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Halozyme's cut from Humira was going to be mid single digits and the penetration was never going to 100% as Humira already comes in SC. Didn't you know that?! ;)
Pegph20 on the other hand is wholly owned by halozyme and has potential to be blockbuster (over a $billion in sales). Not my words. Helen's words in 2015.
I could not agree more with your conclusion
You are correct. But 202 is an open label study as well.
Simply put, the PFS with pegph20 has far exceeded Halozyme's own expectations (they projected all year long that they would have mature data by now). This is fantastic news and it is why share price went from 8's to 14's after the delay in maturity was announced at the last quarterly call. The stock has now taken a breather along with XBI and with the disappointment of Abbvie's decision. Compared to the importance/impact of Pegph20 as a potential blockbuster cancer breakthrough for various types of solid tumors, the abbvie news and the direction of XBI will be of little significance in the near future.
Hard to know for sure. But remember that stage two started enrolling full force in late 2014/early 2015. majority of patients were enrolled in 2015 (we know this from 8-k filing from halozyme in 2015 projecting to complete enrollment In 2nd half of 2015).
This projection was false but one could reasonably conclude that the numbers enrolled in Jan and Feb of this year must been quite small. If stage 1 PFS is any indication and considering multiple pt anecdotes, the number of patients left without progression is likely very small (far better than controll pts but nonetheless small). I wouldn't be surprised if an event/progression in just one pt now would mature the data any day now.
My source was an institutional investor with frequent comunication with Halozyme. But it's not a secret, if you call the company yourself they will tell you the same (that they are told recently not to comment on PEGPH20). The "quite period" is not an official term. It was used by the institutional investor and not Halozyme. Nevertheless, halozyme is not commenting on PEGPH20 as adviced by legal recently and this is a change from just a couple of weeks ago. They have a winner and they want to squeaky clean on how they proceed.
a major announcement on PEGPH20 won't be too far from today. Halozyme has entered into a "quiet period". They have been advised not to comment on PEGPH20 in face of high institutional investor curiosity and interest regarding the data maturity. This was not the case a couple of weeks ago. May indicate an update is imminent.
Here is yet another success story with Pegph20 and prolonged progression free survival. Read all the way to the last post (November update). Nearly a year of PFS with PEGPH20.
No doubt this patient was in the PEGPH20 group (as opposed to your highly unlikely speculation that the control group is somehow miraculously doing well despite all historal data we have on standard chemo).
As you can see in this link and as I have been saying all along, it's an open label study. Patients and oncologists know what they are getting/giving.
With so many success stories out there, soon the oncologists and DMC will demand that the control group pts who progressed and dropped out of study, be given PEGPH20 for ethical reasons and for compassionate use. The control group pt will demand it as well.
https://www.cancerforums.net/threads/47655-New-Poster-Mom-is-Stage-4-and-in-Clinical-Trial?highlight=PegpH20
Halozyme is a high beta biotech that moves in accordance with XBI (biotech ETF). As a speculative stock, it moves down higher % than XBI does (as is the case with most small speculative biotechs.) The recent decline is due to nothing but that and the news from ABBVIE.
There is no indication of a problem with the control group. In fact most oncologists involved in the trial are more excited about PEGPH20 than ever before and more so than any other ongoing pancreatic cancer trial. The market will understand this sooner or later and price will go up every day that data is not mature.
The company (halozyme) is blinded to the study but the principle investigators and patients are not. Just look at the channel 10 news as an example of what the oncologist and patients know.
No I was talking about a different patient. But incidently, my understanding is that she also is still progression free as of late November (almost a minth after that channel ten news release)
Phase 2 is not a blinded study.
Prediction: PFS with Pegph20 to be between 10.5 and 11.5 months vs. 5.5 to 6 moths for the control group.
There is one patient who as of today has been progression free for 19 months.
Please read about and learn the difference between progression free survival and overall survival. As a hypothetical patient in the control group, I could still be alive but have suffered a progression such as a new metastasis. In this case and as I mentioned in my earlier message, I would be begging and pleading to be switched over into the PEGPH20 group. Read my last post one more time.
At what point would the independent DMC observing the PFS data and therefore the ever-widening separation of event curves between control and PEGPH20 groups recommend treating the control patients with PEGPH20 for ethical reasons? I know if I were a patient in the control group (and were still alive) and had learned the data is not mature yet, I would be begging and pleading to receive PEGPH20 now.
New job posting for halozyme. Pay attention to "clinical collaborations, geographic carve outs. strategic alliances, asset divestment/acquisition, and in-licensing
Sense checks partnerships and acquisitions,..."
This tells me that halozyme is getting ready to sell Ex-usa rights to Pegph20 a big pharma/big biotech.
"POSITION SUMMARY:
The Senior Director of Business Development plays a critical leadership role for Halozyme, leading and responsible for business development and strategy projects across the organization, including expanding the Enhanze licensing franchise and pursuing oncology related transactions. This person will be accountable for uncovering new Enhanze opportunities and developing relationships with potential partners that lead to high interest in the Enhanze platform. Additionally, this individual will be involved in searching for and achieving negotiations for potential oncology partners with the correct strategic fit for Halozyme’s pipeline and goals. The Senior Director will achieve impactful levels of inorganic revenue growth of the global Halozyme business using broad-based initiatives with the respective Halozyme functional leads. The individual in this role must also be able to fluently articulate contract structure and the biological science to potential partners.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
Manage drug licensing activity globally and serves as the lead negotiator with the experience and business acumen to effectively close deals. Prepares recommendations for appropriate management actions and keeps the Vice-President fully apprised of activity
Create the term sheets and leads negotiations for projects, interacting with senior members of the potential targets and partner organizations; when relationships encounter challenges under others’ leadership, steps in with rapid and successful corrective action
Support, lead, negotiate, and close deals with potential Enhanze and oncology partners, including but not limited to:
Establish initial contacts, coordinating CDA and MTA agreements,
Articulate and drive the value proposition for partner and Halozyme,
Develop and deliver external presentations and organize meetings with potential leads,
Prepare diligence materials and oversee the due diligence process,
Coordinate multiple functions at Halozyme during discussions with potential partners,
Perform deal valuation (including complex financial and market modeling), coordinate drafting of legal documents, close the deal, and integrate Alliance Management or Investor Relations at appropriate times in the partnering process.
Identify and pursue new Enhanze partners to maximize the value of Halozyme’s technology and products in a way that increases shareholder value and achieves the company’s strategic objectives
Build Enhanze brand and technology awareness with strategic publication and marketing plans, both for presentations at scientific or business conferences and publications in the research literature, which Halozyme R&D will execute
Survey the oncology landscape, approach potential partners, and close deals to further Halozyme’s oncology objectives, including but not limited to: clinical collaborations, geographic carve outs. strategic alliances, asset divestment/acquisition, and in-licensing
Sense checks partnerships and acquisitions, ensuring the most accurate estimates and calculations used for best possible Executive Team discussions and decisions
Conceive and produce strategic plans for the Board of Directors or Corporate Strategy Steering Committee as required
Maintain thorough understanding of how biotechnology companies operate and has knowledge of how companies license development stage and commercial products
Develop deep working knowledge of oncology treatments and trends, major developments and trial outcomes, and player activity in the space
Participate in external thought leader conferences and strategy meetings (e.g., drug development, emerging technologies, clinical conferences, legal updates, etc)"
This is either a new pehph20 study or it's the same preoperative pegph20 UCSF study that has now expanded to Stanford and other UC's. http://meetinglibrary.asco.org/content/159333-173
I have been an investor in Halozyme since 2012. I came across an interesting article (not new) but one that I had not seen mentioned before on any of the boards. It talks about how eliminating some (at least one) components of the stroma may worsen the outcome. I think this is what an earlier post here may have been referring to. Not everything in the stroma is bad for the patients. Let's hope HA is different.
http://www.biocentury.com/innovations/targetsmechanisms/2014-06-12/targets-and-mechanisms-stromal-uncertainties-in-pancreatic-cancer-s9/pdf