Recent Tech Transfer Deals (03/2009)

Our monthly update on technology transfer deals--licensing agreements between companies and universities or other research institutions--in the fields of life sciences, including pharmaceuticals, medical devices, in vitro diagnostics and research/analytical instrumentation and reagents.

In Vitro Diagnostics

Artemis Health Inc.

Stanford University

Artemis Health gets rights to Stanford's prenatal IP

Jan.—Artemis Health (developing prenatal tests) has licensed co-exclusive worldwide rights to Stanford University's IP to create cell-free fetal DNA prenatal diagnostics.

Artemis is working on tests (using whole-cell and cell-free fetal DNA taken from maternal blood) for various genetic abnormalities and chromosomal aneuploidies (unusual amounts of chromosomes). It already has rights to discoveries made by Tufts University's Diana Bianchi, MD that separate intact fetal cells from maternal samples. The newly licensed IP, which was developed by the university's Stephen Quake, PhD, can be used to develop diagnostics for genetic disorders including Down's syndrome, Edwards syndrome (trisomy 18), and Patau syndrome (trisomy 13). In conjunction with the alliance, Artemis has extended its consulting arrangement with Dr. Quake.

Pharmaceuticals

AstraZeneca PLC

Mayo Clinic College of Medicine

Virginia Polytechnic Institute & State University

Virginia Tech Intellectual Properties Inc.

AstraZeneca gets compounds from Mayo and Virginia Tech

Feb.—AstraZeneca has licensed from the Mayo Clinic and Virginia Tech Intellectual Properties (licensing corporation affiliated with Virginia Polytechnic Institute & State University) exclusive worldwide rights to develop, manufacture, and market a group of preclinical triple reuptake inhibitors for depression.

All three entities will also collaborate further to develop additional TRI candidates. While traditional antidepressants such as selective serotonin reuptake inhibitors (Prozac, Zoloft) and dual serotonin/norepinephrine reuptake inhibitors (Effexor, Cymbalta) only target one or two malfunctioning neurotransmitters in the brain, TRIs aim to regulate three neurotransmitters (serotonin, norepinephrine, and dopamine), potentially leading to greater efficacy as well as fewer side effects.

Endo Pharmaceuticals Holdings Inc.

Harvard University

Endo to develop targeted drug delivery tech. from Harvard

Feb.—Endo Pharmaceuticals (generic and branded drugs) has received exclusive worldwide development and marketing rights to Harvard University's targeted delivery technology for the treatment of pain.

Endo is in charge of developing and marketing resulting products. The platform--invented by Harvard's Clifford Woolf, MD, PhD (who is also involved in another industry collaboration, with GSK, that covers pain management) and Harvard Medical School's Richard Kitz, MD, and Bruce Bean, PhD--selectively blocks pain-sensing (nociceptor) neurons while avoiding motor neurons and thus not interfering with motor function or nonpainful stimuli reaction. Just over a year ago, Drs. Woolf and Bean published an animal study that demonstrated how their technology works--the scientists injected a combination of a lidocaine derivative (labeled QX314) plus capsaicin near the sciatic nerves of rats, which lost feeling in their paws but were still able to walk and respond to touching. Capsaicin (the main ingredient in hot peppers) opens up TRPV1 channels, which are heat sensitive and characteristic of only nociceptor neurons, to allow the QX314 to exert its anesthetic effects. The agreement marks Endo's first this year focusing on pain. So far in 2009 the company's dealmaking has strayed from pain to include other therapeutic areas, such as endocrinology and urology (through the Indevus acquisition) and cancer (in a three-year alliance with Aurigene, penned the same day as the Harvard tie-up).

GlaxoSmithKline PLC

University College London

Institute of Ophthalmology

GSK pens three-year eye deal with University College London

Feb.—In a three-year deal, the University College London's Institute of Ophthalmology has agreed to conduct further research on ophthalmic molecules and reagents provided by GlaxoSmithKline.

GSK would get rights to resulting candidates and pay sales royalties. The Institute of Ophthalmology brings to the alliance know-how and experience, research laboratories, as well as funding and a staff--to be led by Philip Luthert, PhD, and David Shima, PhD (who is formerly of Eyetech Pharmaceuticals, which discovered Macugen, a breakthrough AMD treatment at the time it was launched)--specifically designated for the collaboration, which aims to study the mechanisms behind eye diseases. GSK hasn't been heavily involved in ophthalmology R&D in the past. With the exception of a few out-licensing agreements, it hasn't done much dealmaking in this category, and in fact the company only shows one ophthalmic candidate, Phase II pazopanib for AMD, on its most recent pipeline chart. But the Big Pharma overhauled its drug discovery division last year to focus on eight therapeutic areas including ophthalmology, which will be led by a new discovery performance unit called Ophthiris.

Johnson & Johnson

Centocor Ortho Biotech Inc.

Medical Research Council

Medical Research Council Technology

Centocor works on immunotherapeutic under MRC patent license

Jan.—[Medical Research Council Technology], the tech transfer arm of Medical Research Council (MRC), has licensed J&J's Centocor Ortho Biotech exclusive rights to its immunotherapeutic for respiratory disease and related patents.

Centocor will pay development milestones and sales royalties. MRC's [Laboratory of Molecular Biology] discovered the candidate, which was further progressed by MRC's drug discovery division, but no other information was disclosed. MRC, a publicly funded UK organization, spends about 15% (£85.5mm; $171mm) of its budget on research in infectious and immune diseases, and studies the mechanisms of immunity and immune tolerance and rejection. As far as respiratory disease, the only therapeutic listed as available for licensing on MRC Technology's website is a recombinant protein for inflammatory lung disorder. The alliance adds an earlier-stage project to the newly formed Centocor Ortho Biotech's immunology pipeline, which consists primarily of advanced candidates (although lead ustekinumab, for psoriasis, recently received a complete response letter requesting more data for the NDA and a REMS). The division was created last year when J&J decided to consolidate its biotechnology subsidiaries--Centocor and Ortho Biotech--into one following disappointing sales of Ortho's EPO drug Procrit and lack of leadership in Centocor after the company's president resigned.

MBiotec GMBH

Helmholtz Association

Helmholtz Center for Infection Research

MBiotec starts operations with license to Helmholtz compound

Feb.—German company MBiotec GMBH is starting up its newly founded business with an exclusive license to Helmholtz Center for Infection Research's toll-like receptor 2/6 agonist MALP2S for all cancer indications. The deal was facilitated by Helmholtz's tech transfer partner Ascenion, which made an equity investment in MBiotec.

Discovered by Helmholtz's Peter Muhlradt, PhD, who researched the candidate over the past twenty years, MALP2S is a synthetic form of a macrophage-activating lipopeptide produced in mycoplasma. The compound, believed to stimulate both the innate and adaptive immune systems, will be administered with chemotherapy and has been studied in pancreatic cancer (inoperable adenocarcinoma of the pancreas), showing safety and anti-tumor activity in Phase I/II. MBiotec has applied for orphan drug status in the US and EU. Besides oncology, MALP2S has also been evaluated for wound closure, sepsis, and as an adjuvant--and is exclusively licensed to AmVac AG in this area.

NasVax Ltd.

Tel Aviv University

Ramot at Tel Aviv University Ltd.

Ramot licenses AD antibody and vaccine to NasVax

Feb.—Ramot at Tel Aviv University has exclusively licensed its Alzheimer's disease vaccine and antibody (what it terms blocking b-site 1, or BBS1, technology) to vaccine adjuvant developer NasVax.

NasVax is in charge of development and marketing resulting products. The BBS1 antibody, as well as the antibodies elicited by the BBS1 vaccine, binds to the beta secretase cleavage site on the amyloid precursor protein in order to interfere with the initial steps of beta amyloid production, thus preventing the peptide from aggregating in the brain. Ramot's antibody and vaccine, which have already shown safety and efficacy in animals, have the potential to target AD at an earlier stage and are not expected to prompt unwanted complement or microglial activation or cause other adverse side effects, giving these candidates an advantage over other immunotherapeutics. The licensed IP was discovered by a group led by Tel Aviv University's Beka Solomon, PhD, who was actually behind another AD invention (not bapineuzumab) that was acquired in 2001 by Elan and American Home Products (now Wyeth). The present deal is Ramot's second involving amyloid production--in 2007 the organization granted Merz rights to small-molecule AD compounds--and marks NasVax's first venture outside of infectious diseases.