Herceptin

Invitrogen gets breast cancer test approval

Maureen Martino — Wed, 09 Jul 2008 12:19:31 -0400

Invitrogen has won FDA approval of a test that can determine whether a woman with breast cancer will benefit from Genentech's Herceptin. The SPOT-Light test, as it is known, uses a DNA probe for the HER2 gene, which is amplified in 18 to 30 percent of breast cancers and can predict whether a patient will benefit from Herceptin. While a test is already available for Herceptin, many smaller hospitals don't have the resources to process the tests. Invitrogen's SPOT-Light doesn't require specialized equipment and can be processed in most hospital labs.

"Given the emerging potential use of trastuzumab (Herceptin) in the adjuvant setting, the need to accurately determine the front-line HER2 status in breast cancer has never been more critical," said Jeffrey Ross, M.D., of Albany Medical College. Invitrogen's test is yet another step in the direciton of personalized medicine. Such tests allow physicians to choose the right treatment for patients and save money by not giving the expensive drug to patients who won't benefit from it.

- check out Invitrogen's release
- read the Sign on San Diego article for more

SPOTLIGHT: Pertuzumab slows breast cancer in study

Fri, 30 May 2008 06:59:53 -0400

Roche announced that a combination of Herceptin and pertuzumab slowed the spread of breast cancer. Pertuzumab is the first in a new class of agents known as HER dimerization inhibitors. HDIs block the ability of the HER2 receptor to collaborate with other HER receptor family members. Report

Daiichi snares Germany's U3 in $235M acquisition

Wed, 21 May 2008 06:59:58 -0400

Daiichi Sankyo is buying Germany's U3 Pharma for $235 million in cash. The Japanese pharma company gains a developer that's been winning kudos for its work developing antibodies to fight a variety of cancers. And its lead program is bound for the clinic later this year.

Edmond de Rothschild Investment Partners has been backing U3 since 2003, when it was won over by the research work of Axel Ullrich of the Max Planck Institute. Ullrich's research has helped create such cancer blockbusters as Herceptin and Sutent.

"Our acquisition of U3 Pharma is an ideal strategic fit for our oncology portfolio," said Takashi Shoda, president and CEO of Daiichi Sankyo. "We currently have three human monoclonal antibodies in development. Additionally, in March, 2008, we announced that we were expanding our joint research venture with another German company, MorphoSys, for its advanced Human Combinatorial Antibody Library and its phage display technologies."

- check out the press release
- read the AFX report

MAbs are hottest segment of biotech industry

Fri, 12 Oct 2007 06:59:57 -0400

Looking for the hottest segment of the biotech industry? Then take a look at monoclonal antibodies (mAbs). A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. That's by far the fastest-growing segment of the industry. MAbs currently generate global revenues of around $20 billion and include such blockbusters as Avastin, Herceptin, Remicade, Rituxan, Humira and Erbitux.

A major revolution in the mAb market came when drug developers moved away from murine (mouse) antibodies to partially or fully humanized antibodies, which are safer and more effective and allowed mAbs to gain wider usage among patients. And many current mAb therapies are effective for a large number of diseases, making them even more attractive to drug developers.

- check out the Datamonitor report for more

Related Articles:
FDA approves Rituxan for rheumatoid arthritis. Report
FDA approves Avastin for lung cancer. Report
Remicade approved for psoriatic arthritis. Report
FDA approves expanded use of Humira. Report
Erbitux clears late-stage hurdle for lung cancer. Report

ALSO NOTED: FDA approves antibody; Nastech to raise $42M; MGI publishes data; and much more...

Wed, 17 Jan 2007 19:01:30 -0500

> Archemix is gaining up to $10 million up front in fees and research funds in a new collaboration pact to develop aptamer cancer therapies with Germany's Merck KGaA. Archemix concentrates on aptamers, strings of nucleic acid that bind to proteins and disrupt the progression of disease. "This is the fourth major partnership we have formed over the past six months and is consistent with our strategy to enable partners to leverage aptamers as drugs on a target-by-target basis," Archemix chief executive Errol De Souza said in a statement. Release

> The FDA has approved Ventana Medical Systems' monoclonal antibody for assessing breast cancer patients' likelihood of responding to Herceptin. Report

> Nastech Pharmaceutical says it expects to raise $42.9 million through a public offering of 3.25 million shares. Release

> NiCox has gained a €5 million milestone from Merck for their work in the antihypertensive field. Release

> MGI has published Phase III data for Saforis, its treatment for the prevention of oral mucositis in patients receiving mucotoxic cancer therapy. Release

> Whatman has replaced CEO Bill Emhiser with Kieran Murphy after experiencing disappointing results. Report

> Researchers at the Roslin BioCentre in Scotland have advanced a program to use transgenic chickens to create new drugs for a variety of ailments. Report

> Abnormalities in the SORL1 gene have been linked to Alzheimer's in what is being billed as a major advance in understanding the origins of the memory-wasting disease. Report

And Finally... New research indicates that the blockbuster ED treatment sildenafil citrate may increase nasal congestion, impairing the ability to smell. Report

Genentech hiring researchers in big R&D push

Tue, 09 Jan 2007 19:01:36 -0500

Genentech appears poised to announce 70 percent revenue growth for 2006, a monumental increase for a company that started out 30 years ago as a small biotech operation. The huge growth is due to new sales of Lucentis with expanding markets for Avastin, Rituxan and Herceptin. But with its pipeline of new drug prospects growing thin, the focus at Genentech now is beefing up its R&D efforts. Execs say they're hiring new researchers as fast as they can to go to work on a new generation of biologics. Analysts worry that the spectacular growth will have to soon flag as revenue growth begins to settle in at a more measured pace.

- read the article on Genentech's strategy from The Wall Street Journal (sub. req.)

Related Articles:
Genentech strikes $919M deal to buy Tanox. Report
Genentech inks $300M pact with Swiss biotech. Report

ALSO NOTED: Semaphore closes $9.5M round; VaxGen looks to refocus; BioCryst wins $102M contract; and much more...

Thu, 04 Jan 2007 19:01:30 -0500

> Indianapolis-based Semafore Pharmaceuticals has completed a $9.5 million second round of venture financing. Much of the money will be used to advance Semafore's clinical program for SF1126, its lead PI3 Kinase inhibitor for the treatment of cancer. "This is an exciting time for Semafore, as we prepare to initiate Phase l clinical trials of our lead PI3 Kinase inhibitor SF1126 and transition into a clinical stage company," said John Sima, interim CEO and COO of Semafore. Release

> Fresh from losing a big contract for an anthrax vaccine, speculation is heating up about how VaxGen will restructure. The company got a $51 million boost from the sale of its Celltrion stock. Report

> BioCryst has won a $102 million contract from the U.S. government to develop peramivir as a therapy against seasonal and avian flu. Report

> A new study has provided data that shows that Herceptin combined with chemotherapy after surgery for breast cancer improves the chance of surviving three years after treatment. Report

> Enzon Pharmaceuticals has submitted an INDA to the FDA for its HIF-1alpha (hypoxia-inducible factor 1alpha) antagonist. Release

> Software-maker Accelrys is closing its R&D center in Bangalore, India and laying off 60 workers. Report

> MediciNova has established a subsidiary in Japan. Release

> Chutes & Ladders: Xytis Pharmaceuticals has named Vincent F. Simmon, Ph.D., president and CEO. Release

> Scientists at Taiwan University have developed a five-gene test that can help illuminate which lung cancer patients are likely to benefit from chemotherapy. Report

And Finally... Government plans to prevent the creation for animal-human embryos has attracted criticism from the country's scientific community. Article

ALSO NOTED: Europe expands Synvisc approval; FDA issues "approvable" letter for paliperidone; and much more...

Sun, 01 Oct 2006 20:01:30 -0400

> European regulators have agreed to expand the approval of Genzyme's Synvisc to include osteoarthritis of the ankle and shoulder. Report

> J&J says its subsidiary has received an approvable letter from the FDA for paliperidone as a therapy for schizophrenia. But the drug maker did not say what issues were still left to be resolved. Report

> Antisoma says its aptamer therapy AS1411 produced positive Phase I data in a cancer trial. Report

> Acambis has sold Berna Products--which distributes an oral typhoid vaccine in North America--to Crucell for $16.5 million. Report

> Accentia Biopharmaceuticals has gained $25 million in debenture financing. Report

> A combinational therapy of Herceptin and hormonal treatments extended progression-free survival of a certain group of women with advanced breast cancer. Report

> Roche announced that Phase II data supported the combination of Xeloda with Herceptin and Taxotere for breast cancer. Report

> Novartis says that new four-year data for Femara indicates a reduced rate of risk for a recurrence of breast cancer compared with the standard therapy Tamoxifen. Report

> The FDA has expanded the approved use of Rituxan. Report

And Finally… Two American scientists, Andrew Z. Fire and Craig C. Mello, won the Nobel prize for medicine for their work in RNA interference. Article

SPOTLIGHT: JCO warns on radiation, Herceptin

Mon, 14 Aug 2006 20:01:33 -0400

Researched being published today in the Journal of Clinical Oncology warns that Herceptin and radiation--both common breast cancer treatments--can cause heart problems. But the researchers also say the problems are treatable and that women shouldn't avoid the therapies if they are necessary. Article

ALSO NOTED: Biogen says safety first, efficacy second; Roche chief unconcerned by Tykerb; and much more...

Mon, 19 Jun 2006 20:00:50 -0400

> A top executive for Biogen Idec says developers should place a greater emphasis on safety than effectiveness. Article

> Roche's pharmaceutical chief says he isn't concerned by the prospect of new competition for Herceptin from GSK's Tykerb. Report

> Shares of Avanir were depressed by the news that the FDA will extend its review period for Neurodex by 90 days. Report

> Chutes & Ladders: Transave of Monmouth Junction, NJ Timothy G. Whitten as president and CEO. Release

> Sanofi-Aventis has seen a drop of 25 percent in French drug sales as the result of government cost-cutting efforts in Europe. Report

> EMD Pharmaceuticals has submitted an NDA for Cyanokit to the FDA. Release

And Finally… A new study shows how people's perspectives on vaccinations shift as they adopt different roles in the healthcare system, with actions ranging widely in the switch from patient to medical director. Article

ALSO NOTED: Aphton files for bankruptcy; Akorn wins FDA OK; and much more...

Tue, 23 May 2006 20:00:50 -0400

> Philadelphia-based Aphton has filed for bankruptcy. The company is looking for offers to buy its assets. Report

> Akorn shares were on the rise after reporting FDA approval of an ANDA for Orphenadrine Citrate Injection. Report

> Wyeth has developed a new contraceptive from traditional therapies that eliminates a woman's monthly periods. Report (WSJ sub. req.)

> Progenics announced positive results from a Phase III trial of a subcutaneous form of the investigational drug methylnaltrexone for treatment of opioid-induced constipation in cancer and cardio vascular disease patients. Report

> In a clear signal of a looming drug price war, Novartis reportedly has plans to slash the cost of a range of generics in Germany and Switzerland. Report

> Actelion announced that new data provides solid grounds to explore Tracleer as a therapy for idiopathic pulmonary fibrosis. Report

> Wyeth has received final judicial clearance for its revised fen-phen settlement agreement. Report

> Roche expects the UK to issue a license for the early use of Herceptin in breast cancer. Report

> Ranbaxy says three of its AIDS drugs have been added to the WHO list of approved pharmaceuticals for developing countries. Report

> Chimerix has acquired Dr. Leroy Townsend's lifetime library of chemical lead compounds from the University of Michigan. Release

And Finally… A large new cancer trial sponsored by the National Cancer Institute will use genetic profiling to determine which women are likely to benefit from chemotherapy. Article

ALSO NOTED: Study finds for-profit bias; TorreyPines gets positive data in Phase I; and much more...

Tue, 16 May 2006 20:00:50 -0400

> A new study concludes that clinical trials funded by drug companies are more likely to lead to positive results than trials funded by not-for-profit groups. Report

> TorryPines says its Phase I trial for its therapeutic candidate for acute migraines has produced positive data. Report

> Cambridge, MA-based Vertex has launched a Phase I trial of VX-770 as a therapy for cystic fibrosis. Report

> Amarin has acquired global rights to a novel oral formulation of apomorphine for the treatment of "off" episodes in patients with advanced Parkinson's disease. Release

> Genentech will collaborate with Immunogen to develop a manufacturing process for Herceptin. Release

> Intercept Pharmaceuticals has garnered $41 million in equity financing. The financing was led by Milan-based Genextra. Release

> PrimeGen Biotech has created a wholly owned subsidiary--PrimeCell Therapeutics. Release

And Finally… Indonesia has reported five more deaths from bird flu. Article

ALSO NOTED: PerkinElmer buys Spectral Genomics; Europe OKs early use of Herceptin; and much more...

Mon, 01 May 2006 20:00:50 -0400

> PerkinElmer has acquired the screening and diagnostics company Spectral Genomics for an undisclosed amount. Report

> European regulators have backed a request to make Herceptin available for early-stage use against breast cancer, a move that is likely to significantly increase sales while adding new cost pressures to government health agencies. In the U.S., the FDA is giving the application for early use a priority review. Herceptin is sold by Genentech and Roche. Article (WSJ sub. req.)

> Efforts to provide $150 million in state support for the biosciences are running into resistance in Arizona's legislature. Report

> Chemokine has begun a Phase Ib/II trial of its cancer therapy CTCE-9908. Report

> Novocell has hired Alan Lewis as president and CEO. Report

> The FDA will accept Critical Therapeutics' NDA for a time-controlled release version of zileutin. Report

> Tanox has released 48-week results for its HIV drug TNX-355. Report

> Telik has begun a Phase III trial of a combination of Telcyta and Doxil for ovarian cancer. Release

And Finally… A federal plan to deal with a bird flu pandemic is scheduled for release tomorrow, with recommendations for quarantining patients, keeping workers three feet apart and providing surgical masks to sick airline passengers. Article

ALSO NOTED: Bayer ups Schering bid; Antibiotic may work against serious asthma attack; and much more...

Wed, 12 Apr 2006 20:00:50 -0400

> Bayer slightly upped its official bid for Germany's Schering, offering $20.01 billion. Schering's board has recommended the offer. Report

> Researchers say the antibiotic telithromycin, usually used to treat sinusitis, may also help people deal with serious asthma attacks. Report

> Pharmacopeia Drug Discovery will gain a milestone on Schering-Plough's decision to develop one of its compounds for respiratory illness. Report

> Fisher Scientific International is buying Clintrak Pharmaceutical Services for $125 million. Clintrak provides clinical trial printing services. Report

> Edinburgh-based Ardana says that its cream for testosterone deficiency passed a mid-stage trial with 42 patients. Article

> Novacea has launched a Phase III trial for its cancer therapy DN-101. Release

> Chutes & Ladders: ArQule CFO Louise Mahoney is leaving, but plans to stay on until her successor has been named. Report

And Finally… A British court ruling may clear the way for hundreds of women to obtain the breast-cancer therapy Herceptin. Article

Roche files for expanded use of Herceptin

Thu, 16 Feb 2006 19:01:38 -0500

Roche has filed to expand the use of Herceptin in the European Union to include early stage breast cancer. Two days ago, Genentech filed for FDA approval of the same indication. Researchers will rely on data that indicates that Herceptin reduced the chances of cancer relapse by 46 percent when the disease had not spread beyond the breast or into the lymph nodes. The drug has been a pioneer for combining a therapy with a diagnostic test, which identifies about one in four women who can benefit from the drug.

- here's the AP report

Genentech wears crown in drug development

Thu, 22 Dec 2005 19:01:36 -0500

The summer session of the American Society of Clinical Oncology placed the crown of premier drug developer on the corporate head of Genentech. The world's No. 2 biotech company dominated the news from Orlando with a series of startling trial developments in new drugs. "It's what you live for," exulted Susan Desmond-Hellman, president of product development.

Among the highlights: Tarceva made history as Genentech unveiled a series of trials that showed its effectiveness against different cancers. In 2005, Rituxan advanced, Lucentis demonstrated its effectiveness against blindness and late-stage Herceptin data showed its effectiveness against breast cancer.

Genentech's work demonstrated that a single biotech company could successfully push a host of new drug trials and significantly advance the frontiers of medicine. This year has laid the groundwork for even more advances in the years to come with a host of new collaborations and new trials. Genentech has every reason to view 2005 as an unqualified triumph. It's a victory--or a series of victories--that sheds a positive light on what biotechnology is capable of achieving. Genentech's story has helped clarify the major role that biologics will play in the research and development of new therapies.

ALSO NOTED: Hana BioSciences raises $14.7M;CepTor wins $1.5M milestone; Herceptin wins raves; and much more...

Wed, 19 Oct 2005 20:00:50 -0400

> South San Francisco-based Hana Biosciences has raised $14.7 million through a private placement. Release

> CepTor has pocketed a $1.5 million milestone payment from JCR Pharmaceuticals after the Japanese company filed an Investigational New Drug application for Myodur (C-101) in muscular dystrophy. Release

> Genentech's Herceptin is attracting widespread attention for the remarkable benefits it has demonstrated against breast cancer. Report

> The Senate has approved a bill to stop using Medicare and Medicaid money for Viagra. Article

> Connetics of Palo Alto, CA, has filed a patent infringement lawsuit against Agis Industries in response to Agis' submission of an abbreviated new drug application for a generic version of clobetasol propionate foam. Release

And Finally... The use of sleeping pills by children and very young adults surged 85 percent between 2000 and 2004. Report

ALSO NOTED: Genaera touts Phase II results; Genentech reports big increase in profits; Predicant lines up debt financing; and m

Mon, 10 Oct 2005 20:00:50 -0400

> Genaera reported that a Phase II trial of Evizon with Visudyne demonstrated its safety and vision stabilization for patients with wet, age-related macular degeneration. Release

> The phenomenal success of Avastin and Herceptin for cancer has helped swell Genentech's quarterly net income by 56 percent. Article

> Predicant Biosciences has lined up $7.5 million of debt financing from Hercules Technology Growth Capital. Release

> Boston-based Surface Logix said that an early-stage trial of SLx-2101 for sexual dysfunction shows it was safe and well tolerated and demonstrated signs of pharmacokinetic activity. Release

And Finally… Although still relatively rare in the US, the incidence of liver cancer is rising fast. Article

ALSO NOTED: Adams Respiratory sets IPO price; Parexel buys QdotPharma; Amrad gains patent; BioAlliance prepares for Phase III;

Wed, 20 Jul 2005 20:00:50 -0400

> Adams Respiratory Therapeutics has priced its IPO at $17 per share. Release

> Parexel has acquired QdotPharma -- a Phase I and IIa proof of concept business in South Africa -- for $6 million. Release

> Drug discovery company Amrad has been granted a US patent for therapeutic antibodies that could potentially be used to treat asthma and other respiratory diseases. The Melbourne, Australia-based biotech has been working for two years with Merck to develop the antibodies; the patent approval is a key milestone in the deal, estimated to be worth $112 million excluding royalties. Story

> BioAlliance Pharma has applied with the FDA to conduct a Phase III trial of its anti-fungal agent, miconazole Lauriad, an extended-release tablet intended to treat oral candidiasis. Such infections are common among immunocompromised patients. Pending FDA clearance, the company plans to start the trial in the fourth quarter. Miconazole Lauriad is its lead drug. Release

> The FDA put on hold CytRx's planned Phase II trial of ALS treatment arimoclomol, pending review of additional information provided by the company. Release

> Indian drug maker Ranbaxy Laboratories won tentative approval from the FDA to manufacture and market its anti-diabetes drug, Glimepiride, in the US. Full agency approval could come by October. The drug is designed to lower blood glucose in patients with Type II diabetes. Story

> The British health secretary put Herceptin on regulatory fast track for use in patients with early-stage breast cancer. The drug is already used in women with advanced disease. Report

> Danish partners invested €5 million in Avesta Nordic Research, which is developing treatments for osteoporosis and related bone disorders. Story

> Aphton is enrolling patients in a new Phase I/II trial of its pipeline compound IGN311, a monoclonal antibody intended for use against epithelial cancers. Release

> APT Pharmaceuticals raised $6 million in venture capital to fund a Phase II clinical trial of its lead compound, an inhaled version of hydroxychloroquine (HCQ), for the treatment of asthma. Release

> Oncolytics Biotech wins a second European patent for its method of producing infectious mammalian reovirus, intended as a potential cancer therapeutic. Release

And Finally... The plaintiff's lawyer in the first Vioxx trial scored new points in the case, showing a training video for sales reps which tells them to tell doctors that the drug was not linked to higher rates of heart attacks and sidestepping a question on higher blood pressure. Story

C&L: North tapped to run Inimex

Tue, 07 Jun 2005 20:01:32 -0400

Vancouver-based Inimex Pharmaceuticals has appointed Dr. John R. North as president, CEO and director. Dr. North was executive vice president of R&D at Inimex for the past year. From 1998 until 2003, Dr. North served as chief scientific officer at QLT.

Altus Pharmaceuticals has named Sheldon Berkle president and CEO and a member of the board of directors. Berkle was most recently executive vice president of Boehringer Ingelheim Pharmaceuticals.

Novasite Pharmaceuticals has named Tim Harris president and CEO. Dr. Harris was most recently CEO of Structural GenomiX.

John C. Hodgman has joined Aerogen as president and CEO. Jane E. Shaw, PhD, has resigned as CEO and effective June 30 will resign as chairman of the board; as of that time, Jean-Jacques Bienaime will become Lead Director of Aerogen.

GammaCan International announced that Vered Caplan, formerly the company's director of business development, has been appointed to serve as acting CEO. Dr. Dan Gelvan has resigned from his position as CEO.

Aphton has appointed Manfred Ruediger, PhD, to the newly created position of executive vice president and COO. Dr. Ruediger served as CEO and managing board member of Igeneon.

Midlothian Laboratories announced that Jim Harwick has been named co-president, effective immediately. He will work with Bryce Harvey, co-president of Midlothian, to oversee all aspects of the business. Harwick most recently served as senior vice president of finance at ProEthic Pharmaceuticals.

Ingenium Pharmaceuticals has appointed Michael Grau, Dipl. Betriebswirt, MBA, to the position of CFO. Grau joins Ingenium from Morphosys, where he was senior director finance and accounting.

Micromet welcomes Carsten Reinhardt, MD, PhD, as its new senior vice president, clinical development. Dr Reinhardt joins Micromet from Roche, where he was the International Medical Leader for the Herceptin Program.

Pharmacyclics has hired Geoffrey Cooper, PhD, as senior vice president, business development. Dr. Cooper joins Pharmacyclics from OSI Pharmaceuticals, where he was vice president of corporate development.

VaxGen has accepted the resignation of James M. Cunha, CFO. Kevin C. Lee, a certified public accountant with more than 20 years of experience in finance and VaxGen's senior director of finance, has been named acting CFO.

Arginox Pharmaceuticals has appointed David R. Hathaway, MD, as chief medical officer. Dr. Hathaway has held senior executive positions at Restoragen, a development-stage biotechnology company focused on peptide hormones, and was a consultant to Amylin Pharmaceuticals after its acquisition of Restoragen.

Thomas R. Beck, MD, has joined Dyax as executive vice president, business and product development. Dr. Beck has held an interim management role at Dyax since early this year.

Sylvia McBrinn has been appointed senior VP to head and establish Vernalis US commercial activities.

Cellegy Pharmaceuticals has appointed Frank J. Malinoski, MD, PhD, as vice president, research and development of its Women's Health Operation. Most recently, Dr. Malinoski held positions of increasing responsibility with Wyeth Pharmaceuticals.

Pacific Biometrics hired John Jensen as its new controller. Jensen joins PBI from Utility, where he served as controller and vice president of operations and oversaw strategic planning and finance.

ImpactRx announced two executive appointments: Michael S. Hunt joins ImpactRx as a member of the board of directors and Beth Everett is the company's new CIO.

ProEthic Pharmaceuticals has promoted Wes Heaton, its former national sales director, to director of operations.

Stellar Pharmaceuticals has nominated Robert H. Kayser for election to the company's board of directors.

Eximias Pharmaceutical has appointed Dr. Ruedi E. Waeger, most recently president and CEO of Aventis Behring, to its board of directors.

David R. Bethune has been elected to the Cambrex board of directors.

Frank J. Ryan has been elected to the board of directors of Digene.

Predix Pharmaceuticals has appointed Ian F. Smith to its board of directors.

Reata Pharmaceuticals announced that Charles A. Sanders, MD, has been named to the company's board of directors. Dr. Sanders is the former chairman and CEO of Glaxo.

TranXenoGen announced the resignation of George Uveges as a non-executive director.