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Monthly Archives: October 2007

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

A new issue of the Journal of Commercial Biotechnology has just been posted. Drop me a line if you would like to make a submission.

Volume 13, Issue 4


Neil Henderson


Is ‘evergreening’ a cause for concern? A legal perspectivePDF
Scott Parker, Kevin Mooney
Exploiting the business opportunities in biotech connections: The power of social networksPDF
Ian P McCarthy, Leyland Pitt, Colin Campbell, Rian van der Merwe, Esmail Salehi-Sangeri
The roles and responsibilities of the EU qualified person for pharmacovigilance under Volume IXa March 2007PDF
Graeme Ladds
Investing in new medical technologies: A decision frameworkPDF
Emma Cosh, Alan Girling, Richard Lilford, Helen McAteer, Terry Young
Innovative capabilities and strategic alliances: Who is gaining what in the pharmaceutical industry?PDF
Marisa Ohba, Paulo N Figueiredo
Industrial enzymes in bioindustrial sector development: An Indian perspectivePDF
Anuj Kumar Chandel, Ravinder Rudravaram, Linga Venkateswar Rao, Pogaku Ravindra, Mangamoori Lakshmi Narasu

Legal and Regulatory Updates

Legal and regulatory updatePDF
Gerry Kamstra, John Wilkinson

Book Reviews

Book Review: The Economics of Biotechnology: Volumes I and IIPDF
Iraj Daizadeh
Book Review: Global Governance of Food and Agriculture IndustriesPDF
Alan McHughen
Book Review: The International Politics of Genetically Modified Food: Diplomacy, Trade and LawPDF
Robert Paarlberg
Science Business: The Promise, the Reality and the Future of BiotechPDF
Weijun Li

Wired has an article on the potential for the pharmaceutical industry to support the international space station, using the microgravity environment to grow better quality crystals than can be grown on earth, in less time.

Protein crystals can be used to improve drug discovery, but the distance from crystal to drug is very long. Much time and money need to be invested to develop or modify drugs based on crystallographic findings, which makes me wonder what the value of improved crystals might be — enough to justify growing them in orbit?

Courtesy of DrugPatentWatch.com:

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

TradenameApplicantGeneric NamePatent NumberPatent Expiration
CLARINEXScheringdesloratadine4,659,716OCT 01,2007
CLARINEXSchering Ploughdesloratadine4,659,716OCT 01,2007
CLARINEX D 24 HOURScheringdesloratadine; pseudoephedrine sulfate4,659,716OCT 01,2007
CLARINEX-D 12 HOURScheringdesloratadine; pseudoephedrine sulfate4,659,716OCT 01,2007
COVERA-HSGd Searle Llcverapamil hydrochloride4,946,687OCT 02,2007
DYNACIRC CRReliant Pharmsisradipine4,816,263OCT 02,2007
DYNACIRC CRReliant Pharmsisradipine4,946,687OCT 02,2007
DYNACIRC CRReliant Pharmsisradipine4,950,486OCT 02,2007
ESTROSTEP 21Warner Chilcottethinyl estradiol; norethindrone acetate4,962,098OCT 09,2007
ESTROSTEP FEWarner Chilcottethinyl estradiol; norethindrone acetate4,962,098OCT 09,2007
LEXXELAstrazenecaenalapril maleate; felodipine4,803,081OCT 03,2007
NEXIUMAstrazenecaesomeprazole magnesium4,786,505OCT 20,2007
NEXIUMAstrazenecaesomeprazole magnesium4,853,230OCT 20,2007
OXYCONTINPurdue Pharma Lpoxycodone hydrochloride5,266,331OCT 26,2007
OXYCONTINPurdue Pharma Lpoxycodone hydrochloride5,549,912OCT 26,2007
OXYCONTINPurdue Pharma Lpoxycodone hydrochloride5,656,295OCT 26,2007
PERMAXValeant Pharm Intlpergolide mesylate4,797,405OCT 26,2007
PLENDILAstrazenecafelodipine4,803,081OCT 03,2007
PRILOSECAstrazenecaomeprazole4,786,505OCT 20,2007
PRILOSECAstrazenecaomeprazole4,853,230OCT 20,2007
PRILOSEC OTCAstrazenecaomeprazole magnesium4,786,505OCT 20,2007
PRILOSEC OTCAstrazenecaomeprazole magnesium4,853,230OCT 20,2007
PROPULSIDJanssen Pharmacisapride monohydrate4,962,115OCT 09,2007
PROPULSID QUICKSOLVJanssen Pharmacisapride monohydrate4,962,115OCT 09,2007
VOLTARENNovartisdiclofenac sodium4,960,799OCT 03,2007
ZOVIRAXGlaxosmithklineacyclovir4,963,555OCT 16,2007

Courtesy of DrugPatentWatch.com