Gardasil

In Phase III, Gardasil prevents HPV in men

Maureen Martino — Thu, 13 Nov 2008 09:47:58 -0500

It looks like Gardasil may not just be for girls anymore: a Phase III study of Merck's HPV vaccine found that the jab prevented 90 percent of external genital lesions caused by the disease men aged 16 to 26. In a study of 4,000 men, only three subjects who got the shot developed lesions; there were 31 cases in the placebo group. Gardasil prevents lesions caused by types 6, 11, 16 and 18

Merck said that the company remains on track to submit an sBLA for Gardasil for use in men by the end of 2008. The findings were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference.

- see Merck's release
- read the WSJ blog post

Three new therapies approved by the FDA

John Carroll — Mon, 15 Sep 2008 12:01:53 -0400

There was a lot of action on the regulatory side of new drug discovery today. Here's a list of the top hits:

Denmark's Lundbeck has filed an NDA for is schizophrenia drug Serdolect. The drug has had a tremendously controversial history and was withdrawn in 1998--two years after its initial approval--on fears that it could trigger heart problems
The FDA has approved ProStrakan's patch to prevent nausea and vomiting among cancer patients. Sancuso has been in development for the past five years.
The FDA has approved Talecris Biotherapeutics' Gamunex, an immune globulin product for the treatment of chronic inflammatory demyelinating polyneuropathy, a rare autoimmune disorder.
On Friday Merck's Gardasil was approved for two new gynecological cancers. Report

- here's the release on Serdolect
- read the ProStranka's release on Sancuso
- check out the Gamunex article
- see FiercePharma's Gardasil report

ALSO NOTED: AstraZeneca teams up on Alzheimer's; Breast cancer vaccine posts positive data; and much more...

Thu, 17 Apr 2008 06:59:50 -0400

> AstraZeneca and the Washington University School of Medicine in St. Louis have announced a research collaboration that will focus on ways to diagnose and treat Alzheimer's disease. The major focus of the alliance will be biomarkers, characteristic changes in the brain and spinal fluid, that physicians can use to diagnose Alzheimer's disease and track its response to treatment. Report

> Researchers report that Apthera's NeuVax breast cancer vaccine significantly reduced the risk of reoccurrence in patients expressing the HER2-neu protein. Report

> Dynogen Pharmaceuticals has scrapped plans to go public via a reverse merger with a SPAC called Apex Bioventures Acquisition. The company is focused on gastrointestinal and genitourinary disorders. Release

> More evidence that biologic drugs are where it's at: Experts are predicting tough times ahead for contract manufacturers that focus too closely on Big Pharma's bread-and-butter small-molecule products. Report

> Researchers at Johns Hopkins have come up with a synthetic vaccine for HPV that can be delivered as a nasal spray. The current vaccine, Gardasil, is delivered via three injections. Report

> San Diego-based Illumina is commercializing three new products aimed at a better understanding of the molecular mechanisms that give rise to cancer. Report

> The nexus between academic researchers and investors is a prime breeding ground for biotech start-ups. The Wall Street Journal profiles one prime example: MIT scientist Robert Langer and Polaris Venture Partners' Terry McGuire, who have teamed up on 13 new companies in 15 years. Report

And Finally... Want to get a good forecast of the influenza strains Americans, Europeans and other people around the globe need to guard against? Then look to Asia. Report

SPOTLIGHT: Booming vaccine market swells Sanofi's revenue

Thu, 14 Feb 2008 06:59:53 -0500

A sign of the times? When Sanofi-Aventis presented its 2007 results earlier this week, it trumpeted the 14.5 percent sales growth in its vaccines group. That's more than double its pharma growth--and it's without Gardasil, because Sanofi doesn't consolidate its Merck joint venture revenues. Now, vaccines account for 10 percent of group revenues. As In Vivo notes, "Rarely have so many of Big Pharma's slides been devoted to this once-unfashionable category." Report

ALSO NOTED: Strativa acquires Onconase rights; Neurocrine gets new CEO; SAFC plans biologics expansion; and much more...

Tue, 15 Jan 2008 06:59:50 -0500

> Strativa has acquired commercialization rights to the late-stage Onconase from Alfacell. Onconase is in Phase III for inoperable malignant mesothelioma, a rare form of cancer. Alfacell gets $5 million up front and another $30 million on FDA approval. Report

> Chutes & Ladders: Gary Lyons is stepping down as CEO of Neurocrine Biosciences, making way for COO Kevin Gorman, Ph.D. Lyons will stay on the board. Release

> SAFC is planning a $12 million expansion of its biologics manufacturing facility. Release

> VGX Pharmaceuticals announced that the FDA accepted the Investigational New Drug application for its lead anti-inflammatory compound, VGX-1027. Release

> Molecular Partners inked a collaborative research and license deal with Centocor Research & Development. The collaboration will focus on the development of DARPins--Designed Ankyrin Repeat Proteins--a novel class of therapeutic proteins to treat inflammatory diseases. Release

> Call it the comeback kid. Tysabri nabbed a new indication from the FDA yesterday, as a second-line treatment for the intestinal disorder Crohn's disease. Report

> If GlaxoSmithKline can challenge Merck to a head-to-head trial (Cervarix versus Gardasil), then AstraZeneca can throw down the gauntlet before Pfizer. In this case, the products in question are statins--AstraZeneca's Crestor and Pfizer's Lipitor. Report

> Gardasil captured more territory for Merck and Sanofi-Aventis yesterday when French health officials recommended that vaccine against Human Papilloma Virus, or HPV. Report

> It's a pile-on. Experts and non-experts alike are expounding on yesterday's dismal ENHANCE results. For every cardiologist of unshaken faith, there are a half-dozen or more detractors gleefully trashing Merck and Schering-Plough. Report

And Finally… A landmark case aimed at requiring drug developers to make experimental therapies available to dying patients ended in a dead end yesterday as the Supreme Court declined to hear the case. Article

GSK hit with Cervarix application delay

Mon, 17 Dec 2007 06:59:58 -0500

After hearing that the FDA is demanding more information on Cervarix before it can be approved, analysts are estimating that GlaxoSmithKline could face delays of up to two years in launching the therapy in the U.S. That's a significant blow for the UK drug maker, which had been hoping to go head-to-head against Merck's Gardasil and replenish sales in the U.S.--which have been hit hard by dwindling sales of Avandia. Adding to the confusion and uncertainty, Glaxo declined to spell out exactly what the FDA is looking for. That could mean anything from a short delay of a few months to answer technical questions to a serious time lag as researchers harvest more data from ongoing clinical trials of the vaccine.

- see GSK's release on the setback
- here's the report on the delay from The Guardian

ALSO: Is Tykerb GSK's cancer breakthrough? Report

Related Articles:
GSK shakes up R&D. Report
It's Merck v. Glaxo in vaccine battle. Report
GSK prepares to go head-to-head with Merck. Report
Merck's Gardasil OK'd for pricey rollout. Report

ALSO NOTED: FDA mulls "behind-the-counter" status; Hyperion makes management changes; and much more...

Thu, 04 Oct 2007 06:59:50 -0400

> Once, the gap between prescription drugs and over-the-counter sales was a wide No Man's Land where few products roamed. Now, the FDA may settle more medications in this country, known as behind-the-counter (BTC) sales, in part to improve access for the uninsured. Report

> Hyperion Therapeutics has made senior management appointments and closed up to $15 million in debt financing from Comerica Bank and Life Sciences Capital. Release

> Hollis-Eden has reported preclinical data for HE3235, a cancer treatment. Release

> One more strike against diabetes drugs: Australia's regulators are warning that the class of drugs including Avandia and Actos may boost the risk of bone fractures in older women. Report

> There has been a deluge of Gardasil/Cervarix news in the last few weeks as GSK and Merck fight for ascendancy in the multi-billion dollar market. Report

And Finally... University of Cincinnati researchers believe identifying a genetic "fingerprint" could help predict which specific therapies will be most effective for patients with gastric cancer. 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.

GSK prepares to go head-to-head with Merck

Wed, 17 Jan 2007 19:01:36 -0500

With a huge market at stake, GlaxoSmithKline says it will mount a head-to-head study of its cervical cancer vaccine Cervarix against Merck's Gardasil. The Phase III trial involves 1,042 volunteers in two arms, each taking one of the two vaccines. The trial will compare the immune response of 18 to 24-year-old women to two types of human papillomavirus. Secondary objectives are laid out for immune responses among older women.

- check out GSK's press release
- read the AFX report on the trial

PLUS: The Guardian covers the development of a new generation of virus-vectored vaccines that promise to take on a number of diseases like malaria. Report

Related Articles:
Merck's Gardasil OK'd for pricey rollout. Report
Cervarix more effective in girls aged 10-14. Report
Merck's McGlynn has key role developing vaccines. 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: Gardasil still hard to find; EC approves Exjade; FDA to review nonconsent trial rules; and much more...

Tue, 29 Aug 2006 20:00:50 -0400

> Merck's cervical cancer vaccine, Gardasil, has been hailed as a major breakthrough, but it's still hard to obtain. Many doctors appear to be waiting a few months before they start giving the shots, saying that they're waiting for insurers to sign on to covering the therapy. Article (sub. req.)

> The European Commission has approved Novartis' Exjade for patients with transfusional iron overload. Report

> Following the controversy over PolyHeme the FDA says it will review its rules for nonconsent trials. Report

> Americans are tipping the scale even more toward obesity. A new report from the Trust for America's Health concludes that Mississippi and a host of Southern states are the worst offenders. Thirteen states now have obesity rates that exceed 25 percent of the population and none of the 50 states are under federal guidelines that suggest a maximum obesity rate of 15 percent. Obesity is a major target for new drug therapies now in clinical testing. Article

> Wyeth says that the FDA has extended its review period for the extended release form of its depression drug, desvenlafaxine succinate. Wyeth now expects a ruling by January 22. Report

> Octagon Research Solutions, which supplies IT programs to the life sciences industry, has raised $10 million in new venture funding. Report

> Government investigators say that a new $275 million study of chemotherapy patients contains unreliable data. Article

> Bio-Reference Laboratories said it will buy the Maryland gene-testing outfit GeneDx for $10 million up front and another $7 million in milestone payments. Report

And Finally… British officials are warning people against unfounded claims of stem cell "miracle cures" that have been cropping up around the world. Article

ALSO NOTED: Group backs Gardasil; Astellas halts program; and much more...

Thu, 29 Jun 2006 20:00:50 -0400

> A key federal advisory group has endorsed Merck's cervical cancer vaccine, Gardasil. The vote by the Advisory Committee for Immunization Practices makes it likely that the government will covering the cost of the shot. Insurers like Wellpoint have already begun to issue coverage approvals, setting up Gardasil as a blockbuster with an estimated potential of $3 billion a year. Report

> Astellas has pulled the plug on the experimental immunosuppressant drug FK778 after disappointing Phase II data failed to demonstrate clear superiority over other therapies. Report

> Skyepharma has licensed the European rights to DepoBupivacaine. Release

> Par Pharmaceuticals has received FDA approval for a generic version of GSK's depression drug Parnate. Report

> Eli Lilly and Company has licensed Admensa Interactive from Inpharmatica. Release

And Finally… The backlash against Europe's animal rights activists has set in. Article

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

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

ALSO NOTED: Merck waits for news on Gardasil, Januvia; Pfizer wins patent case in China; and much more...

Sun, 04 Jun 2006 20:00:50 -0400

> It's a big week for Merck, which is hoping to move two blockbusters--Gardasil and Januvia--past important milestones. Article

> Pfizer won a landmark patent protection case in China, signaling the Chinese government's willingness to protect big drug companies' blockbuster meds. Report (WSJ sub. req.)

> New market research indicates that the growing popularity of Enbrel and Humira will help expand the market for RA drugs to $10 billion in 2015. Release

> Cabrellis Pharmaceuticals announced its launch after its spinout from Conforma Therapeutics, which was sold to Biogen Idec. Report

> WellGen CEO David Evans died after a sudden illness. Release

> Myogen has launched a Phase III trial of Darusentan in patients with resistant hypertension. Release

> The FDA has approved a new wrinkle cream from Allergan. Report

And Finally… Strict mothers were five times more likely to raise overweight children than mothers who were flexible but good at setting rules. Article

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