Recent News

Recent News

Apr

17
2015

AMERIGEN Announces Tentative Approval of Generic Bystolic®

Lyndhurst NJ, USA, April 17, 2015 – Amerigen Pharmaceuticals Limited today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Bystolic (R) (Nebivolol HCl 2.5, 5, 10 and 20mg instant release tablets). Based upon available information, Amerigen believes that it is a first applicant to file an ANDA for Bystolic® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Forest Laboratories markets Bystolic® in the U.S. for the treatment of hypertension, to lower blood pressure. U.S. sales of Bystolic® were

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Jan

09
2015

Fosun Pharma to invest in Amerigen Pharmaceuticals

Lyndhurst NJ, USA, January 9, 2015 – Amerigen Pharmaceuticals Limited (“Amerigen”) today announced the signing of an agreement with an affiliate of Fosun Pharma (“Fosun”) under which Fosun will invest USD 35 million in newly issued equity in Amerigen. Amerigen intends to use the proceeds primarily to deepen its product pipeline through additional investments in product development and business development. As a result of its investment, Fosun will also be entitled to a seat on Amerigen’s board of directors. Commenting on the deal, John Lowry, Amerigen’s President and CEO, stated “I am delighted to welcome Fosun as an investor in

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Aug

27
2014

Amerigen Pharmaceuticals Limited and the Ningbo Menovo Pharmaceutical Co., Ltd, today announced they had entered into a collaboration agreement regarding the development of generic pharmaceuticals, primarily targeting the United States market

Lyndhurst NJ, USA and Ningbo, China, August 27, 2014 – Amerigen Pharmaceuticals Limited (“Amerigen”) and the Ningbo Menovo Pharmaceutical Co., Ltd, (“Menovo”) today announced they had entered into a collaboration agreement regarding the development of generic pharmaceuticals, primarily targeting the United States market. Under the terms of the agreement, Amerigen and Menovo will jointly develop products for Amerigen to commercialize in the United States. Menovo will be responsible for manufacturing API and finished product whereas Amerigen will be responsible for clinical, regulatory and commercial activities in the United States. Amerigen will also provide support and assistance to Menovo in obtaining

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Aug

20
2014

Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg Tablets into the China domestic market.

Lyndhurst NJ, USA, August 20th, 2014 – Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg Tablets into the China domestic market. Under the terms of a marketing and distribution agreement with Sinochem Jiangsu Pharmaceutical Co., Ltd., Amerigen is manufacturing the product at its US FDA approved and China CFDA certified oral solid dose facility in Suzhou, China. Sinochem is distributing the product under the Suzhou Amerigen label with exclusive sales rights in the People’s Republic of China. John Lowry, Amerigen’s

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Apr

03
2014

Amerigen has reached an agreement with UPM to commercially manufacture two ANDA products

April 2, 2014. Amerigen Pharmaceuticals, Inc. has reached an agreement with UPM, a division of Gregory Pharmaceutical Holdings, Inc., for UPM to commercially manufacture two ANDA products for a 10 year supply term.  In addition, the agreement allows for UPM to develop and potentially commercially supply several additional ANDA products for Amerigen over the next few years.  UPM acquired the 475,000 square foot Pfizer manufacturing facility in Bristol, Tennessee in July of 2013 and, eventually, all of these products will be made at this new facility. Dr. John M. Gregory, Chairman and CEO of Gregory Pharmaceutical Holdings, Inc., said, “UPM has

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Mar

12
2014

Amerigen Pharmaceuticals Limited announces that its ANDA for carbidopa 25mg tablets has received final approval from the U.S. Food and Drug Administration

LYNDHURST, N.J., March 12, 2014 /PRNewswire/ — Amerigen Pharmaceuticals Limited announces that its ANDA for carbidopa 25mg tablets has received final approval from the U.S. Food and Drug Administration. The product is a generic equivalent of Valeant’s Lodosyn® and has been launched under an Amerigen Pharmaceuticals label. John Lowry, Amerigen’s President & CEO commented: “We are very pleased to receive our first ANDA approval. This product was entirely self-developed and manufactured by Amerigen and is the first ANDA approved for which Lodosyn® is the reference listed drug. We look forward to further approvals this year and transitioning our pipeline of

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Sep

27
2013

Amerigen subsidiary Suzhou Amerigen Pharmaceuticals enters into service agreement with Top Tier Multi-National Pharmaceutical Company

Lyndhurst NJ, USA, September 27th, 2013 – Amerigen Pharmaceuticals Limited today announced its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co., had entered into a service agreement with a Top Tier Multi-National Pharmaceutical Company (“The Firm”) to support various research and development projects for The Firm’s China market initiatives. Under the terms of the agreement, Amerigen will employ its analytical, formulation and clinical trial materials assets at its US FDA approved and China CFDA certified finished solid dose facility in Suzhou, China for project activities selected by The Firm. Terms of the agreement are undisclosed. John Lowry, Amerigen’s President & CEO commented:

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Sep

26
2013

Amerigen Pharmaceuticals Ltd. today announced its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co., had entered into a marketing and distribution agreement with Sinochem Jiangsu Pharmaceutical Co., Ltd.

Lyndhurst NJ, USA, September 26th, 2013 – Amerigen Pharmaceuticals Ltd. today announced its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co., had entered into a marketing and distribution agreement with Sinochem Jiangsu Pharmaceutical Co., Ltd. regarding Amerigen’s generic mecobalamin 0.5mg immediate release tablets. Under the terms of the agreement, Amerigen will manufacture the product at its US FDA approved and China CFDA certified finished solid dose facility in Suzhou, China. Sinochem is granted exclusive sales and distribution rights to the product in the People’s Republic of China in exchange for undisclosed payments to Amerigen. The first commercial shipments of the product, which

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Jul

31
2013

Amerigen Pharmaceuticals Limited announces collaboration with Forest Laboratories Inc.

Lyndhurst NJ, USA, July 31th, 2013 – Amerigen Pharmaceuticals Limited today announced it had entered into a collaboration agreement with Forest Laboratories Inc. regarding the development of a number of specialty generic products. Under the terms of the agreement, Amerigen will use its formulation expertise to develop a range of complex generic products and will commercialize such products in the United States. Forest will make undisclosed milestone payments to Amerigen and will receive royalties on US sales of such products. In addition, Forest will have an option to acquire rights to register and commercialize certain products in Latin America. John

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Mar

15
2012

Amerigen announces ANDA filing and BYSTOLIC® patent challenge

East Brunswick NJ, USA, March 15 th, 2012 – Amerigen Pharmaceuticals Limited today confirmed that its subsidiary Amerigen Pharmaceuticals Inc. has filed an Abbreviated New Drug Application (“ANDA”) containing a paragraph IV certification for a generic version of BYSTOLIC® with the US Food & Drug Administration (“FDA”) and is seeking approval to market its nebivolol hydrochloride tablets prior to expiration of U.S. Patent 6,545,040. On March 13th 2012, Forest Laboratories and Janssen Pharmaceutica filed suit for patent infringement against Amerigen in the District of Delaware. Based upon available information, Amerigen believes that it may be a first applicant to file

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