8-K - ELTP - Equibles

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

May 5, 2021

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<br><br>of incorporation)	(Commission File Number)	(IRS Employer<br><br>Identification No.)

165 Ludlow Avenue, Northvale, New Jersey 07647

(Address of principal executive offices)

(201) 750-2646

(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)
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☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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. ☐

Securities registered pursuant to Section 12(b) of the 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 8.01.	Other Events.
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On May 4, 2021, Elite Pharmaceuticals, Inc. ("Elite" or the “Company") issued a press release to announce the launch of Loxapine Succinate capsules (“Loxapine Capsules” or the “Product”), 5 mg, 10 mg, 25 mg and 50 mg with its distribution and marketing partner Prasco, LLC (“Prasco”).

A copy of the press release is being finished with this Current Report on Form 8-K as Exhibit 99.1.

On February 14, 2020, Elite Pharmaceuticals Inc. (“Elite”) entered into a license, supply, and distribution agreement, and amended on July 30, 2020, with Prasco to be the exclusive United States distributor for Elite’s Abbreviated New Drug Application (ANDA) for the Loxapine Capsules. The product will be distributed under the Burel label.

Under the Agreement, Prasco will provide sales, marketing, and distribution for the Product, and Elite will manufacture the Product and receive manufacturing fees and a profit split. The term of the License Agreement is three years, with one year renewal terms.

Item 9.01	Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release dated May 4, 2021

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:<br> May 5, 2021	ELITE<br> PHARMACEUTICALS, INC.
	By:	/s/<br> Nasrat Hakim
		Nasrat Hakim,<br> President and CEO

Exhibit 99.1

Elite Pharmaceuticals Enters into an Exclusive DistributionAgreement with Prasco, LLC and Announces Commercial Launch of Loxapine Capsules

NORTHVALE, N.J. – May 4, 2021 – Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today that its distribution and marketing partner Prasco, LLC (“Prasco”), has launched Elite’s generic Loxapine capsules.

Elite entered a license, supply, and distribution agreement (“Agreement”) with Prasco for Elite’s Abbreviated New Drug Application (ANDA) for Loxapine Succinate capsules, 5 mg, 10 mg, 25 mg, and 50 mg (“Loxapine Capsules”). Loxapine is indicated for the treatment of schizophrenia and is currently listed on the FDA drug shortage list.

Prasco will be the exclusive U.S. distributor for Loxapine capsules, which will be marketed under Burel Pharmaceutical’s label. Under the Agreement, Prasco will provide sales, marketing, and distribution for the product, and Elite will manufacture the product.

"Elite is excited to partner with Prasco to launch Loxapine,” said Nasrat Hakim, President and CEO of Elite. “Prasco have the scale, infrastructure, reputation, and expertise to be an excellent partner for the distribution of this product for Elite."

“Prasco is honored to align with Elite Pharmaceuticals in bringing much needed supply to this critical product,” said Chris Arington, Prasco CEO, “Loxapine tablets will be made available through Prasco’s network of wholesalers and distributors to provide nationwide access for patients.”

About Prasco, LLC

Prasco, is a privately held healthcare company located in Mason, Ohio. Over 50 of the most innovative and trusted pharmaceutical companies have relied on Prasco to bring their products to the US generic marketplace. Prasco is the acknowledged category leader in Authorized Generics, providing patients with high quality products at more affordable prices in over 60,000 US pharmacies. For more information, visit the company's website at www.prasco.com

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Glenmark Pharmaceuticals, Inc. and TAGI Pharma. 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:

For Elite Pharmaceuticals, Inc.

Dianne Will, Investor Relations, 518-398-6222

Dianne@elitepharma.com