INDUSTRY NEWS
acquired by Alkermes in 2011 as part of its business combination with Elan Drug Technologies; Alkermes’ rights to RITALIN LA®, FOCALIN XR®, VERELAN® , ZOHYDRO® ER, and BIDILTM; and the late-stage, parenteral formulation of Meloxicam IV/IM, a nonsteroidal anti-inflammatory drug, which has completed multiple phase 2 trials for the management of moderate-to-severe acute pain, as well as related technology.
“We are streamlining Alkermes’ manufacturing operations for our commercial products and late-stage pipeline into our two GMP facilities in Athlone, Ireland, and Wilmington, Ohio,” said James Frates, Chief Financial Officer of Alkermes. “With this transaction, we are capturing value from non-core assets, as we continue to execute on our strategy and focus on the key driver of our future growth—our late-stage pipeline of innovative medicines for central nervous system diseases.”
Ironwood Pharmaceuticals Initiates Phase I Clinical Study of sGC Stimulator IW-1973
Ironwood Pharmaceuticals, Inc. has announced that dosing has begun in a Phase I clinical study of IW-1973, the first clinical compound in a broad, pharmacologically differentiated library of soluble guanylate cyclase (sGC) stimulators discovered by Ironwood. Data are expected in the second half of 2015. Ironwood expects to advance a second sGC stimulator, IW-1701, into a Phase I clinical study later this year.
“We look forward to exploring the potential of sGC stimulators across multiple, select therapeutic opportunities within a broad potential range that may span cardiovascular diseases, fibrosis, muscular dystrophy, glaucoma, dementia, and diabetic complications,” said Mark Currie, PhD, chief scientific officer and president of research and development at Ironwood. “It is rare in drug discovery to have the opportunity to modulate one of the fundamental regulators in the human body, and we are fortunate to have the pharmacologic expertise to advance what we believe can be strongly differentiated molecules in this space.”
The randomized, double-blind, placebo-controlled Phase I clinical study is designed to assess the safety, pharmacokinetic profile, and pharmacodynamic effects of IW-1973 in healthy volunteers.
The IW-1973 Phase I study is the seventh clinical study ongoing in Ironwood’s research and development pipeline this year. Other clinical studies conducted by Ironwood include an ongoing Phase IIa clinical study of IW-9179 in diabetic gastroparesis and a recently completed Phase IIa clinical study of IW-3718 for refractory gastroesophageal reflux disease. Clinical studies ongoing with partners include Phase III trials with linaclotide for adults with irritable bowel syndrome with constipation, for China and for Japan, as well as a Phase III trial with a 72 mcg dose of linaclotide in adult patients with chronic idiopathic constipation and a Phase II clinical study of linaclotide for adults with opioid-induced constipation, both in the U.S.
About IW-1973
IW-1973 is an investigational soluble guanylate cyclase (sGC) stimulator discovered by Ironwood. SGC is an enzyme found inside cells throughout the body; it modulates levels of the second messenger cyclic guanosine monophosphate (cGMP), a signaling molecule that regulates many
physiological changes and may be relevant for the treatment of a broad range of diseases including cardiovascular diseases such as pulmonary arterial hypertension and congestive heart failure as well as fibrosis, muscular dystrophy, glaucoma, dementia, and diabetic complications. Data from preclinical studies of IW-1973 suggest a pharmacokinetic profile consistent with once daily dosing and showed a gradual lowering of blood pressure without profound hypotension or tachycardia in animal models. Ironwood established its expertise with guanylate cyclase C (GC-C), another modulator of cGMP, through the discovery and development of linaclotide; the company then leveraged that GC-C expertise to discover and patent a broad library of chemically distinct sGC stimulators. Ironwood is currently utilizing medicinal chemistry, formulation and pharmacology to drive toward optimizing these molecules for pursuit of various indications and dosing schedules.
PDS Life Sciences Helps Major Pharma Company Receive the First FDA Acceptance of a BLA Filing Incorporating SEND Requirements
PDS Life Sciences, a leading global provider of intuitive data management software and solutions for life sciences research, helped a major pharmaceutical company become one of the first to successfully submit a Biologics License Application (BLA) that incorporated the FDA’s new Standard for Exchange of Nonclinical Data (SEND).
The company approached PDS because of the project’s complexity, needing to convert and prepare non-standardized data from numerous heterogeneous studies for submission quickly. PDS provided complete submission management services, including the composition of a Study Data Reviewer’s Guide. As a result, the FDA accepted the entire data package.
“Other solution providers may tout their SEND clients,” said Sayed Badrawi, CEO of PDS, “but PDS is the first to publicly advise a successful submission of a new drug application to the FDA that adhered to SEND requirements.”
The FDA has issued final guidance on standardized electronic data. Data for studies starting after Dec. 17, 2016, supporting applicable NDAs, BLAs, and ANDAs, and studies starting after Dec. 17, 2017, supporting IND submissions, must be submitted in SEND format.
“Our goal is to make SEND implementation a benefit to our clients, not another hurdle,” said Badrawi. “This project confirms our ability to do just that and demonstrates the leadership and support PDS will uphold as the industry makes the transition to SEND compliance.”
Biomedical Systems Launches Next-Generation eCOA Technology
Biomedical Systems, a premier global provider of centralized diagnostic services, launched its second-generation clinical outcome assessment software offering 3 easy-to-use platforms to collect patient data. This new electronic patient recorded outcome (ePRO) technology improves patient and investigator user experience, improves patient compliance, and expedites study setup by simplifying site tasks and reducing errors.
Pharmaceutical Outsourcing | 70 | March/April 2015
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