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The role of generics in
inhaled drug delivery
Paul Ballington
Ballington Hall Associates
Objectives
 Review the opportunity for generic inhaled  Assess the regulatory and reimbursement Clear on what is a generic
 Generic drug law …. that permit, incentivise or require pharmacists in certain circumstances to substitute a drug product with the same active ingredients and of the same generic type for the drug Is there really a generic
opportunity for inhaled drugs?
– Many key therapies coming off patent  2008 asthma / COPD market worth $25 bil ion – Generics account for $1 bil ion, mostly US albuterol Is there really a generic
opportunity for inhaled drugs?
– Most off patent, but short-term fairly small opportunities compared with respiratory disease What about novel therapies?
Respiratory disease market
 6.3% of population Volumes stabilising  Growing at 14% Smoking cessation therapies expected not to impact “People live longer and they have more time to develop COPD and unfortunately the rate of COPD will increase consistently in the near future. So, we are very concerned about the great burden of this disease over the next 5 or 10 years.” (KOL) New products aplenty!
– Beclometasone / formoterol pMDI– COPD and asthma– Chiesi, launched 2008 in Italy and Germany – Generic competitor already launched in Germany  Inuvair, Schwarz Pharma (bought by UCB) – Repriced in Germany at the same reimbursement price New products aplenty!
– Indacaterol, Breezhaler dpi– COPD only– EMEA approval December 09  Flutiform (SkyePharma , Abbott, Mundipharma) – Fluticasone / formoterol pMDI– Asthma only– Some FDA delays but filed in US New products aplenty!
 MFF258 (SPL) mometasone / formoterol QMF 149 (Novartis indacaterol / mometasone Beyond Advair (GSK) 642444 / fluticasone  NVA237 (Novartis) glycopyrrolate Aclidinium (Almiral )  QVA 149 (Novartis) indacaterol / glycopyrrolate Will newer inhaled products succeed?
therapeutic and pharmacoeconomic benefits  Lower priced generic equivalents could persuade purchasers to restrict use of novel agents Restrictions on new products?
– Spiriva Respimat restricted to those patients who  Respimat price same as Handihaler plus drug Respimat price 10% higher than drug refil – Spiriva France - 2 years from approval to gain Generic impact
Is it the same for oral and respiratory drugs? % brand value from generic launch
Spain
Japan

Impact of generic prescribing –
reversing trends
There are now four salbutamol HFA-MDIs
approved in the US:
Xopenex-HFA, Sepracor, approved March 2005
Proventil-HFA, Schering-Plough, approved in 1996
Ventolin-HFA, GSK, approved in 2001
Pro-Air-HFA, Teva / UCB, approved November 2004
The average price of a generic salbutamol CFC
MDI was $0.013, compared to $0.16 for a
salbutamol HFA MDI, a 12.6x difference

HFA albuterol USA
CFC albuterol
HFA albuterol
What are the market drivers for
generic inhaled products?
Toward generics
Against generics
– Regulatory hurdles – Cost of regulatory / US is the major market – regulatory
– Must be virtual y identical to brand– Substitutable at pharmacy level  No need for salesman to visit GP / Pharmacist  505(b)(2)
OIP guidelines
 Pressurised and non-pressurised metered dose inhalers, dry powder inhalers and nebulisers have different flow-dependent pulmonary deposition
patterns. Handling of these devices – and the resultant patient preference – differs – The relevant patient population must be adequately investigated and subsequently clearly defined in order that the prescriber can be assured that the product is only prescribed to and used by suitable patient groups. – The dossier submitted has to include sufficient in vitro data such that the flow deposition characteristics of the products within the range of clinical y relevant pressure drops/flow Substitutability
– pMDIs may be substitutable– DPIs may not be substitutable Substitutability
“Switching ICS inhaler devices without a consultation was associated with worse asthma control. Therefore the possible costs of adverse effects on asthma control should be weighed against savings in acquisition cost before instituting mass switching of Switching inhaler devices without a face-to-face
evaluation and consultation is inadvisable.”
“Inhaled corticosteroids for asthma: impact of practice level device switching on asthma control.” Thomas et. al. BMC Pulmonary Medicine 2009, 9:1.  Poor generics penetration but increasing Summary so far
Opportunities exist for directly substitutable
products
Where patents have expired or are revoked
 Budesonide, salbutamol, formoterol, etc.
US opportunity currently limited to HFA pMDIs
Unless formulation patents are insurmountable
DPIs could be successful – depends on substitution
Japanese opportunity very limited
How a generics company tackles the
respiratory market
Historically, generics have “piled high, sell
cheap”
– US CFC albuterol market almost destroyed in value terms; – Tender / bidding process means little marketing / salesforce  Modern generic houses often part of bigger
Or very large companies
Teva speciality pharmaceuticals
 Joint promotion of Teva’s respiratory care products with UCB in USA – January 2008 "The respiratory therapy arn identified as a key growth area given the incidence of asthma, allergic rhinitis, and COPD (chronic obstructive pulmonary disease). Our collaboration with UCB, a company known for excellence in the respiratory market, will help us achieve a stronger presence in this growing therapeutic area."  Clearly see investment in US salesforce as – Sets them up for newer inhaled generics Generic strategy - inhaled drug delivery
Prepared to invest in development?
– Up to $50m and N years– Normal y $3m and <12 months  Prepared to invest in development
infrastructure?
Prepared to invest in salesforce
– Own teams, copromote or contract hire  Up to $100m investment before payback
The opportunity for generics in the
respiratory market
Stick to clear opportunities where brand leader
strategies are limited
Generic combis – pMDI where patents al ow Seek differentiation to leverage higher margins
Novel device offerings which require sel ing Requires a range and a salesforce but gives higher margins Go for the big opportunities
Conclusions
Single entity directly substitutable pMDIs worth
attacking in some markets, especially the US
Combinations with or without complex device -
only for the brave and well funded
 Development, patent and reimbursement uncertainties Potential need to change paradigm of generics company Will the market still be there? BUT…….
Advair / Seretide is a very good asthma treatment
If novel therapies have only marginal benefits
and/or budget holders drive cost constraints “I have a feeling that my hands will be forced in about half of
my patients just because of cost, so I have a feeling that it will
be difficult for me to argue if there is a lower cost generic
alternative.” – US key opinion leader

Generic versus “new” brand
 Datamonitor projections are for a major decline in Advair sales as Beyond-Advair responds to significant sales pressure from GSKand Novartis NCEs respond to promotion  Assuming intervention by budget holders and the availability of generic products capable of substitution, generics could perform very wel The role of generics in inhaled drug
delivery
Only a few can afford the development
But the rewards are very attractive
They will need specialist help
– In-licensing – device / propel ant– Formulation – HFA / DPI– Respiratory clinicals– Regulatory

Source: http://www.ddl-conference.org.uk/files/DDL20presentations/8.Ballington.pdf

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