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Lipocine Announces USPTO Declaration Of Interference Between Lipocine And Clarus Patent Applications

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Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (“USPTO”) declared Interference No. 106,128 between Lipocine, Inc. (“the Senior Party”) owned U.S. Patent Application and Clarus Therapeutics, Inc. (“the Junior Party”) owned U.S. Patent Application. In preparation for the Interference, the USPTO withdrew the Clarus Application from issue.

This follows the pattern of previous Interferences as shown below:

  • Interference No. 106,045 decided in Lipocine’s favor and resulted in the cancellation of Clarus patent 8,828,428.
  • Interference No. 106,120 decided in Lipocine’s favor and resulted in the cancellation of Clarus application 15/723,976.

“We are pleased with the actions and judgements ordered by the PTAB which validates the strength of Lipocine’s patent portfolio,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.

About Lipocine

Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information. For more information, please visit www.lipocine.com.

Forward-Looking Statements

This release contains “forward-looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine’s product candidates and related clinical trials, the timing of completion of clinical trials, the potential uses and benefits of our product candidates, our product development efforts, the timing of processes related to intellectual property, and the timing of ongoing litigation. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

SOURCE Lipocine Inc.

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Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19

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Grifols (MCE: GRF, MCE: GRF.P,NASDAQ: GRFS), a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people’s health and well-being, today announced it will begin a clinical trial in Spain to evaluate the safety and efficacy of a new COVID-19 drug based on the Grifols immunoglobulin Gamunex®-C and containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.

The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination. In addition, it could protect the elderly and healthcare workers as well as immunocompromised patients for whom vaccination isn’t recommended. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway.

Grifols expects this clinical trial, led by the researchers Oriol Mitjà and Bonaventura Clotet, from Germans Trias i Pujol Hospital in Barcelona, to begin in February 2021, with the possibility of results in the spring.

About 800 patients, all asymptomatic but having tested positive for the virus in a diagnostic test, will participate in the clinical study, receiving subcutaneously Grifols’ immunoglobulin rich with anti-SARS-CoV-2 antibodies.

The Grifols immunoglobulin Gamunex®-C, whether administered intravenously, intramuscularly or subcutaneously, has proven to be safe and efficacious in the prevention of diverse infectious diseases in immunocompromised patients and has been used for this for more than 15 years.

According to Dr. Mitjà, “This treatment based on immunoglobulins would provide a combination of polyclonal antibodies that, compared with monoclonal antibodies, offers a greater diversity that could improve the degree of protection against the virus.”

Dr. Antonio Páez, Medical Director at Grifols, underscores that the potential treatment “is easy to refrigerate while its subcutaneous administration facilitates its distribution and use in any doctor’s office, avoiding hospitalization. If the new therapy’s efficacy is confirmed, it could be administered to people who test positive for the virus through PCR and antigen tests in hospitals and primary care offices.”

Grifols, a global leader in the production and distribution of immunoglobulins and hyperimmune immunoglobulins, currently has underway more than 25 research initiatives to treat different stages of COVID-19, from early exposure to the virus to severe cases requiring hospitalization and intensive care.

In October 2020, Grifols, together with other companies and various U.S. health agencies, began the clinical trial ITAC (Inpatient Treatment with Anti-Coronavirus Immunoglobulin) to evaluate the efficacy and safety of the anti-SARS-CoV-2 hyperimmune globulin in hospitalized and serious cases. Results are expected during the first half of 2021.

About Grifols

Grifols is a global healthcare company that since its founding in Barcelona in 1909 has enhanced the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services in more than 100 countries.

As pioneers in the plasma industry, Grifols is one of the largest plasma companies, with a growing network of donation centers worldwide. It develops this plasma into essential medicines used to treat chronic, rare and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation through transfusion. And the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Grifols, with more than 24,000 employees in 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry.

In 2019, Grifols’ economic impact in its core countries of operation was 8.5 billion euros. The company also generated 148,000 jobs, including indirect and induced.

The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).

For more information, please visit www.grifols.com

LEGAL DISCLAIMER

The facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.

SOURCE Grifols, SA

Related Links

https://www.grifols.com

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Northern Vertex Reports Revenue of US$23.4 Million and Production of 12,401 Gold Equivalent Ounces for Quarter Ending December 31, 2020

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Northern Vertex Mining Corp. (TSXV: NEE) (OTC Nasdaq Intl.: NHVCF) (the “Company” or “Northern Vertex”) is pleased to announce revenue of $23.4 million and production of 12,401 gold equivalent ounces for the quarter ended December 31, 2020 from the Company’s 100% owned Moss Gold Mine in NW Arizona.  Gold equivalent production is calculated at realized gold and silver prices for the quarter of $1,888 and $24.66 respectively. All figures are US dollars unless otherwise noted.

Highlights for the quarter ending December 31, 2020:

  • Revenue of $23.4 million
  • Gold equivalent production of 12,401 ounces
  • Gold production 11,124 ounces
  • Silver production of 95,804 ounces
  • Repayment of $8.5 million of debt
  • $8.3 million cash on hand at December 31st, 2020

Ken Berry, President and CEO commented, “I am delighted to report continued robust production in a strong gold market.  In the last six months, we have generated $50.2 million in revenue on the production of 27.1 gold equivalent ounces. The exemplary performance of our operating team this quarter allowed us to maintain strong production and revenue levels while executing the transition from mining the center pit to pioneering and operating the west pit. With a strong balance sheet, an aggressive exploration program and 3 drill rigs onsite, I look forward to updating our shareholders with our upcoming drill results.”

Operating Results for the Quarter Ended December 31, 2020:

Three Months Ended
Dec 31, 2020

Three Months Ended
Dec 31, 2019

Ore mined

tonnes

570,742

521,818

Grade

g/t

0.53

0.75

Tonnes stacked per day (average)

tpd

6,810

5,399

Contained gold ounces stacked

Oz

11,073

12,043

Gold ounces sold

Oz

11,760

9,925

Silver ounces sold

Oz

147,109

61,183

Gold equivalent ounces sold*

Oz

13,721

10,740

*Note: Gold equivalent ratio of 75:1.

Mine Plan Sequencing from center pit to west pit

During the quarter, mining operations transitioned from the centre pit into the west pit, where bulk disseminated stockworks dominate.  This transition enabled higher tonnage mining rates and more favourable strip ratios that are expected to lead to lower costs and lower cut-off grades as compared to the narrow-vein mining previously conducted in the centre-pit.

Cash Position

The Company’s cash position of $8.3 million at December 31, 2020 is expected to be augmented by the C$22.6 million financing announced by Northern Vertex and Eclipse Gold in connection with the merger of Northern Vertex and Eclipse Gold (see press release dated January 14, 2021).  Subject to the satisfaction of certain conditions, the merger between Northern Vertex and Eclipse Gold is expected to close on February 12, 2021.

Debenture Payment

The Company also announces that under the terms of the convertible debentures issued under the convertible debenture indenture dated July 31, 2020 (the “Indenture”) between the Company and Computershare Trust Company of Canada, it has elected to satisfy its obligation to pay an aggregate of C$140,250 in interest accrued on the C$6.71 million convertible debentures by issuing to such debenture holders on the interest payment date of December 31, 2020 an aggregate of 269,712 common shares.

The Company will pay to each such debenture holder approximately 4.02 common shares per $100 principal amount of debentures held as at the applicable interest payment record date. Under the terms of the Indenture, no fractional common shares will be delivered upon payment of the interest obligation and the Company is not required to pay the cash equivalent of any amount less than $5.00. The issuance of common shares in payment of interest remains subject to Exchange approval.

Safety/COVID-19

The Company’s policies have been recently modified, with new procedures put in place during the second fiscal quarter due to an onset of a number of COVID-19 cases among our team members.  Despite health concerns, our team was able overcome localized challenges and maintain full gold production at the Moss Mine. As at December 31, 2020, we have seen the benefits of our upgraded procedures and the Moss Mine had no known cases of COVID-19.

About Northern Vertex Mining Corp.

Northern Vertex Mining Corp. owns and operates the Moss Mine, currently the largest primary gold and silver mine in Arizona.  Focused on low cost gold and silver production, the Company has experience across all areas of operations, mine development, exploration, acquisitions, and financing of mining projects. The Company intends to consolidate additional producing or value-adding gold assets within the Western US.  Through mergers and acquisitions Northern Vertex’s corporate goal is to become a mid-tier gold producer.

ON BEHALF OF THE BOARD OF NORTHERN VERTEX
“Kenneth Berry”
President & CEO

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements:

This news release contains statements about our future business and planned activities. These are “forward-looking” because we have used what we know and expect today to make a statement about the future. Forward-looking statements including but are not limited to comments regarding the timing and content of upcoming work and analyses. Forward-looking statements usually include words such as scheduled, may, intend, plan, expect, anticipate, believe or other similar words. Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies.  Many factors, known and unknown, could cause actual results to be materially different from those expressed or implied by such forward-looking statements.  We believe the expectations reflected in these forward-looking statements are reasonable. However, actual events and results could be substantially different because of the risks and uncertainties associated with our business or events that happen after the date of this news release. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date made. As a general policy, we do not update forward-looking statements except as required by securities laws and regulations.  US investors should be aware that mining terminology used for Canadian mineral project reporting purposes differs significantly from US terminology.         

SOURCE Northern Vertex Mining Corp.

Related Links

www.northernvertex.com

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ROSEN, A TOP RANKED LAW FIRM, Continues to Investigate Securities Claims Against OrthoPediatrics Corp. – KIDS

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Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of OrthoPediatrics Corp. (NASDAQ: KIDS) resulting from allegations that OrthoPediatrics may have issued materially misleading business information to the investing public.

On December 2, 2020, Culper Research published a report entitled “OrthoPediatrics Corp. (KIDS): Even Channel Stuffing Can’t Save This Company[.]” The report alleged that OrthoPediatrics has “engaged in a channel stuffing scheme that has systematically and significantly overstated revenues.” On this news, the Company’s stock price fell $5.40 per share, or 12%, to close at $39.35 per share on December 3, 2020.

Then on December 14, 2020, Culper Research published a second report entitled “OrthoPediatrics Corp. (KIDS): Pleading the Fifth” in which it concluded that the Company “is a structurally broken business which has relied on nefarious tactics to inflate its reported revenues.”

Rosen Law Firm is preparing a securities lawsuit on behalf of OrthoPediatrics shareholders. If you purchased securities of OrthoPediatrics please visit the firm’s website at http://www.rosenlegal.com/cases-register-2015.html to join the securities action. You may also contact Phillip Kim of Rosen Law Firm toll free at 866-767-3653 or via email at pkim@rosenlegal.com or cases@rosenlegal.com.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

SOURCE Rosen Law Firm, P.A.

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www.rosenlegal.com

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