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Yesterday I reported that Cangene, one of Canada’s oldest and largest biotechnology companies was reorganizing and laying off 120 employees. Today, the French drug maker Sanofi-Aventis announced that it would eliminate 100 jobs at its Montreal area (Laval) facility to allow for better integration of Genzyme, the Massachusetts-based biotechnology company that was acquired last year for more than $20 billion. About 1,700 employees work for Sanofi’s Canadian division.

Today’s layoff news comes only day after Johnson & Johnson announced that it would close its Montreal research center and layoff 126 employees. This is bad news for Montreal which emerged as one of Canada’s hot pharmaceutical and biotechnology zone in the early 2000s. 

The Canadian biotechnology sector is much smaller than its US counterpart but there are several high profile companies that have been able to establish themselves as players in the global biotechnology industry. Hopefully, these companies will be able to weather to the economically-challenging times that are currently plaguing the Canadian biotechnology industry.

Until next time...

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

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A study conducted in November 2011 by Cegedim Strategic Data, a market research and promotional audit firm analyzed the world’s top 100 pharmaceutical companies expenditure on traditional promotional (marketing spends) and then compared that spending with their presence on Facebook and Twitter.

Not surprisingly, Pfizer, Novartis and Merck (the world’s largest big pharma companies) finished in the top three for traditional promotional spending. However, their use of social media i.e. Twitter and Facebook varied widely. For example, Pfizer—the top promotional spender—was first in its number of Twitter followers and third in the number of likes on Facebook. On the other hand, second ranked Novartis was fifth in the number of Twitter followers and in seventeenth position for likes on Facebook. Finally, third ranked Merck was fifteenth in the number of Twitter followers (third for the number of tweets) and in the tenth position for the number of likes on Facebook (but has more pages than any of its Facebook competitors).

Other notable companies included:

• Johnson &Johnson, eleventh in promotional spending and number two on the number of Facebook likes
• Roche, number fifteen on the promotional spending list was ranked number two for the number of Twitter followers
• Proctor and Gamble which ranked a distant 54^th in promotional spending was number four on the Twitter follower list

What does this all mean? A whole lot of nothing because nobody can determine what effects the use of social media has on the bottom line for most pharmaceutical companies. Unlike other industries, where social media can be used to sell products, it cannot be used for direct promotional purposes in the life sciences industry. While most people will tell you this is because of the lack of guidance by FDA on the use of social media, the bottom line is that social media will never be allowed for direct-to-consumer advertising in the pharmaceutical industry. That said, pharma and biotech will have to find other uses for social media including clinical trial recruitment and retention, adverse event reporting, employee recruitment and retention and education and outreach.

Until next time...

Good Luck and Good Tweeting (and Liking)

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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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While video may be losing some of its “newness" and cache in social media circles, it continues to grow and has become a mainstay of networking platforms like Facebook, Twitter, and of course YouTube!  Despite its popularity in most industries, the life sciences industry continues to eschew its use. The reasons for this are not clear but it is counter intuitive given the billions of dollars the pharmaceutical and biotechnology companies annually invest in direct-to-consumer advertising. 

Several big pharma companies, most notably Johnson & Johnson, have attempted to increase the use of video to connect with its stakeholders but its efforts haven’t yield much of an ROI. I suspect that most industry insiders will tell you that the main reason why video is not routinely used is the lack of regulatory guidelines guiding its use on social media platforms. While this is a facile explanation, the existing regulatory guidelines for direct-to-consumer television advertising certainly apply to video!

In a post today on the EyeonFDA blog, Mark Senak offers a variety of ways in which life sciences companies can leverage video to their advantage to promote good will among shareholders and stakeholders alike. His ideas make sense and are very much within the regulatory guidelines for direct-to-consumer advertising. Whether or not direct-to-consumer advertising is a good thing is a topic for another post!

Until next time...

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

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There are signs that the economy is improving and that unemployment levels have dropped from a high of 10.1 % to current levels which are hovering around 9.5 %. While this is good news, job cuts continue at many pharmaceutical and biotechnology companies as drug candidates fail in clinical trials and technological advances make certain employees dispensable.

Yesterday, Johnson and Johnson announced that it would layoff 300 of 400 employees who work at the Fort Washington, PA plant that was responsible for the recent Tylenol brouhaha and recall. According to a post on the Pharmalot blog:

”The employees are being let go because it is not clear when the plant will operate again. A J&J spokeswoman says the “best estimate” is the middle of 2011. It isn’t clear at this point whether or not any McNeil executives who oversaw operations at the troubled facility will also be shown the door."

In other news, Adolor, a Pennsylvania-based specialty drug maker, announced yesterday that it was laying off 30 workers or 30 per cent of its workforce to preserve capital and advance its opioid bowel dysfunction clinical development program through proof-of-concept studies in 2011. Also on Friday, the company stated in a press release that two new drug candidates it was developing with Pfizer to treat pain caused by osteoarthritis did not work better than a placebo in a Phase II clinical trial involving 400 patients. The company has one drug on the market, Entereg, a treatment that helps restore bowel function in adults who have undergone bowel re-section surgery. Earlier in the week, GlaxoSmithKline, which co-developed Entereg, scaled back its relationship with Adolor.

Finally, Eli Lilly & Co told its employees that it plans to cut 340 information technology jobs in 2010. Most of the cuts will take place in Indiana (Lilly’s corporate headquarters is in Indianapolis). The company has 1,350 information technology employees nationally. Earlier this year, Lilly has said it will eliminate 5,500 jobs by the end of 2011 to save $1 billion.

Until next time...

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

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Johnson & Johnson’s McNeil Consumer Healthcare, already under Congressional investigation for selling allegedly tainted Tylenol, announced late Tuesday that it was recalling other products made in the Puerto Rico manufacturing facility in question.

According to an article in today’s New York Times, “McNeil Consumer Healthcare, the Johnson & Johnson unit, said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills. McNeil did not respond to a reporter’s query about how many bottles those lots amounted to.”

Since last November, McNeil has recalled about 11.7 million bottles of various Motrin products and about 6.3 million bottles of Tylenol Arthritis Pain caplets made at the Puerto Rico plant in question. The company began the product recall after receiving numerous consumer complaints about a moldy odor emanating from some of its products.

Company representatives contend that the moldy smell was caused by contamination from a chemical byproduct of a substance used to treat wooden transport pallets. Further, McNeil suggested that the risk of serious medical problems was remote and people should not stop using the products (yeah right).

The current recall just adds to McNeil’s growing manufacturing problems. The company is already under scrutiny by the House Committee on Oversight and Government Reform over a recall last April of an estimated 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec.

I suspect that more problems will be uncovered as the FDA and Congressional investigations continue. Serious manufacturing and quality problems can almost always be avoided or minimized when company executives and management makes a bona fide commitment to quality systems. Clearly, the heads of McNeil Consumer Healthcare might benefit from remedial current good manufacturing practices (cGMP) training.

Until next time...

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

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Johnson & Johnson is arguably one of the world leaders in bringing social media to the pharmaceutical industry. Marc Monseau and his dedicated team oversee a network of blogs, video channels and Twitter feeds while some of J&J’s brand companies even sponsor patient advocacy communities like ADHD Moms and ADHD Allies. However, the company’s recent handling of manufacturing problems and recall of Tylenol and other pediatric medicines seemingly flies in the face of openness and transparency; two of the underlying tenets and guiding principles of social media.

In an article in today’s New York Times, Natasha Singer reports that “a Congressional investigation into a recent recall of children’s Tylenol and other pediatric medicines has been stymied by the manufacturer, Johnson & Johnson, raising the prospect that new measures — like issuing of subpoenas to compel cooperation — could be invoked.”

McNeil Consumer Healthcare, the unit that manufacturers Tylenol and other over-the-counter medications, is no stranger to scrutiny by the US Food and Drug Administration (FDA). It is currently being investigated for a pattern of violations in manufacturing practice and quality control issues that have led to recalls of several medications. Last month, the agency suggested that it was considering criminal penalties or other actions against McNeil executives.

According to the times article, the House committee opened its investigation in early May shortly after McNeil announced a voluntary recall of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec. FDA investigators uncovered evidence that the products, made at a company plant in Fort Washington, Pa., may have included metal particles, or too much of the active drug ingredient, or inactive ingredients that did not meet testing standards.”

Manufacturing problems are not uncommon in the pharmaceutical industry and it isn’t clear what J&J has to lose by not fully cooperating with FDA officials. In fact, failure to cooperate could lead to harsher penalties and larger fines. However, I suspect that McNeil hasn’t been forthcoming because of allegations of a so-called “phantom recall” that took place last year, where J&J contractors secretly removed alleged defective products from store shelves.” Nevertheless, ongoing media coverage of the recall and the circumstances behind it are beginning to cast a very negative light on McNeil products and the J&J brand.

Pharmaceutical social media advocates contend that one of the reasons why pharma companies ought to use social media tools is information dissemination and so-called damage or crisis control. While I haven’t been assiduously screening all of the J&J social media channels, it seems like now would be an ideal time to begin to leverage them. 

It is unfortunate that an innovative and progressive pharmaceutical company like J&J has come under fire. However, product quality and safety is of paramount importance to consumers. And companies that cannot ensure those product attributes must move quickly and decisively to reinstate them. To that end, J&J ought to fully cooperate with FDA regulators, fix its Tylenol problems and then use its abundant social media channels to reinstate public confidence in McNeil Consumer Healthcare and the J&J brand! After all, isn’t that what social media is all about?

Until next time...

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

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Times are tough in the financially-struggling pharmaceutical industry and seemingly getting tougher.

First, Bristol-Myer Squibb (BMS) announced last week that it will freeze salaries but not cut yearly performance bonuses for its employees. One week later, Johnson & Johnson (J&J)—a company known not to be upstaged or outdone by a competitor—is planning on cutting the yearly performance-bonuses for 38% of its workforce and will freeze the salaries of certain other employees.

While BMS publicly announced its salary freeze, J&J plans were uncovered in an internal announcement and other company documents obtained by The Wall Street Journal. According to the Journal article, “The health-care giant told employees Jan. 25 that it is making the moves to standardize compensation across its various businesses and regions, thereby making it easier for its workers to move around within the company. In the U.S., the changes will bring bonus targets in line with market levels, one document said.”

Interestingly, J&J hasn't yet reported its CEO, William Weldon’s compensation for last year. In 2009, Mr. Weldon turned down a salary raise. His total compensation in 2008 fell 4.1% from the year before to $29.4 million, according to the most recent regulatory filing.

The salary freeze and bonus cuts help to explain why a good friend and lifelong J&J employee (25 years and counting) wasn’t too keen on the company during a visit earlier this week. During a conversation, in which I unknowingly lauded J&J’s treatment of its employees, my friend quipped “Looks can be deceiving; J&J is like every other big corporation. People really don’t matter—it’s all about P&L”

Until next time...

Good Luck and Good Job Hunting!!!!

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Johnson & Johnson announced today it would eliminate as many as 8,200 jobs, or 7% of its work force, to help the company cope with what it expects will be a slow economic recovery amid damped demand for drugs, medical devices and consumer products. J&J employs about 117, 000 workers globally. While the job cuts will be global, many losing their jobs will be outside of the US. 

J & J joins a growing list of pharmaceutical and life sciences companies that have announced new layoffs. Pfizer Inc., the world’s biggest drugmaker, plans to fire 19,000 workers following its acquisition of Wyeth and had already cut 10,000 positions since 2007. J&J began firing as many as 4,400 employees from its pharmaceutical and stent divisions in late 2007. Finally, Merck recently announced that it will be eliminating 16,000 workers after its merger with Schering Plough closes later this year.

J&J’s announcement is more bad news for New Jersey which is still reeling from the earlier loss of tens of thousands of pharmaceutical and life sciences jobs.

Until next time...

Good Luck and Good Job Hunting (forget New Jersey)

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The Eye on FDA blog reported today that AstraZeneca and Sanofi-Aventis have joined the ranks of Abbott, GSK, J&J and SanofiPasteur on YouTube. Pharmaceutical companies are taking advantage of the power of YouTube and other social media sites because regulatory guidance hasn’t been issued on its use to promote products or brand awareness. In other words, this is uncharted territory and companies can essentially 'test the waters' to see how far regulatory agencies will let them go.  I suspect that early life sciences company adopters of social media will garner substantial ROI before regulatory guidance is issued.

A lack of regulatory oversight, the ability to manage and control content and the low costs associated with creating Internet videos make YouTube and other social media sites attractive to pharmaceutical and biotechnology companies. The life sciences sector is just beginning to recognize the power of social media and the role that it may play in promoting products and brand awareness to consumers.  Expect many more life sciences companies to experiment with social media in the near future--its a veritable goldmine!

Until next time…

Good Luck and Good Video Watching!!!!!!! 

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Late yesterday, drug maker and consumer healthcare giant Johnson and Johnson announced that it was buying Mentor, a Santa Barbara, CA maker of skin care products, liposuction equipment and MemoryGel breast implants. According to industry analyst the $1.07 billion that J&J will spend to purchase the company “represents a giant premium for Mentor.” Mentor will become a stand-alone unit of J&J’s Ethicon a leading supplier of sutures, mesh and other surgical products. The cosmetic surgery and anti-aging markets are huge and are expected t to grow as the baby boomer generation continues to age.

J&J is on something of a buying spree and will continue to buy specialty companies to to offset possible losses that may from a weak drug pipeline of its pharmaceutical division. In November, the company purchased Omrix for $438 million, a biopharmaceutical that develops biosurgical and passive immunity products. The deal is expected to close this month.

Unlike most other pharmaceutical companies, J&J has been able to successfully run a diversified conglomerate company that specializes in both pharmaceutical and consumer healthcare products. It is a cash rich company that has a reputation for treating its employees very well! Who said that “beauty is only skin deep?”

Until next time

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

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U.S. regulators have delayed a decision on approval of an antibiotic from Johnson & Johnson and Basilea saying they need further audits of clinical sites, the two companies said on Wednesday.

Ceftobiprole, a broad-based spectrum antibiotic targeted mainly against infections caused by methicillin-resistant Staphylococcus aureus (MRSA), is Basilea's lead product and the news hit the Swiss biotech shares, which plummeted 27 percent.

In a so-called complete response letter on the drug's approval application, for complicated skin and skin structure infections, the Food and Drug Administration (FDA) said it was unable to review the clinical data submitted with the NDA until issues of data integrity had been resolved. The FDA has asked J&J to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring."

Ceftobiprole is approved in Canada and Switzerland and has been recommended for approval in the European Union. A new application in the United States is planned within a year.

Late last week, FDA rejected an NDA for another antibiotic, iclaprim, being developed by Arpida, another Swiss company. It has been a bad two weeks at FDA for approval of new antibiotics—drugs that we desperately need.

Until next time….

Happy Thanksgiving

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Can anything else go wrong at Amgen? FDA regulators said on Thursday that they were reviewing the results from two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs, sold by Amgen Inc (Epogen & Aranesp) and Johnson & Johnson (Procrit). For those you who don’t know, J&J licensed Procrit from Amgen so there is really little difference between J&J’s Procrit and Amgen’s Epogen. Aranesp is a second generation, longer-acting version of Amgen’s Epogen.

In the studies, researchers used  Aranesp or Procrit to elevate a patient's level of hemoglobin to 12 grams per deciliter or higher, although many patients did not reach that level. Current warnings on the drugs say hemoglobin levels should not rise above 12 for patients with cancer. The FDA said the studies showed that patients with breast or advanced cervical cancer who were treated with the drugs died sooner, or had more rapid tumor growth, than similar patients who were not given the medications.

Based on these new data, it is almost certain that the agency will insist on label changes to include strong warnings regarding the use of EPO drugs to treat oncology patients. Maybe there is a black box warning in Amgen’s future?

Amgen's stock hit a new 52-week low on Thursday, dipping down to $45.25 and closing at $45.69. It has traded as high as $76.95 in the last year but has taken a beating with the decline of its anemia-drug franchise.

The similarities between Amgen and Pfizer are becoming more apparent each day. Both are largest companies in their respective sectors (biotech and pharma) and have relied almost exclusively on blockbuster franchises (and weak pipelines) to bolster their stock prices! As you may recall, both companies have laid off large numbers of employees over the past year to cut costs. Maybe bigger (biggest) is not always better?

Until next time….

Good Luck and Good Job Hunting!!!!

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I hate to be the bearer of bad news (don’t kill the messenger) but 2007 has been rife with corporate downsizing and job layoffs. According to a post at Fierce Biotech, jobs cuts were primarily driven by “Concerns about patent expirations, falling sales due to drug safety concerns, redundancy from acquisitions and a general need to streamline operations”. The companies that have “laid-off” the most workers are:  

1. Pfizer-10,000 
2. Astra Zeneca-7,600 
3. Bayer-6,100 
4. Johnson & Johnson
5. 5,000 Amgen-2,600

Companies that did not make the list but have quietly been laying off workers or freezing jobs include GlaxoSmithKline, Merck, Eli Lilly and Bristol-Myers Squibb.

It is not a good time to be looking for a job in the pharma or biotech industries. That said, there is always hope and let’s “hope” that 2008 is a better year for both industries.

Until next time….

Good Luck (you will need it) and Good Job Hunting!

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