Although GlaxoSmithKline plc has quietly shuttered its Center of Excellence for External Drug Discovery (CEEDD), the pharma maintains it is not deprioritizing early program partnerships. Instead, GSK thinks its R&D scientists have adopted the strategies brought in by CEEDD, and that there is no longer a need for a group dedicated to creating external alliances.

GSK established the CEEDD in 2005 as part of an initiative to build its pipeline by tapping into external talent. The program, which involved approximately 20 GSK scientists, ran through 2012 and brought 16 alliances to the organization. By 2011, however, external alliances were being generated increasingly by non-CEEDD scientists, and CEEDD was no longer the primary driver of external early stage opportunities (see "Selected deals between GSK and biotechs or academic institutions").

The original goal of CEEDD was to establish partnerships for early programs that would share both the risk and the control with the partner. Previously, most of GSK's early stage deals involved the pharma taking control of the asset. CEEDD deals involved an option-based structure including an up-front payment, sharing of risk up to an option point at Phase II proof of concept (POC) and milestones and royalty payments. At Phase III, optioned programs would be taken over by GSK.

The CEEDD group focused on identifying emerging biotech companies with platforms that could yield multiple products. Most CEEDD alliances involved 4-10 programs and were agnostic to therapeutic area. The program stages ranged from discovery to Phase II.

Partnerships included joint steering committees that set goals and oversaw operations. The intent was for GSK to keep a light touch in the relationship until shortly before the option decision. Research was done by the partners' scientists, who were able to use GSK facilities to carry out experiments if needed via GSK's Scinovo group. That group was set up in 2009 as part of the GSK open innovation model, and provides all GSK partners with access to consultants, the GSK CRO network and facilities for performing studies.

Jason Gardner, who led CEEDD and is now head of GSK's regenerative medicine Discovery Performance Unit (DPU), described the culture in R&D before 2005 as risk averse, with a pipeline dominated by internal efforts.

For example, he said, one prevailing belief at GSK was that chemokine receptors weren't druggable.

Despite that, in 2006 CEEDD investigated-and partnered with-ChemoCentryx Inc., which has a platform of orally administered therapeutics that are highly selective for specific chemokine receptors. In 2009, GSK exercised an option to license exclusive worldwide rights to vercirnon (formerly Traficet-EN), a CC chemokine receptor 9 (CCR9; CDw199) antagonist that showed positive Phase II data in inflammatory bowel disease (IBD). The molecule now is in four Phase III trials.

In 2011, GSK exercised an option for exclusive, worldwide rights to CCX354 for rheumatoid arthritis (RA). The CC chemokine receptor 1 (CCR1; CD191) antagonist is in Phase II testing.

CEEDD's freedom to explore therapeutic areas without restriction led it to expand the activities of GSK. In 2009, the pharma did not have a rare diseases group and had not done any work on Duchenne muscular dystrophy (DMD). That year, CEEDD formed an alliance with Prosensa B.V., which uses exon-skipping antisense technology to create RNA-based compounds for DMD.

GSK obtained exclusive worldwide rights to PRO051 and exclusive options to three other RNA-based compounds for DMD. The deal was expanded in 2010 to include two programs in DMD that target additional disease-related exons.

The lead compound from the alliance, drisapersen (PRO051), now is in Phase III testing with data expected in late 2013.1

The deal ultimately led GSK to establish a rare diseases group and enter a new disease space.

An academic issue

By late 2010, alliances with early stage biotechs were more common throughout GSK, but deals with academics were still sporadic. To remedy that, GSK established the Discovery Partnerships with Academia (DPAc) group in 2011 to identify discovery opportunities with translational potential in academic organizations.2

The push into academia has had clear results. Last year was by far GSK's most productive in terms of forming deals with universities and institutes.

Looking back, Gardner believes CEEDD's legacy was proving to GSK that the company could work productively with external entities and that it changed the overall shape of the pipeline. "Now external partners are seen as adding something useful rather than intruding on your territory," he said.

The number of internal programs at GSK has not changed significantly since 2005, but the number of external ones has grown from a small minority to about 50% of all the company's early stage programs, according to GSK spokesperson Melinda Stubbee.

The majority of CEEDD's scientists have remained with GSK. Successful programs at clinical POC stages have been transferred directly to clinical development groups. For example, the ChemoCentryx CCR9 program is now run by the Immuno-Inflammation Medicines Development Center. Other programs were transitioned during the past year for management by DPUs.

Fishburn, C.S. SciBX 6(23); doi:10.1038/scibx.2013.565
Published online June 13, 2013

REFERENCES

1.   Fulmer, T. BioCentury 21(22), A1-A6; June 3, 2013

2.   Osherovich, L. SciBX 6(10); doi:10.1038/scibx.2013.230

COMPANIES AND INSTITUTIONS MENTIONED

ChemoCentryx Inc., Mountain View, Calif.

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K.

Prosensa B.V., Leiden, the Netherlands