Replies to post #52914 on Biotech Values

[DewDiligence]

OctoPlus In-Licenses GLP-1 Agonist

[This could eventually be a competitor to Exenatide LAR. OctoPlus’ polymer technology has been demonstrated with Locteron, a long-acting interferon alpha for HCV that is in phase-2 (#msg-21566438).]

http://biz.yahoo.com/iw/070927/0307664.html

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Thursday September 27, 1:45 am ET

LEIDEN, NETHERLANDS--(MARKET WIRE)--Sep 27, 2007 --
OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO), the drug delivery and development company, announces today that it has acquired exclusive worldwide rights to develop and commercialise a family of compounds, including a GLP-1 agonist product candidate for the treatment of type 2 diabetes from Canadian biopharmaceutical company Theratechnologies (Toronto:TH.TO). The product candidate has been selected by OctoPlus for development into a long-acting controlled release formulation that may substantially reduce the required dosing frequency in diabetes therapy, compared to current products on the market or in development, and with a potentially better tolerability profile. OctoPlus has initiated pre-clinical development of this product.

…GLP-1 (glucagon-like peptide 1) is a metabolic hormone that plays a central role in glucose handling. Various drug development efforts are directed towards its potential therapeutic benefit in diabetes treatment, and the only currently available GLP-1 based therapy requires twice-daily injections. [This is referring to Byetta, of course.] Last year, GLP-1 based therapy generated US$ 430 million in revenues and this number is expected to grow significantly.

OctoPlus' controlled release technology platform comprises polymer-based drug delivery technologies that can be combined with active pharmaceutical ingredients to gradually release the therapeutic in the body during weeks or months. In July, OctoPlus showed its leading role in controlled release delivery of proteins and peptides with the publication of promising results from an ongoing Phase IIa study with its lead product Locteron(TM), a controlled release formulation of interferon alfa for the treatment of chronic hepatitis C. OctoPlus' controlled release technology in Locteron shows its potential to induce fewer side effects, improve patient compliance and provide more convenient once-every-two-week dosing in comparison to current therapies, and with similar efficacy.

Under the terms of the license agreement, OctoPlus will pay Theratechnologies milestone payments and royalties during the development and commercialisation of the product. The majority of these milestone payments are related to the successful completion of various clinical phases and the achievement of preset sales levels, and could amount to up to EUR 36 million.

Joost Holthuis, Chief Executive Officer of OctoPlus, comments: "We are delighted to expand our product portfolio with the addition of this promising GLP-1 agonist product candidate in a major therapeutic area. We are fully committed to successfully developing a truly long-acting formulation of this product, which continues to be an unmet need in diabetes therapy. Our recent success with Locteron gives us confidence that we will be able to apply our extensive controlled release experience to GLP-1 based molecules."

…About OctoPlus

OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics, other drugs, and vaccines.

Our pipeline consists of 5 products in preclinical and clinical development. Our lead product is Locteron, a sustained-release formulation of interferon alfa for the treatment of chronic hepatitis C, which we are co-developing with Biolex Therapeutics. Locteron is in Phase IIa clinical development. Furthermore, our pipeline comprises a product candidate for the treatment of chronic middle ear infection, which is also in Phase II development, a pre-clinical GLP-1 product candidate for the treatment of diabetes and two pre-clinical-stage single-shot vaccines.

In addition, OctoPlus is a leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industry, with a focus on difficult to formulate active pharmaceutical ingredients in injectable formulations. The earnings and expertise that we derive from rendering formulation and manufacturing services help to support our own drug development programs.

OctoPlus is listed on Euronext Amsterdam under the symbol OCTO. For more information about OctoPlus, please visit our website www.octoplus.nl.

About Theratechnologies

Theratechnologies (Toronto:TH.TO - News) is a Canadian biopharmaceutical company that discovers innovative drug candidates in order to develop them and bring them to market. The company targets unmet medical needs in financially attractive specialty markets. Its most advanced program is tesamorelin, which has recently completed patient recruitment for its confirmatory Phase III clinical trial for a serious metabolic disorder known as HIV-associated lipodystrophy. The company also has other projects at earlier stages of development. For more information, visit www.theratech.com.
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[lumpy9200]

AMLN

Well, here is the opinion of Lehman's Jim Birchenough (courtesy of Boston Matty on IV). Note estimate of $4.5 billion in world wide sales for Exenatide LAR. This is much more compelling than the $2 billion I threw out in my previous post.


Lehman's Dr. Birchenough concedes on price

Investment Conclusion

We are increasing our price target on AMLN to $55 from $39 but maintaining our 2-Equal weight
rating ahead of upcoming phase IIb data for once weekly Exenatide LAR. While we expect LAR
superiority to Byetta BID to support eventual upside to flat Byetta trends, we believe execution
risk beyond the data, competitive visibility and unrealistic commercial expectations suggest a
brief trade rather than a sustainable investment.
Summary

AMLN will report data from its 300 patient phase IIb study of weekly Exenatide LAR vs Byetta BID
shortly in 4Q07. With prior phase IIa data suggesting HbA1c reduction of 1.7% and 8.3lb
weightloss after only 15 weeks investor focus is on AMLN ability to replicate apparent superiority to
Byetta BID and on the implications for such data.

Based on review of historical data, comments by AMLN management and recent investigator
feedback we do expect LAR superiority over Byetta BID with HbA1c results likely >1.7%.

While AMLN shares could trade up an additional 10% on positive data, we believe that commercial
expectations beyond our $4.5bln global estimate are stretched and would note FDA, manufacturing
and competitive risk as limiting sustainable upside.

[DewDiligence]

AMLN – A tidbit from NVO’s UBS webcast that may interest you: the presenter said that inhaled insulin is all but doomed to be a non-factor in the market due to the advent of GLP-1 drugs. The premise is that GLP-1 drugs will routinely be added to a regimen that includes long-acting, basal insulin.

What makes this admission remarkable is that NVO is one of the companies who has an inhaled-insulin program!