Business models and opportunities for cancer vaccine developers

Figures & data

Table 1. Cancer vaccine products approved in developed and emerging markets. MVax autologous vaccine for melanoma from Avax Technologies has been approved in Switzerland in 2005 but the company ceased to exist in 2009 and no further information of MVax status could have been obtained

Company	Product	Description	Indication	Approval status	Recent financial report and product sales	Projected sales	Cost of treatment	References
BMS	Yervoy (ipilimumab)	Anti- CTLA-4 (cytotoxic T lymphocyte- associated antigen 4) and gp100 melanoma antigen peptide	Advanced melanoma	Approved by FDA and EMA in 2011	Reported almost $100 million sales from the time of approval in March 2010	Different analysts predict peak sales of around $2–6 billion	$120000 per course	http://www.reuters.com/article/2011/07/28/us-bristolmyers-idUSTRE76R2FM20110728
Dendrion	Provenge (Sipuleucel-T)	APC-containing peripheral blood mononuclear cells (PBMCs) co-cultured with prostate antigen	Metastatic castrate resistant prostate cancer	Approved by FDA in 2010	Reported sales of $50 million in 2010 and $200 million in 2011	Peak sales are predicted to reach $300–300 million	$93000 per course	Datamonitor^2
Antigenics	Oncophage	Heat shock protein purified autologous cancer vaccine	Metastatic renal carcinoma	Approved in Russia in 2010 Rejected by EMA in 2009	Revenues of $3.4 million in the fiscal year ended December 2010, an increase of 0.8% over 2009. The company's operating loss was $21.8 million in fiscal 2010, as compared with an operating loss of $27.7 million in 2009. Its net loss was $22.7 million in fiscal 2010, as compared with the net loss of $31.1 million in 2009.	Antigenics has signed agreement with ChemRar High Technologies to set up manufacturing and distribution of Oncophage in Russia. Revenues are expected by 2020.	Not disclosed.	http://drugdiscoverynews.com/index.php?pg=77&articleid = 5857 Accessed on 14/03/2012
Biovest International	BioVaxID	Tumour-specific idiotype conjugated to keyhole limpet hemocyanin, plus GM-CSF	B-cell cancers	Compassionate use in France, Germany, Greece, Spain and UK	For the fiscal years ended September 30, 2011 and 2010, net losses of $15.3 million and $8.2 million, respectively and negative cash flow from operating activities of $3.8 million and $0.8 million, respectively. As of September 30, 2011, an aggregate accumulated deficit of $161 million.No current revenues from therapeutic vaccine segment were reported	Private funding offering of $7 million was reported. No accurate estimate of projected revenues is available	Not disclosed.	http://www.biovest.com/investor-relations/sec-filings Accessed on 14/03/2012
Corixa/ GSK / Schering Plough	Melacrine / Melacine	Lysate from melanoma cell lines with proprietary adjuvant	Advanced melanoma	Approved in Canada in 1999. Halted develop-ment in US in 2001	No revenues from sales in Canada were reported. Distribution rights were given to Schering Plough in 2001. Corixa has been acquired by GSK an and Melacine is not sold in any countries.	The product has been off-shelf since the negative outcome at FDA Advisory board in 2001.	Not disclosed.	http://www.coulterpharm.com/default.asp?pid=invest Accessed on 14/03/2012
CreaGene (Seoul)	CreaVaxRCC	Autologous monocytes treated with GM-CSF and IL-4	Metastatic renal carcinoma	Approved in Korea and launched in 2010	No revenues were currently reported and stated funded support was announced.	No disclosed data	Not disclosed.	http://www.scripintelligence.com/multimedia/archive/00162/Scrip_Asia_100_2011_162496a.pdf Accessed on 14/03/2012
Genoa Biotechno-ologia	Hybricell	Autologous monocytes treated with cytokines and converted into dendritic cells and fused with patient-derived tumor cells	Various cancer	Approved in Brazil	No revenues were currently reported. Extensive academic collaborations were announced.	No disclosed data	Not disclosed.	http://www.genoabiotec.com.br/newsmidia.php?op=74&tp=N Accessed on 14/03/2012
Vaccinogen (USA)	OncoVax	Irriadiated autologous tumor cells with BCG	Colon cancer	Approved in Switzerland and under hospital exemption in Netherlands in 2010	No revenues are currently available.	Datamonitor predicts that pricing strategy will follow Provenge and therefore revenue dynamics will be similar to Provenge’s	Not disclosed.	Datamonitor^4
Center of Molecular Immunology (Cuba)	CimaVax EGF	EGF conjugated to rP64k	Lung cancer	Approved in Cuba in 2008	Funded by government and available in limited number of strongly indicated cases	Not appropriate	Not disclosed.	Rodriguez et al.^5
Shenzhen SiBiono Genetech	Gendicine	Genetherapy based on adenovirus engineered to express wild-type p53	Various types of solid tumors (available for all routes of administration)	Approved in China in 2003	It is reported that > 6000 patients with various solid tumors in China received Gendicine (including > 1000 overseas patients). Gendicine sales were estimated to be $3.6 million in 2007 and sales of $16 million in 2008.	According to Compound annual growth rate (CAGR) of 68.30 per cent over the period 2004 to 2011 is reported. It is projected that > 50000 cancer patients will receive treatment with Gendicine	The drugs' price tag - 3800 yuan (£252) per dose of Gendicine or $30000 per course	Cancer therapy China;^6 http://www.reuters.com/article/2008/01/23/idUS184855+23-Jan-2008+BW20080123 Accessed on 14/03/2012
Shanghai Sunway Biotech	Oncorine (H101)	Recombinant adenovirus oncolytic virus engineered to express wild-type p53	Head and neck tumors (intra-tumoral injections)	Approved in China in 2005	Sales were reported to be unsatisfactory (< £1 million) in 2009.	There are about 30,000 to 40,000 new patients with head and neck tumors in China each year, but most opt for surgery plus chemotherapy instead of using the expensive Oncorine	Price is 3680 yuan (£244) per dose of Oncorine or approximately $25000–30000 per course of treatment	Cancer therapy China;^6 http://www.rsc.org/chemistryworld/Issues/2007/September/GeneDreamsTroubledMarketRealities.asp Accessed on 18/03/2012
MSD, Sanofi Pasteur, GSK	TheraCys (BCG; Sanofi- Aventis); OncoTice (BCG; Organon/MSD). PACIS (GSK/Shire)	Alive BCG vaccine	Superficial bladder cancer	Approved in the USA, EU, Canada, Japan and many other countries	Combined market for BCG therapies in bladder cancers in the USA, UK, Germany, France, Italy, Spain, Japan, Brazil, Russia, India and China was $131 million in 2010. Sales of ImmuCyst in the UK, a treatment for non-muscle-invasive bladder cancer, reached £3.7 million in the 12 mo to 30 April 2011	Premium priced intravesical vaccine formulations, such as Urocidin (intravesical formulation of Mycobacterial cell wall-DNA complex (MCC) are projected to reach $386 million in sales by 2020.	$169.10 per week or $8800 per annum	Datamonitor;^7 Sievert et al.;^8 http://www.globaldata.com/reportstore/Report.aspx?ID=Bladder-Cancer-Global-Drug-Forecasts-and-Treatment-Analysis-to-2020-Volume-1-2011&ReportType=Industry_Report&coreindustry=Industry_Report&Title=Pharmaceuticals_and_Healthcare Accessed on 14/03/2012
Epeius Pharmaceuticals	Rexin-G	Genetherapy	Chemotherapy-resistant solid malignancies	Approved in Philippines in 2007	Not disclosed	Status of announced phase 3 studies is not reported on clinicaltrial.gov	Unknown	Gordon and Hall;^9 Epeius Biotechnologies.^10

Figure 1. The key trends and implications that will shape biotech industry involved in cancer immunotherapies.

Table 2. Cancer vaccine products approved in South Korea²⁹

Product	Company	Indication	Approval
CreaVax-RCC (DC-based)	Creagene	mRCC	2007, conditional
INNOLAK (NK-based)	Innomedisys	NSCLC	2007, conditional
Immunecell-LC (NK-based)	Innocell	HCC	2007, conditional
NKM (NK cells)	NKBio	Lymphoma	2007, conditional

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