Dalton Announces Drug Development and Manufacturing Agreement with Cerium Pharmaceuticals Inc.

Toronto, Canada - January 17, 2017- Dalton Pharma Services today announced the signing of a drug development and manufacturing services agreement with Cerium Pharmaceuticals, Inc., an emerging biopharmaceutical company based in Gaithersburg, Maryland, USA. Cerium is dedicated to the development and commercialization of medicines for patients with rare (orphan) diseases.

 In support of Cerium's drug development program, Dalton Pharma Services will provide formulation developmentcGMP liquid filling, analytical method validation, quality control release testing and ICH stability services.

 "Our expert capabilities in formulation development and sterile fill/finish of APIs combined with our strength in cGMP API manufacturing has led to the signing of this important drug development and manufacturing agreement," said Peter Pekos, President and CEO. "We are excited to have this opportunity and look forward to participating in Cerium's drug development program, which has great promise for providing a therapy for a major unmet medical need."

 Gregg Lapointe, CEO of Cerium remarked, "Dalton is an excellent fit for our needs, and we are delighted to be partnering with a company whose client focus and commitment to quality match our own.  Cerium will benefit greatly from having Dalton's facilities, experience, technical expertise and array of integrated services to move our drug from R&D to cGMP manufacturing."

About Cerium:

Cerium Pharmaceuticals seeks to develop and commercialize medicines for rare and ultra-rare diseases, no matter how small the patient population. Our goal is to address unmet medical needs by leveraging the basic discovery work performed by others and entering after project feasibility is established. From this point, we create collaborative networks tailored to each project, which provide a wide range of support for drug candidates. 

 About Dalton:

Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved and FDA registered cGMP contract service provider of integrated chemistry,  drug development and manufacturing services to the pharmaceutical and biotechnology industries. We bring 30 years of experience to our client's projects and emphasize quality, speed and flexibility.

 Dalton can accelerate your drug development program by integrating process development, cGMP API manufacturing and sterile or solid finished dose manufacturing all at a single location. For our full range of in-house services including cGMP sterile fill/finish services please visit www.dalton.com

 Our CMO 2016 and 2017 Leadership Awards in the categories of Quality, Reliability, Capabilities, Expertise, Compatibility and Development from Life Science Leader reflect our ongoing commitment to our clients, peers and the business community. 

In 2016 Dalton was certified as A Great Place to Work®.

 For further information contact:                            

Peter Pekos
President & CEO
Dalton Pharma Services
Tel: 416-661-2102

Cerium Pharmaceuticals Announces Orphan Drug Designation for Tetracosactide in the Treatment of Infantile Spasms

Gaithersburg, Maryland- November 2012. A new potential treatment for a devastating rare seizure disorder has been granted “Orphan Drug” status by the Office of Orphan Products Development of the Food and Drug Administration (FDA). The designation makes Cerium eligible to receive certain market exclusivity, tax credits and fee waivers, if the medicine is approved in the United States for the designated indication.

Tetracosactide hexaacetate is a long acting synthetic adrenocorticotropic hormone (ACTH), which is used outside the United States in the treatment of a wide variety of diseases. The orphan drug designation was granted for the treatment of infantile spasms, which occurs in early infancy.

Infantile spasms, also know as West Syndrome, is an extremely rare condition affecting approximately 800 to 1800 babies per year in the U.S. Most cases of infantile spasms take place during the first year of life with the maximum incidence between 3 and 7 months. A unique seizure type characterizes the disorder and a substantial body of research indicates that the complete elimination of spasms should be the primary goal of treatment. Early diagnosis and prompt treatment are associated with positive long-term outcomes.

Available treatments in the U.S. include H.P. Acthar® Gel (animal based ACTH) and Sabril® (vigabatrin). While not currently approved in the U.S., long-acting tetracosactide is widely used in the treatment of infantile spasms around the world and is approved more than 50 countries.

About Cerium

Cerium Pharmaceuticals, Inc. is an emerging biopharmaceutical company dedicated to the development and commercialization of medicines for patients with rare (orphan) diseases. Cerium’s core focus is to acquire currently marketed products and mid-to-late stage development compounds for rare diseases with established project feasibility, leveraging basic discovery work already performed by others. Cerium’s unique business model pairs a core management team has extensive expertise in clinical development, regulatory affairs, and commercialization of rare disease medicines, linked to a network of academic researchers, specialized consultants, third party service providers and contractors. Cerium employs an optimized infrastructure to quickly develop and commercialize new orphan medicines.

About US Orphan Drug Designation

The US Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US, or that affect more than 200,000 people but are unlikely to recover the costs of developing and marketing the drug. Orphan designation by the FDA qualifies the sponsor for incentives provided for in the Orphan Drug Act, which can include design support for clinical trials, fee waivers, tax incentives, eligibility for expedited review, and seven years of market exclusivity upon approval.