Bayer HealthCare Pharmaceuticals today launched a new tool using a technology that many people with multiple sclerosis (MS) already have in their pockets or purses – their iPhone. 

The new iPhone application, myBETAapp™, provides tools that are customized for Betaseron® (interferon beta-1b) patients, making it the first application developed for use with a specific MS medication. 

myBETAapp is the newest offering in Bayer's comprehensive patient support program, BETAPLUS®.  The application provides patients with injection reminders, injection site rotation assistance and injection history.  Through the Internet, myBETAapp also gives patients access to the BETAPLUS Web page on Betaseron.com, including links to educational tools, peer support and contacts listed on the site.  With active phone service, patients enrolled in the BETAPLUS program can dial directly to speak to BETA Nurses, who are specially trained in MS.

According to Sally Jewell, Director, BETAPLUS/BETA Nurse Programs, "For many years, the assistance provided to Betaseron patients through BETAPLUS, including personalized nursing care, has been instrumental in helping patients stay committed to their treatment.  This newest addition allows patients to carry that support with them in their iPhone/iPod touch wherever they go, whether that's at home, at work or on vacation."

Starting today, Betaseron patients will have free, exclusive access to the application by visiting betaseron.com/app or betaseron.com, where they can also access more information on Betaseron and BETAPLUS.

"Bayer is committed to the care of MS.  BETAPLUS, our comprehensive support program for people taking Betaseron, helps to address the day-to-day needs of people living with this disease," said Paul Bedard, Vice President and General Manager, Neurology, Bayer HealthCare Pharmaceuticals.  "MyBETAapp is an extension of our ongoing commitment to help improve the management of MS."

BETAPLUS offers a dependable support program for people who are taking Betaseron.  The wide range of resources includes one-on-one training and regular follow-up calls by an MS-trained BETA Nurse, access to the Peer Mentor Program, and Access Specialists who can work with a patient's insurance company.

Source: Bayer HealthCare Pharmaceuticals (03/06/10)

Bayer Schering Pharma AG announced that the Chinese State Food and Drug Administration (SFDA) has approved Betaferon® (interferon beta-1b) therapy for patients with relapsing-remitting multiple sclerosis (MS). Bayer plans to launch Betaferon in China by mid 2010. Betaferon is available in more than 100 countries around the world.

“This approval is good news for MS patients in China, allowing them access to Betaferon, that has been demonstrated to modify the course of MS,” said Habib Dable, Global Head, Neurology/Ophthalmology of Bayer Schering Pharma AG. "The approval of Betaferon in China underscores Bayer’s ongoing commitment to address the unmet medical needs of people around the world. With the foundation of a research and development center in Beijing in February 2009, Bayer has strengthened its engagement in the Region. In the upcoming five years, a total of 100 million Euro is planned to be invested in a center for clinical research in Beijing."

The approval is based on established efficacy and safety data from pivotal Betaferon clinical trials, along with findings from a single-arm study designed to demonstrate the efficacy and safety of Betaferon among Chinese patients with relapsing-remitting MS. During the multi-center six-month study, Betaferon significantly decreased the number of newly active lesions on MRI in Chinese patients. The data in MS patients from China is comparable with data from Betaferon studies in different patient populations and with Bayer’s post-marketing experience.

About the Betaferon study in China
In the multicenter single-arm open label study, 39 patients were enrolled into a three-month pre-treatment phase followed by a six-month treatment phase. The primary efficacy endpoint was the number of newly active lesions during six months on therapy.

Newly active lesions were defined as new T1 Gd-enhancing lesions and non-enhancing T1 lesions appearing new (or enlarged) on T2-weighted scans at months three and six (cumulative six-month number divided by two), compared to the number of newly active lesions during a three-month pre-treatment period. In the treatment period, significant decreases were observed for the primary endpoint. The mean number of newly active lesions in the pretreatment group was 4.77, vs. the 1.55 in the treatment group (p<0.0001).

Adverse events (AEs) were usually self-limiting and mild or moderate. The most frequent AEs were flu-like-symptoms, injection site reactions and hepatic function abnormality. None of the patients discontinued treatment because of AEs or laboratory toxicity.

Source: Bayer Schering Pharma AG (01/12/09)

Bayer will launch a titration pack for patients with multiple sclerosis (MS) that is specially designed to make it easier for them to start Betaferon® (interferon beta-1b) therapy. From now on, the titration pack will be available in Germany. More European countries will follow in 2009. The four-week pack facilitates a gradual increase in dose as recommended for patients new on Betaferon®.

Betaferon® is a well-established therapy for people starting their MS treatment as early as after the first signs of the condition. Findings from the recent landmark BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) trial have shown that gradual dose titration of the medication contributes to a high acceptance of Betaferon® treatment from the start. Delivering Betaferon® in an easy-to-use titration pack for the first four weeks of therapy will simplify the titration process for physicians, MS-nurses and patients.

"The new pack will make it easier for people with MS to start therapy. The titration process helps the body to better adjust to the medication, resulting regularly in fewer side effects. This is important because greater patient comfort, especially during the start of the therapy, can improve patient compliance to therapy and, consequently, its effectiveness," said Habib Dable, Vice President and Global Head, Neurology/Ophthalmology of Bayer Schering Pharma`s Global Business Unit Specialty Medicine.

Source: Medical News Today © 2009 MediLexicon International Ltd (29/03/09)

Bayer Schering Pharma has announced that it will launch a 30-gauge needle for its multiple sclerosis treatment Betaferon in the US.

According to the company, this needle will be the thinnest needle of any injectable disease-modifying therapy for people with multiple sclerosis (MS). The needle is said to be as thin as those commonly used for insulin and pediatric injections.

The needle has already been successfully introduced in more than 17 European countries and Canada, said Bayer. In a study in Europe, Betaferon patients using the 30-gauge needle reported more than 50% of their injections were pain-free immediately after injection. The thinnest, 30-gauge needle will be introduced in the US with an optional autoinjector called Betaject Lite, the company said.

Hans Bishop, head of specialty medicine at Bayer Schering Pharma, said: "Betaferon is a an effective well-tolerated treatment for people with relapsing forms of MS, as well as those with the earliest signs of the disease. Introducing the thinnest needle of any MS treatment in the US is another important step in our commitment to make it easier for people with MS to start therapy and continue using it."

Source: Pharmaceutical Business Review ©2008 Progressive Media Group (17/09/08)

According to a recent North American survey, almost all (97 per cent) people living with Multiple Sclerosis (MS) are committed to controlling their lifelong condition by any means necessary.¹ Nonetheless, they are faced with significant barriers that may prevent them from adhering to a treatment regimen. For example, the majority of patients (56 per cent) stated at least one barrier about injections that makes them uncomfortable; most often cited was the length of a needle (33 per cent), followed by the thickness (31 per cent).1 In addition, anxiety was the most common negative emotion around injections (61 per cent).

“The data identifies a need for an improved, patient friendly and effective device that can help patients adhere to therapy, which translates to better management of their symptoms and improved quality of life, with less chance of relapse occurring,” said Nathalie Girouard, RN, Therapeutics Nurse, Ottawa Hospital/MS Clinic. “Adherence to effective and consistent treatment in the early stages is critical in delaying the progression of the disease and providing protection against the development of definite MS.”

According to the survey, 90 per cent of people consider the strongest motivator for starting MS treatment is realizing that it will help slow disease progression.¹ Patient motivation can be increased by offering solutions to the barriers, including using the thinnest needle available (70 per cent), co-pay assistance or other financial support (69 per cent), having a good injection technique (69 per cent), and using an autoinjector (55 per cent).¹

New Autoinjector Responds to Patients’ Needs

Bayer has launched the new Betaject Lite autoinjector and a 30 gauge needle. It has thinnest needle of all disease modifying therapies, resulting in less pain, fewer injection site reactions, less needle anxiety, and better adherence and long-term outcomes.

The new Betaject Lite autoinjector uses the effective BETASERON® (interferon beta-1b) therapy. The Betaject Lite autoinjector enhances compliance, so patients can benefit from BETASERON in delaying progression of their MS and helping to maintain their quality of life. Since BETASERON was first approved for use in Europe and the United States, this year marks 15 years of achievements for BETASERON in the treatment of patients with MS.

Eighty-two per cent of people surveyed see benefits to using a thinner needle, including less pain during injection (55 per cent), greater comfort during injection (54 per cent), less bruising (42 per cent), less pain after injection (40 per cent), less anxiety immediately before injection (34 per cent) and less impact on mood when anticipating injections (30 per cent).¹

“MS is a disabling disease and it is always important to have new treatment options available to manage the complexity of this disease in the easiest most successful way possible,” said Nathalie Girouard, RN, Therapeutics Nurse, Ottawa Hospital/MS Clinic. “I am confident that the Betaject Lite autoinjector and 30 g needle will help to reduce the negative emotions and anxiety that are associated with injections, empower MS patients to better adhere to their medication regimen and take control of their lives.“

The survey also determines that nurses play a pivotal role in supporting and motivating MS patients and helping them cope with the daily challenges of their disease. Patients also value the advice and tips nurses recommend, including ways to avoid side effects and injection site reactions (68 per cent), information on financial assistance (58 per cent), offering a variety of injection techniques (54 per cent) and helping patients choose proper rotation of injection sites (49 per cent).¹

References

¹ Russell Research Survey, 2008 

Kappos L et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology 2007; 67(7):1242-9. 4 BETASERON® Product Monograph. Bayer Inc., December 21, 2007.

Source: PharmaLive (12/09/08)

Bayer AG, Germany's largest drugmaker, said European regulators recommended its Betaseron treatment for use in early stages of multiple sclerosis.

The Committee for Medicinal Products for Human Use backed adjusting the medicine's label to say Betaseron can delay the progression of disability when used after the first attack of the disease, the Leverkusen, Germany-based company said in a faxed statement today. The European Commission generally approves the London-based committee's decision within three months.

The addition may boost Betaseron sales, helping the drug catch up to rivals Rebif, made by Merck KGaA, and Biogen Idec Inc.'s Avonex. Bayer will depend on steady revenue from Betaseron to help growth until sales from cancer treatment Nexavar and anti-clotting drug Xarelto kick in.

"Adding the disability data to our label will clearly differentiate Betaseron from all other products in the market place and strengthen our position," Darlene Jody, head of Bayer's therapeutics unit, said in the release.

MS affects the central nervous system - the brain, spinal cord and optic nerves. The fatty tissue surrounding and protecting nerve fibers is lost, inhibiting their ability to conduct electrical impulses. The exact cause of the disease isn't known.

Betaseron is approved for the treatment of relapsing forms of MS, as well as for use in patients after the first attack of MS.

In March, Bayer gained control over manufacturing of the medicine by settling a dispute with Swiss rival Novartis AG. Bayer said it will pay Novartis, which makes Betaseron under contract, $110 million for a California plant and another $90 million for inventories of the product. Novartis will be allowed to sell its own version of Betaseron in two years.

Source: Bloomberg.com © Bloomberg LLC 2007 (05/12/07)

Novartis makes Betaseron for Bayer, based in Leverkusen, Germany, and Bayer needed to increase supplies of the product, its best-selling medicine. Bayer agreed to pay $110 million for a factory in Emeryville, California, and another $90 million for inventory of Betaseron, Basel, Switzerland-based Novartis said today in an e-mailed statement.

Bayer sued Novartis last year for manufacturing data in a plan to switch to Boehringer Ingelheim GmbH facilities. As part of today's pact, Novartis will start selling its own branded version in the first half of 2009, and Bayer will help support the Swiss drugmaker's regulatory application. Sales of Betaseron, which Bayer gained with the purchase of Schering AG, rose 10 percent to 264 million euros in the fourth quarter.

``In addition to improving the profitability of the Betaseron franchise through this transaction, we believe a second independent brand will reinforce the existing growth of the global MS market,'' Arthur Higgins, who runs Bayer's drug- making unit, said today in the statement.

Source: Bloomberg.com Copywrite Bloomberg L.P. All Rights Reserved (26/03/07)

Drugs and chemicals group Bayer and Swiss rival Novartis are closer to settling a legal wrangle in the United States over the production and marketing of Bayer's key Betaseron drug, a paper reported.

The companies have made a joint request to a California court to postpone a deadline set for next Tuesday so that they can continue with settlement talks, the Financial Times Deutschland said on Friday.

The firms' lawyers wrote in December that the trial should be postponed until Feb. 20 "to make it possible to conclude the settlement negotiations currently being carried out between the parties", the paper said.

The dispute is over rights relating to multiple sclerosis medication Betaseron, which is one of Bayer unit Schering's star performers. Schering said in November it was suing Novartis in connection with the drug.

Bayer was not immediately available to comment. Novartis declined to comment.

Source: Reuters Health Information Copyright © 2007 Reuters Limited. All rights reserved. (12/01/07)

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