Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape. Perjeta. Stivarga. Marquibo. Bosulif. Xtandi. Krypolis.

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1 Krypolis Bosulif Inlyta Erivedge Xtandi Stivarga Alimta Gleevec Marquibo Perjeta Synribo Zaltrap Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape By Bill Bowman, JD What a year 2012 has been. So far this year, the FDA has approved ten new brands for cancer treatment and eight supplemental applications were cleared for existing products. Much of this activity has occurred since the onset of summer, including eight new brands and four supplemental applications. Table 1 provides a summary of 2012 year-to-date FDA activity. NOVEMBER 2012 ONCBIZ.COM ONCOLOGY BUSINESS REVIEW 1

2 Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape This rapid influx of so many new agents has dramatically altered the level of promotional activity, as companies vie for increasingly limited face time with busy oncologists. Further, the FDA approved six new oncologic products in 2011 and granted sndas for two more. The net effect of all these recent product launches is a fiercely competitive marketplace that can shift dramatically on a monthly basis. OBR has collaborated with ImpactRx to evaluate the changing promotional landscape due to the rollout of all these new brands. ImpactRx employs a proprietary database of 425 practicing oncologists equipped with iphones/ipads, enabling physicians to enter information on company representative visits at the point of engagement. This mobile research model provides both a marketplace view in real time and longitudinal tracking of changes in oncologists attitudes and behaviors. ImpactRx tapped into this database of approximately 3,000 monthly representative visits (including sales representatives, medical science liaisons, clinical study coordinators, and reimbursement specialists) with oncologists to determine which brands are being discussed most frequently. In order to assess the most up-todate impact of these new product approvals, we will first focus on promotional activity for the month of September 2012 and compare it with activity for the prior month, based on the number of representative visits. Later, we will compare September 2012 with September 2011 and assess longer-term trends going back to Table 1. Oncology Product Approvals Approvals (New Molecules) Brand Company Indication(s) Approval Date Synribo Teva Chronic Myeloid Leukemia October 26, 2012 Stivarga Bayer Metastatic Colorectal Cancer September 27, 2012 Bosulif P zer Chronic Myeloid Leukemia September 4, 2012 Xtandi Marqibo Medivation/ Astellas Talon Castration-Resistant Prostate Cancer Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia August 31, 2012 August 9, 2012 Zaltrap Sano Metastatic Colorectal Cancer August 3, 2012 Kyprolis Onyx Multiple Myeloma July 20, 2012 Perjeta Genentech HER2+ Metastatic Breast Cancer June 28, 2012 Erivedge Genentech Metastatic Basal Cell Carcinoma January 30, 2012 Inlyta P zer Advanced Renal Cell Carcinoma January 27, 2012 Alimta Lilly New Indication/Label Updates Label updated to include PFS data for maintenance therapy following 1 st line therapy in nonsquamous NSCLC October 17, 2012 Abraxane Celgene Non-small Cell Lung Cancer October 12, 2012 A nitor Erbitux Novartis Lilly/BMS Advanced HR+/HER2 Breast Cancer 1 st Line Metatstatc KRAS Mutation Negative Colorectal Cancer (with FOLFIRI) July 20, 2012 July 9, 2012 Votrient GSK Advanced Soft Tissue Sarcoma April 26, 2012 A nitor Novartis Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) April 26, 2012 Gleevec Novartis Adjuvant therapy in Kit+ GIST January 31, 2012 Velcade (Sub-Q) Millennium New Formulation When Table 2 is compared to the earlier table listing new product approvals, we quickly note that three of the brands in the Top 10 list (Xtandi, Kyprolis and Multiple Myeloma/ Mantle Cell Lymphoma January 24, ONCOLOGY BUSINESS REVIEW ONCBIZ.COM NOVEMBER 2012

3 Zaltrap) were approved since this past summer. In particular, Xtandi (indicated for castration resistant prostate cancer) has quickly captured second place behind the reigning leader Afinitor, which was also recently cleared for marketing of advanced hormone receptor-positive/her2 negative breast cancer. Zaltrap (metastatic colorectal cancer) is also rapidly gaining on the leaders. Erbitux remained in the Top 10 in spite of the activity generated by these new arrivals, perhaps owing to its recently approved sbla for first-line treatment of KRAS mutation negative mcrc. This is not surprising, as breast, prostate and colorectal are big tumors where one would expect a high volume of promotional activity. Yet, Kyprolis (multiple myeloma) and Jakafi (myelofibrosis; approved in November 2011) target less common malignancies and each of these made the Top 10. [Note: Stivarga (also approved for metastatic colorectal cancer) did not make the September list due to its late breaking approval that month and Abraxane was just cleared for its new indication in advanced NSCLC.] If we take this analysis a step further and compare promotional activity for September 2012 versus September 2011, more striking differences are noted (Table 3). Most of the leaders from a year ago no longer appear in the current Top 10 list. The cytotoxic agent Jevtana (castration-resistant prostate cancer), in particular, has dropped from 4th to 44th position. This is undoubtedly based to a large extent on the launches of Zytiga and more recently Xtandi. Both of these brands are also indicated for castration-resistant prostate cancer and are also aiming to be used in the chemotherapy-naïve setting, which could further displace Jevtana. (Sanofi may have also moved resources from Jevtana to support its recent Zaltrap launch). Tasigna (CML) faces new competition from Bosulif (previously treated CML), which appeared on Table 2. Top 10 Oncology Brands Discussed by Company Representatives (September 2012) 2 Brand Sept 2012 Rank Change in Rank from Previous Month A nitor 1 No change Xtandi 2 N/A Xgeva 3 1 Kyprolis 4 3 Zaltrap 5 22 Alimta 6 3 Velcade 7 1 Jaka 8 10 Avastin 9 5 Erbitux 10 5 Joined the Top 10 in September How other new products fared in September: Perieta - 17th, Inlvta - 20th, Bosulif - 38th Table 3. Top 10 Oncology Brands Discussed by Company Representatives in September 2011: Where are they now? 3 Brand Sept 2011 Rank Sept 2012 Rank Xalkori 1 16 Xgeva 2 3 Alimta 3 6 Jevtana 4 44 Avastin 5 9 Erbitux 6 10 Tasigna 6 13 Sutent 8 24 Zytiga 9 15 Revlimid NOVEMBER 2012 ONCBIZ.COM ONCOLOGY BUSINESS REVIEW 3

4 Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape the scene in early September The recent movement of Sutent to the 24th position may be due in part to the January 2012 approval of Inlyta, as both of these Pfizer brands are approved for advanced renal cell carcinoma and Inlyta is being targeted for pre-treated patients in a crowded market. (Some of Sutent s promotion is also directed at GIST and pancreatic neuroendocrine tumors/pnet). These brands joined the Top 10 list in September 2012: Xtandi Zaltrap Jakafi Other recently approved products reported a high level of promotional activity in September: Abraxane was already in 12th place prior to its October snda approval Perjeta ranked 17th Inlyta was in 20th position Bosulif appeared in 38th place (with less than a full month of data) Figure 1 shows representative promotional activity directed at oncologists since 2010 by quarters. If we look at these trends, it appears as if there has been only a modest increase in the average number of reported details for the first 3 quarters in 2012 compared with the first 3 quarters in 2011 (averaging 26.0 details per oncologist per quarter vs 24.0 per quarter, respectively). This upward tick may well be due to all the recent launch activity and any associated field force expansions. Yet, as multiple new products have come to market this year, one might expect a sharper increase in promotional activity than is shown here. Further, if we look back to the first 3 quarters of 2010, oncologists reported seeing 27.6 representatives per quarter, on average. This means that oncologists are not Figure 1. Oncology Representative Detailing Activity for All Promoted Brands (2010-Q3 2012) * 24.0* 26.0* Q Q Q Q Q Q Q Q Q Q Q Average No. Oncologists No. Details 10,105 10,031 9,882 8,022 9,131 9,163 8,892 9,252 10,263 9,627 9,178 * Average number of reported details per oncologist (Q1-Q3) 371 9,413 4 ONCOLOGY BUSINESS REVIEW ONCBIZ.COM NOVEMBER 2012

5 seeing more representatives, in spite of the rapid influx of so many brands. In fact, detail activity may have reached its peak, based on the overall downward trend seen since the first half of In other words, the volume of reported detailing activity has not kept pace with the ever growing armamentarium of oncology agents. These findings indicate that even with so many new launches, oncology representatives will face increased challenges in gaining entrée to see oncologists and promote their brands. Further, oncology practices are rapidly undergoing consolidation or are being acquired by hospitals in growing numbers. 5 These parallel trends in oncology practice business models can only exacerbate the increasingly fierce competition for critical face time with oncologists. In the months ahead, heightened competition and further shifts in promotional activity directed at oncologists can be expected, as more new products come to market (including Genentech s trastuzumab emtasine/t-dm1) and as the dust begins to settle for all recent entrants. References 1. FDA website: company press releases. 2. Internal ImpactRx analysis based on monthly longitudinal tracking data. 3. Ibid. 4. Internal ImpactRx analysis based on quarterly longitudinal tracking data. 5. Community Oncology Alliance, Practice Impact Report, April 4, About the Contributors Bill Bowman, JD is the Senior Manager of Product Management at ImpactRx. ImpactRx, a Symphony Health Solutions Company, is the leading provider of consultative and analytically-based promotional effectiveness solutions to the healthcare industry. ImpactRx specializes in measuring sales and marketing effectiveness in Oncologists offices. Powered by its longitudinal and normative data assets, ImpactRx s consulting analytics and custom research capabilities provide unparalleled insight into the dynamics of the Oncology marketplace. Through its i-enabled network of 425 targeted oncologists and its proprietary, state-of-the-art research technology, ImpactRx captures not only treatment decisions in response to promotion, but also the attitudes, perceptions and beliefs underlying those decisions. The integration of its comprehensive behavioral and attitudinal data with its innovative consulting analytics, global research expertise and therapeutic knowledge enables ImpactRx to deliver breakthrough solutions to its Oncology clients. These solutions empower clients to improve brand performance by making more informed and effective decisions around marketing strategy, field and channel execution and pre-launch and launch planning. For more information, visit NOVEMBER 2012 ONCBIZ.COM ONCOLOGY BUSINESS REVIEW 5