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Drug delivery

Interest in companies finding ways to introduce medicines to patients more safely and effectively
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This month's review focuses on deals announced in June 2011. The table captures the top 19 deals by value where financial terms were publicly disclosed and one collaboration for which no terms were disclosed, which has an interesting theme.

The deals range across several therapeutic and disease areas, including diabetes, oncology, infectious diseases (hepatitis C), autoimmune and anti-inflammatory diseases, CNS (insomnia, neurodegenerative diseases, Parkinson's disease), ophthalmic and cardiovascular diseases. There are several technology platform and drug delivery product deals and some non-traditional pharma deals.

The introduction of novel drug delivery systems is more than simply looking for ways to differentiate products and therapies; the safety and efficacy of current treatments may be improved if their delivery speed, duration and targeting can be predicted, monitored and controlled.

From both the cost and global healthcare perspectives, finding methods to administer currently injectable-only medications in oral form and delivering expensive multi-dose, long-term therapies in more cost efficient and timely ways are also important. The promise of administration methods that allow patients to treat themselves safely is as significant as other healthcare developments, particularly in developing countries.

In the drug delivery space, quickly following its deal with ViroPharma in May, Halozyme licensed its Enhanze technology to Interexon to develop a sub-cutaneous alpha 1-antitrypsin replacement therapy. Enhanze uses human enzymes known as hyaluronidases to increase the absorption and dispersion of biologics. Halozyme receives $9m upfront and up to $54m in development and regulatory milestones. Meanwhile, Amarantus BioSciences agreed to license Generex's RapidMist buccal technology for a non-refundable licence fee of $10m ($5m in stock and a three-year promissory note). Amarantus intends to use the technology with its proprietary MANF proteins (which modify cell apoptosis) and the companies will use the technology jointly to develop an oral diabetes treatment.

In another drug delivery deal, Pfizer paid $2.3m to pSivida to amend their existing research and collaboration agreement focused on pSivida's bio-erodible drug-delivery implant technology system, Durasert. Under the amendment, pSivida has the right to develop a long-term sustained-release latanoprost implant for reduction of intraocular pressure in patients with ocular hypertension or glaucoma through phase II clinical trials. At that point, Pfizer has an option (for $20m) to take a licence to develop and commercialise the product candidate, plus up to $147m in milestones.

Ligand licensed its Captisol-enabled intravenous formulation of clopidogrel to The Medicines Company (TMC), for an upfront payment of $1.75m plus up to $22m in milestones, royalties and an exclusive supply contract. In an interesting side note on the topic of Contingent Value Rights (CVRs), this deal triggered CVR-related payments to Cydex Pharmaceuticals' CVR holders (following Cydex's acquistion by Ligand in January 2011). Ligand will pay 50 per cent of the $24m to Cydex CVR holders. In addition, Ligand may have to make payments to Prism Pharmaceuticals, the previous holder of the programme. 

In the drug delivery space… Halozyme licensed its Enhance technology to Interexon

In May 2011, Merck and Roche announced an alliance in the Hepatitis C field, which was seen as a pre-emptive strike against Vertex's Incivek. Undeterred, Vertex continued its investment in this field through a development and commercialisation deal with Allios BioPharma. Vertex is potentially paying over $1.5bn for two pre-clinical assets from Alios. ALS-2158 and ALS-2200, as a dual nucleotide regime, act upon the HCV polymerase to inhibit the enzyme that is essential for the replication of the virus. Vertex paid an upfront of $60m and has potential total R&D milestone payments of $715m and sales milestones of up to $750m. 

Merck and Roche were both actively involved in other strategic deals in June. In another demonstration of the increasing levels of co-operation between big pharma, Roche and Bristol-Myers Squibb (BMS) announced a collaboration in the study of combination therapy in advanced skin cancer. Roche's verumrafenib will be used with BMS's ipilimumab to treat metastatic melanoma in a phase I/II study to determine the efficacy and safety of the combination. No financial terms were disclosed.

Korean agreement  
Merck also made a strategic deal with Hanwha (South Korean petrochemicals group) understood to be worth $720m. Merck will conduct the clinical development, manufacture and commercialisation worldwide (excluding Turkey and South Korea) of a biosimilar version of Enbrel (etanercept for rheumatoid arthritis, with 2010 sales of $3.3bn).

This follows a number (nine in the first six months of 2011 compared to seven in the whole of 2010) of other recent biosimilar deals joining unlikely bedfellows with a combined price tag of $1.5bn aiming to compete against the biologics facing the patent cliff in the near future. The partners are looking for a 'win-win'; the big pharma industry has the expertise but is not necessarily willing to go it alone, preferring to share the costs of development ($100m over five to six years) and challenges of manufacturing, whereas the 'partners' are looking for ways to diversify into solid new revenue sources and gain access to broader
international markets.

Asian presence
Other large biosimilar players establishing in Asia are Reliance and Dr Reddy's in India, with their own versions of erythropoietin (EPO) and rituxan, as well as LG, Celltrion and now Samsung (following its $266m deal with Quintiles to contract manufacture biosimilars in oncology and autoimmune diseases). They are all gaining valuable experience in the complexities of the manufacturing processes.

However, the transition from local and regional markets to global markets has its challenges, as shown by Reliance's withdrawal of its European Medicines Agency application for its copy of EPO after regulators asked for more data. More surprises are likely as the uncertain regulatory environment is refined; Europe is currently consulting on how to treat biosimilar antibodies and the US Food and Drug Administration's general guidance is expected later this year.

Continuing the theme of the non-traditional pharma business model, June also saw Royalty Pharma acquire Prosidion's patent estate and associated royalty stream relating to the use of dipeptidyl peptidase IV (DPP-IV) inhibitors for the treatment of type 2 diabetes, for a total cash payment of $609m. Prosidion was acquired as part of Astellas' purchase of OSI Pharmaceuticals in June 2010. Since 1996, Royalty Pharma has grown to become the global leader, assembling a diversified portfolio of royalties in leading biopharmaceutical products, with a managed risk profile and $6bn assets under management. Interestingly, Prosidion retains two drug candidates in development for diabetes and obesity, until Astellas completes its review of strategic alternatives for these assets.

Other deals of note were Boehringer Ingelheim's (BI) agreement with Zealand Pharma for rights to its ZP2929 - GLP1 receptor agonists against type 2 diabetes and obesity, further building the $1.2bn alliance created by BI and Eli Lilly (Lilly) earlier this year. Lilly is continuing to build its franchise through partnerships despite the suit filed by Amylin in May, alleging anticompetitive behaviour. 

The fourth diabetes 'deal' this month is a termination. Last year's $625m deal between Diamyd Medical and Ortho-McNeil-Janssen Pharmaceutical (OMJP), regarding the GAD65 gene-based therapy, Diamyd, for the treatment and prevention of type 1 diabetes and associated conditions, has been terminated following the failure of the phase III study to meet the clinical efficacy endpoints. OMJP had paid a non-refundable upfront of $45m, which Diamyd retains along with its rights to the product.


Licenser Acquired/Licensee Acquirer

Product/Technology

Deal type

Headline ($m)

Alios BioPharma/Vertex Pharmaceuticals

ALS-2158, ALS-2200 HCV
polymerase antagonists

Development, Commercialisation Licence

1,525

Merck/Hanwha +

Enbrel biosimilar for RA

Development, Commercialisation partnership

720

Prosidion (Astellas)/Royalty Pharma

DPP-IV inhibitors (T2D) patent estate

Divestment

609

Zealand Pharma/Boehringer Ingelheim

ZP2929 - GLP1 receptor
agonists (T2D and obesity)

Development, Commercialisation Licence

598

Diamyd Medical/Ortho-McNeil-Janssen Pharmaceuticals

GAD65 based Diamyd for prevention and treatment of T1D/associated conditions

Return of rights

see below

Biotest/Abbott

BT061 – anti CD4 antibody

Development, Commercialisation Licence (co-promotion EU5)

480

Affectis Pharmaceuticals (formerly Neuronova AG)/Merck Serono

Oral P2X7 antagonists for
neurodegenerative diseases

Development, Commercialisation Licence

409

Pfizer/Clovis Oncology

PF1367338 - PARP inhibitor for solid tumours

Development, Commercialisation Licence

255

pSivida/Pfizer

Implant for SR latanoprost for
glaucoma and ocular hypertension

Option to license

169

Somaxon Pharmaceuticals/ Paladin Labs ++

Silenor for insomnia

Commercialisation

134

Halozyme Therapeutics/Intrexon Corp

rHuPH20 enzyme drug delivery
technology for COPD and genetic emphysema

Licence to use technology

63

Pluristem Ltd/United Therapeutics Corporation

PLacental eXpanded (PLX) cells - platform technology for PH

Development, Commercialisation Licence

55

Pfizer/BioMarin

Manufacturing facilities

Divestment

49

Medivir/Meda +++

Xerese for herpes labialis

Commercialisation licence

45

EraGen Biosciences/Luminex

Molecular diagnostic test kits/assays

Acquisition

34

GSK/Adolor

Enetereg for gut recovery post-surgery

Reacquisition of rights

25

Ligand Pharmaceuticals/The Medicines Company

Captisol-Enabled Clopidogrel anti-platelet medication

Development, Commercialisation Licence

24

Sam Amer & Co/Ventrus Biosciences

VEN309 topical ointment for haemorrhoids

Development, Commercialisation Licence

23

Generex /Amarantus BioSciences

RapidMist buccal drug delivery
technology for use with MANF proteins

Development, Commercialisation Licence

10

Roche/Bristol-Myers Squibb

Verumrafenib and ipilimumab
combination for metastatic melanoma

Clinical collaboration

-

Diamyd keeps the $45m 'non-refundable' upfront payment but no other termination fees apparent from the press release. All deals are worldwide unless otherwise noted: + Excluding Turkey and South Korea  ++ Canada, South America and Africa +++ US, Canada and Mexico.



Bridget Lacey

The Author
Bridget Lacey is a consultant at Medius Associates

To comment on this article, email pme@pmlive.com

 

 

 

 

 

11th August 2011

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