Pullan Consulting
Biotech Business Development Consulting
www.pullanconsulting.com and www.lindapullan.com
email: lpullan@msn.com 805-558-0361
Issue #31
Pullan's Pieces
Commentary on Science & Business of Drug Development
For Business Development & Others
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A partnering profile of GSK
In this issue, I thought I would try to give you my analysis of the public information on GSK as a partner. I’d love to hear what you think of partner profiles as an occasional newsletter topic. (By the way, this is just my synthesis of public information. GSK had no role in it!)
GSK Vision
GSK is diversifying and restructuring to be efficient and innovative in a world with fewer blockbusters.
Although prescription drugs are by far the biggest part of the business, GSK is increasing its emphasis on
· consumer healthcare products (where it sees growth especially in emerging markets),
· vaccines (where it sees margins comparable to drugs and the potential for transformation with therapeutic vaccines), and
· business in Japan (where can take advantage of the 10 years of exclusivity for its pipeline).
GSK R&D Structure
GSK is attempting to make R&D more entrepreneurial, more like small biotechs, with smaller units with P&L responsibilities. GSK is also trying new models for interactions with companies and academia. GSK spends about $1.2B or13.7% of its turnover on R&D. GSK research is concentrated in Centres of Excellence of Drug Discovery (CEDDs), and there are 8 therapeutic areas (not all of which seem to be full CEDDs):
- Infectious diseases (with 45 projects in preclinical thru Ph 3 in PharmaProjects, includes vaccines)
- Metabolic pathways (with 23 projects with metabolic as the primary therapeutic area)
- Neurosciences (with 45 projects)
- Respiratory (with 25 projects)
- Immunoinflammation (28 projects as immunological or musculoskeletal)
- Oncology (not a CEDD, but about 1000 people including development and discovery as of Sept 2008) with 20 projects, including cancer vaccines)
- Ophthalmology (only a Phase I AMD project visible)
- Biopharmaceuticals (the former Domantis, with 11 antibodies listed)
In at least the Infectious Diseases CEDD, there is a commitment to a slimmed-down (with layoffs) internal structure and to building their drug discovery portfolio in part through outside deals (“virtualising a portion of its pipeline”).
GSK has increased external review of research projects with a Drug Discovery Investment Board (with senior GSK leaders and outsiders from venture capital, etc) to review all drug projects and allocate capital. Teams of 5-80 scientists with 3-year business plans compete internally for those resources.
GSK Partnering Units
CEEDD: GSK set up a Centre of Excellence for External Drug Discovery (CEEDD) for option relationships, where the smaller partner companies develop the drugs until clinical proof of concept. Christoph Westphal formerly CEO of Sirtris (acquired by GSK) is the new head of the CEEDD.
GSK Corporate Venture Fund was created in 2008, and will invest in start-up incubator companies based on GSK-generated assets and in early stage companies using advanced technology to develop innovative healthcare products.
GSK 2008 Acquisitions
- Sirtris Pharmaceuticals (sirtuins, enzymes involved in aging) for $720 million in cash. Sirtris will operate as an autonomous drug discovery unit.
- BMS’s mature products business in Egypt for $210 million
- Genelabs Technologies for small molecule HCV drug discovery for $57 million
- AZ Tika, a Swedish OTC medicines business owned by AstraZeneca for $211 million.
GSK 2008 Alliances
GSK’s use of options, allowing a partner to develop the drug until clinical proof of concept, is consistent with their greater entrepreneurial character, and should be attractive to partners. GSK’s use of University of Cambridge as an academic incubator for drugs from GKS or the University is unusual. In the collaboration with the Harvard Stem Cell Institute, GSK envisions scientists swaps, with time spent in each other’s lab.
Deal Type | Stage Dev | Company | Therapeutic Area | Focus | Upfront | Milestones | Royalties | Other |
Academic Collaboration | Discovery | Immune Disease Institute | Infectious Diseases | Joint grant proposals in targeted areas of research |
| Grants over 5 years |
| GSK gets a Right of First Negotiation for substantial portion of new technologies |
Academic Collaboration | Discovery | MRC | Neuroscience (depression) Metabolic (obesity) | Jointly funded program to identify genes associated with common diseases | Each will invest $1.5M over 3 years |
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| JSC to run, sharing of databases and sample collections |
Academic incubator | Preclinical and early clinical development | University of Cambridge | Neuroscience (Obesity and addictive disorders) | Investigate efficacy and safety of drugs from GSK or academia |
| Compensation of Cambridge for financial risk on success |
| GSK provides access to clinical research & imaging facility & preclinical data. The results can be published |
Asset Sale | Marketing (off patent drugs) | Aspen |
| GSK sells Aspen 4 off patent products with sales of about $133M for outside the USA | $250M to GSK |
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| GSK to transfer manufacturing |
Co-dev and co-commercialization, cost and profit sharing | Phase III | Actelion | Neuroscience (sleep disorders) | Almorexant, an orexin receptor antagonist | $141M | $391M in milestones for primary insomnia and potentially up to $2.6B if all 3 indications successful | Cost/profit sharing where co-commercilized. Actelion books sales, has paid-for sales force in certain countries for a time. In emerging markets, shares profit. | The two parties continue independent orexin research, can exercise option to jointly select, develop & promote new antagonists. |
Joint Venture | Discovery | Neptunus | Infectious diseases (vaccines) | to co-develop flu & pre-pandemic vaccines, first for China, Hong Kong, Macau | $32M for 40% stake, option to increase to majority in 5 yrs |
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License | Phase 1 | AFFiRiS | Neuroscience (Alzheimer’s) | 2 therapeutic Alzheimer’s vaccines based on Affitope protein tech) | $31M | Up to $600M | Not specified | Options on preclinical candidates |
License | Ph 1 | Almire Pharmaceuticals | Respiratory | FLAP inhibitor for respiratory and cardiovascular |
| Up to $425 in upfront and milestones | Tiered royalties |
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License and Profit sharing | Marketed and pipeline | Aspen (South Africa) and its joint venture Strides |
| Commercilzation of branded pharmaceuticals in emerging markets | Limited upfront to cover additional registrations | Profit sharing based on sales |
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Not for profit collaboration | Discovery | Medicines for Malaria Venture (not for profit) | Infectious Diseases | MMV will fund research at GSK on macrolides for malaria |
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| JSC to oversee work at GSK |
Option | Discovery | Archemix | Immunoinflammation | Aptamers (oligos to bind proteins) | $27.5M ($6.5M in equity) | up to up to $200M for each of the 7 programs royalties tiered up to double digits. | Tiered up to double digit | GSK has option at clinical POC or earlier. |
Option | Discovery | Cellzome | Immuno-inflammatory | Kinase-targeted drug candidates | $21M (cash and equity) | Up to $173M in milestones for each of 7 programs | Up to double digits | GSK has option at clinical POC or earlier. |
Option | Discovery | Dynavax | Immuno-inflammatory | Inhibitors of toll-like receptors | $10M | Up to $200M for each program | Tiered up to double digit | GSK has option at clinical POC or earlier. Dynavax can o co-develop & co-promote 1 product. |
Option | Discovery | Mpex Pharmaceuticals | Infectious Diseases | To develop efflux pump inhibitors to use antibiotics for gram negative infections | $8.5M and $6.5M equity financing commitment | Up to $200 to $250M for each product candidate | Tiered royalties | GSK has option at clinical POC or earlier. |
Option | Discovery | Regulus Therapeutics | Inflammatory diseases | To discover microRNA targeted therapeutics | $20M (with a $5M note converting to Regulus stock) | Up to $144.5M for each of the 4 therapeutics | Tiered royalties up to double digit | GSK has option at clinical POC or earlier. |
Profit share | After 2 Phase III trials | Valeant Pharmaceuticals | Neuroscience (epilepsy) | Regitabine (potassium channel opener) and backups | $125M | Up to $545M for Regitabine (up to $150M on backups, funded by GSK). | 20% outside profit share regions (and up to double digit on backups) | Co-fund development, co-commercialize and profit share up to 50% in the US, Canada, Australia, NZ |
Research grants with JSC | Early research | Harvard Stem Cell Institute |
| Stem cell science | $25M over 5 years |
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| HSCI & GSK researchers to spend months in each other’s labs. |
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How can I help you?
I am happy to do small tasks with no long-term commitment. Let me help tailor a presentation, make a few contacts, think about valuation or give you some candid feedback.
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Pullan Consulting
Linda M. Pullan, Ph.D.
Biotech Business Development
www.pullanconsulting.com and www.lindapullan.com
e-mail: lpullan@msn.com
805-558-0361
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