+Timos Papagatsias

Wednesday 26 September 2012

Template: Pipeline analysis (up to seven competitors)

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I have been extremely busy the past few months but eventually managed to find some time to finalize this Excel model, which allows you to analyze and compare pipelines of up to seven competitors. 

The model also goes one step further and gives an initial estimate of "attractiveness for investment" for these companies, based solely on number of assets in the different development stages (i.e. a company with 10 assets in Phase III has more chances of returning an investment versus a company with only 3 assets in Phase II etc.). The next step in the development of this template will be an add-on to this model which will calculate potential profits per product in a given time horizon (to be released in a future post). 

The model requires minimal input from the user: only the number of pipeline products per development stage for each company and an estimation of the likelihood of success for a product at each stage are required.

The output is a single A4 sheet (please check with "Printing Area" settings on your machine) which contains an overview of the analysis and a few graphs which can be fully modified to focus on particular competitor or pipeline strength etc.

The Excel file containing the model is not password-protected and no cells have been locked; it can be fully modified and used for other applications/comparisons apart from company pipelines. 

You can download the model here (follow the link and then go to "File --> Download"; it is an .xslx file).

Drop me a line with comments / suggestions

Wednesday 1 August 2012

Grow your own vaccines...literally!

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Interesting news were announced recently by GE Healthcare and iBio Inc. who formed a global alliance in order to commercialize plant-based technologies for the production of biopharmaceuticals and vaccines.

IBio brings into the deal its innovative iBioLaunch plant-based vaccine manufacturing platform, whereas GE Healthcare brings its own expertise on start-to-finish biopharmaceutical manufacturing. According to iBio, a protein of interest could be generated within 3 weeks, cutting down significantly on development costs.

IBio's stock is currently (1st of August 2012) trading at USD 1.15, down ~27% from USD 1.58 on 26th of July, the day of the announcement of the deal with GE Healthcare, so it could be a good opportunity to go long on it. An interesting company to follow more closely going forward, especially since the recent FDA approval of Elelyso (Pfizer) which is used for enzyme replacement therapy of Type 1 Gaucher disease and is produced in plant cells (the very first drug produced through bio-pharming to be approved by the FDA). Should iBio's platform work as expected there will be some good news coming from the company; at least that is what GE Healthcare believes.


Saturday 7 April 2012

Template: Comparison of sales for up to five competitors

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I hope you will find the template below useful; it allows you to compare up to five  pharmaceutical products in terms of sales/profits over a period of time.

Calculation of threat from generics is also feasible and useful in guiding assumptions around the growth of the product over time.

Competitor vs Competitor template (follow the link and then go to "File --> Download"; it is an .xlsx file).

You can modify the template as you wish and use it for other applications of course; let me know of any comments/suggestions.


Website Update

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Having been very busy in the last two-three months I have now found some time to update BioHive:

  • Modification of the Biofinance section of the website with addition of "In focus" (current opinions and news - still "Under Development"), "Companies I follow" (self explanatory - still "Under Development")  and "Resources" pages
  • Some minor aesthetic changes in the Home page of the website


Wednesday 25 January 2012

The Gene Therapy that came in from the cold...

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Despite not making any big headlines, a very important development took place in early December 2011: the very first Gene Therapy treatment was approved outside China (Gendicine, an adenovirus-based p53 gene transfer product, and Oncorine, an E1B-deleted adenovector for the treatment of head and neck cancer have both been in the Chinese market since 2004 and 2006 respectively)! The Human Stem Cell Institute's (HSCI) product, Neovasculgen, a plasmid-based vector encoding VEGF (165 aa), driven by a minimal CMV promoter, received the nod from the Russian authorities following positive results in its Phase IIB/III trial.

Neovasculgen's target population are patients suffering from Peripheral Arterial Disease (PAD) and Critical Limb Ischemia (CLI). For more information you can find an interview with the company's CEO hereSale of Neovasculgen is scheduled for Q2 2012 in Russia followed by launch in Ukraine.

This piece of news comes right after Amsterdam Therapeutics was denied approval of its Gene Therapy candidate, Glybera, for the treatment of lipoprotein lipase deficiency (LPLD). But does the approval of Neovasculgen indicate that in the next few years more and more Gene Therapy products are to be approved??

In a previous post, I highlighted the companies most active in developing Gene Therapy products: Oxford Biomedica, Sibiono, Genzyme, Introgen, Diamyd to name a few. In the meantime, Sanofi added two more products in Phase I development: RetinoStat for the treatment of age-related macular degeneration and StarGen for the treatment of Stargardt disease; both assets originally from Oxford Biomedica. So the interest is there from big (and not so big...) pharma...but what is happening with the regulators? 

Well,decent efforts by both the EMA and FDA in the past few years indicate that the two agencies are trying their best to educate themselves and the public on these new approaches. As everyone is aware by now, safety is the prime concern for both agencies. Companies with Gene Therapy products in their pipelines should be prepared to invest significant amounts of time and energy in establishing informative interactions with the regulatory authorities, in order to understand each other's needs and priorities. 

I am relatively confident that we will see a Gene Therapy product approved either by the EMA or the FDA by 2020; not so sure what HSCI's plans are with Neovasculgen either and whether the company aims for approval outside Russia. Costs associated with developing and testing Gene Therapy products have increased and budgets have shrunk in the past few years but I am optimistic for the future...