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Thursday, September 17, 2009


Top 10 Biologics Sales Top $41 billion

Sales of the Top 10 biotech drugs exceeded $41.5 billion in 2008, according to a new report issued by BioWorld Today. Amgen’s Enbrel topped the list with worldwide sales of $5.9 billion, followed by Genentech Rituxan ($5.08 billion), Abbott’s Humira ($4.5 billion) and Genentech’s Avastin ($4.5 billion) Genentech and Amgen both have 4 drugs in the top 25 with total sales of Genentech drugs reaching $15.7 billion in 2008 and Amgen’s totaling $14.9 billion.

1. Enbrel

Immunex Corp. patented the first biological response modifier approved for the treatment of rheumatoid arthritis (RA), called Enbrel, after cloning the soluble tumor necrosis factor (TNF) receptor gene in 1989. TNF, found in high amounts in the joints of arthritis sufferers, promotes inflammation. The genetically engineered fusion product Enbrel inhibits TNF by binding to it, which aids the patient by reducing the swelling, stiffness and pain from RA. Immunex, acquired by Thousand Oaks, Calif.-based Amgen Inc. for $10.3 billion in July 2002, continues to manufacture Enbrel. Enbrel sales for 2008 were up, despite U.S. approval of Humira for psoriasis.

2. Rituxan

Rituxan has experienced a gainful 12-year market run, bringing in more than $22 billion through 2008. Considering the dramatically increasing prevalence in its disease indications, Rituxan could become the first biologic to join big pharma blockbusters in the exclusive $50 billion club. Genentech Inc. and Biogen Idec Inc. state on their websites that they are preparing to make FDA submissions for Rituxan in previously untreated and relapsed chronic lymphocytic leukemia. A Phase III trial for Rituxan in treating vasculitis is ongoing.

3. Humira

Approved for five indications in the U.S., the revenue for Humira has been increasing rapidly over the years, more than tripling in sales from 2005 to 2008. In 2007, it brought in more than $3 billion, and it continued the trend in 2008, reaching sales of more than $4.5 billion. According to Abbott's 10-K filed in February 2009, the company forecasts worldwide Humira sales to increase more than 25 percent in 2009. Cambridge Antibody Technology Group plc (CAT), of Cambridge, UK, developed the technology for Humira and initiated the research program. In 1995, it signed an agreement with Knoll Aktiengesellschaft, which was acquired by Abbott in March 2001. CAT was acquired by MedImmune Inc. in 2007.

4. Avastin

The first anti-angiogenesis drug approved for cancer treatment, Avastin usually is combined with cancer-killing chemotherapy. A humanized IgG1 monoclonal antibody targeting vascular endothelial growth factor (VEGF), it helps stop new blood vessel formation in tumors and it also may improve drug delivery so that chemotherapy can kill more effectively. Even without approval for wet age-related macular degeneration, many doctors use it instead of the more expensive drug Lucentis (ranibizumab, Genentech). There also is huge interest in using Avastin in combination therapies, and the drug is being studied in 30 cancers in more than 450 trials.

5. Herceptin

Breast cancer patients with human epidermal growth factor receptor-2-positive tumors are candidates for Herceptin therapy. Even though the drug is only appropriate for a patient subgroup, Herceptin's success is validating the premise that pharmacogenomic drugs can attain blockbuster revenue. Herceptin has been on the market for a dozen years, in the billion-dollar annual revenue club for at least the last seven years, has no non-litigious patent competition until 2019, and has numerous ongoing trials to expand its application even further. Such factors could render Herceptin a stalwart workhorse for Genentech and an enduring ROI for Roche for most of the upcoming decade.

6. Remicade

Remicade was developed by Centocor, a Johnson & Johnson company. As a chimeric monoclonal antibody, Remicade uses both mouse and human components. According to Robert L. Shook in his book Miracle Medicines (2007), mouse cells are used to produce a protein, which is a cross between a mouse and human protein. It is engineered into a gene structure and introduced into a mouse cell to produce a specific protein, Remicade. The drug is administered by intravenous infusion.

7. Gleevec

Novartis AG developed the first anticancer drug that targets cancer cells more specifically. Gleevec, a 2-phenylaminopyrimidine derivative, inhibits a number of abnormal tyrosine kinase enzymes, thereby turning off the signal of Bcr-Abl, a protein that is associated with cancer. Iimatinib mesylate is marketed in the U.S. as Gleevec, and in Europe and Australia as Glivec.

8. Neulasta

Neulasta is the leading anticancer therapeutic used to maintain the utility of the immune system during solid tumor chemotherapy. The drug is a synthetic form of the natural granulocyte-colony stimulating factor that promotes an increase in infection-resistant neutrophils, and it is made using the bacteria Escherichia coli. The drug binds to cell surface receptors of neutrophil precursors to change cell behavior through signaling processes that induce the production of neutrophils.

9. Lantus

Lantus has the same type of glucose-lowering power as both commercial NPH hu insulin and insulin that is naturally produced by non-diabetics. Lantus (insulin glargine) is a soluble injectable human insulin analog produced by recombinant DNA technology (in K12 laboratory strain of E. coli). One asparagine replaced by glycine and two arginines at one end of its structure are the only difference from human insulin. Lantus minimizes spikes in insulin levels and provides 24-hour basal insulin levels with one dose, because it forms microprecipitates that are released slowly and constantly into the patient's system over a longer period of time than NPH hu insulin.

10. Aranesp

Aranesp springs from what could have been a huge loss for Amgen in the anemia market. The company licensed its epoetin alpha to Ortho Biotech Products LP, except for one indication in the U.S. Outside of the U.S., Ortho Biotech markets it as Eprex for all approved indications; inside the U.S., the drug is marketed as Procrit for indications other than kidney dialysis. Amgen's Epogen, the only indication the company retained rights to in the country, is indicated in the U.S. for the treatment of anemia in patients with end-stage renal disease. Its blockbuster Aranesp is a longer-lasting formulation of EPO.

Source: BioWorldToday

Saturday, September 12, 2009


FDA Embraces Personalized Medicine

The U.S. Food and Drug Administration will create a new position in the Office of FDA’s Chief Scientist that will concentrate on coordinating and upgrading the agency’s genomics-related activities and the fields of science that are involved in the analysis of complex DNA, protein, and small molecular expression patterns.

Frank Torti, acting commissioner of food and drugs, made the announcement in early February in a podcast on the FDA’s website. The first person to fill the newly post of senior genomics advisor will be Liz Mansfield, a scientist who has held high-level policy and scientific positions at the FDA and in the private sector. In her new role, Mansfield will focus on the FDA’s goal of providing FDA physicians and scientists with tools and personnel capable of high level analysis of complex genetic data.

“Through genomics, scientists are able to develop medical products and nutritional recommendations that are sometimes called ‘personalized medicine’—recommendations and therapies designed for individuals of a certain genetic makeup,” said Torti.

He noted that developing products that take into account genetic make-up should increase a product’s effectiveness and decrease the risk of harmful side effects. For the FDA, he said, insights gained through genomics point a way to faster and more efficient evaluation of new medical therapies and toward enhanced food safety.

Torti explained that the FDA’s emphasis on a coordinated genomics effort is the outcome of the June 2008 FDA Symposium and Retreat on Genomics, the recommendations of FDA’s advisory Science Board, and the agency’s own internal planning.

The creation of a new position devoted to coordinating the agency’s genomics effort is another step in the FDA’s efforts to improve its use of new technologies to promote and protect public health. In August 2008, the FDA and Medco Health Solutions, the nation’s leading pharmacy benefit manager, entered into a two-year research partnership to study genetic testing and the impact of genetics on the efficacy of prescription drugs. The agency has started talking to several personal genomics firms about possible alliances that could help the FDA track adverse drug reactions (post-marketing) by accessing the companies’ growing genomics databases, Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology, said in November..

“We stand as you know on the brink of a new era of personalized medicine and personalized health records,” said Torti. “To help advance this progress, the FDA must use the most advanced tools for evaluating the new and frequently highly complex products regulated by our agency. Further integration and coordination of the latest genomic technology into the FDA’s processes and decision-making will better protect and promote the public health.”

Source: The Burrill Report

Thursday, September 3, 2009


Genetics 2010: Model Organisms to Human Biology meeting

You are invited to attend the Genetics 2010: Model Organisms to Human Biology meeting. The meeting will be held June 12-15, 2010 at the Sheraton Boston Hotel, in Boston, Massachusetts.

On Saturday evening, June 12, the meeting will open with a plenary session at 7:00 pm followed by a Keynote Address by Gary Ruvkun, PhD, Harvard Medical School and Massachusetts General Hospital from 9:15 pm until 10:00 pm. A social will be held immediately after the session from 10:00 pm until 11:30 pm. The meeting will end on Tuesday, June 15 at 1:00 pm.

Join researchers in exciting Boston, Massachusetts where you can:

Keynote Speakers

Organizing Co-chairs

Plenary Sessions

Wednesday, September 2, 2009


Pfizer to pay record $2.3B penalty for illegal drug promotions

WASHINGTON (AP) -- Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drugmaker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.

Authorities called Pfizer a repeat offender, noting it is the company's fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.

As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.

"They were entertained with golf, massages, and other activities," said Mike Loucks, the U.S. attorney in Massachusetts.

Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.

To prevent backsliding this time, Pfizer's conduct will be specially monitored by the Health and Human Service Department inspector general for five years.

In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.

Associate Attorney General Thomas Perrelli said the settlement illustrates ways the Justice Department "can help the American public at a time when budgets are tight and health care costs are rising."

Perrelli announced the settlement terms at a news conference with federal prosecutors and FBI, and Health and Human Services Department officials.

The settlement ends an investigation that also resulted in guilty pleas from two former Pfizer sales managers.

Officials said the U.S. industry has paid out more than $11 billion in such settlements over the past decade, but one consumer advocate voiced hope that Wednesday's penalty was so big it would curb the abuses.

"There's so much money in selling pills, that there's a tremendous temptation to cheat," said Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports.

"There's a kind of mentality in this sector that (settlements) are the cost of doing business and we can cheat. This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship."

The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators. Authorities said Pfizer's salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

Use of drugs for so-called "off-label" medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. They said the junkets and other company-paid perks were designed to promote Bextra and other drugs, to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness.

Bextra, for instance, was approved for arthritis, but Pfizer promoted it for acute pain and surgical pain, and in dosages above the approved maximum. In 2005, Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market amid mounting evidence it raised the risk of heart attack, stroke and death.

A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra.

The $1 billion in civil penalties was related to Bextra and a number of other medicines.

A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state's Medicaid program.

Pfizer's top lawyer, Amy Schulman, said the settlements "bring final closure to significant legal matters and help to enhance our focus on what we do best -- discovering, developing and delivering innovative medicines."

In her statement, Schulman said: "We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls and pioneer new procedures."

In financial filings in January, the company had indicated that it would pay $2.3 billion over the allegations.

The civil settlement announced Wednesday covered Pfizer's promotions of Bextra, blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. The agreement with the Justice Department resolves the investigation into promotion of all those drugs, Pfizer said.

The government said Pfizer also paid kickbacks to market a host of big-name drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec.

The allegations came to light thanks largely to five Pfizer employees and one Pennsylvania doctor, who will now share $102 million of the settlement money.

FBI Assistant Director Kevin Perkins praised the whistleblowers who decided to "speak out against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims."

To rein in the abuses, the government's five-year monitoring will force Pfizer to notify doctors about Wednesday's agreement, encourage them to report any similar behavior, and publicly post any payments or perks it gives to doctors.

Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal health care programs. Some of that money will be shared among the states: New York, for example, will receive $66 million, according to the state's attorney general, Andrew Cuomo.

When Pfizer originally disclosed the settlement figure, it also announced plans to acquire rival Wyeth for $68 billion. That deal, which would bolster Pfizer's position as the world's top drugmaker by revenue, is expected to close before year's end.

Shares of Pfizer dropped 14 cents to $16.24 in midday trading.

By Linda A. Johnson.

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