Robert Uhl - Senior Director of Investor Relations
Jonathan Lim - President and Chief Executive Officer
Gregory Frost - Chief Scientific Officer
David Ramsay - Chief Financial Officer
Robert Little - Chief Commercial Officer
Eun Yang - Jefferies
Andrew Vaino - Roth Capital
Kevin Degeeter - Oppenheimer
Chris Geston - UBS Financial Services
John Borzilleri - GRT Capital
Eun Yang - Jefferies
Halozyme Therapeutics Inc. (HALO) Q2 2008 Earnings Call August 8, 2008 8:00 AM ET
Good morning, ladies and gentlemen. My name is Ashley and I will be your conference operator today. At this time, I would like to welcome everyone to the Halozyme Second Quarter 2008 Pipeline Update Conference Call. [Operator Instructions].Thank you.
Mr. Robert Uhl, you may begin your conference.
Robert Uhl - Senior Director of Investor Relations
Thank you, Ashley and thanks also to everyone for participating in today’s call. I am Robert Uhl, Senior Director of Investor Relations at Halozyme Therapeutics. Joining me on the call today from Halozyme are Jonathan Lim, President and Chief Executive Officer; Gregory Frost, Chief Scientific Officer, David Ramsay, Chief Financial Officer and Robert Little, Chief Commercial Officer.
This morning Halozyme released 2008 second quarter financial results. If you have not received this news release, or if you would like to be added to the company’s distribution list, please call Alex Schlam at 858-704-8288. This call is also being webcast live over the Internet at www.halozyme.com and a reply will be available on the company’s website for the next 30 days.
Before we begin, let me remind you that during this conference call, we will be making forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides the Safe Harbor for forward-looking statements.
All statements made during this conference call that are not statements of historical facts constitute forward-looking statements. The matters referred to in forward-looking statements could be affected by the risks and uncertainties of Halozyme’s business both known and unknown. Such risks inherent to Company’s business are described in our filings with the Securities and Exchange Commission, as well as in our press releases. The company’s actual results may differ materially from those expressed and/or indicated by such forward-looking statements.
With that I’d like to now turn the call over to Halozyme’s President and CEO, Jonathan Lim.
Jonathan Lim – President and Chief Executing Officer
Thank you, Robert. Good morning, everyone. Thank you for joining us especially on this auspicious day of 08-08-08. I’m excited to be able to give you an update on the substantial progress that Halozyme has made since our last conference call on our proprietary and partnered programs.
I’ll provide an update on our Insulin program that includes both regular and analog formulations. Gregory Frost, will discuss the status of our other proprietary program such as PEG PH20. Bob Little will be updating you on our partnered programs with Roche, Baxter Medication Delivery and Baxter Bioscience. And David Ramsay will give you a snapshot over our financial results.
Last year we made a strategic decision at Halozyme to focus additional resources on the development of our proprietary pipeline that would harness our unique scientific understanding of the matrix. And this is the extracellular space between cells that contains structural proteins and various fibrous components.
We believe, we are starting to see tangible results of that investment, in fact, I’m proud to say that we’ve identified at least four multi-billion dollar franchises, which we are pursuing in parallel in important diseased areas such as Endocrinology, Oncology and dermatology and in the area of drug delivery. In each of these four franchisees, we have identified and are developing innovated new drugs that are either best in class or first in class with blockbuster potential and they all have the potential to generate lucrative partnerships for Halozyme, provide attractive product revenue generating potential for the company in the future or in some cases both.
Five key internal programs comprise our current proprietary product development portfolio. The Endocrinology franchise currently consists of the insulin and bisphosphonates, which utilize our PH20 enzyme and apply it to already marketed pharmaceuticals to transform them into what we believe we’ll be value added proprietary products with meaningful patient benefits. The oncology franchise which you’ll be hearing more about from Dr Frost. Consists of PEG PH20, this is a new molecular entity targeting the metrics environment of tumor cells and Chemophase which utilizes the PH20 enzyme for local administration in the treatment of bladder cancer.
Our dermatology franchise is anchored by HTI501, yet another new molecular entity, which targets the metrics in both aesthetic as well therapeutic areas of dermatology. So, I’m not going to provide you with an update on the diabetes program, which some of you may remember by its former code name Cheetah.
In June HALO presented the data at the American Diabetes Association or ADA meeting from its Phase I clinical trial that tested the co-formulation of PH20 with two commercially available insulin products, Humulin R or regular insulin and Humalog a fast-acting analog insulin. The results yielded data for the co-formulations that more closely mimicked physiologic meal-time insulin response compared to either insulin administrative loan. For example, the combination showed significantly faster absorption of each insulin that began within minutes after the injection.
We also saw faster and greater glucose lowering activity, greater peak insulin levels in plasma and lower variability of key parameters across subjects. Even, the combination of PH20 with Humulin R were regular insulin was superior to the fast-acting analog, Humalog alone with more rapid systemic absorption, greater maximal systemic exposure and a faster metabolic effect.
Based on this study, our enzyme boosted regular insulin in a way that makes it better than the current gold standard insulin analog. This successful page one euglycemic clamp study was conducted in 26 healthy volunteers and from concept to data presentation at ADA took roughly eight months. The HALO development team demonstrated impressive discipline focus and agility to achieve this rapid timeline and I want to congratulate them all on their outstanding work.
Now, let’s talk about the next steps. Before the end of the year, our goal is to advance the insulin program into Phase II development that will enroll diabetic patients. We’ve conducted extensive discussions with key opinion leaders in diabetes, outside consultants, potential partners and among our own internal scientific and commercial teams to determine the trial design that will provide maximal information. Our, next study will be a Phase II trail in type one patients with PH20 in combination with both regular insulin as well as insulin analog.
This study will measure glycemic response to a standardized meal along with pharmacokinetic and pharmacodynamic data in patients. This study will now require many patients perhaps on the order of about 20 to 25. However, because of the nature of the study design, the data derived will provide powerful insights into the affects of PH20 on insulin absorption and glycemic response in the diabetic patients. We intend to have data ready for presentation at ADA and at the European Association for the study of diabetes or EAST meeting next year.
Our clinical program will seek to demonstrate compelling clinical advantages for the enzyme insulin combination compared to insulin analogs alone. Such as reduced frequency of hypoglycemic events, better predictability of insulin treatment or reduced weight gain, if a combination product with a profile more like the body’s own natural insulin to demonstrate clinical benefit in any one of these three parameters, they could become the best in class product and potentially reduce the long-term complications and associated cost of treating diabetics.
Let me reiterate, our clinical development program will be designed to demonstrate a unique clinical benefit resulting in a differentiated insulin enzyme combination product that will ensure it’s acceptance by multiple stakeholders including patients, physicians and third party payers. We also believe that our 505B2 filing will be the appropriate pathway to an NDA filing for insulin plus PH20 and as similarly expedited path to market is available in Europe.
The prandial or meal-time insulin market is estimated at just over $3 billion of annual sales for the US and Europe and growing fast, which represents a substantial commercial opportunity for HALO.
We are moving forward with the development of subcu formulations of our enzyme with both the analog and regular insulin that would have similar presentations and stability profiles to its currently marketed products. Due to generation of additional clinical data during the next 12 months or so, we believe we can increase the value of the program for our shareholders and for potential partners.
So, at this point, I’m going to turn the call over to Greg Frost, our Chief Scientific Officer will provide an update on our four other proprietary programs.
Gregory Frost - Chief Scientific Officer
Thanks, Jonathan and good morning everyone. I’d like to start off with an update on our two oncology programs. Intravenous PEG PH20 for solid tumors and Chemophase for bladder cancer followed by brief updates on our dermatology and bisphosphonates R&D efforts.
Last month we presented efficacy date at the AACR Translational Cancer Medicine meeting in Monterey. In animal tumor models with intravenous PEG PH20, alone ending combination with either docetaxel and liposomal doxorubicin. Hyaluronan or HA is a dominant component of the extracellular matrix in subsets of many solid tumors that may increase resistance to Chemotherapy. Earlier this year we demonstrated that removal of HA around the tumor with our novel PEG PH20 enzyme results in a reduction in tumor size that exceeds NCI criteria to be considered in anti-tumor agent.
HA removal also leads to significant reductions in tumor interstitial fluid pressure or IFP. And tumor Diffusion-weighted MRI signals. Many experts believe that elevated tumor IFP may limit the response to cytotoxic treatment regimens in multiple solid tumors. Our most recent studies clearly demonstrate a substantial increase in anti-tumor activity for a combination of PEG PH20 with these two chemotherapy agents.
For example, in the xenograph PC-3 prostate cancer model, a tumor that produces abundant pericellular HA, tumor volume growth over time was significantly reduced and survival significantly prolonged for the PEG PH20 plus docetaxel treatment group compared to the control and docetaxel alone groups. In addition significant reductions in tumor mass were observed following treatment with pegylated enzyme alone that bears further investigation of monotherapy activity in HA expressing tumors.
In contrast, using a prostate tumor model that does not produce HA, the xenograph D-145 no significant changes in IFP (inaudible) intravenous PEG PH20 treatment, the results for this HA negative model also demonstrate a no meaningful difference in tumor volume growth between docetaxel alone and PEG PH20 plus docetaxel treatment groups. These results support the proposed mechanism of action that only HA over expressing tumors are most resistible to PEG PH20 therapy.
Based on our animal studies, treatment with PEG PH20 alone and with chemotherapy is well tolerated without significant increases in neutropenia compared to chemotherapy alone.
These studies continue to reinforce our belief that our PEG PH20 program could lead to a potentially first in class monotherapeutic and chemo adjuvant therapeutic for HA producing solid tumors. A significant proportion of advanced cancers including prostate, breast, ovarian, pancreatic, and gastric carcinomas produce HA rich coatings which can prevent tumor cells from coming in contact with another, elevating IFP and modifying some potentially important signaling events. PEG PH20 has shown it can completely eradicate these types of sugar coatings leading to a reduction in tumor volume in IFP within hours of intravenous administration. The results we have seen so far fuel our excitement for this program and our preclinical toxicology and manufacturing efforts are continuing full speed ahead. We are making preparations to initiate studies in cancer patients using PEG PH20 during the first half of 2009.
Now, moving a short distance from the prostate to the bladder for discussion of our Chemophase program. At the end of June we announced updated results of our ongoing Phase I/IIa trial in superficial bladder cancer demonstrating the safety and tolerability of induction and maintenance dosing of Chemophase, a combination of PH20 enzyme with mitomycin. This study reported no dose limiting toxicities, no observed side effects attributable to the enzyme and established the dose for subsequent clinical trials. The highest dose studied in the current trail 800,000 units of PH20 enzyme plus mitomycin will be incorporated into the future pivotal trail program. Based on the success of this ongoing trail, we are planning for meetings with FDA and European regulators in order to determine the optimal pathway to drug approval.
Turning to dermatology, I would like to spend a minute talking about HTI501. HTI501 lysosomal proteinase enzyme is a new chemical entity in the lead product in our dermatology program. This new recombinant human enzyme conditionally degrades collagen and other protinatious components under the skin that form fibroseptae. Fibroseptae are fiber like anchors in the skin, they contribute to the dimpled appearance of cellulite.
HTI501 may be clinically useful in medical as well as aesthetic dermatology indication such as cellulite, scarring, and Dupuytren’s contracture. It is a pH dependent enzyme with activity that we believe can be tightly controlled in the extracellular space with specific formulations. This ability to control HTI501 may be an advantage relative to collagens that tend to demonstrate persistent degradation of surrounding tissue when administered. Data for HTI501 presented at two medical meetings during the second quarter demonstrated that the enzyme can degrade collagen and vitro at pH 5 to 6, but is completely inactive at physiologic pH of 7.4. In Rat and Porcine models administration of the enzyme resulted in the release of hydroxyprolene, a marker for collagen degradation. A pH 5, but not a pH 7.4. The highly controlled the way in which HTI501 appears to show activity can prove to be differentiated and desirable attribute in the patient setting.
We are moving forward with additional studies in three animal species to test efficacy to optimize formulations and the amount of enzyme to administer and gather toxicology data in support of clinical trails which we are targeting to begin by the end of next year. Cell lines that express HTI501 have been transferred in to our manufacturing group for CGMP process development and scale up.
Turning to osteoporosis our fifth proprietary initiative is our bisphosphonate PH20 program for osteoporosis, which targets a multi billion dollar market that includes both oral and intravenous products. IV bisphosphonates offer some advantages over the oral products which see patient discontinuation rates of 50% within 12 months of starting treatment due to GI side effects. However, IV administration represents an inconvenience to patients and to general practitioners who generally do not have the ability to administer IV medications. The subcutaneous administration of bisphosphonates alone without PH20 produce unacceptable skin irritation and the injection side reactions for the patients. For these reasons our market research has concluded that a convenient subcutaneous in-office bisphosphonate treatment would result in a strong willingness amongst physicians to treat osteoporosis to prescribe our product.
In animal studies that we’ve conducted, co-administration of bisphosphonate with PH20 demonstrates comparable bioavailability for sub-Q injection relative to IV. And the ability to administer much higher doses of bisphosphonate as much as three to five folds without significant injection side reactions. Based upon the favorable pre-clinical results we’ve seen so far, we are targeting to enter the clinic with the bisphosphonate PH20 combination formulation by the end of the year.
Now I’ll turn the call over to Bob Little, who’ll update you on our partnered programs.
Robert Little – Chief Commercial Officer
Thank you, Greg and good morning. We currently have three partnerships in place with two companies Roche and Baxter BioScience for Enhanze Technology and a partnership with Baxter Medication Delivery for HYLENEX, our FDA approved drug.
Let’s start by discussing Halozyme’s partnership with Roche. Overall our Roche line is moving forward exactly as planned. For example we are continuing to successfully implement the scale-up of a higher yielding PH20 enzyme manufacturing process that will support Roche’s needs as well as Halozyme’s internal programs. The recent bid by Roche to acquire the portion of genetic, it does not already owned may have made some of you wonder what it means to the future of the Halozyme partnership. Our deal already grounds Roche and all of its affiliate’s worldwide rights to apply in our Enhanze Technology to 13 biologic targets and specifies three of the targets on an exclusive basis. Therefore we see no material impact on our relationship if and when the genetic acquisition offer closes. We have to provide more details regarding the status of the Roche programs by the end of this year.
Our second Enhanze Technology partnership is with Baxter Bioscience. And in March, Baxter presented positive results from their GAMMAGARD Enhanze Technology Phase I/II clinical trial at the American Academy of Asthma, Allergy, Immunology Conference known as the AAAAI. Currently Baxter is preparing to begin its Phase III clinical trial for the GAMMAGARD Enhanze combination in early 2009. Also in late July positive nine month interim data from a Phase II trial testing GAMMAGARD and Alzheimer’s Disease was presented Alzheimer’s Association meeting. Baxter has committed its plans to conduct further studies in this patient population and additional favorable results could expand the use of GAMMAGARD. Investment analysts peg the growing world about GAMMAGARD franchise of roughly $1 billion of annual sales. Administration of this lifelong therapy for primary immunodeficiency and other potential uses in the future in the home setting by a subcutaneous administration could provide greater patient convenience as well pharmacoeconomic benefits.
Moving on to Baxter Medication Delivery regarding the Baxter, HYLENEX relationship. Our belief remains strong of this partnership and the HYLENEX product have significant patient benefit as well as sales potential. The segment that Baxter is currently targeting is the ophthalmic or ambulatory surgical centers, pediatric hydration and the long-term care on nursing home market. Baxter has stated in the past that believes the product represents $500 million annual sales opportunity. Introduction into the ophthalmic surgery market a niche opportunity just started during the second quarter for the most significant launches in pediatric and long-term care market should be rolling out during next year. Enrollment in the Multi-center infused pediatric re-hydration study that involves leading pediatric hospitals is now complete. Results of this study should be available in October and it will prove highly useful as Baxter launches HYLENEX into the pediatric market during 2009.
With regards to the long-term care market, we believe that HALO is going to offer nursing home inclinations are cost affective and patient friendly alternative to hospitalization by allowing subcutaneous hydration in the nursing home setting. Baxter is currently gathering health economic data for least facilities in owe to better understand the cost benefit implications of subcutaneous administration. We at Halozyme remain very encouraged by the strong commitments as Baxter’s top management has expressed to invest in the commercial and clinical support for HYLENEX and its push for opportunities in new markets.
Finally, taking now about other enhanced technology partnership opportunities, I have to say our discussion activity with multiple potential partners is more active now than it ever has been. And they are exploring kind of the use of our enzyme with their proprietary drug and biologic compounds. Additional development partnership structures with the right terms and with the right partner remain an important objective for Halozyme.
I’ll turn the call now over to David. Thank you.
David Ramsay – Chief Financial Officer
Thank you, Bob and good morning everyone. The net loss for the second quarter 2008 was $11 million or $0.14 per share compared with the net loss for the second quarter of 2007 of $4.8 million or $0.07 per share. For the six months our net loss totaled $21 million or $0.27 per share compared to $8.2 million or $0.11 per share during the first half of 2007. Revenues for the second quarter of 2008 were $1.4 million compared to $709,000 for the second quarter of 2007. Revenues under collaborative agreements for the second quarter 2008. Were also $1.4 million compared with $539,000 for the second quarter of 2007. Revenues under collaborative agreements in 2008 primarily consisted of the amortization of upfront fees received from Baxter and Roche, totaling $588,000 and then also research and development reimbursements from Baxter totaling $554,000 and Roche of $210,000 during the period. R&D expenses for the second quarter of 2008 were $8.9 million compared with $4.1 million for the second quarter of 2007, reflecting increased compensation expense largely due to the increase in our research and development personnel as well increased R&D spending on our insulin, bisphosphonates and PEG PH20 clinical and preclinical program, as well as the increase production cost associated with the manufacturing scale-up of our PH20 enzyme.
SG&A expenses for the second quarter of 2008 were $3.8 million compared with $2.4 million for the comparable period in 2007, reflecting increased compensation expenses as well as higher legal and facilities expenses as compared with prior year quarter. We remain in a very strong financial position with cash and cash equivalents of $82.4 million as of June 30, 2008, compared with $97.7 million as of December 31, 2007.
That concludes my prepared remarks and now, I’ll turn the call back over to Jonathan.
Jonathan Lim - President and Chief Executive Officer
Thanks, David. At this point I’d like to summarize for you, some of the goals and events that we expect will occurred within the next several quarters. And that further demonstrate the breadth and depth of our technology platform and our product franchisees. Commencement by the end of this year of the Phase II clinical program for PH20 insulin, a potentially best in class prandial insulin for the treatment of diabetes, initiation of a Phase I clinical trial for PH20 bisphosphonates, the only subcutaneous bisphosphonates for the treatment of osteoporosis in the fourth quarter of this year.
Third is meeting with regulators to discuss the next clinical development steps for two programs, the Chemophase pivotal trails and superficial bladder cancer and the Phase I clinical trial for PEG PH20 in solid tumors. Finally, we’re anticipating initiation of the Phase III clinical trial in early 2009 by Baxter Bioscience for GAMMAGARD and Enhanze Technology. We look forward to future discussions with you regarding exciting progress we’re making with our preclinical and clinical efforts in our various programs. But, especially for our proprietary pipeline and to help the investment community achieve a deeper understanding of our scientific expertise and our business strategy, we’ll be hosting a Research Day for analysts on October 8, in New York City. So, please mark your calendars and hold the date.
With that overview let’s open it up for questions. Operator? Ashley could we go forward with questions and answers now, please.
[Operator Instructions]. The first question is from Eun Yang with Jefferies.
Hi, thanks. I have a couple of questions on the diabetes program. First, Biodel has a similar product, the new drug delivery over insulin and clinical development and they are coming out with a Phase I data towards the end of this year. And, could you help us understand the advantages that you may have, your program may have over Biodel?
Sure. So, we both have Sub-Q formulations of different insulins, the power of PEG PH20 technology is the fact it can interface with either of the proprietary insulins better on the marketplace in terms of any one of the three analog insulins that are used for meal-time administration, the other thing is that we are able to co-formulated it with the regular insulin products, and as you can see we have a differentiated profile on both the PK and the PD dimensions for actually all of those products. We have ready to use formulation. So, we’re targeting basically a very simple to use administration via a pen type of system and also will be seeking to directly compare the performance characteristics of our product versus the best in class products that are on the market today.
They all show that the, not just the Humulin but they also show insulin analogs are using there drug delivery system, they were able to achieve a better insulin of absorption. So, far based on the Phase I data you have seen with PH20 and Biodel’s data, is there any, is it hard to differentiate how those two products are working differently or similarly?
Well, I’ll speak to the performance characteristics of our product and basically if you look at both the impact on the T-max or the time to maximal concentration and if you also look at the C-max or the maximal concentration itself the combination of PH20 with regular insulin and the combination of PH20 with basically the analog product you will see that there is a profound increase in the C-max for both products, both Halo products and there is also a profound decrease in T-max for both products. And, the overall area under the curve is increase where you wanted to increase which is the early time points. But, it also has significantly decreased where you wanted to decrease which is later on in the insulin absorption Phase to avoid the hypoglycemic events. So, for the same dose of insulin given with PH20, we believe that the T-max and the C-max from a pharmacokinetic profile are really compelling. And so, if you really want to do a true apples-to-apples types of comparison with similar doses I’d encourage looking at the T-max the C-max that area under the curve and just seeing what you can see there.
Okay, thanks. And then, a second question is on Phase II for insulin program planned for later this year, if I heard you correctly you said that it’s going to be in Type 1 diabetic patients?
So, is there any particular reason or are there any reasons why you are limit to Type 1 versus Type 2?
Type 1 patients tend to have a more predictable profile in terms of the overall metabolic response. So, it tends to be a better patient population to do these early feasibility studies in terms of preferred concept.
Okay. And then the last question is in terms of like a potential outcome that you are predicting to see or like to see and one of them has kind of lesser weight gain and in Biodel’s study there actually saw some less weight gain with their product at six week timeframe. So, how long your study -- the question is how long your study is going to be and secondly how early, how soon can you see impact on the weight gain?
Yeah, it’s a good question. So, we are going to be exploring a number of Phase II studies in parallel, that look at such metrics as meal time glucose control, we are also going to be looking at patient variability amongst other basically endpoints that we can study very quickly. Weight gain is more of a long term type of metric that you would look at and so, in the context of our pivotal studies we would be looking at weight gain.
You are welcome.
The next question is from Andrew Vaino with Roth Capital.
It’s quick question on the 505B2 filing. I assume would you guys be using (inaudible) data as comparative data?
We would be looking at basically referencing the data that’s already out there for regular insulin product.
Okay. And secondly, as far as the location of your clinical sites, where will they be, is it going to be mostly North America?
For the Phase II studies that’s correct.
Okay, thank you.
The next question is from Kevin Degeeter with Oppenheimer.
Hi, thanks guys. Couple of quick question if I may, one more on insulin here, for the analogs, what are you going to use in the Phase II, which product?
We were probably use Humalog because they are in broke wide fixed rate, so, Humalog and Humulin worked very well in the Phase I and so we use the same products.
Alright. And maybe changing gears here a little bit on GAMMAGARD, I guess, Baxter is taking a little bit longer than they had previously thought to finalize their Phase III design for the Alzheimer’s study, does that have any impact on the timing and kick off for the Phase III combination on page 5?
No, none whatsoever, we were right on track, Kevin.
Okay, perfect. And, do you hope to be above, I mean, with regard to Roche I recognized we received pre-limited news well here, I mean, is there any expectations in 2008 you will provide some levels specificity on that program at all?
Yeah, Kevin, as per Bob’s remarks we do hope to provide an update before the end of the year.
And, that we would at the Analysts Day or perhaps some other venue?
Some other venue.
Okay. Terrific, and I guess in terms of duration of treatment going back to diabetics for a moment, I’m assuming this initial Phase II is going to be relatively short perhaps I missed this?
That’s correct. The Phase II program that we were looking at is really for rapid proof of concept in diabetic patients as opposed to healthy volunteers.
So, how single I mean injection, I mean, multiple over how many days can you?
Yeah there could be multiple injections but they will all be less than 28 days in duration in terms of the actual trial itself or the follow up during the trial.
Okay, terrific. And I am assuming the next step would be type 2 patients?
That’s correct but we don’t necessarily have to do a Phase II study in a type 2 population but we are still mapping that out.
Okay. I guess I’ll get back in queue and let some others to ask questions.
The next question is from Chris Geston with UBS Financial Services.
Actually, thank you. My questions have been answered. I appreciate it.
The next question is from John Borzilleri with GRT Capital.
Good morning, thanks. Couple of questions. I saw the press release on Chemophase and I see it hopefully you have identified a dose of 804 pivotal, is there any efficacy data from that trial you could give us? And the second is, my concern with the technology has been chronic safety, is it essentially dissolving tissue (inaudible) someone subcu for years or (inaudible) with the cancer. Can you talk about how you gain comfort or chronic use of the technology with drugs and data that will be generated on that front?
Sure, this is Greg Frost here. Let me try and answer those two questions specifically about Chemophase and secondly regarding chronic administration. So, the first one regarding Chemophase, that study is designed specifically it’s a single arm dosage relating study. So, what you are looking at in this population is the safety of intravascular exposure of the enzymes with the cytotoxic therapy and to be primary endpoint is establishing the safety, if you don’t have any serum exposure of the mitomycin that would actually cause neutropenia that’s above about 400 nanograms/ml likely cause neutropenia, a 100 nanograms/ml would be the base that we setup. And then in the context of giving that material with repeat administration of the duration of the therapy that’s effectively what we put in place to ensure that we can go through and get safe exposure over pivotal studies. So, because of these in the context that this is a relatively broad population from exposure, it’s not really in the efficacy data that we conclude from that but in the context of meeting of our endpoints is something that we consider to be a positive study.
In the second perspective, regarding safe exposure of high levels of PH20 we had previous safety exposure in toxicology model demonstrating that have multiples of PH20 several logs above therapeutic doses that were effectively be no effect level. We also as Walter Bee had presented previously in the early part of the year completed recently toxicology studies with a nine month repeat exposure study by subcutaneous administration in non-human primates.
Okay. Can I just a follow up on the Chemophase I mean I guess I am having trouble understanding how you could have the dose to find for pivotal trial that have any efficacy data?
Well, that’s actually quite common with biologicals. So, in a biological you often don’t actually get a maximum tolerated dose and that effectively would be consistent with this compound as well.
Okay, all right. Thank you.
[Operator Instructions]. The next question is from Eun Yang with Jefferies.
Hi, thanks. I want to ask you, if I heard it correctly again, Jonathan, when you talked about a plan to Phase II for the insulin program. You mentioned that you are actually -- you guys are talking to potential partners as well in terms of the design of the trial? Does that mean that you would get an input from a potential partner and partner would be involved in the running the clinical trials as well?
Eun, Halozyme will be running the Phase II program, but we have mentioned previously that we are open to partnerships. And so, we are exploring both pads in parallel. But we are fully committed to taking one of the insulin programs forward all the way through to approval and commercialization.
Okay. And then the second question is kind of more general. Now that, to inhale the insulin potentially the pretty much here wiped out from the marketplace. Are you seeing more interests in your program or is that kind of not so much of changed in terms of partnership opportunities?
I will say Halozyme seems to be in the right place at the right time especially with this particular program. So, the interest level has been very high and I would say that the inhaled insulin situation has been one contributor to that but more importantly the power of the PH20 combination with both insulins has been very compelling and the Phase I data have really opened eyes amongst the care well community as well as amongst potential partnership.
There are no further questions at this time. I will now like to turn the call over to Jonathan Lim for closing remarks.
Okay. Well, with five proprietary programs and three partnered programs all of which are part of our blockbuster franchises in metabolism, oncology, dermatology, and drug delivery. Halozyme truly has a unique and exciting business strategy that aims to leverage the core technology and a knowledge base at the company. We are not just developing one or two products as is the case with many biotech companies. Instead Halozyme intends to leverage its core technology and matrix expertise across the number of therapeutic categories that represent large established markets and substantial commercial opportunity.
We believe this strategy will provide multiple shots on goal that can drive significant value for our shareholders. We look forward to updating you again soon on our progress and remember to mark you calendars for Investor Research Day on October 8, which will be in New York. Again, thank you for your support, your interest in Halozyme and for your participation in today’s call.
Thank you. This concludes today’s Halozyme's second quarter 2008 pipeline update. You may now disconnect.
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