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The Blog of Drug Discovery News

Looking for similars parity

So, I’m seeing talk of biosimilars showing up a bit more on the news feeds and in my e-mail inbox. Hard to say yet whether it’s a sign of a rising trend in pharma and biotech or whether it’s just a little jump in the frequency.

But I will say that in our January issue (heading out in the mail and also available online – key stories here and full issue in PDF form here), we had a sizable commentary about biosimilars. Given that the FDA is supposedly going to finally catch the U.S. up somewhat with its European peers in terms of an approval pathway and regulatory guidelines, I won’t be at all surprised to see a lot more stories on biosimilars like the one below that hit the newswires yesterday:

Merck & Co. and PAREXEL form strategic alliance focused on clinical development of biosimilar candidates

WHITEHOUSE STATION, N.J. & BOSTON—Merck & Co. Inc. and PAREXEL International Corp., a leading global biopharmaceutical services provider, today announced that they have entered into an alliance by which PAREXEL will provide strategic access to global clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures, a division of Merck, is focused on the delivery of high quality biosimilars to the patients that need them.

“PAREXEL has extensive, industry-leading experience with biosimilar development, and we truly understand the scientific complexities, and regulatory pathways involved,” said Josef von Rickenbach, chairman and chief executive officer of PAREXEL. “We are committed to working with Merck BioVentures to assist in advancing its biosimilar portfolio in this rapidly developing market segment for the benefit of patients worldwide.”

Under the terms of the agreement, PAREXEL will provide Merck BioVentures with strategic access to a broad range of regulatory strategy and clinical development planning capabilities for the development of certain broad classes of biosimilars across various therapeutic areas, including exclusivity for certain candidates. The agreement also provides for the establishment of a dedicated Merck BioVentures unit within the PAREXEL organization. Further details of the agreement were not disclosed.

“Through this agreement, Merck BioVentures has secured broad strategic access to PAREXEL’s proven biosimilar clinical development experience,” said Michael Kamarck, president of Merck BioVentures. “This agreement positions Merck BioVentures for success with an industry leading partner that has the expertise and resources to conduct clinical development of our diverse portfolio of candidates to allow timely delivery of products to the marketplace.”

I think probably the biggest hangup for biosimilars (and thus news about any work on them) really has been the sluggish pace at which FDA seems to have been addressing this topic. I know that biosimilars pose many more challenges than do generic versions of some small-molecule drug or the like, but I can’t help but think that with European regulators already having trod this ground that the FDA has really been dropping the ball (as opposed to simply being wisely cautious).

Of course, that assumes that they agency even makes good on getting workable guidelines out this year. Lot of people and organizations fail at New Year’s resolutions.


January 13, 2011 Posted by | Corporate, Government, Labwork & Science | , , , | 1 Comment

Alzheimer’s prevention: A call to arms

As our managing editor, Jeffrey Bouley, discussed last week, in our November issue we detail one group’s effort to develop to “launch the era of Alzheimer’s disease prevention research”—before another generation of patients is lost (see “An ounce of prevention”).

That effort, the Alzheimer’s Prevention Initiative, is a project launched by the Banner Alzheimer’s Institute, a nonprofit, collaborative research center in Phoenix.

Led by reknowned Alzheimer’s researchers Drs. Eric Reiman and Pierre Tariot, the API aims to test potential Alzheimer’s treatments and identify new biomarkers that could lead to earlier and more accurate diagnoses for Alzheimer’s patients.

Reiman and Tariot have been carrying the torch for Alzheimer’s disease prevention for many years. In the course of reporting on their work, Reiman shared with me an article they penned this year with colleague Jessica Langbaum that they consider “a call to arms.” The article, “Alzheimer’s Prevention Initiative: a proposal to evaluate presymptomatic treatments as quickly as possible,” was published in the Future Medicine journal, Biomarkers in Medicine.

The article contends that the evaluation of presymptomatic Alzheimer’s treatments must become an urgent priority, identifies what is holding us back and proposes new public policies and scientific strategies to overcome these roadblocks.

Here’s an excerpt from the piece:

“Alzheimer’s disease (AD) is an unacceptable problem. It takes a catastrophic toll on patients and family caregivers, and it is projected to have a financially overwhelming effect around the world in our children’s lifetime. In our opinion, the greatest roadblock in the scientific fight against AD is not necessarily the discovery of new treatments, but the means to evaluate them presymptomatically, when they may have their greatest impact, in a sufficiently rapid and rigorous way. It currently takes too many cognitively normal research subjects, too many years and too much money to evaluate more than a few presymptomatic AD treatments using clinical end points. Brain imaging and other biomarkers of AD progression and pathology have the potential to accelerate the evaluation of presymptomatic AD treatments. However, regulatory agencies are unlikely to provide accelerated approval for a presymptomatic AD treatment based solely on biomarker end points, without additional evidence from randomized clinical trials (RCTs) to conclude that a treatment’s biomarker effects are reasonably likely to predict a clinical benefit. In the meantime, sponsors are reluctant to conduct presymptomatic AD trials without a regulatory approval pathway. This dilemma may at first seem like an insurmountable ‘catch-22,’ leading to a sense of nihilism and a lack of urgency, but inaction is not an option.”

The article makes a compelling case for a sea change in the way scientists, researchers and pharmaceutical companies approach treating this devastating disease. To view the entire piece, please click here to download this PDF file: Reiman.

October 21, 2010 Posted by | Academia & Non-Profit | , , , | 1 Comment

GSK out more than $2 billion in settlement

GlaxoSmithKline PLC recently took a $2.36 billion charge to settle most Avandia product liability cases and other litigation facing the company. The settlements include lawsuits regarding the diabetes drug Avandia (rosiglitazone) and liability and antitrust litigation over its drug Paxil (paroxetine). For Avandia, which a joint U.S. Food and Drug Administration (FDA) advisory committee voted should remain on the market with labeling or prescribing restrictions, a “substantial majority” of product liability cases has been resolved, the company says. The FDA also recently announced that it is investigating whether GSK failed to fully inform the agency about heart risks associated with Avandia. According to the FDA, GSK defended the drug’s safety to the agency and the public while debating internally about data and analyses pointing to increased cardiac risks. Later, after the drug was approved, GSK produced two separate sets of new data, finding that heart side effects jumped by 29 percent and 31 percent in Avandia patients, but did not disclose this data until May 2006, the FDA says.

September 5, 2010 Posted by | Corporate, Government | , , | Leave a comment