Executive Profile: Plexxikon's Kathleen Glaub

Kathleen Glaub.

Coming from a family of immigrant entrepreneurs, Kathy Glaub carried on the family tradition by joining drug development company Plexxikon in 2001 as its 10th employee. She has helped guide the company, now with 45 employees, through one of the most celebrated drug approvals of the past 10 years, the metastatic melanoma drug Zelboraf in August 2011. Along with a commercialization deal with Genentech Inc. and a companion diagnostic by Roche Molecular Diagnostics, Zelboraf set up Plexxikon for its April 2011 sale to Daiichi Sankyo for a potential $935 million.

Onyx Pharmaceuticals CEO Tony Coles headlines SF Business Times Biotech Forum — June 14

Onyx Pharmaceuticals CEO Tony Coles will headline the San Francisco Business Times' annual Biotech Forum.
The event begins with registration at 7:30 a.m. Thursday, June 14, at the Hilton San Francisco Union Square, 333 O'Farrell St.
Coles will be interviewed on stage by San Francisco Business Times biotech reporter Ron Leuty before joining a panel of Bay Area biotech industry experts. In addition to Coles, the panel will feature:
• Gideon Bollag, senior vice president for research, Plexxikon;
• Lissa Goldenstein, president and CEO, Auxogyn;
• Craig Muir, partner, Third Rock Ventures; and
• Glenn Oclassen, president and CEO, Transcept Pharmaceuticals.
Additionally, the event will feature presentations from three up-and-coming Bay Area life sciences companies -- Avalanche Biotechnologies, Organ-i and Neuraltus Pharmaceuticals -- about their businesses and the big scientific problems they are trying to solve.
Christie Smith, principal and West region life sciences leader at Deloitte Consulting LLP, will give opening remarks.

To order tickets for the event, call or email Jacquie Bischoff at 415-288-4972 or jbischoff@bizjournals.com. Tickets cost $70 per person or $750 for a table of 10.

Melanoma drug from Roche, Plexxikon wins European approval

A metastatic melanoma drug developed by Roche and Plexxikon Inc. won approval Monday from European regulators.
Zelboraf, a twice-a-day pill that targets patients with a specific mutation in a protein called BRAF V600, was approved by the European Commission for adult patients with the most aggressive form of skin cancer.
It was approved in August by the U.S. Food and Drug Administration. A European panel in December recommended approval.

Plexxikon, Roche melanoma drug moves closer to European OK

A European drug review panel recommended that the melanoma treatment Zelboraf, developed by Berkeley-based Plexxikon Inc., be approved by regulators, the company said Friday.
Approval could come as early as February, said Swiss drug maker Roche, which is marketing Zelboraf.
The oral drug is aimed at metastatic melanoma patients who have a specific mutation of a protein called BRAF. That mutation is found in about half of all melanoma cases.

Roots of new melanoma drugs run deep in Bay Area

Zelboraf, the melanoma treatment approved Wednesday by the FDA, is a great Bay Area story — developed by Berkeley’s Plexxikon Inc., marketed by South San Francisco’s Genentech Inc. and accelerated by a diagnostic test developed by Pleasanton’s Roche Molecular Diagnostics.
You can’t get much more Bay Area than that.
But Zelboraf isn’t the only new melanoma drug with a Bay Area connection. Bristol-Myers Squibb’s Yervoy, approved by the Food and Drug in March, largely owes its development to research done by Dr. James Allison and colleagues in the mid-1990s at the University of California, Berkeley.

Genentech melanoma drug, Roche companion diagnostic win FDA approval

A groundbreaking drug-diagnostic combination for metastatic melanoma patients was approved by federal regulators, nearly two months before approval was expected.
Zelboraf, developed by Berkeley’s Plexxikon Inc. and marketed by South San Francisco’s Genentech Inc. , will treat patients with the deadly skin cancer who have a specific mutation, known as BRAF V600E. That mutation, found only in cancerous tumors and in a vast majority of malignant melanomas, is detected in a test developed by Roche Molecular Diagnostics of Pleasanton.

One-on-One with Roche Molecular Diagnostics' Paul Brown

In the personalized medicine revolution, Roche Molecular Diagnostics is positioned to be the major arms supplier.
The Pleasanton-based unit of Swiss drug maker Roche developed, for example, a diagnostic test that helped Berkeley drug maker Plexxikon find melanoma patients who had a specific genetic mutation for clinical trials. Targeting those skin cancer patients using RMD’s test helped Plexxikon accelerate its trials and show strong results.
RMD and Roche-owned Genentech , which is marketing the drug, on Wednesday won Food and Drug Administration approval of the drug and the companion diagnostic.
What’s more, RMD is central to Roche’s mandate that the development plan for every therapeutic include a companion diagnostic or biomarker.
Paul Brown, a 25-year veteran of Roche’s pharma division, about 14 months ago joined RMD as CEO. He oversees about 500 people at the Pleasanton site as well as 170 or so at a facility outside Zurich.
Brown sat down with me last month to talk about the company’s efforts, the FDA and the role of diagnostics in improving health care.

Genentech finds diagnostic companions on road to drug development

Perhaps Genentech has a new slogan in the works: Have companion diagnostic, will travel.
The South San Francisco-based U.S. subsidiary of Swiss drug maker Rochefor the past couple years has mandated its research arm to tie in companion diagnostics with drug development. That extends to Genentech partnerships as well, said James Sabry, vice president of partnering for Genentech.

ASCO showcasing Bay Area cancer therapies

The cancer drug world will focus on Chicago at this weekend’s American Society of Clinical Oncology meeting.
As I reported in last week’s print edition, this opportunity to report data from recent studies is a make-or-break meeting for many drug developers. It’s a chance to hook up with potential clinicians, investors and partners.
Here is a quick look at what some Bay Area companies are showcasing at ASCO.

Bay Area cancer drug developers pin futures on ASCO

It is make or break time for cancer drug powerhouses and wannabes alike, and that’s not lost on companies like ACT Biotech.
Impress clinicians at the American Society of Clinical Oncology’s annual meeting June 3 to 7 in Chicago, and those scientists will want to be part of a company’s next trial. Wow investors and a company buys additional life for itself. Blow away Big Pharma and find a partner.
Bottom line: Be there or perhaps cease to be.
For every Genentech Inc., the South San Francisco biotech cancer drug powerhouse, that is presenting at ASCO, there is an ACT, a 3-year-old company with an experimental stomach cancer drug that it hopes to take into a Phase III trial later this year. For every Onyx Pharmaceuticals Inc., looking to extend its Nexavar franchise into breast cancer, there’s an Exelixis Inc., which is betting its future on the power of one drug against several cancers.
Other ASCO presenters include OxiGene Inc., SciClone Pharmaceuticals Inc. and Berkeley’s Plexxikon Inc., which has teamed with Genentech and its parent, Roche, on a potential melanoma treatment.

Plexxikon, Daiichi Sankyo complete potential $935 million deal

Daiichi Sankyo Co. Ltd. completed its acquisition of Plexxikon Inc., giving shareholders $805 million upfront with the possibility of near-term milestone payments of another $130 million on Plexxikon’s potential melanoma drug.
Plexxikon will retain its name, employees and Berkeley facilities, and it will continue research and development operations as an independent unit of Tokyo-based Daiichi Sankyo.

After earthquake, tsunami, Bay Area biotechs keep close eye on Japan ties

The devastation caused by the earthquake and tsunami in Japan apparently isn’t halting the biotech wheels of commerce between Asia and the Bay Area, though companies are keeping a close eye on recovery operations.

Plexxikon starts mid-stage Hodgkin trial

Plexxikon Inc., which last week said it will be sold to Daiichi Sankyo Co. for as much as $935 million, has started treating Hodgkin lymphoma patients in a mid-stage trial.
The Berkeley biotech drug developer has drawn much attention for the late-stage melanoma-fighting drug PLX-4032, but the 30-patient Phase II trial in Hodgkin lymphoma patients is with a drug called PLX-3397.

Melanoma drug developer Plexxikon to be sold for $805M to Daiichi Sankyo

Drug company Plexxikon Inc. will be bought by Daiichi Sankyo Co. for $805 million and possible milestone payments of $130 million more.

Berkeley-based Plexxikon has a melanoma drug in late stage clinical development. It’s developing that drug, PLX4032, with partner Roche, which owns South San Francisco-based Genentech. Genentech made a deal to promote the drug with Plexxikon last year and will keep that agreement with Daiichi Sankyo if this merger goes through.

Plexxikon starts Phase I trial of rheumatoid arthritis drug

Plexxikon, Roche melanoma drug improves survival

Melanoma drug, companion diagnostic marry Plexxikon, Roche Molecular Diagnostics

Genentech, Plexxikon ink sales deal