QDIS Blog

Ranbaxy seems to be acquiring companies world-wide. Now they are purchasing a Russian generic drug manufacturer, Akrikhin for a reported $100 million.

‘Ranbaxy close to $100mn Russian buy’:

Akrikhin has a website but unfortunately it is only in Russian. Ranbaxy won’t comment on the reported purchase but they did state they are looking at acquisitions. They have purchased the following companies in the past five months:

• Allen SpA (formerly division of GlaxoSmithKline) in Italy; March 2006 for undisclosed amount
• Terapia in Romania March 2006 for $324 million
• Mundogen (formerly division of GlaxoSmithKline) in Spain; July 2006 for undisclosed amount
• Ethimed in Belgium; March 2006 for an undisclosed amount

Here are articles on these acquisitions.

The Telegraph - Calcutta : Business
Ranbaxy Acquires Leading Romanian Pharma Company Terapia for US $324mn
Ranbaxy Pharmaceuticals Inc. To Acquire The Mundogen Generic
Ranbaxy acquires Belgian generics company - Pharmaceutical Business Review

I think Ranbaxy is already well on its way to becoming one of the top world-wide generic manufacturers. The challenge will be how to develop and instill a corporate culture in light of the rapid expansions into many different cultures. It will be interesting to see how well they integrate these companies into their current operations.

Technorati Tags: pharma M&A, Ranbaxy

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I’ve heard some folks claim that since society doesn’t seem to be able to keep cigarettes out of the hands of young people that the same thing will happen with Plan B. I would like to point out that while we know Plan B is safe and effective when used as directed, cigarettes most certainly are NOT safe but they are effective at causing lung cancer. Comparing cigarettes to Plan B is comparing apples with oranges.

Another argument is that women may not take it as directed, that is they may choose to take the pill regularly (whatever that means). Again, any OTC medicine can be misused. Is that the fault of the manufacturer? Is that any reason not to make available a safe and effective medicine? Something having a possibility (chance greater than zero; no matter how small) does not translate into a probability.

Don’t get me started on the rights of the pharmacists. I think that a pharmacists should have the right, if they have religious beliefs against it, to not sell Plan B. However, if the company that employes this pharmacist elects to carry Plan B, then they should always have a pharmacist on staff at all hours to allow the sale to occur. I also think that some pharmacists with strong conservative beliefs cross the line from being a pharmacists to giving medical advice in some situations and no one seems to be interested in that potential problem.

Technorati Tags: Barr labs, emergency contraceptive, FDA, plan b

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Wow!! I certainly didn’t expect this to happen so quickly! I am glad to see the FDA finally approved Plan B after years of putting off the decision due to political pressure.

FDA Grants OTC Status to Barr’s Plan B(R) Emergency Contraceptive: Financial News - Yahoo! Finance

I thought that the approval would drag on for at least 6-8 more months and that there would be haggling over the packaging information. I can only say I feel this is a move in the right direction for the FDA.

Technorati Tags: Barr labs, emergency contraceptive, FDA, plan b

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I have reported on Ketek several times before. I personally think new antibiotics are desperately needed, but I also think care should be exercised in prescribing new drugs. As always, you have to weight the benefits vs the potential downside. It seems the marketing alliance between Sanofi and Astellas Pharma has been discontinued.

PharmaLive: Discontinuation of Marketing Alliance on Ketolide Antibiotics, “Ketek Tablets 300 mg” :

After Oct. 1, 2006, Sanofi will be the sole marketer in Japan. While I’m not privy to any specific information, it would appear to me that maybe Astellas has second thoughts about being associated with Ketek in Japan.

The same announcement (pdf) is also on the Astellas website. What is interesting to me is what it doesn’t say. No reason is given and only the 300 mg tablet is listed.

For those who may not have been paying attention, Astellas Pharma is a large Japanese pharmaceutical company formed in 2005 by the merger of Fujisawa Pharmaceutical and Yamanouchi Pharmaceutical.

Technorati Tags: Ketek, ketolide antibiotic, antibiotics, Sanofi-Aventis, telithromycin

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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

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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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In looking at all the AIDS information coming out of Toronto this week, I came across a useful site that show drugs that are in development for AIDS/HIV.

First is thebody which has a list of antiretrovirals in development as of June 30, 2006.

The Body: 2006 Antiretrovirals in Development Pipeline

One of the nice things about this page is that it doesn’t just list the drugs but gives links to online resources such as abstracts from conferences. THere i also a chart of entry inhibitors, integrase inhibitors, maturation inhibitors, and other drugs.

Aidsmeds.com also has a list of both approved and investigational drugs that is fairly extensive.

Alphabetical List of Drugs for HIV & AIDS

Technorati Tags: aids drugs, HIV drugs

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