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Yearly Archives: 2007

My recent presentation at the “Biotechnology for Turkey” conference has been posted online. My central thesis was that the challenges faced by Turkey (and most any other location) are shared by many states within the United States. I’ve heard too many people opine for the seemingly easy start-up environment in the United States. The reality is that outside of the major hubs, biotechnology can be very hard to develop. It can even be difficult within the major hubs. So, instead of looking longingly at the strong position of leading regions in the U.S., why not look at the aggressive strategies being used by developing regions?

Check out my talk here.

Guest content from John Avellanet, managing director of Cerulean Associates:

The US Food and Drug Administration (FDA) intends to increase regulatory enforcement, extending the recent trend of laboratory and clinical site inspections to unapproved drugs and reformulations. How can you avoid compliance trouble?

At the Food and Drug Law Institute’s 5th Annual Enforcement and Litigation conference, several FDA compliance directors spoke out on FDA enforcement priorities and provided recommendations to improve compliance.

Laboratory & Clinical Inspections
The first two targets for enforcement are laboratories and clinical sites. Of the violations found, data integrity and policy/protocol adherence are the top two by a large margin, with data integrity involved in 95% of findings. Mitch Lazris, an industry defense attorney, noted that IT departments continue to be the weak link in the compliance chain.

Two main factors lead to inspections: problems with the integrity of the information submitted to the FDA and complaints by former employees, contractors, vendors, clinical trial participants and even the sponsors themselves.

Unapproved Drugs
The FDA estimates that approximately 2% of all prescriptions are for unapproved drugs or formulations. Priority will be given to those drugs that pose safety risks, with pediatric formulations at the top of the list. Drugs that lack evidence of efficacy are also considered to be “unapproved” now that all “generally recognized as safe” (GRAS) interpretations were revoked in 1968 (21 CFR 310.100).

Recommendations
Panel members made multiple concrete suggestions for executives:

  1. Conduct benefit-risk analyses for every product-related decision (such as labeling, reformulation, etc.); ask yourself how you’ll defend the decision in front of jurors increasingly suspicious of the high profits of (big) “pharma.”
  2. Train individuals to understand what they are committing to, not just the procedure or protocol steps.
  3. Clarify to IT their accountabilities for electronic data integrity—there are no magic bullet technological solutions, so be wary of “another system” to solve the problem; push for a “quality” approach, not a technological one.
  4. Use caution with universities that perform both the role of sponsor and investigator for clinical trials. Segregation of duties is critical.
  5. Do not use reputation or brand to select sites, vendors or systems; inspectors look for information integrity and process adherence.
  6. Rapidly respond to 483s as this shows you understand the gravity of the findings and have a positive attitude about the need for compliance.
  7. Use design control to your advantage to minimize risks during clinical trials, labeling decisions and so forth.
  8. Address all findings from audits, 483s and so on; remember to document the steps taken and the results. Expect the FDA to pursue court action if you insist on only fixing one or two items.

Following the panel’s recommendations will give you a stronger compliance program, minimize your costs, improve your bottom line and help you avoid enforcement action.
More recommendations and compliance strategies are on the Cerulean website.

About the Author
John Avellanet is a leading authority on simplifying and streamlining regulatory compliance and quality system programs so clients can achieve faster time-to-market. He can be reached through his independent consultancy, Cerulean Associates LLC (www.ceruleanllc.com) at: john[at]ceruleanllc.com.

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in December 2007
*Drugs may be
covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
DOVONEXLeo Pharmcalcipotriene4,866,048DEC 29,2007
FASLODEXAstrazenecafulvestrant4,659,516DEC 11,2007
KYTRILRochegranisetron hydrochloride4,886,808DEC 20,2007
KYTRILRochegranisetron hydrochloride4,886,808DEC 29,2007
MERIDIAAbbottsibutramine hydrochloride4,746,680DEC 11,2007
REQUIPGlaxosmithklineropinirole hydrochloride4,452,808DEC 07,2007
TACLONEXLeo Pharm Prodsbetamethasone dipropionate; calcipotriene hydrate4,866,048DEC 29,2007
ZINECARDPharmacia And Upjohndexrazoxane hydrochloride4,963,551DEC 21,2007
ZYRTECPfizercetirizine hydrochloride4,525,358DEC 25,2007
ZYRTEC-D 12 HOURPfizercetirizine hydrochloride; pseudoephedrine hydrochloride4,525,358DEC 25,2007

Courtesy of DrugPatentWatch.com

At a recent event was recently asked about investment outcomes for venture capitalists. I didn’t have any recent data, so I said that VCs generally expect that 1/3 of their investments will see great returns, 1/3 will see modest or no returns, and 1/3 will not be profitable.

VC Fred Wilson as Union Square Ventures recently analyzed his career in venture capital and posted his results. He’s got an enviable record of only 20% of deals failing to deliver, and more than 1/3 delivering a greater than 5x return.

Fred’s not into biotech, so I’d be hesitant about applying these numbers to biotechnology investing, and I’d be interested to see what the trends are in biotech VC.

Bio-Rad’s got an interesting website up: RethinkPCR.

The company’s name isn’t posted on the front page, but is readily available in the contest terms and conditions and privacy policy. It’s an interesting strategy to acquire consumer intelligence. Of course, consumers don’t always ask for what they want — they tend to ask for incremental improvements rather than revolutions, and they may not even accept the changes they ask for — but it will be interesting to see if any innovative new PCR products emerge.

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in November 2007
*Drugs may be covered by more than one patent

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ANDRODERMWatson Labstestosterone4,849,224NOV 12,2007
ANDRODERMWatson Labstestosterone4,983,395NOV 12,2007
AVITAMylan Bertektretinoin4,971,800NOV 20,2007
COMTANOrionentacapone4,963,590NOV 27,2007
ELOCONScheringmometasone furoate4,775,529NOV 21,2007
FLECTORInst Biochemdiclofenac epolamine4,948,805NOV 09,2007
MERIDIAAbbottsibutramine hydrochloride4,929,629NOV 29,2007
MYLOTARGWyeth Pharms Incgemtuzumab ozogamicin4,970,198NOV 30,2007
PROVIGILCephalonmodafinil4,927,855NOV 22,2007
STALEVO 100Orioncarbidopa; entacapone; levodopa4,963,590NOV 27,2007
STALEVO 150Orioncarbidopa; entacapone; levodopa4,963,590NOV 27,2007
STALEVO 50Orioncarbidopa; entacapone; levodopa4,963,590NOV 27,2007
TOPROL-XLAstrazenecametoprolol succinate4,927,640NOV 22,2007
TYLENOL (CAPLET)Mcneil Consacetaminophen4,968,509NOV 06,2007
URSO 250Axcan Scandipharmursodiol4,859,660NOV 19,2007
URSO FORTEAxcan Scandipharmursodiol4,859,660NOV 19,2007

Courtesy of DrugPatentWatch.com

Today marks the 25th anniversary of the FDA’s approval of the first drug produced by biotechnology, Genentech’s Humulin. I often use Humulin as a case study for biotechnology, because Genentech’s bacterial-fermentation approach to making insulin was revolutionary compared to the previous methods of harvesting insulin from pig pancreas.

Thanks for OpenMarket for reminding me of this important anniversary. Their post on the topic is here

I’ve been waiting to write up the Exubera story for the next edition of Building Biotechnology, and the story just keeps getting better.

Exubera is was Pfizer’s innovative answer to the diabetes drug market. The market is so saturated with competitive products, that the only way to capture significant market share is to innovate. Either produce a better drug — difficult, unless you can think of something better than resolving an insulin deficiency by administering insulin! — or improve on current delivery methods. Answering the second challenge, Pfizer developed an inhalable version of insulin. This drug promised to eliminate the need for injections or implantable dosage systems.

Early responses were positive (Washington Post and NPR), but in what is being painted as a marketing catastrophe