Healthcare Industry News:  COPAXONE 

Biopharmaceuticals Drug Delivery Neurology

 News Release - September 15, 2008

Betaseron(R) to Offer the Thinnest Needle in Multiple Sclerosis

WAYNE, N.J., Sept. 15 (HSMN NewsFeed) -- Bayer HealthCare Pharmaceuticals Inc. today announced that Betaseron®* (interferon beta-1b), its treatment for relapsing forms of multiple sclerosis (MS), will soon be available with a new 30-gauge needle, which will be the thinnest needle of any injectable disease- modifying therapy for people with MS. The new needle is as thin as the needle commonly used for insulin and pediatric injections.

"One of the barriers that many people with multiple sclerosis face in starting an MS treatment is injection anxiety," said Ludger Heeck, Vice President and General Manager, Specialty Medicine, Bayer HealthCare Pharmaceuticals Inc. "Betaseron is a safe and effective treatment for people with relapsing forms of MS, as well as those with the earliest signs of the disease. By introducing the thinnest needle of any injectable disease- modifying medication for MS, we are taking another important step in our commitment to continuously improve Betaseron and its use to help people start and stay on Betaseron long term, particularly those who may have resisted because of anxiety and concerns about injections."

According to a recent North American survey of people with MS, "Injection Anxiety and Barriers to MS Treatment Commitment," the majority of people with MS have, at some point, felt anxiety, nervousness, and fear associated with their injections. Also in the survey, which interviewed 220 people in the United States and Canada who have been diagnosed with MS in the past five years, the majority (56%) of respondents named at least one thing about injections that made them uncomfortable, most often the length (33%) and thickness (31%) of a needle. This was followed by "the thought of a needle" (28%) and "the sight of a needle" (21%).(1)

Additionally, two-thirds (67%) of participants in the survey agree they would be more comfortable injecting themselves if they knew they were using the thinnest needle possible, and about half of the patients surveyed who are not currently on therapy stated they would consider/reconsider taking an injectable MS drug if a thinner needle was shown to be less painful. Benefits cited by participants to using a thinner needle include less pain during injection (55%), less bruising (42%), less pain after injection (40%), and less anxiety immediately before injection (34%).(1)

"Discomfort and anxiety around injections affect many people with MS. Injection anxiety actually can be so high that it keeps people with MS from taking their medication consistently, which is essential to help slow disease progression," stated Dr. Mark Cascione, Neurologist, Tampa Neurology Associates and Medical Director, South Tampa Multiple Sclerosis Center. "The new Betaseron 30-gauge needle is a welcome advancement for people with MS, and particularly for those with anxiety about their injections."

Issues around injections, such as injection anxiety, injection fatigue and injection site pain, are among the top reasons patients cite for not starting or continuing an injectable medication.(1) Betaseron therapy requires half as many injections as COPAXONE®* (glatiramer acetate) with a needle that is 25 percent thinner.(2,3) Additionally, in a study, significantly more Betaseron than Rebif®* patients were pain-free at all time points measured (immediately after injection, and 30 and 60 minutes after injection) over the course of 15 injections.(4) Also in that same study, Betaseron patients using the new 30-gauge needle reported more than 50 percent of their injections were pain-free immediately after injection.(a,b,4)

The new thinnest, 30-gauge needle will be introduced with an optional new autoinjector called BETAJECT® Lite.*(c) In a survey of patients who used the new 30-gauge needle along with the new autoinjector, 98 percent were "satisfied" or "very satisfied" with the new thinner needle and autoinjector after their first injection,(5) and nearly all of the patients who tried the BETAJECT Lite(c) said the new autoinjector was easy to use.(5)

There have been no changes to the formulation or the mixing process of Betaseron -- it is still the same effective medication that patients and doctors have relied on for more than 15 years. People who are currently taking Betaseron can log onto www.betaseron.com/thinner for more information about the new needle and to request the optional BETAJECT Lite autoinjector.

About Betaseron

Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

The most commonly reported adverse reactions are lymphopenia, injection- site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. Betaseron should be used with caution in patients with depression. Injection-site necrosis has been reported in four percent of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information. More information, including the full Prescribing Information, is available at www.betaseron.com.

About Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

(a) N=306; 211 patients used the BETAJECT® Lite autoinjector with the 30-gauge needle, 17 injected BETASERON® manually

(b) Mean proportion of pain-free injections per patient

(c) If you choose to use the BETAJECT Lite autoinjector, you can only use it with Betaseron with the new 30G needle. Use of Betaseron with an autoinjector other than BETAJECT LITE may result in patients not receiving their full recommended dose.

* Trademarks are the property of their respective owners:

Betaseron® and BETAJECT® Lite are registered trademarks of Bayer HealthCare Pharmaceuticals.

COPAXONE® is a registered trademark of Teva Neurosciences, Inc.

Rebif® is a registered trademark of EMD Serono, Inc.

(1) "Injection Anxiety and Barriers to Treatment Commitment Survey." Fielded by Russell Research. Funded by Bayer Healthcare Pharmaceuticals, Inc. March 25, 2008.

(2) COPAXONE® [Package Insert]. Kansas City, MO: Teva Neuroscience, Inc.; 2007.

(3) Data on file, Bayer HealthCare Pharmaceuticals; 2008

(4) K. Baum, C. O'Leary, F. Coret Ferrer, E. Klimova, L. Prochazkova, and J. Bugge for the BRIGHT Study Group. Comparison of injection site pain and injection site reactions in relapsing-remitting multiple sclerosis patients treated with interferon beta-1a or 1b. Mult Scler 2007 13: 1153-1160.

(5) Bugge JP, Rel L. Assessment of Betaferon Application Systems in Portugal: Patients' Feedback. Study Poster. CMSC 2007



Source: Bayer HealthCare

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