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The Consolidated Biotech Thread 2006     

ADAM - 28 Dec 2005 17:45

A new Year and a new thread. This page is dedicated to listing potential news flow from the many different Biotechs on the market.

See www.ukbiotechs.com - a nice site dedicated to the discussion and informtion on UK Biotechs

Enter into the 2006 Biotech Investor Challenge at Biotechs.com

I currently have interests in ARA, ASM, AZM, CENS, PTI and VER (Last Updated 27/12/2005)

THE CONTENDERS

Acambis.gif

LATEST NEWS

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2006

Completetion of the maunfacturing of 182.5 million doses of ACAM2000 smallpox vaccine. Possible licensing of ACAM200 Third payment from Baxter of 2.6m in relation to the Canton manufacturing facility. ChimeriVax-JE initiate Phase III trials Data from C.Difficile Vaccine trials. Possible contract for MVA3000 expected February Initiate a clinical trial in HIV infected of MVA3000 Clarification on the future of Arilvax(TM)

Company Summary

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Click here for Product Pipeline: progress.gif

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LATEST NEWS

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2006

Cetilistat - Updates from Takeda on clinical development in Japan [2005 AGM presentation]

Cetilistat: Commencement of Phase III clinical programme

Renzapride: News on the crystal form patent application.

Colal-Pred: possible commencement of U.S. Phase III clinical trials in the treatment of acute ulcerative colitis.

Company Summary

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Click here for Product Pipeline: progress.gif

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LATEST NEWS

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2006

Commencement of full Phase III studies on vaccines against allergy to the most common pollens. Pollinex(R) Quattro submission for registration in H1 2006.

Company Summary

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Click here for Product Pipeline: progress.gif

ANTISOMA

LATEST NEWS

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2006

Data on AS1404 in regards to disease progression and survival. R1550 phase I trial data on patients with metastatic (spreading) or locally advanced breast cancer. Starting of trials into AS1409 Starting of trials into AS1410 - H1

Company Summary

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Click here for Product Pipeline: progress.gif

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LATEST NEWS

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2006

H1 2006 Start PIII trial of Testo Cream

H2 2006 Launch InvicorpTM H1 2006 Results from PII trial of Terbutaline H1 2006 InvicorpTM mutual recognition H2 2006 PIII data and regulatory submission of Testo Cream H1 2006 Teverelix LA and other collaborations

Company Summary

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arkcol.jpg

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2006

Phase II results of EG005

Company Summary

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CeNeS

LATEST NEWS

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2006

Morphine-6-glucuronide (M6G) - Results of Phase III trial in Europe mid-2006 Results of consultation with FDA over IND status of M6G. Possibly resulting in a quicker commencement of PIII trials. Application for an IND for CNS 7056X in the US. Announcement of a new pre-clinical development candidate before mid-2006.

Company Summary

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Click here for Product Pipeline: progress.gif

Evolutec

LATEST NEWS

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2006

rEV598 - Complete preclinical studies (Due end of 2005) rEV131 - NDA submission end 2006

Company Summary

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innovata_logo.gif

LATEST NEWS

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2006

Awaiting Year End Results

Company Summary

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LATEST NEWS

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2006

2005-2006 TroVax commercial collaboration H1 2006 TroVax Special Protocol Assessment for Phase III from FDA H1 2006 ProSavin regulatory approval for start of Phase I/II trial H1 2006 MetXia Phase II efficacy data in pancreatic cancer May 2006 TroVax Phase II full report in colorectal cancer (ASCO1) Mid 2006 TroVax Phase III trial in renal cancer to start H2 2006 ProSavin Phase I/II trial in Parkinsons disease to start 2006 TroVax Phase II trial in breast cancer to start (NCI2) 2006 MAb-toxin Phase I/II trial in cancer to start (Wyeth2) 2006 Canine TroVax-Vet trial in cancer to start (Intervet2)

Company Summary

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Click here for Neurotherapy Product Pipeline: progress.gif

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2006

None as of yet, Awaiting Merger completion

Company Summary

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2006

Hoodia Gordonii - Commencement of Clinical Studies. Asthma - Start of proof of concept studies.

Company Summary

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2006

Tostrex is expected to be launched in certain other European territories during the second half of 2006. Rectogesic is expected to be launched in certain other European territories during 2006. Oestradiol-glucoside Subject to obtaining FDA approval, it is currently envisaged that the study will be initiated in 2006 and will complete in 2007. Transdermal anti-emetic patch ProStrakan anticipates initiation of Phase III trials in Q4 2005 with results in 2006 and earliest launch in 2008. Testosterone-glucoside a single and multiple dose Phase IIa study with candidate formulations is planned to provide data mid 2006

Company Summary

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Click here for Product Pipeline

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LATEST NEWS

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2006

Awaiting End of Year Results

Company Summary

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LATEST NEWS

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2006

Submission of manufacturing changes to CroFab(TM) DigiFab -UK Product Launch Q1 EU approval of DigiFab Vorazaze - US approval H1 Vorazaze - European approval H2 Prolarix - Start of Phase II study in HCC (Mid 2006) Aniotensin Vaccine - Start of Phase IIa study H1

Company Summary

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LATEST NEWS

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2006

Completion of VR004 Phase IIb Clinical evaluation of VR040 to commence

Company Summary

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Vernalis

LATEST NEWS

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2006

Frovatriptan: MRM efficacy data H1 06 Frovatriptan: MRM regulatory submission H1 06 V10153: Completion of Phase IIa in stroke H1 06 V1003: Completion of Phase IIa (Reckitt Benckiser) H1 06 V24343: Start of Phase I in obesity and related disorders H2 06 Apokyn Half Yearly sales data H2 06

Company Summary

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XTLbio

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2006

Awaiting Final Results End of December

Company Summary

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York Pharma

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2006

YP006 New Abasol indication - Formulation validation ongoing and entering clinical development in 2006 Meeting with FDA regarding Abasol Abasol - filing in Japan and US H2

Company Summary

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ADAM - 26 Feb 2006 22:11 - 11 of 21

Mayo bounces back in biotech
By Danny Fortson

Published: 26 February 2006

John Mayo, the former chief executive of Marconi, is returning with a $500m (286m) venture to buy development-stage drugs orphaned by the cash-starved biotech industry.

Celtic Pharma, based in Bermuda but with offices in London and New York, is the only fund of its kind that focuses on buying drugs rather than companies. The firm trawls cash-starved biotech companies for promising late-stage drugs that it intends to shepherd through clinical development. The firm hopes that once the drugs get to approval it will be ableto sell them to big pharmaceutical groups.

"There is a capital drought in the biotech sector and a pipeline problem in the pharma sector," said Mr Mayo, the joint founder. "We're basically arbitraging those two conditions."

Mr Mayo, a former banker, helped demerge Zeneca from ICI and then moved to Marconi, where he led a disastrous acquisition spree. The other founder is Stephen Evans-Frekes, who sold his biotech company, Sugen, to Pharmacia, now Pfizer, for $720m in 1999.

Celtic expects to close its first $500m fund next month, and then plans to raise $500m in mezzanine funds to bring its available cash to $1bn.

Since June, the company has accumulated a portfolio of eight drugs and plans to acquire up to 20 in total. "Measured in that way, it would make us one of the biggest pharmaceutical companies in the world," said Mr Mayo.

The firm's first drug due for approval is a pain-relieving gel for osteoarthritis sufferers. Celtic says it could replace the $5bn in sales that evaporated after Merck's Vioxx was withdrawn and others in its class, such as Celebrex, were forced to add strong warnings to their labels.

The drug's approval in Switzer- land is expected next year and approval in major markets would come in 2008.


http://news.independent.co.uk/business/news/article347697.ece

ADAM - 05 Mar 2006 09:43 - 12 of 21

The results for month two of the competition are ready and due to a stong performance by a lot of the Biotechs invloved all players made gains on last months totals.

The sector as a whole provided a return of 0.48%.

See the individual company percentage gains and leaderboard here:http://www.ukbiotechs.com/phpbb/index.php?f=108

ADAM - 09 Apr 2006 08:30 - 13 of 21

Here is the latest Bio Challenge Results. Strong performances from Allergy Therapeutics
and Vectura and helped stem what turned out to be a very bad month for the sector
with ASM, OXB, PYM, PLE and YRK all losing substantial ground.

As usual here is the company summary with all the featured companies' 2006
gains to date: http://www.ukbiotechs.com/PercentageGains.htm


Here is the current leader board, Indalo losing a place with his choice of
OXB, which has come back since the begining of April and Dr Biotech gaining
on the back of other's misfortunes: http://www.ukbiotechs.com/Leaguetable.htm


You can enter the competition for free any time during the year, just choose
which combination of bios will give you the greatest return.

Enter Here!

ADAM - 05 May 2006 21:36 - 14 of 21

Have updated the Biotech Challenge Tables: http://www.ukbiotechs.com/phpbb/index.php?f=108

All the companies as a whole added 2.5% during April, mainly thanks to strong performances by Antisoma, Evolutec, Oxford Biomedica, Phytopharm and Vectura.

However the shine was taken off by continued falls of Acambis, CeNeS, Innovata, Proteome and York Pharma. Which meant that even after the great gains by those mentioned above the companies featured ended the year up until April down 1.76% (March -4.38%)

ADAM - 25 May 2006 21:59 - 15 of 21

Drug FDs seek biotech deals
Finance directors and pharmaceutical company boards have developed an interest in biotech companies

Nicholas Neveling, Accountancy Age, 25 May 2006

ADVERTISEMENTAstraZenecas recent move for small biotechnology company Cambridge Antibody Technology is the beginning of further acquisition activity in the sector, according to analysts.

Finance directors and pharmaceutical company boards have developed an interest in biotech companies, as it is often easier to buy in technology than develop new compounds in-house because of internal regulations.

'The pharma companies are a bit like oil tankers, in that they find it hard to change direction very fast. Its often easier to buy in a brand new piece of technology. It also gives them the ability to cut through bureaucracy,' said Brett Pollard, life sciences analyst at Numis.

The interest in biotechnology deals comes after a highly successful year for the sector, as it raised record amounts of capital and gained increased credibility.

According to Ernst & Youngs global biotechnology report, revenues in the sector grew 18% in 2005 to a record high of $63.1bn (33.7bn). Biotechnology also raised $19.7bn its highest level since the 2000 stock market bubble.

For UK FDs planning to dabble in the biotech market, however, there are a number of risks that need to be managed. The European market has been far less buoyant than in the US, raising only $4bn.

Pollard warned that raising capital to pursue takeover targets in the UK was a difficult task. He said it was much easier for US companies to access finance, which meant that UK FDs were under pressure because they had to raise capital every year.

We dont often set our companies up to be competitive on a global scale, because every 12 to 18 months a lot of the companies are having to come back to the market and do another road show, Pollard said. If you put that together with the interim preliminary results then they get less and less time to manage the companies.

http://www.accountancyage.com/accountancyage/news/2156930/drug-fds-seek-biotech-deals

ADAM - 05 Jul 2006 08:01 - 16 of 21

Viagra alternative on fast track for counter
By Katherine Griffiths

(Filed: 05/07/2006)

The development of the first treatment for impotence available without prescription is to be fast-forwarded under a deal between GlaxoSmithKline and Futura Medical.

Futura, which has been working on a gel for erectile dysfunction, yesterday said it had signed a deal with GSK, which will see the UK pharmaceuticals giant pay about 2.4m to fund 65pc of the drug's clinical development.

At the moment, the impotence market is dominated by prescription drugs such as Viagra, made by the world's largest drugs manufacturer, Pfizer.

GSK is set to run the development programme, which will involve up to three studies involving about 1,500 men.

The programme is expected to be completed in time for regulatory submissions in 2008, Futura said. The first clinical study is expected to start before the end of 2006.

Futura, which is listed on the junior Aim market, also intends to raise up to 2.5m after costs via a share placing.

GSK has been keen to increase its over-the-counter business. As well as small deals such as the one with Futura, it recently attempted to dramatically increase its presence in this market by buying Pfizer's portfolio of non-prescription brands.

http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2006/07/05/cnfutura05.xml&menuId=242&sSheet=/money/2006/07/05/ixcity.html

ADAM - 05 Jul 2006 08:01 - 17 of 21

Viagra alternative on fast track for counter
By Katherine Griffiths

(Filed: 05/07/2006)

The development of the first treatment for impotence available without prescription is to be fast-forwarded under a deal between GlaxoSmithKline and Futura Medical.

Futura, which has been working on a gel for erectile dysfunction, yesterday said it had signed a deal with GSK, which will see the UK pharmaceuticals giant pay about 2.4m to fund 65pc of the drug's clinical development.

At the moment, the impotence market is dominated by prescription drugs such as Viagra, made by the world's largest drugs manufacturer, Pfizer.

GSK is set to run the development programme, which will involve up to three studies involving about 1,500 men.

The programme is expected to be completed in time for regulatory submissions in 2008, Futura said. The first clinical study is expected to start before the end of 2006.

Futura, which is listed on the junior Aim market, also intends to raise up to 2.5m after costs via a share placing.

GSK has been keen to increase its over-the-counter business. As well as small deals such as the one with Futura, it recently attempted to dramatically increase its presence in this market by buying Pfizer's portfolio of non-prescription brands.

http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2006/07/05/cnfutura05.xml&menuId=242&sSheet=/money/2006/07/05/ixcity.html

ADAM - 05 Jul 2006 08:02 - 18 of 21

Report: Biotech losing its 'buzz'
By David Morrill, BUSINESS WRITER



A cooldown in deal making and investor interest has caused a downward slide in the biotechnology sector in the second quarter of this year, according to a report released Monday by a Bay Area-based life sciences firm.
Unlike last year, when the "buzz" that surrounded biotech was strong, investor confidence in biotech is now at a "low ebb," said life sciences firm Burrill & Co. of San Francisco.

"Biotech seems to be a victim of its own 2005 stellar success when the best-of-breed biotech companies led the charge and outperformed the markets by 22 percent by year-end," Steve Burrill, chief executive of Burrill & Co., said in a statement. "It appears that investors now believe that these companies are fully valued and have moved their attention to other sectors."

The downward slide was tempered slightly last week with news that Genentech Inc. received approval on the final day of the quarter from U.S. regulators for its age-related eyesight drug, Lucentis, Burrill said.

Still, despite the news, which helped raise shares of South San Francisco-based Genentech 2 percent in the month, Genentech shares were down 3 percent for the quarter and 12 percent in 2006, Burrill said.

For the quarter, the Burrill Biotech Select Index fell 18 percent, while the Nasdaq was down


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7 percent. All the news for the biotech sector isn't all bad, however, the report said.

"The traditional quiet summer months cannot come soon enough for biotech," Burrill said. "However, despite this rough patch on the capital markets, biotech remains in excellent shape and continues to develop innovative products, record clinical successes and announce scientific breakthroughs, and we expect to see biotech bounce back in the fall."

Deal making cooled after a strong first quarter of the year, Burrill said. Partnering deals totaled about $1.8 billion.

"The almost $6.5 billion raised in the first quarter was always going to be a hard act to follow and it is not surprising that the number of partnering deals would eventually level off," Burrill said.


"Nevertheless, the over $8 billion raised to date leads us to believe that partnership deals will generate at least $16 billion to $17 billion by the end of the year."

http://www.insidebayarea.com/business/ci_4010967

ADAM - 10 Aug 2006 08:42 - 19 of 21

Probe could mean headache for drug groups
By Stephanie Kirchgaessner and Christopher Bowe
FT.com

Published: August 8 2006 19:26 | Last updated: August 8 2006 19:26

The criminal investigation into Bristol-Myers Squibb and Sanofi-Aventis centres around the disclosure by a generic drugmaker that it had secured a verbal agreement with them over an authorised generic version of their blockbuster drug Plavix.

For regulators at the Federal Trade Commission, last months revelation by Canadas Apotex, which has been fighting to enter the market for Plavix, was significant enough to alert criminal investigators at the Department of Justice.

Just a few days later, having secured a warrant from a judge, the FBI raided the offices of the chief executive and another senior officer at Bristol and sent subpoenas to the offices of Sanofi. The companies jointly market Plavix, the worlds second-biggest selling drug.

The companies involved in the probe have not been charged with wrongdoing. But a person familiar with the investigation says prosecutors are examining whether Bristol-Myers and Sanofi sought to arrange a side agreement with Apotex in order to secure regulatory approval of a legal settlement both companies knew was out of favour with the FTC, but was critical to their profits.

For investors, the legal wrangling over the future of Plavix appeared to have ended last March, when Bristol-Myers and Sanofi announced that they had agreed what is known as a reverse settlement with Apotex. Although such settlements are legal, they are heavily scrutinised by the FTC, which has argued that they are anticompetitive, particularly when they include payments to delay generic competition for a blockbuster drug.

Under the terms of the deal, Apotex would abort its legal challenge to the companies patent for Plavix for reimbursement payments of at least $40m.

It also allowed it to launch a cheaper generic version of Plavix almost a year before the blood thinners maximum patent lifespan expired in mid-2012.

What was not disclosed at the time was that the two companies also promised not to launch their own generic version of Plavix to compete with Apotexs generic.

Such authorised generics are increasingly being launched by branded drug companies as a way to counter generic threats. By launching their own low-priced generic drugs, the companies aim to discourage and punish generic rivals.

For Plavix with more than $4bn in US sales this year the provision could have secured Apotexs eventual significant and lucrative revenue stream against price competition from a Bristol and Sanofi generic.

A person familiar with the probe said Bristol-Myers took the authorised generic provision out of its agreement and resubmitted the deal to the FTC in June in the hopes of addressing some of the FTCs early concerns with the agreement.

But the disclosure by Apotex, at the same time, that it had secured a verbal agreement that, in effect, kept the provision alive, prompted the FTC to involve criminal authorities in the probe.

One attorney familiar with the pharmaceutical market said it would be difficult for any criminal prosecutor to prove such an agreement existed without written evidence.

Bristol has said its conduct has been entirely appropriate and that it was co-operating fully with the investigation.

But the probe nevertheless raises the spectre of continued, if not significantly threatening, legal problems for Bristol. The group has expended enormous energy to put behind it a series of legal problems, ranging from shareholder litigation over failed heart drug Vanlev to a federal criminal investigation into an accounting scandal.

Last year the group entered into a deferred prosecution agreement with the US attorneys office in New Jersey to help settle allegations that Bristol manipulated wholesaler inventories of its drugs artificially to boost profits.

Under the agreement, Bristol pledged to abide by strict corporate governance provisions for two years.

The agreement included Peter Dolan, chief executive, relinquishing his role as chairman of the company, a $300m payment to shareholders and the installation of an independent corporate monitor. The monitor, former federal judge Frederick Lacey, did not return calls for comment.

But the prosecution could be reinstated if Bristol is found to have committed any criminal conduct.

The US attorneys office in New Jersey said it was watching the ongoing investigation by the antitrust division of the Department of Justice closely.

Bristol yesterday said it was not possible to assess the impact, if any, of the pending criminal investigation on the deferred prosecution agreement

ADAM - 26 Oct 2006 12:53 - 20 of 21

I have updated the Biotech Percantage Gain Table here. Sorry for the delay but recently I haven't had the time .

Overall the total percentage gain for the companies listed above is -9% YTD.

http://www.ukbiotechs.com/PercentageGains.htm

ADAM - 03 Dec 2006 10:29 - 21 of 21

Competition

Under a month to go and all change at the top of the Biotech Challenge Leader Board.

After leading for most of the year disappointing performances from PTI and AZM have dragged my score down and I am currently now in 3rd place!

http://www.ukbiotechs.com/Leaguetable.htm

Only an outstanding recovery by AZM will save me now.

Also it is nearly time to update the UKBiotechs table for 2007 and I was wondering how many people were find this thread of use as it takes quite a lot of time and effort.

Also the UKBiotechs website is up for renewal soon and I would like to know whether people are using that site as well.
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