academic physician
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JTF3
We are all in shock and in despair and have had huge losses. Most of us have had and continue to suffer through. But, we have to recover and collect our wit and objectively think about our situation and our investment thesis- and what to do and where to go next. After thinking about this a very long time- I have decided the best course of action for now is to be invested through Reduce It data. In the meantime if anything positive happens- that would be great. For me that is the best option for now. There is a reasonable possibility that AMRN may partner for Reduce it or be bought out.
I do think this is not a lost investment- I think we still have good possibility.
Yes but it clearly states that the director must provide written documentation to the sponsor so that they can then request a meeting. My one concern is that whether FDA should have notified the company before the panel meeting or it can occur after the panel meeting. It would seem very unfair to spring this at the panel meeting so that the company is unprepared as it was in this case. IMO, it should have been done before the panel meeting. It may be possible that FDA can notify AMRN prior to the PDUFA date and then have a type A meeting with AMRN- this seems unfair as FDA panel was allowed to ruled on something that was not agreed to in SPA.
That's exactly my point. It appears that FDA has not followed their regulations and are in violation. They have also outline the steps for dispute as I enclosed below.
Let's hope this happened.
They clearly were not given this written document by the director as required by FDA regulation. In all AMRN conferences leading up to FDA meeting, AMRN has repeatedly stated that no concerns were raised by the FDA- unless of course AMRN was lying- which I don't think is possible.
But AMRN apparently was never notified by the FDA so they never had chance to discuss this issue. Clearly, this qualifies for dispute resolution. Again, it all comes down ti whether the director has given AMRN a written document noting such a change. Presumable, this was not done.
If AMRN is telling the truth and they were not notified by the FDA regarding the change in SPA agreement, FDA has violated their policy and regulation and AMRN has a clear path for justice. It all comes down to whether AMRN is telling the truth- which I believe they are as they appeared to be completely blindsided and unprepared for the panel meeting.
We have hope!
From FDA regrading dispute resolution:
VII. DISPUTE RESOLUTION
A sponsor should first try to resolve disagreements with FDA action under the special protocol
assessment program with the review or applications division. Any dispute regarding study
design should be resolved before starting the trial. If the sponsor is not satisfied with the
response provided by FDA, the sponsor can decide to pursue the Agency's procedures for formal
dispute resolution as described in regulations (21 CFR 10.75, 312.48, and 314.103) and the
guidance for industry, Formal Dispute Resolution: Appeals Above the Division Level (March
2000, 65 FR 12019). However, if an advisory committee evaluates a protocol as part of special
protocol assessment, further review by the advisory committee need not be obtained as part of
dispute resolution.
This is the process for dispute resolution which AMRN should proceed with if FDA did not follow the proper steps.
No.
Here is the definition of Type A meeting per FDA:
V. MEETINGS
If a sponsor requests a meeting with CDER or CBER after receipt of a special protocol assessment letter, the request will be handled as a request for a Type A meeting under the PDUFA goals for meeting management. This meeting will be scheduled to take place within 30 calendar days after receipt of the written request for the meeting. At the Type A meeting, the Agency representatives and the sponsor should discuss any remaining issues and uncertainties
regarding the protocol. If CDER or CBER believes that meeting with a sponsor would be the best way to resolve outstanding issues regarding a special protocol assessment, the Agency can suggest that the sponsor request such a meeting. Any meeting with the sponsor should be scheduled and conducted under the policies and procedures established by CDER and CBER.9
Obviously, Type A meeting did not take place. If Bruno is telling the truth, AMRN was given a written documentation in writing.
If this is true, then AMRN has a major case. Their agreement has been violated.
My recollection was that the margin would be at .85.
From FDA SPA regs:
B. Changes in Documented Special Protocol Assessments
As stated in the PDUFA goals for special protocol assessment and agreement, having agreed to the design, execution, and analyses proposed in protocols reviewed under this process [i.e., carcinogenicity protocols, stability protocols, and phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim], the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.
Thus, documented special protocol assessments should be considered binding on the review division and should not be changed at any time, except as follows:
• Failure of a sponsor to follow a protocol that was agreed upon with the Agency will be interpreted as the sponsor's understanding that the protocol assessment is no longer
binding on the review division.
• If the relevant data, assumptions, or information provided by the sponsor in a request for special protocol assessment change are found to be false statements or misstatements or are found to omit relevant facts, the review division will not be
bound by any assessment that relied on such data, assumptions, or information.
• A documented special protocol assessment can be modified if (1) FDA and the sponsor agree in writing to modify the protocol (section 505(b)(4)(C) of the Act) and (2) such modification is intended to improve the study. A special protocol assessment modified in this manner will be considered binding on the review
division, except under the circumstances described below.
• A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has
begun (section 505(b)(4)(C) of the Act). If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This meeting will be a Type A meeting under the PDUFA goals for meeting management.
The key statement here is "If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This meeting will be a Type A meeting under the PDUFA goals for meeting management." If Bruno is being truthful- this requirement did not happen. FDA is in clear violation of their binding regulation.
If that's true, AMRN has every right to challenge FDA for reneging on the SPA. It clearly states this on the newly revised FDA policy regarding the binding nature of SPA.
STS,
Thanks for your input and I hope you are right- that would be even better for AMRN. I was basing my 60 mil estimate based on the Q1-2013 expense noted on their financial statement which stated the cost for study at 15 mil.
This means if they can keep the cost of salaries for 275 sales force and the rest of the employees to a reasonable level. My estimate based on pure speculation is 400 employees at average cost of 160,000 (including benefit) would be 64 mill. I would welcome a more accurate number from someone more knowledgeable.
Cost of the drug at 80 % margin would be around 20 mill dollar per 100 mill in sales. Again, I would appreciate input from others.
What this means is that the break-even point could be around 120 million dollars.
120 million in revenue can be achieved by weekly sales of 12,500 scripts. 12,500 (scripts per week) X 184 (whole sale cost per month)X 52 (total weeks per year) = 120 million.
Currently we are at about 8,000 scripts per week (6500 as reported by Symphony + 20 % under-reporting). If scripts continue at current pace, the weekly scripts will reach 12,500 level some time in Q2 2014.
Bottom-line is we could be in the black sometime mid-2014.
Zumantu,
Thanks for your thoughtful post.
I think your points are very good and generally agree with your assessment.
I do think your sales assessment is too optimistic. If vascepa keeps current growth pace (6500 per wk Symphony, ~8,000 total per wk), we can expect 8000 per wk (10,000 total per wk) by end of the year. Assuming similar projectory of growth (which may be a stretch), we can expect ~ 20,000 per wk by end of 2014. This puts the revenue for 2014 at around 100-150 million per year and 200-250 million per year for 2015. Of course the growth may be slow (or could accelerate) and there is the concern with generics starting in 2015. If vascepa can capture 20,00 per week by end of 2014 (and the discounts go away) then AMRN would be in good shape financially going forward. At a wholesale price of 184 per 30 day prescription, that translates into about 190 million dollar per year pace. Assuming the cash burn rate can be controlled to 150 million dollars (60 million for R+ D, 90 million for other expenses), we could potentially achieve positive revenues by the end of next year. It all depends on the sales projection and amounts of discount being applied. If this scenario occurs then, AMRN could be in good shape financially.
I think both partnership and buyout will be in play. I disagree with your assessment of Reduce It. If Reduce It is positive, the annual peak sale for vascepa will be closer to 10 billion dollars and the company will be well worth over 20 billion market cap. This will become the number on selling drug.
When I have more time I will post a more detailed analysis- with the intent of being more realistic and conservative.
I am sorry to hear of your loss. We all lost great deal and fully empathize with you.
I have made a decision to hold up to reduce it results. Current price doesn't make any sense. I do think there is a chance for buyout or partnership as well. I would try to value the company as objective as possible- which is sometimes very hard to do.
Godluck- I hope things turn positive. May be we will get a surprise in sales.
AMRN was very poorly prepared for the questions asked. DId a horrible job in answering questions. The consultants were excellent.I was appalled by the AMRN representatives- deeply disappointed. This could have been salvaged with a better debating team.
At this point. options are very limited. 3 options: 1) sell the company; 2) Partner for vascepa sales or for reduce it study or both;3)GIA and dilute the shares. I personally like option 2 the best. I still see a good probability of reduce it out come study. If this happens, I foresee a potential 10 billion dollar drug but this will not happen until possibly 2017 and there will be lot of pain in-between. After assessing all options, I am in for the long run.
With Marine indication alone, I see peak sales between 200-500 million by 2015- which should value the company at 1-2 billion market cap.
Jesse,
I agree with your points. Unfortunately, AMRN did a very poor job in answering these questions during the meeting. While there is always a chance that the FDA can go against the panel, this would be a low probability considering that they were concerned about the outcome study. However, I would love to see AMRN do all it can to have FDA approve the drug with the stipulation that they would withdraw the indication for TG between 200-500 if reduce it results are negative.
I am resigned to the fact that I will have to wait for reduce it data.
Thanks for all your hard work and your efforts.
I think the 2 best options are: 1. sell the company, 2. Partner for Reduce-it to an interested party- this would be a potential win-win. The completion of study will require about 300 mill (60 mil per year currently). The interim look will take place sometime 2014-2015- chance it could be positive. If positive outcome, you have a potential 10 bill per year drug. Knowledgeable pharma could be interested as low investment cost potential mega blockbuster.
Very depressing day.
Amazing. Public forum speakers are doing much better job than AMRN. Tone has changed in favor of AMRN- they are doing fabulous job- one even addressed the glucose issue- better than AMRN.
Let's keep praying.
I can only hope AMRN does better in the second half and pray for a major turnaround from the committee members- I just haven't heard any positive support or tone from the members so far. AMRN must do a better job answering outstanding issues. I agree turnaround is possible but for now it's looking grim IMHO.
Unfortunately, at this point, it is a strong rejection. They have to do better after lunch to have any chance. The tone is entirely negative at this point. I don't see any positive votes at the moment.
AMRN did a very good job in presentation bu very poor job in question and answer session. They have failed to present the case that lowering TG leads to improved cardiac outcome. I thought they missed a crucial opportunity to point out the fact that it is the patients with high TG benefit not low TG levels as were done in the studies. They really needed to emphasize the subgroup analysis which show that elevated TG levels are the ones that benefit- which is the indication they are after.
I am praying for a miracle at this time. The must do better or else its over. So far AMRN reps have been terrible on their feet.
Good luck to All Longs. Let's hope that AMRN hits it out of the park.
Speed
We will see how great Dr. Miller and Dr. Bay are after the FDA meeting. I hope they hit it out of the park.
I hope everyone understands the implication of this post. This post addresses the first issue regarding the effect of mineral oil on lipid parameters.
A key issue raised was that the 4 ml mineral oil in the placebo pills may have caused an increased in lipid profiles. Mineral oil is not lipid. Lipid refers to fats and store energy in the form of fatty compounds made up of fatty acids. Mineral oil is not lipid. Mineral oil is inert and made up of CH not Acids (COOH- which are part of lipids- require fatty acids) and is poorly absorbed. It's net nutritional value is 0 calories. Just because it's referred to as oil does not mean it is absorbed fatty acid. In this regard, FDA reviewer appears to be confusing lipid with oil. Chemically or biochemically, mineral oil does not affect lipid composition ( such as LDL cholesterol) or synthesis. I hope AMRN address this issue in this manner to educate the FDA reviewer of her error.
This is from fit bid website
Nutrition Facts
Generic - Mineral Oil
Servings:
Calories 0 Sodium 0 mg
Total Fat 0 g Potassium 0 mg
Saturated 0 g Total Carbs 0 g
Polyunsaturated 0 g Dietary Fiber 0 g
Monounsaturated 0 g Sugars 0 g
Trans 0 g Protein 0 g
Cholesterol 0 mg
Vitamin A 0% Calcium 0%
Vitamin C 0% Iron 0%
*Percent Daily Values are based on a 2000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.
By the way the serving size is for 1 tablespoon which is 5 ml. In the study, placebo contained 4 ml mineral oil. Thus, it can be argued that the mineral oil consumed by the patients in the placebo group had 0 caloric value and could not have been the source of elevated LDL cholesterol.
FYI, mineral oil is inert and made up of CH not Acids (COOH) and is poorly absorbed. It's net nutritional value is 0 calories. Just because it's referred to as oil does not mean it is absorbed fatty acid. Chemically, it is defined as "An oil is any neutral, nonpolar chemical substance, that is a viscous liquid at ambient temperatures, and is immiscible with water but soluble in alcohols or ethers. Oils have a high carbon and hydrogen content and are usually flammable and slippery. Oils may be animal, vegetable, or petrochemical in origin, and may be volatile or non-volatile.[1]"
Mineral oil unlike some of the oil used in cooking or for consumption does not have any nutritional value.
This is from fit bid website
Nutrition Facts
Generic - Mineral Oil
Servings:
Calories 0 Sodium 0 mg
Total Fat 0 g Potassium 0 mg
Saturated 0 g Total Carbs 0 g
Polyunsaturated 0 g Dietary Fiber 0 g
Monounsaturated 0 g Sugars 0 g
Trans 0 g Protein 0 g
Cholesterol 0 mg
Vitamin A 0% Calcium 0%
Vitamin C 0% Iron 0%
*Percent Daily Values are based on a 2000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.
Slowmover,
I agree this was one of the 2 issues brought up by the FDA and one which requires a response from AMRN. If you read this section carefully, FDA also points out the literature supporting the usage of mineral oil as a placebo and the lack of mineral oil effect on lipid levels and on fat soluble vitamin absorption and the data from Marine suggesting lack of vascepa on statin effect- so I think FDA is open minded on this issue but they bring up the possibility that mineral oil may have impacted the lipid profile in placebo patients. The usage of mineral oil should be easily addressed by AMRN. They should also point out that vascepa produced a 17% decline in TG level from baseline.
I still think the central issue is whether the decline in lipid parameters is indicative of clinical benefit based on the summary comments by the FDA BD.
WM,
That is precisely the point. As noted in the FDA and AMRN BD, major cardiology and endocrinology associations including AHA and the NCEP ATP III guidelines recommend treatment for elevated TG. In fact AHA specifically recommends that patients with elevated TG be considered for treatment " with EPA plus DHA at a dose of 2 to 4 g per day". It is up to AMRN to clearly inform the panel about the current recommendations and why reducing the TG are beneficial in patients treated with statins that have persistent elevation in TGs- this is straight out from NCEP ATP III guideline. Having been through 5 FDA panel meetings, anything can happen and does happen- but in this case the issues are very clear and limited to one central issue whether lowering lipid parametets translate into clinical benefit. Hopefully, AMRN will address understand this issue and hit a home-run. We can only hope at this point- but the bottomline is that AMRN can do this.
This is not necessarily the case. They will do whatever they believe to be the best interest to the public. In general, they go with the panel recommendation especially if it is one sided.
I think FDA basically would like to know whether they should approve Vascepa based on improvement of lipid parameters and whether the improvement translates to improvement in clinical outcome.
I personally believe there are ample evidence to support this issue. AMRN has to present a convincing evidence for the panel to support vascepa usage. What is clearly in their favor is that all major cardiovascular and endocrinology societies including AHA, endocrinology association, and the NCEP ATP III guidelines recommend treatment for elevated TG. They need to present the recommendations of these key societies.
KC
To answer your question, FDA does not get a vote. They present their concerns or issues and ask for advice from the panel. The final decision cones from the FDA review committee- the director has the final say- although the FDA review committee makes the final recommendation. Although SPA is there, FDA does not have to go with SPA fulfillment if they feel the science has changed significantly. In this case, the key issue is whether reducing TG or other lipid parameters is sufficient for meaningful clinical outcome. This is somewhat controversial issue based on recent negative outcome studies but an issue which AMRN can address satisfactorily. Keep in mind that all key Cardiology and ENdocrinology societies recommend lowering TG in patients at risk for CAD. AMRN must present the recommendation by these societies- it would be a compelling argument.
To me the big issue is not can AMRN respond appropriately to the 2 central issues asked. The two issues are critical but can be addressed relatively easy. The big question is will they respond appropriately. They need to show the data from recently published studies showing that mineral oil has no effect on fat absorption to provide direct evidence to refute this possibility. In similar vein, they have to address the TG lowering benefit by showing 2 or 3 key studies that demonstrate a direct correlation with increasing CV risk with elevated TG level (including the recent gene correlation study) then discuss the 2 or 3 recent negative studies and why the studies were flawed and address the key studies that showed benefit and how the studies were done with higher doses. Most importantly, the presentation must be to the point and easy for the panel understand. It should be noted that in the FDA BD, when raising these concerns FDA also balanced the concerns by addressing how TG may also be beneficial and that mineral oil studies showed that they did not affect absorption- AMRN must use this to their advantage.
Let's hope AMRN does it right.
JL,
I agree. I think FDA raises very important but reasonable issues. As far as BD goes, relatively straight forward. Let's hope AMRN is up to the challenge.
Speed
Comments regarding FDA Briefing Document (BD):
I just finished reading both FDA BD and Amarin BD. I thought FDA BD was very well done- it was fair and to the point. As for AMRN BD, it was somewhat dense and disjointed – somewhat verbose. It could have been better focused, to the point, and addressed the central issues better.
First of all, I don’t think FDA BD is not all that negative as had been led to believe. In fact, IMO the points raised are reasonable and appropriate for discussion.
For the panel meeting, following 2 issues are up for discussion and for vote. The good news is that there are only 2 issues that were asked for discussion so it should be easy for AMRN to focus on these points. They must answer these issues directly and in a convincing manner. If they answer these 2 issues, FDA panel vote will be strongly positive. Mainly, they have to make a case that lowering TG and improvement of lipid parameters are important for CV risk reduction. The other point they need to address is why the use of mineral oil as a placebo did not affect lipid parameters in placebo treated patients. These 2 issues can easily be answered and must be addressed by AMRN.
These are issues that have been raised before and issues which AMRN must have been well prepared for. I do not see this as a negative issue or a surprise. These issues must have been anticipated. It is their AMRN’s job to educate the panel on these issues: mainly that mineral oil is not absorbed so it does not raise lipid levels and that it does not interfere with statin absorption and that lowering TG (and other lipid parameters) in dyslipidemia patients translates into clinical benefit. IMHO, there are no surprises in the BD- only what we anticipated. FDA is not asking for outcome study but asking for the evidence to support Vascepa usage clinically prior to outcome data.
1. DISCUSSION: In ANCHOR, 12 weeks of treatment with Vascepa 4 g/day led to an estimated median -21.5% (95% CI, -26.7% to -16.2%; P<0.0001) change in fasting triglycerides, compared with the mineral oil placebo, among statin-treated patients with mixed dyslipidemia at high cardiovascular risk. Changes in other lipid/lipoprotein parameters (selected secondary and exploratory endpoints) are summarized in the table below. Please discuss the efficacy results from the ANCHOR trial, including the clinical significance of the observed changes in lipid/lipoprotein parameters and your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population.
2. VOTE: Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation.
In the FDA BD, FDA brings up a concern regarding the increase in TG level and other lipid parameters in patients given placebo. Since placebo used was mineral oil, they bring up the possibility that the mineral oil may have led to the increase in lipid parameters in placebo patients- suggesting that the efficacy of Vascepa may not be as robust if the placebo did not increase the lipid values. They also discuss why mineral oil was selected and the available data suggesting that mineral oil has no effect on lipid parameters. This was brought up as a point for discussion and a concern that might have affected the study outcome and conclusion. This was one major issue that FDA discussed extensively in their review. FDA is rightly concerned about this issue and for asking discussion on this topic by the review panel. This issue can be easily answered. AMRN answered this in their BD- but in a dense and clumsy manner. In the panel meeting, AMRN must address this issue directly and clearly so that the panel members can see that the use of mineral oil was appropriate and most reasonable.
The other issue deals with the concern that TG lowering may not affect clinical outcome given the recent negative studies. Again, this is a reasonable concern by the FDA and one which AMRN had to be prepared to answer. They need to make a strong case why the other studies were poorly designed and could only have failed at the low doses used. Vascepa studies show that high dose of EPA is required- even 2 gm was not very effective so any dose less than 1 gm would have failed. It is imperative that AMRN provide very clear and to the point answers that will convince the panel members. Anchor approval will be completely dependent on their presentation. The approval is fully within AMRN’s control at this time. FDA concerns were reasonable and they appeared to be opened minded and asking for panel guidance.
GLTAL and let’s all hope for a top notch presentation by AMRN.
Thank you Rod for the post.
This is a very compelling story and provides the background as to how IPLEX was made available for ALS patients in Italy. Carl Bruno certainly has passion for life and may have had an important impact in the treatment of ALS. His progress on IPLEX has been amazing in that it shows that IGF/BP3 is effective for the treatment of Carl Bruno's ALS. There is every reason to believe that it will be effective for others. ALS is a progressive neurological disease that results in rapid neurological deterioration and death. If indeed IPLEX is effective for most or even some of ALS patients, because of the devastating effects of this disease, IPLEX will be used by all ALS patients that can afford the drug. This drug has the potential to be a major breakthrough for ALS. Because of its approval for usage in Italy, clinical data on effectiveness will be availabe very shortly. I can't imagine that any ALS patient in Italy that has the opportunity to use this drug will not use this potentially life saving drug. If the data shows effectiveness, there will be major clamoring by ALS patients in US, and the drug will be rapidly approved by FDA in US (due to political pressure from ALS advocacy groups) under orphan drug designation as no other effective therapy are available. For the sake of ALS patients, my hope is that IPLEX is indeed highly effective for all ALS patients as it was in Carl Bruno.
What a great day! We needed this news in the worst way after the beating we took in the trial.
Number of important development from today's news.
1. New potential indication for Iplex (ALS) that we had not discussed. Based on Italian request and prior science in this area, there is areal possibility of new important indication for this drug. As ALS is a progressive deadly disease without any good therapy- after this news, there will be clamoring for the drug all across the world and rightly so. No alternativ therapy so what have you got to lose.
2. This new potential indication could also have positive impact regarding the ruling against injunction. This news further demonstrates the potential utility of this drug for many untreatable diseses. It would be against public interest and against humanity to stop this potentially important drug therapy.
3. This opens up the potential partner for Europe. Cephalon would be an ideal partner based on thei expertise in IGF and their on-going interest in neurological diseases. INSM would be perfect for them as they can expend their pipeline in a major way. INSM can get much needed cash infusion and also solve the patent infringement issue with IGF from Cephalon.
4. Even without partnership with Cephalon, the visibility of INSM has been greatly enhanced by this news and will be helpful in obtaining future partnership agreement. Additionally, this brings up the strong possibility of having a new provider for IGF.
5. With this PR exposure, additional news with Europe IPLEX approval, HARS (AIds lipodystrophy data), Noonan's data, and MMD data that are to be announced over next few month will have much greater exposure.
6. Even with an injunction, Cephalon's IGF may be a way to overcome the injunction. This will allow INSM to continue to make IPEX in US, since Cephalon has their own patent for IGF production.
What a great day for INSM investors. Let's hope for many more in the next several months.
Speedrunner
Hector- In my view, injunction is highly unlikely for reasons stated below.
As mentioned before, for injunction to be granted Supreme Court has ruled that the following 4 tests must be overcome by the plaintiff:
(1) that it has suffered an irreparable injury;
(2) that remedies available at law are inadequate to compensate for that injury;
(3) that considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and
(4) that the public interest would not be disserved by a permanent injunction.
Plaintiff has failed the 4 "tests" for following reasons.:
1) TRCA will not suffer "irreparable" injury. There are clear remedies that can repair the damages "such as royalty payments" or other reparations..
2) Remedies are available to adequately compensate for the injury suffered; that is royalty payment of 15 or 20 % more than fairly adequately compensates for the injury. This was what the jury ruled and the ruling was not unreasonable IMO. Infact many would argue that it was too harsh.
3) In considering the balance of hardships between the plaintiff and defendant, the injuction would completely tip the balance against the defendant and will lkely lead to bankruptcy and closure of INSM. As given as example in the past, when faced with this type of situation, courts have required royalty payments in favor of injunction.
4) Most importantly, there are clear advantages of IPLEX to Increlex. There are less side effects (related to seizure and hypoglycemia) but may be just as important it is much more convenient to use in that it only requires 365 painful injections per year (to a small child) versus 730 injections per year for increlex. Public interest will be greatly disserviced by not allowing kids to have fewer injections.
All 4 tests must be met for injunction to be granted. No reasonable individual can rule for injuction. Certainly, a public servant- such as highly qualified judge, a guardian of law and public interest- will require royalty payment in favor of injuction.
In regards to your statement about the finacial condition of the company, I generally agree that INSM is in deep finacial trouble and will require additional financing and "dilution" of stock. This is an important area of concern. But, there are many potential positives that can lift the stock price over the next 6 month.
1. Injuction not being granted (IMO greater than 90 %) will greatly lift the stock price.
2. Positive ruling in favor of inequitable conduct on 151 (IMO 45% chance).
3. Positive P2 data on MMD showing clear benefit. Major increase in share price (~ 90,000 patients in US and Europe, 1 to 2 bill market). (IMO- very likely)
4. Positive data on Noonan's. (IMO- very likely) Again 1 to 2 bill market.
5. Data on AIDs lipodytrophy.
If any of the above come to pass, we could have a marked increase in share price (especially the P2 studies with MMD and Noonan's). With higher share price, although necessary financing shouldn't be as painful. Also, with the positive results, there is a dramatic increase in potential partnership with company like PFE.
I am a firm believer that based on pathophysiology of diseases MMD and Noonan's, IPLEX is highly likely to be effective in these disease states and that is the main reason why I own this stock. If the P2 data is positive, then the P3 studies can be quickly completed (within 2 years) and data submitted for orphan drug approval (<200,000 patients). The drug can be submitted to FDA by late 2008, most likely in 2009. Assuming worst scenerio in the courts, INSM will pay royalty payments till 2010, patents 151 and 272 expire in 2010; IGF will be made via eukayotic process (plant cells) by Phyton Biotech by 2010 and patent 414 will no longer apply.
Like other longterm investor, this verdict has been very painful but there is tremendous amount of hope going forward.
JMHO.
If there are no more damages to be announced that we don't know about, the amount awarded is not bad at all. The question is, is there additional damages to be paid that have not been announced. If there aren't any more, the future remains bright with all those new potential indications which are likely to be in $billion dollar range (such as MMD).
I am very positive about the damage awarded given that we lost the infringement decision.
Does anyone know for sure how much royalty payment that INSM has to pay?
TRCA was awarded 7.5 mill- Is this the only damage?
TIA.
I think what you are referring to is the agreement with Phyton Biotech to make Iplex via plant cell expression system. Since the patent by TRCA is for prokaryotic expression sytem (that is bacterial system), a eukaryotic system (plant) to express or produce IGF would bypass TRCA patent process.
Attached is the news release:
Phyton Biotech Signs Development Agreement With Insmed
EAST WINDSOR, N.J. and GLEN ALLEN, Va., July 31, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Phyton Biotech, Inc., a DFB Pharmaceuticals affiliate, and Insmed Incorporated (Nasdaq: INSM) have announced an agreement whereby Phyton will utilize its cGMP plant cell fermentation technology to develop a manufacturing process that could be utilized to meet the future demand of IPLEX(TM) (mecasermin rinfabate [rDNA origin] injection) as it expands with the development of IPLEX(TM) in broader therapeutic indications. IPLEX(TM) was approved by the FDA in December 2005 for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
One of the key attributes of Phyton's cGMP plant cell fermentation technology is that it can be scaled up to any size needed. Phyton's German subsidiary, Phyton Biotech GmbH, operates the world's largest commercial cGMP manufacturing facility for plant cell fermentation, with bioreactors up to 75,000 liters in size.
"The efficiencies and economies of scale assured by our plant cell fermentation system provide an excellent solution to meet the future demand for IPLEX(TM) as its use expands into broader therapeutic indications," said Magnus Precht, President of New Jersey-based Phyton Biotech.
"We recognize the potential of Phyton Biotech's technology to help Insmed address the anticipated future demand for our product," said Insmed CEO Geoffrey Allan, Ph.D. "If this cutting edge technology proves successful with our product, we believe it will give Insmed a long-term competitive advantage over companies utilizing older technologies."
"Our ability to genetically manipulate plant cells and to scale production combine to offer an advantage in the marketplace," said Mr. Precht, "The Phyton plant cell fermentation technology has utility not found in other cell expression systems."
"This agreement is an important step toward DFB's and Phyton's strategic goals of developing and manufacturing novel pharmaceutical products," said H. Paul Dorman, CEO and Chairman of DFB Pharmaceuticals.
The companies expect that the development conducted under the agreement will demonstrate the efficiencies of Phyton's unique plant cell expression technology and its ability to produce the quantities of IPLEX(TM) needed to meet the long-term demand for the product.
About Phyton Biotech, Inc.
Phyton Biotech, Inc., based in East Windsor, N.J., is a subsidiary of DFB Pharmaceuticals, Inc. Phyton's proprietary plant cell culture technology platform is used to develop and manufacture products with applications in the pharmaceutical and biotech industries. Phyton is focusing its research and development efforts on developing transgenic protein therapeutics utilizing Phyton's broad expertise in plant cell suspension culture technology. Other current Phyton projects include production of paclitaxel for Bristol-Myers Squibb's TAXOL(R) oncology product and development of DiAthegen LLC's protein therapeutics focused in the endocrine and oncology areas. Phyton is on the web at http://www.phytonbiotech.com .
Based in Fort Worth, DFB Pharmaceuticals, Inc. is a privately held Texas corporation that provides technology-driven pharmaceutical products, outsourcing services, and licensing opportunities to the healthcare industry worldwide through Phyton and its other affiliates, HEALTHPOINT, Ltd. and Coria Laboratories, Ltd., both branded marketing organizations; DPT Laboratories, Ltd., an outsourcing service organization to the pharmaceutical industry; and DFB Bioscience, focusing on cell based therapeutic research and development. Visit http://www.dfb.com for additional information.
About Insmed Incorporated
Insmed, Inc., based in Glen Allen, Virginia, is a biopharmaceutical company focused on the development and commercialization of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit http://www.insmed.com . The company's leading product, IPLEX was approved as an orphan drug by the United States Food and Drug Administration in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
About IPLEX
IPLEX, a complex of recombinant human IGF-I and its binding protein IGFBP- 3 (rhIGF-I/rhIGFBP-3), is the only once-daily IGF-I replacement therapy. It is also the only FDA-approved therapy that provides both rhIGF-I and rhIGFBP-3 to treat children with severe primary IGFD. The drug, which was launched in May 2006, is also being investigated for various other indications with unmet medical needs, including extreme insulin resistance, myotonic muscular dystrophy and HIV Associated Adipose Redistribution Syndrome (HARS).
SOURCE Phyton Biotech, Inc.; Insmed Incorporated
Magnus Precht of Phyton Biotech, Inc., +1-609-426-2520, or
magnus.precht@phytonbiotech.com ; or media, Kathy Jeavons of Ketchum Public
Relations, +1-202-835-9473, or kathy.jeavons@ketchum.com ; or investors, Tim Ryan of
The Trout Group, +1-212-477-9007, ext. 24, or Tryan@troutgroup.com , both for Insmed
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