In Vivo is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Gastrotech Pharma AS

Executive Summary

Denmark's Gastrotech Pharma is harnessing gastro-intestinal hormones such as ghrelin and GLP-1 to develop more effective therapies for irritable bowel syndrome and cachexia.

You may also be interested in...



Roche Signs Up Ipsen--Again

Roche's October 2003 in-licensing of Ipsen's Phase I GLP-1 analog buys the Swiss group an initial stake in the fast-growing diabetes market. Most established diabetes players already have a compound in this class, but the partners hope that Ipsen's expertise in peptide delivery will set this program apart from competitors'. As the second licensing agreement between Roche and Ipsen in less than a year, the deal further validates Ipsen's pipeline, and suggests that Roche's carefully-managed partnership strategy continues to encourage repeat business.

Zealand Deals Diabetes Drug to Aventis

Denmark's Zealand Pharma inked its second Big Pharma deal in as many months when it out-licensed its lead product, a Phase II diabetes treatment, to Aventis. Zealand's accelerated development of the product--which was tested immediately in patients, bypassing healthy volunteers--provided the firm with clinical proof of prinicple, on a budget.

Safety First...and Last

Even if industry observers are correct and the US Food and Drug Administration has changed its rules for drug approval and is now tilting toward assessing safety, not efficacy, first, the current policy falls squarely within the agency's legislative mandate. Historically, it has asked companies to conduct additional clinical trials when doubts about safety remain. But even within that requirement, the FDA has room to maneuver. And a new school of thought is leaning toward post-marketing risk management to detect serious and rare adverse effects after a drug has reached the market on the basis that its benefits outweighs its risks.

Topics

Related Companies

Related Deals

Latest Headlines
See All
UsernamePublicRestriction

Register

IV004862

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel