QDIS Blog

Although small by normal standards, I did want to post, in my seemingly non-ending stream, about another merger. Starpharma is acquiring Dendritic Nanotechnologies for $6.9 million.

Dendritic Nanotechnologies to be Acquired by Australian Nanobiotech Company Starpharma Holdings Ltd.: Financial News - Yahoo! Finance

It would appear that Starpharma is acquiring them for their technologies and patents related to forming dendrimers.

Technorati Tags: pharma M&A, pharmaceutical deals, Dendritic Nanotechnologies, Starpharma

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Seems Sanofi-Aventis still is not giving any guidance on when Acomplia (rimonabant) may be approved. It has been seven months with no word from the company.

Sanofi Remains Tight-Lipped - Forbes.com:

Other articles say that Sanofi is downplaying the impact of delays in getting Acomplia approved. My thought is if they can’t really say there is no impact and not give some sort of update regarding what the current situation is. They did say they are amassing data from European studies to show the drug is safe but they gave no details on why this was being done or what reservations the FDA may have had. The article does mention “secondary effects” and that to me sounds ominous (depending on what they are and how serious it may be). Although there is no data to directly support it, I think the US regulators are being more cautious than usual due to the so-called Vioxx effect.

It would be nice if Sanofi would give some indication of what reservations the FDA had and some sort of timeline as to when they may complete their amassing of data and submit it to the FDA. They almost certainly won’t get approval this year and I am doubtful if they could get approval in the first quarter of next year. Given the potential blockbuster nature of this drug, it will be interesting to see how this story develops and when (or if) they will get US approval.

Other Resources

• Drug Development Technology - Acomplia (Rimonabant) - Investigational Agent for the Management of Obesity
• Rimonabant - Wikipedia, the free encyclopedia
• Wonder pill, Rimonabant, makes you lose body weight and keep it off

News Articles

• Yahoo! News Search Results for rimonabant OR Acomplia
• rimonabant OR Acomplia - Google News

Technorati Tags: Acomplia, diet drug, rimonabant, Sanofi-Aventis

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I know I’ a little late in posting on this but thought it was important enough to address it now. I really hate to see the process of getting a new FDA commissioner reduced to political bickering.

• Senate HELP Committee Approves Von Eschenbach Nomination To Head FDA; Some Senators Say They Will Place Hold On Nomination
• Senate panel clears FDA nominee - Yahoo! News

Seems some Senators are now holding up the nomination because Sen. Jim DeMint (R-S.C.) want a specific product pulled from the market (RU-486, aka Mifeprex (mifepristone)) and Sen. David Vitter (R-La.) wants to hold up the nomination until the FDA allows drug imports from overseas.

In the Case of Senator Clinton and Senator Patty Murray they only wanted the FDA to live up to their own commitment and make a decision regarding Plan B. They did not insist that a product be approved.

My opinion is if these Senators want to make legislate, then introduce legislation, don’t use these as excuses for holding up a nominee.

See Eye on FDA’s post entitled No holds Barred for another blog posting on this.

Other Resources

• Yahoo! News Search Results for senate fda nomination Eschenbach
• Senate fda nomination Eschenbach - Google News

Technorati Tags: FDA

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Forbes it seems has weighed in on the move by Gilead to acquire Myogen for a 50% premium.

Gilead’s Big Shift - Forbes.com

The article says that several analyst didn’t like this because they felt it took Gilead’s focus away from antivirals. My thought on this is that you can never keep analyst happy, they seem to enjoy being negative. Now everyone wants Gilead to stay focused on just antivirals. At other times they have said that other companies (not necessarily Gilead) are too focused and should diversify. The problem is, they never really give their rational as to why that should be the case and why the current timing is wrong.

I personally think that gilead had money and needed to use it to diversify. I do think they probably paid too much. a 50% premium is a little on the expensive side but as I said earlier, I feel the potential for ambrisentan may be worth it.

Technorati Tags: Gilead, Myogen, pharma M&A, pharmaceutical deals, ambrisentan

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Seems you can’t turn on your computer and read pharmaceutical news these days without seeing another merger or acquisition being announced.

Gilead to acquire Myogen for $2.5 billion - Yahoo! News

Gilead is the most recent player to spend a lot of money to purchase another company. They will spend over $2.5 billion to purchase Mycogen. Some analysts were shocked that Gilead, who only has experience in the HIV area, would go for a company that is outside this “area of expertise”. To me, it just makes sense; they are looking to diversify which is a good thing. Also Myogen has good pipeline of anti-hypertension drugs which show promise. Ambrisentan should have an NDA filed by the end of the year and is looked at as a potential billion dollar a year block-buster drug.

Gilead had already purchased Corus in Seattle, WA earlier this year for an inhaled antibiotic and so this further diversification should not have come as a shock. Corus’s inhaled antibiotic was for infections common among cystic fibrosis patients and is for a pulmonary disorder. Myogen markets Flolan which is one of the few drugs used to treat primary pulmonary hypertension (by agreement with GlaxoSmithKline).

Other Resources

• Gilead — Gilead Sciences to Acquire Myogen, Inc. for $2.5 Billion
• Myogen Press Release - Gilead to Acquire Myogen.pdf
• Yahoo! News Search Results for Gilead Myogen
• Gilead Myogen - Google News

Technorati Tags: Gilead, pharma M&A, pharmaceutical deals, Myogen

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Merck has said that they will not file an NDA for MK-0524B. It is being co-administered with simvastatin (Zocor ®).

Merck Revises Regulatory Filing Timeline for MK-0524B, an Investigational Fixed-Dose Combination of MK-0524A and Simvastatin: Financial News - Yahoo!

Although the clinical trial schedule has NOT changed, the filing will not take place in 2007 as previously planned.

MK-0524B is an extended release version of niacin along with a flushing inhibitor. Niacin use to be used before the statins came on the market for controlling cholesterol. It works by not only lowering the LDL but also raising the HDL (good cholesterol). The main problem was the flushing the niacin causes and many patients quite taking niacin because of this side effect. I personally take niacin (over-the counter; OTC) in a non-flushing formulation since my total cholesterol is low but my HDL is very low so the ratio is not what it should be. I’ve been taking 500 mg twice daily for about a year now and am interested to see what the cholesterol levels are next time they are checked.

It is interesting that Merck is not comparing their new drug against a cheap OTC non-fluhing formulation of niacin. It is interesting that the drug would appear to be a triple combination; MK-0582A (an extended release version of niacin), a DP-1 selective antagonist (prevents flushing) and simvastatin.

Further Information

• Merck Revises Regulatory Filing Timeline for MK-0524B, an Investigational Fixed-Dose Combination of MK-0524A and Simvastatin
• Merck MK-0524B - Yahoo! Search Results
• Yahoo! News Search Results for Merck MK-0524B
• Merck MK-0524B - Google News

Technorati Tags: Merck, MK-0524B, niacin, simvastatin, Zocor

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The merger and acquisition mania in the pharmaceutical industry continues unabated. Now, Amgen will acquire Avadia, a San Francisco area company that specializes in Avimer proteins for $380 million.

Chemical & Engineering News: Latest News - Amgen Will Acquire Protein Specialist Avidia:

AS I have stated before, I don’t see this activity abating anytime soon and it will likely continue into next year, especially in Europe.

Disclosure: I do own a few shares of Amgen.

Other Resources

• Amgen - Media - Press Release
• AMGEN TO ACQUIRE AVIDIA, A PRIVATELY HELD BIOPHARMACEUTICAL COMPANY IN THE SAN FRANCISCO BAY AREA
• Yahoo! News Search Results for Amgen Avidia
• Amgen Avidia - Google News

Technorati Tags: Amgen, pharma M&A, pharmaceutical deals, Avidia

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Just wanted to let you know that I was at the Podcast Expo in Ontario Friday and Saturday last week and then took a couple of days vacation while I was in southern CA. The Podcast Expo was great and I learned a lot and hope to apply what I’ve learned to the Searching the Internet podcast and the website soon.

It was also great to get to meet many people whose podcasts I listened to and who I have communicated with over the past year. It was nice to be able to put names with faces.

I am now back and will be blogging on a regular basis.

Technorati Tags: Podcast Expo 2006

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