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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

_____________________________________________

 

 

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

 

 

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

 

 

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

 

 

 

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

 

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

 

 

Not for profit collaboration

Discovery

Medicines for Malaria Venture (not for profit)

Infectious Diseases

MMV will fund research at GSK on macrolides for malaria

 

 

 

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

 

 

HSCI & GSK researchers to spend months in each other’s labs. 

 

 

_____________________________________________

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. 

_______________________________________

 

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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