Study Suggests Risperidone Long-Acting Injection Combined with Standard Treatment Helped Delay Time to Relapse in Patients with Bipolar Disorder

Patients with frequently relapsing bipolar disorder had a significant delay in the time to an initial relapse when risperidone long-acting injection (RLAI) was combined with standard treatment, according to a new study. The study compared patients who received RLAI and standard treatment to those who received standard treatment combined with placebo.

The study was presented yesterday at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disordersin Montreux, Switzerland.1 This one-year, phase 3, trial is the first placebo-controlled study to explore the use of a long-acting injection medication in the maintenance treatment of frequently relapsing bipolar disorder (FRBD). FRBD, defined as four or more manic or depressive episodes in the previous year that require a doctor's care, may affect 20% of the 27 million people with bipolar disorder worldwide.2, 3

The study compared the time to the next mood episode, also known as a relapse, in FRBD patients receiving RLAI plus standard treatment vs. patients receiving placebo plus standard treatment. For most patients, standard treatment consisted of mood stabilizers, antidepressants, anxiolytics or combinations thereof. The trial showed that time to relapse was significantly longer in patients receiving RLAI compared with placebo (p=0.004) and the relative risk of relapse was 2.4 times higher with placebo. The relapse rates were 47.8% with placebo and 22.2% with RLAI.

"Patients with frequently relapsing bipolar disorder require more healthcare interventions than patients with fewer episodes, and there is a huge unmet need for new treatments," said Dr. Joseph Calabrese, Co-Director of the Bipolar Disorders Research Center, University Hospitals Case Medical Center, Case Western Reserve University. Dr. Calabrese is a consultant to the study sponsors, Ortho-McNeil Janssen Scientific Affairs, L.L.C. "Risperidone long-acting injection is administered once every two weeks by a healthcare professional and avoids the need for patients to remember to take daily antipsychotic medications. "

In the study, 139 patients were randomized to receive either RLAI 25-50mg intramuscular injection (n=72), or placebo injections (n=67) adjunctive to standard treatment. Patients receiving RLAI plus standard treatment were eligible to enter the double blind phase of the trial if they met predefined criteriaa for being stable the last four weeks of the 16-week open-label stabilization phase.

In the study, Frequently Relapsing Bipolar Disorder: Evidence for an Effective Treatment Using Adjunctive Risperidone Long-Acting Injectable, 67% of patients randomized received a 25 mg dose of RLAI, 29% received a 37.5 mg dose and 4% received a 50 mg dose, administered once every two weeks.

The primary efficacy endpoint in the double-blind phase of the trial was the time from randomization to relapse, where relapse was defined as the first occurrence of a mood episode as determined by an independent Relapse Monitoring Board (RMB).b

The results showed a significant difference in time to relapse (p=0.004), with a more than two-fold higher risk of relapse in the placebo group (47.8%) than the RLAI group (22.2%). In addition, scores on the Clinical Global Impression–Bipolar–Severity (CGI-BP-S) scale for overall bipolar disorder and the Clinical Global Impression-Bipolar-Change (CGI-BP-C) scale worsened significantly (p<0.05) in the placebo group compared with the RLAI group.

Treatment-emergent adverse effects (TEAEs) occurred more frequently in the group that received placebo and standard treatment (76.1%) than in the group that received RLAI and standard treatment (70.8%), as did serious adverse effects (placebo=19.4%; RLAI = 13.9%). The most common TEAEs (greater than 5%) in the double-blind phase were tremor (RLAI = 23.6%; placebo = 16.4%), insomnia (RLAI = 19.4%; placebo = 23.9%), muscle rigidity (RLAI = 11.1%; placebo = 6%); weight gain (RLAI = 6.9%; placebo = 1.5%) and hypokinesia (RLAI = 6.9%; placebo = 0%). A total of 5 patients discontinued due to adverse events in the double-blind phase (3 in the RLAI group and 2 in the placebo group).

Risperidone long-acting injection is marketed in the U.S. by Janssen, Division of Ortho-McNeil Janssen Pharmaceuticals, Inc. The formulation is manufactured by Alkermes, Inc. (Nasdaq: ALKS). Ortho-McNeil Janssen Scientific Affairs, LLC, funded the study.

About Bipolar Disorder

It is estimated that 27 million people worldwide2 suffer from bipolar disorder, also known as manic-depressive disorder. It is characterized by debilitating mood swings, from extreme highs (mania) to extreme lows (depression). Signs of mania include euphoria, extreme irritability or rage, accelerated or disorganized thinking and an increase in risky behaviors. Signs of depression include intense sadness or despair, loss of energy, insomnia and suicidal thoughts.

A classification of patients identified as "rapid-cycling" and also having four or more episodes during the previous 12 months, is estimated to occur in approximately 10-20% of patients with bipolar disorder seen in mood disorder clinics. The types of mood episodes (manic, depressed, mixed) seen in these patients can occur in any pattern. The course of their illness is characterized by a requirement for more health care resources, more concomitant medications and poorer outcomes.4

About Risperidone Long-Acting Injection

Risperidone long-acting injection is the first and only long-acting, atypical antipsychotic to be approved by the U.S. Food and Drug Administration and now is approved in more than 70 countries worldwide. The treatment uses Alkermes proprietary Medisorb® technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. Janssen markets Risperidone long-acting injection in the United States. The formulation is manufactured by Alkermes, Inc. (Nasdaq: ALKS). Available in 12.5 mg, 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia. For more information about RISPERDAL CONSTA, visit www.risperdalconsta.com.

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. As the company celebrates its 50th year in mental health, it currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more information about Janssen, visit www.janssen.com.

Alkermes, Inc. is a biotechnology company that uses proprietary technologies and know-how to create innovative medicines designed to yield better therapeutic outcomes for patients with serious disease. Alkermes manufactures RISPERDAL® CONSTA®, marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and Janssen-Cilag, a subsidiary of Johnson & Johnson, outside of the U.S. Alkermes also developed and manufactures VIVITROL®, marketed in the U.S. primarily by Cephalon, Inc. The company's pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Alkermes is headquartered in Cambridge, Massachusetts, with research and manufacturing facilities in Massachusetts and Ohio. For more information about Alkermes, visit www.alkermes.com.

a Stable remission was achieved if, during the last 4 weeks of the 16-week OL stabilization phase the subject had not met DSM-IV-TR criteria for active mood disorder; the subject had no crisis interventions; the subject’s Young Mania Rating Scale (YMRS) and Montgomery-Asberg Depression Rating Scale (MADRS) total scores both remained ≤10 and the Clinical Global Impression – bipolar severity (CGI-BP-S) score remained ≤ 3 and the subject’s medications and doses of other psychotropic medications remained unchanged.

b RMB = a fully independent, blinded, international board of 3 psychiatrists considered experts in the treatment of bipolar disorder. They reviewed all clinical data and determined whether the patient met relapse criteria.

References

1 Aphs L, Kujawa M, Macfadden W et al., Frequently relapsing bipolar disorder: evidence for an effective treatment using adjunctive risperidone long-acting injectable, presented at the 14th Biennial Winter Workshop on Schizophrenia, Montreux, Switzerland, February 2008.

2 The Global Burden of Disease. World Health Organization, 2003. Available at
http://www.who.int/mip/2003/other_documents/en/globalburdenofdisease.pdf, accessed January 18, 2008

3 DSM-IV-TR, American Psychiatric Association, 2000.

4 DSM-IV, American Psychiatric Association, 2000

Unique Lens Material Helps Minimize Contact Lens Wearers' Discomfort And Dryness Symptoms Under Adverse Environmental Conditions, Study Shows

New research suggests that a novel silicone hydrogel material could help keep contact lens wearers from discarding their contacts due to discomfort caused by feelings of dryness, the most commonly reported reason people discontinue contact lens wear. Using a controlled clinical model for evaluating dryness, researchers report that patients experienced less discomfort while wearing contact lenses made with senofilcon A (ACUVUE® OASYS™ Brand Contact Lenses) than they did either while wearing no lenses or while wearing their usual contact lenses in a controlled adverse environment. The findings appear in the current issue of Current Medical Research and Opinion.

Contact lens wearers frequently complain of sensations of eye discomfort and dryness associated with wearing their lenses. Roughly 51 percent of lapsed lens wearers cite discomfort as the primary reason they discontinued wearing their lenses. Forty percent attribute their contact lens abandonment to dryness.

"Most soft contact lenses materials have demonstrated a susceptibility to environmental factors which can lead to clinical symptoms normally associated with ocular dryness," says Sheila Hickson-Curran, Director, Medical Affairs, Vistakon. "In addition to humidity, variables such as air movement (wind), temperature, and blink-rate altering visual activities such as reading and computer use can exacerbate signs and symptoms of dryness in contact lens wearers."

"Senofilcon A has previously shown promising results for reducing lens-wear related symptoms of dryness and discomfort," she adds. "This study shows that contact lenses made with senofilcon A may be superior to other soft lens materials in terms of minimizing dryness symptoms associated with exposure to adverse environmental conditions. Senofilcon A was also found to reduce discomfort symptoms even beyond that experienced with no lens, indicating a protective effect."

About the Study

The purpose of the study was to compare the ability of ACUVUE OASYS™ (senofilcon A) contact lenses to wearer's habitual contact lenses to provide relief from ocular discomfort during contact lens wear in adverse environmental conditions.

Researchers used the Controlled Adverse Environment (CAE) model, a proprietary state-of-the-art model for conducting ocular dryness studies, to investigate dryness during contact lens wear. Typically incorporated into clinical trials studying ocular dryness, the CAE is used to exacerbate dryness symptoms in a reproducible, controlled manner by closely regulating humidity, temperature, airflow, lighting, and visual tasking. Acute ocular drying conditions are optimized in the CAE by using appropriate exposure times and requiring subjects to perform a visual task such as reading or working on a computer.

Eleven participants completed a single-center, double-masked, randomized, cross-over, CAE study. Participants were current, successful contact lens wearers with histories of ocular discomfort during lens wear in windy or dry environments.

Study participants underwent a total of three 75-minute CAE exposures during a two-week period – once with no lenses, once wearing a new pair of their habitual contact lenses, and once wearing senofilcon A contact lenses. Subjects were not permitted to use rewetting drops or tear substitutes for at least 12 hours prior to visits and were not allowed to wear their contacts for at least 72 hours prior to visits.

When wearing senofilcon A contact lenses, study participants reported significantly lower subjective ocular discomfort scores during exposure to a controlled adverse environment than they did when wearing their habitual contact lenses. Participants reported better mean discomfort scores across all time points during CAE exposure while wearing senofilcon A lenses (1.62 ± 0.71 points) than they did while wearing their habitual contact lenses (2.21 ± 0.80 points, p <0.05). Senofilcon A lenses also yielded significantly better mean overall discomfort scores versus no lenses (2.73 ± 0.79 points, p<0.0001)

The study was supported by funding from Vistakon®, Division of Johnson & Johnson Vision Care. Inc.

ACUVUE®, Brand Contact Lenses are indicated for vision correction. As with all contact lenses, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from VISTAKON®, Division of Johnson & Johnson Vision Care, Inc., by calling 1-800-843-2020 or by visiting ecp.acuvue.com (for eye care professionals) or www.acuvue.com (for consumers).

ACUVUE® OASYS™, and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.

Court of Appeals Upholds Verdicts in Favor of Cordis Corporation On Patents Infringed by Medtronic, Inc. and Boston Scientific Corporation

The Court of Appeals for the Federal Circuit in Washington, D.C. today upheld two separate 2005 jury verdicts that found Medtronic, Inc. and Boston Scientific Corporation infringed coronary stent patents owned by the Cordis Corporation, a Johnson & Johnson company. Cordis now intends to ask the U.S. District Court in Delaware to reinstate the damages judgments of $271 million against Medtronic and $324 million against Boston Scientific, plus interest.

"We are very pleased that the Court of Appeals has recognized the validity of the prior verdicts," said Todd Pope, Worldwide President, Cordis Corporation. "We will urge the U.S. District Court to move expeditiously to reinstate the two previous damages judgments, along with the interest that has accrued during the appeals process."

Injunctive relief is not an issue because the infringing Medtronic and Boston Scientific stents are no longer on the market. In March of 2005, separate juries found that Medtronic's GFX and Microstent II infringed Cordis' Palmaz (762) and Schatz (984) patents, and that Boston Scientific's NIR stent infringed the Palmaz patent. The Palmaz and Schatz patents relate to the fundamental design of the first coronary stent developed and introduced by Cordis.

Both patent infringement cases were originally tried in 2000, with Cordis receiving favorable jury verdicts. After a series of procedural rulings and appeals, both cases were retried in March of 2005, with Cordis prevailing again.

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.

Submission of Marketing Authorisation Application for VELCADE (bortezomib) in Europe

Janssen-Cilag International NV, has submitted a Marketing Authorization Application to the European Medicines Evaluations Agency for the use of VELCADE® (Bortezomib) for the treatment of patients with previously untreated multiple myeloma (MM).

Millennium Pharmaceuticals, Inc., the Company's co-development partner, also submitted a supplemental New Drug Application (sNDA) with the United States Food & Drug Administration (FDA).

The submission is based on data from the randomised, international, open-label phase III VISTA (VELCADE® as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone) study, which compared VcMP with MP as a treatment for previously untreated patients. The study was conducted at 151 centres, enrolling 682 patients in 22 countries across Europe, North and South America, and Asia.

The primary endpoint was time-to-progression, with secondary endpoints including response rates, time to and duration of response, progression-free survival, overall survival, and measures of clinical benefit such as time to next therapy. Patients on the VELCADE®-based regimen experienced a 35 percent complete response rate, defined by complete disappearance of M-protein. Furthermore, responses were durable; median duration of response for complete responders was 24 months. The median time to next therapy or treatment, a measure of clinical benefit has not been reached. This is an important benefit for patients since they have time off medication after completing treatment in contrast to other therapies. After a median of 16.3 months follow-up, a survival benefit has already been demonstrated.

This study was featured earlier this month as an oral presentation at the American Society of Hematology (ASH) 49th Annual Meeting and Exposition in Atlanta, Georgia.

Multiple myeloma (MM) is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths.1

In 2002, there were approximately 85,700 cases of MM worldwide.2

Only 30 percent of MM patients survive longer than five years,3 with more than 18,000 people in the European Union dying each year from the disease.

About VELCADE®

Currently VELCADE® is indicated in the EU as monotherapy for use in patients with progressive MM who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.

VELCADE® is the market leader in treating relapsed multiple myeloma with over 85,000 patients treated worldwide. VELCADE® is being co-developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Millennium Pharmaceuticals, Inc. Millennium is responsible for commercialisation of VELCADE® in the U.S. Millennium and Ortho Biotech Inc. currently co-promote VELCADE® in the U.S. Janssen-Cilag companies are responsible for commercialisation in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialisation in Japan.

VELCADE®has a predictable safety profile and a favourable benefit–risk ratio. The most common side effects reported with VELCADE®include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy, which is reversible in the majority of patients.

About Janssen-Cilag
The Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at www.janssen-cilag.com.



1 www.multiplemyeloma.org.

2 GLOBOCAN 2002, www-dep.iarc.fr.

3 Brenner H. Lancet 2002; 360:1131-1135.

Three Phase III Trials Show Rivaroxaban Outperformed Enoxaparin in Preventing Venous Thromboembolism After Major Orthopedic Surgery

Phase III clinical trial results released today underscore that rivaroxaban, the oral, once-daily, investigational anticoagulant, was significantly more effective than enoxaparin, the standard of care, in preventing venous thromboembolism (VTE) in patients undergoing total hip or knee replacement surgery. Rivaroxaban-treated patients consistently experienced lower rates of VTE events compared to enoxaparin-treated patients across three large studies as well as demonstrating a similar rate of major bleeding events. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare AG.

Data from the RECORD1 and RECORD2 studies, evaluating rivaroxaban in total hip replacement surgery, were presented at the 49th Annual Meeting of the American Society of Hematology. Additional data from the head-to-head RECORD3 study, which showed similar statistically significant results for rivaroxaban compared with enoxaparin in total knee replacement surgery, also were presented.

Studies presented include:

• RECORD1 (n=4,541), which demonstrated a 70 percent relative risk reduction
  (RRR) (p<0.001) in total VTE when compared with enoxaparin and an 88
  percent RRR (p<0.001) in major VTE


• RECORD2 (n=2,509), which demonstrated a 79 percent RRR (p<0.001) in
  total VTE when compared with enoxaparin, again with an 88 percent RRR
  (p<0.001) in major VTE


• RECORD3 (n=2,531), which demonstrated a 49 percent RRR (p<0.001) in
  total VTE when compared with enoxaparin, and a 62 percent RRR (p=0.016) in
  major VTE


• Major bleeding rates were similar for both drugs (less than or equal to 0.6
  percent) and differences were not statistically significant


• No routine blood monitoring was required in the Phase III RECORD program at
  the 10mg dose, based on the Phase II data and pharmacokinetic profile

"In RECORD1, 2 and 3 we have three Phase III trials showing unprecedented results in major orthopedic surgery for the prevention of VTE, and this is genuinely exciting," said Dr. A.G.G. Turpie, Principal Investigator in the RECORD program, Professor of Medicine, McMaster University, Canada. "In three different trials across large patient populations, we have seen rivaroxaban outperform the current standard of care, enoxaparin, without compromising on safety. This is strong clinical evidence that we are making a major leap forward in oral anticoagulation in orthopedic surgery."

A key secondary endpoint of the study measuring the reduction of symptomatic VTE, also showed clinically meaningful results in favor of rivaroxaban. For this endpoint, the trials showed an RRR of 45 percent (p=0.222) in RECORD1, an 80 percent RRR (p=0.004) in RECORD2 and a 66 percent RRR (p=0.005) in RECORD3, compared to the standard regimen.

"The symptomatic VTE findings in the RECORD trials are extraordinary," added Dr. Turpie. "Previous trials were successful in identifying trends towards reducing symptomatic VTE, but with RECORD2 and 3 we are seeing clinically relevant reductions in symptomatic VTE for the first time in orthopedic surgery. These results are a major milestone in the evolution of anticoagulation therapy."

Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a range of patients who could benefit from prevention and/or treatment of blood clots. Rivaroxaban works at a pivotal stage in the coagulation process to directly inhibit the enzyme Factor Xa.

Detailed Study Results

Data presented at the ASH meeting are from RECORD (Regulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE), a global program of four pivotal trials involving more than 12,000 patients comparing oral, once-daily rivaroxaban, with subcutaneous enoxaparin in the prevention of VTE after elective, major orthopedic surgery. Following are summary results from RECORD1, RECORD2 and RECORD3:

RECORD1 (Abstract #6)

The RECORD1 trial compared the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total hip replacement surgery. The duration of thromboprophylaxis in both treatments was five weeks. The study met its primary endpoint, and demonstrated a 70 percent RRR (p<0.001) in total VTE (composite of deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality), for patients treated with rivaroxaban compared with those treated with enoxaparin (1.1 percent and 3.7 percent, respectively). In addition, against the secondary endpoint, an 88 percent RRR (p<0.001) in major VTE (composite of proximal deep vein thrombosis, non-fatal pulmonary embolism and VTE-related death) was observed in patients treated with rivaroxaban (0.2 percent and 2.0 percent, respectively). Rivaroxaban also demonstrated a similar rate of major bleeding to enoxaparin (0.3 percent and 0.1 percent, respectively, p=0.178).

RECORD2 (Abstract #307)

The RECORD2 study evaluated the safety and efficacy of rivaroxaban compared with enoxaparin and placebo. The duration of thromboprophylaxis in patients undergoing total hip replacement was 35+/- 4 days (extended prophylaxis) for rivaroxaban or 10-14 days for those receiving enoxaparin, followed by placebo. The primary and secondary endpoints were the same as for RECORD1 with a 79 percent RRR (p<0.001) in total VTE and an 88 percent RRR (p<0.001) in major VTE for patients treated with rivaroxaban compared with those treated with enoxaparin. Rivaroxaban demonstrated a similar rate of major bleeding compared to enoxaparin (0.1 percent and 0.1 percent, respectively, p=0.980), despite the greater treatment duration with rivaroxaban in this study.

RECORD3 (Abstract #308)

The RECORD3 trial compared the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total knee replacement surgery. Enoxaparin was initiated 12 hours before surgery, and rivaroxaban was initiated 6-8 hours after surgery; both treatments were continued for 10-14 days. Primary and secondary endpoints were the same as for RECORD1 and there was a 49 percent RRR (p<0.001) in total VTE and a 62 percent RRR (p=0.016) in major VTE for patients treated with rivaroxaban compared with those treated with enoxaparin. Rivaroxaban demonstrated similar rates of major bleeding to enoxaparin (0.6 percent and 0.5 percent, respectively, p=0.774).

Copies of the abstracts may be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm

Unmet Needs in Venous Thromboembolism (VTE)

VTE, a disease process that begins with a blood clot in a vein, includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients undergoing major orthopedic surgery are at risk for VTE because, during the surgery the large veins of the leg that carry blood back to the heart can be damaged, significantly increasing the risk of coagulation and thrombosis.

Each year approximately 700,000 people elect to have hip and knee replacement surgeries in the U.S. and a blood clot is the most common cause of re-hospitalization for this patient group. In fact, VTE is considered the most frequent preventable serious and potentially fatal complication following major orthopedic surgery. But the threat stretches beyond orthopedic surgeries. Blood clots are one of the leading causes of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for acute myocardial infarction (heart attack); those undergoing major orthopedic surgery; and acutely medically ill patients.

About Rivaroxaban

To date, rivaroxaban is the most studied oral, direct Factor Xa inhibitor in clinical development. More than 20,000 patients have been evaluated in the completed Phase II programs and enrolled thus far in the Phase III programs. Almost 50,000 patients are expected to be evaluated in the total clinical development program.

Bayer HealthCare submitted a regulatory filing to the European Agency for the Evaluation of Medicinal Products (EMEA) at the end of October 2007 for approval to market rivaroxaban in the EU for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs. Upon regulatory approval, rivaroxaban will be commercialized in Europe by Bayer Schering Pharma. A filing for rivaroxaban for a similar indication in the U.S. is planned in 2008, where upon approval, it will be will commercialized by Scios Inc. and Ortho-McNeil, Inc., both of which are wholly-owned subsidiaries of Johnson & Johnson.

Johnson & Johnson Pharmaceutical Research and Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

New Phase III Trial Results for Rivaroxaban to be Presented at the 49th Annual Meeting of the American Society of Hematology

Findings from three phase III clinical trials of rivaroxaban will be presented in the plenary session and during oral presentations at the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia, from December 8 to 11, 2007. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare, AG.

The studies evaluated rivaroxaban in head-to-head comparison with enoxaparin, the current standard of care, for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery. The presentations will highlight results from the recently-completed RECORD1 (Regulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) and RECORD2 studies in total hip replacement surgery as well as additional data from the RECORD3 trial, which evaluated rivaroxaban in total knee replacement surgery. Copies of the following abstracts can be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm.

Oral Rivaroxaban Compared with Subcutaneous Enoxaparin for Extended Thromboprophylaxis after Total Hip Arthroplasty: The RECORD1 Trial Abstract# 6. Plenary presentation: Sunday, Dec. 9, 3:10 p.m., Hall A1, Georgia World Congress Center
Extended Thromboprophylaxis with Rivaroxaban Compared with Short-Term Thromboprophylaxis with Enoxaparin After Total Hip Arthroplasty: The RECORD2 Trial
Abstract# 307. Oral presentation: Monday, Dec. 10, 11:00 a.m., Rooms B312-B313a

Rivaroxaban – an Oral, Direct Factor Xa Inhibitor – for Thromboprophylaxis After Total Knee Arthroplasty: The RECORD3 Trial
Abstract# 308. Oral presentation: Monday, Dec. 10, 11:15 a.m., Rooms B312-B313a

Four additional abstracts will be presented as poster presentations on Saturday, December 8 and Sunday, December 9, 2007.

Johnson & Johnson Pharmaceutical Research and Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

New Long-Term Data Suggest Clinical Differences in Safety and Efficacy Between CYPHER Sirolimus-Eluting Coronary Stent and Taxus Stent

An analysis of fifteen-month data from the Western Denmark Heart Registry found that patients who received the CYPHER® Sirolimus-eluting Coronary Stent had a lower risk of blood clots (stent thrombosis) and were less likely to need another procedure at the same lesion site (target lesion revascularization) than patients who received a Taxus Stent. The study is being shown at the Transcatheter Cardiovascular Therapeutics 2007 meeting (TCT 2007).

The differences between the CYPHER® Stent and the Taxus Stent in terms of definite stent thrombosis, definite/probable/possible stent thrombosis and target lesion revascularization were statistically significant and favorable for the CYPHER® Stent. Patients who received the Taxus Stent were 55 percent more likely to develop definite stent thrombosis than patients who received the CYPHER® Stent [confidence interval (CI) 0.21-0.94]. Taxus Stent patients were also 49 percent more likely to develop definite/probable/possible stent thrombosis than patients who received a CYPHER® Stent (CI 0.30-0.87). In addition, the CYPHER® Stent performed considerably better than the Taxus Stent in terms of target lesion revascularization, as Taxus Stent patients were 32 percent more likely to need a repeat procedure compared with patients who received the CYPHER® Stent (CI 0.52-0.90).

"The study data show that the clinical outcomes following drug-eluting stent implantation may depend on the type of stent used to treat a patient with coronary artery disease," said Professor Leif Thuesen, MD, DMSci, from Aarhus University Hospital in Denmark.

"The CYPHER® Stent continues to demonstrate excellent outcomes in clinical trials and in real-world settings," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "These findings are consistent with the results of other studies recently published in peer-reviewed medical journals [i.e. Stettler et al. Lancet 2007;370:937-48, Schömig et al. J Am Coll Cardiol 2007;50:1373-80, and Daemen et al. Lancet 2007;369:667-78] and build on the growing body of evidence indicating that the CYPHER® Stent and the Taxus Stent should be evaluated separately."

The Western Denmark Heart Registry is a multi-center, prospective, observational registry of all patients in western Denmark who receive coronary angiograms or coronary interventions, including percutaneous interventions and bypass surgery. This analysis evaluated patients from the registry who received a drug-eluting stent – either the CYPHER® Stent or Taxus Stent – from January 2002 through June 2005. Patients who received a combination of drug-eluting and bare metal stents (BMS) were excluded. All patients were followed for 15 months.

The primary endpoints of the study were stent thrombosis, myocardial infarction and death. No significant differences were found in the clinical outcomes of myocardial infarction or death.

Stent thrombosis was defined according to the Academic Research Consortium (ARC) definitions for thrombosis: definite, which required confirmation of a clot by angiogram at follow-up; probable, which included a heart attack in the treated vessel in patients who did not have an angiographic confirmation of a thrombosis; and possible, which included sudden unexplained death.

About the CYPHER®Stent

The CYPHER® Stent is the most studied drug-eluting stent in history and has been chosen by cardiologists worldwide to treat more than three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.

The CYPHER® Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of a sirolimus-eluting stent, the CYPHER® SELECT™ Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER® SELECT™ Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.

For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.

About Cordis Corporation

Cordis, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.

Johnson & Johnson Announces $10 Billion Share Repurchase Program

Johnson & Johnson today announced that its Board of Directors has approved a share repurchase program, authorizing the Company to purchase up to $10 billion of the corporation's shares of common stock.

"This share repurchase program is consistent with our strategy of providing value to our shareholders while maintaining flexibility to continue to invest in future growth opportunities," said William C. Weldon, Chairman and Chief Executive Officer.

Share repurchases will take place on the open market from time to time based on market conditions. The repurchase program has no time limit and may be suspended for periods or discontinued at any time. Any shares acquired will be available for general corporate purposes. The Company had approximately 2,896.6 million shares of common stock outstanding as of April 29, 2007.

The Company intends to finance the share repurchase program through a combination of available cash and debt. The Company expects to retain its triple-A credit rating. Johnson & Johnson will discuss the share repurchase plan on its second-quarter earnings conference call on July 17, 2007.

Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 121,000 men and women in 57 countries and sell products throughout the world.

Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Repla

Late-breaking Phase III clinical trial data presented today at the XXI International Society on Thrombosis and Haemostasis (ISTH) Congress demonstrate that once-daily rivaroxaban achieved superior efficacy in the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery in a head-to-head comparison with enoxaparin, the current standard of care. Patients in the RECORD3 (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) study who were treated with rivaroxaban demonstrated a 49 percent relative risk reduction (RRR) (p<0.001) in the composite primary endpoint of deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all-cause mortality compared to those treated with enoxaparin. A 62 percent reduction of risk (p=0.01) for developing major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) – the secondary endpoint of the trial – was observed in the patients treated with rivaroxaban. Rivaroxaban also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6 percent and 0.5 percent, respectively).

Rivaroxaban is an investigational, oral, once-daily direct Factor Xa inhibitor. It is an anticoagulant – a drug designed to prevent and treat blood clots – in advanced clinical development for the prevention and treatment of thrombosis in acute and chronic settings, enabling convenient administration in both the hospital and at home.

Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development L.L.C. and Bayer HealthCare AG.

Lead RECORD3 investigator, Michael R. Lassen, MD, of Hoersholm Hospital, University of Copenhagen, Denmark, commented: "The RECORD3 results are exciting, as they indicate that rivaroxaban may better meet the needs of many patients undergoing orthopaedic surgery. It's an important step for this category that a once-daily, oral medication has demonstrated better efficacy in preventing VTE than the current standard of care, while also displaying a promising safety profile. In addition, it is important to note that symptomatic VTE, a secondary endpoint of the study, showed results in favour of rivaroxaban."

Detailed Study Results

RECORD3 is a 2,531-patient, phase III, double-blind trial that assessed the safety and efficacy of 10 mg oral, once-daily rivaroxaban started six-eight hours after surgery versus 40 mg subcutaneous, once-daily enoxaparin started the evening before surgery in elective total knee replacement (TKR) surgery. Both regimens were continued for 10-14 days. The primary efficacy endpoint of the study was the composite of DVT, as diagnosed by mandatory venography, non-fatal PE and all-cause mortality. The primary safety endpoint was major bleeding. Results showed that DVT, non-fatal PE and death occurred in 9.6 percent (79/824) of patients receiving rivaroxaban versus 18.9 percent (166/878) of patients receiving enoxaparin (RRR 49 percent; p < 0.001).

Major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) – the main secondary efficacy endpoint of the study – occurred in 1.0 percent of the rivaroxaban-treated group and in 2.6 percent of the enoxaparin-treated group. The difference was statistically significant (p=0.01) in favour of rivaroxaban, with an RRR of 62 percent. A reduction was also demonstrated in symptomatic VTE, a pre-specified additional secondary endpoint in the study. Symptomatic VTE occurred in 1.0 percent of patients who received rivaroxaban, compared to 2.7 percent of those in the enoxaparin comparator group, resulting in an RRR of 64 percent.

In the rivaroxaban- and enoxaparin-treated groups, major bleeding rates were 0.6 percent and 0.5 percent, and any bleeding rates were 4.9 percent and 4.8 percent, respectively. The RECORD3 trial demonstrated superior efficacy of rivaroxaban versus enoxaparin, with similarly low bleeding rates, in patients undergoing TKR.

Garry Neil, MD, group president for central nervous system and internal medicine research & development at Johnson & Johnson Pharmaceutical Research and Development commented: "We believe rivaroxaban could alter the landscape of antithrombotic therapy. An effective once-daily oral anticoagulant that can be administered safely and conveniently in the hospital and home settings has the potential to improve upon current therapies and help to treat the significant number of under- and un-treated patients at risk for life-threatening thrombotic events."

The trade name of rivaroxaban is expected to be Xarelto®, pending health authority approval.

Results from other phase III trials in the RECORD program, RECORD1 and RECORD2 are expected to be available by H2 2007.

Unmet Needs in Venous Thromboembolism (VTE)

VTE is a type of thromboembolic disease that affects approximately 6.5 million people worldwide annually. Thromboembolic disease, which is caused by the obstruction of a blood vessel by a blood clot, is a leading cause of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for myocardial infarction (heart attack); those undergoing orthopaedic surgery at risk for developing DVT and PE; and hospitalized, medically ill patients immobilized by cancer, congestive heart failure, acute respiratory disease, or other illnesses.

About Rivaroxaban (Xarelto®)

Phase IIb data – presented at ISTH in 2005, and published in the Journal of Thrombosis and Haemostasis in 2005 and 2006, and the additional once-daily ODIXa HIP study published in Circulation in 2006 – indicate that rivaroxaban offers predictable anticoagulation, which strongly suggests that routine coagulation monitoring will not be required. In addition, data show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulant.

To date, rivaroxaban is the most studied oral direct Factor Xa inhibitor in development.

More than 15,000 patients have been evaluated in the completed phase II programs and enrolled thus far in the phase III programs. More than 40,000 patients are expected to be evaluated in total.

The RECORD3 trial is part of the joint clinical development program led by Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare. Upon regulatory approval, rivaroxaban will be commercialized in the United States by Scios Inc. and Ortho-McNeil, Inc. Bayer Schering Pharma will market rivaroxaban throughout the rest of the world.

The companies plan to submit regulatory filings for the prevention of VTE in orthopaedic surgery in late 2007 in Europe and in 2008 in the United States.

About Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of Johnson & Johnson, the world's most broadly based producer of health care products. Johnson & Johnson Pharmaceutical Research and Development is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. Johnson & Johnson Pharmaceutical Research and Development is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

Cordis Corporation Resolves Corporate Warning Letter

Cordis Corporation today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that all items outlined in the company's warning letter have been resolved.

"We are pleased that the FDA warning letter is now resolved," said Rick Anderson, company group chairman, Cordis Corporation. "This is an important achievement for Cordis. We are committed to ensuring that our systems and procedures continue to provide for quality products and services that fulfill the clinical needs of interventional cardiologists."

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.

More information about Cordis Corporation can be found at www.cordis.com

CVRx, Inc. Closes $65 Million Financing

CVRx, Inc., a private medical device company, has completed a fourth round of private equity financing totaling $65 million. The company has developed the Rheos(TM) Baroreflex Hypertension Therapy(TM) System, the only implantable device designed to control hypertension, a leading cause of heart and kidney disease, stroke and death. Johnson & Johnson Development Corporation was the lead investor. In conjunction with the financing, Dr. Brad Vale, vice president, Johnson & Johnson Development Corporation joined the CVRx Board of Directors.

Other participants in this round included new investor BBT Fund L.P., and existing investors New Enterprise Associates, Thomas Weisel Healthcare Venture Partners, InterWest Partners, ABS Ventures, Frazier Healthcare Ventures and SightLine Partners. With this financing, the total investment in CVRx exceeds $125 million.

"We are excited to have the confidence and support of our investors. The early clinical trial results have been promising, and we look forward to providing a new treatment option to the millions of patients whose hypertension does not respond to drug therapy. We have a strong, experienced management team to execute our plan, and these funds will help us complete this important trial," said Nadim Yared, president and CEO of CVRx.

Preliminary data from European and U.S. early clinical trials evaluating the safety and clinical effectiveness of the Rheos System were presented in a Late-Breaking Emerging Technologies Session at the recent American College of Cardiology conference. The findings showed a significant reduction in blood pressure in patients with drug-resistant hypertension who have a systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including a diuretic. The ACC presentation reported office measurement results after six months of active Rheos therapy for the first 21 European and U.S. patients enrolled in these trials. Systolic blood pressure was reduced by an average of 21 mmHg (187 mmHg vs.166 mmHg); and diastolic blood pressure was reduced by an average of 16 mmHg (112 mmHg vs. 96 mmHg). CVRx, Inc.

Rheos Pivotal Trial in Progress

CVRx received investigational device exemption (IDE) approval from the Food and Drug Administration to begin a U.S. pivotal clinical trial that is evaluating the safety and effectiveness of the Rheos System in 300 patients. The blinded study is a prospective, randomized, placebo-controlled clinical trial that is being conducted at multiple medical sites in the United States and in Europe. To be enrolled in the trial, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic, and their systolic blood pressure must be greater than or equal to 160 mmHg. Study results are intended to support the Pre-Market Approval (PMA) application for the Rheos System to the FDA.

The Rheos System: Working with the Body's Own Mechanisms

The Rheos System provides a "physio-rational" method to reduce blood pressure. The system's proprietary technology uses the body's own natural blood pressure regulation system (the baroreflex) to control blood pressure.

The system electrically stimulates the baroreflex, which sends signals to the brain suggesting a blood pressure increase. Then, the brain acts to lower blood pressure by sending signals to various parts of the body, including the blood vessels, heart and kidneys.

The Rheos System includes:

A small pulse generator that is implanted under the collar bone;
Two thin lead wires that are implanted at the left and right carotid arteries and connect to the pulse generator; and
The Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.
Hypertension: The Need for a New Treatment Option

High blood pressure, also referred to as hypertension, affects about 72 million people in the United States alone.(1) Hypertension causes an estimated one in every eight deaths worldwide. Each incremental increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal levels is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.(2),(3)

About Johnson & Johnson Development Corporation

Organized in 1973, Johnson & Johnson Development Corporation (JJDC) is the venture capital subsidiary of Johnson & Johnson. JJDC makes private equity investments in venture funded health care companies. Portfolio companies include those in the fields of pharmaceuticals, biotechnology, medical devices, diagnostics and consumer products. JJDC also leads and manages internal investments in selected promising technologies. For more information, go to www.jjdevcorp.com

About CVRx, Inc.

CVRx, Inc., is a private company founded in 2001 and headquartered in Minneapolis. Its senior management and technical teams have many years of experience commercializing implantable medical devices. For more information on CVRx and the Rheos pivotal clinical trial, visit www.cvrx.com

Footnotes:

(1) Heart Disease and Stroke Statistics. American Heart Association - 2007 Update.

(2) U.S. Renal Data System. USRDS 2003 Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2003.

(3) Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-1913.

CAUTION: CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only.

CVRx, Rheos, Baroreflex Hypertension Therapy are trademarks of CVRx, Inc.

Ethicon Endo-Surgery, Inc., Files For FDA Approval Of New Gastric Band For Treatment Of Morbid Obesity

Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, today announced that it has submitted a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its adjustable gastric band, an implantable device intended to treat morbid obesity.

The company's submission includes results from a prospective multi-center clinical trial of 276 patients with a body mass index (BMI) of 40 or more (100 pounds or more above ideal body weight) or a BMI of 35 or more, with one or more obesity-related conditions such as Type 2 diabetes. The primary endpoint for the study was percent of excess weight loss at three years. Patients with these BMI are classified as morbidly obese.

The clinical trial was designed to evaluate the safety and effectiveness of the device, which has been commercially available outside the U.S. since 1996 and has been implanted in over 100,000 patients worldwide. The device is a soft, adjustable band that is fitted around the uppermost part of the stomach during laparoscopic surgery, creating a small pouch and restricting food consumption.

"The submission of this application to the FDA is an important milestone as we seek to provide the bariatric community more treatment options and solutions for morbid obesity, a life-threatening disease that continues to grow throughout the world," said Kenneth Sumner, Ph.D., vice president, Worldwide Clinical and Regulatory Affairs, Ethicon Endo-Surgery, Inc. According to the American Society for Bariatric Surgery (ASBS), about 15 million people in the U.S. have morbid obesity, and in 2006, about 177,000 people had some type of bariatric surgery.

About Ethicon Endo-Surgery, Inc.

Ethicon Endo-Surgery, Inc., develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information on the company can be found at www.ethiconendo.com.

Voluntary Drug Recall -- Ortho-McNeil Pharmaceutical, Inc., Issues A Nationwide Recall Of GRIFULVIN V/Griseofulvin Oral Suspension

Glass bottles of griseofulvin oral suspension (liquid) [GRIFULVIN V®], microsize 125 mg/5mL, a prescription medicine used to treat ringworm and other fungal infections, are being voluntarily recalled as a precaution from wholesalers and retail pharmacies nationwide. The voluntary recall is a precaution based on two reports of glass fragments found in bottles of the liquid formulation. Consumers who believe they are in possession of recalled product should contact the pharmacy where the medicine was purchased.

The voluntary recall is being conducted by Ortho Dermatological, Division of Ortho-McNeil Pharmaceutical, Inc., manufacturer of GRIFULVIN V® and griseofulvin oral suspension, which has a Patriot Pharmaceuticals, L.L.C., label. This voluntary recall is limited to the liquid formulation of the medication and does not include any other dosage form.

The two reports of glass fragments are believed to be the result of bottle breakage during shipping and handling. A plastic over-wrap placed on bottles of this medicine for protection might have made it difficult to detect breakage that occurred during shipping and handling, and action is being taken to change the over-wrap to prevent this possible occurrence in the future. In the unlikely event that a damaged bottle has been dispensed, a potential exists for injury due to accidental ingestion of glass fragments. There have been no reports of adverse events from the reported glass fragments in broken bottles.

The lots were shipped to distributors in the United States only between August 23, 2005, and March 14, 2007. Lot numbers are listed at the end of this press advisory and posted on www.aboutgrifulvin.com. Lot numbers can be found on the back of the product label only on four-ounce (120 mL) glass bottles filled by the manufacturer. Consumers with pharmacy-dispensed bottles, which were filled at the pharmacy and do not contain lot numbers, should contact the pharmacy where they purchased the medicine to determine if they are in possession of product that has been recalled.

In addition to contacting the pharmacy where the medicine was purchased, consumers who believe they are in possession of recalled bottles of GRIFULVIN V® griseofulvin oral suspension (liquid) may also call 1-800-426-7762. Consumers who believe they are in possession of affected product from Patriot Pharmaceuticals, LLC, griseofulvin oral suspension (liquid), may call 1-800-510-0383. Consumers should direct medical questions to their health care providers. Adverse reactions experienced with the use of this product should be reported to the company using the telephone numbers above.

The company is voluntarily conducting this recall in cooperation with the U.S. Food and Drug Administration and sending urgent recall letters to wholesalers and pharmacies nationwide. In addition, the company is taking action to supply new inventory to its customers.

Griseofulvin Oral Suspension (microsize) 125 mg/5ml
(PATRIOT Pharmaceuticals, L.L.C.)
Lot No. Expiry Date
5LA410 03/31/2007
6BA565 03/31/2008
6KA031 10/31/2008
5LA411 03/31/2007
6BA566 03/31/2008
6KA032 10/31/2008
5LA412 03/31/2007
6CA593 03/31/2008
6KA033 10/31/2008
5LA413 03/31/2007
6CA594 03/31/2008
6KA034 10/31/2008
5LA414 03/31/2007
6CA595 04/30/2008
6KA035 10/31/2008
5LA415 03/31/2007
6CA596 04/30/2008
6KA036 10/31/2008
5LA416 03/31/2007
6CA597 04/30/2008
6KA990 09/30/2008
5LA417 03/31/2007
6DA622 04/30/2008
6KA991 09/30/2008
5LA418 03/31/2007
6DA623 05/31/2008
6LA109 10/31/2008
5NA469 03/31/2007
6DA624 05/31/2008
6LA110 10/31/2008
5NA470 03/31/2007
6DA625 05/31/2008
6LA111 10/31/2008
5NA471 03/31/2007
6DA626 06/30/2008
6LA112 11/30/2008
6AA494 01/31/2008
6GA725 07/31/2008
6LA113 11/30/2008
6AA495 01/31/2008
6GA726 07/31/2008
6LA114 11/30/2008
6AA496 01/31/2008
6GA727 07/31/2008
6LA128 11/30/2008
6AA497 01/31/2008
6GA728 07/31/2008
6LA130 11/30/2008
6AA505 01/31/2008
6GA729 07/31/2008
6MA173 11/30/2008
6AA506 01/31/2008
6HA839 07/31/2008
6HA840 07/31/2008
6MA175 11/30/2008
6AA508 01/31/2008
6HA841 08/31/2008
6MA176 11/30/2008
6AA509 01/31/2008
6HA842 08/31/2008
6MA194 11/30/2008
6AA516 01/31/2008
6HA843 08/31/2008
6MA231 11/30/2008
6AA517 01/31/2008
6HA844 08/31/2008
6MA232 11/30/2008
6AA518 02/29/2008
6HA845 08/31/2008
6MA233 12/31/2008
6AA519 02/29/2008
6HA847 08/31/2008
6MA234 12/31/2008
6AA520 02/29/2008
6HA848 08/31/2008
6MA235 12/31/2008
6AA521 02/29/2008
6HA849 08/31/2008
6MA236 12/31/2008
6AA532 02/29/2008
6HA850 08/31/2008
6MA238 12/31/2008
6AA533 02/29/2008
6HA867 09/30/2008
6MA239 12/31/2008
6AA534 02/29/2008
6HA870 09/30/2008
6MA240 12/31/2008
6AA535 02/29/2008
6HA871 09/30/2008
6MA241 12/31/2008
6AA536 02/29/2008
6HA872 09/30/2008
6MA242 01/31/2009
6BA561 03/31/2008
6HA875 09/30/2008
6MA246 01/31/2009
6BA562 03/31/2008
6KA028 09/30/2008
6MA247 01/31/2009
6BA563 02/29/2008
6KA029 10/31/2008
6BA564 03/31/2008
6KA030 10/31/2008



GRIFULVIN V® brand (griseofulvin oral suspension) microsize Suspension 125mg/5ml
Lot No. Expiry Date
5CA136 03/31/2007
5CA138 03/31/2007
5CA139 03/31/2007
5CA143 03/31/2007
5CA144 03/31/2007
5CA145 03/31/2007
5CA146 03/31/2007
5CA147 03/31/2007
5CA148 03/31/2007
5CA149 03/31/2007
5CA150 03/31/2007
5CA151 03/31/2007
5CA164 03/31/2007
5CA165 04/30/2007
6CA616 03/31/2008
6DA636 04/30/2008
6DA637 04/30/2008
6DA638 04/30/2008
6DA640 04/30/2008
6DA646 04/30/2008
6DA647 04/30/2008
6DA648 04/30/2008
6DA649 04/30/2008
6DA657 04/30/2008
6EA670 05/31/2008
6GA731 07/31/2008
6HA846 07/31/2008
6HA851 08/31/2008
6HA868 07/31/2008
6HA873 09/30/2008
6HA874 08/31/2008
6JA936 09/30/2008
6JA937 09/30/2008
6KA987 09/30/2008
6KA988 09/30/2008
6KA989 09/30/2008
6MA193 11/30/2008

Cordis Corporation Starts Pivotal Trial for ExoSeal Vascular Closure Device

Cordis Corporation, a worldwide leader in developing and manufacturing interventional vascular technology, announced today the start of the pivotal trial for the ExoSeal™ Vascular Closure Device. The ECLIPSE Trial is a multicenter, non-blinded, randomized study designed to measure the safety and efficacy of the ExoSeal™ Vascular Closure Device versus manual compression to close vascular access sites in patients having undergone diagnostic or interventional procedures. The trial will encompass 400 patients from 18 medical centers across the United States.

On February 13, Principal Investigator Chiu Wong, M.D., associate professor of Medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center, and a Cordis Corporation consultant, treated the first patient in the trial. Prior to the start of the ECLIPSE Trial, the ExoSeal™ Vascular Closure Device had been used in 150 patients participating in a first-in-human study for the device.

"The results from the first-in-man study were very encouraging, and this trial will help us determine whether those results can be maintained in a larger number of patients," said Dr. Wong. "As an interventional cardiologist, I welcome the opportunity to investigate a device that could help patients recover faster from a catheterization procedure."

The ExoSeal™ Vascular Closure Device features a synthetic bioabsorbable polymer and is being studied to determine whether it can enable expedited hemostasis (the cessation of bleeding), faster patient ambulation (ability to walk) and reduced bed-stay after a catheterization procedure. It also represents Cordis Corporation’s entry into the vascular closure device market. Nearly eight million patients undergo cardiac catheterization procedures annually.

"The swift progress of the ExoSeal™ Vascular Closure Device from the proof-of-concept stage to a pivotal trial in only seven months marks a major milestone in Cordis Corporation's efforts to accelerate the development of new devices to improve the treatment of vascular diseases," said Campbell Rogers, M.D., chief technology officer, Cordis Corporation. "The ECLIPSE Trial will help us evaluate whether the ExoSeal™ Vascular Closure Device could make a significant and positive difference in patients' comfort as well as recovery time following a catheterization procedure."

Catheterization procedures involve the temporary insertion of a catheter into an artery, usually the femoral artery, through a vascular puncture. While a variety of methods, such as manual compression, sandbags and mechanical clamps have been used to close the puncture site and stop the bleeding after the catheter is removed, many of these methods cause significant discomfort and require several hours of bed-rest.

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease. For more information, visit www.cordis.com

CYPHER Sirolimus-Eluting Coronary Stent Demonstrates Sustained Benefits Compared To Bare-Metal Stents In Five-Year Randomized Clinical Trial

Clinical investigators at the American College of Cardiology's 56th Annual Scientific Session (ACC.07) reported today that the clinical benefit of the CYPHER® Sirolimus-eluting Coronary Stent compared to a bare-metal stent (BMS) in the SIRIUS Trial was preserved from the initial nine-month follow-up out to five years. In addition, no differences were observed between the CYPHER® Stent and the BMS in the safety measures of myocardial infarction (heart attack), death or stent thrombosis (blood clots).

At five-year follow-up, patients in the CYPHER® Stent arm experienced significantly lower rates of target vessel failure (TVF), the primary endpoint of the trial, than those who received the BMS (22.5 percent for the CYPHER® Stent versus 34.7 percent for the BMS; p<0.0001). In the trial, TVF was defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR, or re-treatment of the blocked vessel).

"Our findings reinforce the existing body of evidence supporting the long-term benefits of the CYPHER® Stent as an effective treatment for coronary artery disease," said Co-principal Investigator Martin B. Leon, M.D., Chairman Emeritus, Cardiovascular Research Foundation and Associate Director, Center for Interventional Vascular Therapy, Columbia University Medical Center. "The CYPHER® Stent has provided significant benefits for many patients since we initiated the SIRIUS Trial."

In this long-term follow-up, the CYPHER® Stent also demonstrated lower rates of target lesion revascularization (TLR, or re-treatment at the same arterial site) and major adverse cardiac events (MACE), which include myocardial infarction and death, compared to the BMS. The TLR rate for the CYPHER® Stent was 9.4 percent versus 24.2 percent for the BMS (p<0.0001), and the MACE rate for the CYPHER® Stent was 20.3 percent versus 33.5 percent for the BMS (p<0.0001). These five-year outcomes support the previously reported results of the trial.

There was no significant difference in the overall rate of stent thrombosis between the CYPHER® Stent and the BMS, regardless of the definition of stent thrombosis employed. The definitions include the original SIRIUS Trial protocol definition and the Academic Research Consortium (ARC) definition. At 5 years, the protocol definition identified a rate of 1.0 percent stent thrombosis for the CYPHER® Stent versus 0.8 percent for the BMS (p=0.75). The definite/probable ARC definition identified a stent thrombosis rate of 1.2 percent for the CYPHER® Stent versus 1.8 percent for the BMS (p=0.43). While the data demonstrated slight numeric differences in the timing of such events between the CYPHER® Stent and the BMS, at no point throughout the five-year period were the differences statistically significant.

In addition, there was no significant difference in the mortality or the myocardial infarction rates between the CYPHER® Stent and the BMS at five-year follow-up. The mortality rate was 8.4 percent for both stents, while the myocardial infarction rate for the CYPHER® Stent was 6.2 percent, compared to 6.5 percent for the BMS (p=0.90).

"The data presented throughout ACC.07 reinforce the importance of evidence-based medical decisions," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Cardiology Division of Cordis Corporation. "As previously announced, Cordis is expanding the SIRIUS Trial to eight years of follow-up to provide physicians with longer term data about the CYPHER® Stent that will assist them in making informed treatment decisions."

The SIRIUS (Sirolimus-coated BX VELOCITY® Balloon-Expandable Stent in Treatment of Patients with De Novo Coronary Artery Lesions) Trial, sponsored by Cordis Corporation, served as a pivotal study for the U.S. approval of the CYPHER® Stent in 2003 and is the longest running U.S.-based study for a drug-eluting stent.In the double-blinded, multi-center randomized trial, patients were divided into two treatment groups: 533 patients received the CYPHER® Stent and 525 patients received a BMS. Of the original 1,058 participants, 93.8 percent of patients (501 patients receiving the CYPHER® Stent and 491 patients receiving a BMS) participated in the five-year follow up.

About the CYPHER® Stent

The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.

Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER® SELECT™ Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER® SELECT® Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.

For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com

*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.

March Of Dimes, Johnson & Johnson Pediatric Institute, L.L.C., Launch Prematurity Prevention Partnership

To reduce the rate of preventable preterm births in targeted areas of Kentucky, the March of Dimes and Johnson & Johnson Pediatric Institute, L.L.C., today formally launched Healthy Babies Are Worth the Waitsm, a three-year partnership with the Kentucky Department for Public Health. The announcement was made at a news conference prior to the opening of the Kentucky Public Health Association's annual meeting here.

Six Kentucky hospitals representing diverse geographic regions are participating in Healthy Babies Are Worth the Waitsm and are divided into "intervention" and "comparison" sites.

The three intervention sites – King's Daughters Medical Center in Ashland; Trover Clinic/ Regional Medical Center in Hopkins County; and University of Kentucky Hospital in Lexington – will employ an innovative model combining interventions that are diverse, linked elements of clinical care, public health and public education. These include consumer awareness and education; access to screenings and referrals for treatable or preventable conditions; consistent clinical care during the prenatal period and appropriate care between pregnancies; and professional education. The primary goal of Healthy Babies Are Worth the Waitsm is a 15 percent reduction in the rate of singleton (one baby) preterm births in these targeted areas.

Lake Cumberland Regional Hospital in Somerset, Norton Hospital (Downtown) in Louisville, and Paducah's Western Baptist Hospital will serve as comparison sites, providing traditional high quality perinatal services and care.

Preterm birth (defined as birth before 37 completed weeks' gestation) is the leading cause of infant death in the U.S. and puts babies at great risk for lifelong disabilities such as cerebral palsy, blindness and physical and neurological impairment.

Just a few extra days in the womb can make a difference, the organizations said today at the news conference. Even babies considered "late preterm," those born between 34 and 36 weeks, are more likely than full-term infants to experience acute problems after birth, be re-hospitalized, or die within the first year of life.

Nationally, rates of preterm birth have increased more than 30 percent since 1981 and today more than 520,000 babies are born too soon each year; 400,000 of these (or about 80 percent) are late preterm births. In Kentucky, more than 14 percent of births in 2005 were delivered preterm – one of the highest rates in the nation (the U.S. rate is 12.7 percent).

"Preventing preterm birth not only saves babies' lives and improves the future for them and their families, it can lessen the long-term toll such births take on our communities," said Ruth Ann Shepherd, M.D., FAAP, director, Adult & Child Health Improvement, Kentucky Department for Public Health. "We hope that Kentucky's experience with Healthy Babies Are Worth the Waitsm will one day help other states protect their most vulnerable populations so that together we can permanently reverse this trend."

Coordinated Efforts in Public and Professional Education

Healthy Babies Are Worth the Wait sm takes a "bundled" approach to reducing the known risk factors for preterm birth during prenatal care and between pregnancies.

Education at multiple community levels, via myriad channels, will be critical to the partnership's ongoing efforts. To augment the relationships between expectant mothers and their health care providers, the local health departments serving intervention sites will be integral in reaching community members with information about the known risk factors for, and ways to prevent, preterm birth. Further, a tool kit will be available at www.prematurityprevention.org for use by community leaders ranging from social or civic organizations to houses of worship. Finally, ongoing professional education will be available for health care providers at intervention sites.

"Our experience has shown that resolving a public health issue as serious as preterm birth requires commitments from a community's individuals, influential groups and the public and private sectors," said Dr. Jennifer L. Howse, president of the March of Dimes. "We hope that Healthy Babies Are Worth the Wait sm inspires others to do all they can to make sure the babies in their families and communities are born full term if there are no medical problems for either mother or baby."

On-site planning and baseline data collection occurred at all three intervention sites during January and February of this year; implementation began in March and will continue through June 2009. Follow up and evaluation will continue through December 2009; interim reports on results will be made available. Successful outcomes from this model in reducing the rate of preventable singleton preterm births could be replicated in other regions of the country.

"Parents are often unaware about the serious consequences of preterm birth because medical technology is saving babies who once would not have survived. However, babies born even just a few weeks early who physically appear healthy are at risk," said Bonnie J. Petrauskas, a director of the Johnson & Johnson Pediatric Institute, L.L.C. "Healthy Babies Are Worth the Waitsm will bring together parents, providers and communities in an environment that fosters understanding of preterm birth and what can be done to help babies get a healthy start in life."

About the March of Dimes

The March of Dimes is a national voluntary health agency whose mission is to improve the health of babies by preventing birth defects, premature birth and infant mortality. For more information, visit the March of Dimes Web site at www.marchofdimes.com or its Spanish language Web site at www.nacersano.org

About the Johnson & Johnson Pediatric Institute, L.L.C.

The Johnson & Johnson Pediatric Institute, L.L.C., is an education-based entity within Johnson & Johnson Corporate Contributions, which has a mission to make life-changing, long-term differences in human health by targeting, through community engagement, the world's major health-related issues. Johnson & Johnson Pediatric Institute, L.L.C., partnerships focus on safe, healthy pregnancies and deliveries, and improved care for babies who might otherwise succumb to preventable conditions.

About the Kentucky Department for Public Health

The Department for Public Health is a part of the Cabinet for Health and Family Services. Through its expansive services, Department for Public Health reaches thousands of Kentuckians each year by developing and operating all public health programs and activities for the citizens of Kentucky. These health service programs are aimed at prevention, detection, care and treatment of physical disabilities, illness and disease. More information about DPH can be found at www.chfs.ky.gov/dph

ACUVUE Celebrates 20th Anniversary Of First Disposable Contact Lens With Launch Of New 1•DAY ACUVUE MOIST

Twenty years after revolutionizing the contact lens industry with the introduction of the first disposable soft contact lens, VISTAKON®, Division of Johnson & Johnson Vision Care, Inc., today announced the U.S. launch of 1•DAY ACUVUE® MOIST™ Brand Contact Lenses with breakthrough LACREON™ technology.

LACREON™ technology employs a unique process that permanently embeds a water holding ingredient, similar to that found in natural tears, into the proven etafilcon A material of the 1•DAY ACUVUE® Brand. This technological advancement locks in moisture that lasts throughout the day, offering relief for the most frequently reported complaints of contact lens discomfort – dryness and end of day comfort. The new daily disposable lenses also eliminate the need for cleaning, disinfecting solutions and storage, and, compared to two-week lenses, may provide improved comfort for patients who experience mild discomfort and itching associated with allergies during contact lens wear.

"Two decades ago, with the introduction of ACUVUE®, it was immediately clear that a new, clean lens every week or every two weeks was a healthier paradigm," says Cristina Schnider, O.D., director, Medical Affairs, Vistakon. "Today, many eye care practitioners and consumers favor daily disposable contacts because of their health and convenience benefits."

Demonstrated Benefits for Eye Allergy Sufferers

Approximately two million allergy sufferers have eye allergies as their primary allergy, according to the Asthma & Allergy Foundation of America. For many of the nation's 38 million contact lens wearers, allergy season can bring tears, and more, to their eyes.

"Allergy sufferers who wear contact lenses that you use for two weeks or more may experience discomfort and symptoms such as ocular itching, tearing and redness when wearing their lenses, because allergens may build up on the lenses over time," explains Leonard Bielory, M.D., professor of Medicine, Pediatrics and Ophthalmology, director, Division of Allergy/Immunology & Rheumatology, UMDNJ-New Jersey Medical School. "When worn on a daily disposable basis, 1•DAY ACUVUE® MOIST™ may provide improved comfort for many patients who experience mild discomfort and itching associated with allergies during contact lens wear, compared to lenses replaced at intervals of greater than two weeks."

Lenses Also Offer UV Protection

All ACUVUE® Brand Contact Lenses offer effective UV-blocking. 1•DAY ACUVUE® MOIST™ block approximately 82 percent of UV-A radiation and 97 percent of UV-B radiation† *. On average, contact lenses without UV blocking block approximately 10 percent of UV-A radiation and 30 percent of UV-B radiation.

Although UV-blocking contact lenses provide important added protection for patients, they should not be viewed as a stand-alone solution. "For more complete protection, UV-blocking contact lenses should always be worn in conjunction with high-quality UV-blocking sunglasses and a wide-brimmed hat," says Dr.Schnider.

To receive a free trial pair certificate for 1•DAY ACUVUE® MOIST™ visit www.acuvue.com (Professional exam fees not included) and look for "Click-to-be-Contacted," a new online service that offers patients a quick, easy way to schedule an eye exam for contact lenses.

1•DAY ACUVUE® MOIST™ is available by prescription only for vision correction. An eye care professional will determine whether contact lenses are right for individual patients. Although rare, serious eye problems can develop. To help avoid these problems, patients should follow the wear and replacement schedule and the lens-care instructions provided by their eye doctor. Individuals should not wear lenses if they have an eye infection or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. If one of these conditions occurs, they should contact their eye doctor immediately.

Johnson & Johnson Vision Care Inc.

The VISTAKON division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses which it markets under such brand names as ACUVUE®, ACUVUE® ADVANCE™ with HYDRACLEAR™, ACUVUE® ADVANCE™ for ASTIGMATISM, ACUVUE® OASYS™ with HYDRACLEAR™ PLUS, ACUVUE® and ACUVUE® 2; 1•DAYACUVUE®; 1•DAY ACUVUE® MOIST™; ACUVUE® BIFOCAL; ACUVUE® TORIC, and ACUVUE® 2 COLOURS™.

ACUVUE®, ACUVUE® ADVANCE™, HYDRACLEAR™, ACUVUE® OASYS™, ACUVUE® 2 COLOURS™, 1•DAY ACUVUE® MOIST™, LACREON™ and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.

† Helps protect against transmission of harmful UV radiation to the cornea and into the eye.

* WARNING: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed. NOTE: Long term exposure to UV radiation is one of the risk factors associated with cataracts. Exposure is based on a number of factors such as environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-Blocking contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-Blocking contact lenses reduces the risk of developing cataracts or other eye disorders. Consult your eye care practitioner for more information.

U.S. District Court Grants Permanent Injunction Prohibiting Mylan From Marketing Generic Version Of TOPAMAX (topiramate)

A U.S. District Court has upheld the validity and enforceability of the TOPAMAX® (topiramate) patent, and today issued a permanent injunction against Mylan Laboratories, Inc. The injunction prohibits Mylan from selling generic topiramate tablets and capsules in the U.S. until the Ortho-McNeil Neurologics, Inc., compound patent on TOPAMAX® expires in 2008.

Mylan filed an Abbreviated New Drug Application ("ANDA") to market topiramate before the expiration of the patent, claiming the patent was invalid. Ortho-McNeil Neurologics, Inc., filed a patent infringement complaint against Mylan in April 2004. A preliminary injunction against Mylan was granted on October 23, 2006.

The final ruling, issued by U.S. District Court Judge Stanley R. Chesler in Newark, NJ, directs the U.S. Food and Drug Administration (FDA) to change the effective date of Mylan's approvals to market its generic topiramate products to no earlier than September 26, 2008, the date of the TOPAMAX® compound patent expiration. Cobalt Pharmaceuticals, which Ortho-McNeil Neurologics, Inc., sued in October 2005, agreed to be bound by the outcome of the Mylan case.

TOPAMAX® is indicated as monotherapy in patients with newly diagnosed epilepsy or for conversion to monotherapy in patients with epilepsy. It is also indicated as adjunctive therapy for adults and children (aged two and above) with partial onset seizures or generalized tonic-clonic seizures, and in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox Gastaut syndrome. TOPAMAX® is indicated in adults for the prophylaxis of migraine headache. The usefulness in the acute treatment of migraine headache has not been studied.

Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Inc., focuses exclusively on providing solutions that improve neurological health. The company currently markets products for Alzheimer's disease, epilepsy and acute and preventative migraine treatment. Ortho-McNeil Neurologics, Inc., in conjunction with internal and external research partners, continues to explore new opportunities to develop solutions for unmet healthcare needs in neurology.

TOPAMAX® Important Safety Information for Epilepsy

Serious risks associated with TOPAMAX® include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis), and hyperventilation (rapid, deep breathing) or fatigue. More severe symptoms of metabolic acidosis could include irregular heartbeat or changes in the level of alertness. Chronic, untreated metabolic acidosis may increase the risk for kidney stones or bone disease. Your doctor may want to do simple blood tests to measure bicarbonate levels.

Other serious risks include increased eye pressure (glaucoma), decreased sweating, increased body temperature, kidney stones, sleepiness, dizziness, confusion and difficulty concentrating. Tell your doctor immediately if you have blurred vision or eye pain.

More common side effects in adults are nervousness, coordination problems, fatigue, speech problems, slowed thinking, memory difficulty, tingling in arms and legs and double vision; and in children, fatigue, loss of appetite, nervousness, memory difficulty, aggressive behavior and weight loss.

As monotherapy, the most common side effects of TOPAMAX® (in the 400 mg/day group and at a rate higher than the 50 mg/day group) in adults were tingling in arms and legs, weight decrease, sleepiness, loss of appetite, dizziness and difficulty with memory; and in children, weight decrease, upper respiratory tract infection, tingling in arms and legs, loss of appetite, diarrhea and mood problems.

In combination with other antiepileptic drugs (AEDs), the most common side effects of TOPAMAX® in adults (200 to 400 mg/day) were sleepiness, dizziness, nervousness, loss of muscle coordination, fatigue, speech disorders and related problems, psychomotor slowing, abnormal vision, difficulty with memory, tingling in arms and legs and double vision; and in children (5 to 9 mg/kg/day), fatigue, sleepiness, loss of appetite, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction and weight decrease.

Tell your doctor about other medications you take.

Please see full U.S. Prescribing Information at www.TOPAMAX-epilepsy.com

TOPAMAX® Important Safety Information for Migraine

Serious risks associated with TOPAMAX® include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis), and hyperventilation (rapid, deep breathing) or fatigue. More severe symptoms of metabolic acidosis could include irregular heartbeat or changes in the level of alertness. Chronic, untreated metabolic acidosis may increase the risk for kidney stones or bone disease. Your doctor may want to do simple blood tests to measure bicarbonate levels.

Other serious risks include increased eye pressure (glaucoma), decreased sweating, increased body temperature, kidney stones, sleepiness, dizziness, confusion and difficulty concentrating. Tell your doctor immediately if you have blurred vision or eye pain.

More common side effects are tingling in arms and legs, loss of appetite, nausea, diarrhea, taste change and weight loss.

Tell your doctor about other medications you take.

Please see full U.S. Prescribing Information at www.TOPAMAX.com or call 1-888-526-7736.