Berlex Laboratories

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Introduction

Berlex Laboratories, Incorporated is a research-based pharmaceutical company headquartered in Montville, New Jersey with operations in Wayne, New Jersey; Bothell, Washington; Seattle, Washington; and Richmond, California. Berlex is the US affiliate of Schering AG, headquartered in Berlin, Germany. While its parent company bears a similar name, Berlex is in no way affiliated with the US-headquartered pharmaceutical company Schering-Plough. In 2004 Berlex recorded US sales of $ 1.3 billion, accounting for 25% Schering AG's global sales. Approximately 1/3 of Schering's research takes place in the US under the purview of Berlex's Biosciences division. Berlex employs approximately 2,400 people in the United States. As of April 4th 2007, Schering-Berlex were bought out by Bayer and will be converting over to the Bayer brand name.

Products

As of 2006, the Berlex portfolio consists of 19 Food and Drug Administration (FDA)-approved drugs within the business areas of female healthcare, diagnostic imaging, oncology, and therapies related to the treatment of cardiovascular and neurological conditions. These products are:

• Angeliq® (drospirenone and estradiol)
• Betapace AF® (sotalol HCI)
• Betapace® (sotalol HCI)
• Betaseron® (interferon beta-1b)
• Campath® (alemtuzumab)
• Climara Pro™ (estradiol/levonorgestrel transdermal system)
• Climara® (estradiol transdermal system)
• Feridex I.V.® (ferumoxides injectable solution)
• Fludara® (fludarabine phospate)
• Leukine® (sargramostim)
• Levlen® 28 (levonorgestrel and ethinyl estradiol tablets)
• Levlite® (levonorgestrel and ethinyl estradiol tablets)
• Magnevist® (gadopentetate dimeglumine)
• Menostar™ (estradiol transdermal system)
• Mirena® (levonorgestrel-releasing intrauterine system)
• Refludan® (lepirudin)
• Tri-Levlen® 28 (levonorgestrel and ethinyl estradiol tablets)
• Ultravist® (iopromide)
• Yasmin® (drospirenone and ethinyl estradiol tablets

Research and Development

According to its website, Berlex's current research and development is focused in the same areas as its extant, FDA-approved products: diagnostic imaging, therapeutics, gender-specific healthcare, and oncology. Berlex claims to have in its product pipeline at least 8 oncology drugs in various stages of development.

Berlex and Controversy

1.Leukine. Berlex paid for a study that ran in the May 26, 2005, issue of the New England Journal of Medicine, which concluded that its leukemia drug Leukine “decreased disease severity and improved the quality of life in patients with active Crohn’s disease.” The lead author, Joshua Korzenik of Harvard Medical School and Massachusetts General Hospital, was a paid consultant for Berlex, and he co-invented the patent behind the drug. Korzenik created a "firewall" to protect the integrity of the study, consisting of two committees to review the study results and process as well and sending trial data to outside clinicians for review.[^ a b "Med school drug pushers: How scientists are selling out to drug companies", by David S. Bernstein, The Phoenix. Published April 12, 2006. Accessed 8 Feb 2007)

2. Diane-35. The Working Group of a Canadian women's health organization wrote to the Medical Advisory Board of Health Canada to complain about the ad campaign for Diane-35, which violates Canada's laws about direct-to-consumer advertising. The focus of the formal complaint is not just the illegality of prescription drug advertising in Canada, but the poor safety record of this drug and the misleading way in which it is being targeted at young women. The Working Group has called on Health Canada to force Berlex to stop the campaign, to apply strict fines and require that they issue corrective advertising to address the misinformation that has been perpetuated with this campaign.

3. Yasmin. Berlex was cited in 2002 and 2003 by the FDA for false and misleading prescription drug advertising. [1] [2]

References

http://www.berlex.com

1. Text of FDA letter to Berlex, ordering them to cease false and misleading advertising of Yasmin.

2."Med school drug pushers: How scientists are selling out to drug companies," by David S. Bernstein, The Phoenix