Roche sees its capabilities with both drug and diagnostics development as the key to maintaining a leadership position in targeted oncologics and personalized medicine.

Going forward, Roche is hoping to take advantage of its dual expertise as both a pharmaceutical company and a major player in the diagnostics business. This historical experience will allow the company to "leverage the potential synergies between two pillar models of having pharma and diagnostics under one roof," Roche Global Pharma Development Head Eduard Holdener maintained during the firm's June 19 oncology review.

As public debate and regulatory agendas have emphasized the importance of personalized medicine as the future of healthcare, Roche has adopted its business model to reflect this priority. Holdener reported that Roche is now requiring project teams to submit a biomarker strategy as part of the overall drug development plan - a move AstraZeneca has also taken (¹ Also see "Personalized Medicine Is Closer Than You Think, FDA’s Throckmorton Says" - Pink Sheet, 8 May, 2006., p. 23).

Despite industry's concerns that personalized medicine approaches could limit drug use, at Roche "we are not shying away from identifying a subpopulation most suitable for certain treatment for fear that this strategy will shrink the market and reduce revenues," Holdener continued.

"There is no drug program in Roche that is not directly associated with a biomarker activity," Roche Centralized Diagnostics R&D Head Joachim Eberle said in a separate session.

"What's important in an organization like ours is really that the expertise in...the broader sense exists."

"There is, on one hand, the pharma element where we really have the biology and clinical expertise, where we know about health economics, we know how to commercialize drugs, but also how we need to design clinical trials," he noted.

"Diagnostics, on the other hand, should have the tools in hand, the technologies to assess the various marker measuring principles, and should be able to develop things either as standalone components or what I think is even more important at a later stage - ultimately the element that allows the use of these assays even with less experienced professionals," he continued.

Co-development of companion diagnostics has been stressed as a key element for FDA's Critical Path drug development initiative - an element that is not suitably addressed by current business and regulatory models. FDA's Center for Drug Evaluation & Research Deputy Director Douglas Throckmorton has pointed to co-development as "critical."

Holdener pushed market leadership in personalized cancer therapies as part of Roche's overall strategy to maximize success of its oncology program.

In cancer therapeutics, "Roche has actually become number one in the world with a 25% share of the supply of oncology medications," Pharmaceuticals CEO William Burns noted, adding "that's certainly a significant outperform to any of the other players."

He acknowledged however, that number does not take into account supportive care such as erythropoietin.

In the first quarter, Roche's oncology portfolio accounted for 46%, or CHF3.6 bil. ($2.9 bil.), of the total CHF7.7 bil. ($6.2 bil.) in pharmaceutical sales.

Roche's oncology products include a mix of internal development - like Xeloda (capecitabine) - and also products brought through external collaborations - like Rituxan (rituximab) from Biogen Idec.

Holdener asserted the firm has reached a leadership position in oncology "through the innovation of the molecules, as well as through the innovative and competitive approach of clinical development programs to transform the molecules into differentiated medicines, and to bring their full potential to fruition."

In terms of "personalized cancer therapies," Roche has demonstrated success with targeted oncologics, such as the HER2 agent Herceptin (trastuzumab), the vascular endothelial growth factor inhibitor Avastin (bevacizumab), both through its relationship with Genentech, and the epidermal growth factor receptor inhibitor Tarceva (erlotinib), partnered with OSI.

As part of its strategy to concentrate on personalized cancer therapies, Roche is "investing in biomarker programs for further maximized potential of oncology drugs in the future," Holdener said.

According to Erberle, the firm has developed dual proteomic and genomic targets in colorectal, breast, prostate and lung cancer.

Developing biomarkers as part of its plan for development of personalized medicine is one of "five principles underpinning the Roche strategy for continued success in the oncology field," Holdener said.

The first principle is "to focus on developing first-in-class or best-in-class treatments." Holdener cited Xeloda, Tarceva and its continuous erythropoietin receptor activator R-744 (CERA) as "good examples of best-in-class products," although CERA has not yet launched in the U.S. The supportive care product is under review for renal anemia and is in Phase II for cancer-related anemia, with submission slated for 2009. Avastin, Herceptin and Rituxan are first-in-class examples.

A central part of Roche's oncology strategy - one where the firm has a clear track record of success - is to match internal innovation with external sources of innovation "to keep the development pipeline healthy," Holdener said.

Last year, Roche's pharmaceuticals division screened 572 partnership opportunities in oncology, of which 25 were selected for a first review and 16 went through due diligence. In the end, the process yielded three oncology transactions, Holdener said.

In seeking external collaborations, where Roche has often relied on its relationship with Genentech as well as other less formalized sources, the firm's standards "are grounded on a success profile for potential partners...who have global expertise, complementary approaches, shared priorities," the exec stated.

Echoing Holdener's remarks, Burns maintained the company's progress in the oncology arena over the last five years can be attributed to its approach to innovation, which is "a combination of research in our own centers" with licensing and acquisitions.

Burns commented on the company's licensing strategy at the Biotechnology Industry Organization annual meeting earlier this year, stressing the importance of flexibility to the success of such arrangements (² Also see "Big Pharma Seeking Simple Deals In Complex Biotech Licensing Environment" - Pink Sheet, 15 May, 2006., p. 6).

Another part of Roche's oncology strategy is to "maximize the value of our current assets already established in the market with one indication by expanding their potential through new indications in treatment," according to Holdener.

Acknowledging that growing drugs by adding indications "is a relatively low risk strategy," Holdener described the potential to test anticancer drugs across different tumor types, for use in various treatment settings (such as adjuvant or metastatic), and for use in different treatment combinations. Roche brand execs outlined how this is being executed through step-by-step lifecycle programs for each product.

The Swiss drug maker is also focusing on excellence in conducting and designing clinical trials as an element of its oncology strategy. The fifth principle is to "keep the execution of its clinical program world class," through "innovative trial design, strategic site selections, global trial implementation, efficient patient recruitment, [and] long term relationships with collaborative groups," Holdener said.

Holdener also touted Roche's Phase III success rate for oncology. He noted that Roche has "a very clear trend in improving our success rate in Phase III across all therapeutic areas."

"For the last five years...our success rate for new molecular entities in oncology [was] 67% and [the firm recognized a] basic 100% achievement across many Phase III programs, new indications in oncology, which is a very high level compared to industry," he concluded.

Underlying Roche's strategy is a firm commitment to lifecycle management - for example, with a focus on establishing their products as standard of care and on building additional indications for the brands.

There are several submissions pending at FDA for supplemental indications for Herceptin, for instance, which currently is approved for treatment of metastatic HER2 positive breast cancer.

In the first quarter, Genentech submitted a supplemental BLA for Herceptin for the adjuvant treatment of early-stage HER2 positive breast cancer, Burns noted [Editor's Note: This story previously incorrectly reported that Herceptin was also pending for first-line, non-squamous, non-small cell lung cancer.] The firm anticipates filing an sBLA for an indication for patients with HER2 positive advanced gastric cancer in 2008.

Roche To Build On Pharma, Diagnostics Expertise For Personalized Medicine

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