ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Files An 8-K Regulation FD DisclosureItem 7.01
On July 7, 2017, in a press release, Elite Pharmaceuticals, Inc., or Elite, reported topline results from a pivotal bioequivalence fed study for SequestOx™(oxycodone hydrochloride and naltrexone hydrochloride), Elite’s investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The mean Tmax of SequestOxTM was 4.6 hr with a range of 0.5 hr to 12 hr and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr with a range of 0.5 hr to 12 hr. A key objective for the study was to determine if the reformulated SequestOxTM had a similar Tmax to the comparator when taken with a high fat meal. Elite will pause, not proceed with the rest of the clinical trials, and seek clarity from FDA before deciding on the next steps for immediate release SequestOxTM. Elite will continue to pursue extended release products with its proprietary abuse deterrent technology
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of Elite’s filings under the Securities Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Caution Concerning Forward Looking Statements
This Current Report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, Elite’s ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOx™ by the FDA, the steps Elite may take as a result of the CRL, the results of an End of Review Meeting and what actions the FDA may require of Elite in order to obtain approval of the NDA. These forward-looking statements are not guarantees of future action or performance. These risks and other factors, including, without limitation, Elite’s ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Elite’s ability to operate as a going concern, are discussed in Elite’s filings with the Securities and Exchange Commission, including its reports on Forms 10-K, 10-Q and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
| Item 9.01 | Financial Statements and Exhibits. |
| 99.1 | Press Release dated July 7, 2017 |
ELITE PHARMACEUTICALS INC /NV/ ExhibitEX-99.1 2 v470524_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Elite Pharmaceuticals Reports Topline Results from a Pivotal Fed Bioequivalence Study for SequestOx™ NORTHVALE,…To view the full exhibit click here
About ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP)
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company. The Company is principally engaged in the development and manufacture of oral, controlled-release products. The Company develops and manufactures generic products, products using controlled-release drug technology, products utilizing abuse deterrent technologies, and it develops and markets generic controlled-release and abuse deterrent pharmaceutical products. Its segments include Abbreviated New Drug Applications (ANDA’s) for generic products and New Drug Applications (NDA’s) for branded products. The Company owns approximately six different approved ANDA’s. The Company’s product, SequestOx, is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone, which incorporates five milligram, 10 milligram, 15 milligram, 20 milligram and 30 milligram doses of oxycodone into capsules. SequestOx is used for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.