Executives
Beverly Holley - Director of Investor Relations
Craig Wheeler - President and CEO
Rick Shea - Chief Financial Officer
Analysts
Bret Holley - Oppenheimer
Joseph Schwartz -Leerink Swann
Eric Schmidt - Cowen And Company
Frank Rango - Purchase Management
Greg Gilbert - Bank of America
Biren Amin - Stanford Group
John Lowe - John B. Lowe BA
Momenta Pharmaceuticals Inc. (MNTA) Q4 2008 Earnings Call February 12, 2009 10:00 AM ET
Operator
Thank you for standing by, you are currently on hold for the Momenta Pharmaceuticals Q4, 2008 Earnings Conference Call. (Operator Instructions)
Good morning ladies and gentlemen, and welcome to the Momenta Pharmaceuticals, Fourth Quarter, 2008 Earnings Call. This call is being recorded. (Operator Instructions). I would now like to turn the call over to Miss Beverly Holley, Director of Investor Relations. Please proceed.
Beverly Holley
Thank you and good morning. I want to welcome all of you to Momenta’s conference call, to discuss financial results for the fourth quarter, and full year 2008, and provide a corporate update. With me on the call today, with prepared remarks are Craig Wheeler, President and Chief Executive Officer, and Rick Shea, Chief Financial Officer. Also on the call with us are Bruce Leicher, General Counsel, and Rod Riedel, Vice President of Regulatory Affairs.
Following our remarks we will open the call to questions. Before we begin, I’d like to mention that our call today will contain forward looking statements. Various remarks that Momenta Pharmaceuticals may make about its results of operations, regulatory filings and review, intellectual property rights, development and manufacturing efforts, litigation, legislative developments, operating expenses and belief, future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those stated or implied by these forward-looking statements as a result of various important factors including those discussed in the risk factors section of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2008, as well as other documents that the company files with the Securities and Exchange Commission from time-to-time.
In addition, any forward-looking statements represent the company's views only as of today, and should not be relied upon as representing its views as of any subsequent date. While the company may elect to update forward-looking statements at some point in the future, it specifically disclaims any obligation to do so whether as a result of new information, future events or otherwise, and therefore you should not rely on these forward-looking statements as representing the company's views as of any date subsequent to today.
With that, I will now turn this call over to Craig Wheeler, Momenta’s President and Chief Executive Officer.
Craig Wheeler
Thank you, Beverly and good morning everyone and thanks for joining us. This morning I will provide an update on recent corporate development of Momenta, beginning with M-Enoxaparin. Second, I will provide an overview of our plans and goals for the company for 2009. Finally, Rick will give you an overview of our 2008 financials and provide financial guidance for 2009.
Gaining FDA approval for the M-Enoxaparin ANDA continues to be the top priority for the company. Since there is no mandated time table for the FDA action on the ANDA, the timing of any potential approval is uncertain. Together with our partners Sandoz, we are preparing for a 2009 approval and launch.
As we mentioned last quarter, the Orange Book patents for Lovenox were rendered unenforceable, and the final mandate issued in the litigation triggering the initiation of the 180 day market exclusivity period in early October of 2008. This period will expire less then two months from now, on April 1, 2009.
Although Sanofi-Aventis recently filed a petition for cert (ph) to the United States Supreme Court, there’s a request for review, not an appeal by right, and it does not stop the 180 market exclusivity period.
Moreover, we continue to believe that there is a low likelihood that the Supreme Court will agree to hear the case. Consequently, from April 1, 2009 onwards, our ANDA will be eligible to receive final approval from the FDA. We and Sandoz are working towards the goal of launching the product as soon as possible after receiving regulatory approval.
With respects to the review of our ANDA, including our immunogenicity amendments filed in September of 2008, we are in regular communication with the agency as would be expected. In addition, we believe our ANDA addresses the issues raised in the Sanofi-Aventis Citizens Petition.
We believe that our methods for thorough characterization have enabled us to produce a product that meets the FDA’s requirements for sameness. While approval of the M-Enoxaparin ANDA cannot be assured, we do believe we are in a well position for positive action.
As we consider the logistics surrounding the launch of M-Enoxaparin, one issue we continue to watch very carefully, is the matter of heparin supply. As a result of the global contamination issue, the FDA is in the process of performing plant inspections of the Chinese suppliers of heparin, including those facilities that supply heparin to Sandoz for the manufacture of M-Enoxaparin.
Sandoz noted in the most recent Novartis earnings call, that the FDA had already inspected the facilities of two of the four Chinese heparin suppliers that Sandoz uses. Inspections for the other two facilities are projected to be concluded by late March, however, it is difficult to know when the results of these inspections will be available.
We are confident that our quality systems and analytic testing methods have, and will continue to assure that the heparin used to manufacture M-Enoxaparin is contaminant free. However, any disruptions of the heparin supply resulting from these inspections has the potential to impact our supply chain. We’ve taken actions to diversify our sources of heparin, and are monitoring the inspections closely.
I’ll now discuss M356, our generic version of Teva Copaxone, which we are developing in collaboration with Sandoz. Our ANDA for this product is currently under review at the FDA.
As we noted in our last call, in response to our P4 notification to Teva in July of 2008, Teva filed a patent infringement suit against Sandoz and Momenta in August. We and Sandoz filed our initial response to Teva’s suit in November of 2008, and the next major step in the district court is the scheduling of discovery, leading to pre-trial motions and claims construction. We and Sandoz plan to vigorously defend the suit, and to seek a decision at the earliest possible stage in the case.
In addition, in September of 2008, Teva filed a Citizen’s Petition, requesting that the FDA not approve an ANDA or a 505(b) (2) application for generic Copaxone, without clinical studies due to the complexity of Copaxone, and the limitations of methods for analyzing a complex product such as Copaxone.
Other parties have also filed documents to the Citizen’s Petition docket. While we agree that the composition of Copaxone is highly complex, we believe that we have developed novel methods to analyze and thoroughly characterize Copaxone that our M356 ANDA will meet the FDA’s requirements for demonstrating the sameness of M356 to Copaxone.
Turning to M118, our novel anticoagulant currently in clinical studies. We are continuing to enroll patients in our eminent PCI trial. We are projecting to complete patient accrual in the first half of 2009. We expect to have top-line data on this Phase IIa study late in the second quarter of this year, and plan to report on such data at a medical meeting following completion of data analysis.
As we have discussed in the past, it is our intention to seek a partner for M118 to support our clinical and commercialization efforts.
Next, I would like to discuss follow-on biologics. As previously stated, that we consider development of follow-on biologics to be a major area of opportunity for Momenta and for our investors.
We are not alone in identifying this emerging opportunity, as of evidenced by the recent announcements by major industry players such as Teva, Merck, AstraZeneca, and Lonza regarding their plans for developing follow-on biologics.
We view the increased interest in follow-on biologics as confirmation of the significant market opportunity there. We believe that it is only a matter of time before follow-on biologics become a reality in the United States. We have participated in the debate between the generics manufacturers and the innovators, and absolutely concur that follow-on biologics need to be developed within a framework that insures patient safety.
We firmly believe that the science and technology available today, combined with innovations that we and others are developing will allow the manufacture of safe, and effective follow-on biologics.
We now need a regulatory pathway. There appears to be a commitment by both the administration and the Congress to legislate that pathway. We are very pleased that the administration and the new Congress view FOB legislation as a priority. How quickly will ultimately depend on the pace of other high-priority actions on the economy, which are currently the focus of Washington.
Regarding content of the potential legislation, we support passage of a bill that allows for therapeutically equivalent, substitutable biologics, and that gives FDA the discretion to decide the need for clinical trials on a case-by-case basis.
We also support the creation of an Orange Book type process for biologic products that includes transparency and identifying the relevant patents being asserted by the innovator, and a process to litigate in parallel with the regulatory review period.
In our FOB program at Momenta, our efforts are directed towards building the technology tool kit, and the product process knowledge that will allow us to develop, not simply bio similar versions of biologics, but interchangeable biologics.
So in summary, our goals for 2009 are to receive regulatory approval for M-Enoxaparin and to launch the product; to substantially advance the regulatory review of M356 and to execute the product and process development activities required to support the approval and commercialization of the product; to complete the M118 Phase II clinical study, submit the study results presentation at an appropriate medical meeting, and to advance discussions with suitable collaborative partners in order to further progress the M118 development program; to advance our follow-on biologics program with the ultimate intent of building leading competitive positions, including a portfolio of therapeutically equivalent, substitutable, bio-generic products.
I’ll now turn it over to Rick to provide a financial update.
Rick Shea
Thank you Craig. Revenue for the fourth quarter of 2008 was $2.9 million compared to $10.0 million for the same period last year. The decrease was the result of a decrease in reimbursable expenses associated with the development of M-Enoxaparin.
As we have previously discussed, the manufacturing cost to pre-launch inventory for
M-Enoxaparin are incurred directly by Sandoz and do not flow through Momenta’s expenses or our collaborative revenues.
Research and development expenses for the fourth quarter of 2008 were $15.4 million, compared with $19.6 million for the same period in 2007. The decrease in research and development expenditures was principally due to decreased development costs for M-Enoxaparin, since as we discussed, the commercial costs for M-Enoxaparin are incurred directly by Sandoz.
The net loss for the fourth quarter of 2008 was $18.4 million or a loss of $0.50 per share, as compared to a net loss of $14.3 million or loss of $0.40 per share for the fourth quarter 2007. The increase in the net loss was the result of an increase in cell funded R&D expenses and lower interest income.
We ended the year 2008 with $108.5 million in cash and marketable securities compared with $135.9 million at the beginning of the year. In the fourth quarter, we've raised $24.1 million in a registered direct offering.
Our cash burned for the fourth quarter was $11.0 million. The lower cash burn for Q4 compared with Q3 2008 was partly due to the timing of R&D expenses which fluctuate from quarter-to-quarter and due to balance sheet items, lower receivables, and higher payables at December 31st, compared to September 30th.
With respect to our guidance for 2009, we're looking at a range of scenarios relating to the potential of approval and launch of M-Enoxaparin. As well as potential partnering activity, excluding any new collaborative partnering, we're projecting 2009 collaborative revenue's to be approximately 10 to 25% above 2008.
Since we consider our year-end cash balance to give us two year runway we plan to manage our expenses so that under any scenario our cash burn does not exceed approximately $55 million for 2009. We're of course hopeful that an approval and launch of M-Enoxaparin will provide additional cash in 2009.
This concludes my financial review. We'll now open the calls for questions.
Question-and-Answer Session
Operator
(Operator instructions). And we will go first to Eric Schmidt of Cowen And Company.
Eric Schmidt - Cowen And Company
Good morning. Let me start with a question on M-Enoxaparin. Craig, are the discussions with the FDA solely focused on the amniogenicity filing or are they a little bit more wide ranging than that and if so, could you comment what else is being debated?
Craig Wheeler
Well, we don't comment specifically on the conversations with the agency as we're in communication with them quite frequently at ODD. But I would say the focus of the agency at this point and time is around right now making sure that they have the heparin inspection in China done.
Eric Schmidt - Cowen And Company
Okay and on that note, would all four suppliers need to pass inspection prior to approval or might you get away with, you know, fewer successful suppliers but just less product at the end?
Craig Wheeler
Yes, again, we can't predict the FDA's approval requirements but we do – I guess I could say confident that the inspections will be completed quickly and that they will not have any problems. But we don't know that for sure yet.
Eric Schmidt - Cowen And Company
So you wouldn't know if you could get approval with just one or two suppliers out of China?
Craig Wheeler
It really depends on the FDA and their view of the product. Remember this is an unapproved product at this point and time. So and they're working through plowing new ground in China with the inspection of these suppliers.
Eric Schmidt - Cowen And Company
Okay. Then turning over to your fellow on biologics programs. Any update on, you know, what your partnership thoughts are there and also when we may learn a little bit more about your internally developed candidates?
Ian Fier
Yes, so I think we're right at this point and time trying to be crisp about what we think our advantages in terms of building the technology. We're looking at different partnership options including timing of those partnerships and we'll make those decisions I think as legislation get involved and some of the players get clarified and where we can be at with our technology to maximize value for the shareholders.
I do not expect that you will see us talking about specific products soon. Because we are really trying to figure out what the pathway is and we want to make sure we retain any competitive advantage we have in terms of being able to choose the products as well as develop the products without attracting undue competition for what we are doing.
Eric Schmidt - Cowen And Company.
Okay, last question just a record keeping item of the two programs that Novartis was working on in the space M178 and M249 just for my records which one was dropped?
Craig Wheeler
M249 was dropped. That was a program that was a program that they had to they had asked us to work on with them and it was a minor part of the collaboration. I think it was to include about $10 million of the $188 million of potential milestones for the program. And they dropped it based on their commercial view of the molecule.
Biren Amin - Stanford Group
And M178 is still undisclosed?
Craig Wheeler
Still undisclosed and still continuing.
Eric Schmidt - Cowen And Company
Yes. Thank you.
Operator
Our next question comes from Joseph Schwartz of Leerink Swann
Joseph Schwartz - Leerink Swann
Hi, thanks for taking the question. We was wondering if you could give us an insight into the clinical and regulatory groups review as opposed to the manufacturing groups review at the FDA. How did these review processes relate to each other? Does the manufacturing group work solely in parallel or do they need to see clinical and regulatory groups review dance to any point before they start working on the API of the M-Enoxaparin.
Craig Wheeler
Yes. So you know I can tell you what we understand. But you know I think you have to refer to the FDA to get specifics on how they view it. But typically these groups do not work in a completely serial manner. They will work in parallel. There's often times crossed talk between the different groups and different parts of the application.
Particularly in applications such as ours where there's a lot of technology that is being brought to bear and I think understanding that needs to be generated. So beyond that I think we don't have really much to comment.
We do – I guess I will come back and say one of the things I hope that the FDA as well as we have learned that some of the parallel things that have to go on should happen sooner. We are very frustrated about the fact that we actually got amniogenicity questions two years after the application when those were questions that could have been asked much earlier.
And we think we are optimistic that the agency is thinking that way now.
Joseph Schwartz - Leerink Swann
Okay and how do the changes in leadership at the FDA and also the Southern District Court of New York impact the review process?
Craig Wheeler
Yes, well the Southern District, we don't think will impact the review process at all it's for the litigation. And leadership changes in the FDA well there really haven’t been specific leadership changes yet. I mean there is a temporary leader in place. And you know we are still have not seen any changes in the people that we are dealing with and all the way up the ranks for the people that actually manage in the application.
So no changes at this point and time on the agency on the legal side. You know we are aware of some changes there but we don’t see any that adversely impacts the litigation ongoing.
Joseph Schwartz - Leerink Swann
Okay, great, thank you.
Craig Wheeler
Sure.
Operator
Our next question comes from Bret Holley of Oppenheimer
Bret Holley - Oppenheimer
Yes, thanks for taking the question. Craig, I was just wondering if you could give a little bit more detail about the orange book, the potential advent of an orange book? I guess I struggled to see how you could kind of move forward by a similar – without such an article.
Craig Wheeler
Yes, I am happy to comment on that. It's something we think is important as well. There are multiple proposals in front of Congress in terms of ways to handle that. Everything from you know trying to actually have separate legal reviews of applicants to see what patents might be infringed and disclosed to process of doing things in series in opposed to parallel.
From our perspective, the easiest way to accomplish this is an orange book like system. That has worked well. The patens we believe in this area can be clearly identified. We don't buy a lot of the arguments of this complexity and people won't know what covers. We think they can be clearly identified.
And so we think it is important to create a process and follow them biologic both discloses those patens as well as creates a process for litigating those patens in parallel to any FDA review of the product.
Bret Holley - Oppenheimer
And on the issue of Bio similars versus Bio betters. " Bio betters" I mean where do you stand on that? And I guess you're going towards interchangeability but how can you really prove interchangeability in a clinical trial, unless you're running a head-to-head trial with the founder product?
Craig Wheeler
Well, you know if you go back to the principles that we use as a company, we believe that substitutability starts with total characterization and then reverse engineering and manufacturing process that allows you to manufacturer within the range of bands of the innovator.
So our premise is first to be able to characterize those biologics fully, to be able to understand what's necessary actually reverse engineer and manufacturer them in analytic basis should therefore provide a very strong basis for both defining what kind of clinical trials may or may not be necessary but also providing just like they do in the M-Enoxaparin cases the standard for equivalence in substitutability.
Bret Holley - Oppenheimer
So I guess you are saying that based on your technology the trials that you would run, I mean you wouldn't view the trials of having to be that extensive or – I mean clinical trial data is you know subject to variability it's you know it's not an exact science. So that's what I'm just wondering if you put it – even if you believe you have the exact copy of something. Putting it into a clinical trial, it just introduces noise.
Craig Wheeler
We agree with that and so I think the point we've always tried to make is that these analytics in cases of equivalence hold you to a much higher standard of making sure you have the equivalence in the clinical trials made. Because of the variation of the numbers you would actually see in the trial.
We do anticipate that in many of these biological you will see trials that will be mandated or are required. These analytics and in cases of equivalence that hold you'd say much higher standard of making sure you have equivalence in the clinical trials may because of the variations in the numbers that you'll actually see in the trial.
We do anticipate that in many of these biologics you will see trials looking– that will be mandated or that will be requested early on that we'll be asking questions around the potentially mutagenicity or switching agent.
But we actually believe that the technology as it gets more mature will actually get people more comfort that. You're going to learn more through the characterization and the manufacturing controls of these biologics than you'll ever get from abbreviated clinical trials.
Bret Holley - Oppenheimer
Okay. Thanks a lot.
Craig A. Wheeler
Did you want me to come back, Bret, and talk a little but about the Bio betters?
Bret Holley - Oppenheimer
Yes, all right. It's all right. I thought you were just crossing that off for some reason.
Craig A. Wheeler
No, I'm happy to make a comment on that. You know, Bio betters is certainly something where our technologies and others that are developing do create the possibility for enhancements to biologics.
Where we see a disconnect is that when you're improving a biologic, when you're improving it's availability, when you're changing it's kinetics, we view that as a new application.
We are not sure how they're going to be able to find a pathway that doesn’t require you to actually go and look at how that drug behaves broadly in that clinical setting. So we think that possibility is there but we really think of them as a completely different category then the Bio similars and Bio generics.
Bret Holley - Oppenheimer
Great thanks for the additional information.
Craig A. Wheeler
Sure, no problem.
Operator
Our next question comes from Biren Amin of Stanford Group.
Biren Amin - Stanford Group
Yes, thanks for taking my questions. I may have missed this but were there any issues cited by the FDA in it's report of the two Chinese heparin suppliers?
Craig A. Wheeler
Those two suppliers Sandoz and (inaudible) have been cleared so they're ready to supply.
Biren Amin - Stanford Group
Okay, and with regards to M356, can you share with us if there's been any questions raised by the FDA with regards to that and to filling and if so were they similar in nature to what you face with M-Enoxaparin.
Craig A. Wheeler
So I will say that we certainly are in the process of review with the agency on that application. The kinds of questions that you get in many of these applications really depend upon the specifics of the molecule.
So I would say with the conversation dialogues we have and the kind of questions are really related to Copaxone which is a very different mixture. It's a peptide mixture as opposed to a sugar mixture.
So can you get in the same classes of discussions but they're very different because the science behind the molecule.
Biren Amin - Stanford Group
All right. Great. Thank you.
Craig A. Wheeler
Sure.
Operator
And we'll go next to Greg Gilbert of Bank of America.
Greg Gilbert - Bank of America
Thanks, good morning. A couple, first on generic Lovenox, where do you stand on the process of manufacturing launch quantities or can you share what your key decision points there other than approval.
Craig A. Wheeler
So, what I'll say is that we are actively planning for launch and so as I said in the script in this year. So of course, we're in the process of manufacturing and building inventories and those types of things but decision points are not unlike a new drug process where you have to manufacture and determine where you want to have your hold points and how much you want to have built and when you pull the trigger to put full supplies for example into syringes.
And that really is based on where you think the launch is coming and what kind of half life or stability life you have in the different hold points.
And so we're managing that supply chain to prepare for a launch but obviously we are watching that inventory to make sure we are watching the dollars carefully as well.
Greg Gilbert - Bank of America
On follow on biologics, is there any key milestones in 2009, other than potential legislation, that could shape the debate and perhaps shed some more light on the potential timeline like workshops or anything like that.
Craig A. Wheeler
You know, I think there could be. This is one where I think it really could be influenced by whoever ends up as commissioner and how they want to begin the dialogue at the agency. You know my own view on that is the agency has been probably a bit quiet on it waiting to see what the legislation is that comes out of Washington and what mandate they get.
But you know lacking that or having that path behind them will probably put the agency into higher gear in terms of thinking about how they will process these applications.
Greg Gilbert - Bank of America
And lastly a big picture question, do you have a view on how the Teva Lons arraignment shapes the landscape other than highlighting Tev's intereset, what do you think it does to the landscape given that Lons is such a big player and has so much production capacity.
Craig A. Wheeler
Well certainly, it's an advantage for Teva in terms of it being able to access capacity but it's important to note that Lons had noted in signing that agreement that was not locking up all of their capacity, they were working with others that they'd already had contracts with and they were limiting the competition between others and their customers. So I think that's a good deal in terms of you know bringing two companies together that actually can begin to build capacity but I think it doesn’t fundamentally change things because it doesn’t take one of the major biologics take us completely out of the action.
Greg Gilbert - Bank of America
Thanks, a lot.
Craig A. Wheeler
Sure.
Operator
(Operator Instructions) We'll go next to Frank Rango with Purchase Management.
Frank Rango - Purchase Management
Yes, hi, Craig. You pointed out that there are less than two months in the exclusivity period that Ampstar has and I wondering if you thought that the heparin supply issues are the primary reason that’s being held up?
Craig A. Wheeler
In terms of the, when you say …
Frank Rango - Purchase Management
The heparin inspection issues?
Craig A. Wheeler
Okay. Holding up what, I'm sorry.
Frank Rango - Purchase Management
Holding up their application. I mean they're running out of their exclusivity period that they fought so hard over the years and the courts to get. And I'm just wondering if in your view it’s the inspections that’s are an issue for them as well as a potential issue for M-enox.
Craig A. Wheeler
Well, on specific inspections problems that they may be having or not. And I don't know but, you know, I would hope in terms of our strategy that its more than just the heparin supply issues that are holding up characterization and understanding what they actually have in their product.
Frank Rango - Purchase Management
Well, you’ve spoken hypothetically about a possible deal with the exclusivity holder. I mean its obviously becoming less and less of a possibility with the exclusivity running out but could there be any discussions that would possibly accelerate a process getting to market by working with the exclusivity holder.
Craig A. Wheeler
At this point in time, I don't really see any specific need to hold those discussions. We only have – we have less than two months left in the exclusivity period and we don't yet have an approval in hand. So, we're anticipating that by the time you really get into any discussions like that, it would be time to launch on the move and have problem.
Frank Rango - Purchase Management
Right, thanks.
Craig A. Wheeler
Sure, thanks.
Operator
And our next question goes to Joseph Schwartz of Leerink Swann.
Joseph Schwartz - Leerink Swann
Hi, thanks for taking the follow up. I was wondering if you could remind us on N356 have you formally requested a Bio equivalence waiver and what is the status of that? And if the FDA did not grant that how should we think about you being to show that your drug is pharmaceutically equivalent given I don’t believe there's a bio marker for Copaxone but maybe plasma concentration or something as simple as that.
Craig A. Wheeler
Yes, so first off I'll talk about the regular inventory finds and just the way that we're not commenting specifically on the interactions of the agency so what we are not talking about the specifics but I will tell you that when we prepared this application, we had put a lot of thought into the biology of the compound so we understand in a number of ways how to understand how this compound works biologically so we are I would say from a knowledge perspective prepped and ready for those kinds of discussions.
Joseph Schwartz - Leerink Swann
Okay. Great.
Craig A. Wheeler
Sure.
Joseph Schwartz - Leerink Swann
Have you advanced to a point where you've discussed the release specs of Enoxaparin with the agency and just recognizing that you had this very close collaboration when you applied your technology to solve the heparin contamination crisis. Have you discussed using that technology on an ongoing basis if and when Enoxaparin comes to market as well as other heparins potentially?
Craig A. Wheeler
Yes, so I think the way to answer your question is that release specs are part of any of course they we were and continue to plan for and continue to launch with the agency. Our technology built into how we look at our product of course takes advantage to our continuing review using our analytics and so those are kind of built into the application.
Joseph Schwartz - Leerink Swann
Okay. Thanks again.
Craig A. Wheeler
Sure.
Operator
And our next question comes from John Lowe at John B. Lowe BA.
John Lowe - John B. Lowe BA
Yes, can you tell me if you can launch product prior to resolution to your patent litigation with Teva?
Craig A. Wheeler
You cannot launch product until you are passed the 30 month litigation stay. Once you are passed that stay if you have an approval you can launch at risk, but that's a decisions that the companies make based on how they view the litigation and the risks that they facing.
John Lowe - John B. Lowe BA
I know that 30 months, how many have already passed and when do you expect that date to expire?
Craig A. Wheeler
For that date started in February, I'm sorry it started in October and would run to February 2011.
John Lowe - John B. Lowe BA
October of this?
Craig A. Wheeler
Of this fall.
Richard P. Shea
2008.
Craig A. Wheeler
2008.
John Lowe - John B. Lowe BA
I'm sorry say it once more, the date when it expires.
Craig A. Wheeler
February 2011 for M356.
John Lowe - John B. Lowe BA
That's the Lovenox generic.
Craig A. Wheeler
No that's the Copaxone generic.
John Lowe - John B. Lowe BA
Oh, I see. Is there any patent litigation with regard to your Lovenox generic?
Craig A. Wheeler
So, yes there-- with patent litigation. There is patent litigation but because of the patents have been overturned and we totally applied for litigation.
Steven B. Brugger
The 30 month stay expired last fall in Lovenox when the final decision was entered by the District Court in the case brought by Sanofi-Aventis against Teva and AmpStar was unrelated to our litigation.
Unidentified Analyst
Okay. Thank you very much.
Craig A. Wheeler
Sure. Thank you.
Operator
(Operator Instructions). And it appears we have no further questions on the phone at this time. I would like to turn the call back over to Craig Wheeler for any additional or closing remarks.
Craig A. Wheeler
Okay. Thank you. And thank you for joining us on the call. We look forward to updating you on our progress in the coming months. So thanks and good bye.
Operator
Again, ladies and gentlemen, this does conclude today's conference. We thank you for your participation and have a wonderful day.
Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.
THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.
If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!