Insmed Inc (INSM)

[saltmountain2000]

Omnitrope: Not currently relevant but maybe in future

Coin,

I remember doing some background research online about Omnitrope (a Sandoz Novartis generic version of Pfizer's Genotropin) a few weeks ago when the topic popped up on on the INSM Yahoo board. Here's message 60070 from that board:

Subj: Re: Omnitrope...
By: saltmountain2000
Date: 01/28/06 06:16 am

Omnitrope is a Sandoz product. Here's an excerpt from the FDA news release of 1/25/06 about the current state of the Omnitrope NDA:

"The drugmaker, which filed its application to market Omnitrope (somatropin recombinant) in June 2003, sued the FDA last September after the agency refused to approve or deny Sandoz' NDA for Omnitrope, and refused to explain why it had not rendered a decision or give a timetable for when it would issue a decision."

http://www.fdanews.com/dailies/drugdaily/2_269/news/50977-1.html

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Also, check out this link:

http://www.leaddiscovery.co.uk/pr/pr24100501.html

... which says:

"All first generation and biogeneric hGH preparations so far require daily parenteral administration which is inconvenient for the patient. Less frequent administration and pain-avoiding needle-free delivery systems would constitute a real advantage. Ongoing R&D projects concentrate on slow-release and long-acting hGH molecules as well as on oral and pulmonary delivery systems... The number of hGH manufacturing companies in countries without patent protection and, therefore, potential biogeneric producers, is small despite a continuosly growing market due to life cycle management measures and label extensions."

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While somewhat dated, the following article gives a great synopsis of the marketing and production issues associated with biogenerics.

http://www.bioportfolio.com/news/datamonitor_87.htm

Furthermore, the article really hits the nail on the head when it states that players in this field are usually biotech start-ups or established companies looking to expand their portfolios.

"The latter group either form partnerships or make acquisitions to bring the necessary expertise in-house, while the former group possess in-house development and possibly manufacturing capabilities but are likely to need external input when it comes to marketing and distribution."

Sound familiar?

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The following link also provides some insight into why the FDA threw roadblocks at Omnitrope. This has implications for INSM in the future when the patent expires.

https://www.cbinet.com/includes/inthenews/articles/Biogeneric_Approvals.cfm