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Betaseron

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Chemical Name: Interferon beta-1b

Brand Name: Betaseron (U.S. and Canada)

Generic Available: No

 

Description: Betaseron is a medication manufactured by a biotechnological process from one of the naturally occurring interferons (a type of protein). In a clinical trial of 372 ambulatory patients with relapsing-remitting MS, those taking the currently recommended dose of the medication experienced fewer exacerbations, a longer time between exacerbations, and exacerbations that were generally less severe than those of patients taking a lower dose of the medication or a placebo. Additionally, patients on interferon beta-1b had no increase in total lesion area, as shown on MRI, in contrast to the placebo group, that had a significant increase.

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Proper Usage

ˇ        Betaseron is injected subcutaneously  (between the fat layer just under the skin and the muscles beneath) every other day. The physician or nurse will instruct you in the preparation of the medication for injection and the injection procedure itself, using a specially designed set of training materials. Do not attempt to inject yourself until you are sure that you understand the procedures.

ˇ        Betaseron must be kept cold. Be sure to store it in a refrigerator before and after the medication is mixed for injection.

ˇ        Do not reuse needles or syringes. Dispose of the syringes as directed by your physician and keep them out of the reach of children.

ˇ        Since flu-like symptoms are a common side effect associated with at least the initial weeks of taking Betaseron, it is recommended that the medication be taken at bedtime. Taking acetaminophen (TylenolŽ) or ibuprofen (AdvilŽ) thirty minutes before each injection will also help to relieve the flu-like symptoms.

ˇ        Because injection site reactions (swelling, redness, discoloration, or pain) are relatively common, it is recommended that the sites be rotated according to a schedule provided for you by your physician.

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Precautions

ˇ        Betaseron should not be used during pregnancy or by any woman who is trying to become pregnant. Women taking Betaseron should use birth control measures at all times.

ˇ        During the clinical trial of interferon beta-1b, there were four suicide attempts and one completed suicide among those taking interferon beta-1b. Although there is no evidence that the suicide attempts were related to the medication itself, it is recommended that individuals with a history of severe depressive disorder be closely monitored while taking Betaseron.

 

Possible Side Effects

ˇ        Common side effects include flu-like symptoms (fatigue, chills, fever, muscle aches, and sweating) and injection site reactions (swelling, redness, discoloration, and pain). Most of these symptoms tend to disappear over time. If they continue, become more severe, or cause significant discomfort, be sure to talk them over with your physician. Contact your physician if the injection sites become inflamed, hardened, or lumpy, and do not inject into any area that has become hardened or lumpy.

ˇ        Depression, including suicide attempts, has been reported by patients taking Betaseron. Common symptoms of depression are sadness, anxiety, loss of interest in daily activities, irritability, low self-esteem, guilt, poor concentration, indecisiveness, confusion, and eating and sleep disturbances. If you experience any of these symptoms for longer than a day or two, contact your physician promptly.

 

Betaseron support line (Pathways): 800-788-1467; 800-948-5777 (financial issues)  

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Twelve-Year Follow Up of Betaferon (Interferon Beta-1b) in Multiple Sclerosis Shows Sustained Benefits and Tolerability


BERLIN, GERMANY -- March 11, 2002 -- The effects of long-term treatment of multiple sclerosis (MS) with BetaferonŽ (interferon beta-1b) were presented at a Schering symposium for neurologists on March 9 in Vienna, Austria.

Results from the 12-year follow-up study, the longest period that any beta-interferon has been studied, showed sustained clinical benefits for the patients and high long-term patient compliance and tolerability.

Prof. George Rice, Department of Clinical Neurological Sciences, University of Western Ontario, Canada, and lead investigator of the follow-up study, commented: "We can see from this follow-up that early and prolonged treatment of MS using Betaferon results in a sustained benefit for patients in terms of their burden of disease when monitored by magnetic resonance imaging (MRI). In those patients who continue the treatment for 12 years, the drug was tolerated exceptionally well. The follow up was designed to look at MRI-based disease activity measures, not to examine the frequency and severity of attacks. Interferons are known to show a clear influence on the disease measured in this way: It is reassuring that this benefit is durable".

The follow-up study -- the longest ever conducted on the treatment of MS -- followed 31 patients with MS who had participated in the first placebo-controlled, double-blind clinical trial with a beta interferon (Betaferon). Over 12 years, Betaferon-treated patients showed a decrease in the burden of disease measured by MRI as compared to untreated patients.

The flu-like symptoms, which are seen frequently with beta-interferon use, were found to disappear over time, dropping from 66 percent to 5 percent in the 12th year. Another important observation from this follow-up was that neutralising antibodies, which tend to develop in the first years of treatment (about 40 percent of patients in this follow-up), disappeared in almost all patients.

"Together with the positive long-term benefit of Betaferon, the follow up has shown that many side effects that initially concerned people with MS disappear over time, an important fact for patients and physicians," said Dr Rice.

These encouraging results will be further evaluated in the other patients who participated in the pivotal trial.

SOURCE: Schering AG

 

FDA Approves Room-Temperature Formulation of Betaseron (Interferon Beta-1b) for Multiple Sclerosis

MONTVILLE, NJ/EMERYVILLE, CA -- January 15, 2002 -- Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany, and Chiron Corporation today announced the approval of a new room-temperature formulation of BetaseronŽ (interferon beta-1b) for subcutaneous injection.
Betaseron, the first therapy approved in the United States to treat relapsing-remitting multiple sclerosis (MS), will be the first and only MS therapy available as a room-temperature formulation (25 degrees Celsius/77 degrees Fahrenheit), providing a convenient option for MS patients in the United States. The new formulation will be available for patients during the middle of 2002.

"Because it requires no refrigeration, the new room-temperature formulation provides greater convenience for patients and pharmacies, allowing many more options when traveling and for storage. With fewer potential interruptions in their medication regimen, these patients can continue their treatment and, in many cases, remain active in their endeavors," said Ralph Makar, Vice President, Marketing, Therapeutics, of Berlex Laboratories.

Multiple Sclerosis is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect up to 350,000 people in the United States, and is the major acquired neurologic disease in young adults. People who develop MS may not immediately recognize their condition because the symptoms of MS are nonspecific and may be similar to those of other diseases. Common signs and symptoms of MS include fatigue, psychological and cognitive changes, weakness or paralysis of limbs, numbness, vision problems, speech difficulties, problems with walking or motor skills, bladder problems, and sexual dysfunction.

Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. People with this form of MS typically have mild to moderate disability. About 50 percent of people with the relapsing-remitting disease advance into the secondary progressive form within 10 years. Betaseron is approved for secondary progressive MS in Europe, Canada, and Australia. In these regions, it is the only approved therapy for the treatment of both the relapsing-remitting form as well as the more advanced secondary progressive form of MS. Betaseron is not approved for secondary progressive MS in the United States.

The recommended dose of Betaseron is 250 mcg (8 MIUs) every other day, which delivers an average total of 875 mcg (28 MIUs) per week.

Serious side effects include depression, suicide, suicidal ideation, and injection site necrosis (skin breakdown, drainage of fluid and tissue destruction), which have been reported in 5 percent of patients in a controlled MS trial. The necrotic lesions are typically 3 cm or less in diameter, but larger areas have been reported, and they may occur at single or multiple sites.

Common side effects of Betaseron therapy include flu-like symptoms, shortness of breath, menstrual disorders, and injection site reactions (redness, pain, swelling, and blue-black discoloration have been reported).

SOURCE: Chiron Corporation

 

Interferon Beta-1b Produces Greater Benefit Than Interferon Beta-1a In Multiple Sclerosis 

 

TURIN, ITALY -- October 4, 2001 -- Results from the Independent Comparison of Interferon (INCOMIN) trial, released at this week's Italian Neurological Society (INS) meeting (1), reveal clinically relevant differences of between 42 to 56 percent in the benefit of interferons used to treat multiple sclerosis (MS) when studied for a significant period, and that the beneficial effects of interferon beta-1b become more pronounced over time when compared to interferon beta-1a.

Professor Luca Durelli, Chief, MS Centre of University Department of Neurosciences, Turin, Italy, and principle investigator of the INCOMIN trial said: "The final results from the INCOMIN study confirm the interim, one-year data presented earlier this year at the annual meetings of the American Academy of Neurology and European Society of Neurology, where the study was granted with an award (2,3).

Over the full two-year duration of the INCOMIN study, interferon beta-1b continues and extends the benefits of treatment over interferon beta-1a on the first clinical outcomes we have analyzed in relapsing-remitting MS (RRMS)."

"Similar effects have been seen in other clinical studies, but those trials have been short term in the context of a chronic disease that may have a 20-25 year course," continued Dr. Durelli. "Our two-year study provides a clinically relevant result in terms of guiding prescribing choice. There is now clear evidence that high dose and frequent therapy with interferon beta-1b is superior to the current dosing of once weekly with interferon beta-1a. We can clearly see that all beta interferon regimens are not the same."

The prospective, randomized, multi-center study on 188 people with relapsing-remitting MS was supported by research grants from the Multiple Sclerosis Association of Italy and the Italian Ministry of Health and was conducted independently of the pharmaceutical industry. Patient randomization to treatment arms was performed by independent statisticians with allocation concealment. The clinical evaluation was conducted on an open-label basis, while medical resonance imaging (MRI) scans were analyzed blind of the treatment used.

The primary clinical endpoint of the INCOMIN study -- the number of relapse-free patients -- showed the significant advantages of treatment with interferon beta-1b over interferon beta-1a during a two-year period, with the clinical benefits for patients becoming more pronounced over time.

The proportion of relapse-free patients at two years was 51 percent in the interferon beta-1b group versus 36 percent in the interferon beta-1a group (P=0.036). This means a 42 percent increased probability that patients treated with interferon beta-1b remained free from relapses compared to those treated with interferon beta-1a.

The treatment benefit was particularly pronounced in the second year of the study, with 72 percent of the patients receiving interferon beta-1b remaining relapse free, compared with 49 percent of those receiving interferon beta-1a (P=0.001) and representing a 47 percent increased probability that patients treated with interferon beta-1b would remain free from attacks. These results underline the importance of conducting studies for a sufficient time in order to provide a robust result.

In addition, progression of the disease -- defined as a worsening of 1.0 or more on the EDSS scale, confirmed after six months and maintained until the end of the follow-up -- was significantly slower in patients treated with interferon beta-1b, with 14 percent of patients worsening compared with 30 percent in those treated with interferon beta-1a: a relative risk reduction of 56 percent in favor of interferon beta-1b (P=0.005).

The study's other primary endpoint -- the number of patients without new T2 lesions as detected by MRI -- reinforced these clinical findings. Of the patients receiving interferon beta-1b over 24 months, 55 percent were free of new T2 lesions in the brain compared with only 26 percent of those on interferon beta-1a: a relative increase of 112 percent in favor of interferon beta-1b (P=0.0003).

Lesion activity was also significantly higher in patients receiving interferon beta-1a, with 75 percent showing disease activity by MRI, compared with just 49 percent of those on interferon beta-1b (P=0.0008).

Treatment was discontinued due to lack of a clinical response by 10 patients receiving interferon beta-1a and by only three of those receiving interferon beta-1b.

Data for the other secondary endpoints are still being analyzed and the full data will be published in due course.

Commenting on the results, Dr. Durelli said: "The full results will be published shortly, but these are important data that clearly differentiate between the beta interferon agents. The results prove that high, frequent dosing is very important and is superior to once-weekly dosing."

References:

(1) Annual Meeting of the Italian Neurological Society, 30 September to 3 October 2001 in Rimini, Italy

(2) Luca Durelli, Ferrero B, Ghezzi A, Montanari E, Zaffaroni M, Bergui M, Verdun E, Barbero P and the INCOMIN Trial Study Group. The Independent Comparison of Interferon (INCOMIN) Trial: a multicenter randomized trial comparing clinical and MRI efficacy of IFN beta-1a and beta-1b in multiple sclerosis. Annual meeting of the American Academy of Neurology; Philadelphia; April 2001. Neurology April 2001; 56 (Suppl. 3).

(3) Durelli L, Ferrero B, Oggero A, Verdun E, Ghezzi A, Montanari E, Zaffaroni M and the INCOMIN Trial Study Group. A multicenter trial comparing clinical and MRI efficacy of interferon beta-1a and beta-1b in multiple sclerosis. Annual meeting of the European Society of Neurology; Paris, France; April 2001. Journal of Neurology April 2001; 248 (Suppl. 2).

SOURCE: Professor Luca Durelli, MS Centre of University Department of Neurosciences, Turin, Italy

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Room-Temperature Betaseron Available Nationwide


Innovative MS Therapy Makes Treatment Easier, More Convenient

MONTVILLE, N.J. -- May 15, 2002 -- Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany, announced that the new room temperature formulation of BetaseronŽ (interferon beta- 1b) for SC injection is now available to consumers across the United States.

BetaseronŽ, the first therapy approved in the United States to treat relapsing-remitting multiple sclerosis (MS), is the first and only room-temperature (25°C/77°F) MS therapy approved for relapsing-remitting MS. The innovation provides greater convenience for MS patients and pharmacies, allowing more options for traveling and storage. The FDA approved the new formulation of Betaseron in January.

"Berlex is building on its legacy of providing practical solutions for the MS community. Room-temperature Betaseron is our latest innovation to reach more patients and improve the compliance, retention, and expediency of their treatment," said Ralph Makar, vice president of marketing, Therapeutics, Berlex Laboratories. "Because the new formulation requires no refrigeration, patients have many more options for storage-and fewer precautions-when traveling or pursuing activities outside their homes."

Delbert Richardson, who's been treated with Betaseron since he was diagnosed with MS in 1997, went on an eight-month cross-country cycling trip last year to raise awareness of the disease. He noted, "During my cycling trip the new formulation would have been a helpful added convenience."

Richardson added, "This is another innovation to allow more freedom for people with MS. Now transportation of Betaseron will be easier, and keeping it out of a common space like the refrigerator is especially helpful."

About MS
MS is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect up to 350,000 people in the United States, and is the major acquired neurologic disease in young adults. People who develop MS may not immediately recognize their condition because the symptoms of MS are nonspecific and may be similar to those of other diseases. Common signs and symptoms of MS include fatigue, psychological and cognitive changes, weakness or paralysis of limbs, numbness, vision problems, speech difficulties, problems with walking or motor skills, bladder problems, and sexual dysfunction.

About Betaseron
Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. People with this form of MS typically have mild to moderate disability with EDSS scores of 0-5.5. About 50 percent of people with the relapsing-remitting disease advance into the secondary progressive form within 10 years. Betaseron is approved for secondary progressive MS in

Europe, Canada, and Australia. In these regions, it is the only approved therapy for the treatment of both the relapsing-remitting form as well as the more advanced secondary progressive form of MS. Currently, in the United States, Betaseron is not approved for secondary progressive MS.

In January 2002, the FDA approved a new room-temperature formulation of Betaseron. Betaseron is the first and only therapy available as a room-temperature formulation (25°C/77°F) for relapsing-remitting MS, providing a convenient option for MS patients in the United States. Injections of this formulation should be administered immediately after preparation. If the injection is delayed, the solution should be refrigerated and injected within a three hour time period.

The recommended dose of Betaseron is 250 mcg (8 MIUs) every other day, which delivers an average total of 875 mcg (28 MIUs) per week.


Serious side effects include depression, suicide, suicidal ideation, and injection site necrosis (skin breakdown, drainage of fluid and tissue destruction), which have been reported in 5 percent of patients in a controlled MS trial. The necrotic lesions are typically 3cm or less in diameter, but larger areas have been reported, and they may occur at single or multiple sites.

Common side effects of Betaseron therapy include flu-like symptoms, shortness of breath, menstrual disorders, and injection site reactions (redness, pain, swelling, and blue-black discoloration have been reported).

About Berlex Laboratories
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany (NYSE:SHR), researches, develops, manufactures, and markets ethical pharmaceuticals in five strategic areas: Female Healthcare, Diagnostic Imaging, Dermatology, Oncology, and Therapeutics for life-threatening and disabling diseases. Berlex Laboratories, Inc. has business operations in Montville and Wayne, New Jersey and in Richmond, California. For more information about Berlex and its products, you may visit our Web site at www.berlex.com <http://www.berlex.com/>.

In order to utilize the "Safe Harbor" provision of the U.S. Private Securities Litigation Reform Act of 1995, the Company is providing the following cautionary statement. Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including, but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Company plans and objectives to differ materially from those expressed or implied in the forward-looking statements (or from the past results). Although not exhaustive, the following factors could cause such differences: action by the Company's competitors or the failure or demand for the Company's products to develop as anticipated; legislative and regulatory changes and general changes in public health and approaches to health care and the treatment of ideas; unanticipated difficulties in the design or implementation of clinical trials, studies and investigations, or results that are inconsistent with previous results and the Company's expectations; the failure to obtain and maintain required authorizations from governmental authorities or the loss of or inability to patent or trademark protection for products; the risk of substantial product liability claims; unexpected costs or difficulties in production or distribution or in integrating the business and operations of the Company. These factors and other factors that could effect these forward-looking statements are described in our Form 20-F and our Form 6-K reports filed with the US Securities and Exchange Commission. The Company disclaims any obligation to publicly update or revise these forward-looking statements, whether to reflect new information or future events or circumstance or otherwise.

SOURCE: Berlex Laboratories, Inc.

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