Replies to post #246156 on Avid Bioservices Inc (CDMO)

[md1225]

Kevin between you and mass hysteria with your extensive m and a back grounds one would think you guys could help out this merger?

[spankyvol]

At least PPER got it for free. Lol.

Who says they can't negotiate?

Soon!!!

[nuke661]

jakedog,

Thanks for this link and info. Great stuff to know especially for us Peregrine investors in our current state of affairs. These are the key excerpts for me so far:

But AstraZeneca needed a home run here, and it's claiming a bunt. Getting to home base now--at least in lung cancer--will evidently depend significantly on its success with combos.

AstraZeneca CEO Pascal Soriot has had to caution analysts recently to expect delays in its program, saying that regulators are less likely to feel an urgent need to approve new checkpoint drugs now that the first are on the market.

The company's issues with durvalumab may also help explain why AstraZeneca pushed ahead with a rich, $7 billion deal to buy Acerta, and may indicate that more new deals lie ahead. AstraZeneca projected peak sales of $6.5 billion for durvalumab when it laid out a plan to boost revenue to $45 billion in 2023. If that drug falls off the fast track, the Big Pharma will need more shots on late-stage goals.

There are things here that cause me concern and things that make me more hopeful in closing a deal sooner.

The concerning thing is that I'm hoping we aren't hitching our wagon to an under performing anti-PD-L1 checkpoint inhibitor which will eat up our precious resources while achieving less than optimal results than if we spent more of our money and bought the BMS (when you here me say BMS you need to picture me cursing their name and spitting on the ground) or Merck drugs for our new trials. Along these lines I'm worried that we may have only spent half the money but will get subpar results but, if we'd spent the money for a better performing drug then we may get results that better impress the BP world and the FDA. All of that is conjecture or course.

The words that alleviate some of this concern are the words which imply that because there is a checkpoint inhibitor of AZN anti-PD-L1 type already approved (e.g., Merck's Keytruda) the only reason that AZN's Durvalumab won't achieve speed to market is because the regulator's require higher levels of proof for follow on drugs of the same type. I believe that what AZN is saying is they won't get quick approval because the bar has been raised, and it will take longer to prove they are better than current SOC. If you remember the Keytruda approval letter said that Keytruda had not "proved" they were better and required further validation but they were first to make an impression of there being something there so the FDA gave them first crack at the market. Therefore, if true then it doesn't mean that we partnered at this critical time with a substandard drug, it just emphasizes more as to how important our drug is to AZN. Cha ching!!; especially if we become the critical player to achieve those 45 billion per year revenues by 2023. Yeah, I'm guessing AZN's fuse is even shorter than I was thinking when I wrote those posts yesterday. With all the risk they have due to being late to the party then maybe that Sunrise 1st interim look-in data will have a lot more meaning than I thought. Maybe AZN will have more fear filters on their eyes when evaluating that data.

I don't quite understand this logic; if Durvalumab proves efficacy to at least the level/power that Keytruda did then why can't AZN also get the same access to markets as Merck did with Keytruda, of course while also having to prove out the product per FDA requirements. If this kind of logic is really in play with the FDA then it again makes me mad as hell thinking about the phase II trial sabotage and how detrimental that has been and continues to be for Bavi. I still personally believe that Bavi+chemo has a solid chance of equaling or bettering Opdivo's NSCLC results and doing so across the entire population and not just being classified as efficacious to a limited ~ 20% subset like Opdivo is. But, because Opdivo got approved first now Bavi seems to have to achieve a higher standard. I hope the bit about not being limited to a small subset of the population removes that extra burden for Bavi. This thinking is all geared towards Bavi getting its own approval separate from any other drug combo trials.

Thanks again for this info Jake

[Protector]

jakeDG, thanks for the link.

But AstraZeneca needed a home run here, and it's claiming a bunt. Getting to home base now--at least in lung cancer--will evidently depend significantly on its success with combos.

Good development for PPHM. here is AstraZeneca with a drug of the same quality and performance range as Opdivo and KeyTruda, but because they were NOT with the first ones now suffer the less URGENT character and hence no accelerated approval.

Normal because as said before all these PD-1/PD-L2 drugs perform in a same range and since TWO are approved a 3rd, 4th etc brings no revolution to the table.

The same will be true for the NEXT PHASE. That is the second generation IO with combo's. Here also the PD-xx remain performing in the same range BUT the one that will be first approved in combination with Bavi will again lower the need for a 2nd, 3rd, 4T such combination with another PD-xx.

What may not be so obvious is that PPHM has, willingly or by chance or at least without considering that aspect, chosen a PD-L1 that will for long not be able to be on the market (as explained in the article) and therefore when approved as a Bavituximab combo, CANNOT be sold ALONE.

There will just not be an approval for Durvalumab alone AND when AstraZeneca gets there the others, Opdivo/Keytruda will have taken in their market position and there will be an EXTRA effort needed to dislocated them from there in the SINGLE IO drug approach.

So YES all will be about combo's and the first COMBO for each disease will make the single drug IO solutions obsolete, unwanted and largely underperforming. So INVESTING NOW in the combo's is the way to go for BP's with PD-xx. With AstraZeneca in place with Bavituximab there is no absolute need for PPHM to do this all over with the competing PD-XX and hence if a BP approaches them they should say: OK? but pay for the complete trial + a profit for PPHM.

In the end, without Bavituximab combo's they will ALL be played HOME. I figure they realize this already but they still have to take that DIFFICULT, BP-UNLIKE and COUNTER-STRATEGIC decision to jump on the train while paying the full ticket price. BP isn't used to that, they prefer the breadcrumb approached, but here they have been played in the corner. In the end that is where it will all come to and the lasts ones will pay more and have larger delays because PPHM will field its power as of a 2nd BP singing a deal.

That is were the GO is given. That is why the PPHM PR said : NO EXCLUSIVE COLLABORATION and the AstraZeneca PR said: PARTNERSHIP.

AZ wants to others to stay away, PPHM wants them to come, at PPHM terms.

[biopharm]

Sean Bohen just jumped ship from Roche to join AZ in Sept 2015

"As previously communicated, the treatment and regulatory landscape in lung cancer is evolving," said Sean Bohen, the chief medical officer at AstraZeneca, in a statement. "We now believe it is unlikely that ATLANTIC can be used for regulatory submission as a monotherapy, but we will make that determination following a full analysis of the data. Durvalumab is a cornerstone of our immuno-oncology portfolio with a fast advancing development program focused primarily on novel combinations."

http://www.fiercebiotech.com/story/astrazeneca-hit-another-setback-durvalumab-disappoints-lung-cancer/2015-12-18

-------------------------------------------------

Sean Bohen:

Sean Bohen
Executive Vice President, Global Medicines Development, and Chief Medical Officer of AstraZeneca Pharmaceuticals

Dr Sean Bohen, M.D., Ph.D. is Executive Vice President, Global Medicines Development, and Chief Medical Officer of AstraZeneca Pharmaceuticals LP, responsible for leading the global late stage development organisation for both small molecules and biologics. As Chief Medical Officer, he is also responsible for patient safety across the entire AstraZeneca and MedImmune portfolio and is a member of AstraZeneca Senior Executive Team.
Prior to joining AstraZeneca in September 2015, he spent 12 years at Genentech Inc. in various senior leadership roles and played a pivotal role in the growth of its pipeline and bringing a number of new medicines to market. Latterly, he had oversight of the early development portfolio – bringing pipeline molecules from research through entry into late development, and spanning the therapeutic areas of oncology, rheumatology, respiratory, neurology, ophthalmology, cardiovascular, inflammatory bowel disease, endocrinology, and infectious disease. He led the clinical development of several medicines including the breast cancer drug Kadcyla, which he brought into the Genentech portfolio as team leader. Others include Rituxan and Ocrelizumab for the treatment of autoimmune diseases, Xolair for asthma and Erivedge for advanced basal cell carcinoma. He also steered activities to incorporate diagnostics into clinical programmes at all stages of development.

Dr Bohen was a Clinical Fellow and Clinical Instructor in Medical Oncology at Stanford University School of Medicine and a research associate at the Howard Hughes Medical Institute. A postdoctoral fellow at the National Cancer Institute, he also served as a member of the scientific advisory board of TaiMed Biologics, Inc.
He is a graduate of the University of Wisconsin-Madison and earned his doctorate in biochemistry and his medical degree at the University of California, San Francisco.

http://www.transceleratebiopharmainc.com/leaders/sean-bohen/

lots of key players are jumping ship elsewhere and going to where PS Targeting just may have found a home