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Y-mAbs’ 177Lu-omburtamab-DTPA – GuruFocus.com

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NEW YORK, June 25, 2021 (GLOBE NEWSWIRE) – Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Committee for Orphan Medicinal Products (“COMP”) of the European Medicines Agency (“EMA”) has recommended the granting of the designation of orphan drug (“OMPD”) in the European Union (“EU”) for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma. The positive opinion of the EMA COMP has been sent to the European Commission (“EC”), which is expected to grant the orphan drug designation within 30 days.

Obtaining OMPD for 177Lu-omburtamab-DTPA is part of a global plan aimed at expanding the Company’s European development programs and ultimately obtaining the exclusivity of orphan drugs to protect 177Lu-omburtamab-DTPA for the treatment of medulloblastoma in the EU.

Under EMA Regulation (EC) No 141/2000, an orphan drug designation gives companies access to an assistance protocol and advice to prepare a case that will meet European regulatory requirements and maximize thus the chances of approval at the time of marketing authorization. Once approved, an orphan drug also benefits from a 10-year market exclusivity during which similar directly competing products cannot normally be placed on the market.

The EMA grants the orphan drug designation based on several criteria, including: the potentially fatal and debilitating nature of the disease; the medical plausibility of the proposed orphan indication; a prevalence in Europe of less than five cases per 10,000 inhabitants; there is no satisfactory method of diagnosis, prevention or treatment or, if such a method exists, the drug will be of significant benefit to those affected by this condition.

Y-mAbs Founder, Chairman and Chairman Thomas Gad said: “We are very pleased that COMP has issued a favorable opinion for an orphan drug designation at 177Lu-omburtamab-DTPA which will give us a series of development incentives.

Dr Claus Moller, Chairman and CEO, adds: “We believe the orphan designation strengthens our opportunity to bring 177Lu-omburtamab-DTPA for patients who are in desperate need of alternative methods of treatment. In addition, the designation marks an important step in the expansion of Y-mAbs in European development.

MSK researchers developed omburtamab, which is exclusively licensed by MSK at Y-mAbs. As a result of this license agreement, MSK has institutional financial interests in the product.

About Y-mAbs

Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel antibody-based therapeutics for the treatment of cancer. The Company has a broad portfolio of advanced products, including an FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and a pivotal stage candidate, omburtamab, which targets tumors that express B7-H3.

Forward-looking statements

Statements in this press release regarding future expectations, plans and prospects, as well as any other statements regarding matters which are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. from 1995. These statements include, but are not limited to, statements about our business model and our product development, marketing and distribution plans; current and future clinical and preclinical studies and our research and development programs; expectations related to the timing of initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; rate and degree of market acceptance and clinical utility as well as price and reimbursement levels; retain and hire key employees; our marketing, marketing and manufacturing capabilities and strategy; our position and strategy on intellectual property; additional product candidates and technologies; strategic collaborations or partnerships and their potential benefits; expectations regarding the use of our cash and cash equivalents, and the necessity, timing and amount of any future financing transactions; our financial performance, including our estimates of income, expenses, capital expenditure requirements; developments relating to our competitors and our industry; and other statements which are not historical facts. Words such as ” anticipate, ” ” believe, ” “contemplate”, ” continue ”, ” might, ” ” estimate, ” ” wait, ” “hope”, ” intend, ” ” may, ” ” might, ” ” plan, ” ” potential, ” ” predict, ” ” project, ” ” should, ” ‘ ‘target,’ ” will ‘,’ ” and similar phrases are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and associated technologies are new approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by these forward-looking statements due to various factors, including, but not limited to: risks associated with our financial condition and the need for additional capital; risks associated with our development work; the cost and success of our product development and clinical trial activities; risks of delays in the timing of our regulatory submissions or of not obtaining approval for our drug candidates; risks associated with the commercialization of any approved pharmaceutical product, including the rate and degree of market acceptance of our product candidates; the development of our sales and marketing capabilities and the risks associated with the inability to obtain sufficient reimbursement for our products; risks related to our dependence on third parties, including for the conduct of clinical trials and the manufacture of products; our inability to enter into partnerships; risks associated with government regulations; risks associated with market approval; risks associated with the protection of our intellectual property rights; risks associated with employee issues and growth management; risks associated with our common stocks, risks associated with the pandemic caused by the coronavirus known as COVID-19 and other risks and uncertainties affecting the Company, including those described in the section “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC and in our other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date hereof, and the Company assumes no obligation to update any forward-looking statements, whether as a result of new information, events future or otherwise.

“DANYELZA” and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.

Contact:

Y-mAbs Therapeutics, Inc.
230, avenue du Parc, office 3350
New York, New York 10169
United States

+1 646 885 8505

E-mail: [email protected]

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MTPA Announces PANTHERx® Selected as Exclusive Specialty Pharmacy Service Provider in the United States for EXSERVAN ™ Oral Film (Riluzole)

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JERSEY CITY, NJ, June 25, 2021 / PRNewswire / – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that PANTHERx Rare Pharmacy has been selected as the Exclusive Specialty Pharmacy Services Provider for EXSERVAN (riluzole), an oral film formulation of riluzole for the treatment of amyotrophic lateral sclerosis (ALS).

“As we explored partner specialty pharmacy options for the distribution of EXSERVAN, it was important to find an organization with specific knowledge and experience that could better support the ALS community,” said Kevin o’brien, Vice President of Market Access, MTPA. “PANTHERx is able to deliver on both fronts, in addition to having an unwavering dedication to patients. This is closely linked to our commitment to helping patients. “

Once a patient is prescribed EXSERVAN, they can be enrolled in access to information services. Upon registration, PANTHERx will provide patients with a review and summary of insurance benefit options, including information on eligibility for the Personal Assistance Program for EXSERVAN.

MTPA plans to make EXSERVAN available to patients by the end of June 2021.

“PANTHERx is proud to focus on people living with the implications of a rare disease,” said Rob snyder, President of PANTHERx. “We hope our vast experience will have a positive impact on the members of the ALS community we aim to serve through our distribution of EXSERVAN. We look forward to working with the MTPA to help meet the needs of those affected by this devastating disease.

About EXSERVAN (riluzole) oral film
EXSERVAN, an oral film formulation of riluzole, was approved by the United States Food and Drug Administration (FDA) in November 2019. EXSERVAN was developed by Aquestive Therapeutics, Inc. using its PharmFilm® innovative drug delivery technology. The oral film is placed on the patient’s tongue and dissolves. Pursuant to a licensing and supply agreement, MTPA markets EXSERVAN in the United States and Aquestive is the sole manufacturer and exclusive supplier of the product. For more information visit www.EXSERVAN.com.

INDICATION
EXSERVAN ™ (riluzole) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to riluzole or any of its ingredients.

Before using EXSERVAN, tell your doctor about all the medicines you are taking and about any health problems, including if you:

  • You have liver problems.
  • you are taking certain medicines known to be strong or moderate inhibitors of CYP1A2 such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib or zileuton.
  • If you are pregnant or intend to become pregnant while taking EXSERVAN, or if you are breast-feeding or intend to breast-feed while taking EXSERVAN.

EXSERVAN can cause serious side effects, including:

Liver problems: Cases of liver damage, some fatal, have occurred in patients taking riluzole. See your doctor promptly if you experience unexplained nausea, vomiting, stomach (abdominal) pain, fatigue, weight loss (anorexia), jaundice (yellowing of the skin or the whites of the eyes) and / or dark urine.

Low number of white blood cells (neutropenia): Tell your doctor if you develop a fever while taking EXSERVAN.

Serious lung problems (interstitial lung disease): Tell your doctor if you have lung or breathing problems such as a dry cough and difficult or labored breathing. Stop EXSERVAN immediately if you develop interstitial lung disease.

The most common side effects include numbness in the mouth or tongue, muscle weakness, nausea, lung problems, high blood pressure, and stomach (abdominal) pain.

These are not all of the possible side effects of EXSERVAN. Consult your doctor for medical advice on side effects.

To report side effects, contact Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use EXSERVAN as prescribed. The recommended dose of EXSERVAN is 50 mg orally twice daily at least 1 hour before or 2 hours after a meal. Place the EXSERVAN oral film strip on top of the tongue where it will adhere and dissolve. Swallow normally. Do not cut or split the film or take liquids with EXSERVAN. Do not chew, spit or speak while EXSERVAN is dissolving. Read the EXSERVAN instructions for use.

Please Click here to view the full prescribing information for EXSERVAN.

About Mitsubishi Tanabe Pharma America, Inc.
Situated at Jersey City, New Jersey, Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), the 100% owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC for market approved pharmaceutical products. in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

Mitsubishi Tanabe Pharma Corporation overview
Mitsubishi Tanabe Pharma, founded in 1678, is headquartered in Doshomachi, Ossaka, which is the birthplace of from Japan pharmaceutical industry. With a business focused on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company with one of the longest histories of pharmaceutical companies in Japan.1 In line with the business philosophy of “contributing to healthier lives of people around the world through the creation of pharmaceutical products”, the Company formulated the key concept of Open Up the Future as part of the management plan in the medium term 2016-2020. Through the discovery of drugs that address unmet medical needs, focused on its priority disease areas – immune and inflammatory diseases, diabetes and kidney, central nervous system and vaccines – Mitsubishi Tanabe Pharma will strive to contribute to the health of people. patients around the world. MTPC is the parent company of MTPA. For more information, visit https://www.mt-pharma.co.jp/e/.

PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other trademarks referenced herein are the property of their respective owners.

1 Search by TOKYO SHOKO RESEARCH, LTD.

Media inquiries:
Debbie etchison
908-340-8578
[email protected]

SOURCE Mitsubishi Tanabe Pharma America, Inc.



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Topical Skin Supplement Finalist in P&G Ventures Innovation Challenge

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San Francisco, Calif., Company that developed a topical supplement designed to extend skin life at the molecular level, improving skin health and strength, is among four P&G finalists Ventures Innovation Challenge, to be held online July 14.

One Skin will be represented by co-founder Juliana Carvalho in the competition. It will compete with NanoSpun Technologies, a Los Altos, Calif., Company that develops and produces active living biological tissues for skin care, medical and industrial applications; Ready, Set, Food !, Los Angeles, CA, which focuses on the early introduction of allergens; and Wellesley Pharmaceuticals, Newtown Grant, PA, who developed a pill called Nocturol that is designed to provide eight hours of protection for those who suffer from frequent toilet trips overnight.

One Skin boasts a proprietary peptide, OS-01, which it claims rejuvenates the skin at the molecular level and effectively addresses the negative implications of aging.

One Skin’s proprietary peptide has been shown to rejuvenate the skin at the molecular level.

The finalists will make their presentation to a panel that includes Alex Betancourt, Vice President, P&G Ventures; Anu Duggal, founding partner, Female Founders Fund; Mike Jensen, senior vice president of R&D, P&G Ventures; Michael Olmstead, Director of Revenue, Plug and Play; and Clarence Wooten, co-founder and general partner, Revitalize Venture Studio.

The winner will receive a prize of $ 10,000 and the opportunity to continue to develop their product with P&G Ventures.

Founded in 2015, P&G Ventures partners with entrepreneurs, inventors and startups to discover and create consumer products, brands and businesses that meet consumer needs in areas new to P&G.


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SUPERNUS PHARMACEUTICALS, INC. : Other events, financial statements and exposures (form 8-K)

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Article 8.01. Another article.

At June 10, 2021, Newron Pharmaceuticals SpA (“Newron”), Zambon SpA. (“Zambon”) and Supernus Pharmaceuticals, Inc. (the “Company”), through its subsidiary U.S. operations of MDD, LLC (collectively, the “Plaintiffs”), has initiated litigation against the generic drug manufacturers Aurobindo Pharma Limited, Aurobindo Pharma USA Inc., MSN Private Limited Laboratories (“MSN”), Optimus Pharma Pvt Ltd, Prinston Pharmaceutical, Inc., RK Pharma, Inc. and Zenara Pharma Private Limited (collectively, the “Defendants”) for infringement of three patents covering XADAGO®, the Company’s once-daily product indicated as an adjunct to levodopa / carbidopa in patients with Parkinson’s disease who are experiencing episodes “Off”. US Patent Nos. 8,076,515, 8,278,485 and 8,283,380 (collectively, the “XADAGO Patents”) cover pharmaceutical formulation and methods of treatment with safinamide. XADAGO patents expire between June 2027 and March 2031. The Company has a licensing agreement with Zambon, Newron’s partner, related to the XADAGO patents, and as a new chemical entity, XADAGO is under the FDA’s 5-year exclusivity period which expires on March 21, 2022.

The complaint – filed at United States District Court for the District of Delaware – alleges that the Defendants infringed the XADAGO Patents by submitting to the
United States Food and Drug Administration (FDA) Abbreviated New Drug Applications (ANDA) seeking to market a generic version of XADAGO before patents expire. Filing of the complaint within 45 days of receipt of each of the Defendants ‘Paragraph IV notification letters triggers a suspension of FDA approval of the Defendants’ ANDAs.



Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit 104 - The cover page from this Current Report on Form 8-K, formatted in
Inline XBRL.



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