Fran Heller to lead Bristol-Myers Squibb business development

Former Exelixis Inc. business development chief Fran Heller will join Bristol-Myers Squibb Co. as senior vice president of business development, the company said Friday.

One-on-One with biotech executive Fran Heller

Fran Heller.

Fran Heller is a hawk when it comes to finding a drug deal. Now she's passing on her knowledge of the all-important deal that often determines whether a biotech company lives or dies. On Monday, Heller started her second year of teaching a six-week continuing studies course at Stanford University on the ins-and-outs of the drug development world. Heller has assembled or participated in nearly 100 transactions during her career, including her three years as vice president of business development at South San Francisco's Exelixis Inc., which she left in July 2011. She also was head of strategic alliances at the Novartis Institute for Biomedical Research, vice president of corporate development and legal affairs at Signature BioScience Inc. and worked at Celera Genomics. I spoke with Heller about her Stanford course, called "New Drug Challenges for Biotech and Pharmaceutical Companies," and the hurdles faced by drug-development companies.

FDA takes Exelixis cancer drug off advisory group agenda, approval date stays Nov. 29

Exelixis Inc.'s experimental cancer drug cabozantinib has been removed from the agenda of a Food and Drug Administration advisory committee meeting, the company said Wednesday, but the drug's potential approval date has not changed. Cabozantinib is the first drug from South San Francisco-based Exelixis (NASDAQ: EXEL) to get to this point in the approval process, but it is unclear whether the FDA's decision to remove it from the agenda of the Nov. 8-9 Oncologic Drugs Advisory Committee meeting ultimately could delay a final FDA decision whether to approve the drug. The FDA's decision date for cabozantinib continues to be Nov. 29.

Exelixis shares fall on stock, debt offering news

Exelixis Inc. plans to offer 20 million shares and $225 million in debt, the South San Francisco biotech company said Monday. The company (NASDAQ: EXEL), which could win approval in late November for its cancer drug cabozantinib, saw its stock fall 13 percent after the news. On the day, Exelixis stock lost 73 cents, closing at $4.85 per share.

Researchers launch two cancer trials with Exelixis' 'cabo'

Exelixis CEO Michael Morrissey.

Researchers at Memorial Sloan Kettering Cancer Center and Massachusetts General Hospital have launched separate trials using Exelixis Inc.'s experimental cancer-fighting drug cabozantinib. South San Francisco-based Exelixis (NASDAQ: EXEL) said Thursday that Dr.Naiyer Rizvi, a lung cancer specialist at Memorial Sloan-Kettering Cancer Center in New York, is working on a Phase II trial in non-small cell lung cancer patients. Also, Anuj Mahindra of Massachusetts General Hospital in Boston, is conducting a pilot Phase I trial in patients with relapsed or refractory multiple myeloma.

Exelixis seeks 'cabo' approval in thyroid cancer, but big target is prostate cancer

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Exelixis Inc. believes it can finally see its future, and it’s in cabo.

Cabonzantinib, a cancer drug that potentially could target multiple forms of the deadly disease as well as tumor-related bone pain, was submitted last month for Food and Drug Administration approval for a form of thyroid cancer. The treatment, known as “cabo” for short, takes South San Francisco-based Exelixis the closest to selling a drug after 18 years and a cumulative deficit of $1.1 billion.

Stock offering nets Exelixis $65 million

Exelixis Inc. will net $65 million by selling 12.65 million shares of common stock, the South San Francisco biotech cancer drug developer said Wednesday.
The total includes 1.65 million shares that the underwriters opted to buy.

Exelixis to sell 10M shares to pay for R&D, other expenses

Cancer drug developer Exelixis Inc. plans to sell 10 million shares of common stock
The South San Francisco-based company (NASDAQ: EXEL), which has centered its drug-development efforts around the cancer-fighting drug cabozantinib, said in a Securities and Exchange Commission filing Thursday that it will use net proceeds from the offering for research and development, capital expenditures, working capital and other purposes.

Early data show kidney cancer response to Exelixis' 'cabo'

Exelixis Inc.’s experimental cancer drug cabozantinib showed promise in patients with a form of metastatic kidney cancer, according to a preliminary report from an early-stage trial.
The South San Francisco-based drug developer (NASDAQ: EXEL), which will present the findings Saturday at the 2012 Genitourinary Cancers Symposium in San Francisco, said seven of 25 heavily pretreated patients with metastatic refractory renal cell carcinoma showed at least a partial response in the Phase Ib trial.
What’s more, 19 of 21 patients in the trial showed tumor regression after at least one assessment, the company said.

Slideshow: Best Bay Area life sciences CEOs of 2011

It’s the most wonderful time of the year — slow news days that translate into “10 Best …” stories and other such lists summarizing the previous 12 months or predicting what’s going to happen during the next 12.
So, here’s my list of the best life sciences CEOs in the Bay Area. It’s a purely subjective undertaking, heavily weighted toward CEOs who managed through all or part of a year of adversity.

Exelixis reaps $12M up front in licensing deal with Merck

Merck & Co. will pay $12 million up front to license an anti-inflammatory drug program from Exelixis Inc. — a deal that ultimately could be worth up to $251 million.
The PI3K-delta program, led by the preclinical drug XL-499, targets transfer enzymes, known as kinases, that are expressed in immune system cells. When PI3K-delta is activated incorrectly, researchers believe, it contributes to inflammatory and allergic disorders, such as rheumatoid arthritis and allergic asthma.

Exelixis, National Cancer Institute strike R&D deal around cabozantinib

The National Cancer Institute will study Exelixis Inc.’s experimental cancer-fighting drug cabozantinib in a variety of solid tumors, according to a research and development deal announced Monday.
South San Francisco-based Exelixis (NASDAQ: EXEL) and the NCI’s Cancer Therapy Evaluation Program will undertake clinical trials to evaluate the safety and efficacy of the drug, known as “cabo,” in several cancers. Earlier studies found “encouraging anti-tumor activity,” according to Exelixis.

Exelixis' cabo targets breast cancer in mid-stage trial

A mid-stage trial of Exelixis Inc.’s experimental drug cabozantinib in women with breast cancer that has spread to the bone has started at the Massachusetts General Hospital Cancer Center.
South San Francisco-based Exelixis (NASDAQ: EXEL) said the main point of the 50-patient trial is to see if cabozantinib has an affect on the bone cancers. Women will receive the drug once a day and be evaluated every 12 weeks until the drug’s toxicity proves unacceptable or the cancer progresses.

Exelixis zooms past off-ramp on way to prostate cancer destination

Driving through Utah several years ago, my wife proclaimed as I missed an exit which we had planned miles back to take, “What were you thinking?”
My reply — “I wasn’t” — was all I could say.
Investors in South San Francisco-based biotech drug developer Exelixis Inc. (NASDAQ: EXEL) seemed to be asking my wife’s question. The stock lost nearly 40 percent of its value from Monday’s close to late Tuesday, trading down $3.05 to $4.68 per share.
The downturn came after Exelixis said late Monday that it would push forward on a Phase III trial of its heralded cancer-fighting medicine, cabozantinib, that focuses on relieving bone pain in men with advanced prostate cancer. These are the sickest of the sick — men whose cancerous lesions have spread to the bone and are causing excruciating pain.

On strength of Phase III data, Exelixis looks for cabozantinib submission in first-half 2012

After a strong Phase III trial of its cancer drug cabozantinib, Exelixis Inc. expects to file for approval of the drug in a type of thyroid cancer in the first half of next year.
The South San Francisco company (NASDAQ: EXEL) said cabozantinib registered progression-free survival — or the length of time it takes for a disease to worsen — a median of 11.2 months. Patients in a placebo arm had media progression-free survival of 4.0 months.

Exelixis to report important cancer trial data in Q4

Exelixis Inc. will report initial data from an important cancer trial in the fourth quarter, the company said Wednesday.
The South San Francisco drug developer said it hit a pre-set number of “events” in its Phase III trial of its drug, cabozantinib, in patients with medullary thyroid cancer.

Shrinking biotechs peddle space to deal-seekers

Sometimes the search for quality biotech real estate along the Peninsula is simply a waiting game.
As tight venture capital checkbooks, the weak economy and risk-averse capital markets continue to squeeze cash-intensive biotech companies, deals on subleases for even freshly built space can be found.
It’s the proverbial win-win for companies — one sheds costs, the other gets top-drawer space for a fraction of the market price.
Sublease deals are nothing new, but the amount of ready-to-move-in, biotech-centric sublease space is strong for companies jumping into the lease market.

Growing Threshold, Nodality sublease Exelixis space

Exelixis Inc. is unloading more than 53,000 square feet in South San Francisco to two up-and-coming companies.
Exelixis (NASDAQ: EXEL), which once had a workforce more than 600, said it will sublease 28,180 square feet at 170 Harbor Way to cancer drug maker Threshold Pharmaceuticals Inc. and 25,110 square feet in the same building to Nodality Inc., which is working on clinical tests that can predict cancer and autoimmune diseases.

Exelixis business development boss leaves company

Exelixis Inc.’s head of business development, Fran Heller, left the drug developer Monday, the company said in a Securities and Exchange Commission filing Tuesday.
The news of Heller’s departure as executive vice president of business development comes on the heels of Bristol-Myers Squibb’s decision earlier this month to return a cancer drug to Exelixis (NASDAQ: EXEL). While the company said it would not continue research on that drug, XL-218, it has concentrated on another cancer drug that BMS gave back a year ago, cabozantinib, which the company could partner with a larger drug developer.

Exelixis lands on its feet again with another cancer drug giveback

Leave it to Exelixis Inc. to (again) turn a negative into a positive.
Britol-Myers Squibb will return an early-stage cancer drug, which could have translated into $315 million in bio bucks plus sales performance milestones and double-digit royalties, to South San Francisco-based Exelixis (NASDAQ: EXEL).
Exelixis — now concentrating on cabozantinib, a drug that BMS gave back little more than a year ago — said it has no plans to further research and development or eventually commercialize the drug.
A bummer? Yeah, probably. A lost opportunity? Maybe. A total loss? No.