PrintThree 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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