QDIS Blog

I mentioned in a previous post about the biogeneric boom that some companies weren’t waiting to see what the FDA may decide and were buying companies outside the US. One of those I mentioned was Barr and it seems they announced their offer today for Pliva.

Barr Initiates Formal Tender Offer for PLIVA d.d.

Here is an unofficial translation of the offer (pdf) from Pliva’s website. I’m not familiar with Pliva but they have been around since 1921 and in the 1930’s made sulphonamide and macrolide antibiotics. They claim the discovery of azithromycin sold by Pfizer as Zithromax and it is sold in central and eastern Europe under the tradename Sumamed.

I am hopeful that biogenerics will come to market but I am fearful that it will happen much sooner in Europe than in the US.

For more information, here is the news articles from Yahoo and Google containing both Barr and Pliva.

• Yahoo! News Search Results for pliva barr
• pliva barr - Google News

And here are results for Barr and Pliva using Google Blog Seach and Yahoo Blog Search.

• Google Blog Search: barr pliva
• Yahoo! Search Results for barr pliva

Technorati Tags: Barr Labs, Pliva

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This very short article today is interesting.

Barr refiles morning-after pill bid, FDA says - Yahoo! News:

Barr will re-file its application to sell Plan B. No details were made public and nothing was said about why or what may be different. My best guess is that Barr i going to change the age from 16 to 18 since the FDA has basically state that they would support that. Also, they will likely be submitting new packaging for the over-the-counter product in order to readily differentiate it from the prescription version.

Another interesting aspect will be how different the two version need to be. Will just different packaging be enough? I am curious if the topic of making the pill a different shape or color will come up. This would most likely further delay the approval. Given how things have gone in the past, this would not surprise me.

Another interesting item is that this announcement is not yet on Barr’s website. Maybe they are keeping their head low to avoid further publicity.

Technorati Tags: Barr Labs, morning after pill, plan B

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Some promising news is coming out of the 16th International Aids conference in Toronto. It seems that there may be glimmers of hope regarding the fight against AIDS.

Small victories feature at AIDS conference | Top News | Reuters.com:

Many more people in Africa are getting treated but it still falls far short of treating all who need to be treated. In developing countries just providing good general nutrition went a long way to wards improving their condition.

In general more poor people are receiving treatment so recent pushes are working but there is much more to be done. As an example in Thailand, now 90% of those who needs AIDS drugs are receiving them.

Another interesting aspect is those who test positive for the virus but never develop full blown AIDS. These are people whose genetics should be decoded to see if it can be figured out why these people seem to not suffer from the typical disease progression.

Technorati Tags: aids drugs, HIV drugs

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Some promising news is coming out of the 16th International Aids conference in Toronto. It seems that there may be glimmers of hope regarding the fight against AIDS.

Small victories feature at AIDS conference | Top News | Reuters.com:

Many more people in Africa are getting treated but it still falls far short of treating all who need to be treated. In developing countries just providing good general nutrition went a long way to wards improving their condition.

In general more poor people are receiving treatment so recent pushes are working but there is much more to be done. As an example in Thailand, now 90% of those who needs AIDS drugs are receiving them.

Another interesting aspect is those who test positive for the virus but never develop full blown AIDS. These are people whose genetics should be decoded to see if it can be figured out why these people seem to not suffer from the typical disease progression.

Technorati Tags: aids drugs

Email Ed Vawter

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A recent article on the biogenerics market from a money perspective has appeared on the CNN Money site.

Biogenerics face FDA issues amid biotech barriers. - Aug. 15, 2006:

They predict that the biogeneric market will be $20 billion by 2010, only 4 years away. The question is, how much of that market will the US have vs Europe and the rest of the world.

I personally think there are two areas of concern. One is the process by which biogenerics will be approved in the US. It appears to me that the FDA really isn’t going to do anything about it unless forced by congress. My feeling is they will continue to slowly approve product just as they did with Omnitrope. So instead of having a streamlined well laid out process, the standard full testing of products seems to be the expectation.

Many companies are not waiting to see what the US FDA may decide. As an example, Teva, a large generic manufacturer in Israel has recently purchased biological manufacturers in Mexico and Lithuania. Another example is Barr Labs which is attempting to buy Pliva biologics manufacturers in Croatia. This is too bad, because it means the US may miss out on the job creation that could come from having these operations within the US.

Second without biogeneric or “follow on protein products”, healthcare costs will continue to increase at a rapid rate. Since these biological drugs treat serious indication and they are so costly, they can have a large affect. As more and more big pharmaceutical companies, whose blockbuster drugs are expiring turn to biological drugs, the situation will only get worse.

Technorati Tags: biogenerics, FDA

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