$ELTP purchased 12 ANDAs from Mikah for a mere $10 mil which is $840K per ANDA.
A mere $840 thousand per ANDA, of which, one is not yet approved and 10 others sit collecting dust.
Here's how the great JT dealt with Mikah:
Hydromorphone $225,000 Naltrexone $200,000 -------------------- Cost for both: $425,000
These are two of Elites most important generics. Hydromorphone was acquired May 2010 and launched March 2012. Naltrexone was acquired Aug 2010 and launched Sep 2013. This timeframe included an FDA reclassification which delayed approval, for which the company recorded an impairment equal to the total purchase amount. These 2 were the remaining cherries of the Mikah ANDA collection. JT already had an agreement in place to manufacture phendimetrazine and isradipine for Mikah. He already had the four best Mikah ANDA's sewn up. The rest are garbage not even worth $100,000 each. If they were any good, either JT would've grabbed them up in 2011-12 or Elite would be marketing them by now. $840,000 each is thievery. Give it back.
2012 Annual Statement:
Elite’s Purchase of a Generic Hydromorphone HCl Product
On May 18, 2010, Elite executed an asset purchase agreement with Mikah Pharma LLC (“Mikah”) (the “Hydromorphone Agreement”). Pursuant to the Hydromorphone Agreement, the Company acquired from Mikah an ANDA for Hydromorphone Hydrochloride Tablets USP, 8 mg (“Hydromorphone 8mg”) for aggregate consideration of $225,000, comprised of an initial payment of $150,000, which was made on May 18, 2010. A second payment of $75,000 was due to be paid to Mikah on June 15, 2010, with the Company having the option to make this payment in cash or by issuing to Mikah 937,500 shares of the Company’s Common Stock. The Company elected and did issue 937,500 shares of Common Stock during the quarter ended December 31, 2010, in full payment of the $75,000 due to Mikah pursuant to the asset purchase agreement dated May 18, 2010. Please refer to the Current Report on Form 10Q filed with the Securities and Exchange Commission (“SEC”) on November 15, 2010 for further details on the Hydromorphone Agreement, with such filing being herein incorporated by reference. 5 On May 31, 2011, the Company received a letter from the FDA responding to a Changes Being Effected in 30 Days (“CBE 30”) supplement filed by the Company with the agency to change the manufacturing and packaging location of the Hydromorphone Hydrochloride Tablets USP, 8 mg ANDA purchased from Mikah Pharma. The letter from the FDA informed the Company that the agency has reclassified the application as a prior approval supplemental application which has delayed the commercialization. On January 23, 2012, the Company received a letter from the FDA approving the application. As a result of the delay in commercialization resulting from the reclassification of the Company’s application, the Company recorded an impairment of the ANDA asset acquired from Mikah Pharma pursuant to the Hydromorphone Agreement in an amount equal to the entire purchase price of the acquisition. Please refer to the Current Reports on Form 8-K filed with the SEC on May 24, 2010, June 6, 2011 and January 27, 2012 for further details on Hydromorphone 8mg, with each of such filings being herein incorporated by reference.
Elite’s Purchase of a Generic Naltrexone Product
On August 27, 2010, Elite executed an asset purchase with Mikah (the “Naltrexone Agreement”). Pursuant to the Naltrexone Agreement, Elite acquired from Mikah the ANDA number 75-274 (Naltrexone Hydrochloride Tablets USP, 50 mg), and all amendments thereto, that have to date been filed with the FDA seeking authorization and approval to manufacture, package, ship and sell the products described in this ANDA within the United States and its territories (including Puerto Rico) for aggregate consideration of $200,000. In lieu of cash, Mikah agreed to accept from Elite product development services to be performed by Elite. On December 14, 2011, the Company received an email from the FDA responding to a Changes Being Effected in 30 Days (“CBE 30”) supplement filed by the Company with the agency to change the manufacturing and packaging location of the Naltrexone Hydrochloride Tablets USP, 50 mg ANDA purchased from Mikah Pharma. The e-mail from the FDA informed the Company that the agency has reclassified the application as a prior approval supplemental application which will delay the commercialization. The Company has been notified by the FDA that its filing is under review. As a result of the delay in commercialization resulting from the reclassification of the Company’s application, the Company recorded an impairment of the ANDA asset acquired from Mikah Pharma pursuant to the Naltrexone Agreement in an amount equal to the entire purchase price of the acquisition.
Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)
