UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14D-9
SOLICITATION/RECOMMENDATION STATEMENT
PURSUANT TO SECTION 14(d)(4) OF THE
SECURITIES EXCHANGE ACT OF 1934
TARGANTA THERAPEUTICS CORPORATION
(Name of Subject Company)
TARGANTA THERAPEUTICS CORPORATION
(Name of Person(s) Filing Statement)
COMMON STOCK, PAR VALUE $0.0001 PER SHARE
(Title of Class of Securities)
87612C100
(CUSIP Number of Class of Securities)
Daniel S. Char
Vice President, General Counsel and Secretary
Targanta Therapeutics Corporation
222 Third Street, Suite 2300
Cambridge, MA 02142
Telephone: (617) 577-9020
(Name, Address and Telephone Number of Person Authorized to Receive Notices
and Communications on Behalf of the Person(s) Filing Statement)
With a copy to:
Marc A. Rubenstein, Esq.
Ropes & Gray LLP
One International Place
Boston, MA 02110
(617) 951-7000
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Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.
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The
following is a transcript of a conference call held on January 13,
2009 regarding the proposed tender offer and merger.
Final Transcript
Conference Call Transcript
MDCO The Medicines Company to Acquire Targanta Therapeutics
Event Date/Time: Jan. 13. 2009 / 8:30AM ET
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CORPORATE PARTICIPANTS
Robyn Brown
The Medicines Company VP, IR
Clive Meanwell
The Medicines Company Chairman & CEO
John Kelley
The Medicines Company President & COO
Mark Sumeray
The Medicines Company VP, Medical
Glenn Sblendorio
The Medicines Company EVP, CFO
Mark Leuchtenberger
Targanta Therapeutics President & CEO
CONFERENCE CALL PARTICIPANTS
Lucy Lu
Citigroup Analyst
Liana Moussatos
Pacific Growth Equities Analyst
Eric Farmer
Leerink Swann Analyst
Maged Shenouda
UBS Analyst
Jason Kantor
RBC Capital Markets Analyst
Steve Harr
Morgan Stanley Analyst
Biren Amin
Stanford Group Analyst
PRESENTATION
Good day, ladies and gentlemen, and welcome to The Medicines Company business development
conference call. My name is Katina and Ill be your coordinator for today. (Operator Instructions).
As a reminder, this conference is being recorded for replay purposes.
I would now like to turn the presentation over to your host for todays call, Ms. Robyn Brown, Vice
President, Investor Relations. Please proceed.
Robyn Brown
- The Medicines Company VP, IR
Thank you, Katina, and welcome, everyone, to The Medicines Company conference call to discuss
the proposed acquisition of Targanta Therapeutics. I am Robyn Brown, Vice President of Investor
Relations. This morning, I am joined by Clive Meanwell, Chairman and Chief Executive Officer; John
Kelly, President and Chief Operating Officer; Glenn Sblendorio, Executive Vice President and Chief
Financial Officer; and Mark Sumeray, Vice President of Medical for The Medicines Company.
We are also joined by Mark Leuchtenberger, President and Chief Executive Officer of Targanta
Therapeutics, who will be available for Q&A following some opening remarks.
I would like to remind you that this conference call will contain statements regarding the proposed
transaction between the Company and Targanta, the expected timetable for completing the
transaction, future financial and operating results, benefits and synergies of the transaction,
future opportunities for the combined company, new product development, including obtaining
regulatory approval, and any other statements about the Companys managements future expectations,
beliefs, goals, plans or prospects, constitute forward-looking statements. Any statements that are
not statements of historical fact, including statements containing the words believes, plans,
expects, anticipates, estimates and similar expressions should also be considered to be
forward-looking statements. These forward-looking statements involve known and unknown risks and
uncertainties that may cause the Companys actual results, levels of activity, performance or
achievements to be materially different from those expressed or implied by these forward-looking
statements.
Important factors that may cause or contribute to such differences include uncertainties as to the
timing of the tender offer and merger, uncertainties as to how many of Targanta stockholders will
tender their stock in the offer, the risk that competing offers will be made; the possibility that
various closing conditions for the transaction may not be satisfied or waived; the effect of
disruption of the transaction, making it more difficult to maintain relationships with employees,
licensees, other business partners or governmental agencies, transaction costs; whether results
obtained in clinical studies or in preclinical studies, such as studies referred to above will be
indicative of results obtained in future clinical trials; whether, if the Company consummates the
acquisition, the Company can advance Oritavancin through the contemplated Phase III trial on a
timely basis, or at all, and receive approval from the United States Food and Drug Administrative
or equivalent foreign regulatory agencies for the product; whether if Oritavancin receives
approval, the Company will be able to successfully distribute and market the product, and in that
regard, whether physicians, patients and other key decision makers will accept the clinical trial
results; whether the Company will be able to retain regulatory approvals and such other factors as
are set forth in the risk factors detailed from time to time in the Companys periodic reports and
registration statements filed with the Securities and Exchange Commission, including, without
limitation, the risk factors detailed in the Companys quarterly report on Form 10-Q filed on
November 10, 2008, which are incorporated herein by reference.
Forward-looking statements are made only as of this date of this conference call. Except as
otherwise required by law, the Company specifically disclaims any obligation to update any of these
forward-looking statements.
Now I will turn the call over to Clive Meanwell. Clive?
Clive Meanwell
- The Medicines Company Chairman & CEO
Well, thank you, Robyn. That was quite a speech at the beginning of an early morning here in
San Francisco. I would like to welcome everybody to the call and thank you for joining us this
morning.
This evening we announced that we have entered into a merger agreement with Targanta Therapeutics
Corporation under which The Medicines Company has agreed to commence a tender offer to acquire 100%
of Targantas outstanding shares. We are very pleased to have the opportunity to add the assets and
capabilities of Targanta. The addition of Targantas Oritavancin, a late-stage product, will be
another step forward in our execution of a strategic plan to become a global leader in critical
care medicine. Their professionals can help us develop another aspect of our hospital business
franchise.
Oritavancin has the potential to provide important patient outcome and economic advantages for
hospitals. The hospital market for gram-positive infections is growing robustly worldwide. We
believe that Oritavancin can become an important anti-infective for serious infections involving
difficult to treat bacteria in difficult to treat hospitalized patients. Many of those critically
ill patients are the same patients treated with our existing products.
Let me now turn it over to John Kelley, our President and Chief Operating Officer, who will offer
his perspectives on why we did this transaction.
John Kelley
- The Medicines Company President & COO
Thanks, Clive, and good morning, everyone. We believe that Oritavancin is a perfect fit for
the global organization that we are building here at The Medicines Company. As Clive said, it has
been our vision to become a global leader in critical care medicine. To do that, we believe that we
need to deliver differentiated products and services that will enable caregivers to improve the way
critical care patients are managed in major institutions. Oritavancin is a late-stage opportunity
that has demonstrated efficacy and safety and unique attributes which underscore the potential
for economic dominance. Since our inception, our competitive strategy has been to acquire
late-stage critical care assets that can deliver economic value to payers and unique treatment
options to caregivers in markets where we can create unique relationships. We have done this
successfully with Angiomax. We are starting to do it with Cleviprex, and we look forward to doing
it with cangrelor, CU-2010, and now Oritavancin.
Oritavancin will also leverage our current critical care infrastructure by laying the foundation
for further expansion into hospital anti-infectives from our current cardiovascular platform. We
have done considerable work to identify the leading critical care institutions globally. There are
about 3000 hospitals in 27 countries that deliver 80% of the revenue in this marketplace. There is
a strong overlap with the hospital target for this drug in our existing portfolio. There is also a
strong overlap within the hospital where we are currently selling Angiomax and Cleviprex, namely
the ICU, the surgical suite and the emergency department. That means that we can sell Oritavancin
largely through our existing sales organization.
Finally, this is a large market with significant unmet medical need. The hospital market for
gram-positive infections in the United States alone grew to $1.1 billion in 2007, a 20% increase
from 2005. There are over 3.5 million patients on a global basis treated for hospital acquired soft
skin and tissue infections. The unique characteristics of this drug, including the potential for a
short course of therapy or even a one-time regimen, provide the opportunity for this drug to be a
differentiated product with a significant value proposition for our customers. We are excited and
we look forward to bringing this product to the marketplace.
Now for a brief update on the science of Oritavancin, I would like to turn the call over to Dr.
Mark Sumeray. Mark?
Mark Sumeray
- The Medicines Company VP, Medical
Thanks, John. I would like to give you a brief overview of the scientific and clinical
highlights relating to Oritavancin.
Let me start by stating that Oritavancin is an innovative investigational hospital-based antibiotic
that has potent bactericidal or killing activity against a broad spectrum of gram-positive
bacteria, including multi-drug-resistant organisms such as MRSA, [VISA], VRSA and VRE.
Oritavancins attributes may give it advantages over currently marketed therapies in treating
serious infections. These attributes include excellent tissue penetration and concentration in
specific immune cells called macrophages that accumulate at sites of infection, so drug is
delivered where it is needed; multiple mechanisms of action at the bacterial cell membrane reducing
the probability of resistance; an advantageous pharmacokinetic profile that allows prolonged drug
effects after dosing and Phase II clinical data supporting the use of potential once-only dose to
cure complicated skin and skin structure infections; no effects on renal or hepatic function.
Patients with impaired organ function, which is common in elderly patients and critically ill do
not require dose adjustments or special monitoring for drug levels or toxicity. Safety data from
clinical trials demonstrate that Oritavancin has been well-tolerated with a superior adverse event
profile to vancomycin and no dose limiting side effects have been identified. And finally, the
potential to generate significant cost saving opportunities for hospitals and third-party payers
related to the possibility of a once-only dose to achieve clinical cure of skin infections.
Oritavancin has been administered intravenously to over 2400 individuals and has completed two
pivotal Phase III studies for the treatment of complicated skin and skin structure infections. In
addition, we have Phase II clinical data in bacteremia and preclinical data in Clostridium
difficile and anthrax infections that support our expectation of future indications in the pipeline
for Oritavancin.
As you know, the NDA for Oritavancin was recently turned down by FDA, who identified several
issues, including an insufficient number of MRSA-treated patients in the Phase III program, more
patients who were treated with Oritavancin with adverse events related to infection, and a concern
about the possibility of macrophage dysfunction and the incidence of phlebitis. Naturally, we are
aware of all these concerns and we have performed detailed diligence and discussed these issues
with experts and believe that these can be addressed very satisfactorily in the upcoming next Phase
III studies that weve planned.
So finally, I would like to turn it over to Glenn for a discussion of the financial aspects of the
transaction.
Glenn Sblendorio
- The Medicines Company EVP, CFO
Thank you, Mark. Let me first discuss the detailed terms of the merger agreement that we
signed last night with Targanta Therapeutics Corporation and then move on to 2009 operating cost
implications, project or projected launch timing and future revenue potential of this product.
Under the terms of the merger agreement, Targantas shareholders will receive $2 in cash up front
for each common share tendered, or approximately $42 million. Targantas shareholders may also be
entitled to receive three additional contingent payments which we are calling contingent payment
rights upon the achievement of specified regulatory and commercial milestones within agreed upon
time limits.
First, upon Food and Drug Administration, or FDA approval, of a new drug application for
Oritavancin, specifically for cSSSI, which is complicated skin and skin structure infections, using
a single dose infusion, shareholders would receive an additional $1.20 per share. If the FDA does
not include single-dose infusion labeling, this payment is reduced to $0.50 a share.
Second, upon European Medicines Agency, or EMEA approval of a marketing authorization for
Oritavancin, again for cSSSI, during 2009 shareholders would receive $1 per share. If the EMEA
approval occurs later, this payment is reduced to $0.75 per share. If it occurs after June 30,
2010, shareholders would receive $0.50 a share.
And third, upon achievement of worldwide net sales adding up to $400 million over four consecutive
quarters, a one-time payment of $2.35 per share. To provide you with a dollar figure for these
three contingent payments, the total of the regulatory and commercial milestones, if achieved,
could be approximately $70.3 million to $95.5 million, of which $49.3 million would be a one-time
sales milestone.
Now onto the potential impact on 2009 R&D costs. 2009 R&D expenses would include costs related to
the completion of our cangrelor studies, Angiox spending in Europe, Cleviprex Phase IV studies
CU-2010 Phase I studies and as you remember, that is for surgical blood loss and spending on
Oritavancin Phase III in the latter part of the year. Specifically as it relates to Oritavancin,
spending in 2009 would include additional infrastructure costs that is people, facilities and
overhead which we currently estimated to be $10 million to $12 million, plus an additional $15
million to $20 million if we begin the Phase III trial in the latter part of the year. As you know,
The Medicines Company spends a lot of time on both the design and the cost structure of our trials.
So it may be appropriate as we go forward and learn more about the Phase III design that this
number could vary.
For the years 2010 and beyond, we expect our R&D cost on large trials to decline as we complete
spending on our core products, Angiomax, cangrelor and Cleviprex, leaving room for new development
opportunities such as Oritavancin and CU-2010. We expect the US launch of Oritavancin in 2012 for
cSSSI, and similar to Angiomax we would expect to continue to invest in Oritavancin for further
potential applications, including bacteremia and C. difficile associated disease. We estimate peak
revenue potential in these indications to be greater than $250 million worldwide.
As we stated in our press release last night, the Company plans to announce fourth quarter and full
year 2008 results in February 2009. At that time, the Company will provide expected 2009 full-year
net sales and net income estimates, which would include expected operating costs to develop
Oritavancin, the expected impact of the Financial Accounting Standards Board number 141-R for
business combinations and transaction costs.
A couple of words around the changes in the accounting rules for business combinations. First to
mention, they are significant and we believe that we will be one of the first life science
companies to adopt this new accounting pronouncement. Under the new rules, in process R&D is
capitalized and amortized once an asset is placed into service and contingent consideration like
our milestone payments are recognized on the acquisition date at fair value. Also, deal costs,
which were previously capitalized, are now expensed as incurred. Measuring these arrangements will
present a significant valuation challenge, and we have started that work on our valuation. We are
assessing this now and will provide an update on the accounting in February on our earnings call.
Finally, we expect the upfront acquisition of Targantas common shares and any future milestone
payments with existing cash, avoiding share dilution. Over the last 18 months, as part of our
strategy to grow our critical care portfolio and leverage our existing infrastructure, we have
reacquired ex-US rights for Angiox from Nycomed, funded the expansion of our operations in Europe,
acquired Curacyte GmbH with its early-stage product, CU-2010 for surgical blood loss, and expect to
complete the acquisition of Targanta in February.
Thank you, and I would like to now turn the call back to Clive.
Clive Meanwell
- The Medicines Company Chairman & CEO
Thanks a lot, Glenn. This time, given how busy everyone is this morning, I think we should
open up for a brief set of initial questions. As with all transactions of this kind, we will
continue to provide information to the financial community over the coming weeks, including in our
February scheduled conference call.
As mentioned earlier, we also are pleased to have here with us Mark Leuchtenberger, the Chief
Executive Officer of Targanta Therapeutics, and a longtime professional friend and acquaintance.
Mark and I can both recall the day that we did the Angiomax deal when he was a senior executive at
Biogen. Lets all hope this one turns out so well. Thanks for being here, Mark. So, Katina, could
we please open up for questions?
QUESTION AND ANSWER
(Operator Instructions). Lucy Liu, Citigroup.
Lucy Lu
- Citigroup Analyst
A quick question. Given the fact that FDA just issued complete response in early December, I
am just wondering how much due diligence have you done on this drug? And also, if you can quickly
provide an explanation for the safety findings in the FDA complete response letter. Thank you.
Clive Meanwell
- The Medicines Company Chairman & CEO
I will begin, and I think Mark Sumeray can add to it. We did begin discussions with our
colleagues at Targanta before the advisory board meeting, in fact some many months before. So we
were fairly familiar going into it, and then the advisory board meeting obviously was an
opportunity for a lot of important information to be presented by the company and discussed by the
experts. And, we have continued in that vein ever since.
Mark, do you want to make a comment on the level of diligence and period of time spent?
Mark Sumeray
- The Medicines Company VP, Medical
Sure, yes, thanks Clive. So as Clive mentioned, we have been looking at this opportunity
actually for quite some time, quite some time meaning several weeks prior to the advisory panel
meeting, which of course occurred several weeks prior to the FDAs decision to give a complete
response rather than approval. So we have had adequate time to do a lot of detailed diligence on
the opportunity and discuss all of the issues with a number of world experts in the area.
In terms of the safety concerns that the FDA raised in their complete response, an explanation I
think, if we deal with them one at a time, more patients treated with Oritavancin that had adverse
events related to infections. The FDA identified that as a numerical difference. It wasnt
statistically significant. The trials are fairly small. I would say that that issue is not
something that we anticipate is a real difference between Oritavancin and the vancomycin-treated
patients. The FDA hypothesized that this could be related to macrophage dysfunctions. There has
been no evidence of macrophage dysfunction in any of the in vitro work that has been done to look
at how the drug interacts with macrophages. And, our expectation is that that wont turn out to be
a safety concern when we do a larger and additional pivotal Phase III trial.
In terms of phlebitis, which is another thing that the FDA mentioned in their complete response,
that is something that we feel has been already adequately addressed and is related to giving a
high concentration of the drug too rapidly. And the incidence in fact of phlebitis in the Phase III
program was favorable compared to vancomycin. So again, it is something that we dont expect will
turn into a real issue.
Liana Moussatos, [The Medicines Company].
Liana Moussatos
- Pacific Growth Equities Analyst
I understand that Oritavancin isnt metabolized and accumulates in the body. Can you talk
about the potential for are there potential safety issues just from that?
Clive Meanwell
- The Medicines Company Chairman & CEO
Yes, again, I think we will turn that to Mark. My only observation is that Zithromax, the
worlds biggest-selling anti-invective, has a similar pattern of metabolism. But lets go on to
Mark with specifics of Oritavancin.
Mark Sumeray
- The Medicines Company VP, Medical
Yes, thats true; this drug is not metabolized. It actually is taken up extensively into
tissues, which we believe is a positive attribute to the drug because it means that the drug
penetrates tissues where it needs to penetrate tissues, at the site of tissue infection. This also
means that the drug is released very slowly back into the circulation over time, which is also a
positive thing, we believe, because it reduces the likelihood of any toxicities that would occur
over time, because drug levels in terms of elimination by the liver or the kidney are low.
The final arbiter in terms of any safety concerns will always be clinical trial data, and that is
why we do large clinical trials. We have seen that Oritavancin has a very favorable safety profile
in Phase III trials compared to vancomycin. We certainly havent seen any evidence of tissue
toxicity. In fact, quite the reverse.
Liana Moussatos
- Pacific Growth Equities Analyst
What about longer-term? What is the longest that you have followed a patient after they have
been treated with Oritavancin? Any kind of organ toxicities, like, years later?
Mark Sumeray
- The Medicines Company VP, Medical
Well, years later, no, we havent got that kind of long-term follow-up from the Phase III
clinical trial program. But we dont anticipate any longer-term toxicities and certainly the
profile of the drug is very clean in terms of tissue toxicity, the potential to cause alterations
in cellular DNA as part of the routine testing that one does with drugs to assess longer-term
concerns over drug accumulation in tissue.
So I would summarize by saying, the in vitro data does not suggest that there should be an issue.
Clearly, the safety data, as I said, in Phase III is encouraging. And we anticipate that over time
we will get more data obviously on longer-term follow-up in patients who have been exposed to
Oritavancin.
Clive Meanwell
- The Medicines Company Chairman & CEO
I think we could also add a comment from Mark Leuchtenberger on this point. He has been
working on this for a while.
Mark Leuchtenberger
- Targanta Therapeutics President & CEO
Sure. Glad to join. And let me just say that we are really delighted that we have been able to
join forces with The Medicines Company. I think this is going to be a wonderful opportunity to
advance the drug.
With respect to long-term treatment, there was long-term follow-up done on some of the Phase II
trials, particularly bacteremia. And there were no long-term safety issues identified.
Liana Moussatos
- Pacific Growth Equities Analyst
How long?
Mark Leuchtenberger
- Targanta Therapeutics President & CEO
I dont have that in front of me, but I believe that there was a follow-up in months and
years. I cant give you the exact numbers.
[Eric Farmer], Leerink Swann.
Eric Farmer
- Leerink Swann Analyst
This is Eric Farmer in for Joe Schwarz. I had a quick question on your initial thoughts for
the structure of the Phase III trial in terms of whether you are going to use a fixed dose or a
weight-based, and maybe the number of arms in the trial, percentage of patients who will have MRSA
compared to the prior safety trials and such.
Clive Meanwell
- The Medicines Company Chairman & CEO
Thank you, yes, this is Clive. Well, obviously, all of this is set up by a set of dialogues
with the Food and Drug Administration. I know the Targanta team has already had some informal
contact with them since the advisory panel and so on. So that is step one, is to sit down with the
experts at the FDA and discuss the trial design. But I would imagine that we would be very excited
to put the single dose treatment into the Phase III program based upon the outstanding results at
the Phase II SIMPLIFI trial. In addition, I think putting some form of standard or more
conventional dosing of Oritavancin would seem to make sense to us, too; I think also to the
Targanta scientists and clinicians. And then of course, the control group I think is most likely
going to be something in the direction of vancomycin.
That would be a thumbnail sketch. I think a lot of discussions need to be happening internally as
we put our heads together, and then as I said, a trip down to Washington to meet with the FDA would
be very, very important, I think.
Eric Farmer
- Leerink Swann Analyst
Okay, thats very helpful. And then also, just one more thing on that. Can you just remind us
the percentage of patients who were MRSA patients in the prior Phase II trials and how that might
look in the next Phase III study?
Clive Meanwell
- The Medicines Company Chairman & CEO
Im sorry, I didnt answer that for you, did I? Mark, would you like Mark Sumeray, do you
want to just tackle that one?
Mark Sumeray
- The Medicines Company VP, Medical
Sure, yes. So since the original Phase III trials were performed, clearly the incidence of
MRSA as a causative organism in these kinds of complicated skin infections has increased. And so,
we would anticipate that the background level of MRSA infection would be much higher now than it
was then in any event. In addition, of course, we will ensure that enough MRSA infected patients
are enrolled into the trial. So one would expect at least half the patients nowadays to be infected
with MRSA, and we will ensure that at least half the patients in the trial would have MRSA as a
causative organism.
Eric Farmer
- Leerink Swann Analyst
Okay, thats very helpful. And then my last question is, can you walk us through the last
steps required for this acquisition to go through?
Clive Meanwell
- The Medicines Company Chairman & CEO
Glenn, that sounds like one for you.
Glenn Sblendorio
- The Medicines Company EVP, CFO
Yes, and what was the question? Last steps?
Eric Farmer
- Leerink Swann Analyst
Yes, what are the remaining steps for this acquisition?
Glenn Sblendorio
- The Medicines Company EVP, CFO
We signed the merger agreement obviously last night. That was the first step. And those were
obviously filed with the SEC. The steps after that really is to file the appropriate documents to
tender the shares, which should happen within the next 10 days. And then theres a 20-day period to
tender the shares, which comes to the February date we talked about before completing the
transaction, because this is an all-cash transaction up front.
One other thing to note that we have pointed out in the press release is that there were consents
from approximately 36% of the shareholders already who I believe are Board representatives. So they
were aware of the transaction. So I think we are well on our way. So, most likely a February
closing. I wont say, if you just take that 10 and 20, and those are business days, that puts you
to the middle to the latter part of February to complete.
Maged Shenouda, UBS.
Maged Shenouda
- UBS Analyst
Most of my questions were answered, but maybe you can comment on the efficacy issues cited by
the FDA and what your views are of the various issues presented.
Clive Meanwell
- The Medicines Company Chairman & CEO
Well, Maged, one of the issues presented was an old familiar piece for us, which is the issue
of noninferiority. And the first major trial had a noninferiority margin of 15% prespecified, which
it met. But of course, that trial was done awhile ago, and the standards do tend to change.
The second study, which was very robust, met the 10% margin. I think that was one of the first
things. And its my understanding and again, I will check with both Marks on this occasion, that
the other issue which was discussed earlier was related to just the sheer numbers of patients we
had in the dossier to demonstrate efficacy in MRSA patients. And I think, obviously, from an
effectiveness point of view, since that is hopefully going to be one of the key uses of the drug,
we need to create some additional robust information for that. And I am confident that with a Phase
III study done in a contemporary setting, just as Mark Sumeray said earlier, we will be able to
nail that down.
But I would like to just see whether either of the Marks want to add to that. In terms of was
there anything else on effectiveness that ? Certainly, the microbiology, I think, is spectacular
and was acknowledged as such by the experts on the panel. So weve got a very good, highly active,
highly potent molecule here which works across a spectrum of various resistances, not only MRSA,
but certain vancomycin-resistant bugs. And I think that is also a huge advantage as they begin to
emerge. And of course, we can also anticipate resistance emerging from all the other drugs, which
fortunately have made the choices for doctors better than they used to be. But nothing will be
forever, and new generations of drugs are going to be needed all the time.
By Mark or Mark, any additional thing on effectiveness?
Mark Leuchtenberger
- Targanta Therapeutics President & CEO
No. This is Mark Leuchtenberger. I think that Clive is absolutely right. I think in
particular, just the relative or absolute low number of MRSA patients, because of the time the
trials were done, made our application fall just short of the finish line. And I think there is an
opportunity with this next Phase III to address all those issues. And we are very confident, based
on the 2400 patients that have been treated, looking at efficacy across all those trials that we
will have no problem hitting back that end point with the new trial.
Maged Shenouda
- UBS Analyst
Okay, just a real quick follow-up. I guess I am just scratching my head as to why now, given
that you have a couple of very important data sets coming out with cangrelor, why go down this road
right now?
Clive Meanwell
- The Medicines Company Chairman & CEO
Well, Maged, there are always moments when great assets become available. And unfortunately,
they dont line up perfectly with just when you want them. I am sure that nobody here would
necessarily have predicted when this important opportunity would arise. I think even in tough times
and in terms of the general economy, I think its important that we all look forward and not get
too stuck in the mud in terms of the future of our businesses. It is certainly a tough economic
climate, but that is not a reason not to press forward.
As far as cangrelor is concerned, I think the timing has nothing to do with cangrelor. The timing
has everything to do with the opportunity that presented itself and an opportunity we had begun to
understand quite well and an ability to work with Targanta to get this deal done. So thats
unfortunately, we cant plan these things, but when they come along I think you have to take the
opportunity.
Glenn Sblendorio
- The Medicines Company EVP, CFO
Clive, I would like to add a couple of comments to that about strategy that I think we have
talking to all of you over the last couple of years, is that we said our stated objective from a
strategic standpoint was to expand our critical care business. And over the last couple of years,
we have looked at well over 200 opportunities. So I think we have been very selective and we have
pursued those assets that we thought would be of high value to us and fit our existing model. That
was a couple of years ago or 18 months ago, when we reacquired Angiox, was the first step. We did
an acquisition in August that fit our business quite nicely, and that was Curacyte with some
early-stage discovery capabilities in antithrombin technology, and also see CU-2010 for surgical
blood loss and now this asset. So, Maged, I think we have been very selective and I just want to
reinforce Clives point about timing. Unfortunately you cant always time these things. But I think
we have been selective and waiting for the right time.
Clive Meanwell
- The Medicines Company Chairman & CEO
I think, as well, Maged, look, I think the tendency, understandably, for the financial
community is to compartmentalize drugs into therapeutic areas. But actually, Mark Leuchtenberger
and I share a very common set of customers. They are the 3000 major hospitals around the world who
are treating at least 80% of the critical care patients that come in. And its not just a question
of talking to doctors anymore. The key decision-makers are really the hospital management team and
pharmacy staff, as well as the physicians. And so for us, this is right on strategy.
Maged Shenouda
- UBS Analyst
Thanks. And then just, Glenn, could you just restate your comments about what this will do to
2009 R&D?
Glenn Sblendorio
- The Medicines Company EVP, CFO
Yes, and I made a comment about expenses, and I think it goes back, and then I will repeat
those numbers for you, Maged. I think it relates to discussions that we would have with the FDA and
also discussions and that we have internally, like we normally do, around trial designs. But with
that said, I did give two numbers without giving you the full picture on R&D, and I will give you
maybe some color on that as well.
We said that the acquisition of Oritavancin from an additional infrastructure cost that is
people, facilities and overhead we estimate to be approximately $10 million to $12 million on an
annualized basis. And that additional clinical spending, if we start the Phase III in the latter
part of the year and again, I think a lot of that has to do with the discussions that we will
have with the FDA that would be in the range of $15 million to $20 million.
Now, although I didnt give him a specific guidance on 2009 R&D expense, just remember that we have
three of our assets, our long-term assets, coming off significant trials. So if you take Angiomax,
the big trials, the ACUITY trial, the HORIZONS trials; are behind us. We do have spending in
Europe. Cangrelor will finish this year and Cleviprex will continue with Phase IV studies during
09. So from 2010 on, you would expect to see a drop in our R&D spending on those assets. So,
again, coming back to the timing question, and of course you cant time this, this gives us a great
opportunity to add other assets that could help our growth rate in the future at a point in time
where R&D budgets start to fall off.
Clive Meanwell
- The Medicines Company Chairman & CEO
Maged, let me add something as well. Whether we do or do not secure a patent restoration for
Angiomax, Angiomax will one day go off patent and we have to build a sustainable business. This is
a long-term asset that we are acquiring today potentially, and I think we have to look at how we
are building a global, sustainable leading business.
Operator
Jason Kantor, RBC Capital Markets.
Jason Kantor
- RBC Capital Markets Analyst
Thank you for taking my call; a couple of questions. Could you give us the patent situation
for this drug? How long are you protected on it, and what kind of patents you have? And also, what
sort of royalties you owe and gross margins you might expect?
Clive Meanwell
- The Medicines Company Chairman & CEO
Just dealing with the patent situation, with Mark Leuchtenbergers promise to make sure that I
file the patent on time, we would see I think the patent is 24th of November, 2015. Its a full
composition of matter patent. We would we do know a bit about what Hatch-Waxman restoration
at least, and we would see that adding four to five years, probably five rather than four, the
maximum allowable. And I would also assume that at some point we would go off to pediatrics. I
think all added together, that would take you into the 2020, 2021 range.
Mark Leuchtenberger
- Targanta Therapeutics President & CEO
Thats right, Clive.
Jason Kantor
- RBC Capital Markets Analyst
And then, in terms of royalty and gross margins on the product?
Glenn Sblendorio
- The Medicines Company EVP, CFO
I will comment on an overall basis. I think this looks very similar, probably a little bit
better than Angiomax. The royalty structure doesnt go as high as Angiomax, but we are still
working on the cost structure. So if I was to give a range, I would say with royalties, thats
royalties plus cost, we estimate probably in the low to upper range would be mid-20s. And that
assumes like everything else, Jason, that assumes that we had certain sales levels. It is a
tiered royalty structure. The Targanta folks did a nice job, and they may have disclosed, and I
believe they may have.
Clive Meanwell
- The Medicines Company Chairman & CEO
Yes, Glenn, I was just going to say, Mark might want to comment on this, because, Jason, I
think this is all filed with the SEC and is quite explicit. But, Mark?
Mark Leuchtenberger
- Targanta Therapeutics President & CEO
Yes, it was in our S-1 when we went public, so it starts at a royalty of 10%. Between $200
million and $400 million of royalty goes to 12%, and this is on an annual basis, on a marginal
basis, then goes to 18%, but only after the drug crosses $400 million every year. So if this was a
$1 billion drug, the royalty, weighted average royalty, would be about 15.1%, 15.2%. So I think a
reasonable royalty, and there is an opportunity obviously with larger production, to reduce COGS
and maintain a good margin.
Clive Meanwell
- The Medicines Company Chairman & CEO
That would suggest to me that Mark is better at negotiating royalties than I am.
Jason Kantor
- RBC Capital Markets Analyst
And finally, in terms of clinical trials, are you planning to just run one Phase III trial in
skin infection, or would you run multiples? Are you going to run a bacteremia or osteomyelitis or
some other registrational studies, or is it just the one skin structure study that youre planning
to do?
Clive Meanwell
- The Medicines Company Chairman & CEO
Well, again, not wishing to dwell on the point, but lets put the caveat that we need to go
and see the agency in the front of this answer too. But I think that I would imagine that three
large randomized trials that show it works in skin and soft tissue infections should be adequate.
And then in addition, I think you have a little bit of a decision on what you pick, bacteremia,
anthrax even, or Clostridium difficile program, are the obvious choices between at the moment. I
think well be looking at that more carefully with the Targanta scientists over the next weeks and
months. And naturally, we will let you know immediately. We have a decision. But I think that
certainly bacteremia is a possibility and obviously an important area of medical need.
Operator
Steve Harr, Morgan Stanley.
Steve Harr
- Morgan Stanley Analyst
A couple of remaining questions. How much work have you guys done on the fact that this
prolonged terminal half-life has on resistance and the induction of resistance?
Clive Meanwell
- The Medicines Company Chairman & CEO
Well, I think a lot of work has been done on this, and the mode of action of this drug, its
core mechanistic postulates I think is quite important in that regard. And short of putting this
into large epidemiological scale testing, one will never know until it has been on the market some
years just how resistance plays out. There is a natural tendency to be optimistic about resistance,
and sometimes that turns out to be not quite so the case. I dont personally think that the
resistance pattern here is going to be any worse than any other new high-end anti-invective. I
think there is a reasonable possibility it could be better. But lets just say, we think on balance
it would be reasonable to estimate it would be the same once it has been into many, many patients.
So I dont think we are falling one side or the other of that idea, but there are obviously pros
and cons.
Steve Harr
- Morgan Stanley Analyst
So, as you guys you know, commercially, I think you have always talked about value to the
hospital being an important part of The Medicines Company brand. And this drug, where you are
potentially taking on a lot of upfront cost at the hospital, and in exchange you dont have to send
patients out on an oral antibiotic, how do you create the value for the hospital who has to [is
this the] fixed DRG of the large payment single-dose? And then second, if this ends up being a
single-dose drug, do you think that the in-hospital environment is really your where this drug
is going to have its best impact, or is it really some of these emergency room settings or even
outpatient settings?
Clive Meanwell
- The Medicines Company Chairman & CEO
Youre absolutely right. We are very focused on creating value for payers, and this is no
exception. We have spent a lot of time with health economic experts discussing this whole area in
the last few months, actually. We believe that, whilst you are right, the division between hospital
and community payers can be clear. I think when looking at the management of a patient, we are
pretty confident that people are willing to look at it as a system overall and that the opportunity
here to give a drug once and once only and avoid a lot of costs which are usually incurred in
various parts of the system are available. And the other thing is, in order to answer your
question, we have to make a lot of assumptions about price. And right now, we are a long way from
seeing what the value of the drug is. So we dont want to make too many assumptions about pricing.
So I think there is plenty of information around that would make us believe this could be very
attractive to payers.
Operator
Biren Amin, Stanford Group.
Biren Amin
- Stanford Group Analyst
Just a couple of last questions. First, on potential Phase III design, could you comment on
the active comparator? Would you use Zyvox, or would it be vancomycin?
Clive Meanwell
- The Medicines Company Chairman & CEO
As I mentioned, I think one would typically lean towards vancomycin. But again, more
discussion is needed, and it could conceivably be something else. But I think vancomycin would be
the draft pick right now.
Biren Amin
- Stanford Group Analyst
Okay. And maybe some insights into why you will pursue a single bolus infusion. And could that
dosing regimen potentially change the risk profile, considering FDAs concerns on macrophage
function?
Clive Meanwell
- The Medicines Company Chairman & CEO
Well, again, I am going to turn to my colleague, Mark Leuchtenberger, just for that one, and
see if he wants to pitch in.
Mark Leuchtenberger
- Targanta Therapeutics President & CEO
Sure. I think the opportunity for the single dose we think is really going to be the game
changer in the hospital environment for gram-positive infections. In talking with physicians who
have seen the Phase II SIMPLIFI data, key opinion leaders who we expect to be part of this Phase
III, the excitement around the single infusion, the opportunity to save on infusions, save time in
the hospital, have an early release and all the convenience that comes with that, is very, very
attractive. So I think that its definitely at the top of the priority list in terms of getting to
the market. I dont know if that answers your question.
Clive Meanwell
- The Medicines Company Chairman & CEO
Well, we would like to again thank everybody for joining us on such a busy day for the health
care investment community. We will look forward to catching up with you as much as possible in the
next few days and weeks and months as we move this very interesting and very important asset
towards the clinic for the Phase III, and also ultimately to the place where it is really needed,
which is to treat patients. Thanks very much indeed, everybody.
Operator
Ladies and gentlemen, thank you for your participation in todays conference. This concludes
your presentation. You may now disconnect. Good day.
Important Information About the Tender Offer
This communication is not a recommendation, an offer to purchase or a solicitation of an offer to
sell shares of common stock of Targanta Therapeutics Corporation, a Delaware corporation
(Targanta). Boxford Subsidiary Corporation (the
Purchaser), a Delaware corporation and a wholly owned subsidiary
of The Medicines Company (MDCO), has not commenced the tender offer for shares of Targanta common stock
described in this communication.
Upon commencement of the tender offer, MDCO and the Purchaser will file with the Securities and
Exchange Commission a tender offer statement on Schedule TO and related exhibits, including the
offer to purchase, letter of transmittal and other related documents. Following commencement of the
tender offer, Targanta will file with the Securities and Exchange Commission a
solicitation/recommendation statement on Schedule 14D-9 and
related exhibits. Stockholders should read the offer to
purchase and solicitation/recommendation statement and the tender offer statement on Schedule TO
and, as applicable, related exhibits when such documents are filed and become available, as they will contain
important information about the tender offer.
Stockholders can obtain these documents when they are filed and become available free of charge
from the Securities and Exchange Commissions website at
www.sec.gov
. In addition, stockholders
will be able to obtain a free copy of these documents (when they become available) from Targanta by
contacting Targanta at 222 Third Street, Suite 2300, Cambridge, MA 02142, attention: Investor
Contact.
In connection with the proposed transactions contemplated by the definitive agreement between MDCO
and Targanta, Targanta and its directors, executive officers and other employees may be deemed to
be participants in any solicitation of Targanta stockholders in connection with such proposed
transactions. Information about Targantas directors and executive officers will be available in Targantas solicitation/recommendation statement on
Schedule 14D-9.
Safe Harbor Statement
Statements
in this communication may contain, in addition to historical
information, certain forward-looking statements. All statements
included in this communication concerning activities, events or
developments that Targanta expects, believes or anticipates will or
may occur in the future are forward-looking statements. Actual
results could differ materially from the results discussed in the
forward-looking statements. Forward-looking statements are based on current expectations and
projections about future events and involve known and unknown risks,
uncertainties and other factors that may cause actual results and
performance to be materially different from any future results or
performance expressed or implied by forward-looking statements,
including the risk that the tender offer will not close because of a failure to
satisfy one or more of the closing conditions, including that
Targanta's business will have been adversely impacted during the
pendency of the tender offer; that, if the tender offer and
merger close, MDCO will not be able to advance oritavancin through
the contemplated Phase 3 trial on a timely basis or at all or receive
approval from the FDA or EMEA; and that, if oritavancin receives
approval, MDCO will not be able to successfully distribute and market
the product. Additional information on these and other risks,
uncertainties and factors is included in Targanta's Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form
8-K and other documents filed with the SEC.
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