CPhI Worldwide 2018

*** Dipharma will be present at CPhI Worldwide 2018, October 09 – 11, Madrid, Spain ***

 We will be glad to welcome you at our booth number 10F21 Hall 10

AMERIGEN AND DIPHARMA ANNOUNCE U.S. FDA APPROVAL FOR GENERIC MIGLUSTAT 100 MG CAPSULES

The first generic version of Miglustat is now approved in the U.S.

 

Lyndhurst, N.J. and Chiasso, Switzerland. April 23rd, 2018 – Amerigen Pharmaceuticals Limited (“Amerigen”) and Dipharma S.A. (“Dipharma”) today announced that Amerigen’s Abbreviated New Drug Application (“ANDA”) for Miglustat 100 mg capsules has received final approval from the U.S. Food and Drug Administration. This is the first ANDA to be approved as a generic equivalent to Actelion Pharmaceuticals’ Zavesca®. The ANDA filing was the result of an exclusive collaboration between Amerigen and Dipharma in developing and commercializing Miglustat 100 mg capsules worldwide. Miglustat active ingredient is supplied to Amerigen by Dipharma who holds two granted U.S. patents, US9079856B2 and US8802155B1, one pertaining to a method of synthesis of miglustat and the other to a crystalline form of the same. Amerigen has the right to enforce these patents in the U.S. whilst Amerigen’s affiliates will manufacture the finished product and commercialize it in the U.S., where it has already been launched.

Miglustat is a glucosylceramide synthase inhibitor indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option.

John Lowry, Amerigen’s President and CEO, commented “We are delighted to launch this product following a fruitful collaboration with Dipharma. This is Amerigen’s fifth U.S. product launch and the third time we have brought a first generic to market, with important savings for the American healthcare system.”

Marc-Olivier Geinoz, Chief Executive Officer of Dipharma, expressed his satisfaction regarding the collaboration with Amerigen. “This marks the first approval of a series of products our group has been developing in collaboration with Amerigen for various markets.” he said. “Thanks to this approval, chronically ill US patients and payers will have available a high quality, more affordable alternative to current treatment. For our young company it is a great achievement and it marks a significant milestone in our growth strategy”.

 

About Amerigen

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group’s Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province.

The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA’s with the US FDA and the Chinese CFDA. Amerigen’s focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen’s products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.

About Dipharma

Dipharma S.A. is a Swiss specialty pharmaceutical company, developing high quality, improved, medicines for rare diseases. Dipharma S.A. is part of a third generation group of family-owned companies that have grown to a global presence.

With a portfolio of generic orphan products for the treatment of Phenylketonuria, Gaucher Disease, Hereditary Tyrosinemia Type 1, Urea Cycle Disorders and others, Dipharma S.A. works every day to provide improved solutions for people affected by inborn metabolic diseases at an affordable cost and with a global reach.

For more information, please visit www.dipharma.ch

 

Zavesca® is a registered trademark of Actelion Pharmaceuticals. The U.S. FDA approved Zavesca® in July 2003.

Dipharma PR_ miglustat ANDA

CPhI 2017 Frankfurt, Germany

Dipharma was present at CPhI Worldwide 2017, October 24 – 26, Frankfurt, Germany

We were at our booth number 80M52 Hall 8

 

 

13th ICIEM 2017

Dipharma was present at the ICIEM 2017 International Congress of Inborn Errors of Metabolism, September 5-8, Rio De Janeiro, Brazil.

DIPHARMA ANNOUNCES SUCCESSFUL DEVELOPMENT OF A STABLE, FAST DISSOLVING TABLET FORMULATION OF CARGLUMIC ACID

Dipharma strengthens its pipeline of improved formulations for the treatment of patients suffering from inborn errors of metabolism.

Chiasso, Switzerland, April 4th, 2017 – Dipharma S.A. announces the successful development of a new, fast dissolving formulation of Carglumic acid tablets stable at room temperature.

Carglumic acid is a key therapeutic tool in the management of rare, life threatening inborn metabolic disorders affecting the urea cycle; as such it was a natural candidate for the Company’s products portfolio.

“This achievement is another milestone in the expansion of our pipeline, aimed at improving the life of patients suffering from inborn errors of metabolism.” commented Marc-Olivier Geinoz, CEO of Dipharma S.A. “We worked hard to develop an improved formulation meeting patients’ requirements: today our R&D efforts were rewarded with the confirmation that our new formulation is fast dissolving and stable at room temperature”.

Dipharma S.A. also announces the filing of a patent application claiming new fast dissolving and stable tablet formulations of Carglumic acid, together with the proprietary technology developed to improve the product stability, without modifying the pharmaceutical form the patients are familiar to.

Carglumic acid formulation is the fourth Dipharma product approaching the market: Diterin® (sapropterin dihydrochloride 100 mg tabs) has already been approved in South Korea and Russia for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU), Miglustat (miglustat 100 mg caps) was submitted in the USA through an abbreviated new drug application (ANDA) in 2016 for the treatment of Gaucher disease and Disanit® (nitisinone capsules) was submitted in EU in the last quarter of 2016 for the treatment of hereditary tyrosinemia type I. Dipharma also confirms that the development of several other products for the treatment of rare metabolic diseases is on- going.

 

About Carglumic acid

Carglumic acid tablets 200mg (Carbaglu®) is a prescription drug used in the management of high ammonia levels due to rare inborn errors of metabolism affecting the urea cycle.

For more information on urea cycle disorders, please visit http://www.dipharma.ch/rare-diseases/.

 

 

About Dipharma

Dipharma S.A. is a Swiss pharmaceutical company specialized in developing high quality, improved medicines for rare diseases. Dipharma S.A. is part of a third-generation group of family companies that have grown to a global presence.

With a portfolio of products for the treatment of Phenylketonuria, Gaucher Disease, Niemann Pick Type C, Hereditary Tyrosinemia Type 1, Urea Cycle Disorders and others, Dipharma SA works every day to provide improved solutions for people affected by inborn metabolic diseases at an affordable cost and with a global reach.

For more information, please visit www.dipharma.ch

Carbaglu® is a registered trademark of Orphan Europe

 

 

 

DISCLAIMER

This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments.

Dipharma S.A. operates respectfully of any third party IP rights and/or regulatory exclusivities that may exist in each specific country.

This press release may contain information on pharmaceuticals that are not currently approved or available in your country or region.

20170404_Carglumic_final

BIMDG 2017

Dipharma was present at the 2017 BIMDG Annual Symposium, June 29-30.
We were glad to welcome you at our stand by Chelsea FC Conference Centre, London

DIPHARMA ANNOUNCES THE VALIDATION OF DISANIT® (NITISINONE) MARKETING AUTHORIZATION APPLICATION IN EUROPE

ERRATA CORRIGE. The following press release issued on June 7th 2017 replaces the previous one released on February 23rd 2017

A stable capsule formulation of Nitisinone for the treatment of hereditary Tyrosinemia type-1 (HT-1) is now under marketing authorization (MA) evaluation in the EU.

Chiasso, Switzerland – Dipharma S.A. announces the validation of the MA application for its product Disanit® (Nitisinone capsules 2, 5 and 10 mg) in the EU. The Swiss company also announces plans to file an Abbreviated New Drug Application (ANDA) with the US FDA.

Disanit® is the improved generic version of SOBI’s Orfadin®, which is indicated for the treatment of hereditary tyrosinaemia type 1 (HT-1), a very rare inborn error of metabolism (IEM). Disanit® is a stable capsule formulation that can be stored at room temperature without the need of refrigeration currently up to 24 months.

Disanit® is the third product of Dipharma undergoing a regulatory marketing authorization procedure: Diterin® (sapropterin dihydrochloride 100 mg tabs) has already been approved in South Korea and Russia for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) and Miglustat (miglustat 100 mg caps) was submitted in the USA through an abbreviated new drug application (ANDA) in 2016 for the treatment of Gaucher disease. Dipharma also confirms that the development of several other products for the treatment of rare metabolic diseases is on- going.

“Once approved, Disanit® will be the first capsule formulation of Nitisinone in Europe that can be stored at room temperature currently up to 24 months, simplifying distribution, decreasing cold-chain related wastage and finally improving ease of use for the patients” commented Marc-Olivier Geinoz, CEO of Dipharma S.A. “This regulatory filing is the perfect exemplification of our mission: in Dipharma we strive to improve the life of patients suffering from inborn errors of metabolism. We aim to provide more value to patients and health professionals, at an affordable cost for payers.”

Dipharma S.A. also announces that international patent applications were filed claiming a stable crystalline form of Nitisinone, capsule formulations of Nitisinone with improved long-term stability and the proprietary technology developed to improve the product stability, without modifying the pharmaceutical form the patients are familiar with.

Dipharma S.A. is currently working with its partners to make Disanit® and all the rest of its product portfolio available to patients worldwide.

 

About Disanit®

Disanit® (nitisinone 2, 5 and 10 mg) is the first capsule formulation of Nitisinone that can be stored at room temperature currently up to 24 months, currently under review by EU authorities for the treatment of hereditary tyrosinaemia type 1 (HT-1).

HT-1 is a rare inborn error of metabolism (IEM) in which the body is unable to completely break down the amino acid tyrosine, and so harmful substances are formed, causing serious liver problems and liver cancer. HT-1 is progressive and can be fatal if untreated. For more information on HT-1, please visit http://www.dipharma.ch/rare-diseases/.

Disanit® is to be used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine. These amino acids are normally found in proteins in foods and drinks.

Disanit® was developed by Dipharma S.A., Switzerland. Disanit® is a trademark owned by Dipharma S.A.

Disanit® will be entirely manufactured and packaged in the EU.

 

About Dipharma

Dipharma S.A. is a Swiss pharmaceutical company specialized in developing high quality, improved, medicines for rare diseases. Dipharma S.A. is part of a third generation group of family companies that have grown to a global presence.

With a portfolio of products for the treatment of Phenylketonuria, Gaucher Disease, Niemann Pick Type C, Hereditary Tyrosinemia Type 1, Urea Cycle Disorders and others, Dipharma SA works every day to provide improved solutions for people affected by inborn metabolic diseases at an affordable cost and with a global reach.

For more information, please visit www.dipharma.ch

Orfadin® is a registered trademark of Swedish Orphan Biovitrum

 

DISCLAIMER

This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments.

Dipharma S.A. operates respectfully of any third party IP rights and/or regulatory exclusivities that may exist in each specific country.

This press release may contain information on pharmaceuticals that are not currently approved or available in your country or region.

Disanit submission EU

DIPHARMA and ALVOGEN announce launch of Diterin® 100mg tablets in South Korea

First drug now registered and commercially available in the Republic of South Korea for the treatment of Hyperphenylalaninemia (HPA) due to Phenylketonuria (PKU).

Chiasso, Switzerland and Seoul, South Korea, February 3rd, 2017 – Dipharma S.A. and Alvogen today announced that the pharmaceutical product Diterin® (Sapropterin Dihydrochloride 100mg tablets), indicated for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU), is now commercially available in the Republic of South Korea.

Diterin® is the only drug approved in South Korea by the Korean Ministry of Food and Drug Safety for the treatment of HPA due to PKU, a rare genetic disease leading to an abnormally high concentration of phenylalanine (Phe) in the blood, which can cause brain damage to people affected by it.

“We are happy to provide Diterin® to the South Korean market, as this treatment can make a difference in the management of Phe levels for many patients suffering from lifelong PKU, contributing to prevent the appearance of potential transient to non-reversible mental impairment” said Peter Vazharov, Alvogen S&M VP, Asia Pacific together with Marc-Olivier Geinoz, CEO of Dipharma S.A., who added: “As part of Dipharma’s mission, we will continue to expand our portfolio of high-quality products – including Diterin® – to offer improved solutions to each and every patient suffering from inborn errors of metabolism all around the world”.

Dipharma S.A. also confirms that patents and patents applications were filed protecting Diterin® and its active pharmaceutical ingredient – Sapropterin Dihydrochloride – in many countries of the world, including South Korea.

This commercial launch is resulting from an exclusive collaboration agreement between Dipharma S.A. and Alvogen, under which Alvogen owns the exclusive rights to commercialize Diterin® 100mg tablets in the Korean market. Dipharma S.A. is currently working to make Diterin® available in all the countries worldwide.

20170203_Diterin_launch_PR_Dipharma_Alvogen

DCAT WEEK 2017

Dipharma was present at DCAT WEEK ’17, March 20-23.
We were glad to welcome you by appointment at our suites # 1609 & 1610 by Benjamin Hotel 125 E 50th St, New York

ESPKU 2016 Dublin, Ireland

Dipharma was present.

 

Watch the conference video:

 

CPhI 2016 Barcelona, Spain

Dipharma was present. October 04 – 06, Barcellona, Spain

First Regulatory Submission in USA

An Abbreviated New Drug Application has been submitted to the FDA for Miglustat 100mg Capsules

First Marketing Authorization

Diterin (Sapropterin Dihydrochloride 100mg tablets) obtains its first marketing authorization on 27 October 2015

New Headquarter

New Headquarter Office in Chiasso inaugurated on 18 September 2015