Most of it was Q&A, which would have been interesting except that the sound quality was so poor I found it hard to understand Cormack at times.
I did catch his reiteration that not only are the partnership talks on track to be completed this year but they are still "competitive."
He talked a bit more than in the past about the pain palliation trial in second line patients and what a coup it would be if they could demonstrate both increased survival and pain reduction.
He also talked about the bladder trial for OGX-427, and said that it's the sixth biggest cancer indication and there are few good treatment options. He said the fact that they can infuse the drug into a contained space is a plus. Makes me wonder whether they're hoping to see what kind of early results they may get in this trial before completing the partnership deal. Maybe they'd partner both OGX-011 and OGX-427 at the same time, since he said they plan to do randomized P2 trials for OGX-427, which presumably won't be cheap. Of course, if they were to partner both, it might almost make more sense to get bought out.
I can't tell from the clinicaltrials.gov description whether they could see meaningful efficacy results in the bladder trial:
Anyone have any thoughts about that?
Hey Brus, here's the report. I guess late is better than never(I consider them, JNJ, and the soon to be sold P&G as the worst big pharma has to offer):
LLY Eli Lilly reaffirms its previous 2009 earnings per share guidance of $4.20 to $4.30 on a pro forma non-GAAP basis. (32.82 )
Co announces a new operating model and announced a series of changes to speed medicines from its pipeline to patients. To help achieve this goal, the company will establish a Development Center of Excellence to streamline and accelerate late-stage development of new medicines, and will reorganize its pharmaceutical business into four business units that will operate alongside the Elanco animal health business unit. In addition, the company has set a goal to significantly reduce its cost structure by the end of 2011. Co will organize the company around five global business units: oncology, diabetes, established markets, emerging markets, and Elanco animal health, thereby moving from a predominantly functionally-oriented organization to a business-unit structure. They plan to streamline the organization and align corporate and general and administrative functions to support the business with a focus on improved quality, strong customer service and reduced costs. Co plans to reduce the company's cost structure by $1 billion and lower global headcount to 35,000 by the end of 2011, excluding strategic sales additions in high-growth emerging markets and Japan. In connection with today's announcement, the company confirmed its previous 2009 earnings per share guidance range of $4.20 to $4.30 on a pro forma non-GAAP basis. (Consensus is $4.28)
I agree that this conference was very informative. The Q and A session was excellent.
I just want to comment on Cormack's answers as they relate to partnering. Feel free to tell me I am wrong.
Cormack described the partnership discussions as competitive. He said the company was on target to complete a partnering on 011 this year.
The process is more complicated because the 011 is not just a prostrate drug.
He also said something real interesting. In my view, this was the most important comment that he made.
He described the "ideal partner" as a party who can say "we believe what you believe".
OGXI must have a great deal of confidence in the negotiation process on 011 if that is its end game.
Just as important, Cormack made some comments about OGXI's beliefs.
1. OGXI is a science driven company.
2. Gleave's scientific model is to use the ASO drugs to knockdown clusterin overexpressions to sensitize a number of different tumours in order to augment existing treatments in many different cancers.
3. Gleave is a urologist so 011 application to prostate and 427 application to bladder are compelling areas of interest.
4. The model has great promise in other indicators. 011 cross application and in particular to NSCLC was emphasized by Cormack as having great potential.
5. the company is eager to move into randomized Phase II test for 427, and 427 is regarded as having as much potential as 011.
In my view, OGXI will work hard to get the right partner to ensure 011 succeeds and that patients get the full benefits of the drug as they deserve.
This will also lend credibility to the model of treatment that drives OGXI and add value to its pipeline.
It is purely speculative to define the scope of drugs that will be subject to any announced partnering agreement.
Difficult to tell if partner will develop only prostrate or NSCLC too or other applications.
However, if there is added complexity of discussing the cross application of 011, then 427 would make these discussions even more complex and time consuming.
That tends to suggest 427 will be developed differently. Fact that Cormack referred to partnership discussions and 011 support that view.
That was an excellent synopsis of what i heard as well.
I couple of other thoughts related to your last point.
I think strategically for shareholders, it would be optimum if OGXI partnered only the OGX-011 lead product, not OGX-427...not just yet.
I do think that it is very likely that the partner will pick up much if not all of the development costs associated with the 2 CRPC Phase III trials for which SPAs are already set up. I think the agreement will very likely include developing SCLC (another phase III). I think there will likely be a provision for the partner picking up costs for other trial indications (e.g. breast, ovarian, renal).
But i would prefer to see Onco get more traction with their OGX-427 compound in this ongoing Phase I Bladder and Phase I solid tumor study. And then i would like for Onco to show some progress with a Phase II trial in bladder cancer. Then at that stage they would be able get more value from partnering discussions regarding OGX-427.
It would appear that this 2nd "Gleave" drug has some very promising attributes as its mechanism also has a rather dramatic "Knockdown effect" in a wide range of tumors. I have read some of Gleave's published preclincal studies and its impressive how this targeted drug works. But they need some traction in the clinical trials in order to optimize the embedded value imo.
I highly recommend folks listen to the webcast of this conference. By far, it is the most informative, free flowing, data rich presenttion due to the format employed.
You will learn why OGX-011 is so efficacious and it compares to the competition...why the partnering discussions are so competitive...what makes Onco's assets so unique...how "pain palliation" is of so much interest to the FDA and why the lead reviewer of Onco's Phase II data thought the data was "remarkable".
You will also learn why is considered the holy grail in prostate cancer and why Onco has a good shot at it. Along with who co-founded these drugs Onco is using in the clinic (Gleave).
Pay special attention to the dialogue about NSCLC phase II data and why Onco is tracking the "tail of the survival curve" (3 year survival numbers) and particulary why the deck was stacked against OGX-011 in NSCLC, but still it outperformed historical survival norms.
And lastly, you will gain some insight into why Onco only has 6 million shares outstanding. To say the least, the CEO is exceptionally sensitive to his shareholder base, yet fully in tune with the enormous potential in his "pipeline" within a drug....probably two drugs if OGX-427 shines as brightly as OGX-011 has thus far.
One last thing, though it was not discussed, it think by year's end, we will have a name for OGX-011. Maybe call it "Gleavin" or "Knockthecrapoutofclusterin".