on R&D at all because they in-source all their compounds from universities, from people who have spent a lot of money already developing them. So it's the companies that have got a huge number of employees and are spending a lot of money on R&D that are most at risk, certainly Alizyme, Amarin, Allergy Therapeutics,' he said.
ben.deighton@thomson.com
neil777
- 06 Mar 2008 10:21
- 32 of 93
BTG PLC
06 March 2008
BTG Initiates Clinical Study of Novel Multiple Sclerosis Treatment
London, UK, 6 March 2008: BTG plc (LSE: BGC), the life sciences company,
announces that dosing has commenced in a Phase I clinical study of BGC20-0134, a
potential treatment for multiple sclerosis.
The randomised, double-blind, placebo-controlled study will assess the
pharmacodynamic, pharmacokinetic and safety profiles of single and multiple oral
doses of BGC20-0134 in healthy volunteers.
Louise Makin, BTG's chief executive officer, commented: 'The effective treatment
of multiple sclerosis remains a significant unmet need. We are pleased to have
started clinical development of BGC20-0134, which has the potential to address
different forms of the disease and has the advantage of being an oral product.'
Although the cause of multiple sclerosis is unknown, there is strong evidence
that autoimmune mechanisms are involved in its development. T-cell infiltration
into the central nervous system and resultant dysregulation of key
pro-inflammatory cytokines leads to myelin loss, neuronal damage and the onset
of symptoms and disability. BGC20-0134 is a novel structured lipid designed to
restore the balance between pro-inflammatory (e.g. IL-1b and TNFa) and
anti-inflammatory (e.g. TGFb1) cytokines.
In a pilot study of a prototype compound, patients with the relapsing-remitting
form of multiple sclerosis experienced clinical benefits including decreases in
both relapse rates and EDSS scores (a standard measure of disability in multiple
sclerosis), together with improvements in pain and cognitive endpoints. In
preclinical models of multiple sclerosis, the potency of BGC20-0134 was shown to
be three times that of the prototype compound.
For further information contact:
BTG Financial Dynamics
Andy Burrows, Director of Investor Relations Ben Atwell
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591
About BTG
BTG in-licenses, develops and commercialises pharmaceuticals principally in the
areas of neuroscience and oncology. The company has a substantial and growing
revenue stream of royalties from out-licensed products and a broad, expanding
internal pipeline of development programmes. BTG operates from offices in
London, Philadelphia and Osaka. For further information, visit:
www.btgplc.com
.
neil777
- 14 Mar 2008 08:04
- 33 of 93
Found this on BTG's web site, hopefully will stir the SP!
17-20 March 2008
2008 SIR 33rd Annual Scientific Meeting of the Society for Interventional Radiology
Washington Convention Center Washington, DC, USA
John D Regan, MD, Clinical Director Interventional Radiology, Wake Forest University Baptist Medical Center, and investigator for BTGs Phase II clinical study on Varisolve, presenting