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bimerkjaere

01/18/13 8:14 AM

#108342 RE: freethemice #108129

FTM - here is my take on the top pharmas and their propensity to pick up a product with bavi's profile.


First, we must put bavi in terms of how a major pharma would view the opportunity. This of course will vary by major pharma, but generally it will be that bavi is

1) immuno-oncology drug
2) target of PS has been well verified in role of apoptosis, but mostly unknown role in cancer
3) extremely high risk and reward potential due to:
a) management is clearly a weakness - how much can we trust any results previously reported?
b) no clear benefit seen in response rate and PFS
c) potential for excellent OS results - carries more weight than b)

With that said, I will go through each of the top pharmas likelihood of taking on a product with bavi's profile (ordered by most likely to least likely)

1. Pfizer - has a history of taking on risky candidates, and has said previously that immuno-oncology is an interest. Recent loss of exclusivity with Lipitor has eroded top line, and mngt may want to role the dice to see if they can replace some of that revenue. Additionally, oncology is a key therapeutic area for Pfizer, but they have lagged Roche in this area. If you look at their last-stage oncology pipeline, it is anemic. They failed with axinitib in NSCLC, but it appears dacomitinib will make it to market (erlotinib competitior). Bavi would actually potentially compete with dacomitinib in 2nd-line NSCLC, but I don't think this will be a deterrent. Finally, Pfizer has one of the largest R&D budgets in pharma, and has the cash to risk on bavi.


2. Astrazeneca - All of the top pharma companies are facing patent expirations, but AZ is particularly troublesome as they will lose 80% of their revenue by 2016. With a few recent late-stage failures, AZ needs to license late-stage candidates or do some kind of M&A over the next few years. There are rumors that AZ could look to do a large scale acquisition (e.g BMS), but the more likely scenario is more licensing and small to mid-size deals (see Amylin deal). Oncology pipeline is especially thin, and bavi could fill a big gap. This would be the first move into the immuno-oncology space for AZ (also could be a strategic move as they would be playing into BMS strategy and many pharma experts believe AZ is interested in BMS and is just waiting for the right time to pull the trigger).


3. Roche - clearly Garnick's connection with Roche bodes well for a possible pphm partnership, as he can potentially alleviate some of the uncertainty around bavi's profile with his backing. Additionally, Roche is the clear leader in oncology right now, in both having the top selling product and breadth of portfolio. Roche has made a major move to work on antibody drug conjugates (e.g. T-DM1), and has little experience in immuno-oncology. Additionally, with Avastin, Tarceva, and onartuzumab, they may feel that their late-stage lung cancer pipeline is already stacked. Like Pfizer, Roche spends near the top in R&D, and licensing and partnerships are a major component of their strategy.


4. Merck - over the years Merck has shown its strength to be in the cardiovascular/metabolic space. That continues to be the case (e.g. Januvia franchise), and the bulk of their Phase III candidates continue to support this area. As one of the largest pharma companies, it is a bit shocking to see that they only have 6 cancer products in their entire pipeline (4/6 in Phase II). Merck could be making a decision to deprioritize this TA, but I doubt that they would step out completely. Bavi could be a way for Merck to get back into the oncology game.


5. BMS - arguably the leader in immuno-oncology (e.g. Yervoy, anti-PD1, etc..), and the company made this a priority years ago. BMS will try hold onto that title and I could see them doing a licensing deal on bavi as a strategic move. However, this hinges on whether management believes the bavi story, and my inclination is that this is not the case. Ranked as 4th most likely, it really could be 1st or last based on the above.


6. GSK - historically, one of the more reckless R&D organizations in major pharma as their failure rate is among the highest. Their strategy has been to take on a number of small potential products and throw as many shots at the goal as possible and hope some stick. Vaccines are a different story with GSK, as they are considered one of the best in this category. In fact, they now have a armory of 'antigen-specific cancer immunotherapeutics', including MAGE-A3 and PRAME (both being tried in NSCLC). Although there is an interest in immuno-oncology, vaccines seem to be the path GSK is taking (IMUC's ICT-107 dendritic cell vaccine for brain cancer fits them better).


7. Lilly - sometimes referred to as the sister company to BMS, Lilly shares a lot of the same approaches to drug development. Both BMS and Lilly focus on only a few therapeutic areas to try build expertise and improve success rates (as opposed to Sanofi or GSK). However, Lilly has taken a different approach in recent years by relying on internal development as a significant source of new products. This has not treated them well as they have had multiple high-profile, late-stage failures in the past few years. It will be a stretch for Lilly license a risky bavi and risk another Ph III failure.


Obviously it could be any number of companies I didn't mention (Amgen, Sanofi, etc..), but I feel these are the more likely candidates for taking on bavi. Also, this is how I see it prior to any additional data being presented. If pphm would come out with excellent pancreatic OS result and/or 1st-line NSCLC OS, then I think there will be multiple companies clamoring to sign the deal.

IMO