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[crystalclear] 17/6/2005 19:35

Thanks Matthu!

[matthu] 17/6/2005 05:55

An early stage RA indication for Humira would prove a major boost to Abbott.
(and CAT!)


16 Jun 2005, 17:44 GMT - Abbott's Humira plus methotrexate has been shown to inhibit joint damage in rheumatoid arthritis (RA) for up to two years, as well as demonstrating positive effects on quality of life in recent psoriatic arthritis trials. Although competition in RA remains intense, this data will cheer Abbott as it reinforces Humira's blockbuster potential.

Abbott's Humira (adalimumab) was first launched in 2002 and is currently indicated for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in moderate-to-severe RA.

A two year study carried out by Abbott, named PREMIER, showed that, at two years, 59% of the patients on the combination therapy achieved the American College of Rheumatology (ACR) 50 endpoint, making this the first RA study to meet ACR 50 as a primary endpoint.

Abbott's psoriatic arthritis trial (ADEPT), meanwhile, generated a positive result in improving quality of life for moderate-to-severe psoriatic arthritis patients. At 24 weeks, 58% of patients achieved ACR 20 endpoint, compared to 14% of patients treated with placebo.

If an early stage RA indication is approved, Humira in combination with methotrexate (MTX) will be the first fully human monoclonal antibody to enter the market for the treatment of early stage RA and psoriatic arthritis, increasing the number of patients to whom the drug is currently available.

The RA biologics market is currently dominated by Amgen/Wyeth's Enbrel and Centocor's Remicade, while a close rival in the RA pipeline is the autoimmune suppressant drug Rituxan, marketed by Genentech, Biogen Idec and Roche.

Rituxan, also a monoclonal antibody, is currently indicated for non-Hodgkin's lymphoma but clinical studies have revealed its potential in RA. Results from a phase IIa study of Rituxan plus MTX in moderate-to-severe RA suggest that, if approved in this indication, Rituxan could prove a worthy contender to rival Humira.

Although competition from the likes of Rituxan may prove fierce, an early stage RA approval for Humira will be a clear fillip for Abbott. In February 2005 Abbott upgraded the drug's sales forecast, predicting global revenues of $1.3 billion for this year. This blockbuster potential underlines Humira's key role within Abbott's portfolio. Furthermore, an expanded indication would also allow Abbott to bounce back from a multi-million dollar lawsuit over the drug with its co-discoverer, Cambridge Antibody Technology, reinforcing Abbott's position in the big pharma sector.

[matthu] 31/5/2005 16:22

1459 GMT [Dow Jones] Cambridge Antibody (CATG) +3.2% at 614.25p. Analyst says stock is attracting buyers following the sharp losses since the beginning of the year. "There a few more people that feel the company is now looking good value at these levels so don't be surprised to see some more upside," he adds. (DWE)

"stock is attracting buyers?" only 195 k traded so far today, so it seems the stock is still off most investors' radar. However, maybe the price has been marked up in anticipation of buyers, following which the share has been tipped!

[matthu] 31/5/2005 12:59

Numerous very small trades (12 shares at a time) going through today, and the price is slowly being marked up.

[matthu] 17/5/2005 21:58

The market's initial reaction to CAT's interims was negative, but the clawback today suggests that analysts will come to realise that the action was not a signal of financial distress but rather a strategic decision that will improve the company's long-term financial flexibility and prospects for growth.

[matthu] 17/5/2005 21:55

New Phase III data on Crohn's as an additional indication for Humira:


New Phase III Data Shows Nearly Four Out Of Five Crohn's Patients Responded To Treatment With Abbott's HUMIRA(R) (Adalimumab)

One in Three Study Patients Achieved Clinical Remission after 24 weeks of HUMIRA Therapy

CHICAGO, May 16 /PRNewswire-FirstCall/ -- Patients with moderate to severely active Crohn's disease treated with HUMIRA® (adalimumab) saw continuing improvements in clinical response and clinical remission, according to results from a new Phase III study presented for the first time today at the Digestive Disease Week (DDW) annual meeting.

After 24 weeks, 78 percent -- or nearly four out of five -- patients who completed HUMIRA open label treatment saw improvement in their disease, as measured by a decrease of more than 70 points from baseline in their Crohn's Disease Activity Index (CDAI). Of the 220 patients enrolled in the trial, one in three (33 percent) achieved clinical remission, defined as CDAI of less than 150.

CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, level of general well-being and other measures.

"Crohn's disease is a serious and often disabling illness. The fact that 75 percent of people with the disease will at some time require surgery indicates the importance of finding treatments that may induce sustained response and remission," said William J. Sandborn, M.D., Inflammatory Bowel Disease Clinic, Division of Gastroenterology and Hepatology, Mayo Clinic and Mayo Medical School, Rochester, Minn. "These new data are promising because patients not only showed clinically meaningful improvement during the six- month study, but their response continued to improve over time."

Crohn's disease is a serious chronic and inflammatory disease of the gastrointestinal (GI) tract that affects approximately 500,000 Americans and is typically diagnosed before age 30. Common symptoms of the disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Currently, there is no cure for Crohn's disease, making suppression of inflammatory response the goal of treatment.

The CLASSIC II Study

CLASSIC II (CLinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's) was an extension of the CLASSIC study, a randomized, double-blind, placebo-controlled, multi-center study. CLASSIC II was designed to evaluate long-term efficacy and safety of HUMIRA in patients with moderate to severely active Crohn's disease.

The trial included 220 patients who had participated in the original CLASSIC study but were not in remission at week 0 and week 4 of CLASSIC II. The standard dose for this cohort was open-label treatment with 40 mg of HUMIRA every other week (eow), the same recommended dose used for HUMIRA in rheumatoid arthritis. Patients experiencing flares or persistent non-response to the standard dose were given 40 mg of HUMIRA every week. Of the 220 patients entering the study, 33 percent achieved clinical remission. Of the 156 patients completing 24 weeks of therapy, 78 percent achieved a response, with a decline in CDAI of at least 70 points, and 70 percent achieved a CDAI decline of at least 100 points, compared to their baseline CDAI scores in CLASSIC.

The adverse events in the study were mild to moderate in severity and similar to those observed in previous studies with patients with rheumatoid arthritis. The most common serious adverse events were exacerbations of Crohn's disease and infections.

"Patients with Crohn's disease are seeking out treatments that can help them regain control of their lives," said Rebecca Hoffman, M.D., divisional vice president for Immunology Development at Abbott. "These Phase III study results are encouraging, and reinforce our confidence in HUMIRA."

[matthu] 17/5/2005 15:56

It's worth bearing in mind that the published interim results do not (yet) include the increased level of royalty on Humira. From the results:

Royalty income of £5.2 million was recognised as revenue in the period representing the two per cent royalty rate argued by Abbott on sales of HUMIRA for the six months ended 31 December 2004, received in March 2005.

Further details are provided in the notes to the financial information.

The payment by Abbott of royalty arrears and other related payments pursuant to the High Court Judgment are not reflected in these results. Pending resolution of Abbott's appeal, the royalty arrears payment and royalty receipts in excess of the two per cent rate argued by Abbott will not be recognised as revenue. Similarly, amounts received in respect of CAT's costs will not be recognised until the resolution of Abbott's appeal.

So of $48.7m royalty and back-dated royalty received, only $9.7m has been recognised in the profit and loss as revenue, and $39m has been taken to creditors, and all of the $6.7m costs and interest received has also has been taken directly to creditors.

So the results will improve considerably (assuming Abbott loses the appeal).

[matthu] 17/5/2005 15:33

CAT's share price seems to be recovering marginally. Perhaps investors are swinging round more to the following point of view:


Bio firm the CAT's whiskers
By John Fenton, 17 May 2005
Cambridge Antibody Technology looks on course for significant long-term growth on the strength of its results for the six months to the end of March and upbeat forecasts on several drug development fronts.

The foundations for growth have been built on the balance sheet where CAT has net cash and liquid resources of £178.2m and a substantial and increasing revenue stream from HUMIRA royalties.

A diverse pipeline of licensed antibody product candidates offers good prospects for expansion in the medium term with no financial cost to CAT as these programmes progress through the clinic; notably ABT-874, LymphoStat-B and HGS-ETR1.

Major opportunities for the longer term are provided by CAT's proprietary programmes which, though at an early stage of development, are progressing: CAT-354 in a Phase I clinical trial and GC-1008 expected to enter Phase I trials this year, together with potential products resulting from the strategic alliance with AstraZeneca.

The AstraZeneca collaboration provides CAT with the opportunity both to build a significant pipeline of antibody therapeutics in important diseases in collaboration with a leading pharmaceutical company and to receive financial returns commensurate with its level of investment.

As part of the AstraZeneca Alliance, CAT is committed to supporting and funding half of a minimum of 25 discovery programmes, jointly initiated, over the initial five-year discovery phase. This investment is fully funded by the £75 million equity injection from AstraZeneca made in December 2004.

CAT has the opportunity to invest in the clinical development of selected candidates that result from the joint discovery programmes and to thereby increase potential returns.

All CAT's activities, excluding later stage product development, will either be pre-funded (as with the AstraZeneca discovery activities) or funded from revenues. This will ensure that the business is effectively self -financing up until the demonstration of efficacy in clinical trials.

The company believes it can hit all its growth targets within three years and without growing headcount.

CAT will continue to seek acquisition or product in-licensing opportunities where it is believed they can accelerate the development of the company without increasing its risk profile.

CAT cut its loss after tax to £16.3 (£18 million). Turnover was £9.8m (H1- £8.5m; H2 - £7.4m).

[matthu] 17/5/2005 14:20

Human Genome Sciences Reports Results Of Phase 1 Clinical Trials of HGS-ETR2 and HGS-ETR1 In Patients With Advanced Solid Tumors
Tuesday May 17, 7:15 am ET

Results presented at ASCO provide support for further evaluation in Phase 2 clinical trials -

ROCKVILLE, Md., May 17 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - News) announced today that the results of ongoing Phase 1 clinical trials demonstrate that HGS-ETR2 and HGS-ETR1 are well tolerated in patients with advanced solid tumors, and support further evaluation of each of the novel drug candidates in Phase 2 trials. The results were presented at the 2005 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida.

(HGS-ETR2 and HGS-ETR1 were made in a collaboration between Human Genome Sciences and Cambridge Antibody Technology)

[matthu] 17/5/2005 06:16

Cambridge Antibody to miss earnings goal
DAVID BLACK

CAMBRIDGE Antibody Technology, the biotech group, will fail to reach profitability in 2008 as management had forecast. However, an increasing flow of royalty payments has narrowed its first-half losses.

The group said yesterday its net loss in the six months to 31 March was £16.3 million, down from a loss £17.9m in its previous year. Revenue was up 16 per cent at £9.8m.

Shares in Cambridge have dropped 22 per cent this year after it stopped work on its most advanced experimental product, the glaucoma medicine Trabio.

The company is now depending on payments from partners including AstraZeneca and Abbott Laboratories to help reach profitability.

Chief executive Peter Chambre said: "Within three years, we expect to be in a sustainable position, but to set a goal of profitability will limit investment."

Robin Campbell, an analyst at Jefferies International, said: "The overriding negative that people are going to focus on is not reaching a profit by 2008."

AstraZeneca, the UK's second-largest drug-maker, bought a 20 per cent stake in Cambridge Antibody in November. The two companies are working together on treatments for inflammatory diseases.

Cambridge's shares closed down 2.5 per cent last night, at 565p. Numis analyst Robin Gilbert, in a note to investors, increased his price target on the stock to 550p from 500p, with a "hold" recommendation.

[matthu] 17/5/2005 06:12

Cambridge Antibody

IT IS a bold move for the head of a fledgeling biotechnology company to abandon a strategy that would see the business turn a profit within three years. So Peter Chambre, chief executive of Cambridge Antibody Technology, is asking a lot of his shareholders to accept that the drugs maker will not now, as previously intimated, be basking in the black by 2008.

Instead, CAT will focus all its energies on a research tie-up with AstraZeneca. The inference behind yesterday's guidance is that somewhere within the 25 compounds that the two companies expect to develop over the next five years are enough billion-dollar sellers to set the world alight.

After spending months in the High Court trying to settle a royalties dispute with Abbott, a US partner with whom it developed an arthritis drug called Humira, CAT quite rightly wants to keep as much upside as possible next time it finds a blockbuster medicine. But herein lies the rub. CAT specialises in developing new treatments from antibodies - compounds that help to stimulate the immune defences when the body comes under attack. The science is relatively safe, but not always effective: while Humira is on course to generate peak annual sales of up to $2 billion, two additional anti-scarring drugs failed crucial tests when CAT took them into the clinic.

CAT's shares slipped 14½p to 565p yesterday on the dawning realisation that the new-look strategy represents a leveraged play on the AstraZeneca research deal. These are early days and, so far, the partners have identified just one compound to fold into the partnership. It will be years before any worthwhile news starts flowing out of the research lab and at least a decade before the company nets any meaningful revenues from the arrangement.

But there is a safety net. CAT should eventually make about $60 million a year in royalties from Humira, provided its lawyers can see off an appeal from Abbott. That may not offer much comfort to shareholders who would rather see the management pursue profitability with more urgency. Avoid.

[matthu] 16/5/2005 10:59

weemonkey> yes, if you look at the history of virtually any biotech you would expect years of losses (and sometimes these companies disappear entirely). Is CAT likely to disappear within the next five years? No. It has sufficient cash and R&D funding to see it survive for many years.

If it's immediate dividends you're after, you would invest in a pharmaceutical company, wouldn't you?

But if you look at CAT's current list of licensees (including Abbott, Amgen, Chugai, Genzyme, Human Genome Sciences, Merck & Co, Pfizer and Wyeth Research), you consider the success of Humira (the biggest single earner for Abbott in its entire 115 year history, and Abbott is one of the ten biggest pharmas in the world) and you then consider the latest investment and future funding by AstraZeneca, you begin to realise that a lot of clever people would disagree with you about the future prospects of CAT.

This is a business for patient investors, with the prospect of considerable upside.

Following a successful outcome in the appeal (expected sometime between Nov 2005 to Feb 2006) there will be no looking back.

[weemonkey] 16/5/2005 10:45

this is not a business

this is a money pit

nothing but losses since 1995

[matthu] 16/5/2005 10:40

0817 GMT [Dow Jones] Cambridge Antibody Technologies (CATG) updates on drugs, decision to drop its 2008 profitability target. Dropping target is no big surprise, says John Senior of Evolution Securities. "Everybody pretty much worked that out," given company announced suspension of trials for Trabio in March. Maintains reduce rating. However, shares -2.5% at 565p, given further hit to sentiment within the sector.

[crystalclear] 13/5/2005 19:42

You are reminding us a bit late matthu, but I bought in a week or two ago. As I said a month or two ago, these should be the first results showing income at 5% rather than 2%. So ordinarily, the income for the 6 months should beat the income from the same period the year before by about 2 1/2 times. But if sales of Humira are significantly higher than the year before then things could well be much better than that. I'd expect the sales to grow substantially: as you said, this is an outstanding drug and its not mature in its market yet.

On top of that, low income doesn't cover running costs, whereas profitabilty indicates expansion or a return for shareholders, so there could be a leverage effect too.

Shame I'm too mean and frightened by the market to be more fully invested ;)

[matthu] 13/5/2005 17:01

don't forget - interim results expected 07:00 Monday.

[matthu] 11/5/2005 17:20

Finalists Announced For the Fourth Annual Pharmaceutical Achievement Awards

Outstanding Biologic Drug Product Award
Genentech Inc.: Avastin
Imclone Systems, Inc & Bristol-Myers Squibb Co.: Erbtiux
Abbott Laboratorie: Humira

Business Development Deal of the Year
AstraZeneca and Cambridge Antibody Technology
Pfizer, Inc. and Medarex
Theravance and GlaxoSmithKline

[matthu] 06/5/2005 09:30

ASTRAZENECA'S VIEW OF EVOLVING ALLIANCESThe Executive Director of AstraZeneca's


Global Licensing told an LES
Plenary Session audience on Thursday that there are good times ahead for
biotech operatives looking for alliances with major pharmaceutical companies.Dr. Roger Lloyd is the architect for AstraZeneca's strategic partnering,
including a recently announced research and development alliance with
Cambridge Antibody Technology. Lloyd offers the following advice in today's
alliance environment: -- Partnering is an increasingly competitive arena
-- At the moment, it is a seller's market for biotech developers
-- Never has the biotech industry had so much power
-- Don't be afraid to ask. You might be surprised with what you get
Floyd also offered a cautionary note, pointing out that about 50 percent
of alliances eventually fail, according to the Harvard Business Review. He
said, "This just means we have to work all that much harder to make them
work."

[matthu] 19/4/2005 17:31

Looks like competition?



Cell Genesys, Inc. scientists reported today the development of a proprietary gene expression technology that enables the production of full-length monoclonal antibodies at commercially relevant levels from a single production cell line. Moreover, the time required to develop cell lines that can be used for commercial production can be significantly shortened from months to weeks. This novel technology, which employs adeno-associated viral (AAV) or other viral-based genetic engineering and a unique genetic linkage, may have broad application in commercial scale production of monoclonal antibodies and other complex therapeutic proteins, as well as in the long-term administration of therapeutic antibodies to patients. Cell Genesys scientists, led by Drs. Jianmin Fang and Karin Jooss, reported this work in the April 17 on-line issue of the journal, Nature Biotechnology.

"We believe our proprietary gene expression technology represents a significant improvement over currently available production technologies for therapeutic antibodies and other complex proteins," stated Peter K. Working, Ph.D., senior vice president of research and development. "While this exciting scientific accomplishment lies outside of our current business focus, we plan to generate value from our research and intellectual property through strategic licensing arrangements with other biotechnology and pharmaceutical companies."

Monoclonal antibodies have become important therapeutic agents for the treatment of cancer, arthritis, infection, and other serious diseases. The gene expression technology reported here may be of particular value for the production of stable antibody-producing cell lines. Current antibody manufacturing technologies can be both labor intensive and time consuming. This new technology enables rapid development and identification of single cell lines producing commercially relevant levels of biologically active monoclonal antibodies which could result in expedited and lower cost development, potentially saving as much as a year in overall development time. Moreover, recent experimental results indicate that the production levels achieved with the technology may be more than double those achieved with conventional technologies. Importantly, this gene expression technology can potentially provide the same advantages to the production of therapeutic protein products, including those comprised of multiple subunits or polypeptide chains, such as Factor VIII, a blood clotting factor, as well as chimeric proteins such as TNF-alpha IgG (infliximab).

In addition to the manufacturing application, the new gene expression technology has the potential benefit in the long-term delivery of therapeutic antibodies, which are currently administered by repeated injection into patients. Chronic diseases such as cancer and arthritis may require long-term and repetitive antibody treatment regimens. An alternative approach for cost-effective delivery of therapeutic antibodies is to express the antibodies in vivo (in the body) following gene transfer. Cell Genesys scientists demonstrated in the above-mentioned publication that this technology resulted in continuous expression of biologically active monoclonal antibodies at high concentrations in vivo for over four months and that such treatment has significant anti-tumor activity in preclinical tumor models.

Cell Genesys has several pending worldwide patent applications directed to this gene expression technology.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX® cancer vaccines and oncolytic virus therapies. Clinical trials of GVAX® cancer vaccines include an ongoing Phase 3 trial of GVAX® vaccine for prostate cancer as well as trials of GVAX® vaccines for leukemia, pancreatic cancer, lung cancer and myeloma. Clinical programs of oncolytic virus therapies currently include CG7870 for prostate cancer. Cell Genesys continues to hold equity interests in two former subsidiaries -- Abgenix, Inc., an antibody products company and Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at