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I think people should consider that Jerry Treppel came to Elite to protect his own investment via Ledgemont Capital (now ArcLight Advisors) and has moved on now that Elite is positioned to succeed. He is in his mid 60's and does not need to work anymore. After selling over a million shares this month he still holds over 8 million shares. He also sold his home in Edison, NJ the first week of Feb and purchased a home in Del Ray, FL. Anyone trying to spin it as anything else, is just trying to spin it.
To be honest, I see Jerry being out of the picture a good thing. He has somewhat of a controversial past as an analyst, Ledgemont's recent liquidation and reincorporation under a different business (ArcLight) is suspect and he never brought any actual pharma ops experience to the table. He did a lot to help Elite from going bankrupt and was the right person at the time to get the financial pieces put in place, including lending $1 million to Elite. All of this is good news in the long run for investors.
That was brought to Elite via Mikah (Nasrat Hakim's company) with the Actavis drugs he got. That said, please do some due diligence. There are years and years of historical knowledge on this board. Elite did not wait X years... A little research would show you that.
I agree. Anyone who has followed this company should see that there is no reason why the application is not accepted (the biggest delay has been to do everything the FDA requested prior to submission for that very reason) and no way that Elite does not get a formal Priority Review. That said, I also don't know why anyone would think this product is not going to get approved by the FDA either. These are two widely used safe drugs in a tried and true clinically tested delivery system. There is IMO no longer any risk in investing in ELTP. How individuals can buy in at this pps right 5-9 months from a product launch is amazing to me.
IMO we hear before Christmas as I see no reason it would not have been submitted in late October and Hakim was being conservative on the CC due to the holidays and inability of the FDA to get out of its' own way.
I agree. There is no reason that the application would not have been completed and awaiting the insertion of the validated clinical trial data. Very likely the application was submitted not too far after the late October study results were released publicly. We should hear from Elite via PR when the FDA accepts the application for review in the coming day, weeks or at latest, right after the New Year.
I first bought Eli (ticker symbol when Elite was on NYSE at around $4 pps in 2003-2004, more when it was at about $2 in late 2005 and a major stake in 2010, adding up until this summer.
Erroneous... I'm smart and rich and own a lot of ELTP. I bought a lot at $4 and a ton at under .20. I have a diversified portfolio managed by Wellington, real estate investments and will probably end up making more money from Elite's success than any other investment. I'm not alone. There are some very successful and wealthy individuals invested in this company.
I for one don't need a JAMA or NEJM article to show me anything about naltrexone or any of these opioids that we don't already know. Naltrexone has been safely used since the 1960s (though antagonist studies can be traced back to 1942) and opium is a drug of antiquity traced to 3'rd millennium BC. Pharmacologically, in 1806, morphine the active ingredient in opium was isolated and invented, not too long later codeine was too. In 1946 methadone was synthesized. These drugs have been studied, and re-studied and re-studied. There is nothing Elite is doing that is new, their delivery system is just brilliantly designed (and proprietary and patent protected).
I'm not sure how Elite using bunionectomy in the trial could be in any way shape or form a negative. "The pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group." Foot surgery can be extremely painful postoperatively. There is very little soft tissue surrounding the bones and swelling aggravates the nerves causing most pts a good deal of
What is nonsense? Academic debate is helpful. Let us play.
Nasrat Hakim joined Elite in August 2013 as Director, President and Chief Executive Officer. Mr. Hakim has more than 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. Prior to his leading Elite, from 2004 to 2013, Mr. Hakim was employed by Actavis, Watson and Alpharma in various senior management positions. Most recently, Mr. Hakim served as International Vice President of Quality Assurance at Actavis, overseeing 25 sites with more than 3,000 employees under his leadership. Mr. Hakim also served as Corporate Vice President of Technical Services, Quality and Regulatory Compliance for Actavis U.S., Global Vice President, Quality and Regulatory Compliance for Alpharma, as well as Executive Director of Quality Unit at TheraTech, overseeing manufacturing and research and development. In 2009, Mr. Hakim founded Mikah Pharma, LLC, a virtual, fully functional pharmaceutical company.
Mr. Hakim’s career started in Medical Laboratory Technology from the Academy of Health and Sciences in the U.S. Army based in San Antonio, TX, followed by Graduate Certification in Regulatory Affairs (RAC) from California State University at Sacramento, Sacramento, CA; Bachelor in Chemistry/Bio-Chemistry and Masters of Science in Chemistry from California State University at Sacramento, Sacramento, CA; and a Masters in Law with Graduate Certification in U.S. Taxation from St. Thomas University, School of Law, Miami, FL.
Elite is up 60% so far this week. I'm not sure how anyone could call this anything other than folks are finally starting to realize that this is a real company with a blockbuster product line that is less than 10 months away from commercialization on the first of many abuse resistant opioids and has been largely under the radar to the investment, medical and pharma industries.
Just as illustration. When I attend medical conferences with preeminent thought leaders on pain and addiction, nobody knows about Elite. When we meet with our congressman and senators (the same members actually writing and submitting legislation to combat opioid abuse and call for ART/ADT mandates) they don't know about Elite. Now some might spin that as a negative, that Elite must not have anything special if nobody knows about them. Fair enough, let the PPS and material events be the scoreboard on that as we enter into this maturation period for Elite. This technology cannot be spun and a lot of these thought leaders, politicians, clinicians and pharma folks are going to either know Elite's name or see Elite's technology branded by one of the major household pharma companies over the next couple years.
I have owned this stock since 2004 and never felt more confident in the future. There have been some major ups and downs and a couple times it seemed like bankruptcy was inevitable. There is not need to dwell on the past, to get frustrated by how poorly the company was managed and think with bewilderment how it could have actually taken this long to get to this point, but rather, focus the attention firmly on the future. The reality is that this might be the only company any of us ever invest in that rewards us with such an outrageous bounty.
Since it seems like a lot of new investors are finding out about Elite, I implore you to do your own due diligence... read Elite's press releases and SEC filings. Note the individuals who have joined this company over the last couple years - they have significant pharma experience at some of the biggest and most successful companies in the industry. These folks do not leave the aforementioned companies to work at a little pharma company in Northvale, NJ - it just doesn't work that way.
I initially invested in Elite because of their delivery system, it's simple and brilliant. As an emergency physician day in and day out we grapple with appropriate pain management and responsible prescribing. There is no silver bullet but Elite's technology is incredible and there has never been a more pivotal need for it. I have seen some individuals post on this board that it is "a perfect storm" and I couldn't agree more.
Elite will not be the only company with ART/ADT opioids, if anyone thinks that it's categorically wrong. There are a few companies -- who like Elite -- show exceptional promise. The takeaway is that only a few will exist in a multi-billion dollar market.
It's almost beyond the realm of reality to think that any of us could invest in this company at its current price per share.
What is DILLUTION? You are screaming again! Tough day?
I'm not sure how Elite using bunionectomy in the trial could be in any way shape or form a negative. "The pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group." Foot surgery can be extremely painful postoperatively. There is very little soft tissue surrounding the bones and swelling aggravates the nerves causing most pts a good deal of pain for 2-5 days following this procedure.
Lasers - What and when did Epic have an NDA approved? Thanks.
I am hesitant to give fodder to those who are spreading misinformation about Elite because I do think in the long-term this company is going deliver big-time for investors. But as an investor since 2004 I am pretty irritated with what Veerappan Subramanian may have pulled here and how Elite may or may not have let it happen.
I say “may” because there is nothing out there to prove it otherwise…Elite’s counsel; the board; or Hakim himself needs to explain why in 2014 Elite entered into a settlement agreement with Novel Laboratories, Veerappan Subramanian and VGS Pharma pursuant to the 2006 Strategic Alliance Agreement. The final agreement called for VGS to pay Elite $5,000,000 which resolved all disputes and claims between Elite and the VGS Parties.
A little over a year later, Novel's “sister” company “Gavis” was acquired by Lupin for $880M!
The issue I take with this, is that in late 2006 Elite formed Novel Laboratories with VGS Pharma (49%/50%). I have provided a link to Elite’s 2007 Annual Report which has the full details of the deal at the end of this post.
Around 2008, I recall seeing Novel form a subsidiary called Gavis Pharma. At the time is seemed to be a marketing and sales arm of Novel. I didn’t think much of it at the time, but it became increasingly obvious that Novel was now submitting their applications and growing their pipeline through Gavis. Furthemore, Novel went essentially dark. No submissions, approvals or even website updates.
Why this seems confusing to me... It seems that legal protections were in the initial agreement to mitigate this from happening.
"As long as each of Elite and VGS owns at least 10% of the shares of Class A Voting Common Stock of Novel, each shall designate one of the two directors to constitute the Novel Board of Directors, with the VGS designee to be Dr. Subramanian, unless otherwise approved by Elite. Novel is prohibited from taking of certain actions without approval of the two designees, including, but not limited to, amendments of charter, by-laws and other governance agreements, spin-offs or public offerings of equity securities, a liquidation or dissolution, dividends, authorization or issuance of additional securities or options, bankruptcy, a material change of the business or a business plan, approval of a business plan and the yearly operating budget, creation of a security interest, capital expenditures in excess of 110% of the amount provided in the business plan, investments in excess of the amounts approved in the Business Plan, an increase or decrease of the Board; and any investments by Dr. Subramanian in any competitive company or its affiliate."
I might be missing something. An addendum to the deal, something? But I can’t recall it and I can’t find it. Elite needs to explain to the shareholders, particularly those of us invested in Elite at the time of the Novel alliance what happened here… And, if they were able to get swindled by a strategic partner could Epic or someone else do the same thing?
2007 Annual Report: http://b2i.api.edgar-online.com/EFX_dll/EdgarPro.dll?FetchFilingHTML1?SessionID=fISzeCHOkWaoo-9&ID=5270803
JOINT VENTURE WITH NOVEL
In December 2006, we entered into a joint venture with VGS Pharma, LLC ("VGS") and created Novel Laboratories, Inc ("Novel"), a separate privately-held company specializing in pharmaceutical research, development, manufacturing, licensing, acquisition and marketing of specialty generic pharmaceuticals.
We acquired 49% and VGS acquired 51% of Novel's Class A Voting Common Stock for $9,800 and $10,200 respectively. We initially contributed $2,000,000 to Novel and have agreed to provide additional contributions upon the achievement of certain performance milestones of Novel to be mutually agreed to by Elite and VGS.
In March 2007, Dr. Veerappan Subramanian, Novel's CEO, provided Elite with Novel's initial business plan which identified 22 generic drug products to be developed by Novel and the proposed funding milestones for Elite's remaining contributions to Novel. Pursuant to the agreed upon plan, Elite contributed $2,000,000 on May 15, 2007 and $3,000,000 on June 15, 2007. The remaining contributions to be made by Elite shall be funded in the amounts and upon the occurrence of the following milestones: (i) $10,000,000 upon the submission to the FDA of three ANDAs related to three different prospective products developed by Novel and (ii) $10,000,000 upon the submission to the FDA of three ANDAs related to at least three additional different prospective products developed by Novel; provided that the aggregate contributions to be made by Elite shall not exceed (i) $15,000,000 prior to November 1, 2007 or (ii) $25,000,000 prior to May 1, 2008. The remaining contributions of Elite are not monetary obligations but rather conditions that must be met in order for Elite to maintain its current equity interest in Novel.
In the event that (i) Elite defers for more than 90 days the payment of a contribution installment due to Novel's failure to achieve a performance milestone, (ii) Elite fails to make a requisite contribution following Novel's achieving a performance milestone or (iii) Novel requires additional financing beyond amounts provided in the business plan or Elite's agreed upon additional contributions, Novel may seek such financing through a subscription offering to its Class A Stockholders and, to the extent not fully subscribed, from third parties.
As long as each of Elite and VGS owns at least 10% of the shares of Class A Voting Common Stock of Novel, each shall designate one of the two directors to constitute the Novel Board of Directors, with the VGS designee to be Dr. Subramanian, unless otherwise approved by Elite. Novel is prohibited from taking of certain actions without approval of the two designees, including, but not limited to, amendments of charter, by-laws and other governance agreements, spin-offs or public offerings of equity securities, a liquidation or dissolution, dividends, authorization or issuance of additional securities or options, bankruptcy, a material change of the business or a business plan, approval of a business plan and the yearly operating budget, creation of a security interest, capital expenditures in excess of 110% of the amount provided in the business plan, investments in excess of the amounts approved in the Business Plan, an increase or decrease of the Board; and any investments by Dr. Subramanian in any competitive company or its affiliate.
In the event Elite fails to make its remaining contributions after the occurrence of the relevant milestones event, VGS has the right to purchase at the original purchase price from Elite that proportion of its original shares of Novel Class A Common Stock equal to the proportion of the required additional contributions not made by Elite.
In the event of Dr. Subramanian's resignation from Novel for other than good reason or his termination by Novel for cause or his death or disability as defined in the employment agreement between Novel and Dr. Subramanian, Elite has the corresponding right to acquire up to 75% of VGS's original shares of Class A Common Stock of Novel at the original purchase price; such percentage to be reduced to 50% and 25% and 0% upon the first, second and third anniversary of the Stockholders' Agreement, with a pro rata portion of such reduction to be effected upon the death or disability of Dr. Subramanian during the applicable period. Each of Elite and VGS has a right to acquire at the then fair value, Elite's or VGS's shares of Novel upon the bankruptcy, dissolution or liquidation, a change of control of the other or, if as a result of the purchases at the original purchase price, the percentage of Novel owned by such party is less than 10% of Novel.
On June 5, 2007, the board of directors of Novel agreed to approve a stock option plan (the "NOVEL PLAN") for Novel's key employees. The Novel Plan reserves for granting under the Novel Plan 26,582 shares of Novel's Class B non-voting common stock.
On June 5, 2007, Novel granted 8,861 options to purchase Class B non-voting common shares to Veerappan Suramanian, its CEO, at an exercise price of $22.50 per share. The options vest and become exercisable at the rate of (i) 1,266 option shares on the date of each submission to the FDA of an ANDA for the first six new prospective products developed by Novel which is not the subject of any prior ANDA submitted to the FDA by Novel and (ii) 1,265 option shares on the date of approval by the FDA of a drug product that is the subject of an ANDA related to a prospective product developed by Novel which has not been previously approved by the FDA for Novel.
On June 5, 2007, Novel granted Muthusamy Shanmugam, its Head of Technical Operations, 8,861 options to purchase Novel's Class B non-voting common shares at an exercise price of $22.50. The options vest and become exercisable at the rate of 2,953 on the first, 2,954 on each of the second and third anniversary of the grant date. Novel also entered into an employment agreement with Mr. Shanmugam on June 5, 2007 to act as Novel's Head of Technical Operations. The employment agreement provides for an initial base salary of $170,000 per annum, subject to annual increases at the discretion of Novel's Board of Directors. The initial term of the agreement is three years. Novel shall have the right to terminate the agreement for cause (as defined) or for disability. If Novel elects to terminate the agreement without cause, Mr. Shanmugam shall be entitled to receive, in full satisfaction of all remaining obligations of Novel under the agreement, an aggregate amount equal to the lesser of (i) twelve months of salary or (ii) the salary for the remainder of the actual term.
Novel's business strategy is to focus on its core strength in identifying and timely executing niche business opportunities in the generic pharmaceutical area. As of June 15, Novel has 30 employees.
As of June 15, 2007, Novel has identified 22 generic product opportunities and is actively developing 11 generic products. It is Novel's general policy not to disclose the specific products in its development pipeline or the status of such products until a product reaches a stage that we determine, for competitive reasons, in our discretion, to be appropriate for disclosure.
Hopefully not...
So what you are saying is that an already tested (and widely accepted as safe) polymer is being used with an already tested (and widely accepted as safe) opioid antagonist, with an already tested (and widely accepted as safe) opioid, to create a product (soon to be FDA approved) with patent protection via the United States Patent and Trademark Office?
Well if that's the case, it looks like Elite might just send some shockwaves through the pharma industry.
Great news! The USPTO must really like all this "also ran" tech... Keep getting patent approvals.
That's very significant for Elite and efficacy. Great news.
Depomed just licensed Nucynta last week from Johnson & Johnson (US rights only) for $1 Billion. Nucynta is $150 million per year drug.
Isradapine is already being rx as off label for Parkinson's pts already. That practice will grow substantially as more positive data comes out.
You mean this one? Approximately one quarter of Actavis’ sales are generated in North America, Actavis' single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing
facilities in Elizabeth, NJ; Little Falls, NJ; Totowa, NJ; and Lincolnton, NC.
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aGPUsUfmiEbI
Actavis Inc. Reintroduces Oxycodone
Business Wire
MORRISTOWN, N.J. -- April 17, 2009
Actavis Inc. today announced the reintroduction by its Actavis Totowa
subsidiary of Oxycodone 15 mg and 30 mg tablet products to pharmacies and
customers. Oxycodone is the first product to be manufactured at Actavis’
Little Falls, NJ facility following a recently completed FDA inspection.
In December 2008, Actavis Inc. announced that it reached agreement on a
Consent Decree of Permanent Injunction with the Food and Drug Administration
(FDA) regarding the company’s Actavis Totowa LLC subsidiary. This Decree only
impacted operations at Actavis Totowa’s three facilities: two in Totowa, NJ
and one in Little Falls, NJ.
Actavis agreed to not distribute any products from the Actavis Totowa
facilities until it certified completion of certain enumerated requirements
that demonstrate compliance with FDA’s current good manufacturing practice
(cGMP) and has passed follow-up FDA inspections of the facilities.
“Through an extensive process, Actavis re-qualified all equipment and
utilities for production and packaging – and we re-qualified and revalidated
all methods used to release products from our Totowa facilities,” said Nasrat
Hakim, Vice President of Quality Compliance and Technical Services for Actavis
Inc. “This is a very positive step and took incredible team work. The next
step in the process will involve additional interaction with the FDA so that
we can continue to introduce products as outlined in the Consent Decree.”
The FDA completed its inspection and approved the release of the first two
products as outlined in the Decree: Oxycodone 15 mg and 30 mg tablets.
Subsequent inspections, also as outlined in the Decree, will follow.
“Our customers come first,” said Doug Boothe, CEO of Actavis Inc. “We are
sorry for the inconvenience the recall caused for some but as a company, we
are committed to producing high quality pharmaceuticals, and that’s what we
will continue to do.”
Actavis, a leading manufacturer of generic pharmaceuticals, announced a
voluntary product recall in August 2008 after determining that three of its
facilities did not meet the highest standards for quality manufacturing.
Following the recall, the company enacted a comprehensive remediation program
and engaged an outside firm to assess Actavis Totowa facilities.
“Our long and successful history with Oxycodone made it the right medication
to produce first,” added Boothe. “It is one of the many quality products that
Actavis will have back on the market in the coming months and we are pleased
that our customers have responded so positively to its reintroduction.”
About Actavis Inc.
Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one
quarter of Actavis’ sales are generated in North America, Actavis' single
largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing
facilities in Elizabeth, NJ; Little Falls, NJ; Totowa, NJ; and Lincolnton, NC.
Actavis also has a research and development facility in Sunrise, FL and a
packaging facility in Totowa, NJ. For more information, please visit
www.actavis.us.
About Actavis Group
Actavis is one of the world’s leading generic pharmaceutical companies
specializing in the development, manufacture and sale of generic
pharmaceuticals. Based in Iceland, the company has operations in 40 countries,
with more than 10,000 employees.
I would frame it another way... What did Hakim give Elite? I think we are going to be hearing pretty soon.
Best of luck in your investment. We obviously come from two different schools of thought. At least what we have in common is we'll make a lot of money.
How is any of that speculation?
An efficacy study of this size will take 2-3 months and does not affect the approval timeline, just the filing timeline. This 2-3 months would be built in down the road even after filing in December. It is a moot point.
I agree Hakim should never had said December and I imagine Camargo should get a ding for that. I don't argue with you on that. The reality is, the filing is imminent.
This is a double-edged sword. You have a CEO that is not transparent and everyone is up in arms because they don't feel informed, then you have a CEO like Hakim who is trying to be as transparent with shareholders as possible and they throw him to the dogs when he sets a date that might be off by a few weeks or a couple months. This is the pharma sector and a company dealing with the FDA. An astute investor would understand that. Perhaps it will take getting off the OTC to Elite having an investor pool that actually understands how pharma product development works. In the interim people can either listen to the noise or block it out knowing what is truly going on here, which is all positive. I have been invested in Elite for over a decade and have never felt better about my investment.
No it would not be a material event and not PR'd.
Also, while Elite might have simply not heard back yet from the FDA, there is just as much of a chance that they have heard back, that an efficacy study is required, and launched the study. We would not know.
Yes, in the previous conference call. If someone has the transcript they can share the direct quote. I do not have the transcript.
Two things ought to be clarified here based on recent posts...
Efficacy studies, if needed, are not a surprise. The FDA has been burned by every ART/ADT product thus far and are just protecting themselves downstream if is something happens. That said, nobody knows if the FDA has even gotten back to Elite since the 11/18 meeting. What we do know is that Elite is ready to file and they will not do so until they hear back from the FDA that they meet the filing requirements. This is a very smart approach to filing and we can thank Carmargo -- who has prior FDA reviewers and staffers on its' own staff -- for such guidance. The filing could happen at anytime. If Elite is required to do an efficacy study, the study design and plan has been prepared by Elite, Carargo and CFI Lifetree. This study should take three months at most and does not impact the actual timeline for final approval. In addition, Elite has been told they will receive designated expedited review from the FDA. Things will move very fast. Most importantly, all the prior BE data data tells us the efficacy studies will be successful. These are very well known, clinically acceptable analgesics, pain relievers and an opiate antagonist that have been used for decades. The FDA knows this, because they have approved each one. Lastly, the positive HAL studies will tell us why the this delivery system will be embraced by the clinical community and penetrate this market rapidly.
In regards to Elite's generics. The majority of those will never be produced and it has been and still is posturing. A couple decent money makers are certainly lined up (Isradapine and TBD) to ensure cash was coming in while they worked on their first submission, but I believe after Elite secured the financing they needed, the majority of generics were truly put on the back burner. People harping on these generics are missing the bigger picture of why Hakim was brought on board at Elite. For those that cannot connect the dots, I will simplify it, for the full story is complicated, years in the making and spiderwebs to many places. But to put it simply, he is here to launch a full line of abuse deterrent painkillers. The first of those will be filed soon and approved and the set the stage for a little unknown company to jolt the pharma industry.
I know! I can't wait for Elite's ART to "barely get approved" by the FDA...
Actually I have read all of the patents. I also know they have been approved. Not barely. But approved.
The inventor of Elite's patents is right where he deserves to be right now. If he had the same business acumen that he had in the lab this would be a different story but he nearly bankrupted this company and hindered its' growth for years.
Barely got through the USPTO? Did they not get the patents?
Yes, they did get the patents...
U.S.
ELITE PHARMACEUTICALS GRANTED NEW PATENT FOR ABUSE DETERRENT TECHNOLOGY - http://www.elitepharma.com/investor_relations.asp?goto=383
ELITE PHARMACEUTICALS AWARDED SECOND U.S. PATENT FOR ABUSE RESISTANT DRUG FORMULATION -http://www.elitepharma.com/investor_relations.asp?goto=357
ELITE PHARMACEUTICALS ANNOUNCES ISSUANCE OF U.S. PATENT FOR ABUSE RESISTANT ORAL DOSAGE FORMULATION - http://www.elitepharma.com/investor_relations.asp?goto=344
Canada/Europe
Elite Pharmaceuticals Awarded Second Canadian Patent for Abuse Deterrent Drug Formulation -
http://www.elitepharma.com/investor_relations.asp?goto=391
Elite Pharmaceuticals Expands Abuse Deterrent Technology Patent Portfolio Internationally - http://www.elitepharma.com/investor_relations.asp?goto=379
Or a patent issuance is a material event which a company is obligated to PR due to SEC regs.
Ok. Not worth much more time on this. I have colleagues treating patients with isradapine at my hospital because it works to slow the progression of PD.
Actually you conveniently skipped over phase II (with human subjects) and forgot to mention it is going into phase III.
http://www.ncbi.nlm.nih.gov/pubmed/24123224
Abstract
Isradipine, a dihydropyridine calcium channel antagonist, has been shown to be neuroprotective in animal models of Parkinson's disease (PD). To establish a dosage of isradipine controlled-release (CR) that is tolerable and demonstrates preliminary efficacy for use in a future pivotal efficacy trial a Phase 2, randomized, double-blind, parallel group trial (Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease [STEADY-PD]) was undertaken in subjects with early PD not requiring dopaminergic therapy (dopamine agonists or levodopa) randomized 1:1:1:1 to 5, 10, or 20 mg of isradipine CR or matching placebo daily. The primary outcome was tolerability defined as no more than a 30% difference in the proportion of patients completing the study on the originally assigned dosage between an active and placebo group. If more than one isradipine dosage was tolerable, then a 3-point difference in total Unified Parkinson's Disease Rating Scale (UPDRS) change between baseline and week 52 (or time to sufficient disability to require dopaminergic therapy) was taken as a criterion for selection of the most desirable dosage for future study. STEADY-PD enrolled 99 subjects. The tolerability of isradipine was dose dependent: placebo, 25 of 26 patients (96%); 5 mg, 19 of 23 patients (83%); 10 mg 19 of 26 patients (73%); and 20 mg 9 of 24 patients (37%). There was no difference in change in UPDRS among dosages. The most common adverse events were peripheral edema (30) and dizziness (24). Isradipine 10 mg daily was the maximal tolerable dosage in this study of early PD. A large placebo-controlled trial will be necessary and is planned to assess efficacy of isradipine 10 mg daily to slow progression of PD disability.
© 2013 International Parkinson and Movement Disorder Society.
http://www.urmc.rochester.edu/news/story/index.cfm?id=4042
Researchers Set to Launch Phase 3 Trial for Parkinson’s
April 02, 2014
A $23 million grant from the National Institutes of Health will support a new Phase 3 clinical trial to evaluate the drug isradipine as a potential new treatment for Parkinson’s disease. The study is being co-lead by the University of Rochester and Northwestern University.
“Isradipine has been demonstrated to be safe and tolerable in patients with Parkinson’s disease,” said University of Rochester School of Medicine and Dentistry neurologist Kevin Biglan, M.D., co-principal investigator of the study. “This new study will determine whether the drug can be an effective tool in slowing the progression of the disease and could, thereby, complement existing symptomatic treatments and improve the quality of life of individuals with the disease.”
“If it proves to be effective, this drug will change the way we treat Parkinson’s disease, and the major advantage of it is that isradipine is already widely available, inexpensive and will allow for rapid translation of our research into clinical practice,” said Tanya Simuni, M.D., principal investigator of the study, professor of neurology at Northwestern University Feinberg School of Medicine. “Although we now have very effective symptomatic treatments to manage Parkinson’s, the development of a disease-modifying intervention remains a critical goal.”
Isradipine is a Food and Drug Administration-approved drug to treat high blood pressure. Researchers suspect that the drug may also be effective in treating Parkinson’s for a couple reasons. First, population scale studies have shown that people taking the drug for high blood pressure have a lower incidence of Parkinson’s disease. Additionally, isradipine is in a category of drugs called calcium channel blockers, meaning they inhibit certain cellular functions. Researchers speculate that overactive calcium channels may play a role in the death of the dopamine producing cells in the brain that is one of the hallmarks of Parkinson’s.
Parkinson's disease is a progressive neurological disorder that erodes an individual’s control over their movements and speech. Over time, Parkinson’s patients experience stiffness or rigidity of the arms and legs, slowness or lack of movement, and walking difficulties, in addition to tremors in their hands, arms, legs, jaw or face.
A Phase 2 evaluation of isradipine, which was conducted to determine the safety and appropriate dosage for the drug, was completed in 2012. The study was funded by a $2.1 million grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF), which also supported preclinical research into the effects of isradipine on Parkinson’s progression by Northwestern University.
“Our de-risking model quickly advances promising research ideas toward larger investment and, thereby, closer to clinical application,” said MJFF CEO Todd Sherer, Ph.D. “The NIH funding to continue testing of isradipine brings us one step closer to a disease-modifying therapy that could make a real difference in the lives of millions.”
The new clinical trial – titled STEADY-PD3– will recruit 336 individuals with Parkinson’s disease at 56 sites throughout North America, including the University of Rochester. The study – which is scheduled to begin recruiting Parkinson’s patients later this year – will follow the participants for three years. The primary goal of the study is to determine whether the drug can slow the progression of the disease.
Physicians currently have several tools at their disposal that enable them to effectively manage the symptoms of the disease for a period of time, however, no treatment exists that can slow the progressive deterioration of function. Consequently, many patients diagnosed with Parkinson’s will experience a “honeymoon” period of two to five years during which existing treatments can essentially help them to lead a normal life. But over time, these treatments become less effective.
One of the goals of Parkinson’s research is to identify new therapies – such as isradipine – that could slow the advance of the disease by keeping the brain’s dopamine-producing cells healthier for a longer period of time. Researchers believe that the development of disease modifying approaches – commonly referred to as neuroprotection – and new ways to monitor the progress of the disease when complemented with existing symptom-managing therapies could help hold disability at bay.
“We have good early stage treatments for the symptoms of Parkinson’s disease and individuals who have problems with mobility and coordination can often get back to where they can function at a very high level,” said Biglan. “However, over the long term problems arise due to disease progression and people become less responsive to therapy. If you could slow the progression sufficiently enough, then with existing symptomatic treatments you could manage Parkinson’s symptoms quite well over a much longer period of time.”
STEADY-PD3 – which is being funded by the National Institute of Neurological Disorders and Stroke – will involve researchers from the Parkinson Study Group , which was founded in 1986 and consists of more than 400 active investigators, coordinators, and scientists located at 126 institutions throughout the United States and Canada. The University of Rochester’s Center for Human Experimental Therapies will provide project management and data coordination for the study and David Oakes, Ph.D., with the Department of Biostatistics will serve as lead biostatistician. Carematix will support clinical trial operations including data management and real time uploading of blood pressure readings from patients at home. Verizon Enterprise Solutions will provide the communications technology that enables the exchange of data so that patient information can be securely transmitted to researchers for analysis and interpretation.
These pts don't have time to wait and neurologists know it. They have been off label rx Isradapine for years now for PD In fact, our hospital is one of the original trial sites for the STEADY (Safety, Tolerability, and Efficacy Assessment of Dynacirc for PD). The trial team saw it slowing progression first-hand and implemented it into their practices as a mode of treatment.
Isradapine is being off label rx currently for Parkinson's pts.
Podcast: Drug That May Slow Parkinson’s Progression Granted $23 Million from NIH for Phase III Testing
https://www.michaeljfox.org/foundation/news-detail.php?podcast-drug-that-may-slow-parkinson-progression-granted-23-million-from-nih-for-phase-iii
After proving safe in a study funded by The Michael J. Fox Foundation (MJFF), the compound isradipine is moving to Phase III testing of its effect on Parkinson’s disease (PD) thanks to a $23 million grant from the National Institutes of Health (NIH).
When recruitment begins later this year, this trial will be the most advanced, current study into a disease-modifying therapy for Parkinson’s.
Isradipine is a calcium channel blocker currently prescribed to treat high blood pressure. Data from large studies note a lower incidence of PD among people who take this drug.
“In these epidemiological studies there was approximately 30 percent less risk of developing Parkinson’s in the subgroup of patients treated with this class of drugs for blood pressure,” said Tanya Simuni, MD, director of the Parkinson’s Disease and Movement Disorders Program at Northwestern University and principal investigator of this study.
The NIH funding will move the Safety, Tolerability and Efficacy Assessment of Dynacirc® for PD (STEADY-PD) study into Phase III efficacy testing. Dynacirc® is the commercial name of the isradipine hypertension drug. Simuni and the Parkinson Study Group hope to enroll more than 300 participants at 56 clinical sites throughout North America.
MJFF began funding isradipine research in 2007 with support for a project from D. James Surmeier, PhD, also of Northwestern University, looking at the compound’s neuroprotective effects in PD models. The NIH also funded Surmeier’s pre-clinical work into this compound.
In 2008, the Foundation granted STEADY-PD $2.1 million for the Phase II clinical trial, and researchers published results in September 2013 in the Movement Disorders journal showing that isradipine is safe and tolerable in PD patients. They also determined the maximal, tolerable dosage (10 mg daily).
Drug repurposing — studying a small molecule or compound approved to treat one disease for its effect on another — speeds a drug into clinical trials and hastens approval from the U.S. Food and Drug Administration because detailed information on its pharmacology, formulation and safety is already available and has been reviewed.
“The way I think about it is when I get into the city for work, sometimes I wind up on the local train and it stops 20 times before I get into the city and sometimes you get that golden express train and there’s only one stop,” said MJFF CEO Todd Sherer, PhD. "That’s exactly what we’re trying to do here."