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
I’ll be speaking at the Biotech for Turkey conference in Istanbul on November 7th. This conference, convened by Bosfor Biotech Partners, will cover global biotechnology strategies and developments in Turkey. For more details, contact Bosfor Biotech at the URL above or browse the conference schedule: Biotech for Turkey
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
Legal and Regulatory Updates
|Legal and regulatory update||PDF|
|Gerry Kamstra, John Wilkinson|
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 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|
|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|
Courtesy of DrugPatentWatch.com