IMS Health World Pharma Market Summary May 2011


Sales Through Retail Pharmacies (Twelve months to January 2012)*

NORTH AMERICA  $251.1 billion up 3%
U.S.A. $231.2 billion up 3% 
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CANADA $19.9 billion down 1%  Buy Canada country report

EUROPE (TOP 5)  $112.4 billion no movement
GERMANY $38.6 billion up 2% 
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FRANCE $29.3 billion no movement  Buy France country report
ITALY $16.2 billion down 1%  Buy Italy country report
UK $14.2 billion up 1%  Buy UK country report
SPAIN $14.1 billion down 6% 
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JAPAN (including hospitals) $100.1 billion up 6%  Buy Japan country report

CHINA (hospital) $39.5 billion up 17%  Buy China country report

LATIN AMERICA (TOP 4) $40.2 billion up 18%
BRAZIL $21.9 billion up 19% 
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MEXICO $8.3 billion up 3%  Buy Mexico country report
VENEZUELA $5.1 billion up 35% Buy Venezuela country report
ARGENTINA $4.9 billion up 29%  Buy Argentina country report

AUSTRALIA/NZ $11.5 billion up 6%  Buy Australia country report

The top 5 therapy classes at ATC3 level in the 12 months to January 2012 were:
1. C10A – Cholesterol & trigly. regulators  Buy Forecast for UK Market 
2. A2B - Antiulcerants Buy Forecast for Canada Market 
3. N5A - Antipsychotics Buy Forecast for Japan Market 
4. N6A – Antidepressants & mood stabilisers Buy Forecast for France Market 
5. A10C – Human Insulin & analogues Buy Forecast for Germany Market 

The top 5 products in the 12 months to January 2012 were:
1. Lipitor
2. Plavix
3. Crestor
4. Seretide
5. Nexium

The top 5 corporations in the 12 months to January 2012 were:
1. Pfizer
2. Novartis
3. AstraZeneca
4. Merck & Co
5. GlaxoSmithKline

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*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 Please note this is IMS proprietary and should not be published in any format without reference to IMS Health in the first instance.


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Company News  

M&A 

Amgen entered into a $3.6bn merger agreement with Micromet, a German/US biotech with a Phase II antibody for haematological malignancies, while Bristol-Myers Squibb is to acquire Inhibitex for $2.5bn, to expand its presence in the hepatitis C market. Watson bought Strides Arcolab’s Australian and south-east Asian generics business, Ascent Pharmahealth.

Roche made a $44.50 per share offer for Illumina, valuing the DNA sequencing and diagnostics firm at $5.7bn; the bid was hostile, following a number of rebuffs from Illumina’s management. Two days later, Illumina adopted a shareholder rights plan, but after Roche commenced its tender offer the following day, Illumina’s board of directors said it would review the offer and postpone its 2011 financial results announcements. The tender offer will run until February 24th. Roche has also submitted four nominees for election to Illumina’s board at its annual meeting.

Valeant increased its hostile offer for ISTA from $6.50 to $7.50 per share, and told the ophthalmology specialist it might be willing to pay up to $8.50. ISTA said it would review the offer, but at the end of the month Valeant withdrew its bid due to lack of progress.

Licensing    

Spectrum expanded its interest in Zevalin, which it already markets in the US for non-Hodgkin’s lymphoma, and acquired ex-US (i.e. worldwide) rights to the intravenous product from Bayer. Shire acquired the US rights to Resolor, which it already sells in Europe for chronic constipation in women, from Johnson & Johnson, while Kyowa Hakko Kirin’s ProStrakan subsidiary licensed US rights to Rectiv, for pain associated with chronic anal fissure, to Aptalis. Actavis said it would "shake up" the global diabetes market via the formation of a joint venture with Bioton for the development of insulins, including analogue insulins.

Sanofi’s Genzyme subsidiary announced a global co-promotion agreement for Veracyte’s Afirma Thyroid FNA Analysis, which provides a personalised medicine solution for the improved diagnosis of thyroid nodules. Endo will develop and commercialise BioDelivery Sciences International’s BEMA buprenorphine for the treatment of chronic pain. Nuron Biotech licensed its HibTITER Haemophilus influenzae type B vaccine to Mitsubishi Tanabe for marketing in Japan, while Abbott will sell Apricus Biosciences’ topical erectile dysfunction product Vitaros in Canada.

GlaxoSmithKline exercised its option to licence ChemoCentryx’s CCX354 for rheumatoid arthritis. Biogen Idec and Isis formed a global collaboration for the latter’s antisense therapy for spinal muscular atrophy, ISIS-SMNRx, while LEO Pharma licensed in an oral psoriasis product from Virobay. SFJ Pharma will run a Phase III trial in Asia of Pfizer’s axitinib (Inlyta, see below) as an adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy. Sanofi and Third Rock Ventures launched Warp Drive Bio, a partnership aimed at transforming the discovery and development of natural product drugs. J&J began a cancer drug discovery alliance with Forma Therapeutics, Xenon will collaborate with Roche’s Genentech subsidiary on therapies and companion diagnostics for pain, and Ipsen began a research collaboration with Oncodesign focusing on LRRK2 kinase inhibitors as potential Parkinson’s disease treatments.

Takeda returned the European development and commercialisation rights to Durect’s Posidur, a post-operative pain relief depot, while Astellas terminated its agreement with Theravance for the sale of antibiotic Vibativ. Ipsen returned the rights to Santhera’s Parkinson’s product fipamezole and J&J ceased its OX-CLI and OX-ESI drug discovery collaboration, for asthma, COPD and other inflammatory diseases, with Orexo. Par and Talon ended their agreements with NovaDel for its ondansetron oral spray

Regulatory activity 
 

Pfizer launched Oxecta, the oxycodone product featuring Acura’s Aversion technology (to discourage tampering), in the US. Lundbeck started the sale of ONFI in the US for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged 2+, and launched Sycrest in the UK for the management of moderate-to-severe manic episodes associated with bipolar I disorder.

The FDA granted expanded indications to Baxter's Tisseel, to include general haemostasis in surgery, and to UCB’s anticonvulsant Keppra, which can now be used in children as young as one month old with partial onset seizures. The EC endorsed the CHMP’s positive opinion of J&J and Furiex’s Priligy, clearing the way for it to be approved across the EU for the treatment of premature ejaculation.

New drugs approved by the FDA included: Bydureon, Amylin and Alkermes’ once-weekly treatment for Type 2 diabetes (based on the same compound as twice-daily Byetta); Boehringer Ingelheim and Lilly’s Jentadueto, which combines Tradjenta with metformin, also for Type 2 diabetes; Curis and Roche/Genentech’s Erivedge, the first therapy for advanced basal cell carcinoma; Pfizer’s Inlyta, for the second-line treatment of advanced renal cell carcinoma; Kalydeco from Vertex, the first medicine to treat the underlying cause of cystic fibrosis (in patients aged 6+ and who have at least one copy of the G551D mutation in the CFTR gene); and LEO Pharma’s Picato, a topical gel for actinic keratoses. Astellas and XenoPort’s Regnite was cleared in Japan for the treatment of moderate-to-severe restless legs syndrome.

AstraZeneca and BMS’ closely watched SGLT2 inhibitor for Type 2 diabetes, dapagliflozin, received a Complete Response letter from the FDA, which indicated that additional clinical trials may be necessary. Watson and Columbia’s progesterone vaginal gel 8% was not recommended for the reduction of risk of preterm birth in women with short uterine cervical length by an agency advisory committee. In Europe, the CHMP issued a negative opinion on Allos and Mundipharma’s Folotyn as a second-line therapy for peripheral T-cell lymphoma.

Product issues      

Novartis’ Consumer Health unit recalled a number of products, including Excedrin and Bufferin, in the US because of the potential of foreign or broken tablets in the packs; the manufacturing problem also led to supply issues for Endo’s Opana ER and certain other analgesics.

Medivation and Pfizer announced further disappointing trial results for dimebon in Alzheimer’s disease and announced that they would be discontinuing its development for all indications and terminating their collaboration.

Corporate developments   

Teva announced that President and CEO Shlomo Yanai would be retiring in May; he will be succeeded by Jeremy Levin, a former alliance executive at BMS.

Both the EMA and FDA approved Sanofi/Genzyme’s Framingham manufacturing plant, allowing production of Fabry disease therapy Fabrazyme to recommence. Thirteen major manufacturers began an alliance with the WHO and non-profit organisations to provide free treatments for neglected tropical diseases.

Following its acquisition of Nycomed, Takeda said it would be consolidating its R&D sites, changing to a more diverse portfolio focused on new products, and laying off approximately 2,800 employees (2,100 in Europe and 700 in the US); the plan is expected to reduce income by ¥35bn in the financial year to March 2012. Novartis is cutting 2,000 jobs in the US linked to the patent expiry of top-seller Diovan this September and will take a $900m charge related to reduced sales expectations for newer antihypertensive Tekturna/Rasilez. It announced an agreement to resolve the US class action litigation regarding unpaid over-time by sales representatives, providing up to $99m to be shared amongst eligible class members.

For sales and overviews on major pharma companies, view our Country Reports in the IMS Store.

IMS Company Profiles can be downloaded from the IMS Store here.


Pricing & Reimbursement News  

USA: Publication of draft priorities and agenda for comparative effectiveness research 
The Patient-Centered Outcomes Research Institute (PCORI), established under the 2010 healthcare reforms to co-ordinate comparative effectiveness research (CER) nationally, has published its draft research priorities and research agenda, and invited feedback from stakeholders (including drug manufacturers).

Japan: Korosho announces planned price cuts due to market expansion
The Ministry of Health, Labour and Welfare (Korosho) has confirmed that 16 active ingredients will be subject to re-pricing due to expansion in market size at the next National Health Insurance (NHI) reimbursement price revision, scheduled to take effect on 1 April 2012. 

Spain: Andalucía publishes first retail sector drug tenders
The autonomous community (CA) of Andalucía has published its first retail sector drug tenders, covering 55 presentations (17 off-patent active ingredients

Germany: IQWiG finds no additional therapeutic benefit for Halaven in breast cancer
An early benefit assessment conducted by the Institute for Quality and Efficiency in Healthcare (IQWiG) has concluded that the additional therapeutic benefit over comparators of Eisai’s breast cancer treatment Halaven (eribulin) is "not proven".

Now available from the IMS Store:
Understand P&R issues across the world in our IMS Pricing & Reimbursement Concise Guides and our Pharma Pricing & Reimbursement Magazine, all available in the IMS Store.




Market News 
 

New therapeutic strategies against cancer
F
rom immunotherapy to the epigenetic approach, by way of ground-breaking technologies as a support to radiotherapy: medicine is continually adding to its therapeutic arsenal in the fight against cancer.

On the eve of World Cancer Day (4 February 2012), Prof. Michel Marty, Chairman of Eurocancer and Director of the Centre for Therapeutic Innovations in Oncology and Haematology, located in the Hôpital Saint-Louis (Paris), brought together a panel of researchers and clinicians to meet the press and discuss new cancer-fighting strategies. Although the incidence of these diseases continues to rise, cancer mortality has been falling for two decades in Western countries, particularly in France. "A positive assessment, to be weighed against some major advances", Prof. Marty emphasised.

Immunotherapy: effective but costly
Among the therapeutic "revolutions" of the past few years, Prof. Laurence Zitvogel, of the Institut Gustave Roussy (IGR), ranks immunotherapy highly. This strategy involves stimulating the patient’s immune system so that it attacks the tumour. It has already proven to be effective, for example in peptide vaccines against cancers caused by the human papillomavirus. In 2010, the FDA approved Provenge®, a vaccine by the company Dendreon against prostate cancer. Adjuvanted protein vaccines are currently in phase III clinical trials in bronchial cancer.

Monoclonal antibodies, which take the brakes off the patient’s immune system, have been developed concurrently – these include ipilimumab, made by BMS and authorised by the FDA for metastatic melanoma. It has to be said that this treatment is extremely expensive and there are as yet no validated biomarkers which can determine the sub-population of responder patients (less than 20%). "Immunotherapy is in the process of taking off, with an established beneficial effect shown in reduced mortality and toxicity", Prof. Zitvogel was happy to state. "But we absolutely must sort out the cost problem".

Intervening in epigenetic processes
In the longer term, radical new developments are expected as scientists achieve a better understanding of the biological processes that underlie the transformation of healthy cells into tumour cells. Prof. Dominique Bellet, of the Institut Curie, is convinced that the next decade will see the advent of epigenetics, which governs the modification of gene expression independently of the genetic code. "The contribution of epigenetics to cancer is estimated at 70%", he indicated. "For example, in retinoblastoma, the alterations observed are mainly epigenetic". The subject is of interest to growing numbers of researchers at an international level, particularly in Asia but also at the Institut Curie, where teams are working on identifying epigenetic biomarkers that can predict the progression of tumours.

Improving radiotherapy
Faced with these new strategies, will "traditional" cancer treatments soon become obsolete? According to Dr Jean-Michel Vannetzel, President of the Institut du sein Henri Hartmann, "radiotherapy has more to give. There is still considerable room for improvement". Today, the challenge of this approach – which still involves more than half of patients treated for cancer – is to limit the side effects of the rays on surrounding healthy tissue.

Dr Vannetzel also has high hopes for the technology developed by the company Nanobiotix. This technology increases the efficacy of ionising radiation by injecting nanoparticles, which intensify the action of the rays, into the tumour. A phase I clinical trial is underway at the IGR, during which 27 patients with soft tissue sarcoma will be recruited (ten of whom will be recruited this year). One patient – the first – has already been treated. Jean-Michel Vannetzel is enthusiastic: "The choice of model is ideal for validating the concept". The first results will be available next year.

Further news from Pharmaceutique published in French is available here.

Market forecasts now available from the IMS Store at a therapy level here.


Therapy News

This month’s therapy focus is: Angiotensin Receptor Blockers (ARB)

The following is an excerpt taken from IMS Health Therapy Prognosis USA 2011-2020 and analyses the impact the availability of new ARB triple-combination products may have on therapy class sales and volumes.


Tribenzor, Sevikar HCT (olmesartan/amlodipine/HCT)
Marketed: USA, Germany Pre-registration: Europe Phase III: Japan

Daiichi Sankyo is developing a triple-combination product comprising olmesartan medoxomil, amlodipine and hydrochlorothiazide for the treatment of hypertension. The product was first launched in the USA in August 2010 under the trade name Tribenzor for the treatment of hypertension in patients who are inadequately controlled with any two of the following antihypertensive drug classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. In December 2010, following the close of the European decentralised procedure with a positive recommendation, the product was approved in Germany under the trade name Sevikar HCT. The once-daily single pill is indicated for the treatment of hypertension, as a substitution therapy in adult patients whose blood pressure is adequately controlled with omesartan medoxomil and either of the other components. Phase III trials were initiated in Japan in fourth quarter 2007. In a pivotal registration trial named TRINITY, Tribenzor was compared with three dual combination therapies: amlodipine/HCT, olmesartan/HCT and olmesartan/amlodipine. During this trial, which included 2,492 patients with hypertension, patients were switched from their dual combination therapy to Tribenzor. After 12 weeks of treatment, Tribenzor produced a further reduction in mean blood pressure, which was statistically significant compared with the dual combination therapies. The findings were consistent across prespecified age, gender, and racial subgroups and were the same regardless of hypertension severity.

The American specialists were positive about triple-combination products comprising an ARB, calcium channel blocker and diuretic. It was commented that an obvious advantage of such products was their ability to decrease a patient’s pill burden thereby increasing convenience and ultimately compliance. In addition, it was felt that these agents were superior to dual ARB combinations in terms of blood-pressure control. A few of the cardiologists were especially optimistic because they thought these products would be quite useful for certain high-risk patients such as those with diabetes. Despite these advantages, the respondents predicted the usage of triple combination products would be limited by the number of suitable patient candidates and cost. For example, it was believed that the blood pressure of a significant number of patients was adequately controlled by two agents, therefore, only a fraction of the hypertensive population was expected to require a triple combination product. Additionally, it was predicted that these products would be expensive and as a result, insurance companies were expected to limit their use. Finally, the respondents did not expect a new triple combination product to offer any advantages in terms of efficacy or side effects compared with existing triple combinations nor did they expect these products to become first-line therapy.

It is common practice for physicians to take a step-wise approach to antihypertensive therapy. Therefore, it is likely that ARB triple-combination products will be prescribed to patients who are already receiving a dual ARB combination product from the C9D class. As a result, no impact is expected on the C9C class. Furthermore, patients will be switching between products within the same class which are dosed at the same frequency. Consequently, no impact is expected on C9D volume. It is possible that these products will be priced at a premium due to the addition of an inexpensive generic diuretic, but this is not anticipated to be significant. Bearing in mind the respondents’ comments, it is likely that only a small proportion of unresponsive patients will be switching. In conclusion, IMS Health expects a negligible impact on the forecasted classes due to this event. 

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