One item in Teva's financials that is almost interesting, and that testifies more than anything else to its ability to continue generating substantial revenue from generics, is its generics backlog. When they attended the JP Morgan Conference, Suesskind and Marth unveiled the latest figures (the last update was in October), which reveal that 165 applications are now awaiting approval, with an aggregate $103 billion in sales based on IMS data (an average of $625 million per drug). "This is the first time that we know of that the company has passed the $100 billion mark," said Marth at the conference. Teva filed for Paragraph IV certifications for 94 of these drugs, meaning that it would officially challenge the validity of the main patent on them, and it says that in 45 of these, which have sales of $38 billion, it is the first company to file such an application, so it expects to win exclusivity on them.
With Cowen sounding so optimistic, one cannot but wonder whether there is still cause for concern. The investment house's analysts note that one issue of concern is the possibility that Schering-Plough Corp. (NYSE: SGP) could become more aggressive on its range of inhaler and respiratory products, a line of business in which Teva has been showing strong growth. There is also the risk that someone could challenge Teva's own patent on its multiple sclerosis drug Copaxone. One likely challenger could be Momenta Pharmaceuticals Inc. (Nasdaq: MNTA), but the Cowen analysts are optimistic about this too. "We believe that a generic formulation of Copaxone is unlikely to enter the market within the next 4-6 years," they conclude.
--Hmmm...what would give Cowen impetus to think that the Teva Copaxone patent is vulnerable?
>A poster on another Board (RPRX, naturally) mentioned that MNTA would never be able to get around Teva's patent, totally ignoring that Sanofi's Lovenox patent is, in all likelihood, being negated as we speak by Teva!<
It’s astonishing that someone can be so clueless about the pharma business. The fact is: nearly every big-selling non-biologic drug has already had its patent challenged or soon will. Moreover, the KSR decision by the US Supreme Court makes it considerably easier for a challenger to prevail (#msg-19404785).
Apropos generic Copaxone - The Indian company Natco has already launched the first generic Copaxone on May 07. As far as I know, they didn't challenge Teva's patents in court and sold their version only in India (There are about 50,000 MS patients in there and Natco's generic drug was priced at 40% discount). The reason I use past tense is because I no longer see the drug called Glatimer in their product list.
The co-polymer is glatiramer acetate (also known as Copaxone ([#8482]).
Abstract of EP1837031
There is provided the use of (a) a composition for islet neogenesis therapy comprising a gastrin/cholecytekinin (CCK) receptor ligand and/or an EGF receptor ligand and (b) an agent for suppressing an immune response, for manufacture of a medicament for treating a diabetic subj ect.
Costs and Quality of Life in Multiple Sclerosis A Cross-Sectional Study in the USA
Kobelt, Gisela (kobelt.gisele@wanadoo.fr) (Karolinska Institute Stockholm, Sweden, and European Health Economics, France) Berg, Jenny (info@healtheconomics.se) (Stocholm Health Economics) Atherley, Debbie (University of Washington, USA) Hadjimichael, Olympia (School of Medicine, Yale University, and Barrow Neurological Institute, USA) Jönsson, Bengt (Bengt.Jonsson@hhs.se) (Dept. of Economics, Stockholm School of Economics)
Abstract
SUMMARY Treatment of multiple sclerosis (MS) has changed substantially during the past decade, as new biological disease-modifying treatments have been introduced in a field where only symptomatic pharmacological treatment had been available. The new treatments come at a high cost, between $ 8-12,000 per patient and year. Consequently, it must be expected that the part of total costs represented by drugs has increased, from essentially a very minor part in the nineties (2-5%) to a much larger proportion. However, no studies investigating this development from a societal perspective have so far been published.
Objective
The objective of this study was to investigate the current cost structure in MS and the effect of disease severity on costs and quality of life (utility) for patients treated with the new disease modifying drugs (DMDs) in the US.
Methods
The study follows closely the methodology used in three previous observational studies in Sweden, the United Kingdom and Germany. It is a descriptive bottom-up prevalence-based cost of illness study. The analysis was performed from the societal perspective and did not investigate costs for different payers. Costs were calculated as mean annual cost per patient in the sample, and mean costs for patients using a given resource. All unit costs are for 2004, or were inflated to 2004 using the CPI.
Demographic variables, information on disease severity and disease activity, resource utilization and utility were collected directly from a sub-sample of ~24,000 patients taking part in a regular follow-up since up to 8 years, the North American Committee on Multiple Sclerosis (NARCOMS) Patient Registry. A questionnaire was mailed to a 4,000 randomly selected sample and the target answer rate was 50%.
Results
1,989 (49.7%) of patients contacted returned the questionnaire, but 80 of them were returned empty and had to be excluded. This left a sample of 1,909 (47.7%) for analysis. The mean age of the sample was 49 years and three quarters were women. Their age at first symptoms was 30 years, and time since diagnosis was 13 years.
10.5% of patients had primary progressive, 47.6% relapsing-remitting and 33.3% secondary progressive disease. Less than 1% of patients did not answer the question, but 7.6% were unsure. 28.8% of patients indicated to have experienced a relapse during the past 3 months. 34.8% had mild, 42.7% had moderate and 22.1% had severe disease. Slightly less than one third (31.4%) was in early retirement due to MS.
Total costs are estimated at $ 47,215 per patient and year. The largest proportions of costs are indirect costs ($ 17,581 or 37.2%) and drugs ($ 18,628 or 39.5%). Of the latter, disease modifying drugs accounted for 86% of total drug cost and 34% of total costs ($ 16,050), while OTC medication amounted to $ 122. Informal care represented 9.8% ($ 4614) and services and investments, which were to a large extent paid for by patients themselves, amounted to $ 2707 per patient (5.7%).
Using the new (unpublished) US health status system, the mean utility in the sample was 0.698, with women having higher utility than men (0.709 versus 0.667). Patients who had experienced a relapse in the past 3 months had a utility of 0.648, compared to 0.742 for those who did not.
On the absence of published gender and age specific population values in the US, the UK tariff has been used to estimate the age and gender specific utility loss of MS patients compared to the normal population. The loss of quality-adjusted life years (QALYs) was estimated at 0.255 QALY/patient. Using a willingness to pay for a QALY of $ 60000, intangible costs were estimated at $ 15,315.
Costs increased and utility decreased with decreasing functional capacity. Patients with mild disease had a cost of $ 32,297 and a utility of 0.824; figures for patients with moderate MS were $ 50,293 and 0.679, and for patients with severe MS $ 64,492 and 0.533. The proportion of bed-ridden patients in the sample (EDSS 8.0 or more) was small compared to the expected prevalence. When the proportion was increased to 4%, costs for patients in the severe group increased slightly to $ 65,173 and utility decreased to 0.479. Thus, it appears that the effect of very severe disease is more pronounced on patients’ quality of life than on costs.
Conclusions
The objective of this study was to investigate the overall costs for patients treated with the new MS therapies, and cost distribution among different resources after the introduction of the new MS treatments. In view of the high cost of these treatments, our results are not surprising, with MS drugs representing 34% of total costs. When the use of disease modifying drugs is adjusted to the estimated national average (52%), the share of costs represented by these drugs is 21%.
The findings are consistent with previous studies into the cost of MS: costs and utilities are significantly correlated with functional capacity (EDSS).
This study does not investigate the value of the investment in these treatments. Rather it provides the necessary input into a disease model where costs and utility are linked to disease progression, without treatment, or with different treatments.
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