AstraZeneca plans to further develop AZD3480 (TC-1734) for attention deficit/hyperactivity disorder (ADHD) and will make a $10 million milestone payment to Targacept. AZ will also continue development of AZD1446 (TC-6683) in Alzheimer’s disease. The drug is currently in Phase I and was discovered through the parties’ ongoing research collaboration.

Targacept is also eligible to receive a milestone payment for AZD3480 if ADHD is the only target indication for which AZD3480 is developed further. Targacept remains eligible to receive more than $100 million if development, regulatory and commercial sale milestones are achieved for AZD3480 in ADHD, as well as royalties on any future sales of AZD3480 in any indication. Targacept may also receive future success based milestones for AZD1446 and royalties on any future sales.

“We continue to be enthusiastic about neuronal nicotinic receptors as a promising new mechanism in the treatment of multiple cognitive disorders,” said Bob Holland, vice president and head of the Neuroscience Therapy Area, AstraZeneca. “We believe the therapeutic profile of AZD3480, a non-stimulant, may be an important advance for treating patients with ADHD and we also remain positive about the potential of NNR agonists to treat Alzheimer’s disease.”

“We appreciate the efforts and dedication of our colleagues at AstraZeneca as we work together to develop and deliver the promise of NNR Therapeutics to patients affected by cognitive disorders like ADHD and Alzheimer’s disease,” said J. Donald deBethizy, Ph.D., president and chief executive officer of Targacept. “In addition to AZD3480 and AZD1446, we remain enthusiastic about the breadth and pharmacological diversity of our portfolio. With our pipeline, strong alliances and a cash runway that we expect to fund our operations for at least the next two years, we are well positioned to execute our business plan.”

Absorption Systems has acquired Perry Scientific, Inc., an in vivo toxicology and pharmacokinetics testing company located in San Diego, CA. Perry’s research services include testing for toxicology, medical devices, preclinical models and CNS pharmacology.

In addition to routine preclinical pharmacokinetics testing, Absorption Systems will now conduct GLP studies in the San Diego testing facility, which is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International.

“The acquisition of Perry Scientific furthers our mission to efficiently move clients from the early stages of drug discovery testing for ADME and pharmacokinetics through the definitive safety and toxicology testing necessary for new drug and device submissions,” commented Patrick M. Dentinger, president and chief executive officer of Absorption Systems. “By offering a full range of tests, we will be able to design and perform studies that will get clients to the point of submission to the FDA as quickly as possible.”

“Joining forces with Absorption Systems is a natural step in our growth because our respective businesses are entirely complementary,” said Andrew Perry M.D., Ph.D., founder of Perry Scientific. Now we can offer our customers the convenience and accuracy of having an entire preclinical testing package performed at a single facility—the combined company offers all the services needed to move a new drug from the benchtop to the clinic.”

Biogen Idec's PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) was granted Fast Track designation by the FDA. Biogen plans to enroll more than 1,200 patients in a Phase III, randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of the drug in patients with RMS.

The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and have the potential to address unmet medical needs.

“Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis,” said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology at Biogen Idec. “We look forward to working closely with the FDA to expedite the compound’s development and review process.”

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