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Collaborating with Non-Profits for Clinical Trials

Three companies partner to advance development of their drugs.

MARIE DAGHLIAN

The Burrill Report


Three biotechs partnered with non-profit groups to advance clinical development of their drug candidates. For the drug companies, having the support of a non-profit advocacy group is a non-dilutive way to advance development of their therapies. For the advocacy group, it is a chance to get a potential life-saving therapy to patients faster.

Acetylon Pharmaceuticals formed a business alliance with the Leukemia & Lymphoma Society to support a clinical trial of its first-in-class oral selective HDAC6 inhibitor drug candidate, ACY-1215, in multiple myeloma.

“Multiple myeloma is one of the most common and therapeutically challenging hematologic malignancies, and development of a therapeutic agent that reduces side effects while providing greater efficacy is a key goal for LLS,” says Richard Winneker, SVP of research at the Society.

Acetylon will conduct a three-part phase 1/2 clinical trial of ACY-1215 in adults with relapsed and relapsed/refractory multiple myeloma to achieve human proof-of-concept for selective HDAC6 inhibition. The Leukemia & Lymphoma Society will provide $4.85 million in non-dilutive, milestone-based, and conditionally repayable funding, representing half of the projected costs of the clinical trial. The first part of the trial is expected to begin in the next several months.

Psyadon Pharmaceuticals is collaborating with the Tourette Syndrome Association on a clinical trial to determine the potential efficacy of Psyadon’s drug, ecopipam, for managing the symptoms of the neurological disorder. The Association will also help recruit subjects for the clinical trial of ecopipam. It’s the first drug company collaboration for the Tourette Syndrome Association.

Marked by involuntary movements and sounds called “tics,” Tourette Syndrome is an inherited, neurobiological disorder frequently misunderstood by the public and often misdiagnosed medically. Although various off-label drugs are prescribed by medical professionals for Tourette, only two, pimozide and haloperidol, are approved by the U.S. Food and Drug Administration for its treatment and they often provide only mild to moderate benefit and have poorly tolerated side effects that limit their use.

The FDA granted ecopipam an orphan-drug designation for the treatment of Tourette Syndrome in September 2010. The clinical trial, which has already begun, is a phase 2a, open-label, non-randomized trial to examine the ability of ecopipam to both reduce tic severity and also to determine its safety in adults with the syndrome. Psyadon expects to release data from the trial by mid-2012.

Amylin Pharmaceuticals has entered into a research collaboration with the Juvenile Diabetes Research Foundation to provide financial support for a series of clinical studies to investigate the feasibility of mixing pramlintide, an analog of the human hormone amylin and marketed by Amylin as Symlin, with insulin to treat type 1 diabetes.

People with type 1 diabetes produce neither insulin nor amylin and managing blood sugar with insulin replacement alone is difficult. Pramlintide helps balance blood sugar levels. Currently, patients who use pramlintide must separately administer their daily insulin therapy, either through injections or an insulin pump. The hope is that a co-formulated therapy that harnesses the benefit of both hormones might better mimic the natural physiology of the pancreas and simplify dosing decisions.

The collaboration, consisting of formulation and clinical work, will investigate whether a fixed ratio of pramlintide and insulin can effectively help treat type 1 diabetes. This is the second research collaboration between JDRF and Amylin to advance innovative treatments for people with type 1 diabetes, part of a JDRF effort to accelerate research for a cure for type 1 diabetes.

The JDRF and Amylin are also currently collaborating on a proof-of-concept study at the University of Texas Southwestern Medical Center to investigate the effects of metreleptin, an analog of the human hormone leptin, in patients with type 1 diabetes to determine whether the compound can help decrease insulin requirements and better control glucose levels. To date, the JDRF has funded 39 partnerships with 32 companies and committed approximately $73 million as part of its Industry Discovery & Development Partnerships program.




Global Venture Financings
Company Location Amount Raised (USD M) Principal Activity
Naurex Evanston, IL 18.0 Neurology
WaveTec Vision Aliso Viejo, CA 15.9 Ophthalmic
SpringLeaf Therapeutics Boston, MA 15.0 Drug delivery
Cell Biosciences Santa Clara, CA 13.0 Protein analysis
Molecular Imaging Research (MIR Acquisition) Ann Arbor, MI 7.0 CRO
Prexa Pharmaceuticals Boston, MA 7.0 CNS therapeutics
U-Systems Sunnyvale, CA 6.5 Ultrasound technology
Seventh Sense Biosystems Cambridge, MA 4.5 Blood collection
MoMelan Technologies Cambridge, MA 3.5 Medical devices
CardioDx Palo Alto, CA 2.5 Genomic tests
ImThera Medical San Diego, CA 1.8 Neurostimulation
OncoHealth Fremont, CA 1.6 Diagnostics
Verdezyne Carlsbad, CA N/A Renewable fuels and chemicals
Fate Therapeutics San Diego, CA N/A Stem cell therapeutics
Nextim Oy Finland 19.1 Brain imaging
Stabilitech London, United Kingdom 3.6 Vaccine stabilization technology
caprotec bioanalytics Berlin, Germany 1.4 Tools/Technology
Trillium Therapeutics Toronto, Canada 1.0 Urinary therapeutics
Agnion Energy Pfaffenhofen, Germany N/A Biomass conversion
Total Raised US 96.3
Total Raised Non-US 25.1
Grants 
Company Funding Agency Amount Raised (USD M) Principal Activity
Abaxis Kansas Biosceince Authority 0.7 Blood analysis systems
TerraVerdae BioWorks (United Kingdom) UK Technology Strategy Board N/A Bioplastics
Total Grants  0.7
Public Financings
Company Ticker Amount
Raised (USD M)
Financing Type
Neptune Technologies and Bioresources (Canada) TSX-V:NTB 11.5 PIPE
Cytomedix OTC:CMXI 0.3 PIPE
Biodel BIOD 30.0 PIPE
Marina Biotech MRNA 15.0 Follow on
Nanosphere NSPH 34.5 Follow on
Bioanalytical Systems BASI 5.5 Follow on
Cytomedix OTC:CMXI 2.1 Debt
PDL BioPharma PDLI 135.0 Debt
Complete Genomics GNOM 20.0 Loan from Oxford Finance
Advaxis OTC:ADXS 7.1 Convertible promissory notes
Total Public Financings-US 249.5
Total Public Financings-Non-US 11.5
M&A 
Acquirer Target Deal Value
(USD M)
Focus
Alkermes Elan Drug Technologies (Ireland) 960.0 Biopharmaceuticals
Varian Medical Systems Augmenix 15.0 Tools/Technology
Cell Biosciences Brightwell Technologies (Canada) 9.0 Tools/Technology
PositiveID MicroFluidic Systems 8.2 Tools/Technology
Terumo (Japan) Harvest Technologies N/A Tools/Technology
Alliances 
Company/Licenser Company/Licensee Deal Value
(USD M)
Focus
Allos Therapeutics Mundipharma (United Kingdom) 360.5 Cancer drug license
PharmEngine (Taiwan) Merrimack Pharmaceuticals 220.0 Cancer drug license
Halozyme Therapeutics ViroPharma 83.0 Drug delivery technology license
University of Manchester (United Kingdom) GlaxoSmithKline and AstraZeneca (United Kingdom) 24.0 Inflammatory research collaboration
BioAlliance Pharma (France) Sosei (Japan) 18.5 Antifungal drug license
Leukemia & Lymphoma Society Acetylon Pharmaceuticals 4.9 Cancer alliance
BARD OriginOil N/A Renewables partnership
GreenField Ethanol and Andritz (Canada) Novozymes (Denmark) N/A Renewables joint venture
Pepscan Therapeutics (the Netherlands) Phylogica N/A Autoimmune drug discovery collaboration
Pfenex MedImmune (AstraZeneca-United Kingdom) N/A Technology collaboration
Medtronic Bayer HealthCare (Germany) N/A Diabetes alliance
Seegene (Korea) Akonni Biosystems N/A Diagnostics alliance
Diagenode (Belgium) Becton, Dickinson N/A Diagnostics collaboration
Chronix Biomedical Myriad Genetics N/A Technology license
BioFocus DPI (Galapagos-Belgium) Astellas Pharma (Japan) N/A CNS collaboration
Elan (Ireland) Paladin Labs (Canada) N/A Pain drug license
Juvenile Diabetes Research Foundation Amylin Pharmaceuticals N/A Type 1 diabetes collaboration
Bakoulev Center of Cardiovascular Surgery of Russian Academy of Sciences (Russia) MediStem N/A Heart failure drug collaboration
Tourette Syndrome Association Psyadon Pharmaceuticals N/A Neurology research collaboration


May 13, 2011
http://www.burrillreport.com/article-collaborating_with_non_profits_for_clinical_trials.html

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