cancer therapies

FDA's Pazdur offers advice to cancer drug developers

Thu, 22 May 2008 06:59:54 -0400

Anyone looking for some insight into the way the FDA is examining new cancer therapies should check out the interview BusinessWeek has published with Dr. Richard Pazdur, director of the FDA's Office of Oncologic Drugs. He's looking for developers to shift paradigms, gaining a better understanding of the disease rather than focusing solely on the drug. And keep it real, he advises small biotechs.

"One of the things we have seen is a reluctance, sometimes, of smaller companies to make really critical decisions regarding their drugs, whether to curtail the development of a drug," says Pazdur. "Large companies, because they have a portfolio of drugs, generally if a drug fails to meet specified goals they'll look to abandon that drug--i.e., cut their losses. Whereas as a smaller company, if you only have one drug, then sometimes that is not an option."

- read the Q&A in BusinessWeek

Related Article:
FDA's Pazdur in the middle of intense debate

Pfizer gets new cancer team to advance key drugs

Thu, 15 May 2008 06:59:56 -0400

With the clock ticking on its patent for Lipitor, Pfizer has turned to a group of new executives to lead the company to the promised land of new cancer therapies.

Garry Nicholson, a 30-year Eli Lilly vet, will be responsible for overseeing every aspect of Pfizer's new oncology programs, from the first clinical trial to marketing, notes Forbes. Neil Gibson, formerly chief scientific officer at biotech OSI Pharmaceuticals, has been brought in to direct oncology research. And Briggs Morrison, who was able to speed clinical trials at Merck, has been brought in to do trial design.

"It's an exceptional situation," says Nicholson. "And for someone like me, who is in the business to get as many cancer drugs that extend survival to patients as possible, it is the best situation that I know of."

Pfizer needs all the help it can get. The drug giant is likely to lose 25 percent of its current revenue to generic competition for Lipitor.

- see Pfizer's statement on Nicholson's appointment
- read the article from Forbes

Report: Wilex, GPC nearing merger pact

Wed, 07 May 2008 06:59:58 -0400

Two German biotech companies which share a very big investor are preparing to merge, according to a prominent German newspaper. Wilex and GPC Biotech, both involved in developing new cancer therapies, are each backed by SAP founder Dietmar Hopp. Analysts say that a merger would suit both biotechs. GPC is well funded but doesn't have the late-stage therapeutics that investors love, while Wilex has a compelling late-stage project for kidney cancer. GPC's satraplatin recently failed in a clinical trial, adding to its motivation to merge.

The companies, though, aren't talking about any of it. Complicating the rumors: A third Hopp-based biotech--Heidelberg Pharma--has also been touted as a potential partner for GPC and Wilex. Hopp owns 15 percent of GPC, 28.52 percent of Wilex and 75 percent of Heidelberg. Wilex was a 2005 Fierce 15 company.

Just days ago GPC announced a new round of layoffs, with some of its top execs headed out the door.

- read the AFX report

Takeda makes $8.8B bid for Millennium

John Carroll — Thu, 10 Apr 2008 08:51:20 -0400

Looking to expand out of a budget-bound Japanese market, Takeda is taking a big chunk of its $10 billion war chest and offering $8.8 billion in cash for U.S.-based Millennium Pharmaceuticals. The $25 per share offer is a 65 percent premium over Wednesday's close. Millennium is best known for the cancer drug Velcade, which Takeda is looking to turn into a global blockbuster. That would go a long way toward overcoming the looming patent expirations for Actos and Prevacid.

Recently Takeda and Abbott split up their long-time drug development partnership. That move boosted Takeda to the 14th largest drug company in the world, but investors have been fretting over the absence of a big takeover. Millennium has more than a half billion dollars in revenue last year and also has a number of inflammation and cancer therapies in the pipeline, which would also address Takeda's interest in oncology.

"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda Pharmaceutical Company Limited.

- here's the release
- see this article from Forbes

Millinneum News:
Millennium chief scientist takes offbeat approach
Millennium spent $1.3M on lobbying
Positive Velcade data fuels stock rise
Analysts tag Velcade as blockbuster

Takeda News:
Amgen, Takeda ink massive development deals
Takeda expands R&D budget, may look for buyout.
Safety, efficacy problems sink Takeda drug
Cell Genesys scores $320M blockbuster deal with Takeda

Takeda makes $8.8B bid for Millennium

Thu, 10 Apr 2008 06:59:58 -0400

Recently Takeda and Abbott split up their long-time drug development partnership. That move boosted Takeda to the fourteenth largest drug company in the world, but investors have been fretting over the absence of a big takeover. Millennium has more than a half billion dollars in revenue last year and also has a number of inflammation and cancer therapies in the pipeline, which would also address Takeda's interest in oncology. "Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda.

- here's the release
- check out the report from Forbes

Related Articles:
Millennium chief scientist takes offbeat approach
Positive Velcade data fuels stock rise
Analysts tag Velcade as blockbuster
Amgen, Takeda ink massive development deals
Takeda expands R&D budget, may look for buyout.
Cell Genesys scores $320M blockbuster deal with Takeda

ALSO NOTED: Crucell shares up on TB data; Celera, Merck ink cancer deal; and much more...

Thu, 10 Apr 2008 06:59:50 -0400

> A federal patent office may appeal a court ruling that threw out a new cap limiting the number of times a company can resubmit patent applications. That change was aggressively contested by the biopharma industry. Story

> Shares of Crucell jumped after the developer announced that an early-stage trial of an experimental tuberculosis vaccine demonstrated a promising immune response in volunteers. Report

> Celera has granted Merck a two-year license covering access to up to 10 cancer therapies. Release

> Bausch & Lomb has forged a deal to license select Galapagos compounds as development candidates for therapeutic uses in ophthalmic diseases. Release

> Rep. Henry Waxman and 26 of his Congressional counterparts are wading into the compulsory licensing fray. Report

> Roche is appealing to a higher power on Mircera. Report

> What does Exubera's possible cancer link teach us about drug safety? Report

And Finally... Fuzzy-headed today? Then pop a pill. Professionals of all kinds are doing it these days, according to a survey taken by Nature. Report

Boehringer boasts of late-stage drug potential

Tue, 08 Apr 2008 06:59:56 -0400

A new self-assessment from Boehringer Ingelheim comes with some considerable boasting about the potential for new therapies and new indications now in its pipeline. Pradaxa was recently approved for venous thromboembolism and four other indications are currently in the clinic. Late-stage trials are underway for two experimental cancer therapies, a substance for diabetes type II, and one substance in development for pre-menopausal women with hypoactive sexual desire disorder. R&D spending jumped about 10 percent last year to €1.7 billion.

"We are very optimistic as our financial basis is sound and our prospects are encouraging," says a supremely confident Boehringer Chairman Dr Alessandro Banchi. "And with the forthcoming new product launches and our products in the pipeline, we have once again proved our company's power of innovation and potential for success."

- check out the press release

Related Articles:
Boehringer wins approval in anti-clotting drug race. Report
Boehringer anti-clotting drug performs in Phase III. Report
Pfizer, BMS report Phase II clotting trial success. Report

Pfizer halts Phase III cancer trial on poor results

Wed, 02 Apr 2008 07:59:58 -0400

Pfizer's big push into cancer drugs has hit a snag. The company announced that it is halting a late-stage trial of tremelimumab for advanced melanoma after researchers concluded it was no more effective than standard chemotherapy. More data from the clinical development of the drug will be revealed at the annual ASCO meeting in June. The move to shutter the trial follows Pfizer's decision to beef up its R&D spend on cancer therapies from 12 percent of its budget to 20 percent. And Pfizer has every intention of staying focused on the field as well as tremelimumab.

"Although this outcome is disappointing, Pfizer remains committed to investigating new treatment options for patients with melanoma, a high-risk area of research with significant unmet medical need," said Dr. Charles Baum of Pfizer Global Research and Development. "We continue to focus on additional studies involving tremelimumab alone and in combination with other therapies which are currently ongoing in patients with several types of cancer."

- see Pfizer's release
- read the report in the Wall Street Journal

ALSO: The news from Pfizer stung at Medarex after analysts concluded that a failure for tremelimumab also spelled trouble for another partnership it has with BMS to develop ipilimumab. Its stock dropped 14 percent. Report

Related Articles:
Pfizer seeks salvation in late-stage biotherapeutics. Report
Is Pfizer's CEO as bold as promised? Report
A look inside Pfizer's biotech center. Report
Pfizer hires new R&D chief, launches biotech center. Report
Speculation soars over Pfizer's interest in biotech. Report

SGX shares slide on report of early-stage toxicity

Thu, 27 Mar 2008 07:59:58 -0400

Shares of SGX Pharmaceuticals were sliding this morning on the news that its lead cancer therapy produced unexpected dose-limiting levels of toxicity in early-stage trials. The company said that it was surprised by the toxicity in SGX523 after a careful evaluation of animal data revealed no such tendency. And company officials carefully noted that they're examining other dosing regimens while pursuing the development of additional cancer therapies in its pipeline.

Patients in a low-dose trial of SGX523 involving solid tumors continue to be treated while no further dosing is being provided in an interrupted dosing trial--a repeating 21 day cycle of 14 days on therapy followed by 7 days off.

"From the initial clinical data, the profile of SGX523 appears to be different than the preclinical data would suggest," said Mike Grey, president and chief executive officer of SGX Pharmaceuticals. "We may explore whether alternative doses and schedules are safe and efficacious. We continue the preclinical development of the BCR-ABL inhibitor SGX393 and the second MET inhibitor SGX126. In addition, we are targeting the identification of two development candidates this year from our drug discovery programs to further enhance our pipeline."

- check out the press release

Related Articles:
SGX Pharmaceuticals--Best Pharma Stocks of 2007. Report
SGX Initiates Phase I Trials for SGX523. Report
SGX shares tank on late-stage trial failure. Report

Kosan axes staffers (again), scouts for partners

Wed, 19 Mar 2008 07:59:57 -0400

Kosan Biosciences is laying off more than a third of its 91 workers as the developer concentrates its resources around its lead cancer therapies in a restructuring that has also shuffled its newly appointed president into the CEO's post. Altogether 31 workers are being pink slipped, and Kosan says it may seek out partners among developers looking for early-stage prospects. This isn't the first cutback at Kosan. A year ago the Hayward, CA-based developer slashed 39 jobs and reduced its payroll to 80.

"We believe that this restructuring will strengthen our ability to effectively manage our resources, execute on our development goals and advance our high-value, near-term commercial opportunities," said Helen Kim, the new CEO. Kim joined Kosan as a senior VP in January and was named president last month.

Kosan will circle the wagons around its lead clinical programs: tanespimycin in multiple myeloma and in metastatic breast cancer, and epothilone KOS-1584 in non-small lung cancer.

- read Kosan's release for more
- check out the report from the East Bay Business Journal

Related Article:
Roche drops out of Kosan development deal. Report