QDIS Blog

I don’t remember the FDA issuing a “refuse to file” letter in recent memory but Pharmacyclics got one from the FDA recently for their drug Xcytrin (motexafin gadolinium). It is intended to treat non-small cell lung cancer patients with brain metastases. Here is the FDA definition of “refuse to file”.

Pharmacyclics: FDA Won’t Take Filing - Forbes.com:

The stock dropped 46% on the news and is definitely bad news. The FDA said there was not enough in the filings to bother with a substantial review and that too many clinical trials had failed to show statistically significant differences from between treatment arms. This leads me to wonder who is heading up the regulatory group as this sort of situation should never be allowed to happen.

Looking up refuse to file I found that Imclone received one back on Jan 2002 over Erbitux.

Pharmacyclics had a webcast conference call yesterday and is available for one month. I’ve listened to it and not much new was added. They will be having meetings with the FDA to determine where they will be going next. The company basically thought the meetings with the FDA previously went well and they thought highly of this drug and the data and felt they were encouraged by the FDA to go ahead and make the submission. They also used outside consultants who agreed that they should go ahead with a filing.

They only have about a years worth cash on hand and so it will be interesting to see what happens in the next twelve months.. Only three questions were asked and it was a very short call.

Here is the company’s press release.

Other Resuorces

Xcytrin - Yahoo! Search Results
Xcytrin - Google Search
Google Blog Search: Xcytrin
IceRocket Blog Search: Xcytrin

Technorati Tags: Pharmacyclics, motexafin gadolinium, Xcytrin

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This is old news by now but I wanted to comment. Merck has decided to suspend for now it efforts to lobby states to require Gardasil vaccinations for girls.

Merck suspends lobbying for vaccine - Yahoo! News:

The main reason Merck was pushing so hard to is because GlaxoSmithKline also has an HPV vaccine in late stage trials which will likely be filed later this year. They are certainly trying to take advantage of being the only cancer vaccine on the market right now. I don’t blame them for that but do think the discussion over their tactics was overshadowing the main discussion of protecting young women from HPV which can lead to cervical cancer.

Technorati Tags: Gardasil, Merck

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Pharmaceutical Business Review has a very short article with a few more tidbits about Ranbaxy’s office in New Jersey being raided. Seems no one is commenting about which agency performed the raid but it is thought to be the FDA and that they took not only paper documents but also electronic documents. The FDA has refused to comment.
Technorati Tags: FDA, Ranbaxy

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The mergers continue to move along. Now, British based Shire PLC is buying New River Pharmaceuticalsc here in the US for $2.6 billion.

Shire buying New River Pharmaceuticals - Yahoo! News:

Here’s the Shire press release. Unlike a lot of press releases, this one is full of good useful information including a significant section on the rationale for the acquisitions. This is unusual and I wish more companies would look at this as an example of how to make press releases. Too many times, I find myself wondering what they are deliberately leaving out or it is obvious they are spinning the information to their advantage.

This is another example of a partnership that ends up in a merger. Back in Jan 2005 Shire and New River agreed to a deal on NRP104 which is now called Vyvanse for the treatment of Attention Deficit and Hyperactivity Disorder (“ADHD”). NRP has received an approvable letter and Shire expects to launch for the pediatric indication as well as file for a sNDA for adults in the second quarter of 2007. Shire has always had an interest in ADHD with their Adderall XR product.

It should be noted that Health Canada suspended sales of Addreall XR back in Feb 2005 and so Shire is obviously looking for something new. For another view on the withdrawal in Canada see the article from Pharmaceutical Business Reviews. According to the FDA webpage though, it was brought back to the Canadian market in Aug 2005. Here is the FDA’s statement on Addreall.

I think Shire is hedging its bets and if the situation with Adderall XR should get worse, they have a fall back position. Note the timing of when the Canada situation happened and when they entered into the partnership with New River; Also, the patent for Adderall XR expires this year.

For more information in general about Adderall see the Wikipedia article.

Other Resources

Lisdexamfetamine dimesylate in ADHD phase 3 data presented (Vyvanse)
lisdexamfetamine dimesylate - Yahoo! Search Results
adderall - Yahoo! Search Results
lisdexamfetamine dimesylate - Google Search
adderall - Google Search

Technorati Tags: Adderall, New River Pharmaceuticals, pharma M&A, pharmaceutical deals, lisdexamfetamine dimesylate, Shire Pharmaceuticals, Vyvanse

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Wow, I go to a conference for a week and all kinds of things happened. Here are some of the headlines that caught my attention.

FDA

‘Accelerated Enforcement’ Now Against Unapproved Drugs: FDA will be accelerating enforcing regulations against unapproved and unregulated drugs and are having weekly meetings to discuss priorities.
Killing the Goose That Lays the Golden Drugs: An article stating that there is a need to balance drug safety with access to new therapies.
Press Release: Sanofi-Aventis Announces Update To U.S. Prescribing Information For Ketek - FierceBiotech: More on the Ketek fiasco.
PharmaLive: FDA Announces Label and Indication Changes for the Antibiotic Ketek
Sanofi shares slide as FDA delays Acomplia–again - FierceBiotech: More delays for Acomplia in the US; decision to be made by July.
FDA deny drug application from Advancis - Washington Business Journal: Another antibiotic has hit a snag; Advancis NDA is said to be incomplete and unable to be approved.
US warns Abraxis BioScience about plant problems | Health | Reuters
Abraxis Bioscience, Inc., Warning Letter: From the FDA website.

Government and Congress

GAO warns of Medicare drug overcharging - Boston.com: The GAO is worried about schemes to overcharge the US government for the Medicare Part D Prescription Benefit. The basis is that the complex set of rules makes it difficult to verify the accuracy of drug prices.
Biotech trade group warns of price controls - MarketWatch: The leader of BIO warned against the HHS being able to negotiate drug prices and calls them defacto price controls.
Democrats plan bill for generic biologics - washingtonpost.com: This could be big and I’ve posted before about biogenerics.
Generic Biotech Drugs Could Save $71B - washingtonpost.com: Another article on biogenerics and what impact it may have.
Lawmakers unveil bill to create clear pathway for generic biologic drugs
Newsvine - Texas Gov., Lawmakers in Vaccine Dispute: more about the Gardasil vaccine being required by the govenor for girls in Texas.
Pfizer’s AIDS drug to get faster review - Yahoo! Finance

Pharma News

PharmaLive: Lovenox Patent Infringement Suit Decided Against Sanofi-Aventis
PharmaLive: New Campaign Champions Changes in Medical Prescribing to End Conflicts of Interest
Bayer to file for Nexavar approval for liver cancer - Boston.com: I know folks at Onyx and am glad to see this drug proceeding so well.
Thailand threatens to produce more copycat drugs | Science | Reuters
Thailand plans to break patents on 14 drugs: firms - Yahoo! News
British pharmacy pilots over-the-counter Viagra - International Herald Tribune: Brings new meaning to the question, What’s Up? PharmaLive: Merck Settles Tax Dispute with Internal Revenue Service
Eli Lilly Regains Leaked Papers - washingtonpost.com: A judge orders papers related to Zyprexa to be returned to Eli illy.
PharmaLive: Telik Announces Corporate Restructuring: More lay-offs.
Ariad says close to cancer drug partnership deal | Health | Reuters
PharmaLive: Ranbaxy: Press Statement: Federal officals conducted a suprise search of Ranbaxy’s NJ offices.

Biofuels

Philadelphia Inquirer | 02/12/2007 | Oil firms speak up on alternative fuels: Major oil companies now want a seat at the table for discussing alternative fuels.
New theme heard at oil gathering - Los Angeles Times: Another article on big oil and their interest now in biofuels.
Big Oil says biofuels won’t meet U.S. energy demands - Feb. 15, 2007: more on the big oil views of biofuels.

Biotech

United Press International - Health Business - Seattle Genetics’ drugs get orphan status: I know people at Seattle Genetics and think they have a good business model and am glad to see these products get orphan drug status.
Wired News: Pharm Animals Crank Out Drugs: Another article on pharming, using animals to produce drugs. Covers GTC Biotherapeutics who I’ve mentioned before here and here.
Biotech posts fastest growth globally: Article on the double digit growth (35%) in India’s biotech industry.
Hawaii has more biotech bills - Pacific Business News (Honolulu): The Hawai’i state government had 44 bills before it relating to biotech in 2006.

Other
Refusing to share samples ‘may cause a vaccine delay’-News-World-Asia-TimesOnline: GSK has attacked the Indonesian government for refusing to supply bird flu samples to other companies for research to develop vaccines.
Technology Review: Discovering Drugs with Bubbles: I’ll share my views on this in a later post.
I’ll try to comment on some of these in more detail later this week if I can get some spare time.

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The New York Times had a good article about biotech with a focus on Xoma but it does details the massive amounts of money that have been lost in the biotech sector. Definitely worth a read.

It’s Alive! Meet One of Biotech’s Zombies - New York Times:

Technorati Tags: biotech, biotech companies, Xoma

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According to Bloomberg News, the London Times is reporting (without naming source) that Sanofi-Aventis has decided not to pursue Bristol-Myers Squibb.

Sanofi Halts Takeover Talks With Bristol-Myers, Times Reports

This could be true but I don’;t think it changes the fact that BMS is looking for someone to merge with. Mark my words, before the end of this year, I think a merger for BMS is definitely in the cards. Again, I don’t personally think that approach is sound but think that is most likely what will happen.

Other Sources

Bristol falls, Sanofi rises on report - Yahoo! News

Technorati Tags: Bristol-Myers Squibb, pharma M&A, Sanofi-Aventis

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Seems China has had a problem in the past with their drug approval process. As many as 170,000 approved between 1999-202 drugs may be reviewed. There has been a string of deaths that have been blamed on the corruption of some individuals within the Chinese drug approval system.

China Launches Review of Drug Industry - washingtonpost.com:

Seems Zheng Xiaoyu, formerly director of State Food and Drug Administration (SFDA) in China was fired in 2005 for taking bribes and letting companies circumvent testing procedures and approval processes. Now, drugs approved in China in the time period of will be reviewed. It is good to see China confronting this problem and at least two other deputy director are under investigation.

With China becoming more of a factor in world healthcare it is good to see they are addressing issues to make sure drugs inside China are safe and effective.

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I’ve been busy with other projects recently but am not getting caught up on all the chemistry and science related news from the past few days. One of the important ones was a recent announcement about the government of Thailand breaking patents on Plavix (Sanofi-Aventis and Bristol-Myers Squibb) for heart disease and Efavirenz (Merck) an HIV drug.

FT.com / World / Asia-Pacific - Thai goverment to break drug patents:

This seems to have caught the pharmaceutical industry by surprise. The Thai government says they can not afford the drugs and there are legal processes in place for governments to break patents under World Trade Organization (WTO) rules. There is much conversation about under what circumstances this can take place since the law evidently is unclear and critics are saying that Thailand doesn’t have criteria outlined to determine when this should occur.

I have mixed feelings. I am sympathetic to the cost factor but think the Thai government should have enter into negotiations with the companies first. Also, you need to consider that the Thai government recently was overtaken by a military coup de’etat back in September 2006. So it is unclear how exactly this current government will operate.

I don’t think this will become a trend; I think this particular government may be a an aberration.

Technorati Tags: Thailand

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The mergers continue! Seems even Pfizer who has gobbled up many company in the past hasn’t had its appetite satiated yet.

Pfizer To Acquire BioRexis - Contract Pharma:

Pfizer will acquire BioRexis, a privately held biopharmaceutical company although no financial details were released. BioRexis is developing drugs for the treatment of type 2 diabetes. BioRexis also has a proprietary protein engineering technology that may be why Pfizer was truly interested in them. Pfizer, like many larger pharmaceutical companies is interested in beefing up their biologicals since these tend to have higher prices and currently no generic competition.

Press Release from BioRexis’ Site
Pfizer to Acquire BioRexis to Access Novel Technology Platform and Early Stage Diabetes Pipeline

Technorati Tags: Pfizer, pharma M&A, pharmaceutical deals, Biorexis

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