Remicade Two Year Data in Ankylosing Spondylitis Show Improvement,in Spinal Mobility and Spinal Infl

Findings from the ASSERT Trial Presented at EULAR

BARCELONA, Spain, June 15, 2007 /PRNewswire-FirstCall/ -- Datapresented today at the European League Against Rheumatism (EULAR)Annual European Congress of Rheumatology showed that patients withankylosing spondylitis (AS) who received remicade(R) (infliximab)over two years experienced significant improvement in spinalmobility. In addition, remicade-treated patients showed sustainedreductions in spinal inflammation through two years as detected bymagnetic resonance imaging (MRI).

The recommended dose of remicade in AS is 5 mg/kg given as an IVinduction regimen at 0, 2 and 6 weeks followed by a 5 mg/kgmaintenance regimen every 6 weeks in the United States or every 6-8weeks in the European Union.

AS is a progressive rheumatic disease that leads to inflammationof the back, resulting in pain, stiffness and reduced mobility,which in advanced cases can result in fusion of the vertebrae ofthe spine ('ankylosis'). Data collected from 279 patients with ASas part of the ankylosing spondylitis Study for the Evaluation ofRecombinant Infliximab Therapy (ASSERT) trial were analyzed todetermine the long-term effect of remicade on spinal mobility. Thedouble-blind extension of this 24-week placebo-controlled studyutilized the Bath ankylosing spondylitis Metrology Index (BASMI)and chest expansion measurements to assess range of motion inpatients with AS.

Patients in ASSERT were treated and assessed at six weekintervals through week 102. According to the findings, comparedwith placebo group (N=78), at week 24 the remicade-treated patients(N=201) had a greater improvement in BASMI (defined as a change ofat least 1 in the BASMI score) scores (-0.7 vs. -0.2, respectively;P = 0.02), and in percent change in chest expansion (44 percent vs.19 percent, respectively, P = 0.03). Fifty-one percent ofREMICADE-treated patients vs. 31 percent of placebo-treatedpatients achieved a clinically meaningful improvement in BASMI (P< 0.01). The improvement seen at week 24 was maintained throughweek 102 in those patients who continued in the trial extension(N=161). Furthermore, after crossing over to receive treatment withREMICADE at week 24 following initial treatment with placebo,patients experienced similar improvements in BASMI and chestexpansion scores as patients in the remicade group at weeks 54, 78and 102.

"Ankylosing spondylitis can limit spinal mobility andsignificantly impair a patient's quality of life. These datademonstrate that treatment with remicade improved spinal mobility.Over time, this improvement can be maintained when remicade iscoupled with physiotherapy," said Professor Jurgen Braun, M.D.,lead physician at the Rheumazentrum Ruhrgebiet and Professor ofRheumatology at the Free University of Berlin. "In studying thesame group of patients, remicade therapy also had a positive effecton spinal inflammation, a common and debilitating manifestation ofankylosing spondylitis."

In ASSERT spinal inflammation as detected by MRI was examined.Patients receiving remicade showed improvement in MRI Activityscores at week 24, which was sustained through week 102 in thosepatients who continued in the trial extension (N=161). Patientsinitially in the placebo group showed no change in MRI Activityscores at week 24, but scores improved after crossing over toreceive treatment with remicade. The relationship of spinalinflammation as measured by activity scores on MRI to long-termstructural damage in AS is unknown.

About ASSERT

In ASSERT (Ankylosing spondylitis [AS] Study for the Evaluationof Recombinant Infliximab Therapy), 279 patients with AS for atleast three months, radiographic evidence of sacroiliitis andsymptoms of active disease (BASDAI of at least 4 and visual analogscale for spinal pain of at least 4, each on a scale of one to 10)were randomized to receive infusions of remicade 5 mg/kg at weeks0, 2 and 6 and every six weeks thereafter through week 96 (n = 201)or placebo (n = 78). The primary endpoint of the trial was a 20percent decrease in disease activity score on the Assessment inAnkylosing spondylitis Response Criteria (ASAS 20) at week 24.

At week 24, placebo patients were crossed over to receivetreatment with remicade 5 mg/kg at weeks 0, 2 and 6 and every sixweeks thereafter and continued on remicade through the remainder ofthe study (96 weeks). Starting at week 36, and continuing throughweek 96, patients initially randomized to receive remicade 5 mg/kghad their dose increased to 7.5 mg/kg if they had a BASDAI of atleast 3 in two consecutive evaluations to assess the potential forimproved response through increased dosing. Using these ratherstrict criteria, 106 patients (53 percent) received a dose increasesome time after week 30.

Nine percent of patients who received remicade through week 102discontinued the study due to adverse events (AEs). During thestudy, remicade was generally well-tolerated. At week 24, the mostcommonly reported AEs were upper respiratory tract infections,which occurred at a rate of 15 percent in the placebo group,compared with 14 percent in the remicade group. The only laboratoryabnormalities that occurred more frequently with remicade comparedwith placebo were asymptomatic liver enzyme test elevations. Atweek 24, serious (AEs) were reported in 4 percent ofREMICADE-treated patients, compared with three percent of patientsreceiving placebo. AEs were generally mild and were consistent withREMICADE prescribing information.

There were no reports of congestive heart failure, tuberculosisor serious infections in the study population. Three malignancieswere reported in three patients during the ASSERT study andincluded squamous cell skin cancer, lung cancer and breast cancer.Please see "Important Safety Information" below.

About Ankylosing spondylitis

AS is a painful and progressive form of spinal arthritis andsymptoms of inflammatory back pain often first present in peoplebefore age 35. It typically begins in the late teens and earlytwenties and in severe cases may result in fusing spinal vertebraeand may cause structural damage to hips and other joints. Oftenmisdiagnosed as "just back pain" or undifferentiated arthritis, ASis a systemic inflammatory disease that, in addition to its effecton the spine, can affect internal organs, peripheral joints andvision. The Arthritis Research Campaign, estimates that on theEuropean continent, AS prevalence ranges from 0.2 to 1 percent ofthe entire population. The spondylitis Association of Americaestimates that between 350,000 and one million people in the U.S.suffer from ankylosing spondylitis.

About remicade

REMICADE is a monoclonal antibody that specifically targetsTNF-alpha, which has been shown to play a role in Crohn's disease(CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS)psoriatic arthritis (PsA), ulcerative colitis (UC), pediatricCrohn's disease (PCD) and psoriasis (PsO). remicade is the globalmarket leader among anti-tumor necrosis factor alpha (TNF-alpha)therapies and the only agent approved for the treatment of both RAand CD in North America, the EU and Japan. Additionally, remicadeis the only anti-TNF approved in three different therapeutic areas:gastroenterology, rheumatology and dermatology. The safety andefficacy of remicade have been well established in clinical trialsover the past 15 years and through commercial experience with morethan 924,000 patients treated worldwide.

In the U.S., remicade, in combination with methotrexate, isindicated for reducing signs and symptoms, inhibiting theprogression of structural damage and improving physical function inpatients with moderately to severely active RA. remicade is theonly biologic indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatricpatients with moderately-to-severely active CD who have had aninadequate response to conventional therapy. remicade is alsoindicated for reducing the number of draining enterocutaneous andrectovaginal fistulas and maintaining fistula closure in patientswith fistulizing CD. In December 2004, remicade was approved forreducing signs and symptoms in patients with active AS. In May2005, remicade was approved for reducing signs and symptoms ofactive arthritis in patients with PsA. Additionally, in September2005, remicade was approved for reducing signs and symptoms,achieving clinical remission and mucosal healing, and eliminatingcorticosteroid use in patients with moderately to severely activeUC who have had an inadequate response to conventional therapy.This approval makes remicade the first and only biologic approvedfor the treatment of moderate to severe UC. In May 2006, remicadewas approved for reducing signs and symptoms and inducing andmaintaining clinical remission in pediatric patients withmoderately to severely active Crohn's disease who have had aninadequate response to conventional therapy. This approvalestablishes remicade as the first and only biologic therapyapproved for the treatment of PCD. In August 2006, remicade wasapproved for inhibiting progression of structural damage andimproving physical function in patients with psoriatic arthritis.In September 2006, remicade was approved for the treatment ofadults with chronic, severe (i.e. extensive and/or disabling)plaque psoriasis who are candidates for systemic therapy and whenother systemic therapies are medically less appropriate. In October2006, remicade was approved for maintaining clinical remission andmucosal healing in patients with moderately to severely active UC,who have had an inadequate response to conventional therapy.In the EU, remicade is indicated for the treatment of severe,active CD in patients who have not responded despite a full andadequate course of therapy with a corticosteroid and/or animmunosuppressant; or who are intolerant to or have medicalcontraindications for such therapies. remicade also is indicatedfor the treatment of fistulizing, active CD in patients who havenot responded despite a full and adequate course of therapy withconventional treatment (including antibiotics, drainage andimmunosuppressive therapy).

For RA patients in the EU, remicade, in combination withmethotrexate, is indicated for the reduction of signs and symptomsas well as the improvement in physical function in patients withactive disease when the response to disease-modifying drugs,including methotrexate, has been inadequate, and in patients withsevere, active and progressive disease not previously treated withmethotrexate or other DMARDs. In these patient populations, areduction in the rate of the progression of joint damage, asmeasured by X-ray, has been demonstrated. In carefully selectedpatients with RA who have tolerated three initial two-hourinfusions of remicade, consideration may be given to administeringsubsequent infusions over a period of not less than one hour.

In the EU, remicade is also indicated for the treatment of AS inpatients who have severe axial symptoms, elevated serologicalmarkers of inflammatory activity and who have respondedinadequately to conventional therapy. remicade is also approved forthe treatment of active and progressive PsA in patients who haveresponded inadequately to disease modifying anti-rheumatic drugtherapy. remicade should be administered in combination withmethotrexate or alone in patients who show intolerance tomethotrexate or for whom methotrexate is contraindicated. remicadeis also approved in the EU for the treatment of moderate to severeplaque psoriasis in adults who failed to respond to, or have acontraindication to, or are intolerant of other systemic therapyincluding cyclosporine, methotrexate or PUVA (psoralen plusultraviolet A light).

In February 2006, remicade was approved in the EU for thetreatment of moderately-to-severely active UC in patients who havehad an inadequate response to conventional therapy, includingcorticosteroids and 6-MP or azathioprine, or who are intolerant toor have medical contraindications for such therapies. This approvalmade remicade the first and only biologic therapy approved to treatmoderate-to-severe UC in the EU. In May 2007, remicade was approvedin the EU for the treatment of severe, active Crohn's disease (CD)in pediatric patients aged 6 to 17 years, who have not responded toconventional therapy including a corticosteroid, an immunomodulatorand primary nutrition therapy, or who are intolert to, or havecontraindications for, such therapies.

REMICADE is the only anti-TNF biologic therapy available as anIV form. Unlike self-administered therapies that require patientsto inject themselves frequently, remicade is the only anti-TNFbiologic administered directly by caregivers in the clinic oroffice setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5 mg/kg), UC (5mg/kg), PCD (5 mg/kg), and PsO (5 mg/kg), remicade is a two-hourinfusion administered every 8 weeks, following a standard inductionregimen that requires treatment at weeks 0, 2 and 6. As a result,REMICADE patients may require as few as six treatments each year.In AS (5 mg/kg), remicade is a two-hour infusion administered every6 weeks, following a standard induction regimen that requirestreatment at weeks 0, 2 and 6.

Centocor discovered remicade and has exclusive marketing rightsto the product in the United States.

Schering-Plough markets remicade in all countries outside of theUnited States, except in Japan and parts of the Far East whereTanabe Seiyaku, Ltd. markets the product and in China whereXian-Janssen markets remicade.

Important Safety Information

There are reports of serious infections, including tuberculosis(TB), sepsis and pneumonia. Some of these infections have beenfatal. Tell your doctor if you have had recent or past exposure topeople with TB. Your doctor will evaluate you for TB and perform aTB test. If you have latent (inactive) TB, your doctor should beginTB treatment before you start remicade. remicade can lower yourability to fight infections, so if you are prone to or have ahistory of infections, or develop any signs of an infection such asfever, fatigue, cough, flu or warm, red or painful skin whiletaking remicade, tell your doctor right away. Also, tell yourdoctor if you are scheduled to receive a vaccine or if, you havelived in a region where histoplasmosis or coccidioidomycosis iscommon.

Reports of a type of blood cancer called lymphoma in patients onREMICADE or other TNF blockers are rare but occur more often thanexpected for people in general. People who have been treated forrheumatoid arthritis, Crohn's disease, ankylosing spondylitis, orpsoriatic arthritis for a long time, particularly those with highlyactive disease may be more prone to develop lymphoma. Cancers,other than lymphoma, have also been reported. Rarely, children andyoung adults who have been treated for Crohn's disease withREMICADE in combination with azathioprine or 6-mercaptopurine havedeveloped a rare type of lymphoma, hepatosplenic T cell lymphoma(HSTL), that often results in death. If you take remicade or otherTNF blockers, your risk for developing lymphoma or other cancersmay increase. You should also tell your doctor if you have had ordevelop lymphoma or other cancers or if you have a lung diseasecalled chronic obstructive pulmonary disease (COPD).

Many people with heart failure should not take remicade; soprior to treatment you should discuss any heart condition with yourdoctor. Tell your doctor right away if you develop new or worseningsymptoms of heart failure (such as shortness of breath, swelling ofyou r ankles or feet, or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patientswho are carriers of this virus and are taking TNF blockers, such asREMICADE. Some of these cases have been fatal. Tell your doctor ifyou know or think you may be a carrier of hepatitis B virus or ifyou experience signs of hepatitis B infection, such as feelingunwell, poor appetite, tiredness, fever, skin rash and/or jointpain.

There have been rare cases of serious liver injury in peopletaking remicade, some fatal. Tell your doctor if you have liverproblems and contact your doctor immediately if you developsymptoms such as jaundice (yellow skin and eyes), dark brown urine,right-sided abdominal pain, fever, or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctorif you develop possible signs of blood disorders such as persistentfever, bruising, bleeding, or paleness while taking remicade.Nervous system disorders have also been reported. Tell your doctorif you have or have had a disease that affects the nervous system,or if you experience any numbness, weakness, tingling, visualdisturbances or seizures while taking remicade.

Allergic reactions, some severe have been reported during orafter infusions with remicade. Signs of an allergic reactioninclude hives, difficulty breathing, chest pain, high or low bloodpressure, swelling of face and hands, and fever or chills. Tellyour doctor if you have experienced a severe allergic reaction. Themost common side effects of remicade are: respiratory infections,such as sinus infections and sore throat, headache, rash, coughing,and stomach pain.

Please read important information about remicade, including fullU.S. prescribing information and Medication Guide, at www.remicade.com. Forcomplete EU prescribing information, please visit www.emea.eu.int.

About Centocor

Centocor is harnessing the power of world-leading research andbiomanufacturing to deliver innovative biomedicines that transformpatients' lives. Centocor has already brought innovation to thetreatment of Crohn's disease, rheumatoid arthritis, ankylosingspondylitis, psoriatic arthritis, ulcerative colitis, pediatricCrohn's disease and psoriasis.

The world leader in monoclonal antibody production andtechnology, Centocor has brought critical biologic therapies topatients suffering from debilitating immune disorders. Centocor,Inc. is a wholly owned subsidiary of Johnson & Johnson.

This press release contains "forward-looking statements" asdefined in the Private Securities Litigation Reform Act of 1995.These statements are based on current expectations of futureevents. If underlying assumptions prove inaccurate or unknown risksor uncertainties materialize, actual results could vary materiallyfrom Johnson & Johnson's expectations and projections. Risksand uncertainties include general industry conditions andcompetition; economic conditions, such as interest rate andcurrency exchange rate fluctuations; technological advances andpatents attained by competitors; challenges inherent in new productdevelopment, including obtaining regulatory approvals; domestic andforeign health care reforms and governmental laws and regulations;and trends toward health care cost containment. A further list anddescription of these risks, uncertainties and other factors can befound in Exhibit 99 of Johnson & Johnson's Annual Report onForm 10-K for the fiscal year ended December 31, 2006. Copies ofthis Form 10-K, as well as subsequent filings, are available onlineat www.sec.gov oron request from Johnson & Johnson. Johnson & Johnson doesnot undertake to update any forward-looking statements as a resultof new information or future events or developments.

About Schering-Plough

Schering-Plough is a global science-based health care companywith leading prescription, consumer and animal health products.Through internal research and collaborations with partners,Schering-Plough discovers, develops, manufactures and marketsadvanced drug therapies to meet important medical needs.Schering-Plough's vision is to earn the trust of the physicians,patients and customers served by its approximately 33,500 peoplearound the world. The company is based in Kenilworth, N.J., and itsWeb site is www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this pressrelease contains certain "forward-looking" statements within themeaning of the Private Securities Litigation Reform Act of 1995,including statements related to the approval of remicade for CD inthe EU and the potential market for remicade. Forward-lookingstatements relate to expectations or forecasts of future events.Schering-Plough does not assume the obligation to update anyforward-looking statement. Many factors could cause actual resultsto differ materially from Schering-Plough's forward-lookingstatements, including market forces, economic factors, productavailability, patent and other intellectual property protection,current and future branded, generic or over-the-countercompetition, the regulatory process, and any developments followingregulatory approval, among other uncertainties. For further detailsand a discussion of risks and uncertainties that may impactforward-looking statements, see Schering-Plough's Securities andExchange Commission filings, including Part II, Item 1A, "RiskFactors" in the company's first quarter 2007 10-Q. #46-0607

CONTACT: Media: Cathy Cantone, +1-908-... - cell,+1-908-...,Investors: Alex Kelly, +1-908-298-7436, both ofSchering-Plough; Media:Brian Kenney of Centocor, +1-215-325-2107,+1-215-620-0111 - cell

Web site: http://www.schering-plough.com/

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