Elite Pharmaceuticals Inc (ELTP)

[Couch]

I'll present a few key articles for those interested in the broader discussions surrounding the prescription abuse epidemic. First and foremost for investors here beyond how quickly Elite is able to launch Eli 200 is how quickly will insurance companies begin to cover ADT opioids? Another topic is if you were a medical doctor would you be more comfortable prescribing non ADT or ADT opioids? As you will see the answer is not so easy. Cost/benefit analysis for patients come into play.

***** ~ On this note, so far I believe Massachusetts, Maryland, Colorado and Utah have insurance plans that cover the cost of ADT opioids. Maine looks to have a similar bill that is going to be enacted. Beyond this 23 other states have similar bills that may or may not become law.

http://claad.org/wp-content/uploads/2015/05/ADF-Summit-presentation-150505.pdf

One thing is for certain as more and more opioids are prescribed the prescription abuse epidemic is only going to get worse. Clearly, ADT opioid are only but one factor impacting the discussion. Still, additional states will begin to cover the costs of ADT opioids. Another thing is clearly once you wrap your head around these various articles. ADT opioids are only in their infancy with less than 2% being prescribed. Elite is in the midst of the perfect storm and I do believe now is the perfect time to buy IMO only.

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=77479&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0

After skimming these articles, I'd urge you to consider formulating a question or two for Elites' management to answer. Here is the upcoming CC date with a few already formulated questions that I hope will be asked. To me its an exciting time to be an investor of Elite.

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=77527&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939

A few Questions that deserve asking IMO:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114559205

1) Medicare Drug Plans Favor Generic Opioids Over Those Designed To Avoid Abuse, Study Finds

The abuse of prescription painkillers is a growing problem for seniors, as it is for other age groups. But Medicare drug plans are cutting back on coverage for a specially designated type of painkiller that deters abuse in favor of cheaper generics that don’t have the same deterrent qualities, a new study found.

Despite its abuse-deterrent labeling, OxyContin’s coverage rate in the Medicare drug plans, sometimes called Part D plans, dropped from 61 percent in 2012 to 33 percent in 2015, the study found.

“But they’re never going to be the same price as a generic,” she says. “At some point, payers or policymakers need to decide whether they’re willing to pay a premium to avoid abuse.”

2) Abuse-Deterrent Technologies

http://www.practicalpainmanagement.com/painscan/201506/abuse-deterrent-technologies

Abuse-Deterrent Formulations
Academic researchers and pharmaceutical companies also have taken ownership and a stake in the prevention of abuse, misuse, diversion, and overdose of prescription opioids. “While prescription opioids are an important component of pain management, abuse and misuse of these products have resulted in too many injuries and deaths across the United States,” said Douglas Throckmorton, MD, Deputy Director for Regulatory Programs in the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research. “An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse.”

Studies of cost-effectiveness also will be necessary in addition to studies of efficacy, safety, and abuse deterrence. The acceptance of newer abuse-deterrent drug formulations will require endorsement from clinicians, patients, governmental agencies and third-party payors who typically favor less expensive, non-abuse deterrent generic opioids on their formularies. In order for these agents to be widely prescribed, insurers will need to cover tamper-resistant opioids without the expected roadblocks of lengthy preauthorizations or higher copays. As more postmarketing data about the effectiveness of ADFs becomes available, insurers will be better able to calculate the pharmacoeconomic benefits of these agents in order to justify the additional upfront expense.

Next on Patch » Summer Sunset Lecture Series Pt. 1 - Geology
OP ED: Our Bills Would Increase Access to Opioid Meds With Abuse Deterrent Formulations

http://patch.com/rhode-island/tiverton/op-ed-our-bills-would-increase-access-opioid-meds-abuse-deterrent-formulations

Simply put, ADF medications have the ability to stop addicts from their abusive methods. The opioid market is flooded with cheap, non-abuse-deterrent opioids. Only two-percent of prescribed opioids have any abuse-deterrence. And every day, hundreds of prescriptions for abuse-deterrent formulations are being switched for the non-abuse-deterrent. We have to do better and this legislation enables us to do just that.

3) Abuse-Deterrent Opioids Are Worth The Cost

States across the country are considering legislation concerning abuse-deterrent opioids. And, for good reason.

Although opioid abuse is a major problem, opioids are an important therapy for tens of millions of Americans every year. Many people only require opioid therapies for a short-time, while others who suffer from chronic pain require therapy for the long-term. Chronic pain is a debilitating and costly affliction – estimated to cost over $635 billion a year. It is, therefore, imperative that opioid medications are available to those who need it.

Prescribing abuse-deterrent opioids implies that many patients will be switching from lower-priced generic drugs to higher-priced patented drugs – at least until generic versions of abuse-deterrent formulations become available. The question naturally arises: are the current higher prices for abuse-deterrent opioids worth the expense?

The EconoSTATS study then compared these benefits against the current higher price of abuse-deterrent opioids. The study compared the costs and benefits on a per patient basis. On a per patient basis, and adjusting for abuse reductions associated with the drug, the total annual benefits created by abuse-deterrent opioids are around $4,600. Patented opioids only cost between $600 and $2,800 more than generic versions annually, depending upon the assumptions used.

Therefore, the use of abuse-deterrent opioids creates annual net benefits (benefits minus the additional costs) of between $1,800 and $4,000.

4) Medical cost savings associated with an extended-release opioid with abuse-deterrent technology in the US

http://www.researchgate.net/profile/Edward_Michna/publication/260373049_Medical_Cost_Savings_Associated_with_an_Extended-Release_Opioid_with_Abuse-Deterrent_Technology_in_the_U.S/links/53ecc8b90cf2981ada10e7ca.pdf

Conclusions:
This study provides evidence that reformulated ER oxycodone has been associated with reductions in abuse rates and substantial medical cost savings. Payers and policy-makers should consider these benefits as they devise and implement new guidelines and policies in this therapeutic area.

This study provides evidence that reformulated ER oxy- codone with abuse-deterrent technology has yielded sub- stantial health and economic benefits in the US, with annual savings in direct medical costs of ??$430 million. Payers and policymakers should consider these benefits as they devise and implement new guidelines and policies in this therapeutic area.

Transparency
Declaration of funding
This study was funded by Purdue Pharma, L.P.

5) Prescription Opioid Abuse: Challenges and Opportunities for Payers

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3680126/#R11

Promoting the use of opioid formulations that potentially minimize abuse

Individuals who abuse RxOs often do so by crushing and injecting, snorting, or chewing oral formulations. Several opioid formulations have been designed to prevent or reduce these forms of abuse, including two that have been approved by the US Food and Drug Administration (4, 37, 38), although the abuse deterrence of these formulations is not supported by claims in the label. Because approval of these formulations is recent, data regarding their potential benefits are not available yet. A budget impact model to quantify the potential cost savings associated with a hypothetical opioid formulation designed to resist or deter common methods of extraction estimated potential cost savings to third party payers at 0.6 to 1.6 billion dollars per year (11).

6) Doctors Among Dozens Held in Raids Against Illegal Sales of Prescription Drugs

http://www.nytimes.com/2015/05/21/us/doctors-among-dozens-held-in-raids-against-illegal-sales-of-prescription-drugs.html?ref=topics

Seven doctors and 41 others in four Southern states were arrested Wednesday in raids by Drug Enforcement Administration agents, officials said, part of what the agency called its largest operation against illegal trafficking of prescription drugs. The raids came after a 15-month investigation by the agency, which focused on the illegal sale and distribution of painkillers including oxycodone and hydrocodone and the tranquilizer Xanax.

“I’m not naïve, to tell you that this is going to solve the problem,” Mr. Thyer said. “Oxycodone and hydrocodone are still available on the streets today. This did not fix the problem.”