Elite Pharmaceuticals Inc (ELTP)

[Hike]

Just to keep the home fires burning while we wait on the FDA "prior reviews"....

Let's talk about Isradipine today.

When will it launch? How much is it worth?

Some info to bring you up to speed:

http://www.drugs.com/mtm/isradipine.html

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On June 6th:
http://www.evaluatepharma.com/Universal/View.aspx?type=Story&id=246966

Elite Pharmaceuticals, Inc. announced that it has entered into a commercial Manufacturing and Supply Agreement with Mikah Pharma, LLC (Mikah). Under the terms of the agreement, Elite will perform the laboratory stability studies, manufacturing and packaging for two generic products: Isradipine Capsules USP, 2.5 mg and 5 mg and Phendimetrazine Tartrate Tablets USP, 35 mg. Elite will be compensated at an agreed upon transfer price for the manufacturing and packaging of the products. For the Isradipine product, Elite will receive a 10% royalty on net profits of the finished products. Elite will also receive a onetime payment for each product for the work associated with the technology transfer.

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http://thepharmaceutical-news.com/elite-enters-manufacturing-supply-agreement-mikah-pharma

Isradipine capsules were originally marketed by SmithKline Beecham under the brand name Dynacirc; however, these have since been discontinued, although a 5 mg and 10 mg extended-release tablet version is marketed by GlaxoSmithKline under the brand name Dynacirc CR. Mikah’s generic 2.5 mg and 5 mg capsule version of isradipine was approved by the FDA in April 2006, and shares the market with Watson Laboratories, whose version was approved in January 2006.

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From Aug 2011 10Q

Contract Manufacturing of Isradipine and Phendimetrazine On June 1, 2011, Elite Pharmaceuticals Inc. ("Elite") executed a Manufacturing and Supply Agreement (the "Isradipine/ Phendimetrazine Agreement") with Mikah Pharma, LLC ("Mikah") to undertake and perform certain services relating to two generic products: Isradipine Capsules USP, 2.5 mg and 5 mg ("Isradipine") and Phendimetrazine Tartrate Tablets USP, 35 mg ("Phendimetrazine"), including (a) developing and preparing the documentation required for the transfer of the manufacturing process to Elite's facility and the appropriate regulatory filing for the ANDA, and (b) manufacturing finished dosage forms appropriate for commercial sale, marketing and distribution in the United States of America, its territories, possessions, and commonwealths in accordance with the requirements of the Isradipine/ Phendimetrazine Agreement; Elite shall perform, at its sole cost and expense, all Technology Transfer, validation and qualification services (including: equipment, methods and facility qualification), validation and stability services required by Applicable Laws to commence manufacturing Isradipine and Phendimetrazine for commercial sale by Mikah or its designees in accordance with the terms of the Isradipine/ Phendimetrazine Agreement. During the term of the Isradipine/ Phendimetrazine Agreement and subject to the provisions herein, Mikah shall purchase from Elite and Elite agrees to manufacture and supply solely and exclusively to Mikah, such Isradipine and Phendimetrazine as Mikah may order from time to time pursuant to the Isradipine/ Phendimetrazine Agreement. Mikah will compensate Elite at an agreed upon transfer price for the manufacturing and packaging of Isradipine and Phendimetrazine. For the Isradipine product, Elite will also receive a 10% royalty on net profits of the finished Product. The payment is to be calculated and paid quarterly. Elite will also receive a onetime milestone payment for each Product for the work associated with the Technology transfer. The milestone payment shall be made upon the successful manufacturing and testing of the exhibit batch. The Isradipine/ Phendimetrazine Agreement has a term of five (5) years and shall automatically renew for additional periods of one (1) year unless Mikah provides written notice of termination to Elite at least six (6) months prior to the expiration of the Term or any Renewal Term. Transfer of the manufacturing site to the Northvale Facility, a prerequisite of commercial launch of Isradipine and Phendimetrazine is currently in progress.


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The worldwide market is said to be $79,000,000 (https://w.evaluatepharma.com/secure/Login.aspx?ReturnUrl=%2fUniversal%2fView.aspx%3ftype%3dEntity%26entityType%3dProduct%26id%3d4300%26lType%3dmodData%26componentID%3d1003%26tabId%3d&CanUseGuest=True&CookieTest=True)

, but the US generic market is said to be only $3,000,000. (http://www.ftc.gov/os/caselist/0710063/0710063analysis.pdf)

I am unsure as to number of manufacturers, but not many as Actavis almost had "monopoly" (see: http://www.ftc.gov/os/caselist/0710063/0710063analysis.pdf) on it.

There is one brand name, Dynacirc (Reliant Labs) and one generic made by Abrika.

There are two generics. Abrika was bought by Actavis in 2006. Abrika was required to divest themselves of the Isradpine and sell it to Cobalt Labs)

Brand names:
Clivoten (Italfarmaco (Italy))
DynaCirc (Novartis (Hong Kong, Malaysia, Mexico, New Zealand, South Africa, Singapore, Thailand, Turkey, United States))
Dynacirc CR (Reliant, GlaxoSmithKline)
DynaCire
DynaCire CR
Dynacrine
Esradin (Sigma-Tau (Italy))
Lomir (Novartis (Austria, Brazil, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Netherlands, Norway, Poland, Russia, Sweden), Sankyo (Belgium, Italy), Daiichi Sankyo (Portugal, Switzerland), Mizar (Spain))
Prescal (Novartis (United Kingdom))
Rebriden
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As Mikah "is" Actavis, basically Actavis is outsourcing the manufacture of Isradipine to Elite. Or Actavis sold Isradipine to Mikah and in turn Mikah is outsourcing production to Elite.

Final notes:
1) Isradipine may find new life as a treatment for Parkinsons:
http://parkinsonsfocustoday.blogspot.com/2009/02/future-of-isradipine-and-parkinsons.html

2) It appears that Actavis may be actively divesting itself of it's generics as it transforms itself....see:
http://health.yahoo.net/news/s/nm/actavis-prepares-for-end-of-generic-drugs-model

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My guess is that, if the USA generics market = $3,000,000 and they share it with Cobalt we are talking maybe $1,500,000 in sales for Elite/Mikah. Elite gets 10% royalties + manufacturing, milestones etc. This mean that Isradipine might be worth perhaps $400,000/year in income to Elite. Now perhaps they think they will take market share from the branded product Dynacirc, or that the Parkinson's angle might provide growth or maybe they see a chance of exporting as the worldwide market is quite large. I don't think Isradipine will be real huge for Elite but they all add up.

Thoughts? Any thoughts on how long the ANDA transfer could take?