Project centers on BioFocus compounds shown to amplify therapeutic effect of galanin.

Galapagos could earn €3.3 million (about $4.2 million) in research fees over the next two years as part of a collaboration with Wellcome Trust researchers at the U.K.’s University of Bristol to develop treatments for diabetic neuropathic pain.

The partnership is focused on developing an analgesic based on the protein galanin, which Galapagos says has been shown to reduce neuropathic pain in a number of disease models including diabetes. The firm’s BioFocus service division will provide hit-to-lead and lead optimization services for the project, which is funded by a Wellcome Trust Seeding Drug Discovery Award.

Project leader David Wynick, Ph.D., professor of molecular medicine at the University of Bristol, says studies suggest several compounds from BioFocus’ screening collection can amplify the therapeutic effect of galanin. “In this new collaboration with BioFocus, we aim to further optimize these molecules into potential clinical candidates for the treatment of chronic pain associated with diseases such as diabetes.”

Source: GEN

Popularity: 2% [?]

Aestus’ preclinical candidates will be evaluated.

Aestus Therapeutics and Eisai have agreed to work together on the R&D of therapeutics for psychiatric disorders. The multiyear collaboration will entail preclinical validation of Aestus’ compounds leading to clinical proof-of-concept studies.

Aestus’ candidates were identified through its proprietary analysis of gene-expression datasets, coupled with biological pathway mining on data from relevant disease models. Along with Eisai, the firm will work toward picking lead candidates for further development.

Aestus reports that it has several products for neuropathic pain that are ready to enter Phase II studies. On June 28, Aestus licensed Astellas Pharma’s FK614, a PPAR-gamma agonist, to develop the product for postherpetic neuralgia. The first clinical trial is expected to start later this year. On June 9, the company was awarded a $2 million SBIR grant from the NIH to advance its pain candidates.

Beyond neuropathic pain, the Aestus technology is currently being applied to ALS and schizophrenia. On March 17, the ALS Therapy Development Institute and Aestus reported plans to test potential small molecule compounds to slow or stop the progression of ALS.

Source: GEN

Popularity: 3% [?]

A day after getting a new CEO, Bristol-Myers Squibb has paid $40 million upfront and promised up to $373 million more in milestones to license Allergan’s experimental therapy for neuropathic pain. The oral AGN-209323 still has a long way to go, with researchers preparing for a mid-stage study.

BMS gets worldwide rights to all but one indication–local delivery to the eye–which Allergan will hold on to for now. Under the deal, ExonHit Therapeutics will snare $4 million of the upfront and more than $32 million of the potential milestones.

“We are fortunate to have a deep R&D pipeline, and believe that by partnering programs that extend into primary care, we can maximize the value of our science,” says Scott Whitcup, executive vice president, R&D and chief scientific officer, Allergan.

Like most other pharma companies, BMS has been scrambling to line up new products. It loses patent protection on Plavix in 2012. And yesterday, the company named its Number Two–Lamberto Andreotti–as its new CEO. He will take the helm from James Cornelius, who will remain as chairman.

Source: FierceBiotech

Popularity: 3% [?]

GlaxoSmithKline and XenoPort announced Monday that experimental drug Solzira (gabapentin enacarbil) did not meet the primary endpoint of a Phase II study in adults with neuropathic pain associated with diabetic peripheral neuropathy (DPN). The companies suggested the results “may be a consequence of the unexpectedly high placebo response rate observed in the study.” XenoPort shares dropped 23 percent on the news.

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The trial involved 421 patients with type 1 or type 2 diabetes who experienced signs and symptoms of DPN, and who were randomly assigned placebo, Pfizer’s Lyrica (pregabalin) or one of three doses of Solzira. Findings showed that Solzira did not result in significant improvement from baseline to end of treatment on a pain intensity scale, compared with placebo. In addition, Lyrica did not differentiate from placebo on the same endpoint, the companies said.

XenoPort CEO Ronald Barrett stated that “a high placebo response is not uncommon in DPN studies, and this has been a contributing factor to several failed studies testing different drugs in this patient population.” He added that “the failure of [Lyrica] in this study makes it difficult to draw definitive conclusions about the efficacy of [Solzira].” Atul Pande, senior vice-president of the Neurosciences Medicines Development Center at GlaxoSmithKline, said “we will be evaluating the study results further in order to determine our next steps.”

Source: FirstWord

Popularity: 5% [?]

EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform today announced poster presentations of preclinical data on EPX-102216 and EPX-105287, during the Keystone Symposia Neurobiology of Pain and Analgesia in Santa Fe, New Mexico.

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On February 23, 2009, Christine Kitsos, Ph.D., principal scientist, discovery biology at EPIX is scheduled to give a poster presentation entitled, “Attenuation of Inflammatory Pain by EPX-102216, a Novel CCR2 Antagonist.” CCR2 antagonists represent a novel mechanism of action for reducing the inflammatory response in several diseases by preventing macrophages (a type of inflammatory immune cell) from accumulating in body tissues. EPX-102216, wholly owned by EPIX, is a highly selective, oral CCR2 antagonist with an excellent safety profile that is being further developed for the treatment of pain. Dr. Kitsos will be presenting results that show dose-dependent efficacy in rodent models of chronic inflammatory and neuropathic pain.

On February 24, 2009, Dilara McCauley, Ph.D., director, discovery product leader at EPIX is scheduled to give a poster presentation entitled, “EPX-105287, a Highly Selective Metabotropic Glutamate 5 Receptor (mGluR5) Negative Allosteric Modulator, Reduces Writhing in Mice and Thermal Hyperalgesia in Rats.” EPX-105287, also wholly owned by EPIX, is a novel, potent, highly selective mGluR5 negative allosteric modulator that is being developed for the treatment of neuropathic (chronic) pain and L-Dopa induced dyskinesia (involuntary movement). Dr. McCauley will be presenting results of EPX-105287 displaying dose-dependent efficacy in acute visceral and chronic inflammatory rodent pain models.

EPX-102216 and EPX-105287 are both internally discovered and part of EPIX’s ongoing preclinical and discovery programs targeting G-Protein Coupled Receptors (GPCRs) and ion channels for the treatment of inflammatory diseases, pain and cystic fibrosis. Both molecules are wholly owned by EPIX Pharmaceuticals.

About EPIX

EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen and Cystic Fibrosis Foundation Therapeutics.

This news release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of management. These statements relate to, among other things, our expectations regarding our drug development efforts and the timing and content of corporate presentations. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional information regarding these and other risks that we face, see the disclosure contained in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.

Source: Business Wire

Popularity: 4% [?]

UCB reported Thursday that it is withdrawing its EU application for Vimpat (lacosamide) in the treatment of diabetic neuropathic pain.

The drugmaker noted that its decision was based on the European Medicines Agency’s Committee for Medicinal Products for Human Use opinion that the magnitude of the product’s efficacy for the indication was not convincingly established and that an additional trial would be required.

The drug was recently approved in Europe as an adjunctive treatment for partial onset seizures in patients with epilepsy. The FDA is currently reviewing Vimpat for the epilepsy indication. In July, US regulators issued a not approvable letter for Vimpat in diabetic neuropathic pain.

Source: FirstWord

Popularity: 4% [?]