Sales Through Retail Pharmacies (Twelve months to October 2011)*
NORTH AMERICA $249.8 billion up 3%
U.S.A. $229.9 billion up 3%
CANADA $19.9 billion down 1%
EUROPE (TOP 5) $112.7 no movement
GERMANY $38.4 billion up 2%
FRANCE $29.3 billion no movement
ITALY $16.3 billion down 1%
SPAIN $14.4 billion down 4%
UK $14.3 billion up 1%
JAPAN (including hospitals) $98.2 billion up 6%
CHINA (hospital) $38.3 billion up 18%
LATIN AMERICA (TOP 4) $40.0 billion up 18%
BRAZIL $21.5 billion up 19%
MEXICO $8.4 billion up 4%
VENEZUELA $5.2 billion up 33%
ARGENTINA $4.8 billion up 29%
AUSTRALIA/NZ $11.3 billion up 6%
The top 5 therapy classes at ATC3 level in the 12 months to October 2011 were:
1. C10A – Cholesterol & trigly. regulators
2. A2B - Antiulcerants
3. N5A - Antipsychotics
4. N6A – Antidepressants & mood stabilisers
5. A10C – Angioten-II Antag, Plain
The top 5 products in the 12 months to October 2011 were:
1. Lipitor
2. Plavix
3. Nexium
4. Seretide
5. Crestor
The top 5 corporations in the 12 months to October 2011 were:
1. Pfizer
2. Novartis
3. AstraZeneca
4. Merck & Co
5. GlaxoSmithKline
*Source: IMS HEALTH. Growth rates are calculated at a constant exchange rate, (i.e. at the local currency level).The unique system in Japan reduces the importance of the retail pharmacy in the distribution chain so sales for Japan include hospital data. For the USA, retail, foodstore and mail order pharmacy channels are included. In other countries sales monitored are limited to retail pharmacies only. Please note this is IMS proprietary and should not be published in any format without reference to IMS Health in the first instance.
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Pricing & Reimbursement News
Germany: IQWiG publishes early benefit assessment findings for Victrelis
The Institute for Quality and Efficiency in Health Care (IQWiG) has completed the second of its new early benefit assessments for new innovative drugs. The assessment was of MSD Sharp & Dohme's protease inhibitor Victrelis (boceprevir) for the treatment of chronic hepatitis C (genotype 1).
France: 2012 social security finance bill definitively adopted
The final version of the social security finance bill was adopted on 29th November 2011 by the lower chamber of parliament (Assemblée Nationale).
South Korea: Ministry revises plans for pricing of generics and originals
Following consultation with stakeholders the Ministry of Health and Welfare (MOHW) has made amendments to its plans to reform the pricing of reimbursed generics and original products subject to generic competition.
USA: Lipitor’s patent expires, generic versions launched
Generic versions of the world’s top-selling drug, Lipitor (atorvastatin), have been launched following the 30th November 2011 expiry of Pfizer's patent.
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Market News
With OncoStarter, the Cancéropôle [cancer center] Lyon Auvergne Rhône-Alpes aims to provide innovative oncology projects with the means to bring them to fruition; it also offers them the best chances of accessing research funding.
The "proof of concept" program
launched in 2005 by the Cancéropôle Lyon Auvergne Rhône-Alpes (CLARA) has achieved its objectives, supporting 30 projects since its creation. These projects have received a total of 36 million Euros, 25 million of which were provided by industrial partners. OncoStarter’s success has spread beyond the region’s borders and even beyond France’s borders: last year, a Japanese company, OncoTherapy Science, set up a branch in Lyon to benefit from the program and in 2011 four other foreign companies also submitted their applications, though without being selected.
By the end of the 2011 edition, only five new projects had been retained but nonetheless a number of rejected candidates were judged by the jury to be promising. "Today we are seeing many interesting projects which are not completed or which do not have the right team," comments Peter Pauwels, CLARA’s general delegate. "The Cancéropôle should be able to support everything that has potential, at least once."
The added value of the Cancéropôle
With OncoStarter, CLARA hopes to provide projects that are innovative but lacking in maturity (poorly defined marketing perspectives, insufficient scientific data) with the necessary tools to respond to the requirements of various research aid devices: its own "proof of concept" program of course, but also the national Matwin Program and other funding tools (Oséo, centers for competitiveness, etc.).
This new program also reflects CLARA’s objective of strengthening its activities in the areas of technology transfer and the commercialization of oncology projects, while the regional scientific and technological environment will be significantly altered by the "investments of the future." "These changes have meant that we have had to change our strategy at the Cancéropôle to focus on areas where we can bring added value," explains Peter Pauwels.
Privileged translational research
In addition to financial assistance (from 25 to 50,000 Euros), the projects retained by OncoStarter will also benefit from personalized support provided by CLARA experts. To be able to take advantage of this support, translational research projects must focus on one of the priority or emerging themes at the Cancéropôle and must involve a hospital practitioner.
Two candidates not selected following the 2011 "proof of concept" call for bids have already been retained. One is aiming to improving the delivery of anticancer therapeutic agents encapsulated inside liposomes and released at the tumor site by means of an ultrasound device. The other is using the immunosuppressive properties of a natural protein on the B lymphocyte response in hematological cancers.
Other candidates must submit their applications before October 28. "Our budget allows us to support three to five additional projects," says Peter Pauwels. Each year, two waves of projects will be supported.
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Therapy News
This month’s therapy focus is: Hepatitis B&C
The following is an excerpt taken from IMS Health Therapy Prognosis USA 2011 and studies how new data and guidelines lead to changes in the use of existing products for hepatitis B and C.
The American Association for the Study of Liver Diseases’ (AASLD) Practice Guidelines for the management of Chronic Hepatitis B was published in September 2009; this is the fourth version of the guideline, the last being in 2007. Key changes to the guideline are new recommendations for first- and second-line antiviral agents. Tenofovir disoproxil (Viread) has since been approved by the FDA based on results from two trials showing a superiority of tenofovir compared to adefovir. Based on these findings, the recommendation for first-line oral antiviral medications has been changed to tenofovir or entecavir, and adefovir has been moved to second-line antiviral medication. Interferon remains one of the first-line options for patients who do not have cirrhosis.
Further information has emerged confirming that entecavir has previously unrecognised activity against HIV. Therefore, entecavir is no longer recommended in persons with HBV/HIV co-infection, who are receiving treatment for HBV alone. The guidelines were also updated to include changes in the CDC recommendations on HBV screening. The new recommendations expanded HBV screening to persons born in intermediate endemic areas, i.e. geographic regions with HBsAg prevalence of greater than 2%, those who will be receiving cancer chemotherapy or long-term immunosuppressive therapy, injection drug users and men who have sex with men.
The potential for combination therapy involving direct-acting antivirals in treating HCV has acquired significant attention from pharmaceutical firms. At present, even though the SOC is only effective in about half of all HCV patients, the constituent therapies generate annual net sales of roughly US$2.5 billion. Analysts have predicted that the market could increase fourfold over the next decade. Key to this growth are new specifically targeted antiviral therapies for hepatitis C (STAT-C), which offer greater efficacy, better side-effect profiles and shorter treatment spans. Combinations of new specifically targeted antiviral therapies hold particular promise, offering a greater chance of preventing HCV mutations which could create resistance to individual therapies.
Not only is SOC ineffective in 40-45% of patients, the treatment has a range of potentially severe and even life-threatening side effects that deter a lot of people from completing their treatment regimen. A number of patients have opted to wait for a new wave of treatment that is expected within the next 18 months, a practice known as warehousing. The drugs closest to market, boceprevir and telaprevir, are protease inhibitors derived from technology that led to discoveries made in the fight against HIV. These new treatments are being tested as additions to current SOC. [For further information see the event:
Availability of viral protease inhibitors for the treatment of chronic hepatitis C.]
The international respondents considered that post-exposure prophylaxis for HCV infection would only be given to high-risk patients. This could follow needle-stick injuries and organ transplants for example. The general view was that long-term pre-exposure prophylaxis would not be used within the forecast period.
"If someone got a needle-stick injury, post-exposure prophylaxis might be used to prevent chronic infection taking hold. I can’t see any situation where somebody would be on long-term prophylaxis otherwise."
Internationally, the experts expected significant changes to the treatment of HCV infection as new classes of product become available. This was expected to include increased use of combination therapy. Some hepatologists also expected expansion of combination therapy for HBV infection, as a way to combat viral resistance.
Overall, an increase in total prescribing of products for the treatment of chronic viral hepatitis is anticipated as more use of combination therapy occurs. For both hepatitis B and hepatitis C these practices have already begun to be employed and some of the impact is likely to have been captured in the baseline trend. For HBV infection, additional use of antiretroviral products currently available for HIV is likely; however, as these products are categorised within the J5C class, they will not have a positive impact upon the J5B1 class. Replacement of J5B1 products by J5C medications is evaluated in the event ‘Availability of reverse transcriptase inhibitors (classified in J5C) for the treatment of chronic hepatitis B.’. Similarly, although new products for the treatment of HCV infection will be used in combination with existing medication and will significantly expand the J5B1 class, the impact of this is considered within the ‘New Product’ section. In light of the above factors, IMS Health has not applied any impact to the forecasted class due to this event.
