Form 8-K - Current report

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

October 10, 2024

Date of Report (Date of earliest event reported)

 

ELITE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Nevada		001-15697		22-3542636
(State or other jurisdiction		(Commission		(IRS Employer
of incorporation)		File Number)		Identification No.)

 

165 Ludlow Avenue, Northvale, New Jersey 07647

(Address of principal executive offices)

 

[phone]

(Registrant’s telephone number, including area code)

 

 

 

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		ELTP		OTCQB

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On October 10, 2024, Elite Pharmaceuticals Inc. (“Elite”) announced the Israeli Ministry of Health approval for Elite’s generic version of Adderall®, an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 10 mg, 20 mg, and 30 mg tablets on October 7, 2024.

 

Elite will supply the product to Dexcel Pharma (Or Akiva, Israel), the Company’s exclusive distributor, for the Israeli market. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

 

Under the License and Distribution Agreement with Dexcel, Elite will manufacture and package the generic product under Dexcel’s label. Dexcel will provide sales, marketing, and distribution at its expense. Dexcel will pay an agreed upon transfer price for the product and share profits under certain conditions. Elite’s generic Adderall® product is jointly owned by Elite and Mikah Pharma LLC. The first shipment is dependent on the timing of licensee orders, DEA quotas and manufacturing which could take months.

 

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.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release dated October 10, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: October 10, 2024	ELITE PHARMACEUTICALS, INC.
	By:	/s/ Nasrat Hakim
		Nasrat Hakim, President and CEO

 

 

 

Exhibit 99.1

 

 

Elite Pharmaceuticals’ Generic Adderall^® Receives Marketing Approval from the Israeli Ministry of Health

 

NORTHVALE, N.J. – October 10, 2024 – Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCQB: ELTP), a specialty pharmaceutical company developing niche generic products, today announced the Israeli Ministry of Health approval for Elite’s generic version of Adderall^®, an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 10 mg, 20 mg, and 30 mg tablets. Elite will supply the product to Dexcel Pharma (Or Akiva, Israel), the Company’s exclusive distributor, for the Israeli market. The product is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

 

Under the License and Distribution Agreement with Dexcel, Elite will manufacture and package the generic product under Dexcel’s label. Dexcel will provide sales, marketing, and distribution at its expense. Dexcel will pay an agreed upon transfer price for the product and share profits under certain conditions. Elite’s generic Adderall^® product is jointly owned by Elite and Mikah Pharma LLC. The first shipment is dependent on the timing of licensee orders, DEA quotas and manufacturing, which could take months.

 

About Elite Pharmaceuticals, Inc.

 

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite’s product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit www.elitepharma.com.

 

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, 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, without limitation, risks, uncertainties, 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 products by the FDA and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, 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.

 

Contact:

 

Elite Pharmaceuticals, Inc.

Dianne Will, Investor Relations

518-398-6222

[e-mail]

 

 

Cover	Oct. 10, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 10, 2024
Entity File Number	001-15697
Entity Registrant Name	ELITE PHARMACEUTICALS INC /NV/
Entity Central Index Key	0001053369
Entity Tax Identification Number	22-3542636
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	165 Ludlow Avenue
Entity Address, City or Town	Northvale
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07647
City Area Code	(201)
Local Phone Number	750-2646
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	ELTP
Entity Emerging Growth Company	false

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