ACZ885: new biological drug in development shows potential in treating serious life-long autoinflammatory diseases

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ACZ885, a new biological drug in development, shows potential in treating

serious life-long autoinflammatory diseases

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al+drug+in+development,+shows

Patients with inherited autoinflammatory conditions achieved long-lasting

remission after treatment with ACZ885[1,2] * Human monoclonal antibody

ACZ885 blocks interleukin 1ß, a key chemical messenger that causes

inflammation and tissue destruction * Autoinflammatory diseases produce

symptoms such as fever, joint pain and skin rash and can lead to severe

complications * ACZ885 also being investigated for rheumatoid arthritis

using innovative personalized approach to treatment

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announcement processed and transmitted by Hugin ASA.The issuer is solely

responsible for the content of this announcement. * Patients with inherited

autoinflammatory conditions achieved long-lasting remission after treatment

with ACZ885[1,2] * Human monoclonal antibody ACZ885 blocks interleukin 1ß, a

key chemical messenger that causes inflammation and tissue destruction *

Autoinflammatory diseases produce symptoms such as fever, joint pain and

skin rash and can lead to severe complications * ACZ885 also being

investigated for rheumatoid arthritis using innovative personalized approach

to treatment * Patients with inherited autoinflammatory conditions achieved

long-lasting remission after treatment with ACZ885[1,2] * Human monoclonal

antibody ACZ885 blocks interleukin 1ß, a key chemical messenger that causes

inflammation and tissue destruction * Autoinflammatory diseases produce

symptoms such as fever, joint pain and skin rash and can lead to severe

complications * ACZ885 also being investigated for rheumatoid arthritis

using innovative personalized approach to treatmentBasel, April 8, 2008 -

New data demonstrate that ACZ885, a humanmonoclonal antibody in Phase III

development, achieves long-lastingclinical remission in patients with

genetic autoinflammatorydiseases[1,2].The results indicate that ACZ885 could

develop into a majortherapeutic advance in the treatment of

Cryopyrin-Associated PeriodicSyndromes (CAPS), a group of rare but serious

life-long diseasesincluding Muckle Wells Syndrome[3].In the Phase II study,

CAPS patients treated with ACZ885 showed animprovement in symptoms within

one day and all achieved completeclinical remission within seven days[1].

Clinical remission lasted115 days on average[1].

The results were presented today at the FifthInternational Congress on

Familial Mediterranean Fevers and SystemicAutoinflammatory Diseases in

Rome. " The latest findings are a promising step forward for patients withrare

autoinflammatory diseases, " said Trevor Mundel, MD, Head ofGlobal

Development Functions at Novartis Pharma AG. " We areoptimistic that ACZ885

could become an innovative treatment optionfor patients affected by

inflammatory diseases involving IL-1ß.ACZ885 reflects our commitment to

developing innovative treatmentsthat address unmet medical needs, in

patients with serious but rareconditions. " ACZ885 is also being investigated

in more common inflammatorydiseases such as rheumatoid arthritis (RA), which

affects up to 1% ofthe world's population[4]. A study in RA currently under

way uses aninnovative tailored approach with biomarkers to predict response

totreatment. If successful, this will give suitable patients apersonalized

approach to treating their disease.Unlike other agents, ACZ885 blocks solely

interleukin 1ß (IL-1ß), oneform of interleukin-1 protein that causes the

body to 'attack' itselfin autoinflammatory diseases such as CAPS. Patients

affected by CAPShave symptoms such as fever, fatigue, skin rash, painful

joints andmuscles, and severe headache. They can also suffer from more

severecomplications like hearing loss and amyloidosis, a group of diseasesin

which some organs accumulate high deposits of proteins causingkidney failure

and leading to dialysis or transplantation[3].The study results presented in

Rome involved 20 patients with CAPSaged between six and 50 years, who

received an injection of ACZ885every two months dosed at 150 mg for adults

or two mg per kilobody-weight for children[1,2]. ACZ885 was well-tolerated

in thestudy, with only mild skin reactions at the injection site. The

mostcommon adverse events were upper respiratory tract

infections[2]. " Traditional drugs for autoinflammatory diseases, which work

bysuppressing the immune system as a whole, are not always effective,while

newer therapies control the disease better but areshort-acting, " said

Professor Philip Hawkins of the NationalAmyloidosis Centre at the Royal Free

and University College MedicalSchool, London. " The data for ACZ885 are

exciting for the medicalcommunity as symptoms disappeared within a few days

of treatment andthe response was sustained, so patients may only need to be

treatedevery second month. " The potential of ACZ885 is reflected in its broad

developmentprogram. In addition to the Phase III study program in CAPS and

thePhase II study in rheumatoid arthritis, a Phase II study is alsoongoing

in another condition called Systemic Onset JuvenileIdiopathic Arthritis

(SJIA).Orphan drug status has already been granted to ACZ885 in the

EuropeanUnion and US for treating CAPS, and in the EU for SJIA. Orphan

drugsare those designed to treat serious or life-threatening

diseasesaffecting less than 200,000 people (in the US)5 or less than five

outof 10,000 people (in the EU)[6].DisclaimerThe foregoing release contains

forward-looking statements that can beidentified by terminology such as " in

development " , " potential " , " can " , being investigated " , " could " , " promising " ,

" optimistic " , " commitment " , " will " , " may " , or similar expressions, or by

express orimplied discussions regarding potential marketing approvals

forACZ885 or regarding potential Future revenues from ACZ885.

Suchforward-looking statements reflect the current views of the

Companyregarding future events, and involve known and unknown

risks,uncertainties and other factors that may cause actual results

withACZ885 to be materially different from any future results,performance or

achievements expressed or implied by such statements.There can be no

guarantee that ACZ885 will be approved for sale inany market. Nor can there

be any guarantee that ACZ885 will achieveany levels of revenue in the

future. In particular, management'sexpectations regarding ACZ885 could be

affected by, among otherthings, unexpected clinical trial results, including

unexpected newclinical data and unexpected additional analysis of existing

clinicaldata; unexpected regulatory actions or delays or

governmentregulation generally; the company's ability to obtain or

maintainpatent or other proprietary intellectual property

protection;competition in general; government, industry and general

publicpricing pressures, and other risks and factors referred to inNovartis

AG's current Form 20-F on file with the US Securities andExchange

Commission. Should one or more of these risks oruncertainties materialize,

or should underlying assumptions proveincorrect, actual results may vary

materially from those anticipated,believed, estimated or expected. Novartis

is providing theinformation in this press release as of this date and does

notundertake any obligation to update any forward-looking

statementscontained in this press release as a result of new

information,future events or otherwise.About NovartisNovartis AG provides

healthcare solutions that address the evolvingneeds of patients and

societies. Focused solely on growth areas inhealthcare, Novartis offers a

diversified portfolio to best meetthese needs: innovative medicines,

cost-saving genericpharmaceuticals, preventive vaccines and diagnostic

tools, andconsumer health products. Novartis is the only company with

leadingpositions in these areas. In 2007, the Group's continuing

operations(excluding divestments in 2007) achieved net sales of USD

38.1billion and net income of USD 6.5 billion. Approximately USD 6.4billion

was invested in R & D activities throughout the Group.Headquartered in Basel,

Switzerland, Novartis Group companies employapproximately 98,200 full-time

associates and operate in over 140countries around the world. For more

information, please visithttp://www.novartis.com.References[1.] Lachmann

H.J. et al. Treatment of cryopyrin associated periodicfever syndrome with a

fully human anti-IL-beta monoclonal antibody(ACZ885): results from a

subcutaneous administration study, oralpresentation at FMFSAID, April 8

2008, Rome, Italy.[2.] Kuemmerle-Deschner J.B. et al, Long lasting response

to ACZ885in patients with Muckle-Wells Syndrome, oral presentation at

FMFSAID,April 8 2008, Rome, Italy.[3.]

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