QDIS Blog

C&EN had a nice article on the year in review for the pharmaceutical industry. I’m just now getting caught up on some reading and wanted to let readers know of this, although most may have already read it.

Chemical & Engineering News: Cover Story - Pharma Challenged

One of the facts that stuck out to me was that the US represents 45% of worldwide shares. There is the chart showing other countries. It isn’t stated but I’m assuming this is only for brand name pharmaceuticals and doesn’t include generics.

This is why everyone concentrates their efforts on approval in the US and why many times companies are willing to accept less than acceptable pricing in other countries and hope to make up the difference in the US.

Here is the same sort of chart for generics from The World Generics Market (pdf). Again the US dominates the market although it is considerably smaller than the one above in terms on revenue.

Technorati Tags: generics, pharma stats, pharma worldwide markets, pharmaceutical companies

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Wow! This has got to be one of the largest deals recently. Abbott is shedding its non-pharma units to concentrate on pharmaceuticals. The size of this deal is immense; $8.13 billion!!

PharmaLive: Abbott To Sell Its Core Laboratory Diagnostics Business, Including Point Of Care, To GE
For $8.13 Billion

Abbott will keep its Molecular Diagnostics and Diabetes Care (glucose monitoring) businesses. Not much else in any of the news I could find.

Here are the companies press releases.

• Abbott to Sell Its Core Laboratory Diagnostics Business, Including Point of Care, to GE for $8.13 Billion
• GE to Acquire Abbott’s in vitro and Point-of-Care Diagnostics Businesses for $8.13 Billion, Broadening Capabilities in Growing Global Industry

Other Resources:
Yahoo! News Search Results for abbott ge
abbott ge - Google News
Google Blog Search: abbott ge

Technorati Tags: Abbott Labs, GE, pharmaceutical deals

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I thought I would put together a list of brand name pharmaceuticals whose patents are due to expire this year. Many are expiring between now an 2010 and represent $75 BILLION in revenue; $17.7 billion in 2007. I’ll focus on the near term and those expiring in 2007.

1. Norvasc, prescribed for hypertension
2. Univasc, prescribed for hypertension
3. Zyrtec, prescribed for allergies.
4. Zoloft, prescribed for depression
5. Allegra, prescribed for allergies
6. Zocor, prescribed for lowering cholesterol
7. Pravachol, prescribed for lowering cholesterol
8. Coreg, prescribed to treat congestive heart failure
9. Toprol XL, prescribed for hypertension
10. Provigil, prescribed for narcolepsy
11. Imitrex, prescribed for migranes
12. Clarinex prescribed for allergies
13. Meridia, prescribed to treat obesity
14. Risperdal, prescribed for psychosis

Most of these, except for Norvasc, Meridia, and Clarinex already have a tentatively approved generic.

For a list of brand name drugs expiring from April 2006 through Deb 2008 see RxNews® Newsletter: Patent Expiration - RxSolutions.com

If there are others I have overlooked, please send me a note or leave a comment and let me know. Also, if you want to know when the patent expires in the US for a specific drug, you can use the Electronic Orange Book Home Page from the FDA. Just do a Search by Proprietary Name, then click on the specific Appl. No. on the left side for your specific formulation and strength and this will give you a page of data including the patent expiration.

Here is the page for 10 mg Norvasc tablets.

UPDATE: I recently came across another drug whose patent expires in 2007.

Betaloc (metoprolol), prescribed for hypertension which had sales of $1.9 billion in 2006

Technorati Tags: drug patent expiration, drug patents

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Seems Germany is not impressed with Acomplia from Sanofi-Aventis and it will be on there non-reimbursable drugs list.

PharmaLive: Sanofi-Aventis Intends to Contest in Court the Decision to Classify Acomplia Among Non-reimbursable Drugs in Germany

What this basically means from my understanding is that the drug is considered a “comfort drug” and will not be covered by German health insurance. this means the drug will not be prescribed as widely as it would otherwise. Sanofi has stated they feel the classification is unjustified and will contest the decision.

On another note, I have read that the drug, if approved in the US will likely be called Zimulti.

Other Resources:
Acomplia Report - Acomplia Turned Down for Coverage by German Health Insurance

Technorati Tags: Acomplia, Rimonabant, Sanofi, Sanofi-Aventis

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In what most consider a very risky move, GlaxoSmithKline will pit their cervical cancer vaccine Cervarix ,which is in late stage clinical trials, against Merck;s approved cancer vaccine Gardasil.

Glaxo Goes Head-To-Head With Merck - Forbes.com

GlaxoSmithKline is definitely behind in this regard; Merck’s Gardasil is already approved and on its way towards $700 million in sales it first year. GSK on the other hand won’t even submit an NDA until at earliest 2009 and so will be at least three years behind.

Another problem is that the proposed study is only 1,000 patients and some, including myself, wonder if this will even allow you to see if there is a difference. Also GSK is taking a shortcut and making the argument that testing the response generated by the immune system due to the vaccine will be an indicator that the vaccine works better and longer. This has not been proven to be the case and the FDA in general frowns on such approaches. It will definitely be an uphill battle and I see the likely outcome being the FDA asking for longer term data on how well it protects against cervical cancer and precancerous lesions. This would set back GSK by years. It is a risky gambit.

Many consider this risky and in general, the pharmaceutical industry avoids, at all cost, comparing their drug directly against a competitors. The main exception to this is in anticancer drugs where drugs are always tested against a comparator since it is consider unethical to not treat those affected. The choice of comparator, when it is used, is questionable. Many times the drug chosen as competitor is not the best in the field and few experts would suggest this drug as a first choice for there patients.

I often wonder and have actually asked in meetings why not test against the best in class. Many times upper level management touts their drug as a breakthrough in treatment of a disease and over-hype it to the media and the public. However, in private internal meetings, they want to choose a comparator (if used at all) that gives them the best chance of a positive outcome. I say if they have such confidence that they express in public why is it that behind closed doors they do everything they can to tilt the field in their favor. If they have confidence in public, why does that confidence evaporate in private planning meetings?

Technorati Tags: cancer vaccine, GlaxoSmithKline, Merck, cervical cancer, vaccine

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A recent survey from PriceWaterhouseCoopers shows what I have been talking about for a long time. Namely that the pharma industry has not done a good job of explaining what it does and that there is an increasing credibility gap in the minds of consumers.

PricewaterhouseCoopers LLP :: Consumers and Pharmaceutical Companies Far Apart on Views of Pharma Industry, Finds PricewaterhouseCoopers Survey

Here are the pertinent parts in my opinion.

• Three out of four (74 percent) consumers underestimate the average
financial investment required to research and develop a new drug by
more than 50 percent.

• Consumers are split between believing that pharmaceutical companies
consider important unmet medical needs when deciding to develop a new
drug (55 percent) instead of choosing to develop “me-too” and
“lifestyle” drugs with the greatest sales potential (45 percent). This
compares to 71 percent of industry stakeholders and 91 percent of
pharmaceutical executives, respectively, who say health needs are a top
priority for pharmaceutical companies.

• 94 percent of consumers and 81 percent of industry stakeholders said
that drug companies are too aggressive in promoting unapproved uses of
their product. Fewer than half (47 percent) of pharmaceutical company
executives agreed.

• 62 percent of stakeholders agreed that drug companies often manipulate
or suppress negative clinical trial results to maximize sales. Four
out of five pharmaceutical executives disagreed.

• nearly 94 percent of stakeholders agreed that drug companies spend too
much money on drug promotion overall, including direct-to-consumer
advertising as well as physician education and overall sales force initiatives.
Surprisingly, nearly three-quarters of industry executives agreed.

• More than seven in 10 stakeholders (73 percent) agreed that drug
companies spend too much money and effort attempting to prevent generic
drugs from competing with their branded products. Consumers strongly
agreed that drug companies should be working with generic drug
manufacturers to make generics available upon expiration of their
branded drug’s patent.

• Almost nine out of ten (86 percent) consumers underestimated the cost of
bringing a new drug to market. Independent studies place the cost of developing
a single marketed pharmaceutical product in excess of $800 million. Part of
public’s misconception may stem from the fact that consumers neither understand
who funds drug discovery nor appreciate the cost of failure that factors into each
success in the drug discovery process.

I’ve long said that many of the actions of the pharmaceutical industry just play right into some of these perceptions. I’ve been in the industry for over 14 years and don’t remember any general program geared towards education of consumers of what goes into developing a pharmaceutical.

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Seems the FDA is banning General Electric (GE) from making X-ray machines due to problems as its plants in both Utah and Massachusetts according to Forbes. The FDA filed a consent decree in US District court in Utah on Friday, January 12, 2007.

FDA Bans GE From Making X-Ray Machines - Forbes.com:

This relates back to problems discovered initially in an inspection in Nov-Dev 2004 and resulted in a warning letter dated Mar 31 2005. Here is the actual warning letter. The FDA found that the devices were:

adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacture, packing, storage, or installation are not in conformance with the Quality System/Good Manufacturing Practice (QS/GMP) for Medical Devices Regulation, as specified in Title 21, Code of Federal Regulations (21 CFR), Part 820.

And here is the actual FDA announcement;

GE OEC Medical Systems Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies

Seems the FDA inspection that occurred July-Aug 2005 did not show the required responses to the past warning letter and led to the FDA enforcement. From reading the announcement above it appears that GE did not validate the device design and failed to have a corrective and preventive actions program.

GE stopped shipping the units in September and will not be allowed to distribute them until they pass another inspection. GE have also had to recall several models.

GE Healthcare Press Release

I think it likely you will see more medical device manufacturers come under scrutiny mainly because, from my limited exposure to medical device manufacturers, they do not have as form an understanding of the cGMP requirements as the biotech and pharmaceutical industries do. Also, the concept of “validating the device design” is relatively new and some device manufacturers do not seem to be aware of the guidance documents entitled Design Control Guidance For Medical Device Manufacturers released by the FDA in March 1997 to address this very issue .

Technorati Tags: FDA, FDA enforcement, GE, medical device, cGMP, x-ray machine

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In what could be a nightmare for some pharmaceutical companies, the FDA has notified some pharmaceutical companies that analytical data (primarily bioequivalence) provided in support of some NDAs and ANDA’s may need to be re-evaluated and repeated. Seems during inspections of a Canadian facility of MDS Pharma Services question were raised about the validity of their results.

PharmaLive: FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products :

FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products (from FDA website)

Here are the primary areas of concern from the FDA letter.

• Failure to conduct a systematic and thorough evaluation to identify and correct sources of contamination.
• Failure to investigate anomalous results.
• Lack of assay reproducibility between original and repeat results.
• Assay accuracy not assured under the conditions of sample processing.
• Biased manipulation of study data resulting in the acceptance of failed runs (emphasis mine).
• Failure to demonstrate the accuracy of analytical methods with appropriate validation experiments and documentation.

That these were allowed to go on shows a noticeable disregard for cGMP. Most of these are fundamental issues and not even in areas where there is typically disagreement. It is hard for me to fathom how this could go on! Especially troubleing is the bias manipulation item!!

What is even more interesting is it occurred over the course of four years from 2000-2004 but it is only now that the FDA is sending notices to those potentially impacted. What is also interesting to me is that there is no press release about this on MDS’ own news page. The time period covered is four years from 200-2004! While the FDA website has the warning letters they are poor photocopies and in pdf format and hard to read. Here is another source of the FDA letters in a more easily read format.

FDA Warning Letter, MDS Pharma Services (Facility Inspection)
FDA Warning Letter, MDS Pharma Services (BMIS Inspection)

Here is the actual letters the FDA sent to the affected companies:

Letter to sponsor of Pending Abbreviated New Drug Application(s) (ANDAs)
Letter to Sponsor of Approved New Drug Application(s) (NDAs)

On a personal level, one of the drugs mentioned is loratidine the generic name for Claritin. I personally use this and wonder which generic companies are affected. This is the only specfic compound mentioned that I saw but there is likely others.

This should be a warning to many companies when they rely on others for results. I think it will be a blow to MDS Pharma services and find it very confounding that they have yet to get on top of this issue and put out any sort of statement. In light of all this, I certainly would steer any of my clients away from using MDS Pharma Services.

This is also what many refer to as the cockroach syndrome. If you see one, you know there are more in hiding. My question is if this sort of disregard for basic science principals occurs in this instance, there are almost surely other incidents that have not yet been uncovered.

Technorati Tags: FDA, FDA enforcement, FDA inspection, MDS Pharma Services

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The Seattle PI is reporting that a new startup may rise from out of Icos since Eli Lilly has reported they will get rid of all 700 of Icos’ employees.

Biotech startups may pop up in Icos’ wake

The article talks about Calistoga Pharmaceuticals (no website yet) a startup created with technology from Icos. The effort is being led by Michael Gallatin, a former VP and scientific director at Icos who is now part of a venture capital firm.

I hope this happens. I personally think the beginning of the end for biotech in Seatttle happened when Amgen bought Immunex. I do see some signs of hope such as my recent post on the deal between Genentech and Seattle Genetics. However, the article does say that this new startup would have significantly fewer than 700 employees so it still means people will not have jobs.

I’m hopeful for Seattle but I’m not holding my breath. There have been more negatives than positives in recent years regarding biotech and Seattle.

Technorati Tags: Calistoga Pharmaceuticals, Icos, pharmaceutical companies, pharmaceutical deals

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I’ve mentioned Govtrack recently and wanted to highlight what a great resource I think it is. If you want to track and be alerted to specific bills, then this site makes it easy, especially with RSS feeds (web feeds).

Here is a search for all bills containing “drug OR pharmaceutical” in the House of the 110th Congress with any status.

GovTrack: Bill Search House (drug OR pharmaceutical)

This contains links to the full text of bills of 11 bills.

Here is the corresponding Senate bills.

GovTrack: Bill Search Senate (drug OR pharmaceutical)

The Senate currently only has 6 bills before it at this time. Both these links should continue to work and give you all the bills at later dates.

You can also use topics set up by the Congressional Research service (CRS) to monitor topic. As an example, here is the link for the topic Medicines. There is also an RSS feed (web feed).

I encourage everyone who has an interest in what Congress is doing to us this resource.

Technorati Tags: drug cost, drug imports, drug price, Government Information, Govtrack

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