pharmaceutical industry

Developers tout protein manufacturing breakthrough

John Carroll — Mon, 16 Jun 2008 07:14:21 -0400

A joint venture between Crucell and DSM Biologics--Percivia--has produced a new, more efficient approach to manufacturing monoclonal antibodies and proteins. By relying on human cell lines rather than a traditional chemical approach, officials for the two companies say they can significantly cut the cost of manufacturing. And researchers for the joint venture say they achieved fermentation yields in human cells of 27 grams a liter--a record.

"This new achievement surpasses all other reported titer levels to date with any mammalian system and clearly demonstrates the robustness and power of the PER.C6 platform," said Marco Cacciuttolo, CEO and President of Percivia. "We are particularly enthused with the user-friendliness of the platform and pleased to be able to provide this to our licensees. We strive to revolutionize the pharmaceutical industry in protein production."

Less expensive manufacturing, they add, will allow developers to advance some new products to the market that would not have been able to generate a profit before.

- read the release

Resveratrol potential fires interest in longevity drugs

Fri, 06 Jun 2008 06:59:56 -0400

Interest in longevity drugs continues to grow as new research points to the tonic effects of resveratrol. The New York Times notes that some scientists have become so enamored by the potential of the ingredient they have begun to take it in pill form. And the implications could be huge for any developer like Sirtris.

"The upside is so huge that if we are right, the company that dominates the sirtuin space could dominate the pharmaceutical industry and change medicine," said Dr. David Sinclair of the Harvard Medical School, a co-founder of the company.

- read the article in The New York Times

SPOTLIGHT: Glaxo appraises Sirtris' potential

Thu, 24 Apr 2008 06:59:53 -0400

A somewhat skeptical Matthew Herper at Forbes did a Q&A with Glaxo's Patrick Vallance on the big news that it's buying Sirtris at $22.50 a share. Sirtris has been gaining headlines for its work in the anti-aging field, but the stock price has lagged significantly. Vallance sees great science, great scientists and lots of potential. One excerpt: "We're forever investing in high-risk things. That's what we do in the pharmaceutical industry. We're pretty clear that we see a big opportunity here." On big vs. small: "Now they can do things with a scale and know-how that's much more difficult if you're in a group of 60 people than if you're in a large organization that has done this for years." Report

Roche invests $387M in biotech

Fri, 18 Jan 2008 06:59:58 -0500

Like so many other pharmaceutical industry giants, Roche has announced plans to increase its stake in biotech, pledging to invest $430 million Swiss francs ($387 million) in three sites in Switzerland and Germany. Around 280 million francs will be invested in expanding biotech R&D efforts at Roche's Penzberg, Germany site, specifically in the area of oncology. An additional 150 million francs will be invested at Mannheim and Kaiseraugst in expanding modern syringe filling capacities for drugs such as Mircera, Pegasys or Actemra.

"With our biopharmaceuticals heavily in demand, this step will both safeguard and expand production. Investments like this are very much long term in nature and they create hundreds of jobs in and around the company. It is therefore essential that a stable, industry-friendly environment be maintained in the long term," said CEO Franz Humer in a statement.

- see this release for more

ALSO: Take a look at Roche's pipeline. Report

Related Articles:
Big Pharma makes its big leap into biotech. Report
Pharma goes mad for biotech deals. Report
Roche to boost R&D spend, reorganize research. Report
Roche shakes up R&D, eyes new buyouts. Report

ABPI outlines new Phase I guidelines

Thu, 16 Aug 2007 06:59:54 -0400

Responding to the scandal that erupted in the UK following a disastrous early-stage trial that sent six volunteers to the hospital, the Association of the British Pharmaceutical Industry has published new guidelines for Phase I studies which are designed to help avoid a repeat performance.

"Safety of volunteers for Phase 1 clinical trials is paramount, and this is at the heart of the revised guidelines," said Dr Richard Barker, ABPI Director General. "While the events surrounding the TGN1412 trial were unprecedented, we nevertheless have to do everything to ensure that they never occur again. As a result, conclusions and recommendations made in Sir Gordon Duff's report have been incorporated into the revised guidance."

- check out the release on the new guidelines

Related Articles:
Six men hospitalized after clinical trial goes awry. Report
TeGenero trial disaster leads to regulatory reviews. Report
U.K. researchers driven out by tough regulations. Report
GSK looks abroad for more scientists as U.K. shortage grows. Report

IBM gains $1.4B IT pact with AstraZeneca

Mon, 16 Jul 2007 06:59:57 -0400

IBM has inked a $1.4 billion, seven-year deal to manage AstraZeneca's IT infrastructure around the globe. The deal covers everything from PC management to servers and communications. "IBM will marshal its global resources to provide a flexible and agile infrastructure enabling AstraZeneca to continue implementing its plans to grow and lead in the pharmaceutical industry," said Doug Elix, Senior Vice President, IBM.

- check out the release on the IT deal

Related Articles:
AstraZeneca announces restructuring and buyout. Report
IBM to put worker genetic data off limits. Report
IBM hopes open source will open healthcare IT silos. Report
IBM introduces grid medical storage upgrade. Report

Press Release: Chinese Pharmaceuticals Market Forecast to Become the World's Fifth Largest by 2010

Maureen Martino — Mon, 25 Jun 2007 10:05:03 -0400

Chinese Pharmaceuticals Market Forecast to Become the World's Fifth Largest by 2010

DUBLIN, Ireland -- Jun 25, 2007 - Research and Markets has announced the addition of China's Pharmaceutical Industry - Porter's Five Forces Strategy Analysis to their offering.

The Chinese pharmaceuticals market is forecast to become the world's fifth largest by 2010 - and the largest by 2050. There are still greater market access following China's entry into the World Trade Organization (WTO), multinational investors continue to face a range of obstacles, many of which stem from the legacy of central planning of the industry. These include complex distribution, under-developed retail options, intellectual property infringements and pricing controls and pressures. At the same time, the continuing reliance of leading domestic companies on generic drugs has prevented the emergence of Chinese brands.

However, the industry is still small-scale, with a scattered geographical layout, duplicated production processes, and outdated manufacturing technology and management structure. The Chinese pharmaceutical industry also has a lower market concentration and weak international trading competitiveness, coupled with a lack of patented pharmaceuticals developed in-house.

We analyze China's Pharmaceutical Industry in Michael Porter's Five Forces Analysis. It uses concepts developed in Industrial Organization (IO) economics to derive five forces that determine the competitive intensity and therefore attractiveness of a market. Porter referred to these forces as the microenvironment, to contrast it with the more general term macro-environment. They consist of those forces close to a company that affect its ability to serve its customers and make a profit. A change in any of the forces normally requires a company to re-assess the marketplace.

Press Release: Sarasota's Roskamp Institute Discovers New Class of Drugs That Can Impact Alzheimer's Disease

Maureen Martino — Fri, 26 Jan 2007 13:21:46 -0500

Sarasota's Roskamp Institute Discovers New Class of Drugs That Can Impact Alzheimer's Disease

Discovery Detailed in Neuroscience Letters

SARASOTA, Fla., January 25, 2007 -- The Roskamp Institute announced today the discovery of a new class of drugs that lower the production of the main pathological protein that causes Alzheimer's disease. The discovery is detailed in an article co-authored by Drs. Daniel Paris and Michael Mullan and currently appears in Neuroscience Letters.

The Roskamp Institute, which is devoted to finding treatments for Alzheimer's disease, has been researching drugs that have the potential to stop the production of B-amyloid.

"When B-amyloid builds up in humans, patients develop Alzheimer's disease," said Dr. Michael Mullan, Director of the Roskamp Institute. "By stopping its production we can potentially stop the disease. We have found a whole family of drugs that can stop the production of B-amyloid, giving many companies working on NF-kB inhibitors the opportunity to test these types of drugs in Alzheimer's."

NF-kB (a protein that occurs in all cells in the body) activity results in inflammatory responses due to the switching on of genes that encode proteins that are key in inflammation. NF-kB inhibitors are being developed widely in the pharmaceutical industry primarily for its use in inflammatory conditions such as Arthritis and, until now, have not been thought of as a potential treatment for Alzheimer's.

At the same time, many drug companies are searching for compounds that can lower or stop the production of B-amyloid. The finding that NF-kB controls B- amyloid production means that NF-kB inhibitors might be developed as anti- Alzheimer drugs. One such example is Celastrol, which is researched in the Roskamp Institute's publication, and is available as a food supplement but has never been formally tested in Alzheimer's.

"Although we have known about the important inflammatory role of NF-kB for a long time, we did not know that it controls B-amyloid production," said Dr. Daniel Paris, Senior Scientist of the Roskamp Institute. "This may be one way that the inflammation caused by B-amyloid leads to more B-amyloid being produced -- a positive feedback loop with awful consequences for the sufferer."

The publication details the NF-kB findings and explains why this family of drugs should be tested for their use in treating Alzheimer's disease patients.

For more information on the Roskamp Institute and to view the journal article in Neuroscience Letters, please visit us online at http://www.RoskampInstitute.com. The article can also be viewed directly at http://www.roskampinstitute.com/pdf/NF_kB_Publication.pdf.

CONTACT: Sarah Bascom, +1-850-222-2140 for Roskamp Institute

Web site: http://www.RoskampInstitute.com/

Press Release: Consumers and Pharmaceutical Companies Far Apart on Views of Pharma Industry

Maureen Martino — Tue, 09 Jan 2007 13:18:08 -0500

Consumers and Pharmaceutical Companies Far Apart on Views of Pharma Industry, Finds PricewaterhouseCoopers Survey

Perception Gap is Eroding Public's Trust, Industry's Reputation

NEW YORK, Jan. 9 -- Significant differences between the public's view of pharmaceutical companies and the industry's self perception have caused the pharmaceutical industry to lose the trust of its key stakeholders, according to a PricewaterhouseCoopers (PwC) report released today, titled "Recapturing the Vision: Restoring Trust in the Pharmaceutical Industry by Translating Expectations into Actions." The disconnect is contributing to the decline in the industry's reputation and causing the industry's messages about its value to society to fail in the court of public opinion.

In a nationwide survey of consumers and pharmaceutical industry stakeholders, including physicians, health insurers, researchers and policymakers, PwC found that the public believes the industry has put profits before patients, abandoning its original vision of improving human health. As a result, the public disregards the benefits that pharmaceutical companies bring to healthcare. According to PwC, unless the industry takes decisive steps to understand and narrow the gap between its actions and public perception, its damaged reputation will continue to pose a threat to the long- term success of the industry.
"It is difficult to comprehend how an industry that has saved so many lives should be held in such low public esteem. Yet in the current climate of distrust, the public is questioning the industry's motives and practices from sales and marketing to pricing to drug development," said Peter Claude, a partner in PricewaterhouseCoopers Pharmaceutical and Life Sciences Advisory Services Group. "Pharmaceutical companies need to demonstrate a better balance of their primary healthcare mission with their fiduciary obligation to shareholders through patient-focused behavior. Research has shown that a 5 percent positive change in corporate reputation translates into a 3 percent to 5 percent positive change in market capitalization."
Key findings of PwC's survey reveal striking differences in the public's versus industry's perceptions about pharmaceutical companies:
-- Three out of four (74 percent) consumers underestimate the average financial investment required to research and develop a new drug by more than 50 percent.

-- Consumers are split between believing that pharmaceutical companies consider important unmet medical needs when deciding to develop a new drug (55 percent) instead of choosing to develop "me-too" and "lifestyle" drugs with the greatest sales potential (45 percent). This compares to 71 percent of industry stakeholders and 91 percent of pharmaceutical executives, respectively, who say health needs are a top priority for pharmaceutical companies.

-- 94 percent of consumers and 81 percent of industry stakeholders said that drug companies are too aggressive in promoting unapproved uses of their product. Fewer than half (47 percent) of pharmaceutical company executives agreed.

-- 62 percent of stakeholders agreed that drug companies often manipulate or suppress negative clinical trial results to maximize sales. Four out of five pharmaceutical executives disagreed.

-- More than seven in 10 stakeholders (73 percent) agreed that drug companies spend too much money and effort attempting to prevent generic drugs from competing with their branded products. Consumers strongly agreed that drug companies should be working with generic drug manufacturers to make generics available upon expiration of their branded drug's patent.

Misconceptions about the Cost and Role of Pharmaceuticals in the Healthcare Continuum
The PwC survey found that consumers and stakeholders believe pharmaceuticals comprise a much higher percentage of total healthcare costs than they do in reality. Two-thirds of consumers surveyed by PwC estimated that prescription drugs account for between 40 percent and 79 percent of U.S. healthcare costs. In fact, just 10 percent of healthcare spending goes to drugs, according to Centers for Medicare and Medicaid Services (CMS). According to PwC, this disconnect may stem from the fact that pharmaceuticals can consume a higher share of consumers' out-of-pocket spending than other components of health spending.
"The rise of consumer-directed healthcare will only feed the public's distorted view of how much drugs contribute to overall health spending," said Brian Riewerts, partner, PricewaterhouseCoopers Pharmaceutical and Life Sciences Advisory Services Group. "As consumers share more of the cost of care and make their own decisions about health services and products, they will be far more sensitive to drug pricing-yet they clearly do not appreciate the cost and financial risks of drug research and development. Worse, pharmaceutical companies aren't educating the public because they don't have adequate tools or transparency to accurately track and report the cost of innovation."
Almost nine out of ten (86 percent) consumers underestimated the cost of bringing a new drug to market. Independent studies place the cost of developing a single marketed pharmaceutical product in excess of $800 million. Part of public's misconception may stem from the fact that consumers neither understand who funds drug discovery nor appreciate the cost of failure that factors into each success in the drug discovery process.
Reputation Matters
PwC found that consumers place more value on a pharmaceutical company's reputation when deciding whether to use a given pharmaceutical product than pharmaceutical executives believed. Nearly eight of every 10 consumers (78 percent) said that when given a choice, they will consider a drug company's reputation when choosing which product to take. Only one out of three pharmaceutical executives, however, thought reputation was a factor. One of the chief ways patients become familiar with a company is through direct-to-consumer advertising, which poses a double-edged sword for the industry. In an era of growing consumer power, direct-to-consumer advertising can provide valuable information to a large audience of consumers. However, only 10 percent of stakeholders and consumers think that direct-to-consumer advertising provides complete and useful information, compared with 40 percent of industry executives. Furthermore, nearly 94 percent of stakeholders agreed that drug companies spend too much money on drug promotion overall, including direct-to-consumer advertising as well as physician education and overall sales force initiatives. Surprisingly, nearly three-quarters of industry executives agreed.
The report was developed by PricewaterhouseCoopers' Health Research Institute and PricewaterhouseCoopers' Pharmaceutical and Life Sciences Industry Group. To gather insight into the gaps between the industry's self- perception and the perception held by its stakeholders, PwC fielded a nationwide survey of 500 consumers and 150 members of industry stakeholder groups (doctors from physician groups, researchers, former health policy makers and executives from hospitals, managed care organizations and employers). In addition, PwC surveyed and/or conducted in-depth interviews with 20 pharmaceutical and biotechnology company executives.
About PricewaterhouseCoopers Pharmaceutical and Life Sciences Industry
Group
PricewaterhouseCoopers Pharmaceutical and Life Sciences Industry Group (www.pwc.com/pharma) provides clients with audit, tax and advisory services. The firm has extensive experience in delivering solutions to a wide range of strategic, financial and operational issues. The firm has also developed industry-specific services in the areas of regulatory compliance, IT and financial effectiveness, and performance improvement. The Pharmaceutical and Life Sciences Industry Group is part of PricewaterhouseCoopers' larger initiative for the health-related industries that brings together expertise and allows collaboration across all sectors in the health continuum.
About PricewaterhouseCoopers
PricewaterhouseCoopers (www.pwc.com) provides industry-focused assurance, tax and advisory services to build public trust and enhance value for its clients and their stakeholders. More than 140,000 people in 149 countries across our network share their thinking, experience and solutions to develop fresh perspectives and practical advice.
"PricewaterhouseCoopers" refers to the network of member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity.

CytRx spins off RNAi assets into new company

Mon, 08 Jan 2007 19:01:38 -0500

CytRx has set up a subsidiary devoted to RNAi, or gene silencing, and gathered a stellar group of advisers for it that includes the Nobel Prize-winning Craig Mellow. Tod Woolf, the former CEO at Sequitir, will run the operation, dubbed RXi Pharmaceuticals. Other advisers are: Gregory J. Hannon, Tariq M. Rana and Michael P. Czech. CytRx will own 85 percent of the new company and the advisers will share 15 percent.

"The clinical potential of RNAi technology is garnering strong attention from the pharmaceutical industry, making the timing excellent to acquire these RNAi assets from CytRx," Woolf said in a statement.

- check out the press release
- here's the AP report on the new company

Related Articles:
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Sirna posts positive data on RNAi therapy. Report

FDA, drug industry re-negotiate user fees

Mon, 20 Nov 2006 19:01:35 -0500

The pharmaceutical industry is in the process of negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the FDA, as the current agreement is due to expire at the end of 2007. The biggest proposed change would be for drug companies to pay additional fees that would be used to fund post-marketing drug safety studies. "Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market," notes In-PharmaTechnologist. But in the wake of the Vioxx disaster, post-marketing studies--which are used to determine the long-term effects and unanticipated complications from a drug--have received renewed attention. A recent study found that two-thirds of the post-approval drug trials promised by drug developers have never been started despite the fact that developers promised to undertake the studies in order to gain an approval.

In addition to new fees to fund post-marketing studies, the FDA has reached a deal with drug companies that will require the industry to pay fees for the agency to review TV ads. The money will be used to hire new staffers in order to speed the review process. Both Health and Human Services and Congress must agree to the deals before they can take effect.

- read this report from In-PharmaTechnologist
- check out the Wall Street Journal article (sub. req.)

Related Articles:
Report faults FDA's post-marketing vigilance. Report
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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

Democratic win could be bad news for pharma industry

Maureen Martino — Thu, 26 Oct 2006 12:06:37 -0400

The pharmaceutical industry could face big changes if Democrats gain control of Congress. As mid-term elections near, the increasing likelihood that Democrats could win seats in the House and Senate has pushed the pharmaceutical industry to donate more money to political campaigns than ever before. As of September, the industry has donated $8.7 million to campaigns--$1.7 million more than in 2002. One of the biggest battlegrounds is the Pennsylvania senatorial race, where incumbent Rick Santorum (R) and has received over $450,000 in pharmaceutical industry gifts--more than any other candidate.

“Assailed by Democrats, drug companies are pouring millions of dollars into close races, giving some Republicans a financial edge. In the process, the industry is becoming not just a campaign backer, but also a campaign issue,” observes the Wall Street Journal. The issue at stake is Medicare Part D, which House Democratic Leader Nancy Pelosi has vowed to immediately revamp should Democrats take control after the mid-term elections. Pelosi said legislation would be passed to allow government to negotiate prescription drug prices with drug companies. Under the current system the government must pay full price for the drugs. If this rule is changed, pharma companies may be enjoying far less profit from Part D. Article (WSJ sub. req.)

SPOTLIGHT: Democratic win could be bad news for pharma

Wed, 25 Oct 2006 20:01:33 -0400

The pharmaceutical industry could face big changes if Democrats gain control of Congress, leading pharma companies to donate more money to this year's political campaigns than ever before. At issue is Medicare Part D, which House Democratic Leader Nancy Pelosi has vowed to immediately revamp should Democrats take control. Report

FDA advisers blast agency's safety record

Mon, 09 Oct 2006 20:01:37 -0400

Five current or former members of the FDA's Drug Safety and Risk Management Advisory Committee have penned a strong critique of the agency's safety record, saying the FDA routinely overlooks safety problems associated with new or approved drugs. Writing for the Archives of Internal Medicine, the group says that the FDA doesn't have the money or structure necessary to make it independent of the pharmaceutical industry's influence. Furthermore, the FDA has known about its problems for a decade and done nothing to correct them, says the group, which includes Curt D. Furberg, a professor of medicine at Wake Forest University, Robyn S. Shapiro, Arthur A. Levin, Peter A. Gross and Brian L. Strom. Their remarks closely follow similar criticisms leveled by the Institute of Medicine, which quickly triggered renewed calls for a major overhaul of the FDA.

- read the article on the criticism from The Washington Post

Related Article:
IOM slams FDA, calls for major reforms. Report

Novartis inks biosimulation pact with Entelos

Mon, 21 Aug 2006 20:01:39 -0400

The UK's Entelos has inked a research pact with Swiss drug giant Novartis. Entelos will use its PhysioLab software platform to simulate the physical reaction of patients to new drugs. Novartis, which is putting up R&D money for the venture, will use biosimulation to evaluate the potential of new drugs as well as better design pivotal studies. No financial details were divulged in their announcement.

"The pharmaceutical industry is realizing the benefits of testing targets and drugs in silico before conducting expensive clinical trials," said James Karis, president and CEO of Entelos, in a statement.

- read the AFX report on the deal

Benitec restructures, cuts costs in half

Mon, 17 Apr 2006 20:01:36 -0400

Benitec of Mountain View, CA has cut its workforce in half in order to reduce its burn rate by $100,000 a month. Adding in other cuts, the company expects to reduce its costs by $4 million a year. Sara Cunningham, Benitec CEO, stated, "While these cost reductions will somewhat slow our development timelines in the short-term, we have retained our core scientific team and have thus preserved the current value of our Hepatitis C and HIV drug development programs. Given the tremendous excitement and investment in RNAi, from the pharmaceutical industry and through private and public equity, we will seek to capture the full value of our core assets creatively yet prudently."

- read the release for more

3M puts drug arm on auction block

Mon, 03 Apr 2006 20:01:39 -0400

3M says it is considering selling its drug development and marketing operation. 3M has hired Goldman Sachs to advise it on various alternative strategies, which typically is code for putting a company up on the auction block. The group, which employs 1,500 people, develops and sells drugs in dermatology, women's health, cardiology and respiratory medicine.

"The best way for this business to grow is for it to be free to pursue separate strategies under the direction of a dedicated pharmaceutical industry company with a business model better suited to maximize its potential," said Brad Sauer, executive vice president of 3M Health Care.

- read the report from the San Francisco Chronicle

Six men hospitalized after clinical trial goes awry

Tue, 14 Mar 2006 19:01:37 -0500

All six people taking the experimental drug TGN1412 from Germany's TeGenero fell ill and two were in critical care in a London hospital, according to British newspapers. TGN1412 is a monoclonal antibody designed to treat leukemia, rheumatoid arthritis and other inflammatory diseases. A spokesman for the Association of the British Pharmaceutical Industry said it was extremely rare to see this kind of reaction in a clinical trial. The trial has been suspended until investigators can figure out what caused such severe adverse events.

- here's the report from The Guardian

Isis, Rosetta Genomics in new research pact

Tue, 21 Feb 2006 19:01:38 -0500

Carlsbad, CA-based Isis Pharmaceuticals has teamed its experts in antisense technology with the microRNA researchers at Rosetta Genomics' to look for new therapies to treat liver cancer and other diseases. An example of the transnational development pacts that have been springing up with growing regularity, the alliance will focus on how antisense can regulate microRNA function in the liver, a topic that Isis broached in the current issue of Cell Metabolism.

"MiRNAs appear to regulate at least one-third of all gene expression and represent a new class of drug targets for the pharmaceutical industry," said Amir Avniel, president of Rosetta Genomics.

- read this release for more information