LIGHTNING RELEASES: CHICAGO (4/8/2014) — Meridian Labs Inc., a Buffalo Grove, IL -based specialty pharmaceutical company has completed preparation for the submission of its Investigational New Drug Application (“IND”) submission to the US Food and Drug Administration (FDA) and EU submission to the European Medicines Agency (EMA) for ML-061 Meridian’s proprietary Polysorbate-80 free formulation of Docetaxel. The submission includes in-vitro study data from CycloLab (Cyclodextrin Research & Development Laboratory, Ltd.) showing ML-061’s pharmacology properties, similarity to taxotere, in response to the FDA’s pre-IND meeting questions. In further news, the Company received an allowance of its US patent application for ML-061, US 2013/0296268 Al on November 7, 2013.  Meridian Labs has also received data confirming ML061’s quality and bioequivalence to Docetaxel (taxotere) by an independent third party evaluating a strategic transaction with the Company.  Lastly, Scilucent, an FDA regulatory consulting firm, has reviewed and confirmed Meridian Lab’s 505(b)(2) regulatory pathway and will submit the package on Meridian’s behalf.   

On the strategic/corporate development front, Meridian has received a proposal to acquire the company from a publicly-traded specialty pharmaceutical company. The proposal includes an upfront payment of $10 million and milestones paid to Meridian Labs shareholders upon the filing, approval, launch and reaching a revenue target in the first year of sales. The Company’s board has not entered into exclusive negotiations with any party and has decided to continue to evaluate proposals with its investment banking firm, AmeriTech Advisors, and will make an announcement when appropriate.

In terms of the business development news, Meridian is on track for IND submission in the US and the submission process for the EU is underway for the second quarter 2014.  The Company has a third party pharmaco-economic analysis showing the rationale for a premium price for ML061 over taxotere generic products.  Meridian hired Giles and Associates Consultancy, a pharmaceutical market analysis firm, to perform an extensive survey in oncologist community on the value of Meridian’s Polysorbate-80 free taxotere and the results were very favorable with the oncologists surveyed suggesting they would use the product for a significant portion of patients.  Meridian is in discussions with several large cap diversified pharmaceutical manufacturers about manufacturing ML-061.

About Meridian Labs

Meridian Labs is a specialty pharmaceutical company focusing on the development of cancer treatments through formulation improvements.  The company owns patents on docetaxel and other cancer treatment formulations using the derivatives of beta-cyclodextrin developed through its facilities based in Nanjing, China and Illinois. 

The company’s lead product, ML061, is an IP-protected reformulation of Taxotere in Captisol that eliminates Polysorbate 80 and its associated “Black Box” side effects. Meridian intends to gain approval in the US through 5050 (b)(2) submission and will send a pre-IND meeting request to the FDA to on the submission in teh coming weeks. .

Strategic alternatives the Company may pursue could include strategic investment or other collaboration agreements, a merger, an equity or debt financing, or sale of the Company. The Company does not intend to disclose developments with respect to this process until the evaluation of strategic alternatives has been completed and the board of directors has approved a specific transaction. 

About AmeriTech Advisors

AmeriTech is an investment bank dedicated to providing capital raising and strategic advisory services to emerging growth companies in the technology and medtech sectors with market capitalizations of between $25 million and $500 million. Their bankers have 20 years’ experience at major global investment banks and as senior managers at public companies with experience executing successful transactions. Their goal is to build mutually beneficial relationships between our emerging growth company clients, technology and medtech/pharma partners, and their network of investors

Media Contact: william zhao, Meridian Lab, 847-275-5923, [email protected]

SOURCE Meridian Lab

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