• Clozapine is a member of family of “atypical” anti-psychotic drugs developed by Novartis under “Clozaril”
brand. Expiry of Novartis patent, led to other brands entering the market.
• Regulatory requirements : condition of granting license by MHRA to Clozapines is provision of “patient
monitoring service” by drug manufacturers to
i) monitor potential side effects of drug (reduced white cell count) at required frequencies : FBC
ii) monitor concentration of Clozapine at required frequencies : Clozapine testing
Source:
REGULATORY REQUIREMENTS : CLOZARIL SET-UP & FUNDING
NOVARTIS
Source:
CLOZAPINE TESTING SUBSIDISATION BY DRUG MANUFACTURERS
Source:
CLOZAPINE TESTING : PRICING
Source:
SLaM & ANTI-PSYCHOTIC DRUGS TESTING
• SLaM est savings on drugs costs (Pharmacy) of £0.5-1.0m if switched to alternative supplier
- Est spend on Clozaril drug purchase in order of millions
• Novartis thought to have re-entered negotiation with SLaM re. reducing price of Clozaril in line with
competitors : Strongly in Novartis interest to keep SLaM
- SLaM accounts ~20% all UK Clozaril prescriptions
- SLaM accounts ~20% all Clozaril testing
- unclear whether SLaM have already signed a fully binding contract with alternative supplier (intelligence is
that still in discussion stage)
• Potential switching barriers for SLaM : How will/will Denfleet or Genthon take over Novartis “home service”
free of charge? How will results be returned to SLaM?
Source:
ATYPICAL ANTI PSYCHOTIC DRUG FAMILY : FUTURE MARKET
Source:
NEXT STEPS
Source:
BUSINESS PLAN : MARKET SIZE
JNJ
zaponex unknown
NX
Other atypical antipsychotic drug families 2,242 est 15% based on SLaM usage (RS) 15%
Source:
BUSINESS PLAN : P&L SCENARIOS (CLOZAPINES ONLY)
Assumptions
OH 35%
consumables 5.00
LCMS MS 25,000 Equipment : lqd chrom mass spec available @ £25k/year depreciated over 5 yrs (capex £120-£160k)
Extra costs SOP, standards, licenses (est £1-2k Yr 1 cost)
Staffing requirements
BF 52,000 80% FTE (20% of BF time for training of regional funded clinical scientists) x £65k
Band 7 35,000 £35k - BMS 2 or snr clin scientist
Total 87,000
Source:
BUSINESS PLAN : P&L SCENARIOS (CLOZAPINES ONLY)
# samples 14,947
Sc 2 : Worst Case : Genthon move all samples to JNJ and get SLaM contract; £30 "effective income"/test
NB : However, no reason why we couldn`t enter into discussion w/ Genthon: What are JNJ charging? High possibility of retaining SLaM Zaponex testing
Source:
BUSINESS PLAN : P&L SCENARIOS (CLOZAPINES ONLY)
Source: