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Unlike many of its big pharma competitors which are shuttering US manufacturing facilities, MedImmune, the biologics division of London-based pharmaceutical giant AstraZeneca, Friday, opened a second bioproduction site in Frederick, MD.

The site which will employ 250 or more workers was constructed to manufacture MedImmune’s products including Synagis, a monoclonal antibody-based treatment against respiratory syncytial virus infections in high risk children.

The acquisition of MedImmune by AstraZeneca three years ago signaled the company’s commitment to increasing it biologics offerings in its historically-traditional small molecule drug pipeline. While the reasons for the company’s decision to build a second plant in Frederick aren’t entirely clear, it is great news for Maryland’s expanding commitment to biotechnology. There are approximately 350 biotechnology companies doing business in the state.

The addition of over 250 biotechnology and manufacturing jobs is certain to stimulate the Maryland economy; something that other big pharma companies have been reluctant to do. Investing in biomanufacturing is something that can help the US reinvigorate its moribund manufacturing sector. And, whether you believe it or not, the US is still second-to-none when it comes to manufacturing biologics and other biotechnology products.

Hat tip to MedImmune for the bold move!

Until next time...

Good Luck and Good Job Hunting!!! (try Maryland)

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The US Food and Drug Administration yesterday announced that a consent decree of permanent injunction has been filed against McNeil-PPC, the consumer products division of Johnson and Johnson, and two of its senior executives, for “failing to comply with current good manufacturing practice requirements as required by federal law. The action prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the FDA determines that its operations are compliant with the law.”

McNeil Consumer Healthcare Division’s Vice President of Quality Veronica Cruz and the company’s Vice President of Operations for OTC Products Hakan Erdemir were named defendants in the consent decree, filed with the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia on March 10, 2011. The highest ranking company executives in charge of the facilities named in a consent decree are always included (by law) on the civil action.

The decree also requires McNeil to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, Pa., into compliance.

Consent decrees are civil actions—not criminal ones— and are meant to be remedial rather than punitive. In other words, there are no fines levied and the agency expects the companies under consent decree to bring their manufacturing facilities back in to compliance with Current Good Manufacturing Practices (CGMP). However, if the company fails or refuses to comply with the FDA, criminal charges can be filed against the companies and the two executives mentioned in the consent decree. The agency had little choice but to seek a consent decree of permanent injunction against McNeil because of manufacturing problems and recalls of several of its signature brands including Tylenol, Motrin, Zyrtec, and Benedryl. Criminal charges may be forthcoming because of possible cover ups of the recall that involved hiring outside contractors to purchase tainted produced in bulk to surreptitiously remove them from store shelves.

FDA had little choice but to seek a consent decree because of the seriousness and continuous nature of the problems at its Fort Washington production facility and the fact that J&J senior executives were either unaware or unconcerned with the problems at its subsidiaries. While working under a consent decree may be embarrassing for J&J, the damage caused by the recalls of some of its most visible consumer and OTC brands may be irreparable.

 Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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Previously, BioJobBlog reported on the race between two groups led by the Mars and Hersey companies to sequence and decode the cacao (chocolate) tree genome. It should come as no surprise that the world’s two largest chocolate companies have pitted themselves against one another to decode the wonders of the cacao bean. After all, chocolate is big business and learning how to maximize yields, improve flavors and optimize the levels of cacao bean chemical components would be a boon to the company that was able to obtain the genetic information first!

Currently, most cacao farmers earn about $2 per day, but producers of fine cacao earn more. Increasing the productivity and ease of growing cacao can help to develop a sustainable cacao economy. The trees are now also seen as an environmentally beneficial crop because they grow best under forest shade, allowing for land rehabilitation and enriched biodiversity. Today, many growers prefer to grow hybrid cacao trees—rather than the original variety Theobroma cacao, Criollo)—that produce chocolate of lower quality but are more resistant to disease. Roughly five percent of the world’s current cocoa production is derived from Criollo cacao beans because of increased susceptibility to fungal diseases which results in higher costs and lower yields.

At the last installment of this ongoing saga, the Mars group, September 2010, released a statement that that they had beat the Hershey group and unraveled DNA sequence of the most common cacao bean variety that is used to manufacture most commercial chocolate.

The Mars researchers constructed a preliminary genomic map that covered over 70 per cent of the total cacao bean DNA sequence which is distributed over 10 chromosomes. These data were uploaded to The Cacao Genome Database which is publicly available as long as persons who access the data sign an agreement that stipulates that they “will not seek any intellectual property protection over the data, including gene sequences contained in the database. The Information Access Agreement allows any cacao breeders and other researchers to freely use the genome information to develop new cacao varieties.”

While the Mars group may have beat the Hersey group to the popular press, their research has not yet appeared in an academic journal for scientific scrutiny. Interestingly, the Hersey group yesterday announced that their version of the cacao genome was published in the most recent edition of Nature Genetics. According to the authors,

We sequenced and assembled the draft genome of Theobroma cacao (Criollo), an economically important tropical-fruit tree crop that is the source of chocolate. This assembly corresponds to 76% of the estimated genome size and contains almost all previously described genes, with 82% of these genes anchored on the 10 T. cacao chromosomes.

Analysis of this sequence information highlighted specific expansion of some gene families during evolution, for example, flavonoid-related genes. It also provides a major source of candidate genes for T. cacao improvement.

While Theobroma is often used to manufacture gourmet chocolates that particular variety of cacao tree often remains vulnerable to disease. Information gleaned from this study could be used to breed bioresistant varieties of Theobroma.

Further the authors noted:

Our analysis of the Criollo genome has uncovered the genetic basis of pathways leading to the most important quality traits of chocolate--oil, flavonoids and terpene biosynthesis […] It has also led to the discovery of hundreds of genes potentially involved in pathogen resistance, all of which can be used to accelerate the development of elite varieties of cacao in the future.”

Other genes that were identified include those for the production of cocoa butter, natural antioxidants, hormones, pigments, and aromas. BTW, for those of you who may be interested, cocoa was thought to be domesticated about 3,000 years ago in Central America; making it one of the world’s oldest domesticated tree crops.

It isn’t clear yet how the cacao genomes deciphered by the Mars and Hersey groups match up against one another. Regardless, the big winners here are chocolate lovers. What to you think the world stance will be on genetically engineered chocolate? 

Oy!

Until next time...

Good Luck and Good Eating!!!!!

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The recent manufacturing woes of orphan drug manufacturer Genzyme have been well documented and widely publicized. These problems resulted in massive shortages of some of its top selling drugs Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) causing many of the patients who depend on these drugs to maintain their quality of life to go without reduced or no treatments for months. 

Because both drugs were approved by the US Food and Drug Administration (FDA) as orphan drugs they enjoy seven years of market exclusivity from the date of regulatory approval which prohibits other companies from seeking approval and selling similar drugs in the US. Consequently, Genzyme is the only commercially-available source for the drugs. Genzyme’s ongoing biomanufacturing created massive shortages of both drugs last summer. Because of this, FDA allowed two other companies, Shire and Protolix Biotherapeutics (both have treatments for Gaucher (Protalix) and Fabry (Shire) disease in late stage clinical development), to make their drugs available (at no charge) to patients prior to regulatory approval. This was a relatively rare and bold move by the agency. But, to be fair, they had little choice because so many patients were suffering.  

In case you may be wondering there are approximately 1500 Cerezyme users and fewer than 1000 Fabrazyme users in the US. Despite the small numbers of patients, the cost of the treatments are extraordinarily high; costing patients as much as $200,000 per year for treatment.

According to an article in today’s NY Times as many a 15 percent of American Cerezyme users have switched to a different drug. Fewer patients with Fabry disease have switched mostly because Shire’s drug for Fabry disease Replagal was less widely available. The almost year-long shortages of both drugs have seriously tarnished Genzyme’s reputation. And previously loyal patients are questioning their almost decade long allegiance to the company. This, coupled with a 26 per cent decline in Genzyme’s stock price last year suggest that Genzyme’s standing as one of the top five biotechnology companies in the world may be in serious jeopardy. 

Despite calls for his resignation (and an attempt by Carl Icahn to wrest control of the company), CEO Henri A. Termeer, who has led Genzyme for over 20 years has vowed not to resign. While manufacturing problems are not uncommon in the biotechnology industry, the severity and ongoing nature of the manufacturing problems at Genzyme’s Allston Landing, MA production facility are unacceptable; especially for a company that specializes and prides itself in developing treatment for orphan disease indications. The FDA recently announced that it would fine Genzyme and place its manufacturing operations under a consent degree for an indefinite period of time.

Genzyme representatives now contend full supplies of Cerezyme will be available after May 1 and those for Fabrazyme possible in the third quarter of this year.

While so-called “copycat” or “me too” drugs developed by pharmaceutical companies tend to be vilified by consumers and patient advocacy groups, the agency prefers to approve more than one treatment option for a given disease indication in case one medication doesn’t deliver the intended therapeutic benefits or induces untoward adverse events. Unfortunately, the seven years of market exclusivity awarded to orphan drugs manufacturers that garner regulatory approval for their products prohibits this. The biomanufacturing fiasco at Genzyme suggests that it may be time to reexamine the Orphan Drug Act and modify some of the financial and regulatory terms that were included to induce drug companies to develop new treatments for orphan disease indications.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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Orphan drug manufacturer Genzyme today issued a press release that the US Food and Drug Administration (FDA) notified the company that it intends to take enforcement action to ensure that products manufactured at its troubled biomanufacturing facility in Allston Landing, MA are made in compliance with good manufacturing practice regulations.

The agency’s enforcement action will likely result in a consent decree under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations. Under a consent decree, Genzyme also would be required to make payments to the government and could incur other costs.

The Allston Landing facility was experiencing product quality problems for some time before FDA intervened and threatened regulatory action and sanctions against the orphan drug producer. According to the press release Genzyme will:

work cooperatively with the FDA to restore the agency’s confidence in its ability to operate the Allston plant at the highest standards, building on the progress it has made over the past year to address the manufacturing deficiencies at the Allston plant. This progress includes:

• Retaining a leading quality assurance advisory firm to help develop a comprehensive strategy and risk mitigation plan. More than 30 expert consultants from this firm are currently working at the Allston plant or at other Genzyme manufacturing facilities.
• Naming a new site head and reorganizing and strengthening the management team at the facility.
• Hiring two highly regarded industry veterans to serve as President of Global Manufacturing and Corporate Operations and Senior Vice President of Global Product Quality.

While this is not good news for Genzyme, it is great news for patients who rely on Genzyme’s medicines to manage their oft times devastating and potentially life threatening genetically-inherited diseases.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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It was only a matter of time after J & J launched its health channel on YouTube two weeks ago, that other pharma companies would begin to post videos on video-sharing sites. As a general rule, nobody in pharma wants to be first but after the first company takes the plunge, nobody wants to be left out or behind. Therefore, it came as no surprise when late last week, GlaxoSmithKline (which has a tendency to be second-to-market with competing products), launched a beta version of it so-called GSKCIC channel on You\Tube.

 According to a post on the Pharmalot blog, so far there are only two videos on the channel. One describes the company ongoing commitment and fight against disease in the developing world (ironically, the video ends prematurely).The second, which is full length, features CEO Andrew Witty telling us about his career at GSK (which began in 1985 as a management trainee) and how GSK is looking for a few good employees who “like a good challenge.” Curiously, the day after the Witty video appeared on YouTube, GSK announced that it was laying off about 90 workers or 10% of its work force at its manufacturing plant in Zebulon, North Carolina. A company spokesperson said that more cuts are expected at the North Carolina facility.

Maybe someone at GSK ought to tell its CEO that the company isn’t hiring at the moment?????????

Hat tip to Ed at Pharmalot!

Until next time….

Good Luck and Good Job Hunting!!!!

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