UPDATED: Roche readies for approvals of previously snubbed breast cancer drug

Posted under Blog, breast cancer, Clinical Trials, Companies, Diagnostics, Eli Lilly, Funding, Herceptin, ImmunoGen, Medical Devices, Medical Supply, Pharmaceuticals, Phase III, Pipeline, Roche, Sanofi, Startups, T-DM1, Universities, Videos by rmcbride

Roche ($RHHBY) has turned in positive data from a key Phase III study of its blockbuster hopeful T-DM1 and later this year plans to seek green lights to sell the breast cancer drug in the U.S. and Europe, the company announced today.

The Swiss drug giant revealed top-line results from its 991-patient "EMILIA" study, saying that T-DM1, or trastuzumab emtansine, met one of the main goals of the study in providing a significant boost in survival without patients' cancer getting worse compared with patients who took the two cancer drugs lapatinib and Xeloda. The company didn't have available data on overall survival, which is the second primary endpoint of the study. Detailed results of the trial are expected at an upcoming scientific meeting.

Roche, which boasts the world's largest cancer drug business, sees T-DM1 as an encore to its drug Herceptin in treating HER-2 breast cancers, which account for 15% to 20% of all breast cancers. The experimental drug links Herceptin, an antibody drug, to the chemo agent DM1, providing what the company hopes will be a one-two punch that is more powerful in combating breast cancer than Herceptin or even Herceptin and separate doses of chemo. All patients in the EMILIA trial were previously treated with Herceptin and chemo.

The FDA turned down Roche's early bid for approval of T-DM1 in 2010, saying that the company's Phase II data weren't enough to win the agency's stamp. Roche is obviously upbeat about going back to regulators this year with Phase III results added to its data package for the program.

"We are excited about the EMILIA results because trastuzumab emtansine is our first antibody drug conjugate, and it may help people who still need more treatment options for this aggressive disease," Dr. Hal Barron, Roche's chief medical officer and head of product development, stated. "We will work to submit these data to regulatory authorities as quickly as possible."

ImmunoGen ($IMGN), which licenses its linker tech and the chemo agent for T-DM1 to Roche, could get its first revenue from sales of an antibody-drug conjugate if the drug is approved. To date, the Waltham, MA-based biotech relied on revenue from partnerships with Roche, Sanofi ($SNY), Eli Lilly ($LLY) and others. Biotech commentator Adam Feuerstein noted on Twitter this morning that ImmunoGen's royalty on T-DM1 sales is 5%.

- here's Roche's release
- check out the Reuters report
- get more from Dow Jones

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Corrected and updated: ImmunoGen doesn't license T-DM1 to Roche, as initially reported in this article. ImmunoGen licenses the linker technology and chemo agent DM1 used for T-DM1 to the drug company. We apologize for any confusion. The story was updated after the correction to add that ImmunoGen also licenses DM1 to Roche.

FDA rewards Roche with priority review for blockbuster cancer drug

Posted under Blog, breast cancer, Companies, Diagnostics, Funding, Genentech, Herceptin, Medical Devices, Medical Supply, pertuzumab, Pharmaceuticals, Roche, Startups, Universities, Videos by John Carroll

After racking up a solid set of late-stage data on the experimental breast cancer drug pertuzumab late last year, Roche ($RHHBY) and Genentech scored priority review status for the program, shaving months off of the regulatory process as it drives toward a likely blockbuster approval.

Pertuzumab fits the profile for the kind of new treatments regulators are enamored with. Added to Herceptin and chemotherapy the treatment delivered a median 6.1-month halt in tumor growth among women with HER2-positive breast cancer. The pertuzumab-Herceptin combo is being credited as a better HER2 blocker, and the added benefit comes without some of the potential side effects investigators have been fretting about. Scientists in the field have called it one of the biggest medical advances in several years.

Survival data isn't scheduled to arrive until next year, but the agency's decision to extend priority review status--shaving at least four months off the regulatory process--sends a clear signal that the FDA believes the potential benefits are well worth a regulatory shortcut. In recent months regulators have been handing out approvals on targeted drugs well ahead of deadline, indicating that they are ready to reward developers which can meet the standard on targeted drugs.

Analysts at Vontobel believe that an approval can add close to $2 billion a year in added revenue for Roche.

- read the press release
- here's the Reuters article

Special Report: Pertuzumab - 15 top blockbuster contenders

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Roche, Novartis showcase game-changing breast cancer drug data
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Severin Schwan – The 25 most influential people in biopharma today

Posted under Blog, Companies, dalcetrapid, Diagnostics, Funding, Genentech, Herceptin, Medical Devices, Medical Supply, Pharmaceuticals, Roche, Severin Schwan, Startups, Universities, Videos by Ryan McBride

Championing next-gen personalized meds

Severin Schwan
CEO
Roche Group

Severin Schwan has been a difference maker in the business of targeted cancer drugs and understanding the role diagnostics play in matching the right patients with the right treatments. While not all pharma chiefs are willing to pump as much money as Roche ($RHHBY) into diagnostics and gene sequencing platforms, many of them have been pushing their own companies to follow the lead of targeted drugs such as Roche's Herceptin for breast cancer.

Schwan, of course, pulled the trigger on his Swiss company's landmark acquisition of Genentech in 2009, a megamerger that solidified Roche as the largest provider of cancer drugs in the world. And now the CEO of Roche has his sights set on transforming his company into the world's leader proving DNA sequencers--viewed as essential tools for pinpointing the genetic targets for personalized drugs and diagnostics--via the company's hostile bid to buy Illumina ($ILMN) for $5.7 billion.

Roche very well could end up owning Illumina. Yet even without the San Diego-based maker of DNA decoders, thanks in part of Schwan's leadership, Roche has the infrastructure to both develop drugs against specific genetic targets and introduce companion diagnostics for those therapies. Now, as we see over and over, most major biopharma outfits want a piece of the targeted drug business, with other heavyweights such as Pfizer and Johnson & Johnson ($JNJ) eager to grow their own pieces of the targeted drug pie.

Targeted drugs aim to take out the drivers of diseases and reduce side effects on patients, traits that also make the treatments good for business. Schwann has repeated over and over his cause to make the pharma side of Roche laser focused on innovative drugs to deliver big benefits for patients, expecting only those remedies to garner premium prices from cost-conscious health payers and governments.

Along the innovation lines, Schwan has honored a tradition at Roche of diligent exploration of diseases and development of new drugs since taking over as CEO in 2008. And the company's R&D efforts have positioned the company to bring a slate of potential blockbusters to market, including its projected megablockbuster cardiovascular drug dalcetrapib.

Roche, Novartis showcase game-changing breast cancer drug data

Posted under Afinitor, Blog, breast cancer, Companies, Diagnostics, Funding, Herceptin, Medical Devices, Medical Supply, Novartis, pertuzumab, Pharmaceuticals, Roche, Startups, Universities, Videos by John Carroll

Roche and Novartis ($NVS) put out new data yesterday on two treatments that promise to fundamentally reshape the way the majority of breast cancer patients are treated. Roche clearly impressed specialists and analysts with the news that pertuzumab combined with Herceptin and chemotherapy checked tumor development for a median of slightly more than six months--from 8.5 months to 12.4 months. And Novartis's Afinitor demonstrated a four-month delay in disease progression among metastatic patients.

"These are two new therapies, targeted therapies, that will change the standard of care for women with metastatic disease," Jose Baselga, chief of oncology at Massachusetts General Hospital and a lead author for both studies, tells Bloomberg. "They are elegant, they are hypothesis-driven and they are working through well-known mechanisms."

Afinitor is already approved for other cancers, following Novartis's game plan for mapping a path to a steadily growing marketplace. But it was the experimental pertuzumab that had gripped the attention of the field in the lead-up to the big San Antonio Breast Cancer Symposium. The treatment offers a second pathway to managing HER2-positive breast cancer, which is present in about one in four cases. By offering a much-improved combination therapy for breast cancer, Roche puts itself on the road to an approval that could gain an additional $2 billion a year in revenue while guarding itself against any new biosimilars of Herceptin.

"These are among the most significant findings in drugs for metastatic cancer in the past five years," Dana-Farber's Eric Winer tells The Wall Street Journal. But Roche and Novartis still have a ways to go before they complete their case on breast cancer. The gold standard for cancer data is an overall survival rate, and investigators are still piecing that picture together. Roche has already filed for an approval of pertuzumab in Europe and Genentech filed its BLA in the U.S.

- get the release from Roche
- here's more from The Wall Street Journal
- read the article from Bloomberg
- see the story from Reuters

Special Report: Pertuzumab - 15 top blockbuster contenders

Related Articles:
Roche preps full data on blockbuster hopeful for breast cancer
Afinitor data could be 'game-changer' in breast cancer
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