New MA program with Neuraltus Pharmaceuticals

21 September 2015

Clinigen Group and Neuraltus Pharmaceuticals Announce Partnership to Initiate a Managed Access Program for Investigational ALS Therapy in Europe

Clinigen Group plc's ('Clinigen' or the 'Group', AIM: CLIN) Idis Managed Access (MA) division and Neuraltus Pharmaceuticals, Inc., a privately-held biopharmaceutical company focused on the development of drugs to treat neurodegenerative diseases, announced today that the companies are partnering to initiate a Managed Access program for NP001, Neuraltus' investigational therapy for amyotrophic lateral sclerosis (ALS). The partnership makes the Managed Access program immediately available in selected European countries and is expected to gradually expand over the next year.

ALS, or Lou Gehrig's disease, is a rare and fatal neurodegenerative disease characterized by the degeneration of motor neurons in the spinal cord and brain. There are approximately 400,000 ALS patients worldwide, including 50,000 patients in Europe. Most patients and physicians report only modest slowing of ALS progression from existing treatments for ALS, underscoring the need for new and effective drug therapy.

"By partnering with companies like Neuraltus, Idis Managed Access plays a vital role in providing ethical access to unapproved medicines, like NP001, for patients with unmet medical needs," said Simon Estcourt, Managing Director, Idis Managed Access, Clinigen Group. "Our global regulatory and logistical expertise mean that we can deliver a fast and efficient response to physician inquiries. We look forward to working with both Neuraltus and the ALS community, to help patients in Europe who have no other available treatment options."

"Managed Access programs are about giving patients timely access to potential new therapies for devastating diseases, before the therapies are approved for general use," said Rich Casey, President and Chief Executive Officer at Neuraltus Pharmaceuticals, Inc. "We have received numerous inquiries from physicians, patients and their families regarding access to and inclusion in clinical studies for NP001. The planned Phase 2 study in the United States, coupled with our ability to provide NP001 to qualifying patients under a Managed Access program in Europe, underscores our commitment to the ALS community."

Access to NP001 will be provided by Idis MA to individual ALS patients who meet the established eligibility criteria via a regulatory compliant mechanism, following a physician request. European healthcare professionals can obtain details about the NP001 Managed Access program by calling +44 (0)1932 824 123 or via email at [email protected]. Additional information can also be found on Neuraltus' website.

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About NP001

The cause of ALS is currently unknown, but there is increasing evidence that implicates neuroinflammation with the progression of the disease. It is believed that in people with ALS, there are increased levels of inflammatory (activated) macrophage white blood cells resulting in the release of factors in the central nervous system that lead to damage of motor neurons. NP001, a regulator of macrophage activation, is thought to exert its effect by converting these activated inflammatory macrophages back to their normal phagocytic state.

About Clinigen Group

Clinigen Group is a global pharmaceutical and services company with a unique business model dedicated to delivering the right drug to the right patient at the right time. The Group consists of four synergistic businesses that provide medicines to patients with unmet medical need; through Clinigen CTS we manage the supply of commercial medicines for clinical trials, through Idis Managed Access we run early access programs for our own and other companies' portfolios, our Idis Global Access team works directly with healthcare providers to enable ethical compliant access to unlicensed medicines, and through Clinigen SP, we market our own portfolio of niche commercial products.

We are global leaders in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need. Our Managed Access business provides early access to unlicensed investigational medicines on behalf of pharmaceutical companies.

For more information, please visit www.clinigengroup.com

About Neuraltus Pharmaceuticals, Inc.

Neuraltus Pharmaceuticals, Inc. is a privately-held biopharmaceutical company dedicated to developing and commercializing drugs that address critical unmet needs for patients and physicians, primarily in the treatment of neurodegenerative diseases. Neuraltus recognizes that ALS is a devastating condition, with only one approved therapy, and is focused on developing and bringing its investigational treatments to market as quickly as possible. The Company is collaborating with global ALS specialists and seeking input from patient advocacy organizations to help inform the clinical development path and better understand the needs of people affected by the disease. In addition to NP001, Neuraltus also has a pre-clinical program, NP003, for the treatment of lysosomal storage disorders such as Fabry's disease and Gaucher's disease.

For more information on Neuraltus, please visit www.neuraltus.com.

What is ALS? The ALS Association. Viewed on June 12, 2015. Accessed here: http://www.alsa.org/about-als/what-is-als.html?referrer=https://www.google.com/

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