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I don't have an educated opinion. Obviously, the market thinks it's a long shot. I think their biggest problem is that their phase 2/3 study has a 2031/01 estimated completion date and they estimate they will enroll 2040 patients. So they have ways to go.
Still, I bought some shares for several reasons (in no particular order):
1. I like to follow the companies Halo partners with;
2. At $2.91, its current price, the company has a market cap of about $175M. As of Jun 30, 2024 they had $281M of cash, which should support their activities into the first half of 2027. It's reasonable to expect they will release interim results sooner. There have been opportunities to buy the stock as low as $1.81. It's a very high risk but potentially high reward stock;
3. RA Capital, a good life sciences fund, has bought shares at much higher prices and has not sold;
4. I recently discovered I have the ApoE gene. Actually, it's worse. My wife reminded me that we already knew that from the 23andMe test some time ago and I forgot!
Speaking of ABOS, what do you think of their chances for success in the Alzheimers space?
That might have been the rationale behind the deal with ABOS. I guess the downside is that the terms won’t be as good and it makes sense only if you are able to sign more deals.
There seems to be quite a bit of competition brewing: Alteogen’s deal with Merck, Elektrofi’s partnerships with Janssen and Lilly, hydrogel technology, etc.
Interesting articles. Thank you. But why do you say "...certainly feeds the idea that Elekrofi would be of interest to HALO..."?
Three of the authors of the first article co-founded Recobia Therapeutics, a potential competitor for Halo. They are not a clinical stage company yet, though.
"Currently, one clinical solution to address these issues is co-formulating the mAbs with the rHuPH20 drug delivery technology developed by Halozyme. This technology temporarily reduces tissue backpressure in SC tissue, allowing for increased injection volumes, improved pharmacokinetics profiles, and increased bioavailability of co-administered compounds. This solution remains the only one registered for clinical routine use. Due to the convention of exclusivity, numerous mAbs, including biosimilars, are not available in association with this technology, triggering the need for alternative options. Regarding the enzymatic approach, the window of activity through depolymerization of hyaluronic acid, which enables a local space, is limited and restricts the possibility of prolonged release. On the other hand, hydrogel technology offers a tunable formulation, supporting the development of a delayed administration strategy between two injections, appearing as an appealing option."
"Conflict of Interest
Detappe and Pivot have a patent in the field of hydrogels for subcutaneous administration of mAbs. Detappe, Boudali, and Pivot are co-founder of Recobia Therapeutics which seeks to translate the hydrogel formulation to the clinic."
https://recobiatx.com
Have a well deserved perfect weekend, Helen!!
From your biggest fan.
Found it. It was last call on Fast Money Carter said much “more to come”
Which CNBC show? Thanks for sharing
HALO noted as a buy on CNBC-TV, by one of usual expert panel on at 5:55-6 pm.
I think Helen & HALO are doing JUST FINE !!
Thank you for all your hard work through the years & recently .
This is good news. They added $2B to their estimates. From JPM:
"Argenx
PT raised to €570, on higher Vyvgart ests. and adding empa. Expect outperformance as Vyvgart beats consensus in 2025, driven by CIDP uptake
By James D Gordon AC, Richard Vosser, Zain Ebrahim, John Priestner, Sophia Graeff Buhl Nielsen
Click here for the full document and disclaimers
Raising Dec-25 PT 20% to €570 (prev. Jun-25 €470), reiterate OW. We see Vyvgart beating cons. expectations in 2025, driven by CIDP launch, and we also see teens profitability delivered in 2025. We update for: (1.) strong Q2 results (first take here); (2.) Vyvgart CIDP approval / better pricing (note here); and (3.) recent R&D event, incl. empa PII data/dev plans (takeaways here). We raise Vyvgart MG peak sales from $3bn to $4bn, raise Vyvgart CIDP peak from $3bn to $4bn, and add in 50% POS of empa at c.$1bn peak in MMN. Our NPV per share is increased c.20%, to c.€570. Our updated Revenue forecasts are now broadly inline with BBG cons. for 2024, 13% ahead in 2025, and we see further share price outperformance driven by Vyvgart upgrades, as a result of a strong CIDP launch next year. We also see the company delivering ‘25 Operating profitability (JPMe $525m vs. cons. $361m). On near-term newsflow, we expect competitor Amgen’s* Uplinza PIII MG trial to have positive data at AANEM (Oct 15-18), but we expect most use to be post Vyvgart, and hence not a significant threat. We also see potential upside should Argenx’s Vyvgart Myositis PII trial progress to PIII by year end. Overall, with further Vyvgart upgrades to come in 2025, along with the company reaching strong operating profitability, we expect continued outperformance, and we reiterate our OW.
That is indeed interesting.
Thanks for sharing. From your first link, I learned something new. Apparently, Halozyme has a partnership with Merk that we did not know about. From Table 1 in the article:
Merck KGa
rHuPH20
(Enhanze, Halozyme)
Erbitux
(cetuximab)
Pre-clinical
Hmmm.......articles interested me......
Maybe this info would be of more interest to some....since the problem has been been mentioned here a few times, this is definitely worth a read..........
"What does it take to be an “active ingredient”? "
"CJEU called upon to rule on Articles 1(b) and 3(a) for Halozyme’s SPC application for Herceptin SC (C-456/24)"
"Europe’s highest court has been asked new questions to clarify which components of a medicinal product are SPC-eligible active ingredients. The answers from the CJEU may illuminate how Europe’s other pharmaceutical regulations impact SPC law.
"
Chart would agree that a pause is nigh.
No new patent application postings today, a few new acquired patents posted on Tuesday.
Two recent articles on SC and rhuph20 worth skimming thru.....certainly feeds the idea that Elektrofi would be of interest to HALO.....
"Landscape of Subcutaneous Administration Strategies for Monoclonal Antibodies in Oncology"
https://onlinelibrary.wiley.com/doi/10.1002/adma.202406604
"Hyaluronidase Drug Delivery Systems — the Synthesis and Application. Review"
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4925369
That’s not what typically happens. Usually the analysts recognize that they have underestimated the value and raise their price target to keep up.
Anyone who has been in the market for long enough has seen this pattern.
According to yahoo finance, the average analyst PT is $59.89, so another concern I have is that if there isn't some kind of positive development behind this move, we may get some downgrades. For instance, JPM is "overweight" with a Dec 25 $52 PT. It's not like they are not aware of their upcoming catalysts, halo's fundamentals, CAGR, PE, etc.
… oops I think I posted a little too early. Looks like at least one permabear has not capitulates. Thanks for your post, Maumur.
Maybe, we ate not done after all.
I wonder if we are approaching a temporary top or a pause in this uptrend.
The only reason I say this is that there are signs of capitulation in some of the halo permabears on this board and elsewhere.
One of the most adamant permabears (Easycomeandgo) has left the board and others are posting about holding until the end of the year!
I haven't sold any shares but I have way too much so I am kind of forced to start selling in a way at some point. If I had more confidence in management, I might hold longer. But there have been too many warning signs and I think it makes sense to sell at least a portion of your shares if there is no new deal or some type of unexpected good news in the next few months. If the US patent extension is granted, that may give us a little more time.
In spite of the rally, we are just a few dollars above where we were in November 2022. And if you consider how much inflation we've had... Also, one should take into account opportunity cost. There have been tremendous opportunities in biotech and the market in general in the past two years.
Thanks for sharing.
What are your thoughts?
Holding until end of year. If no deals by then then I'll probably exit.
Holding or selling?
Thank you biotechinvestor...GREAT info !
Top US small cap fund manager Leo Harmon holds Halozyme shares in the Mesirow Small Company Fund that he runs with Kathryn Vorisek. As at the end of June, the position represents their third-largest holding. These two investors are among 18 of the world’s best-performing fund managers that have bought Halozyme shares – each of them among the top 3pc of the more than 10,000 equity managers whose performance and investments are tracked by financial publisher Citywire.
The conviction of these investors has led Halozyme to be given a top AAA Elite Companies rating by Citywire, which rates companies based on their ownership by the world’s smartest professional investors.
“What we really like about this company is the fact that it’s a loyalty company,” Harmon said. By that he’s referring to its deep-rooted relationships with multiple pharma partners, some of which seek approval to use Enhanze technology with several treatments, removing the need for a blockbuster or single wonder drug to make the investment pay off.
“They have multiple opportunities in various types of compounds where they can transition their underlying technology into several different drugs and collect royalties from their large pharma partners,” he said.
The company could be on course to receive between $1bn and $1.5bn in royalty revenues over the next five years purely due to the growth of the overall market, Harmon said.”
https://finance.yahoo.com/news/questor-biotech-firm-profiting-overlooked-190000187.html
You two have been saying this when we were in teens, 20’a and 30’s. You were wrong then and are fundamentally wrong now.
You forget that we have a terrific CAGR between now and 2029 without even a single new deal. Wave 3 and 4 (already signed deals but not approved products) will have a bigger total market than wave one and 2 did.
Anyone reviewing the data will know that this stock is undervalued based on the EPS growth that is already de-risked and even without a single new deal.
Of course new deals will be welcomed and are around the corner but they are not necessary for halo to continue to appreciate in share price.
That sums it up exactly. Failure to grasp this oncoming cliff is just whistling past the graveyard.
Halo is still getting about 75% of its royalties from Darzalex FasPro. According to Helen's projections, revenue growth and royalty growth slow down from 29% (royalties) and 20% (revenue) in 2027 to 5% for both in 2028. Without the EU patent extension, of course the slowdown would have been worse. If granted, the US patent extension will help until 2029 but there is no way the stock can double or appreciate significantly in the next few years without addressing the uncertainty about growth beyond 2029. The analysts at Goldman Sachs, Leerink and JPM may have been too conservative but they are not complete idiots and they have done their homework. The only way out is new deals or a significant acquisition.
I am shocked that Helen and the board are not addressing this more forcefully and with more of a sense of urgency. The deals that are bearing fruit now were signed a long, long time ago! The least they could do is stop the stock buybacks and boost their cash reserves. The longer we go without new deals, the more crucial a transformative acquisition will be.
Agreed with everything other than this rally being “technically” driven.
It’s pure fundamentals!
Nothing ever goes up in a straight line without little pull backs. I for one, would welcome an opportunity to buy more on a dip.
The key is to enjoy bargain buying just as much if not more than watching your portfolio grow.
The catalyst and reasons why halo is still great value are all still intact.
Halozyme opened up a handful of positions, including an executive director of M&A and integration. The stock is looking like it’s about to pop to new levels, especially if there is some significant news coming.
I think we just hit an all time intra-day high.
Enhanz is going to hit some competitive pressure one way or another. A company that's a one trick pony is always vulnerable to that.
One way to fend it off is to aggressively create new partnerships across a wide range of companies. Helen has failed in that mission, despite her endless delightedness. One thing I've learned through real life experience is never trust a CEO. They will lie to you right to your face. Words don't count. Only deals.
I don’t think you really get what I’m saying.
1. I’m very happy when the stock goes up. I bought 18 years ago at 3 and it’s catching fire finally. If Helen is as good as I think she is. (Certain people on this board have been very negative on her in the last few months) this stock can go to 150.
2. I’ve listened to every call since I’ve owned the stock. Results are great but predicting flat q3 so unless deals get done people won’t get excited.
3. This rally has been technically driven. It looks like a possibility of all time high tomorrow so let’s hope for that. Fundamentals are well known and the reason I called for trading in a range is because the market needs to see if the Antares deal is bearing fruit. This will define Helen in the future.
4. I’ve always said buybacks were a good way to deploy excess cash. This is part of the reason the stock is much higher.
5. If you go way back I’ve always said Enhanze is the future of the company. That’s when everyone was so high on Pegph20.
6. I knew Helen was good when pegph20 failed and she repositioned the company that same day. I’m pretty sure she inherited a bad deal and was forced to go forward to failure but she was ready.
7. Bottom line is I’m here until I see a major change in momentum of Enhanze and that’s a long way away if ever.
8. Meanwhile Halo is a leader in the industry and that’s hard to top. I’ve always said cash flow is king and Halo has a lot of it. Cash flow is 33% higher per year than the sock price was 18 years ago.hard to beat that.
Those are a big part of the reason I’m still hanging around. Now if Roaring Kitty could just come around I might exit sooner.
I don’t think you really get what I’m saying.
1. I’m very happy when the stock goes up. I bought 18 years ago at 3 and it’s catching fire finally. If Helen is as good as I think she is. (Certain people on this board have been very negative on her in the last few months) this stock can go to 150.
2. I’ve listened to every call since I’ve owned the stock. Results are great but predicting flat q3 so unless deals get done people won’t get excited.
3. This rally has been technically driven. It looks like a possibility of all time high tomorrow so let’s hope for that. Fundamentals are well known and the reason I called for trading in a range is because the market needs to see if the Antares deal is bearing fruit. This will define Helen in the future.
4. I’ve always said buybacks were a good way to deploy excess cash. This is part of the reason the stock is much higher.
5. If you go way back I’ve always said Enhanze is the future of the company. That’s when everyone was so high on Pegph20.
6. I knew Helen was good when pegph20 failed and she repositioned the company that same day. I’m pretty sure she inherited a bad deal and was forced to go forward to failure but she was ready.
7. Bottom line is I’m here until I see a major change in momentum of Enhanze and that’s a long way away if ever.
8. Meanwhile Halo is a leader in the industry and that’s hard to top. I’ve always said cash flow is king and Halo has a lot of it. Cash flow is 33% higher per year than the sock price was 18 years ago.hard to beat that.
Those are a big part of the reason I’m still hanging around. Now if Roaring Kitty could just come around I might exit sooner.
Yep, I didn’t love the director selling either. But then again, many of the directors were selling when halo was trading in teens and 20’s. They often sell for personal needs or to rebalance their portfolios and not have too much exposure in one name. Just like their selling did not forecast doom and gloom back at far lower prices, it does’t scare me too much now (unless they exit on mass)
CEO only sold the options she was recently rewarded and did not reduce her total holdings. She still owns 600k+ shares.
Not loving the fact that Helen and Posard sold about 30,000 shares each in the past couple of days. I believe Helen had not sold any shares in the past 12 months. Hopefully, they don't know something we don't.
Sure… and all those analysts upgraded their price targets the day after the earnings call because of a “Reddit type of a thing” and not because of the catalysts discussed on CC.
It’s one thing to make a false forecast (no shame in it, it’s not easy to get the future right), it’s another to insist that one would have been right had it not been for some “Reddit type of a thing”
Nah, it’s still just a drift! LOL
Kidding aside, you can believe in some chart/technical analysis for why halo has had 14% run up since the VERY day of the earnings call. Those of us who believe in fundamentals, value and quality have other reasons (I counted 9).
As long as we are both happy…
BTW, since the day of Halo’s earnings, biotech sector (XBI) has only been up 2.8%. But no, there is now way the run up has had anything to do with the earnings/cc! LOL
Probably a Reddit kind of thing where they have a following. Let’s see where it goes but it would be nice to have a deal or two before they decide to get out.
Hard to say what it means. They might have sold some covered calls as hedges and then had to give up some shares as a result, or they may have naturally lightened their number of shares when the dollar amount in their portfolio became a little overweighted in HALO as a result of the recent run up in the pps. Or, they know something we don't . LOL!
Here is why the stock has been going up. If anyone wants to subscribe then you'll get more info. https://www.chartmill.com/stock/quote/HALO.
Hopefully they hang around a while or we get some good news to go along with the move. Who know maybe Roaring Kitty picks it up next.
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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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