Biodel's (BIOD) CEO Errol De Souza on Q3 2014 Results - Earnings Call Transcript

Aug.11.14 | About: Biodel Inc. (BIOD)

Biodel Inc. (NASDAQ:BIOD)

Q3 2014 Results Earnings Conference Call

August 11, 2014, 04:45 PM ET


Paul Bavier - Corporate Secretary and General Counsel

Errol De Souza - President and CEO

Alan Krasner - Chief Medical Officer

Regina Mitri - Controller


Jason Butler - JMP Securities

Matt Kaplan - Ladenburg Thalmann


Greetings and welcome to the Biodel’s Inc. Third Quarter Fiscal Year 2014 Financial Results Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Paul Bavier, General Counsel. Please go ahead sir.

Paul Bavier

Thank you. Good afternoon and welcome to our third quarter fiscal year 2014 conference call. On the call, we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that are described more fully in our filings with the SEC, which are available on our website.

Forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we disclaim any obligation to do so even if our estimates change.

Joining us on today’s call are Dr. Errol De Souza, Biodel’s President and Chief Executive Officer; Dr. Alan Krasner, our Chief Medical Officer, Regina Mitri our Controller. After their prepared remarks, we will open the call to your questions. We hope you can join us on the webcast today, where we will be presenting some slides. These slides will also be available on our website after the call.

Now, I’ll turn the call over to Errol.

Errol De Souza

Thank you, Paul. Good afternoon, everyone. We're pleased to report another quarter of rapid progress across our portfolio of pipeline candidates. This morning we announced positive topline data from study Study 3-152, a Phase 2 clinical trial of our concentrated ultra rapid acting insulin candidate BIOD-531, which completed dosing several weeks ahead of our previously announced schedule.

This afternoon we will focus on the Phase 2 data and discuss next steps for BIOD-531. We will also provide an update on our Glucagon Emergency Management or GEM program. Given the limited time that we have to cover a lot of material today, we will not provide an update on our ultra rapid acting insulin product candidate. We will conclude with a brief overview of our recent funding activities, update you on our third financial results and leave time for questions.

Let me start off with some background information on our concentrated insulin program and then have Alan take you through the details, other results from Study 3-152.

BIOD-531 is a proprietary formulation of recombinant human insulin or RHI, EDTA, citrate and magnesium sulfate. It is formulated at a concentration of 400 units of RHI per milliliter.

Last February, we provided extensive details on positive data from Study 3-150, a Phase 1 clinical trial in which the pharmacogenetic or PK, pharmacodynamic or PD an injection tolerability profiles of BIOD-531, will compare to Humulin R U-500 or U-500R and Humalog Mix 75/25 combined prandial/basal insulin. The data showed that BIOD-531 had a unique combination of an initial ultra rapid absorption profile with a basal duration of action.

Our long-term goal is to demonstrate that BIOD-531’s unique time action profile along with its high concentration is better suited than currently available products to address the needs of one, severely insulin resistant patients with Type 2 diabetes who require a concentrated insulin to cover daily insulin needs which often exceeds 200 units a day.

And two, patients with Type 2 diabetes who have more typical insulin daily requirements of under 200 units per day and use a premix prandial/basal insulin in place of more complex insulin regimen requiring separate doses of prandial and basal insulin.

The clinical trial data from Study 3-152 that we announced earlier today, evaluated the utility of the BIOD-531 in this latter group of patients. Many of these patients with moderate insulin resistance, use insulin premixes to cut these products and that to provide basal and prandial bolus therapy with fewer injections per day.

Currently Eli Lilly and Novo Nordisk market presentations of human insulin or rapid-acting insulin analog such as NovoLog or Humalog premixed with intermediate-acting basal neutral protamine insulins in a variety of ratios. In the U.S., analog-based premixes sell approximately $1.5 billion annually. While the premixes offer prandial and basal coverage with one injection, the prandial coverage is sub-optimal.

Study 3-152 was designed to quantify the expected advantage in postprandial glucose excursions after standardized meals. Dr. Alan Krasner will present the design and results of Study 3-152 in detail after which I will briefly discuss the next steps with the development of BIOD-531.

I will now turn the call over to Alan.

Alan Krasner

Thank you, Errol and good afternoon, everyone. The design and Study 3-152 is shown in the first slide. This study was designed to evaluate whether a single dose of BIOD-531, which can serve better postprandial glucose control for two consecutive meals compared to Humalog Mix 75/25, so as to show that any differences seen with BIOD-531 were not achieved solely by virtue of it being a more concentrated formulation than Humalog Mix 75/25, Humulin R U-500 was also used as a comparative in this study.

The PK and PD of Humulin R U-500 previously observed in Study 3-150 had many similarities to that of Humalog Mix 75/25, particularly with respect to slow absorption and onset of action and therefore was hypothesized that BIOD-531 would also provide better glucose coverage than U-500 in this group of patients.

A secondary hypothesis tested in this study is that because of its greater speed of absorption, after meal dosing of BIOD-531 would provide glucose coverage at least as good as the comparators. Many patients preferred to dose mealtime insulin after meals.

Study 3-152 was a single blinded poor arm crossover study. On separate days in a randomized treatment sequence, subject to treated with BIOD-531 before the mean does attend to this pre-meal BIOD-531 after the meal or post meal, Humalog Mix 75/25 pre-meal or Humulin R U-500 pre-meal. After glucose stabilization overnight, single 0.6 unit per kilogram doses of the study drugs were injected subcutaneously with a standardized breakfast.

In order to assess the duration of glucose lowering, subjects then received a standardized lunch at 330 minutes or 5.5 hours after breakfast. No insulin was given with lunch, which stimulates the real world usage of the comparative products. Glucose levels were monitored frequently for a total of 720 minutes or 12 hours after breakfast dosing.

Four subjects were randomized and 11 patients completed the study. The patients evaluated in this study were a typical population with Type 2 diabetes with moderate insulin resistance who typically use between 50 and 200 units of insulin per day. They had a lien age of 55 years old, mean baseline age via 1C of 9%, mean weight of 99 kilograms, and a mean BMI of body mass index of 33.5 kilograms per square meter.

The next slide shows the mean glucose curve seen in this setting. Visually one can see that compared to the Humalog Mix 75/25, when given before the breakfast meal. This superiority and glucose control is also maintained after lunch despite the fact that no further insulin has been injected subsequent to the breakfast dose demonstrating a clinically useful extended duration of action for BIOD-531.

Let's review how BIOD-531 performs when given after breakfast as seen in the next slide. In BIOD-531 post meal treatment arm, one can see glucose levels start to rise during the breakfast meal; however, the rises are rested by the ultra rapid absorption of the insulin and the overall height of the glucose plateau is similar whether BIOD-531 is used pre or post meal. BIOD-531 is superior to Humalog Mix 75/25 with respect to prandial coverage irrespective of the dose timing relative to the meal.

The next slide shows the data for Humulin U-500. Even through Humulin U-500 is not routinely used in these moderately insulin resistant patients, one can see that if it worked patients would not fare much better than they would with premixed insulin and that both marketed formulations provide inferior glycemic control, relative to BIOD-531.

We also conclude that BIOD-531 does not provide better control by virtue of it having a higher concentration than the U-100 Humalog mix rather it is because of its ultra rapid acting nature.

Quantitative post prandial glucose parameters are shows in the next slide. There are many ways to quantify glucose responses to meals, but to me as a physician, the bottom line is reflected best by the patient's average glucose concentration over extended periods.

Over long periods of time, average glucose is known to correlate with HVA1C, which in turn is known to correlate with risk and diabetic complications. In this study, the average glucose concentration after breakfast was 167.8 milligrams per deciliter with pre-meal BIOD-531 compared to 205.1 milligrams per deciliter with Humalog Mix 75 treatment, the P Value for that difference is less than 0.001 and the mean was 193.1 with Humulin R U-500 treatment with P Value for the difference with BIOD-531 is 0.006.

The average glucose concentrations after lunch were also significantly lower with pre meal BIOD-531 treatment versus Humalog Mix demonstrating the beneficial BIOD-531 duration of effect through a second consecutive meal.

Most notably the average glucose over the entire 12-hour period of observation was significantly lower following pre-meal BIOD-531 treatment, then following treatment with either of the comparative marketed insulin. Post-meal dosing of BIOD-531 also resulted in significantly lower average glucose compared to pre-meal Humalog Mix and trends towards superiority compared to pre-meal Humulin U-500.

You have to understand the potential significance of these differences pending glucose concentrations it is possible to project estimated HVA1C values that would result if the observed mean glucose value to a sustained for a two to three month period. These data are shown in the right panel on this slide.

The projected HVA1C that would result in either pre-meal or post-meal BIOD-531 treatment is 7.8% compared to 9.5% with Humalog Mix 75/25 and 8.5% with Humulin U-500. This represents a potential 1.7 percentage point advantage for BIOD-531 compared to Humalog Mix and a 0.7% percentage point advantage for 531 compared to Humulin U-500.

The percentages of post prandial glucose readings within the targeted glucose range was 70 to 180 milligrams per deciliter are shown in the next slide.

For patients with diabetes, it is generally recommended that peak post prandial glucose be kept under 180 milligrams per deciliter. The percentage of glucose readings in the target range of 70 to 180 milligrams was significantly increased after breakfast and after lunch with pre-meal BIOD-531 versus Humalog Mix 75/25.

Over the course of the entire study day, the percentage of arm target readings associated with BIOD-531 dosed pre or post meal was more than double that associated with Humalog Mix and also significantly greater than that achieved with Humulin U-500.

There were no unexpected safety signals in certain study, meaning visual analog scores and injection discomfort were normally slightly higher for BIOD-531 relative to comparators, but not significantly different. Overall all insulins were well tolerated.

In summary, many patients with type 2 diabetes who use pre-mixed insulin such as Humalog Mix 75/25 may not achieve adequate prandial control due to the absorption of currently available premixed insulin formations.

The preliminary data from study 3152 validate the benefits of the ultra rapid acting onset of action of BIOD-531, seen in our previous Phase 1 study and clearly demonstrate the clinical superiority of this profile on post prandial glucose control compared to Humalog Mix and Humulin U-500.

Furthermore, the extended coverage provided by BIOD-531, superior to the comparators as seen in lower glucose levels after the standardized lunch. Finally, the benefits of BIOD-531 are maintained even when dosed after the meal. This unique pharmacogenetic and pharmacodynamic profile coupled with its high concentration and therefore low volumes and injection hast the potential to conserve clinically significant benefits to a sub-optimally served population of patients with Type 2 diabetes.

Before I turn the call back to Errol, let me provide you with a brief update on our ongoing Study 3-151 evaluating the effects of BIOD-531 in patients who are currently candidates for concentrated insulin namely those who use very high doses of insulin. Originally Study 3-151 had the same design as the study we just presented except that it is enrolling patients who use larger doses of insulin i.e. patients who have significant insulin resistance and are candidates for concentrated insulin.

Based on the exciting results from Study 3-152, we are expanding the scope of Study 3-151. In Study 3-151 we will now monitor glucose over a 24-hour period following both a breakfast dose and a dinner doe, each associated with standardized meals. This stimulates clinical practice in which both Humulin U-500 and Humalog Mix 75/25 are dosed twice daily with breakfast and with dinner.

This expansion of the study will give us valuable data to assess glucose responses to all three meals and during the overnight period. We believe these data would be useful in designing the dosing paradigm for a multi-dose pivotal trial.

I'll now turn the call back to Errol.

Errol De Souza

Thank you, Alan. We could not be more enthusiastic about these results. They confirm our OE assessment that BIOD-531 is an important asset within Biodel's expanding portfolio.

As shown in the next slide, BIOD-531 has many of the desired attributes for the treatment of many patients with Type 2 diabetes. These attributes of BIOD-531 include superior mealtime coverage in comparison with both Humulin R U-500 and premixed insulins such Humalog mix 75/25 has an extended duration of action compatible for twice daily dosing and lower volume of injection compared to premixed insulin.

Thus BIOD-531 may have utility and thus warrant development both in the niche but rapidly growing segment of insulin resistant patients largely treated by endocrinologist for whom Humulin R U-500 is the only option as well as a much larger segment of patients currently using premixed insulins often managed by primary care physicians.

Based on these results, we are establishing plans to further advance for development of BIOD-531 including implementation of the modified study 3-151 that Alan talked about which we project completing in the fourth calendar quarter of 2014 as previously communicated.

In parallel we have already contacted the FDA and are working with the agency to define the safety and clinical development program that will best characterize and assess BIOD-531. We expect feedback from the FDA by the early fourth calendar of 2014 and look forward to updating you on our plans in our next earnings call.

Interestingly use of concentrated insulin and insulin pumps is increasing. At start of the Small Business Innovation Research grant that is being funded by the National Institutes of Health, we have conducted studies in direct swine to evaluate BIOD-531 for use in insulin pumps in comparison with Humalog and Humulin R U-500.

Data from these studies which demonstrate that the rate of absorption and onset of action of BIOD-531 are similar to Humalog and faster than Humulin R U-500 following pumpable administration were presented at the ADA meeting in San Francisco in June and is scheduled for presentation in an oral session at the upcoming 50th annual meeting of the European Association for the Study of Diabetes in Vienna, Austria on September 18, 2014.

This work may lead to evaluation of BIOD-531 administered using insulin pumps for Type 2 diabetes patients who are highly insulin resistant and require several hundred units of insulin per day.

Let me now turn to our glucagon program, which is focused on developing a portfolio of rescue presentations for diabetes patients experiencing severe hypoglycemia or very low concentrations of blood glucose.

We continue to make steady progress in developing our two unique proprietary devices and companion formulations to accomplish this goal. Our most advance program for which we expect to submit an NDA in late 2015 is a device we refer to as a Glucagon Emergency Management or GEM product.

The GEM is a customized version of a dual chamber auto reconstitution syringe manufactured by Unilife Corporation. The device is specifically designed to address and expand an underserved market currently wrestling with cumbersome kits that are especially difficult to use and operate during an emergency.

In the past quarter, we have continued progress in GEM including filing of the IND in order to initiate clinical development. The strategy for clinical development is to demonstrate both pharmacokinetic and pharmacodynamic bioequivalence between high dose glucagon formulation BIOD-961 designed for use in the GEM device and either Lilly or Novo marketed formulation of glucagon.

In order to achieve this, we will begin clinical study with a Phase I trial in which we will measure both pharmacokinetics and glucose response as pharmacodynamics of BIOD-961 compared to Lilly and Novo glucagon. We plan to enroll 12 healthy volunteers and perform a six time crossover trial administering all three glucagon formulations both intramuscularly or IM and subcutaneously or sub-Q on separate dosing days.

With these data, we plan to choose one of the marketed glucagons as the comparative for subsequent pivotal trial in which approximately 30 healthy volunteers will receive BIOD-961 and the marketed comparative both subcutaneously or intramuscularly on separate days in a very similar crossover design.

We anticipate beginning Phase I trial in the fourth calendar quarter of ‘14 and completing it in the first calendar quarter of ’15. The pivotal trial will commence shortly after completion of the phase I trial and complete in the third calendar quarter of 2015.

Human factor studies are being performed to rigorously evaluate the auto reconstruction GEM device designed and in structural labeling as well intuitiveness by users to assure that the GEM device will serve patients in a safe and user-friendly manner as intended.

We are pleased to announce the results of our most recent informative human factor study, which demonstrated that the GEM device should reliably allow caregivers and healthcare professionals to successfully deliver a complete dose safely and with effective protection against accidental needlestick.

In this study, most subjects did not receive any training on how to use the device, while some did. In their first dosing attempt all subjects successfully triggered auto reconstitution of the lyophilized product and diluents deliver the complete marking of glucagon injection and engaged the automatic needle retraction mechanism in a very short timeframe averaging less than a minute regardless of whether they received training session or not.

Two dosing attempts were conducted and all subjects replicated the result in the second dosing attempt. This human factor study reaffirms our belief that the GEM device is intuitive and easy to use and would serve patient caregivers better in an emergency situation than currently marketed glucagon kits.

The study also indicates that the device is near final -- design I should say, is near final completion. Lastly future human factor studies are planned to further compare the usability of the GEM device to the existing manually reconstituted commercial glucagon kits in the hands of representative caregivers. A final affirmative or pivotal human factor study is planned to complete in the said third calendar quarter of 2015.

As we’ve mentioned in our previous call, we have in place all the supply chain arrangements necessary to manufacture of the registration lots required for the NDA submission and scale up of the final commercial product.

We’re working with Unilife and Emergent BioSolutions in the technology transfer process to facilitate the manufacture of the GEM product and are on track to start the manufacturing of six registration lots for the adult and pediatric presentations in the late calendar fourth quarter of 2014 and complete the manufacturing in the first calendar quarter of 2015.

So in summary with regard to the GEM program, we remain on track for production of the registration lots and initiation of a clinical trial in the fourth calendar quarter of 2014 and an NDA submission in late 2015.

The second component of our glucagon program is the Uniject device, which is being developed as a follow-on product to complement the GEM product. Having obtained exclusive access to the Uniject platform from Becton, Dickinson we’ve reinitiated our program late last year to develop stabile liquid glucagon formulations. Utilizing the technology we in-licensed from AJES in 2012. We made solid progress improving the stability of the liquid glucagon formulations and out-testing several formulations with promising stability in animal models.

We also continue to develop stable pumpable liquid glucagon formulations funded by SBIR grant that could further extend market and address other applications such as the development of an artificial pancreas.

Let me now shift gears and provide you with an update on our financing activities in our third quarter fiscal year 2014 financial results in my interim capacity as the Principal Accounting Officer. We have put in place two financing vehicles, an At The Market or ATM facility for the sale of up to 14 million of the company’s common stock and an equity purchase commitment for an additional 15 million of the company’s common stock.

The funding from these vehicles provide Biodel with additional means for accessing the capital to fund our development program including the ability to fund our auto reconstitution glucagon rescue program through filing of an NDA. In July, we raised approximately $2.9 million using the ATM.

With regard to the third quarter of fiscal year 2014 financial results, Biodel reported a net loss for the nine months ended June 30, 2014 of $11.8 million or $0.56 per share of common stock compared to a net loss of $18.5 million or $1.29 per share of common stock for the same period in the prior year. Research and development expenses were $11.6 million for the nine month ended June 30, 2014, compared to $11.1 million for the same period in the prior year. This increase is primarily due to expenses associated for the development of our GEM product.

General and administrative expenses were $4.5 million for the nine month ended June 30, 2014, compared to $5.4 million for the same period in the prior year. Expenses for the nine months ended June 30, 2014 included cost of $0.6 million compared to $1.2 million for the same period in the prior year and the stock based compensation expense related to options and restricted stock units granted to employees and our non-employee directors.

Biodel did not recognize any revenue during the nine month ended June 30, 2014 or 2013. At June 30, 2014 Biodel had cash and cash equivalents of $24.5 million and 21.1 million shares of common stock outstanding.

That concludes our prepared remarks. No we would like the operator to open your call to your questions.

Question-and-Answer Session


At this time, we'll be conducting a question-and-answer session. (Operator Instructions) The first question today comes from Jason Butler of JMP Securities. Please go ahead.

Jason Butler - JMP Securities

Hi, thanks for taking questions and congratulations on the good data this morning. So first question on 531, just thinking forward about potential label and what data or what claims you could get into the label. Do you think it’s a feasible scenario to get a language around administration after a meal in a product label?

Errol De Souza


Alan Krasner

I guess the answer’s yes. In fact some of the prandial insulin has in the label currently, approval before or after meals. Believe it applies to Humalog and AP drive. So, yes, that is an achievable goal.

Unknown person

Go ahead.

Jason Butler - JMP Securities

Sorry. Was your aim is to be get any kind of timeframe around that?

Alan Krasner

You mean the number of minutes for example before the meal versus after the meal?

Jason Butler - JMP Securities


Alan Krasner

Yeah. So that kind of language does exist in those labels. Oftentimes -- let me say, when you’re talking about before the meal for example in Humalog, it’s approved to be used anywhere from 0 to 15 minutes before the meal. The current labeling now is not so specific after meal, but certainly I think our labeling would be consistent with how we’ve conducted this trial and any future trials.

The way we dosed it in this trial within two minutes, which to me is equivalent to immediately before the meal and in this case, we dosed 20 minutes after the start of the meal for the post meal arm. So I suspect if the final labeling is that kind of precision, we would have that kind of instruction.

Jason Butler - JMP Securities


Alan Krasner

By the way to me that’s what’s -- these tapering were used in this trial or what is clinically relevant because that’s when patients are willing to take prandial insulins either right before the meal and again some patients do prefer to take it right after the meal.

But trying to insert intervals of time between a prandial insulin injection and the meal, which in some cases is necessary for example, the U-500 label recommends a 30-minute time interval between the injection of U-500 and then subsequently eating a meal and I can tell you in the real world, the patient care, that’s a very difficult thing for patients to comply with everyday.

So to me the more clinically relevant timeframes are the ones we stated in the study immediately before the meal or just after the meal.

Jason Butler - JMP Securities

Okay great, and then just a question on the glucagon program for the GEM product, can you talk about what amount of stability data or durational stability data you expect to need for submission of the NDA and what data you have today?

Errol De Souza

Sure, that is a negotiation that we'll have with the FDA and our pre NDA meeting or post pivotal trial meeting, which will be around the middle of next year and we could file at least the -- we're planning to put the adult loss and stability towards the end of this year. So we might have close to 12 months of data for the filing of the NDA, but one of the things we were doing Jason is we’re tracking 961 head-to-head versus Lilly’s glucagon and I won't give you -- we've got several months worth of data at 40C that is accelerated stability and we look at least as good as the Lilly formulation that’s out there and so that’s the stability data.

So we’re very confident of the stability of 961 will be at least equivalent to the marketed products that are out there in terms of following up but exactly how much stability data we’ll put into the NDA will be a point of dialogue that we’ll have with the FDA because we can always supplement with additional data while the NDA is being reviewed.

Jason Butler - JMP Securities

Okay, great. Thanks for taking the questions.

Errol De Souza

Thank you.


The next question comes from Matt Kaplan of Ladenburg Thalmann. Please go ahead.

Matt Kaplan - Ladenburg Thalmann

Hi guys.

Errol De Souza

Hey Matt.

Matt Kaplan - Ladenburg Thalmann

So congrats on the progress. It looks like some very positive results that you reported for the Phase II. Based on these results and the prior Phase I it seems to me there are two potential markets you can go after with 531, in particular the market for patients with good amount of insulin resistance that need higher concentration of product and then also patients that are using the mixed products as well to provide postprandial and basal insulin.

Could you I guess question touch on what Alan, could you talk a little bit about what you think is needed from a regulatory point of view, potential clinical trials that you would need to do for either of those or both of those settings?

Alan Krasner

Yeah, hi Matt. I think the clinical development program here would be very similar to new insulin clinical development programs in general, in a sense that the primary goal of all new insulins is to show at least as good HbA1c control, in other words non-inferior HbA1c control with no excess hypoglycemia in that setting. That’s what’s necessary for regulatory approval without any unexpected or new safety problems of course. So I think that’s it would take for approval.

Now with this product candidate 531 I would hope that we could actually show more attractive features than just those but that requires multi-dosed trials to do. I think the standard non-inferior already insulin trial is a parallel group trial where patients are treated for six months, oftentimes some extensions there but again, I wouldn’t see anything radically different about the design of those kinds of pivotal trials.

Errol De Souza

Matt, this is a question that we have actually post to the FDA so that we’re not -- Alan and I are not second guessing what they would require sort of approval of these products and we anticipate receiving their feedback probably in about six weeks or so if they hold to their timelines. But if you think about the utility of this program, just to reiterate what Alan said, let’s go after the large indication.

You could do a trial versus Humalog 75/25 and we’re superior as was demonstrated in this profile. There would be a non-inferiority trial in HVA1C but then we’ve got superiority on two other fronts in terms of better prandial coverage, which the current trial demonstrated and lower volumes of injection and a better duration even with a second meal.

So we’ve got -- that's why we’re excited about those trials we just reported on, which gives us the confidence to go head-to-head against the best selling mix that's out there.

Now the second trial that’s ongoing that will get the data for towards the end of the year, that’s the severely insulin resistant patients that we’re going after, the U-200 and our suggestion to the FDA and they need to come back is we would do one trial in patients -- diabetes patients that use over 200 units of insulin a day and I can tell you that is a growing population.

If you listen to Lilly's last call, most of what they are reporting in Humulin sales in the U.S. are from U-500. Ex U.S. it's the other Humulin 100, but in the U.S. this is the major product that's increasing and we know from at least the moderate insulin resistant patients that we look better we'll have the other trial.

So we think that those trials would be what we would need, the other kinds of question that we've asked the FDA is to give us clarity on sort of the toxicology package that we would need and the kinds of safe -- additional safety data in terms of extension trials. So once we have that, then we can come back. We're very excited about those products and chomping at the bit to move forward, but we don't want to second guess the FDA in terms of what the requirements are.

Matt Kaplan - Ladenburg Thalmann

Sure, fair enough. And then could you also talk a little bit about in terms of the tolerability and injection that you observed in the study?

Errol De Souza

Right. So we measured that by using the visual analogue scale of 100 millimeters visual analogue scale and all the results were quite low. They were normally a little higher in the 531 treatment versus the comparators, but we are still talking about a mean levels of five and below out of 100.

All of these were -- these were also scaled on a absolute severity where you got rid of patient described it as mild, moderate or severe and again the main results of course are in the mild range.

So again I believe that this is a well tolerated formulation just like the others and I suspect that we would see good toleration in the multi dose trial.

Matt Kaplan - Ladenburg Thalmann

Great. Thanks for taking the questions.

Errol De Souza

Thank you.


(Operator instructions) There are no further questions at this time. I will now turn the call back over to Dr. Errol De Souza for closing comments.

Errol De Souza

Great. Thank you for your questions and joining us this afternoon and it's been an incredible quarter. Great data on 531, moving forward on the GEM program, NDA filing towards the end of 2015, we're on a roll and we look forward to delivering on the promise of the Biodel products and building value for shareholders, patients and our employees. Thank you so much.


Ladies and gentlemen, that concludes today's conference call. You may now disconnect your lines.

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