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

Editorial

Editorial PDF
Neil Henderson

Articles

Is ‘evergreening’ a cause for concern? A legal perspective PDF
Scott Parker, Kevin Mooney
Exploiting the business opportunities in biotech connections: The power of social networks PDF
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 2007 PDF
Graeme Ladds
Investing in new medical technologies: A decision framework PDF
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 perspective PDF
Anuj Kumar Chandel, Ravinder Rudravaram, Linga Venkateswar Rao, Pogaku Ravindra, Mangamoori Lakshmi Narasu

Legal and Regulatory Updates

Legal and regulatory update PDF
Gerry Kamstra, John Wilkinson

Book Reviews

Book Review: The Economics of Biotechnology: Volumes I and II PDF
Iraj Daizadeh
Book Review: Global Governance of Food and Agriculture Industries PDF
Alan McHughen
Book Review: The International Politics of Genetically Modified Food: Diplomacy, Trade and Law PDF
Robert Paarlberg
Science Business: The Promise, the Reality and the Future of Biotech PDF
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

Tradename Applicant Generic Name Patent Number Patent Expiration
CLARINEX Schering desloratadine 4,659,716 OCT 01,2007
CLARINEX Schering Plough desloratadine 4,659,716 OCT 01,2007
CLARINEX D 24 HOUR Schering desloratadine; pseudoephedrine sulfate 4,659,716 OCT 01,2007
CLARINEX-D 12 HOUR Schering desloratadine; pseudoephedrine sulfate 4,659,716 OCT 01,2007
COVERA-HS Gd Searle Llc verapamil hydrochloride 4,946,687 OCT 02,2007
DYNACIRC CR Reliant Pharms isradipine 4,816,263 OCT 02,2007
DYNACIRC CR Reliant Pharms isradipine 4,946,687 OCT 02,2007
DYNACIRC CR Reliant Pharms isradipine 4,950,486 OCT 02,2007
ESTROSTEP 21 Warner Chilcott ethinyl estradiol; norethindrone acetate 4,962,098 OCT 09,2007
ESTROSTEP FE Warner Chilcott ethinyl estradiol; norethindrone acetate 4,962,098 OCT 09,2007
LEXXEL Astrazeneca enalapril maleate; felodipine 4,803,081 OCT 03,2007
NEXIUM Astrazeneca esomeprazole magnesium 4,786,505 OCT 20,2007
NEXIUM Astrazeneca esomeprazole magnesium 4,853,230 OCT 20,2007
OXYCONTIN Purdue Pharma Lp oxycodone hydrochloride 5,266,331 OCT 26,2007
OXYCONTIN Purdue Pharma Lp oxycodone hydrochloride 5,549,912 OCT 26,2007
OXYCONTIN Purdue Pharma Lp oxycodone hydrochloride 5,656,295 OCT 26,2007
PERMAX Valeant Pharm Intl pergolide mesylate 4,797,405 OCT 26,2007
PLENDIL Astrazeneca felodipine 4,803,081 OCT 03,2007
PRILOSEC Astrazeneca omeprazole 4,786,505 OCT 20,2007
PRILOSEC Astrazeneca omeprazole 4,853,230 OCT 20,2007
PRILOSEC OTC Astrazeneca omeprazole magnesium 4,786,505 OCT 20,2007
PRILOSEC OTC Astrazeneca omeprazole magnesium 4,853,230 OCT 20,2007
PROPULSID Janssen Pharma cisapride monohydrate 4,962,115 OCT 09,2007
PROPULSID QUICKSOLV Janssen Pharma cisapride monohydrate 4,962,115 OCT 09,2007
VOLTAREN Novartis diclofenac sodium 4,960,799 OCT 03,2007
ZOVIRAX Glaxosmithkline acyclovir 4,963,555 OCT 16,2007

Courtesy of DrugPatentWatch.com