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Happy and healthy New Year to you too.
Happy and healthy New Year to all who post and lurk here. My best to you and your loved ones.
-Fritz
Thanks for sharing that.
"We believe HALO can continue to perform given the stock's defensive properties, continued commercial execution, and pipeline optionality."
They see Enhanze as the key driver of Halo and think the Antares acquisition broadens Halo's platform. "We believe a key area of investor focus for this acquisition is the potential for Halozyme to leverage both the Enhanze platform and Antares' technology to develop a high
volume auto-injector that could strengthen Halozyme's drug delivery offerings and broaden partnership and royalty revenue potential.
"Key catalysts anticipated in 2023. We expect the next key potential milestones
for HALO to be the release of 2023 financial guidance in early 2023 (2022
guidance was provided in early January 2022) and updates for the high-volume
auto-injector as a prototype progresses to clinical evaluation next year. We also
anticipate significant investor focus on updates for Wave 3 pipeline programs
including the SC formulation of efgartigimod, where the PDUFA date for gMG is
3/20/23 and data from the ADHERE CIDP and ADVANCE-Sc ITP studies is
expected in 1Q23 and 2H23, and Ocrevus, where PhIII data from the SC
formulation is expected in 2023."
They project peak royalty revenues of $1.6B in 2028, about $2B in total revenues, which I find kind of surprising, though I don't know what kind of royalties the Antares side of the business is expected to have. They do not break it down.
Their "bear case" PT is $46, the "bull case" PT is $88. The bull case would mean that Wave 4 generates significant value and peak royalty revenues reach about $2B, and product sales also surprise to the upside.
Just saw that. Would love to read these notes to get their take. I guess we can put aside the worry about downgrades fo now. LOL!
PT raised to $65 at Morgan Stanley.
The operative word was "guessing". LOL
Friday is expiry day so I'm guessing it's just partially rolling out to future dates and partially just ordinary hedging of new positions by the pros.
There seems to be unusually high option activity today. Quite a few Dec, Jan, March and June calls have traded. I am no expert and I am not sure what to make of it.
I appreciate your final point about the limitations Horizon may have had in terms of resources, and how Amgen might be able to fund the necessary trials. That may prove to be the key, but, as you say, only time will tell.
I would think Amgen will assume all of Horizon's obligations towards Halo when the acquisition is complete. But even Horizon does not have to complete the development of SC Tepezza with halo. So I am also a little skeptical. If anything, Amgen has a lot more resources and experience so there is more of a chance they may try to develop their own sc formulation, especially since Enhanze Tepezza is still in phase 1. Time will tell.
Best case scenario is that they stick to Enhanze, are able to expedite the development, and they expand globally more quickly than Horizon could. But all of the above is not at all a sure thing.
The Tepezza deal with Horizon goes back two years ago to December 2020 and according to Halozyme's web site it has not gotten past phase 1.
What is not clear to me is how Amgen's acquisition will change the dynamic. Unless I'm mistaken, Amgen has not entered into any deal with Halozyme, so I wonder what their commitment is to Enhanze subcu formulation. Horizon has not been in a particular hurry and Amgen has shown no interest, so I'm skeptical that Amgen/Horizon is a meaningful transaction for Halozyme.
https://www.fiercepharma.com/drug-delivery/horizon-pays-halozyme-190m-to-develop-subq-thyroid-eye-disease-med
https://halozyme.com/enhanze/#pipeline_group_1
This is bullish news. Thanks for posting!
An analyst asked Amgen management about SC Tepezza about 29 minutes in the Acquisition of Horizon conference call. They did not mention Halo and their answer was a little vague (they said they were unable to answer a lot of questions because the acquisition will complete in first half of 2023) but they said they have a lot of expertise in drug delivery and they are definitely interested in SC formulations. It wasn't clear to me how committed they are to Enhanze but they were probably vague because of the above and for competitive reasons.
One potential positive I see: Amgen may be able to expedite development of SC Tepezza and commercialize it more rapidly especially in the row, but I have no idea how interested they are in the SC formulation.
It looks like Vanguard added about 200k shares and now owns 10.02% of Halo.
https://ih.advfn.com/stock-market/NASDAQ/halozyme-therapeutics-HALO/stock-news/89759669/amended-statement-of-ownership-sc-13g-a
How is that relevant here?
Halozyme has a partnership with Amgen now. Amgen is buying Horizon at a purchase price equivalent to a PE ratio of around 45.
And it's a little concerning, though there hasn't been a lot of insider selling in the past year. I hope he and/or other insiders don't continue to sell but it's something to watch.
Right, looks like he sold about a quarter of his holdings. That's a little surprising.
And yet: Benchmark Adjusts Price Target on Halozyme Therapeutics to $68 From $55, Maintains Buy Rating.
Pretty strong stock action in spite of the recent substantial insider sale (Matthew Posard 30K shares).
No, what I posted is all I know.
Don’t get all too excited, shorts. Read the MS article Maumer cited in his post. It reads:
“…the potential to extend
the exclusivity period from the composition of matter patent from 2031 to
2036.”
The combination of matter patent is well and good at least until 2031. What’s at steak is between 2031 and 2036.
All dips are fantastic buying opportunities as they have been for years purely based on superb fundamentals and valuation.
Do you know when and how this litigation was brought to light?
I would say that this issue makes it difficult for analysts to come up with earnings/revenue estimates. What is the likelihood of halo and partners getting the co-formulation patents they can assign to each product? Is it 50%? 80%? I have no idea, and I'm not sure they know either. I would think they feel they need to be conservative. We also don't know exactly how Halo's agreements with their partners are structured for each product. If the co-formulation patent is issued, is the step down royalty rate delayed (and for how long?) or eliminated?
And obviously, the most important co-formulation patent is the one for Darzalex Faspro. A step down royalty rate will definitely adversely affect halo's revenues and earnings starting from 2024, so it'll be interesting to see what kind of estimates analysts come up with for 2024 in the next month or so.
Thank you so much for the clear explanation.
Makes total sense.
-- OJ
The patent rolloff for enhanze is not far off but there is a potential lengthening of patent protection both in the US as well as Europe due to the argument that the co-formulation represents a new drug and therefore a new patent, or at least an extension, should be granted. This is being challenged in the courts and, if HALO loses, their income estimate might well be adversely affected. This topic has been a major source of confusion for a long time.
Could someone please explain this? I don't get the major uncertainty. Sorry to sound so dumb.
-- OJ
That is a major uncertainty.
I found it. Thank you
It’s from Dec 2: Biotechnology Patent/Litigation Tracker - The Month Ahead. Analyst is Matthew Harrison. Note on page 3, exhibit on page 8.
Here's another, shorter post that gets to the point a bit faster.
Nice list, Maumar. Agree that things have been looking up lately for HALO.
I'm guessing item 3 on your list includes the subcutaneous formulation of atezolizumab, made by Roche?
Here's some text cut and pasted from a recent article on the FiercePharma website about the heated competition among manufacturers of the checkpoint inhibitors now used to treat many types of malignant tumors.
My take on this is that at least two very large pharmaceutical companies including Roche and Johnson and Johnson have discovered that Enhanze gives their products an edge over the competition. We may soon be able to add Bristol-Myers Squibb to this list. NCT04810078
This all bodes very well for future royalty income at Halozyme, IMO.
Source: https://www.fiercepharma.com/pharma/roche-having-shared-data-regulators-unwraps-results-subcutaneous-tecentriq-phase-3-trial
I get Morgan Stanley’s reports through Etrade and reviewed all their reports since they started covering Halozyme since your post. I did not see the exhibit you referred to or any mention of “Tracked European oppositions” or “Straw Man” in any of their publications.
Would you please provide the date of the MS report and the number of the page that contains this matter?
Thanks
Please provide a link/reference
I found this interesting note from MS. I think this is a significant catalyst. I believe Darzalex sales in Europe are at least 30% of total sales. This suggests to me that it's not so easy to get co-formulation patents and explains why the stock has not moved even higher. This decision will affect earnings estimates in a major way.
I wonder who the challenger "straw man opponent" is, and if there is a challenge in US as well.
"European Opposition Upcoming Catalysts (Exhibit 5):
Oral hearing on Darzalex Faspro co-formulation patent: European
oppositions allow challengers to invalidate patents centrally at the
European Patent Office, rather than individually at the national courts.
This '770 Patent is important because it: (1) covers the subQ formulation
using Halozyme’s Enhanze technology and (2) has the potential to extend
the exclusivity period from the composition of matter patent from 2031 to
2036. After the oral hearing, a decision is expected in 2Q-3Q 2023.
Exhibit 5: Tracked European oppositions
Drug: Darzalex Faspro
Patent owner: J&J
Challenger: Straw Man Opponent
Next catalyst: oral hearing
Catalyst date: 3/14 to 2/15/23
Challenged patent: EP3,370,770
I think the author of that article got to the $69 PT purely on the basis of technical analysis. But we are starting to see analysts' PTs above $60 (the last one, I believe, was $65 from Wells Fargo) and presumably once SC Efga and SC Tecentriq are approved those targets could go up to around $70. It's all about the future and the market is more confident about the durability of Halo's revenues and earnings. Also, earnings estimates for 2023 are around $3 and if they are close to $4 for 2024, for the stock to get close to $70 sometime in the second half of next year does not seem too far-fetched.
This was a surprising week (for me at least) and it ended on a high note Friday with some decent volume, which had been missing, and end of day trades were at the highs. It might have a little more to run. Absent news I'm also expecting a retracement which could, in time, dip to about $47 or so, but that is assuming another long period of inactivity on the new deals front and the addition of other market downdrafts, both of which are probable. A near term retrace back to the mid $50s is almost inevitable, but I've no idea as to the exact timing there.
Things are moving along and your summary is perfectly on target; the one thing I'm not certain of is the pricing model used to get to that $69. How would you formulate that? How do you see the current pps given the earnings reported?
Obviously, the stock can go back to $55 and even lower. But will the dip last?
The past 12 months have been very interesting for Halo. We haven't had any huge catalysts but we've also had a LOT of positive news:
1. First of all, Darzalex is exceeding expectations by a wide margin. Not that long ago, consensus peak sales estimates were $10B in 2028, now they are $13B in 2026. Conversion rates for both Darzalex FasPro and Phesgo have also exceeded expectations.
2. The Antares acquisition removed uncertainty, the risk of a disastrous acquisition and adds revenue diversification and durability. It's not a game changer but it could become one if they are able to combine Enhanze with a high volume auto-injector. So, it lowers the concentration risk (70% to 80% of revenues were from Darzalex FasPro) that I think to some extent was holding the stock down and provides significant potential upside.
3. Progress in the clinic for Enhanze products has exceeded expectations. We now have strong visibility into two new products that are likely to be approved in the next six months or so, and four more products that will likely be approved in the next couple of years. And they are all blockbuster drugs.
4. On the Dec 1 call, our CFO said that all 5 approved Enhanze products have co-formulation patents that have been issued or are pending.
Taken all together, I am starting to feel that the second PT mentioned in the article I posted on 11/11 is reachable in the next six months or so, unless of course the market crashes. Is it wishful thinking?
"Bottom line strategy: Traders who are long HALO should continue to hold those rewarding positions. Risk to $44 now. Our price targets are now $58 and then $69."
Right, not many go straight up. I blinked and we are blowing right through the 50’s!!
Cheers
Looking at the chart, I think there is a good chance you'll have your order filled.
Agree, they (Roche) must feel pretty sure of themselves.
Based on our conversation, I've placed a limit order to buy more shares if the price should happen to fall back down to $55 any time in the next 90 days.
Yes, that was going to be my answer. They must feel pretty sure they'll get it approved for all indications based largely on your analysis of the nature of the trial.
They are stranglely vague about with which "authorities" they have filed. Europe? FDA? Both? The Bahamas?
Thanks so much for posting this news item, Fred!
This is potentially huge, and it's a big reason why I love Halozyme. Lung cancer is hugely prevalent worldwide, in contrast to some of the other rare diseases, like multiple myeloma, where the Enhanze system is being used in the Darzalex Faspro product. So subQ Tecentriq potentially increases Halozyme's sales revenue by a large amount.
This may also help atezolizumab (Tecentriq) gain market share against the market leader in this space (metastatic non-small cell lung cancer), which is Merck's pembrolizumab (Keytruda). I expect Merck will now attempt to roll out a SubQ formulation of pembrolizumab to compete with Roche and protect its market share, using its own in-house co-formulation technology (as opposed to licensing it from Halozyme).
(But wouldn't it be cool if Merck's proprietary in-house co-formulation product flounders and Merck is forced to license the Enhanze technology too, to prevent encroachment by Roche???)
I've been watching this trial with interest for years, because of the potential increase in sales volume it represents for Enhanze. This is very bullish news.
Go Halozyme!
-- OJ
Roche files for subcu Tecentriq
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phase III results show Roche's subcutaneous formulation of Tecentriq is comparable to intravenous Tecentriq and delivered in minutes
Administered under the skin, the subcutaneous formulation reduces time spent receiving treatment to approx. seven minutes, compared with 30-60 minutes for IV infusion1
Roche has submitted data from the IMscin001 study to health authorities, seeking approval for the subcutaneous option across all approved indications of IV Tecentriq
If approved, Tecentriq would be Roche’s fourth subcutaneous cancer therapy,2-4 helping to improve the treatment experience for patients. In addition, it could save resources for healthcare systems5-10
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Basel, 1 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new pivotal data from the Phase III IMscin001 study, evaluating the investigational subcutaneous formulation of Tecentriq® (atezolizumab), a cancer immunotherapy approved for various tumour types.1 Data showed comparable exposure (levels of the molecule in the blood) and similar safety and efficacy for Tecentriq, when administered subcutaneously (injected under the skin), compared to standard IV infusion, in people with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).
The data will be presented in a mini-oral abstract session at 09:55 CET on Thursday 8 December, at the ESMO Immuno-Oncology Congress 2022 (Abstract #61MO).11
If approved by health authorities, Roche aims to bring this innovation to patients who may benefit from treatment with Tecentriq across multiple tumour types. Data from IMscin001 have been submitted to health authorities globally.
“Checkpoint inhibitors have been transformational for people with cancer, but IV administration can be long and arduous for patients and increase strain on infusion centres,” said Dr. Mauricio Burotto, Medical Director, Bradford Hill Investigación Clínica. “Subcutaneous administration could allow patients to be treated much more quickly and easily compared to IV, improving their overall treatment experience, and reducing waiting lists and treatment delays.”
“These data show that the subcutaneous formulation of Tecentriq can deliver similar benefits to IV administration, without compromising on safety, while offering a faster and more flexible treatment option,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We're excited about the potential of this new formulation to improve both the treatment experience for patients and save resources for healthcare systems.”
Multiple oncology studies suggest that the majority of cancer patients generally prefer to receive treatment subcutaneously due to reduced discomfort, ease of administration and shorter duration of treatment, compared to IV infusion.5-9
While the IMscin001 trial was conducted within the hospital setting, the subcutaneous formulation may be appropriate for out of hospital administration by a healthcare professional.
About the IMscin001 study and data
IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of the subcutaneous formulation of Tecentriq, compared with IV Tecentriq, in patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed. The study enrolled 371 patients.
In August, part 2 of the study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements.11 The geometric mean ratios were 1.05 for observed serum Ctrough (the concentration of drug in the blood immediately before the next dose is administered; 90% CI: 0.88-1.24) and 0.87 for model-predicted area under the curve (a measure of overall exposure to the drug; AUC; 90% CI: 0.83-0.92).11
Efficacy, as measured by the overall response rate and progression-free survival, was similar between the subcutaneous and IV treatment arms and consistent with the known profile of IV Tecentriq.11 The safety profile of the subcutaneous formulation was also consistent with that of IV Tecentriq.11
About the subcutaneous formulation of Tecentriq
The investigational subcutaneous formulation combines Tecentriq with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, and enables the subcutaneous formulation to be rapidly dispersed and absorbed into the bloodstream.
IV Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. IV Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). IV Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.
About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Tecentriq: highlights of prescribing information, US FDA 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s028lbl.pdf. Accessed November 2022.
[2] MabThera SC / Rituxan Hycela: highlights of prescribing information, US FDA 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf. Accessed November 2022.
[3] Herceptin SC / Herceptin Hylecta: highlights of prescribing information, US FDA 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761106s000lbl.pdf . Accessed November 2022.
[4] Phesgo: highlights of prescribing information, US FDA 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. Accessed November 2022.
[5] De Cock E, et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016;5(3):389-97.
[6] O’Shaugnessy, J. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO; 19-21 Sept 2020. Abstract #165MO.
[7] Pivot X, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017;86:82-90.
[8] Rummel M, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.
[9] Denys H, et al. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020;181(1):97-105.
[10] Anderson, K C, et al. Humanistic and economic impact of subcutaneous versus intravenous administration of oncology biologics. Future Oncol. 2019;15(28):3267-3281
[11] Burotto M, et al. IMscin001 (Part 2: Randomized Phase III): Pharmacokinetics (PK), efficacy and safety of
atezolizumab subcutaneous (SC) vs intravenous (IV) in previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC). Presented at ESMO IO; 7-9 Dec 2022. Abstract #61MO.
Roche Investor Relations
Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com
Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
Yee-ha. As of today, the shares I bought in October of 2020 have doubled in value. Can't tell you how satisfying it is to see that 100% growth, when another biotech in which I hold shares remains mired in the doldrums with an unrealized loss of 33% despite long-awaited and stellar phase 3 trial results of its lead compound.
I love Halozyme. I love the low-risk business model, I love the diversity and strength of the company's customer list which reads like a Who's Who among Big Pharma's global players, I love the way the lead product hyaluronidase makes administering medication easier and quicker for both patients and clinicians, and I love the incredible growth potential in the form of royalty income as more and more subcutaneous formulations using the company's lead product are approved for use by the FDA and other regulatory agencies around the world.
Helen Torley certainly seems to know her stuff, and it's great that the company's key executives are making the rounds of the big investor conferences, talking up the value of the stock as a good investment. It's nice to see top firms like Goldman Sachs, Wells Fargo, and Morgan Stanley posting optimistic growth targets for the share price. Plus the company's share buyback program is a good thing, and I'm glad to see the company using debt to finance continuing operations (as opposed to selling more stock and diluting the value of outstanding shares owned by us).
So . . . I'm running out of things to be happy about. Did I miss anything? If so, please feel free to chime in.
Have a good night!
-- OJ
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http://www.halozyme.com
Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology, and dermatology markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases.
The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets. In addition, the company has received FDA approval for two products: Cumulase® and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter Healthcare Corporation. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.
Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.
Products/Pipeline
Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.
The foundation of our capabilities is our recombinant human hyaluronidase enzyme, rHuPH20, which temporarily degrades hyaluronan, a structural protein in the interstitial space. This temporary alteration provides an opportunistic window that allows the delivery of injectable biologics such as monoclonal antibodies, as well as small molecules and fluids. With our enzyme, many pharmaceuticals that would normally be injected intravenously (IV) can be administered subcutaneously (SC). This change in route of delivery may improve patient convenience, enhance pharmacokinetics, boost efficacy, extend the product lifecycle, and reduce cost, in addition to other attributes.
Four key internal programs comprise our current proprietary product development portfolio. The endocrinology franchise consists of Insulin-PH20, which applies our PH20 enzyme to currently approved and marketed insulin products. The oncology franchise consists of PEGPH20, a new molecular entity administered intravenously that targets the external environment of tumor cells, and Chemophase, which utilizes the PH20 enzyme for local administration in bladder cancer. Our lead enzyme in the dermatology franchise, HTI-501, is a new molecular entity which digests collagen and may have applications in both medical and aesthetic dermatology such as cellulite.
Our product development pipeline also includes three distinct partnered programs with two companies; Roche and Baxter BioScience for Enhanze technology, and a partnership with Baxter Medication Delivery for Hylenex, our FDA-approved drug. These partnered programs validate our technology and may generate clinical and commercial milestone revenue based on the achievement of pre-specified events along with sales royalties when products reach the commercial stage. We utilize the cash milestone payments generated from the partnered programs as a source of development funding for our proprietary pipeline projects.
Endocrinology
Our endocrinology development activity focuses on insulin, a mainstay of treatment for people with diabetes. This program combines our PH20 hyaluronidase enzyme with insulin, a frequently prescribed, commercially successful pharmaceutical already approved and on the market.
We believe that the combination of our PH20 enzyme with existing, meal time insulin products such as regular insulin or a fast acting analog could lead to a best-in-class product that more closely mimics the release of natural insulin in the body. The results of a Phase 1 study, where we combined PH20 with Humulin® R (regular human insulin) and with Humalog® (insulin lispro), demonstrated significantly faster and higher insulin plasma concentrations compared to either insulin alone. Faster acting insulin could provide patient benefits such as reduced hypoglycemia, lower intra-subject variability, and less weight gain. These potential benefits would be significant but must first be demonstrated and proven in clinical development.
Our first Phase 2 clinical trial with insulin began in October 2008 and enrolled Type 1 diabetic patients. Data presented from our Phase 1 trial showed that the administration of regular insulin and an insulin analog with our PH20 enzyme led to faster insulin absorption and more rapid effects than either insulin alone. Our Phase 2 trial is designed to demonstrate similar results in Type 1 diabetic patients. We hope to present preliminary Phase 2 results at the American Diabetes Association meeting in June. Additional clinical trials are planned in 2009.
ONCOLOGY
Hyaluronan (HA) is a component of the extracellular matrix that frequently accumulates in human cancers. The quantity of HA produced by the tumor cells directly correlates with increased tumor growth and metastasis and it has been linked with tumor progression and poor prognosis. Previous clinical trials of bovine hyaluronidase showed promise in enhancing chemotherapy regimens using adjunctive systemic hyaluronidase in chemo-refractory patients. In animal studies the removal of HA from tumors with hyaluronidase has demonstrated improved survival, suppression of tumor growth, and enhanced efficacy of certain anti-cancer drugs. Chemotherapeutic agents may be able to better penetrate the tumor once the HA has been removed.
We have also observed significant reduction of tumor interstitial fluid pressure (IFP) following the administration of rHuPH20 in solid tumors grown in mice. Tumor interstitial pressure is widely believed to be an important factor limiting the access of cytostatic regimens to solid tumors. By digesting the HA gel, rHuPH20 may reduce IFP in the tumor and promote more effective delivery of chemotherapy throughout the tumor. This could potentially lead to better patient outcomes and increased survival.
Our PEGPH20 program utilizes pegylated hyaluronidase that allows for intravenous administration to degrade the HA that surrounds tumor cells. The Chemophase program applies the hyaluronidase enzyme along with mitomycin C directly into the bladder where the enzyme can hydrolyze the HA produced by the cancerous bladder cells. Unlike tumor cells, normal cells do not produce HA in this manner and appear not to be adversely affected by the enzyme.
We are investigating pegylated-rHuPH20, or PEGPH20, a new molecular entity, as a candidate for the systemic treatment of tumors rich in hyaluronan, or HA. Pegylation refers to the attachment of polyethylene glycol to our rHuPH20 enzyme, which extends its half life from less than 30 seconds to more than 24 hours. Numerous solid tumors, including prostate, breast, pancreas, colon and non-small cell lung, accumulate HA that forms a halo like coating over the surface of the tumor cell.
In preclinical studies, PEGPH20 has been shown to remove the HA coating surrounding several tumor cell lines. Treatment of PC3 (a prostate cancer cell line that produces HA) tumor bearing mice with PEGPH20 as a single agent demonstrated approximately 70% tumor growth inhibition relative to controls. Repeat dosing with PEGPH20 produced a sustained depletion of HA in the tumor microenvironment. For tumor models that do not produce HA, the presence of PEGPH20 has no effect. An estimated 20% to 40% of certain solid tumors may produce HA.
Administration of the combination of PEGPH20 with docetaxel or with liposomal doxorubicin in HA producing animal tumor models produced a significant survival advantage for the combination relative to either chemotherapeutic agent alone. Therefore, based on these animal studies and other tests conducted by Halozyme, PEGPH20 may represent a potentially innovative treatment approach against tumors that produce HA.
PEGPH20 recently started its first Phase 1 clinical trial which will evaluate the agent over a range of doses. The study will enroll up to 46 advanced cancer patients who will receive treatment cycles of intravenous PEGPH20 as a single agent twice weekly for three weeks followed by one week without dosing. Patients may continue subsequent cycles at their assigned dose as long as there is no tumor progression and no unacceptable toxicity. Groups of four to eight patients will be in each dosage cohort. The primary outcome measures of the study will be to evaluate safety and tolerability of PEGPH20 and to determine the recommended single agent Phase 2 dose. Secondary objectives will be to determine pharmacokinetics, obtain dose limiting toxicities, and observe patients for any evidence of anti-tumor activity.
Chemophase is a chemoadjuvant we have investigated for possible use in the treatment of patients with superficial bladder cancer, which represents a smaller potential market than our other proprietary pipeline opportunities. The Chemophase program combines our PH20 enzyme with mitomycin C, a cytotoxic drug, for direct administration into the bladder immediately after transurethral resection of bladder tumors (TURBT), a standard surgical treatment for the disease. Many bladder tumor cells produce high quantities of HA and thus treatment to remove the HA coating could increase their exposure to mitomycin C. This may lead to a lower recurrence of the cancer and a better prognosis for patients.
In June 2008, we announced the interim results of a Phase I/IIa clinical trial in which the Chemophase combination treatment of mitomycin C plus rHuPH20 enzyme was well tolerated and appears safe. The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme. An ongoing safety trial involves the immediate post operative (IPOP) administration of PH20 and mitomycin directly into the bladder of patients after a TURBT procedure.
DERMATOLOGY
The foundation of our dermatology program is HTI-501, a human lysosomal proteinase that degrades collagen. It may be useful in the treatment of both medical and aesthetic dermatologic conditions such as cellulite, Dupuytren’s contracture and Peyronie’s disease. This pH sensitive enzyme demonstrates activity under mildly acidic conditions but shows no activity at normal physiologic pH. This attribute may be harnessed to exert control over the duration and location of the enzyme’s therapeutic activity.
Tests with HTI-501 in several animal models have produced encouraging results and our pre-clinical investigations of the enzyme will continue throughout 2009.
ENHANZE
Enhanze™ Technology, a proprietary drug delivery platform using Halozyme’s first approved enzyme, rHuPH20, is our broader technology opportunity that can potentially lead to partnerships with other pharmaceutical companies. When co-formulated with other injectable drugs, Enhanze Technology may facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin.
Molecules as large as 200 nanometers may pass freely through the extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin. The principal focus of our Enhanze Technology platform is the use of rHuPH20 to facilitate subcutaneous or intramuscular routes of administration for large molecule biological therapeutics. We are seeking partnerships with pharmaceutical companies that market drugs requiring or benefiting from injection via the subcutaneous or intramuscular routes that could benefit from this technology. In December 2006, we signed our first Enhanze Technology partnership with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche, Inc. In September 2007, we signed our second Enhanze Technology partnership with Baxter Healthcare Corporation and Baxter Healthcare S.A.
HYLENEX
Full prescribing information is available below or at www.hylenex.com
Hylenex is a human recombinant formulation of rHuPH20 to facilitate the absorption and dispersion of other injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. We filed a New Drug Application (NDA) in March 2005 and we received approval of our Hylenex NDA in December 2005.
Hylenex may facilitate subcutaneous delivery of fluids up to one liter without the need for intravenous access, a procedure known as EASI. Importantly, EASI for fluid replacement in terminal patients may be achieved with limited or no need for nursing assistance. Over 1.1 million subcutaneous fluid infusions are performed per year with hospice patients alone (Source: Company estimates based on National Hospice and Palliative Care Organization data, 2001). In addition, over 500 million infusion bags are utilized annually in the United States, some of which could potentially convert to EASI using Hylenex, giving rise to additional market potential (Source: B. Braun, 2003).
During January 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer’s clinical trial, or INFUSE-LR study, which was designed to determine the subcutaneous (Sub-Q) infusion flow rate of Lactated Ringer’s solution with and without Hylenex, determine the Sub-Q infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24 gauge catheters.
During October 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Morphine clinical trial, or INFUSE-Morphine study, which was designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex, to determine the time to maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 12 evaluable patients who received Sub-Q infusions.
For full prescribing information, visit www.hylenex.com or www.baxter.com.
CUMULASE
Cumulase is an ex vivo (used outside of the body) formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes (eggs) prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte. This allows the clinician to then perform the ICSI procedure, injecting the sperm into the oocyte. The FDA considers hyaluronidase IVF products to be medical devices subject to 510(k) approval and we filed our 510(k) application during September 2004.
We received FDA clearance in April 2005. We launched Cumulase in the European Union and in the United States in June 2005. We believe the total ICSI market consisted of an estimated 500,000 intracytoplasmic sperm injection cycles worldwide in 2005 (Source: CDC, 2001; ESHRE, 2002).
Visit www.cumulase.com for more information.
Informative Links
http://www.nasdaq.com/asp/Holdings.asp?FormType=Institutional&page=holdingssymbol=HALO&selected=HALO
(Institutional Holdings)
http://www.cnbc.com/id/15837275?q=HALO
(Big Block Holders from CNBC)
http://www.sec.gov/edgar/searchedgar/companysearch.html
(SEC filings search from SEC.gov Edgar)
http://www.nasdaqtrader.com/Trader.aspx?id=shortinterest (Short Interest)
http://www.newratings.com/main/search_result.m?section=search
(Analyst Ratings)
http://www.insidercow.com/history/company.jsp?company=HALO&B1=Search%21
(Insider Transactions)
http://clinicaltrials.gov/ct2/results?term=rhuph20
http://clinicaltrials.gov/ct2/results?term=hyaluronidase+%28human+recombinant%29
(Clinical Trials)
Clinicals & Partners
http://media.corporate-ir.net/media_files/irol/17/175436/120506RocheHalozymePR.pdf
Halozyme and Roche enter agreement for the application of Enhanze, a novel technology to improve drug delivery
http://media.corporate-ir.net/media_files/irol/17/175436/RocheHalozymeSCRIPPresentation.pdf
(Halozyme and Roche presents “Developing and Managing Strategic Alliances” at the SCRIP conference
May 15-16, 2007 Berlin, Germany)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1049931&highlight=
Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology
http://www.genengnews.com/news/bnitem.aspx?name=32185399
Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously (Enhanze 3-16-08)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=962993&highlight=
Halozyme and Baxter Expand Global HYLENEX Collaboration
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=IROL-secToc&TOC=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvY29udGVudHMueG1sP2lwYWdlPTU0NDgxMjkmcmVwbz10ZW5r (Feb. 12, 2008 Slide Show Presentation)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1093211&highlight=
Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1117082&highlight=
Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences
Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1130327&highlight=
Halozyme Therapeutics Presents Pre-Clinical Studies on Dermal Remodeling With HTI-501, a Lysosomal Proteinase
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1147853&highlight=
http://www.baxter.com/about_baxter/news_room/news_releases/2008/03-16-08-gammagard_liquid.html
Phase I/II data showed that Enhanze Technology™ enabled subcutaneous administration of a monthly dose of GAMMAGARD LIQUID in patients with Primary Immunodeficiency
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1163612&highlight=Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
Cheetah full ADA presentation
http://www.halozyme.com/images/ADA%202008%20Poster%20legal.pdf
Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1177539&highlight=
Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1170737&highlight=
Halozyme Therapeutics Begins Phase 2 Clinical Trial of Insulin With rHuPH20 in Type 1 Diabetic Patients
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1220870&highlight=
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1233454&highlight=
Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1234643&highlight=
Halozyme Deprioritizes Bisphosphonate Program to Reallocate Resources to More Commercially Attractive Internal Programs
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1295922&highlight=
Phase III Trial Begins for GAMMAGARD LIQUID Plus rHuPH20 in Primary Immunodeficiency Patients
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1240232&highlight=
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial With Second Biologic
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1244971&highlight=
Halozyme Therapeutics Presents Positive Pre-Clinical Single Agent Data for PEGPH20
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1248119&highlight=
AACR presentations show that PEGPH20 produces anti-cancer activity in models of breast, prostate, and brain metastases that produce hyaluronan
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1277960&highlight=
Phase 1 Study for Halozyme's Insulin-PH20 Published, Highlights Findings for Faster Acting Insulin Formulations |
|
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1293715&highlight=
Accelerated Insulin Pharmacokinetics and Improved Glycemic Control in T1DM Patients by
Coadministration of Prandial Insulin with Recombinant Human Hyaluronidase
http://www.halozyme.com/ADA%202009%20Poster%20v3%202.pdf
Halozyme Announces Roche Selects Fifth Exclusive Biologic Target
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1297519&highlight
Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID(TM) with rHuPH20 Enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1307856&highlight=
First patient dosed in trial with third Roche biologic formulated with Halozyme’s recombinant human hyaluronidase enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1330295&highlight=
Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration |
Data from the First Pediatric Rehydration Study, INFUSE-PEDS 1, Published Today in Pediatrics |
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1338559&highlight=
Halozyme Announces Roche Doses First Patient in Phase 3 Clinical Trial with Subcutaneous Herceptin(R)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1344910&highlight=
Earnings Transcripts
http://seekingalpha.com/article/68609-halozyme-therapeutics-q4-2007-earnings-call-transcript?source=yahoo&page=1
Halozyme Therapeutics Q4 2007 Earnings Call Transcript
http://seekingalpha.com/article/76655-halozyme-therapeutics-inc-q1-2008-earnings-call-transcript?source=yahoo
Halozyme Therapeutics Inc. Q1 2008 Earnings Call Transcript
http://seekingalpha.com/article/90080-halozyme-therapeutics-inc-q2-2008-earnings-call-transcript?source=yahoo&page=1
Halozyme Therapeutics Inc. Q2 2008 Earnings Call Transcript
http://seekingalpha.com/article/106797-halozyme-therapeutics-inc-q3-2008-earnings-call-transcript?source=yahoo
Halozyme Therapeutics, Inc. Q3 2008 Earnings Call Transcript
http://seekingalpha.com/article/125929-halozyme-therapeutics-inc-q4-2008-earnings-call-transcript?source=trans_sb_previous
Halozyme Therapeutics, Inc. Q4 2008 Earnings Call Transcript
http://seekingalpha.com/article/171883-halozyme-therapeutics-inc-q3-2009-earnings-call-transcript?source=yahoo
Halozyme Therapeutics, Inc. Q3 2009 Earnings Call Transcript
Links to understanding Clinical results
http://www.boomer.org/c/p3/c02/c0210.html
http://health.yahoo.com/other-other/picomoles-per-liter-pmol-l/healthwise--stp1694.html
http://www.unc.edu/~rowlett/units/scales/clinical_data.html
http://www.bio.net/bionet/mm/immuno/2000-July/015983.html
http://www.boomer.org/c/p1/
http://www.merck.com/mmpe/sec20/ch303/ch303a.html
Shares Outstanding: 91,095,288
Float: 73.21M
http://www.deepcapture.com/
(O-T How the market is manipulated and companies destroyed)
Halozyme Therapeutics Inc.
11588 Sorrento Valley Road
Suite 17
San Diego, CA 92121
United States
Phone: 858-794-8889
Halozyme Contact
Robert H. Uhl
Senior Director Investor Relations
858.704.8264
ruhl@halozyme.com
(Disclaimer) Do your own DD and confirm anything said on this board.
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