cervical cancer

ALSO NOTED: GSK releases new Cervarix data; FDA mulls DTC ads; and much more...

Fri, 16 May 2008 06:59:50 -0400

> GlaxoSmithKline has released new Cervarix data that demonstrates the vaccine's ability to generate a high and sustained level of antibodies to neutralize the two most prevalent strains of cervical cancer for up to 6.4 years. Cervarix report

> The French pharma industry worries that up to 32,000 jobs are fodder for the axe, citing pricing pressures, generics, and globalization among the threats to drugmakers. Report

> Brace yourselves: An FDA advisory committee meets today to hash over the possibility of putting a side-effects hotline number in every DTC television commercial. Release

And Finally... The five key vaccine makers say they plan to produce a record 143 million doses of flu vaccine for the U.S. market next season, which should be enough to satisfy demand. Vaccine report

SPOTLIGHT: Sysmex, Matritech end pact

Fri, 28 Sep 2007 06:59:53 -0400

Sysmex and Matritech have dissolved a 2002 agreement under which Sysmex was granted a license for the use of Matritech's NMP 179 cervical cancer technology. Matritech, which is focused on point-of-care diagnostic tests, was recently acquired by Inverness Medical Innovations. Release

ALSO NOTED: New constipation data; GSK touts Cervarix study; Spherix transitions to biotech; and much more...

Thu, 28 Jun 2007 00:01:30 -0400

> Wyeth and Progenics say that a three-month extended study of their constipation therapy produced positive data. Release

> GlaxoSmithKline says that the biggest study yet has produced impressive data on the effectiveness of Cervarix in preventing cervical cancer. It will need plenty of powerful data if it intends to grab market share from Gardasil. Release

> Spherix is transitioning to a full-fledged biotech company with the $17 million sale of its subsidiary to Active Network. Report

> StemCells has agreed to a stay on its patent lawsuit with Neuralstem. Report

And Finally... With billions of dollars of revenue on the line, Amgen is asking Congress not to make "precipitate changes" in the way that the government reimburses for anemia drugs. Report

Press Release: GlaxoSmithKline initiates head-to-head study of cervical cancer vaccines

Maureen Martino — Thu, 18 Jan 2007 13:54:50 -0500

GlaxoSmithKline initiates head-to-head study of cervical cancer vaccines

Study to compare immunogencity of GSK’s cervical cancer candidate vaccine, CERVARIX® , to Merck’s Gardasil®

London, UK & Philadelphia, PA - GlaxoSmithKline announced today the initiation of the first study of its kind designed to compare the immunogenicity of its cervical cancer candidate vaccine, CERVARIX®, versus Gardasil®. The primary objective of the head-to-head trial is to compare the immune responses to HPV types 16 and 18 in U.S. women 18 to 26-years-old. Secondary objectives include evaluating the immune responses to HPV 16 and 18 in women 27 to 35-years-old and 36 to 45-years-old. In addition, the study will compare immune responses to other cancer-causing HPV types. Initial study results are anticipated 12 months after studyenrollmentis completed, and extended follow up will continue for another 17 months.

"Vaccination to prevent cervical cancer may be the most significant healthcare breakthrough for women in our lifetime,” said Dr. Mark M. Blatter, Medical Director of Primary Physicians Research in Pittsburgh, PAand study investigator. “This unprecedented trial, which willenrollmore than 1,000 women,will provide the first scientific evidence to demonstrate how the two vaccines differ with respect to inducing strong and sustained immune responses in women who may be appropriate for vaccination.”

Data published in Vaccine in August 2006 demonstrated GSK’s cervical candidate vaccine, formulated with the proprietary adjuvant system AS04, induced higher antibody levels and more robust immune memory response compared to the same HPV vaccine composition conventionally formulated with aluminium hydroxide adjuvant alone. Furthermore, data published in The Lancet in April 2006 provided evidence that GSK’s cervical cancer candidate vaccine demonstrated protection up to 4.5 years against persistent infection with HPV 16 and HPV 18 — the two most common cancer-causing HPV types — and protection from pre-cancerous lesions. Protection was also demonstrated against infection with the third and fourth most prevalent cancer-causing types of HPV, namely types 45 and 31. Collectively, HPV types 16, 18, 45 and 31 are responsible for approximately 80 percent of cervical cancer cases globally.

“GSK is focused on protecting women from cervical cancer, a devastating disease that often strikes women in the prime of their lives,” said Gary Dubin, Vice President, HPV Vaccines, GlaxoSmithKline. “By conducting this study, we hope to further the scientific understanding of the role of strong and sustained immune responses to HPV vaccination for the benefit of all women.”

Notes to editors:

About the Study

This is a Phase III, randomized, observer-blind, multicenter study, to be conducted among 1,042 patients in the United States. There will be two arms of the study, one arm receiving GSK’s cervical cancer candidate vaccine, one arm receiving Gardasil®, and each arm will be stratified by age (18-26 [n=374], 27-35 [n=334], 36-45 [n=334]). The primary objective of the study is to compare GSK’s cervical cancer candidate vaccine to Gardasil®, in terms of immune responses to the two most common cancer-causing HPV types 16 and 18, which are responsible for at least 70 percent of all cervical cancers worldwide, in adult women aged 18 to 26. Secondary objectives will assess immune responses to cancer-causing HPV types 16 and 18 in adult women aged 27 to 35, and 36 to 45 as well as evaluate immune responses to other cancer-causing HPV types. Results are expected 12 months after patient enrollment is complete, with extended follow up continuing for approximately 17 months after the last study visit (month 7 through month 24).

About Cervical Cancer

The American Cancer Society estimates that in 2006, nearly 10,000 women were diagnosed with cervical cancer and nearly 4,000 died from this disease in the Unites States in a single year. After breast cancer, cervical cancer is the second most frequently occurring cancer in women ages 20 to 39 in the United States.

About GlaxoSmithKline’s Cervical Cancer Candidate Vaccine

GSK’s cervical cancer candidate vaccine was developed to prevent infection and lesions from the two most prevalent cancer-causing types of HPV, specifically HPV 16 and 18. It is formulated with the proprietary adjuvant system, AS04, selected to ensure that this vaccine confers strong and sustained antibody levels over time.

More than 16,000 women worldwide have been vaccinated with GSK’s cervical cancer candidate vaccine as part of completed and ongoing clinical trials.Phase III studies are under way in more than 25 countries with more than 35,000 subjects enrolled in ongoing trials.

GSK plans to file a biologics license application for CERVARIX® for U.S. Food and Drug Administration review by April 2007 for its cervical cancer candidate vaccine. The company submitted a marketing application review to the European Agency for the Evaluation of Medicinal Products in March 2006. Other international regulatory filings followed in Australia, parts of Asia and parts of Latin America in March 2006.

About GlaxoSmithKline

In the next two to five years, GSK expects to launch more major new vaccines in the United States, for example, a vaccine against rotavirus, an improved flu vaccine for the elderly and a meningitis combination vaccines for various ages, including infants.

GlaxoSmithKline–one of the world’s leading research-based pharmaceutical and healthcare companies–is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com.

GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2005, GSK Bio distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and the developing world, an average of more than 3 million doses per day.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the ‘Operating and Financial Review and Prospects’ in the company's Annual Report on Form 20-F for 2005.

ALSO NOTED: Emisphere fires CEO; Crucell in new antibody pact; Watson touts Phase III results; and much more...

Mon, 15 Jan 2007 19:01:30 -0500

> Chutes & Ladders: Emisphere Technologies has fired its chairman and CEO, Dr. Michael Goldberg, without citing a reason for his dismissal. Lewis Bender, senior vice president of business development, takes over in the interim. Report

> Crucell has inked a development deal with Novo Nordisk to develop new antibodies. Release

> Watson Pharmaceuticals announced positive top-line data from two Phase III studies ofsilodosin, its investigational drug being studied for benign prostatic hyperplasia. Release

> BioMarin says its enzyme deficiency therapy Phenoptin has demonstrated positive results in a late-stage trial. Report

> Chutes & Ladders: Ligand Pharmaceuticals has named John Higgins, the former CFO of Connetics, as its new CEO. Report

> The FDA has granted a priority review to Provenge, Dendreon's prostate cancer therapy. Release

> The FDA has given orphan drug status to Hana Bioscience's Marqibo, a cancer therapy. Release

> The FDA has granted an orphan drug designation to two of Lux Biosciences' drug candidates. Lux specializes in ophthalmic diseases. Report

> Ireland's Merrion Pharmaceuticals is touting the results of the latest study on its drug absorption technology. Release

And Finally... A new genetic test may eventually replace the pap smear as a primary method for cervical cancer screening. Report

Merck's McGlynn has key role developing vaccines

Mon, 01 Jan 2007 19:01:35 -0500

BusinessWeek profiles Margaret McGlynn (photo), president of Merck Vaccines for the past 14 months. During that time, Merck has launched four vaccines, including Gardasil as a protection against cervical cancer. These vaccines are at the center of Merck's plans to revive the company from its post-Vioxx debacle. Gardasil alone is expected to generate $2 billion to $4 billion in annual revenue.

- here's the BusinessWeek report on McGlynn

Related Articles:
Merck's Gardasil OK'd for pricey rollout. Report
Idera inks $455M pact for Merck vaccines. Report

ALSO NOTED: Glaxo wins approval for Hycamtin; Affymax forecasts share price;The best (and worst) biotech stocks of 2006; and mu

Thu, 30 Nov 2006 19:01:30 -0500

> President Bush has signed a new law that expands the powers of federal authorities targeting the activities of animal rights groups. Report

> GlaxoSmithKline has won EMEA approval to market Hycamtin, a combinatorial therapy for cervical cancer. Report

> Affymax has forecast a share price of $22 to $24 a share on the 3.5 million shares it plans to sell in its IPO. Report

> Analysts say that Allos Therapeutics is likely to release positive data for two major cancer trials in December. Report

> Eli Lilly will close its Mont St. Guibert operation and take a charge of $100 million to $110 million. Report

> Talecris Biotherapeutics has set up its European headquarters in Frankfurt, Germany. Release

> Researchers have used RU-486 to ward off tumors in mice bred with a gene that promotes breast cancer. Release

> Chutes & Ladders: Amgen has appointed Yuji Orihara president and representative director of Amgen in Japan. Release

> Dutch biotech Crucell has won contracts worth a collective $230 million for two of its vaccine. Report

> New research appearing in the Journal of Biology shows that even low doses of chemotherapy are killing brain cells and cancer drugs are more malignant to healthy cells than diseased cells. Report

> According to a newly-issued report from PriceWaterhouseCoopers predicts the top 7 trends for the healthcare history in 2007. Report

> The best (and worst) biotech stocks of 2006. Report

And Finally…The Clinton Foundation has announced a new deal that will significantly cut the cost of AIDS drugs for children. Article

ALSO NOTED: Emisphere shares dive on Phase II data; NovImmune raises $46M;and much more...

Sun, 29 Oct 2006 19:01:30 -0500

> Shares of Emisphere Technologies took a nasty hit today after the company reported negative Phase II data from a diabetes study. Report

> Switzerland's NovImmune raised $46 million in its second round of financing. Release

> AAIPharma has raised $30 million through a rights offering to existing shareholders. Release

> Shares in Germany's Paion surged today after an independent committee recommended that it resume enrolling patients for a trial of its stroke drug desmoteplase. Report

> In the event of a Democratic takeover of the House next week, start looking for high-profile hearings on the pharmaceutical industry's "profiteering" ways. Report

> GlaxoSmithKline said today that a review of its data indicates that Cervarix can reduce the incidence of cervical cancer by up to 80 percent. Report

> In the 1930s scientists discovered that restricting calorie intake by a third could extend life spans by 30 to 40 percent. Now a number of biotechs are involved in efforts to recreate the effects of a restricted calorie diet in pill form. Report

And Finally… College grads in the U.S. appear to be increasingly unqualified for jobs in biotechnology. Article

VC: Morphotek lands $40M VC round

Wed, 18 Oct 2006 20:01:32 -0400

Morphotek lands $40M VC round

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Morphotek Exton, PA	$40M Fourth	Investor Growth Capital of New York	Morphotek's lead antibody, MORAb-003, specifically targets the folate receptor alpha, a cell surface receptor over-expressed on ovarian, breast, colorectal, lung and renal tumors.
MTM Laboratories Germany	$27.5M Third	HBM BioCapital	Much of that money will go to the development and commercialization of its diagnostic and screening devices for cervical cancer.
Achaogen South San Francisco, CA	$26M Second	Domain Associates	The company will use the money to advance its lead antibacterial program through clinical proof of concept, and to progress additional programs through preclinical development.
EnVivo Pharmaceuticals Watertown, MA	$24M Third	Fidelity Biosciences	EnVivo's first program to enter clinical development later this year is an alpha-7 nicotinic receptor agonist for cognition enhancement in Alzheimer's disease and schizophrenia.
Amyris Biotechnologies Emeryville, CA	$20M First	Khosla Ventures	Amyris is using synthetic biology techniques to develop rare chemicals for use in pharmaceuticals and energy.
Santhera Pharmaceuticals Switzerland	$12.5M Third	NGN Capital	Santhera has a Phase IIb trial underway for JP-1730/fipamezole with Juvantia for Dyskenesia in Parkinson's.
CoDa Therapeutics San Diego, CA	$10M First	Domain Associates	CoDa says it expects to add $5 million to $10 million more to that amount in the next 90 days. Much of that money will go to completing clinical trials.
AGI Dermatics Freeport, NY	$5.5M First	Trevi Health Ventures	AGI is developing skin cancer prevention therapies along with skin care products.
Prolacta Bioscience Monrovia, CA	$5M Second	Arcturus Capital, DFJ Mercury, Philip Capital, Funk Ventures Capital, and the Gideon Hixon Fund	Prolacta specializes in the nutritional needs of underweight, premature, and critically ill babies.

German diagnostics firm garners €22M

Sun, 08 Oct 2006 20:01:35 -0400

Germany's MTM Laboratories has raised €22 million in its third round of venture funding. The developer says that much of that money will go to the development and commercialization of its diagnostic and screening devices for cervical cancer. HBM BioVentures and HBM BioCapital led the round.

"MTM Laboratories is taking a unique marker approach to the screening and diagnosis of cervical cancer, the largest existing screening market in oncology," said Dr. Erich Platzer, founding partner and investment advisor of HBM Partners. "We feel that the strength of the science combined with the development and commercialization experience of the team makes MTM a very attractive investment."

- see the release for more information

PLUS: France's Faust Pharmaceuticals has raised 8.2 million euros in bridge financing. Faust says the money is the first tranche in a €25 to €35 million financing round. Release

Scientists find that HIV drug attacks HPV virus

Thu, 24 Aug 2006 20:01:37 -0400

A team of researchers have concluded that the HIV drug lopinavir attacks the HPV virus that causes cervical cancer. The scientists say that the oral drug could be reconstituted as a cream that would help prevent surgery to remove early-stage cancer. They also note that the current vaccines being developed will not protect women who have already been exposed to the HPV virus. In the UK alone, some 50,000 women have surgery each year to remove the cancer.

- here's the BBC report on lopinavir

Merck's Gardasil faces critical new hurdle

Thu, 22 Jun 2006 20:01:35 -0400

The FDA's approval of Gardasil as a vaccine to prevent cervical cancer faces a series of new critical hurdles. Chief among them is gaining the support of the Advisory Committee on Immunization Practice, which will be hugely influential in determining the states' attitude toward the new vaccine. Failure to gain ACIP's endorsement would slice into a market that may reach as high as $3 billion a year.

- here's the report on Gardasil from TheStreet.com

ALSO NOTED: Panacos CEO dies; Alltracel touts cholesterol data; and much more...

Wed, 14 Jun 2006 20:00:50 -0400

> Chutes & Ladders: Panacos Pharmaceuticals says that CEO Samuel Ackerman died after suffering from a heart attack at a conference. Report

> Alltracel Pharmaceuticals says a study of a combination therapy using Alltracel Bioactive demonstrated a successful reduction of LDL cholesterol. Report

> Indevus' once-daily formulation of Sanctura for overactive bladder met its primary endpoint in the first of two clinical trials. Report

> The FDA has expanded the use of GlaxoSmithKline's Hycamtin in combination with cisplatin to treat cervical cancer. Report

> India's Nicholas Piramal has struck a deal to buy one of Pfizer's plants in the UK. Report

> Researchers announced that Prozac works no better than a placebo in treating anorexia. Article

> Samaritan Pharmaceuticals plans to begin a late-stage trial of its lead HV drug therapy. Release

And Finally… Researchers say that heavily wrinkled smokers have a five times greater chance of contracting lung disease than unlined smokers. Article

C&L: Jones to retire from Digene

Tue, 13 Jun 2006 20:01:32 -0400

In a move that caught most observers by surprise, Digene CEO and founder Evan Jones said he plans to retire after 16 years at the helm. Digene is profitable and has been developing a test that identifies the virus that causes cervical cancer. His successor will be recruited from outside the company.

Isolagen has named Nicholas Teti CEO and chairman. Susan Ciallella, who will stay on as president, acted as interim CEO after Frank DeLape resigned.

Penwest Pharmaceuticals has named Jennifer L. Good, the company's current president and COO, to the position of CEO and a member of the board of directors.

Michael J. McKelvey has been named president and CEO at eResearch Technology.

MicroIslet announced that Dr. James R. Gavin III, M.D., Ph.D, who was appointed interim president and CEO of MicroIslet in January, has been named president and CEO.

Enzo Biochem has named Carl W. Balezentis, Ph.D. to the newly-created position of president of Enzo Life Sciences.

NeoPharm announced that Lawrence A. Kenyon has tendered his resignation as the company's executive vice president, CFO and corporate secretary.

NexMed announced that Vivian Liu, the company's executive vice president, has also been appointed to serve as its COO.

Carsten Boess has joined Insulet Corporation as CFO.

Cardiome Pharma has named Curtis Sikorsky, CA to the position of CFO.

Nabi Biopharmaceuticals has appointed Jordan I. Siegel as the company's senior vice president, finance, CFO and treasurer.

Russ Austin is being promoted to senior vice president, general counsel, and board secretary at Battelle.

Laura Brege has been appointed executive vice president and chief business officer of Onyx Pharmaceuticals.

Proprius Pharmaceuticals has named David W. Anderson, Ph.D. as its new chief scientific officer.

Sidney Mazel, Ph.D. has joined the management team of MedImmune as senior vice president, product planning and portfolio management.

Altus Pharmaceuticals has named Burkhard Blank, M.D. as senior vice president medicine, regulatory affairs and project management.

Novavax has appointed Mariann Caprino vice president of corporate communications and investor relations.

Cubist Pharmaceuticals has appointed Sylvie Gregoire, Pharm. D., to its board of directors.

VasoGenix Pharmaceuticals has named Jerome A. Halperin, recently retired from the Food & Drug Law Institute as president and CEO, to its board of directors.

John Macomber has been named to the board of directors of Stem Cell Innovations.

QLT has appointed Dr. Ian John Massey to its board of directors.

Kosan Biosciences has elected Kevan Clemens, Ph.D., to its board of directors.

BioSyntech has elected Dr. Joyce Tsang to its board of directors.

Aspreva Pharmaceuticals has named William Hunter, MD, MSc to its board.

William R. Mattson, Jr. has been elected to Oscient Pharmaceuticals' board of directors.

Merck's Gardasil OK'd for pricey rollout

Thu, 08 Jun 2006 20:01:39 -0400

In an expected win for Merck, the FDA has approved Gardasil as a vaccine against cervical cancer and genital warts caused by the human papilloma virus. Merck has already caused some controversy with its price for Gardasil. At $360 for a three-shot course, Gardasil will immediately join the list of some of the most expensive drugs on the market. Health officials are expected to make Gardasil a recommended therapy for all 11 and 12-year-old girls, a big market that may be somewhat inhibited by religious conservatives who have objected to the vaccine due to their beliefs that it would encourage promiscuity. The vaccine protects females from 70 percent of all cervical cancers, provided it is administered before they are exposed to the virus. Cervical cancer is the second-leading cause of death among women around the world.

- here's the article on Gardasil from The New York Times

Merck wins FDA, EMEA approval for Zostavax

Thu, 25 May 2006 20:01:39 -0400

Merck has won FDA and European approval for Zostavax, its vaccine against shingles. The agency called the vaccine an important tool in the fight against a chronic disease accompanied by great pain. In trials, Zostavax reduced the incidence of shingles among people aged 60 to 69 by 64 percent. The effectiveness of the vaccine dropped significantly past 70. The approval marks Merck's continuing success in the vaccine field. It recently won approval for the vaccine RotaTeq to protect infants from rotavirus and is expecting an FDA decision soon on its vaccine against cervical cancer.

- read this Wall Street Journal article on Merck (sub. req.)

Gardasil gets unanimous FDA panel support

Thu, 18 May 2006 20:01:39 -0400

Merck's Gardasil, billed as the first vaccine to prevent cervical cancer, is now just one step away from commercial approval after a unanimous vote in its favor by a federal advisory committee. Merck says that Gardasil can reduce deaths from cervical cancer by two-thirds and has already begun an early ad campaign aimed at generating buzz about the therapy. Dr. Monica Farley, the head of the committee, enthusiastically endorsed Gardasil, commending Merck for the impressive amount of data that was available for members to study. All of that spells what is likely to be a quick trip through to final FDA approval. Merck plans to sell a full regimen of Gardasil for $500. A full set of data on its therapeutic effect on men is expected in 2008.

- here's the article from the Los Angeles Times on Gardasil

FDA staffers raise Gardasil questions

Wed, 17 May 2006 20:01:38 -0400

FDA staffers have raised concerns that Gardasil, the closely watched vaccine against cervical cancer, may actually increase the rates of a cancer precursor. Staffers have also asked an expert committee--which is meeting today to review Gardasil--to examine the potential impact on other infections related to HPV as well as a few birth defects among children born to women around the time they began to take the vaccine. Documents also underscore, though, that the FDA staffers see Gardasil as essentially safe and effective. Merck believes that Gardasil offers a chance to cut the number of deaths from cervical cancer by two thirds.

- here's the AP report on Gardasil

SPOTLIGHT: Merck not waiting on FDA

Tue, 16 May 2006 20:01:33 -0400

The FDA hasn't issued a decision on Merck's Gardasil to protect women from cervical cancer, but the drug maker has already begun an ad campaign aimed at generating some consumer buzz for the therapy. Report

Remicade get approval in Europe for UC

Wed, 08 Mar 2006 19:01:36 -0500

Centocor's Remicade has received EU approval for the treatment of ulcerative colitis, a chronic inflammatory disease. This is the eighth approved use for Remicade in the EU and the first biologic therapy approved to treat UC in the European Union.

- see this press release

ALSO: GlaxoSmithKline has submitted its vaccine Cervarix to European regulators for approval. Their submission comes only months behind Merck's Gardasil, which was presented for approval late last year. Both vaccines aim to treat cervical cancer and will compete for market share if they are approved. Article