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.
neil777
- 05 Apr 2007 14:57
- 3 of 93
Good post!
But i suppose It depends on what way you look at it, and where you bought in at.
I bought in @91p so from my point of veiw, long term looks fine.
On the other hand, i have a friend that bought in @6+ and can't stand to hear to the letters btg
hangon
- 12 Apr 2007 16:09
- 4 of 93
For BTG [BGC], I paid over 9 in the past, but also at 92p (close to yours). However, where yr friend may have slipped-up is not recognising that when the whole market is falling it's best to bite the bullet and get out - I sold at a loss abt 4, but bought-in again about 2.50 - The FDA-ruling created a further fall .... (was it 75p?) but it went past me and it was only when some news (and Market buying) raised the sp, did I come in stronger. I think my average is now about 2. However, it is no longer my No.1 investment as OXB has overtaken even though for a while BTG was the greatest cash-input.
OXB continues to be a sound investment, with very good management IMHO.
However, I'm not so convinced by BTG - Last year was much the same as
previous years (exclude the Varisolve fiasco, anyone can get it wrong once!) and, you know, I suspect we shall hear much the same this AGM.
Still, it is a fantastic potential if only it comes off..........My hope is "It will" and then maybe OXB will become no.2 again.
I see BTG is rising, always a good sign.....let's hope it more than investor-driven.
(The earlier "loss" is sitting on my tax-return so maybe one-day I can use it....it could be a long wait..............however, it means that I now own more shares for the same "original" investment...and if BTG comes good, then that is a better position to be in than holding onto the original stock.
Lets say you have 1000 invested at 10
...and sell at 5...you have 500 and a Loss of 500
Let's say the sp fell to 1 and reluctantly you buy-in,
Let's say 2008 the sp rises to 3 and you sell out.............
500 has bought 500 shares and you sold for 1500, take away the loss 500 leaves you with the original 1000........All square.
However if BTG rose above 3 - and it may well do - then every 50p is another 250 profit. If your friend did nothing, BTG has to rise to 6 for evens.......yet the above investor would have gained a further 1500 (ie 1.5x the investment).
.............(Maybe you should keep mum.)
On the face of it "we" appear to have done the right thing....but others sold and waited.....making use of their money between-times.....indeed I wonder if I should top-slice OXB just to secure some profit.....maybe tempt fate with BTG!
Regards
neil777
- 12 Apr 2007 17:02
- 5 of 93
I think the 3 year bear market skewerd a lot of people, but what you have done is turned a 9 disaster into something more workable, well done!
AZM is my No1 and BTG 2nd...........no risk then.
Neil
neil777
- 13 Apr 2007 08:47
- 6 of 93
Good news this morning, BTG has landed $46m on the drip, and maybe a further $20 to come.
Every little helps
hangon
- 13 Apr 2007 13:31
- 7 of 93
I agree neil777, it shows that the workers at BTG are not drinking coffee all day (unlike the Execs, who sup on thick wines), I recall a memory-deal with Hitachi about 4 years ago - so this might be the same, or unrelated - it's odd that we never quite know...and that makes folks nervous - OK it's "commercially sensitive" - but is it?
Well, at least it's serios money and it also shows that there is life in some non-medic IP....so that's the "Good News" I was unaware of, (recently) and supports two day's sp improvement.
Great! . . . . . . . . Onward and upward.
neil777
- 19 Apr 2007 14:06
- 8 of 93
More good news today with AQ4N deal.......on a roll!
hangon
- 19 Jun 2007 11:49
- 9 of 93
- Look at the Graph - do we (few) really know better?
This was my No1 holding but that position has slipped greatly this last year - it's not quite an also-ran, but I'm sorely worried it might not recover...Oh very Dear!
neil777
- 19 Jun 2007 13:15
- 10 of 93
I know what you mean hangon, but looking at the NMX4570 the whole sector has been hammerd lately.
Hopefully when it recovers it should help, and with some news due this year, fingers crossed good news, who knows where the SP will go.
For now i'm staying put
hangon
- 20 Jun 2007 12:35
- 11 of 93
I've been reading the Annual Report and it does seem the execs are controlling things (and not taking all the cash for themselves!) - so I guess it's a hold also.
Any views on Woolworth...a well respected (if dull) cash generator? - indeed so is Jessops, but I sold-out rather too hastily at about current levels having thought their 2nd PW was the last...should have known. I still hold WLW although it marginally in Loss-territory about the same measure as BTG.....+ve hopes!
-Not that Retail has any connection with BTG, I hasen to add....just curious for a second opinion.
neil777
- 20 Jun 2007 16:23
- 12 of 93
Hard for me to comment on WLW, its not one that i track, or have much intrest in to be honest.
But if i had to give an opinion, WLW is a bit confused a sells most things jack of all trades but master of none, it may come back but cant see it setting the world on fire. imho
Neil.
neil777
- 18 Jul 2007 09:14
- 13 of 93
This seems to have given the lack luster dummy sp a bit of a lift.
BTG PLC
18 July 2007
BTG plc: 2007 Annual General Meeting and Interim Management Statement
London, UK, 18 July 2007: BTG plc (LSE: BGC), the life sciences company, today
issues the following AGM and Interim Management Statement, which is a summary of
comments to be made by Sir Brian Fender, Chairman, and Dr Louise Makin, Chief
Executive Officer, at the company's AGM at 10.30am today.
The Group reported strong results for the year ended 31 March 2007. Increased
recurring royalties from licensed products and good realisations from the
divestment of non-core IP together with reduced operating and administrative
costs have enabled the Group to report a second consecutive year of profits.
There was good progress both in BTG's internal pipeline of pharmaceutical
programmes and in its licensed programmes.
Since year-end, BTG has continued to make good financial and operating progress
in the year to date, in line with Board expectations. As part of the divestment
programme, two licences were granted for patents relating to storage capacity in
semiconductor chips, generating $44m in gross income plus an additional $22m if
an option is exercised and other conditions are satisfied. In addition, an
agreement to grant exclusive worldwide rights to the experimental cancer
treatment AQ4N was signed with KuDOS Pharmaceuticals Ltd and Novacea, Inc. These
deals have generated approximately 11m net of costs and taxes in the current
financial year.
The Group is actively seeking additional licensees for the semiconductor IP and
for its remaining physical sciences technologies. It is also seeking development
and commercialisation partners for a number of pharmaceutical programmes
including plevitrexed, which was recently granted orphan drug status in the US
for ovarian and gastric cancer.
There is good momentum in the internal development pipeline, which comprises ten
full development programmes, of which four are undergoing clinical trials, plus
four additional research programmes.
BGC20-1259, under development for dementia, completed a Phase I study. The drug
was well tolerated and has been shown in this and other studies to occupy key
molecular targets associated with cognitive improvement and the alleviation of
depressive symptoms. In addition, although the study was not powered to
demonstrate statistically significant changes in cognition in the healthy young
and elderly volunteers, there were significant dose-related improvements in
self-assessed calmness, power of attention and quality of working memory. These
encouraging results are planned to be explored in a Phase IIa study in people
with Alzheimer's disease, which is anticipated to start in the second half of
this financial year.
BGC20-0134, a structured lipid for the treatment of multiple sclerosis, and
BGC20-1531, an EP4 receptor antagonist for migraine, both continued through late
preclinical development ahead of their first Phase I studies, which are
scheduled to commence towards the end of 2007. BGC945 also continued to progress
through preclinical development and is anticipated to enter Phase I studies in
the first half of 2008.
A Phase II study of BGC20-0582, a proprietary formulation of a GRAS (generally
regarded as safe) compound for head lice, is expected to start in late summer
2007, with the results due before the end of the calendar year.
A third centre has started recruiting patients for the Varisolve(R) US Phase II
safety study. This is on track to complete treatment and follow-up of 50
patients around the end of the financial year.
Progress is also anticipated in several licensed programmes. The approval of
Genzyme Corporation's sBLA for Campath(R) as a first-line treatment for chronic
lymphocytic leukaemia (CLL) would significantly increase the number of CLL
patients available for treatment with Campath(R). Genzyme also expects by the
end of 2007 to commence two pivotal Phase III trials of Campath(R) in multiple
sclerosis following the excellent efficacy results in Phase II.
Tolerx, Inc. is continuing with a dose-optimisation Phase II study of TRX4, a
monoclonal antibody for the treatment of type 1 diabetes, ahead of a Phase III
study planned to begin before the end of the year.
Outlook
The Group's financial position is strong, with the revenues earned to date from
one-off transactions, the anticipated continued steady growth in recurring
royalty revenues and a healthy cash balance. This will enable investment in R&D
to increase as planned to around 15-16m this year to expand and further develop
the Group's pipeline of pharmaceutical products. Overall, the financial and
operating performance of the Group is expected to be in line with internal
expectations.
Louise Makin, Chief Executive Officer, commented:
'We have made a strong start to the year. With 11m generated in one-off
revenues already, continued steady growth anticipated in our recurring royalties
and a healthy cash position, we can progress our current development programmes
and explore options to strengthen our pipeline further.
'Building value in our pipeline is the key route by which we will create
shareholder value. We look forward to reporting significant progress during the
remainder of the year, including the progression of several programmes into
Phase I studies, the start of two Phase II studies, the completion of our
Varisolve(R) and head lice Phase II studies and the completion of the proof of
mechanism sleep apnoea clinical study. We believe we are well positioned to
become a leading life sciences company and to create significant shareholder
value.'
For further information contact:
BTG Financial Dynamics
Andy Burrows, Director of Investor Relations Ben Atwell/Anna Keeble
+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
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 -