Top 10 late-stage cancer drugs in 2012

Posted under BBI608, Blog, Boston Biomedical, cabozantinib, Cancer Drugs, carfilzomib, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Medivation, Pharmaceuticals, Pipeline, Startups, T-DM1, tivozanib, Universities, Videos, Xalkori by rmcbride

Thousands of experimental meds are winding their way through various stages of clinical trials today, and the largest category among the contenders is cancer drugs. Of the hundreds of cancer programs under surveillance at FierceBiotech, we've culled the most promising programs we could find.

We welcome contrary views about our picks, but we saw four of the 10 drugs we selected last year--Seattle Genetics' ($SGEN) Adcetris (brentuximab vedotin), Pfizer's ($PFE) Xalkori (crizotinib), Plexxikon's Zelboraf (vemurafenib, formerly code-named PLX4032) and Roche's ($RHHBY) Erivedge (vismodegib)--gain FDA approvals since last year. The others remain in the hunt for regulatory nods, and we've included many of them in this year's roundup.

Like in last year's edition of this report, we've emphasized drugs that are at the very least headed into late-stage development. Most of the programs featured have provided compelling safety and efficacy data, yet we also highlighted a lesser-known drug called BBI608 because it's an excellent example of how the field of new drugs targeting cancer stem cells has matured. Dainippon Sumitomo saw enough promise in the program to scoop up its developer, Boston Biomedical,in a deal that could be worth more than $2.6 billion.

Please alert us to what you think are glaring omissions and, importantly, tell us why those missing programs should have been included here. For instance, To be clear, we've only included drugs here that are new biologics or chemical entities that haven't been approved yet. -- Ryan McBride (Email | Twitter)

• BBI608 – 10 Promising Late-Stage Cancer Drugs – 2012
• Cabozantinib – 10 Promising Late-Stage Cancer Drugs – 2012
• Carfilzomib – 10 Promising Late-Stage Cancer Drugs – 2012
• Enzalutamide (formerly MDV3100) – 10 Promising Late-Stage Cancer Drugs – 2012
• Ponatinib – 10 Promising Late-Stage Cancer Drugs – 2012
• Regorafenib – 10 Promising Late-Stage Cancer Drugs – 2012
• Talimogene laherparepvec (OncoVex) – 10 Promising Late-Stage Cancer Drugs – 2012
• T-DM1 (trastuzumab emtansine) – 10 Promising Late-Stage Cancer Drugs – 2012
• Tivozanib – 10 Promising Late-Stage Cancer Drugs – 2012
• Zaltrap (aflibercept concentrate) 10 Promising Late-Stage Cancer Drugs – 2012

J&J wows analysts with early success of Zytiga PhIII for prostate cancer

Posted under Blog, Companies, Dendreon, Diagnostics, Funding, Medical Devices, Medical Supply, Medivation, Pharmaceuticals, Prostate Cancer, Provenge, Startups, Universities, Videos, Zytiga by John Carroll

The news just keeps getting better for Johnson & Johnson's new prostate cancer drug Zytiga (abiraterone). Investigators unblinded a late-stage study of the drug--plus prednisone--for prostate cancer victims who had not been treated with chemotherapy. The blockbuster drug is already approved for treatment-resistant cases and the news heralds a quick-step expansion of the prospective patient population.

No data was delivered, but Johnson & Johnson ($JNJ) says the independent monitoring committee members for the study were satisfied that they had the results they were looking for on progression-free survival as well as the co-primary endpoint of overall survival along with key secondary endpoints. The move paves the way for J&J to start filing for expanded use later this year.

According to Adam Feuerstein at TheStreet, a J&J spokesperson confirmed that investigators had established a statistically significant response for PFS and a "strong trend" on OS, though the data in that category was not statistically significant. The independent data monitors "stopped the trial based on the totality of the data they saw," Kellie McLauglin told TheStreet, which included a statistically significant benefit for all secondary endpoints.

Dendreon ($DNDN), which will face additional pressure from an increasingly popular rival treatment to Provenge, saw its shares slide 13% on the news. Zytiga has been eating up market share as its reputation as a faster acting, more convenient therapy for prostate cancer--quick to ease pain and other effects of cancer--has spread among patients and physicians.

"The COU-AA-302 study has been a key priority for us as we expand our understanding of the utility of Zytiga in metastatic prostate cancer," said William N. Hait, the global chief of Janssen R&D. "We're delighted that these data will soon be added to the growing body of literature about this important medication."

The Phase III results also have implications for Medivation ($MDVN), which has a lot at stake with its late-stage program for MDV-3100. Medivation has been counting on a new approach that does away with the need for prednisone, which can trigger high blood pressure.

- here's the press release
- here's the report from TheStreet

Related Articles:
J&J's Zytiga's pain relief, ease of use beat Provenge
UPDATED: Medivation shares skyrocket on positive PhIII prostate cancer data
What will Dendreon's new chief do about Provenge?

UPDATED: Aragon raises $42M for closely-watched prostate cancer drug

Posted under Aragon Pharmaceuticals, Blog, Companies, Diagnostics, Funding, MDV3100, Medical Devices, Medical Supply, Medivation, Pharmaceuticals, Prostate Cancer, Startups, Universities, Videos by John Carroll

Now that San Diego-based Aragon Pharmaceuticals has wrapped its early-stage work on their anti-androgen prostate cancer drug ARN-509 with some encouraging indications of its impact on tumors, the biotech has married up with a nontraditional investor to round up $42 million in Series C cash. A group called the Topspin Fund, headed by one-time hedge fund wiz Jim Simons, put up half of the cash, which should get the developer through the crucial proof-of-concept stage and on the way to a potential partnership deal.

For an early-stage drug, ARN-509 has attracted a significant amount of buzz in the biotech field. The treatment was discovered by a team of scientists led by Charles Sawyer, a Howard Hughes Medical Institute investigator who is credited with MDV3100, another prostate cancer treatment that has been heralded as a potential game changer at Medivation ($MDVN). Sawyer sometimes refers to ARN-509 as the "Son of Medivation," and a number of observers have indicated that it could have a blockbuster future if it can survive the clinical trial process.

Aragon needed the capital on a short timeline, CEO Rich Heyman tells FierceBiotech. Investigators were able to transition from a successful Phase I into a Phase II, enrolling about 100 late-stage patients in half the time initially projected.

"The data looks very encouraging," he says, noting that the early-stage numbers indicated a drop in PSA levels among patients--a significant biomarker for the disease.

The cash should last "about 2 years," says the CEO. "It depends on if we decide to partner ARN-509 for the pivotal Phase III study." If they do score a pact, he adds, then Aragon will be able to swiftly shift gears and turn the spotlight on its follow-up program for breast cancer as the partner moves forward on the prostate cancer drug.

Much of the buzz in the field has centered on the potential for combo drugs among various developers, and Aragon is excited about the prospects of a combination study with abiraterone, J&J's ($JNJ) new prostate cancer drug obtained in the Cougar buyout. Combining the two drugs would hit "two focal points of androgen-dependent prostate cancer," something the CEO says would amount to "androgen annihilation."

There's also potential for a tie-up with a PI3 kinase inhibitor, which helped inspire Aragon's decision to ask Carol Gallagher, who helmed Callistoga and its PI3 kinase inhibitor program ahead of its sale to Gilead ($GILD), to sit on the company's board.

Aragon hasn't been the only company pumped about ARN-509's potential. Medivation sees this program as part of the IP package it licensed from UCLA. And Medivation has already claimed ownership. 

"We have filed a lawsuit against UCLA because we believe Medivation has exclusive license rights to ARN-509 under the exclusive license agreement and sponsored research agreements between us and the academic institution," Medivation noted in a statement to FierceBiotech today. "The lawsuit alleges that ARN-509 is a close analog of MDV3100, and was invented in the same laboratory at the academic institution from which we licensed MDV3100. The purpose of this lawsuit is to fully enforce Medivation's rights under these agreements. The lawsuit does not affect our intellectual property rights in MDV3100; only our alleged exclusive license rights to ARN-509 is at issue. This lawsuit is pending in the California Superior Court. Discovery is ongoing."

- here's the release from Aragon

Related Articles:
Aragon Pharma readies first cancer trial after $22M B round
Abiraterone vs. MDV3100: A prostate cancer drug showdown

Ian Read – The 25 most influential people in biopharma today

Posted under Blog, Companies, Diagnostics, Dimebon, Funding, Ian Read, Lipitor, Medical Devices, Medical Supply, Medivation, Pfizer, Pharmaceuticals, Startups, Universities, Videos by Mark Hollmer

Focused on the bottom line

Ian Read
CEO
Pfizer

New Pfizer ($PFE) CEO Ian Read took the top spot in late 2010 with a mandate to make the sluggish drug giant more nimble, if it ever was.

Read is enormously important to the industry because his initial solution amounted to a sea change--a $1.5 billion reduction in spending on research and development. That, so far, has translated into about 4,220 job cuts announced over the previous year as of Jan. 4, including 1,100 in Connecticut, and most of the 2,400 jobs at Pfizer's Sandwich, U.K., lab, as reported by The Guardian and others. Observers will be tracking those changes closely, wondering if drastically reducing in-house R&D in favor of later-stage drug development can be more successful.

Wall Street analysts loved the greater focus on the bottom line, and now Pfizer's competitors--including Eli Lilly, AstraZeneca and others--now face profound pressures to do the same unless they can improve the performance of their similarly struggling R&D operations.

The other part of the equation: Read swore off large acquisitions in favor of licensing deals and companies with mid-to-late-stage drug candidates, a potentially cost-effective way to outsource development and fill the gaps created by gutting the company's in-house R&D. Partnerships, however, remain a mixed bag for Pfizer. Earlier this year, Pfizer wrote off its $725 million partnership deal with Medivation after that company's Alzheimer's drug Dimebon disappointed in Phase III trials.

Still, the job's not over yet. Read committed to an ongoing review of all of the company's operations, with some big changes. He's streamlined some global management functions and Pfizer announced plans to shed its $3.6 billion animal health business and its $1.9 billion nutritionals business and focus on its late-stage pipeline. But some observers want the company to commit to far more aggressive downsizing and streamlining.

Read, meanwhile, is trying to keep Pfizer in play with generic competition through discounts and co-pay assistance programs, a unique solution also likely to be closely watched by industry.