flu

Emergent adds new space for biotech start-ups

John Carroll — Mon, 16 Jun 2008 07:24:42 -0400

Emergent Technologies (ETI) has doubled its office space, taking new digs in Austin that includes new laboratory space for the biotech companies that it helps foster. ETI specializes in creating new companies that are engaged in commercializing research pioneered at regional universities.

Thomas Harlan, president and CEO of ETI, told the Austin Business Journal that the company had just run out of room. ETI moved from 12,000 square feet into 23,000 square feet of space. ETI closed a $27 million fund in the spring of 2007 and used the money to launch three companies: Mimetic Solutions, Beacon Sciences and AeonClad Coatings.

"The biotech sector is a limitless one," Harlan told the newspaper. "We're delighted to be sitting in a region where there's abundant deal flow, in terms of the science coming from the university."

- read the report in the Austin Business Journal

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

Intercell snaps up Iomai in $189M deal

Tue, 13 May 2008 06:59:57 -0400

The little Maryland-based vaccine developer Iomai, which has posted some impressive data on a new therapy for traveler's diarrhea as well as an adjuvant for bird flu vaccines, is being bought out by Intercell for about $189 million. Intercell gains a mid-to-late-stage product in the needle-free diarrhea program, adding it to a Japanese encephalitis vaccine it has in development. The diarrhea patch is scheduled to enter Phase III in the first half of 2009. Intercell is looking for approvals of its vaccine by regulators around the globe this year.

In the deal, Iomai's public investors get cash for their shares while a group of large stakeholders will exchange their Iomai shares for shares in Intercell. Iomai was featured as one of FierceBiotech's emerging drug developers.

- here's the release
- read the AP story

Acambis lands $425M smallpox vaccine contract

Wed, 23 Apr 2008 06:59:56 -0400

The U.K.'s Acambis has won a $425 million contract to supply the CDC with its smallpox vaccine for 10 years. Acambis will establish a U.S.-based manufacturing capability for ACAM2000 and deliver a minimum of nine million doses per year of the drug. "The net proceeds will enable us to invest in manufacturing facilities for the U.S. contract, progress our vaccine for hospital-acquired C.difficile infections and further our program of new vaccines against influenza, genital herpes and other significant unmet medical needs," Acambis head Ian Garland told ShareCast.

- see the Acambis release
- read this report from ShareCast

Feds ok Iomai Phase II adjuvant patch study

Wed, 16 Apr 2008 06:59:54 -0400

Health and Human Services is giving Iomai the green light to do a mid-stage dose ranging study of its adjuvant patch for bird flu vaccine. HHS provided a $128 million contract backing Iomai's effort last year, and was rewarded with dramatic Phase I/II data on its ability to boost the effectiveness of bird flu vaccine.

The U.S. government, like other governments around the world, has been stockpiling vaccine to fight a potential pandemic. Iomai's patch worked well enough to provide protection to many people after a single dose, rather than the two usually required. That would allow physicians to stretch available vaccines over a much larger population on a much quicker basis.

"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," said Iomai CEO Stanley C. Erck. "Based on the data from this new Phase II study, Iomai and HHS will evaluate whether to proceed next with a pivotal Phase III trial."

- here's the press release

ALSO: South Korea has mobilized troops to help fight the spread of H5N1 in poultry. Report

Related Articles:
Emerging Drug Developer: Iomai. Report
Iomai gets boost in bird flu vaccine adjuvant study. Vaccine report
Iomai vax patch guards against traveler's diarrhea. Iomai report
Vaccine-maker Iomai files $83M IPO. Report

Peregrine reports positive cancer data

Tue, 11 Mar 2008 07:59:55 -0400

Peregrine Pharmaceuticals is posting positive data from two ongoing, mid-stage trials of its cancer therapy Cotara. The trial data assessed Cotara's safety and efficacy in treating patients with glioblastoma multiforme, a deadly form of brain cancer. The drug appeared to be safe and well tolerated, with no dose-limiting adverse events. And several volunteers surpassed the median expected survival time for relapsed GBM patients.

"In view of the short expected survival time of approximately six months in this patient population, it is promising that we have early GBM patients in these trials who have survived past the six-monthtimeframe, with one patient now surviving 15 months post-treatment," said Steven W. King, president and CEO of Peregrine.

- check out the release

Related Articles:
India OKs Peregrine trial. Report
Peregrine touts early avian flu virus data. Report

Breakthrough reported in flu vaccine research

Mon, 10 Mar 2008 07:59:57 -0400

A Japanese chemical company saw its stock shoot up 20 percent this morning, the maximum allowed on the Japanese market, after researchers for NOF and Japan's National Institute of Infectious Diseases announced that they had found a way to create a new vaccine that could protect people from all types of bird flu viruses. One of the researchers said that the new approach targets the inside of the virus, preventing it from replicating. Current vaccines rely on alerting the immune system to attack the virus and become ineffective when the virus mutates.

"We are continuing the joint study in the hope that it will have universal effect on human influenza as well as a variety of other influenza viruses," said NOF. Any vaccine for human use is still far off, though. Researchers plan to start testing the vaccine in biotech mice in April.

- read the AFP report

Related Articles:
Breakthrough in understanding mechanism of bird flu. Report
Antibodies used to protect against bird flu. Report
Bird flu scientist says annual mutations likely. Report
Experimental vaccines show efficacy against H5N1 viruses. Report

Novartis established nonprofit vaccine institute

Fri, 22 Feb 2008 06:59:54 -0500

Novartis has established the Novartis Vaccines Institute for Global Health, a nonprofit venture that will take aim at diseases in the developing world. The NVGH, which will be separate from Novartis' commercial vaccine operations, will use the company's vaccine tech to make products that address unmet needs. These vaccines will be tailored for developing country needs and will be introduced first in those countries. The NVGH is a public private partnership and will also collaborate with other groups to build strength in resources.

- here's Novartis' release

ALSO: Carlsbad, CA-based Invitrogen has launched the Invitrogen Foundation, a nonprofit outfit designed to raise understanding of biotechnology, and encourage students to pursue careers in science. Report

Related Articles:
Novartis injects $816.5M in vaccine plant. Report
Novartis to build $600M flu plant in NC. Report
Novartis wins $220M flu vaccine contract. Report
Has the Gates Foundation created a malaria 'cartel'? Report

SPOTLIGHT: Research links efficacy to thoughts

Thu, 31 Jan 2008 06:59:53 -0500

A patient's thoughts and feelings can play a big role in determining just how effective their annual flu shot can be, says a new study from the University of Wisconsin. In the study, researchers divided young women into two camps: one group that felt they were living up to their goals and satisfied with their lives and another group that wasn't. That first group with poor self-esteem demonstrated a significantly weaker response to their flu shot--delivered during the flu season--with lower levels of immunoglobulin M antibodies. Report

SPOTLIGHT: Gates backs new vaccine technology

Thu, 17 Jan 2008 06:59:53 -0500

PATH is using a $39 million grant from the Gates Foundation to help developing countries identify ways to manufacture and stockpile vaccines that could be used to defend their populations against an influenza pandemic. Developed countries have already spent millions of dollars stockpiling hundreds of millions of doses of flu vaccine. But PATH notes that developing countries are likely to be left to their own devices in the event of a pandemic. The Gates moneys will go to public and private vaccine development partnerships. Report

Sanofi launches trial of revolutionary flu vaccine

Wed, 07 Nov 2007 06:59:56 -0500

Sanofi-Aventis has launched a mid-stage study of a new seasonal flu vaccine that hopes to advance a completely new method to make vaccines. The vaccine is made from cell cultures as opposed to the traditional egg-based approach. This experimental vaccine uses a cell line--PER.C6--licensed from Crucell. Sanofi-Aventis' closely-watched development program is expected to short circuit the slow, crude manufacturing process now in place and help revolutionize the whole vaccine business.

"This project is part of a contract awarded in 2005 by the U.S. Department of Health and Human Services (HHS) aimed at accelerating the development of a new cell culture-based influenza vaccine," Sanofi-Aventis said in a statement.

- take a look at the release from Sanofi
- read the report from In-PharmaTechnologist.com

Related Articles:
Sanofi vaccine effective against new bird flu strains. Report
Sanofi's avian flu drug gets mixed results. Report
Sanofi underscores pipeline advances, setbacks. Report
What's Warren Buffett buying now? Report

ALSO NOTED: Pharmaxis touts late-stage study; ALS gains orphan drug status; H5N1 passed human-to-human; and much more...

Wed, 29 Aug 2007 06:59:50 -0400

> Pharmaxis says that a late-stage study of its experimental drug for a chronic lung condition demonstrated its effectiveness. Release

> Advanced Life Sciences says the FDA has granted orphan drug status to its cancer drug, ALS-357. Report

> Simmering fears of a bird flu pandemic have been heating up in the wake of a new study that confirms human-to-human spread of the deadly disease. Experts at Fred Hutchinson Cancer Research Center confirm that the avian influenza A (H5N1) virus in 2006 spread between a small number of people within a family in Indonesia. A number of biotech companies have joined the race to develop a vaccine against bird flu. Report

> Families of Spinal Muscular Atrophy and Tikvah Therapeutics announced a collaboration to accelerate the clinical development of TIK-201 for the treatment of spinal muscular atrophy. Release

> Tercica says it expects the FDA to make a decision on Somatuline Autogel later in the week. Report

> The FDA has accepted Merck's NDA for Cordaptive. Report

> Roche has lost turf to Amgen in their patent battle over Mircera, an anti-anemia drug now under FDA review. FiercePharma

> In another step under the patent shelter for AstraZeneca's Seroquel, the company won approval from Dutch regulators for an extended release form of the drug. FiercePharma

And Finally…The battle of the bulge is not going well for the forces of slim. A new study shows that obesity grew worse in 31 states last year, with no state posting an advance. Report

ALSO NOTED: Schering-Plough licenses acadesine; Alchemia raises $15M; DOR action date extended; andmuch more...

Thu, 19 Jul 2007 06:59:50 -0400

> Schering-Plough has licensed acadesine, an adenosine regulating agent, from PeriCor Therapeutics. No terms were released. Release

> Australia's Alchemia announced a $15.2 million placement. Release

> DOR BioPharma announced that the action date for the FDA's review of its NDA for orBec for the treatment of gastrointestinal graft-versus-host disease has been extended to October 21, 2007. Release

> Par Pharmaceutical has settled a patent despite with Ortho-McNeil Pharmaceutical. Release

And Finally... A collaboration between the Scripps Research Institute and IBM to find new antidotes to flu before new mutations surface is making some initial progress. Report

ALSO NOTED: Dr. Reddy's takes a gamble on biogenerics; Coley receives $5M from Dynavax; and much more...

Fri, 29 Jun 2007 00:01:30 -0400

> Brian Orelli of the Motley Fool profiles a risky move by generic drugmaker Dr. Reddy's Laboratories. Article

> In New Jersey, the biotech industry is booming. Article

> Coley will receive at least $5 million from Dynavax Technologies for the nonexclusive marketing rights to commercialize Coley's hepatitis B vaccine Heplisav. The therapy is in late-stage trials. Release

> Keryx Biopharmaceuticals presented positive data on the clinical activity of KRX-0401 (perifosine) in patients with advanced multiple myeloma and Waldenstrom's macroglobulinemia. Release

> An expert panel has delayed a decision on endorsing FluMist for children under 5, a move that will likely close that market to MedImmune for the upcoming flu season. Report

> The European Commission has granted Merck KGaA marketing approval for its fertility drug Pergoveris. Report

> France's NicOx has begun its third pivotal Phase III clinical trial for naproxcinod in patients with osteoarthritis of the hip. Release

And Finally... Research shows that exercise creates new brain cells. Release

SPOTLIGHT: New bird flu strain emerges

Wed, 17 Jan 2007 19:01:33 -0500

The World Health Organization says that two Egyptians were infected by a new strain of bird flu that is resistant to Tamiflu. They don't know how the strain developed, but noted that it is worrying as Tamiflu remains the primary protection against the H5N1 version of avian flu. Report

Bird flu outbreaks spread across Asia

Mon, 15 Jan 2007 19:01:36 -0500

Indonesia is preparing more hospitals to take victims of a new bird flu outbreak, as one facility reports that its small isolation ward has been filled. At least one family cluster has been affected as officials report the deaths of at least four people in that country in just the past week. Japan, meanwhile, is reporting that it has confirmed the presence of the lethal H5N1 version of bird flu in poultry, its first outbreak in three years. And reports of bird flu in poultry in Vietnam and Thailand have also surfaced. In many ways, the current spate of new cases fits into a well-established winter pattern in the Northern Hemisphere. As cold weather spreads, more victims surface, renewing fears that the virus could mutate into a new form that could trigger a human pandemic. Health officials, though, say that this year, government agencies appear to be responding much more quickly, in order to contain any outbreaks that occur. The fear of a pandemic has also prompted major efforts to develop new vaccines to protect populations. But that effort is still in a very early stage.

- here's the report on avian flu from ENS

Related Articles:
Vietnam steps up efforts to control bird flu. Report
New bird flu death adds to toll. Report
WHO calls for $10B in bird flu vaccine research. Report
The challenges of infectious disease. Report

FDA approves refrigerated formulation of FluMist

Sun, 07 Jan 2007 19:01:35 -0500

The FDA has approved a new version of the inhalable FluMist that can be kept refrigerated instead of frozen. The regulatory approval is a notable win for the manufacturer, MedImmune, which has been confounded by difficulties in developing a market for the flu vaccine. MedImmune expects that the refrigerated reformulation will make it easier to keep the vaccine on hand and boost sales. The new vaccine will be available in August for the coming flu season.

- check out MedImmune's release on the approval
- here's the UPI's report on the approval

Related Articles:
MedImmune investor urges company to seek bidders. Report
MedImmune gets nod for new vaccine tech. Report
MedImmune touts new FluMist version. Report

Acambis shares plunge after U.S. nixes contract

Mon, 13 Nov 2006 19:01:38 -0500

Shares of Acambis took a beating after the company announced it was no longer in the competition for a U.S. contract to provide smallpox vaccine. Its stock plunged 39 percent after company officials said it was no longer being considered. Acambis said that it would arrange a meeting with government officials to "seek clarification." "We are surprised that the U.S. government would eliminate Acambis," CEO Gordon Cameron said. "We believe that our proposal would have met the requirements."

- here's the International Herald Tribune report on Acambis

Related Articles:
Acambis completes vaccine BLA. Report
Acambis researching single-shot solution to flu. Report

Roche's Tamiflu ads spark criticism

Maureen Martino — Wed, 01 Nov 2006 12:55:12 -0500

If Roche has its way, a gaggle of happy penguins will charm consumers into stocking up on flu drug Tamiflu. Using penguin characters from a current children's feature as a theme, Roche Pharmaceuticals has developed a multi-million dollar ad campaign to create demand for the costly medication. Tamiflu, which has attracted international attention as a possible stopgap in the war against bird flu, is designed to slow flu progression and minimize symptoms. The ads, which come just before the start of flu season, don't mention Tamiflu specifically. Critics say the promotion is irresponsible. Dr. Jerry Avorn, a Harvard Medical School professor, argues that the drug's benefits are minimal. Worse, he suggests that if consumers use Tamiflu heavily, Americans will develop a resistance to the drug and won't benefit from it if and when bird flu does become a pandemic. The drug is already proving to be a bonanza for Roche. The pharmaco reported that Tamiflu sales rose to $1.3 billion during the third quarter of this year, an increase of 88 percent over the Q3 '05. Report

WHO calls for $10B in bird flu vaccine research

Mon, 23 Oct 2006 20:01:35 -0400

The World Health Organization is warning governments around the globe that they need to invest another $10 billion if they expect to be able to stockpile enough vaccines to ward off a global bird flu pandemic. The WHO's global plan also calls for a big increase in seasonal flu vaccine production in order to expand vaccine production capacity and long-term R&D efforts to build better pandemic vaccines.

WHO would like to see annual production of seasonal vaccines boosted from 350 million to 560 million doses. And several billion dollars in new investments in R&D would offer the world a reasonable chance of gaining new vaccine protection from bird flu in three to five years.

- here's the report from the Financial Times for more information

Related Articles:
Indonesia agrees to release bird flu data. Report
WHO study points to threats of avian flu. Report
The challenges of infectious disease. Report