NOVEMBER 2012 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 1

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 supple-mental applications. Table 1 provides a summary of 2012 year-to-date FDA activity.

Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape

Stivarga®

Bosulif™

Xtandi®

Marquibo®

Erivedge®

Zaltrap®

Inlyta®

Krypolis®

Synribo®

Alimta® Gleevec®

Perjeta™

2 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • NOVEMBER 2012

This rapid influx of so many new agents has dramatically altered the level of promotion-al activity, as companies vie for increasingly limited face time with busy oncologists. Further, the FDA approved six new onco-logic 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 chang-ing promotional landscape due to the rollout of all these new brands. ImpactRx employs a proprietary database of 425 prac-ticing oncologists equipped with iPhones/iPads, enabling physi-cians 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’ atti-tudes and behaviors.

ImpactRx tapped into this database of approximately 3,000 monthly representative visits (including sales representatives, medical science liaisons, clinical study coordinators, and reimburse-ment specialists) with oncologists to determine which brands are being discussed most frequently. In order to assess the most up-to-date 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,

2012 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® Medivation/Astellas

Castration-Resistant Prostate Cancer August 31, 2012

Marqibo® Talon Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

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

New Indication/Label Updates

Alimta® Lilly

Label updated to include PFS data for maintenance therapy following 1st line therapy in non-squamous NSCLC

October 17, 2012

Abraxane® Celgene Non-small Cell Lung Cancer October 12, 2012

A nitor® Novartis Advanced HR+/HER2– Breast Cancer July 20, 2012

Erbitux® Lilly/BMS 1st Line Metatstatc KRAS Mutation Negative Colorectal Cancer (with FOLFIRI)

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

New Formulation

Velcade® (Sub-Q) Millennium Multiple Myeloma/ Mantle Cell

Lymphoma January 24, 2012

Table 1. Oncology Product Approvals 20121

Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape

based on the number of representa-tive visits. Later, we will compare September 2012 with September 2011 and assess longer-term trends going back to 2010.

When Table 2 is compared to the earlier table listing new prod-uct approvals, we quickly note that three of the brands in the Top 10 list (Xtandi, Kyprolis and

NOVEMBER 2012 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 3

Zaltrap) were approved since this past summer. In particular, Xtandi (indicated for castration resis-tant prostate cancer) has quickly captured second place behind the reigning leader Afinitor, which was also recently cleared for marketing of advanced hormone receptor-pos-itive/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 activ-ity generated by these new arrivals, perhaps owing to its recently approved sBLA for first-line treat-ment 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 promotion-al activity. Yet, Kyprolis (multiple myeloma) and Jakafi (myelofibro-sis; 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 dif-ferences 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 can-cer), 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 can-cer and are also aiming to be used in the chemotherapy-naïve set-ting, which could further displace

Jevtana. (Sanofi may have also moved resources from Jevtana to support its recent Zaltrap launch).

Tasigna® (CML) faces new com-petition from Bosulif (previously treated CML), which appeared on

Brand knaR 2102 tpeS Change in Rank from htnoM suoiverP

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

Table 2. Top 10 Oncology Brands Discussed by Company Representatives (September 2012)2

Joined the Top 10 in SeptemberHow other new products fared in September: Perieta - 17th, Inlvta - 20th, Bosulif - 38th

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 10 18

Table 3. Top 10 Oncology Brands Discussed by Company Representatives in September 2011: Where are they now?3

4 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • NOVEMBER 2012

the scene in early September 2012. 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 prod-ucts 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 quar-ters. 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 oncolo-gist 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 expan-sions. 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 representa-tives per quarter, on average. This means that oncologists are not

0.0

5.0

10.0

15.0

20.0

25.0

30.0

Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012 Q3 2012

362 355 370 375 367 381 384 386 369 374 36310,105 10,031 9,882 8,022 9,131 9,163 8,892 9,252 10,263 9,627 9,178

3719,413

Average

No. Oncologists |

No. Details |

* Average number of reported details per oncologist (Q1-Q3)

27.6* 24.0* 26.0*

Figure 1. Oncology Representative Detailing Activity for All Promoted Brands (2010-Q3 2012)4

Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape

NOVEMBER 2012 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 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 2010. In oth-er words, the volume of reported detailing activity has not kept pace with the ever growing armamen-tarium of oncology agents.

These findings indicate that even with so many new launch-es, oncology representatives will face increased challenges in gain-ing 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 busi-ness models can only exacerbate the increasingly fierce competi-tion 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

About the ContributorsBill 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 atti-tudes, perceptions and beliefs underlying those decisions. The in-tegration 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 www.impactrx.com.

(including Genentech’s trastuzum-ab emtasine/T-DM1) and as the dust begins to settle for all recent entrants.

References1. FDA website: www.fda.gov; 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, 2012.