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The Pharmalot blog reported today that Eli Lilly & Co one of the more progressive big pharma companies to experiment with crowdsourcing and social media to generate new R&D opportunities today announced that it most company employees and executives will not receive base pay increases this year. The company did not announce a freeze in bonuses, however.

In a sign of solidarity with the 99 %, John Lechleiter, PhD Lilly’s outspoken and sometimes controversial CEO, requested that he not receive an increase to his $1.5 million annual salary and incentives. Interesting, as Ed Silverman cogently points out in the Pharmalot post, Lechleiter’s bonus target is 140% of his base salary which put his total compensation for the upcoming year at around $16.4 million!

Last week, the company disclosed that it missed analyst’s stock price estimates and its leading product Zyprexa (antipsychotic) yielded lower than expected sales revenues because of generic competition. Zyprexa sales dropped 44 percent in the fourth-quarter to $749.6 million.

Don’t be surprised if layoffs are next. It may be time for Lilly employees to dust off those CVs and resumes.

Until next time...

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While China and India have gotten the most attention as emerging pharmaceutical markets, Latin American markets most notably Mexico and Brazil (okay, it is a South American country but it can be included in Latin America) have been quietly expanding as rapidly as the Indian and Chinese markets. To wit, Denmark-based, Novo Nordisk—the world’s largest insulin maker—recently announced that it will be beefing up its medical consultant (aka sales reps) presence in Latin America over the next two to three years. During this period, the company expects to increase its current headcount of 300 to 800 employees.

Novo currently holds a 50 percent share of the Latin American insulin market. The company currently generates annual sales in Latin America of approximately $360 million. But, its main rivals Sanofi Aventis and Eli Lilly & Co, which sell faster-acting insulins, are beginning to cut into Novo’s market share.  The solution: add more sales reps in the region. While this may be great news for Latin American sales reps, it is not good news for American sales reps. Unless, of course, these reps speak Spanish and are willing to relocate!

Until next time...

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

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I received a heads-up from the American Chemical Society’s (ACS) Sergio Lewis about a free webinar entitled “How to Secure and Nurture a Vibrant Chemistry Career in the 21^st Century.” The webinar is scheduled for December 1, 2011 from 2:00-3:00 PM and will be led by Brian Fahie, PhD from Eli Lilly & Co. The presentation will be followed by a Q&A session.

For more information you can download the program here. To register follow this link.

Until next time...

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

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Mark Senak, author of the outstanding EyeonFDA blog, tweeted today, that Eli Lilly & Co had launched a YouTube Channel. According to a post on the company’s blog Lilly Pad, its new channel dubbed the “Lilly Health Channel” will “videos on health and wellness, employee and community outreach efforts, health innovation, Lilly programs and other non-product-branded initiatives.”

While the announcement of a launch of another pharma-sponsored YouTube channel is no longer new or novel, Eli Lilly has been trying to transform itself into a modern, social media and crowdsourcing-focused pharmaceutical company. For example, Lilly is one of only a handful of big pharma companies that sponsors its own corporate blog. Moreover, the company is a leader in using so-called crowdsourcing to discover and develop potential new drugs. It has spun off at least two ventures that utilize a crowdsourcing approach to new drug discovery. Finally, unlike most other big pharma CEOs, its chief executive John Lechleiter has been outspoken about the lack of innovation and available workforce talent in the US life sciences industry. 

Is Lilly truly the pharmaceutical company of the future? That remains to be seen! 

Until next time... 

Good Luck and Good Viewing!!!!

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A report in Bloomberg News today suggested that Eli Lilly & Co. Chief Executive Officer John Lechleiter, PhD told a technology conference today that unfavorable US permanent resident (green card) laws are to blame for declining US innovation in the life sciences. With this in mind, Lechleiter plans on calling for US immigration officials to issue more green cards and adopt a shorter and simpler process for highly skilled foreign nationals to gain permanent residence in the US. According to Dr. Lechleiter, one of only a handful of big pharma CEO who is also a PhD-trained scientist, current green card regulations are so-called job killers and force many talented foreign nationals to return to their native countries to work with firms that directly compete with American life sciences companies. Unlike most of his peers, Lechleiter has been very outspoken about the lack of US life sciences innovation.

While Lechleiter comments may have been appropriate five or more years ago, they are no longer germane to America’s waning innovation in the life sciences. There is little doubt that many bright and talented foreign nationals were denied permanent residency during the Bush era (2000 to 2008) because of stringent immigration policies and limits on the numbers of green cards allotted for persons from certain parts of the world; mainly China, India and the Middle East. This, in turn, forced many life scientists—many of whom desperately wanted permanent residency in the US—to return to their home countries to look for work and gainful employment.

As Lechleiter rightly asserts, these scientists found work with companies that began to directly compete with US life sciences. This phenomenon, coupled with the rapid assent of the middle class in many of these nations, made it possible to begin to conduct Western style research at a much lower costs in these countries. To that end, by 2007, most big pharma companies—many of whom had dwindling pipelines and monstrous overhead costs—realized that it would be more cost effective to outsource or move R&D to countries with emerging pharmaceutical and biotechnology markets and a well trained R&D workforce. And, for the past four years downsizing and outsourcing of R&D are exactly what have been taking place at many American big pharma and biotechnology companies.

In my opinion, the larger question that must be addressed, as far as US innovation in the life sciences is concerned is: why are so few Americans willing to pursue scientific careers? To wit, the main reason why so many foreign life scientists were educated and trained in the US over the past 20 years was because there weren’t enough American students to fill the incoming roster at most American graduate training programs. Put simply, America’s growing lack of innovation in the life sciences over the past decade can be directly attributed to far fewer Americans pursuing scientific careers and an increased reliance on foreign nationals—who were unable to stay in the US—to innovate! While changing US immigration laws may allow some foreign nationals to more easily remain in the US, there simply aren’t enough life sciences jobs left in the US to make it worth their while! In fact, the likelihood of them finding life sciences jobs in their home countries is now greater than it is in the US. In my opinion, the only way to restore American innovation in the life sciences is to convince American students that pursuing scientific careers is worthwhile and that the requisite training for industry jobs is available to them.

Interestingly, after leading with changes to US immigration laws, Lechleiter also suggested that America’s innovation problem could be solved by lowering US corporate tax rates and American companies should not be forced to pay taxes on oversea earnings. Also, he asserted that the US Food and Drug Administration (FDA) should stop putting off decisions or erring on the side of avoiding risk when considering new drug applications. 

This begs the questions, how do lower taxes, no overseas taxes and expedited drug approvals help to spur American innovation when most life sciences R&D is conducted outside of the US?

Until next time...

Good Luck and Good Innovating!!!!!!!!

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Bloomberg news today reported that Bayer AG’s Chief Executive Officer Marijn Dekkers said that he would consider a “merger of equals” to bolster the company’s sagging healthcare division. The division, a minor revenue source for Bayer AG, posted $25.1 billion in sales last year.

While Dekkers did not name the companies that he considers to be Bayer’s “equals”, convention wisdom suggests the list is likely to include Eli Lilly & Co, Bristol Myers Squibb (BMS) and Amgen, one of the last remaining, large, independent biotechnology companies. Lilly and BMS both  had  sales revenue similar to Bayer's last year whereas Amgen had lower sales of $15.1 billion. 

The reasons for a potential merger are not entirely clear. However, Bayer Healthcare is waiting to hear about regulatory approval of its new anticoagulant Xarelto medicine for irregular heartbeat patients who face the risk of a stroke. Analysts predict that Xarelto may exceed $2.5 billion in global sales. Approval of Xarelto will change Bayer’s valuation and consequently, don’t expect merger talks to begin until after FDA renders its decision on the drug.

Meanwhile, Bayer’s top-selling multiple sclerosis (MS) treatment betaseron faces competition from a similar Novartis drug called Extavia, and from its new oral MS medication Gilenya. Sales of betaseron fell 5 percent in the first quarter. Moreover, sales of Bayer’s birth-control pill Yaz dropped 18 percent after Teva Pharmaceutical Industries Ltd. introduced a generic version of the medicine.

Lilly, BMS and Amgen all face significant challenges in the future and both BMS and Amgen have been repeatedly mentioned as takeover targets. However, from a historical perspective mergers of mediocre or struggling companies rarely yield stronger, more financially robust ones! But, what do I know, I am just a scientist!

Stayed tuned for more updates.

Until next time...

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

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Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules.

To that end, an article that appeared in FiercePharma last October noted that eleven big pharma companies had paid a total of over $6.0 billion in fines to the US government over the last two years or so. The biggest losers include Eli Lilly paid over $1.4 billion in fines because of alleged illegal marketing of its anti-psychotic drug Zyprexa and Pfizer which paid $2.3 billion for marketing missteps with three drugs including Bextra (pain), Geodon (schizophrenia) , Lyrica (neuropathic pain) and Zyvox (antibiotic). 

More recently, GlaxoSmithKline agreed to pay $750 million fine in a whistle blower lawsuit that alleged that the company had sold "adulterated products" manufactured in a Cidra Puerto Rico production facility. Also, the company announced last February that it intends to pay $3.4 billion to settle lawsuits alleging the improper promotion and sale of several of its products including the blockbuster diabetes drug Avandia and Paxil (depression).

The article also included a timeline of some of the other major settlements that have recently taken place (seen below)

Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Infraction: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Infraction: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest's off-label use of Celexa for children's use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Infractions: Allergan's $600 million Department of Justice settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.

Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Infraction: The Irish drugmakers received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company's U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Infraction: Though J&J's more infamous woes stem from its phantom recalls, two of the troubled drug maker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Infraction: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug's safety.

Despite concerted efforts by the US Food and Drug Agency to limit off-label promotion of prescription drugs, most pharma companies continue to see how far they can push the envelope before the agency catches up with them. Given the current budget woes facing FDA, don’t be surprised if the frequency of off label promotion and misrepresentation of prescriptions drugs continue to rise.

Until next time...

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

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For the past three years or so, Eli Lilly CEO John Lechleiter has publicly criticized America’s lack of math, science and engineering preparedness. Further, he has lamented that this lack of preparedness has resulted in a lack of innovation and that it threatens the US standing as a leader in the pharmaceutical and biotechnology industries. Finally, Lechleiter squarely places the blame on American science educators. 

Therefore, it came as somewhat of surprise to me when I learned that Lilly (and many other pharmaceutical companies) are outsourcing an increasing amounts of drug discovery and development to Chinese contract research organizations (CROs pharma companies continue to outsource drug R&D to ostensibly lower development costs and get drugs to market faster. According to Chuan “Joe” Shih, a former Eli Lilly employee of 25 years and executive vice president of integrated drug discovery at Crown Bioscience a Shanghai-based CRO, the total annual cost for one researcher at Lilly might run $300,000 to $350,000 a year. The figure at Crown is one-third of that. Shih also disclosed that Pfizer was one of Crown’s clients.

In addition to Crown, Eli Lilly has outsourced R&D to other Chinese CROs that includeWuXi AppTec and ChemExplorer. It also operates its own research-and-development center in Shanghai and is building a diabetes research center here. Like Lilly, big pharma companies like Roche, Novartis and others have also established research centers in China.

Some analysts contend that the reasons given for the current R&D outsourcing trends—lower costs and faster market times—are red herrings. They suggest that establishing R&D in China helps position companies to sell into the huge, emerging Chinese market. Within the next decade or so, the Chinese market may eclipse the US as the major pharmaceutical market in the world.

Interestingly, in an interview in Shanghai Lilly’s Lechleiter said that he believed that CROs in China have more to offer than cost savings. “The skill level and the quality and the increasing availability of high-skilled and high-quality operations in the contract-research space render these firms globally competitive,” he said. Further, he added that in recent years, Lilly has had difficulty getting green cards or permanent resident visas for some of the Chinese people graduating from American universities it wants to hire. “So we need to follow the talent, and I expect there will be people recruited to the U.S. who will want to stay in the U.S. And there will be Chinese people and others who want to come back here. Our research center in Shanghai gives them a place to land.”

Does this mean that Lechleiter has given up on his quest to improve American science preparedness and American innovation? And, what will become of the 100,000 or so American pharmaceutical scientists who were laid off in recent years or those new minted American PhDs who cannot find work in the US? Is that the fault of the American education system or pharmaceutical companies that are trying to maintain profit margins at any cost or improving the likelihood of success in emerging markets in developing nations?

Until next time…

Good Look and Good Job Hunting (try the BRIC countries)

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The Japanese drug maker Eisai, Co announced that it will cut at least 900 jobs over the next five years to improve operating margins to offset the impending lost of patent protection for Aricept its blockbuster Alzheimer’s  disease treatment. The company did not specify where the cuts would take place.

In other news, based Eli Lilly & Co announced plans to outsource its R&D bioanalytical functions to Advion Biosciences a contract research organization that is building new laboratories Lilly’s home town of Indianapolis, Indiana. Ithaca NY-based Advion is building a 22,000 sq ft facility that will focus on ADME and toxicology experiments that are required for new molecules to enter human clinical testing.

Advion offers a range of Good Laboratory Practice-compliant and discovery bioanalytical services, including liquid chromatography-tandem mass spectrometry (LC/MS/MS) for determining small-molecule drugs, macromolecule therapies and biomarkers; immunoassay services; ADME (absorption, distribution, metabolism, and excretion) screening; cytochrome P450 inhibition and induction study support; metabolism profiling; metabolite identification; sample management; and sample storage.

According to a press release:

 “Lilly will transition its own drug discovery bioanalytical capabilities to Advion and will offer employees affected by the move the opportunity to join Advion. The new laboratory is expected to be fully operational by the end of May 2011.”

This is another example of big pharmaceutical companies exiting the R&D space. Because of the rampant downsizing and outsourcing of R&D functions to CROs, now could be one of the better times in years to start a biotech company. Big pharma is relying on starts up companies and academic laboratories to be the major source of new molecules that they develop. That said, the age of big “in-house” drug discovery operations at big pharmaceutical companies is drawing to an end. 

Until next time...

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

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After seven months of public bickering over an appropriate sale price, the NY Time reports today that Sanofi Aventis may have hammered out a deal that would enable the French drug maker to acquire the world’s largest orphan drug manufacturer Genzyme for $19 billion. According to the report, Sanofi will acquire Genzyme for a $74 per share which is up from it previous offer of $69 per share.

Most analysts and the Genzyme management team felt that the previous $69 per share offer was too low and that the tipping price would be in the mid 70s. This made sense even to outsiders like me because Eli Lilly purchased ImClone, a company with only one approved product on the market, for $70 per share several years ago. Genzyme has multiple FDA-approved products with a strong late stage drug development pipeline. Not surprisingly, Sanofi tendered a low initial stock price purchase offer to give itself flexibility when it decided to enter into serious negotiations.

Despite the long drawn out and tiresome melodrama, the deal is a good one for Sanofi, a company that desperately needs to bolster its biotechnology pipeline and also for Genzyme which has been rocked by biomanufacturing and quality problems for the past couple of years.

Now that this deal is imminent, does anyone have an idea about which biotechnology company may be the next takeover target?

Until next time..

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

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The pharmaceutical industry, not unlike all big business during the disastrous Bush Administration, was virtually unregulated. Bush and his cronies managed to accomplish this feat by destabilizing the US Food and Drug Administration (FDA) and essentially hamstringing any regulatory authority that it had. Not surprisingly, many pharmaceutical companies saw an opportunity to increase their bottom lines by engaging in off label marketing of many of their approved drugs—a practice clearly forbidden by the agency. 

Despite the fact that off label marketing is illegal, many big pharma companies knowingly and willfully engaged in the practice. Luckily, the Obama administration has reinvigorated and restored the regulatory powers at the agency and FDA is now aggressively investigating and punishing companies that had promoted off-label use of their products over the last decade.

The New York Times today reported that Novartis joins a growing list of pharmaceutical companies that have settled government investigations into health care fraud in the last few years, including Pfizer, which paid $2.3 billion; Eli Lilly, $1.4 billion; Allergan, $600 million; AstraZeneca, $520 million; Bristol-Myers Squibb, $515 million; and Forest Laboratories, $313 million. Pfizer, Lilly, Allergan and Forest pleaded guilty to crimes in the cases. The company was fined $422 million settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs. 

According to the article, the five other drugs involved in the civil settlement are Diovan, a hypertension drug that is the company’s top-selling product, at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had worldwide sales of $1.2 billion last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation that was later withdrawn from the United States market.

It is important to make a distinction between the practices of off-label drug use and off label marketing. As many of you may know, licensed US physicians are allowed to prescribe any FDA-approved drugs if they believe that their use will benefit patients. This is off-label drug use. However, in contrast, it is illegal for companies to actively promote or market approved drugs for therapeutic indications for which they have not received regulatory approval. This is off-label marketing and a strategy that has been used by companies to increase sales of approved products without having to spend money on expensive clinical trials that are required to prove safety and efficacy for a new drug to gain regulatory approval. While this may be a backdoor strategy for companies to boost product sales, it clearly puts patients at risk because the actual safety and efficacy for the indications has not been adequately tested and proven.

Many drug makers have been critical of FDA’s increase scrutiny of drug safety and have argued that it has negatively impacted the regulatory approval rates of new experimental medicines. While this may be troubling to many pharmaceutical executives, the FDA was created to insure that all approved drugs are safe and effective and the risk to Americans who use them is minimal. In other words, the agency is simply doing its job—something it was prevented from doing for the past eight years!

Until next time,

Good Luck and Good Job Hunting!!!!

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Over the past few months, a number of celebrities have agreed to help pharmaceutical and biotechnology companies pitch their products in direct-to-consumer advertising campaigns. Perhaps this is related to the economic downturn and these actors are having trouble finding high paying gigs to support their lifestyles. Alternatively, their motives may be altruistic or they or one of their loved ones may suffer from a life-altering or threatening illness.

The latest addition to the celebrity pitchperson parade is the soap opera diva Susan Lucci. After her husband Helmut Huber was unexpectedly diagnosed a decade ago with atrial fibrillation—a type of irregular heartbeat that increase the risk of stroke five-fold, Lucci yesterday announced that she and her husband would partner with Boehringer Ingelheim the National Stroke Association and StopAfib.org to launch a new education campaign to raise awareness of atrial fibrillation. Financial terms of the relationship were not disclosed.

In other news, Amgen and Pfizer yesterday announced the joint launch of "Psophisticated Style:  A Guide to Everyday Style and Psoriasis™," an online resource, providing a wealth of style advice specifically for people with psoriasis.

The new online presence will be hosted by B-list celebrity Tim Gunn, mentor to the designers on TV's "Project Runway" and chief creative officer of Liz Claiborne, Inc. and dermatologist Susan C. Taylor, M.D., the style guide includes five videos, which illustrate various style issues for individuals with psoriasis. Practical and insightful highlights from each video are also available and can be printed.  The new website is well designed and has a decidedly web 2.0 look and feel to it. And, you can even follow Psophisticated Style on Facebook and share the site with your friends!

According to a press release Addressing Psoriasis™ was developed to inspire people with plaque psoriasis to actively manage their condition, be more confident and not allow the condition to inhibit their everyday style. 

Despite the slow uptake, Pharma’s attitude on the use of social media is beginning to shift. Last week, Eli Lilly &Co announced the launch of Lilly Pad a blog and twitter feed designed to provide information and helpful tips to patients with diabetes. Yesterday at the Business Development Institute’s HealthCare Social Communications Leadership Forum in Manhattan, Todd Siesky , Public Relations Manager, Roche Diabetes Care described an innovative and creative initiative (started two years ago) to establish a network of influential bloggers in the diabetes space. The bloggers are not paid and do not benefit financially from their interactions with the company. Roche interacts with the blogging network on a quarterly basis and has held two summits to bring the bloggers together to brainstorm and interact with one another (Roche covers airfare and hotel accommodations).

Also, Ted Phelan, Senior Regional Scientific Manager Medical Affairs at Astra Zeneca gave an illuminating talk about his company’s efforts to build a physician community in the gastrointestinal therapeutic space. Ted’s take away from his impromptu presentation (the originally scheduled Astra Zeneca representative couldn’t attend) was you won’t be successful unless you understand the needs of community members (he is married to a physician).

For those of you who may not closely follow the pharmaceutical social media space, building Facebook fan pages and creating a Twitter feed are no longer de rigueur. Instead, the next big thing is building company-sponsored, unbranded, online patient and physician communities around different therapeutic indications! Move over Patients Like Me, there may be some new kids on the block in the very near future!

Until next time...

Good Luck and Good Tweeting!!!!!

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The ever watchful Mark Senak of the highly informative EyeonFDA blog today reported that Eli Lilly had taken the social media plunge by creating a twitter account (@Lillypad) and also launching a blog cleverly entitled the LillyPad (get it; pad=launching point etc and the word pad is hot because of the iPAD). Ah, those clever pharmaceutical marketers; they never miss a thing!

As Mark points out in his post, Lilly had previously launched a YouTube Channel in 2008 called LillyDiabetes that almost immediately disappeared after he first blogged about it! According to the EyeonFDA post Lilly launched the blog and joined Twitter

"[b]ecause we feel passionately about a lot of issues that are important to our company and our industry, and we know there's plenty of passion well beyond our own walls.  Policy issues like health care reform have been top-of-mind with the public for a long time.  And industry watchers are placing an increased premium on trends like corporate citizenship.  These are important dialogues, and we're happy to provide a forum and participate."

However, as Mark aptly posited in his post, why are we so amazed when a pharmaceutical company launches a blog or engages in a social media campaign? After all, recent research indicates that nearly one-third of companies are blogging and that number is expected to increase to 43 percent by 2012. In fact, pharmaceutical company blogs are quickly becoming de rigueur. So, don’t be surprised if other companies jump on the social media bandwagon over the coming months. Maybe in the future the launch of a pharmaceutical blog, Facebook page or Twitterfeed may no longer be big news or even worthy of a blog post!

A quick perusal of the LillyPad blog reveals that many of the posts deal with issues like improving math and science education, job creation, American innovation, and healthcare solutions. Interestingly, many of these posts are consistent with recent public statements made by Lilly’s CEO John Lechleiter, PhD. It would be great if the LillyPad blog continues to post articles that provide Lilly stakeholders with insights into what management is thinking. This will certainly go a long way to help to create a “conversation’ between the blog and its followers: something that is critical to the success of any corporate social media campaign.

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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The once venerable drugmarker Eli Lilly & Co yesterday announced that it would co-brand its Humulin insulin product with Walmart one of the world’s largest retailers starting in mid September. According to a Lilly spokesperson the product will be sold in U.S. Wal-Mart pharmacies.

Humulin, with $1 billion in worldwide sales for Lilly last year, will be Lilly’s first co-branded product with a retail pharmacy and will replace Wal-Mart’s current Relion insulin brand. The Lilly-Walmart deal is indicative of the massive changes that are taking place in the pharmaceutical industry as generic products begin to encroach on blockbuster brand name product franchises. 

The move will undoubtedly expand the product lifecycle of Lilly’s Humulin brand given Walmart’s vast distribution channels and its gargantuan customer base.

Until next time...

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

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John Lechleiter, PhD, chairman and CEO of Eli Lilly & Co. today told members of the Detroit Economic Club that the US is losing its competitive edge and that “evidence is mounting for an innovation crisis in the life sciences”

Lechleiter blamed the crisis on US tax and immigration policies over the last 10 years that have reduced research and investment funding and driven away foreign-born, U.S.-trained scientists.

He also attributed the problem to the US Food and Drug Administration’s new emphasis on drug safety.  “The FDA approved 92 drugs the last five years. That is the lowest of any five-year period,” he said. “We lose patent protections (on brand name drugs) and that is $100 billion less revenue for the industry and less for research and development” said Lechleiter. Further, he said that “American drug companies still spend 40 percent more on research in development in the U.S. than in other parts of the world.”

To avert the crisis, Lechleiter suggested the following: 

1. Increase and improve education for students in math and science
2. Change immigration laws to allow more H1-B visas for scientists and ease the process that allows immigrants to gain green cards to work in the U.S. The last time the H1-B visa cap was raised was in 1990
3. Increase federal funding for pharmaceutical and basic science research, which has declined over the last five years
4. Change tax policies to provide more incentives for research and development. The U.S. lags behind the rest of the world in offering R&D tax credits, he said. Moreover, the U.S. should not tax foreign subsidiaries of U.S. corporations

Lechleiter, who was trained as a chemist, is the only CEO of a major pharmaceutical company who holds a PhD degree. Therefore, his ideas resonate more for me than those of his business-only CEO counterparts. To that end, his suggestions regarding improving math and science education, immigration reform (which I have long contended is killing US competitiveness) and increasing federal funding for research make sense. However, the notion that US tax laws and lack of corporate tax incentives is stifling American innovation and competitiveness is pure hogwash.

While corporate tax rates may be higher in the US than elsewhere, there are so many loop holes that most corporations pay less than their share fair. Further, let’s not forget that the personal income tax rate is much higher in the rest of the developed world than it is in the US. It is just so “American” to not want to pay taxes and then demand and expect government services at no cost to the taxpayer (at least in Europe they pay high taxes and get good services).  And, let's not forget that despite their heavy tax burden it was American corporations not foreign ones that caused the recent global recession.

That said, I gotta give John some credit for his suggestions; three out of four (or a .750 average) isn’t bad in baseball or the pharmaceutical industry!

Hat tip to Ed at Pharmalot

Until next time...

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

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Eli Lilly and Co. announced last Thursday that it plans on cutting 200 sales and marketing support jobs in its U.S. biomedicine group. More than half of those cuts will take place in Indianapolis, the corporate headquarters of the company. The cuts are the latest wave of the drugmaker's previously announced plans to chop 5,500 jobs worldwide by the end of 2011. The layoffs will be the largest since Lilly eliminated 200 jobs from its research laboratories in March.

Big pharmaceutical companies have been laying off marketing and sales reps for the past three years or so in response to lack of newly approved drugs and anticipated revenue losses from blockbuster drugs that are nearing patent expiry. According to a recent survey conducted by SDI Health the number of pharmaceutical sales reps has shrunk to roughly 81,780 in last year’s third quarter from 101,818 in 2005: a nearly 20 per cent. Further a recent post on the Pharmalot blog revealed that “last year, the number of docs willing to see most reps fell nearly 20 percent, the number of prescribers refusing to see most reps increased by half and the number of management-planned sales calls that were nearly impossible to complete topped 8 million” according to ZS Associates, which monitored interactions involving 500,000 physicians nationwide.

Declining revenues from brand name prescription drugs combined with the changing attitudes of physicians to sales reps suggest that marketing and sales jobs in the pharmaceutical industry may become scare in the future. However, as the biotechnology continues to mature, the need for sales reps with backgrounds in molecular biology and protein-based drugs will continue to increase.

While most physicians are very familiar and comfortable with small molecule prescription drugs, their understanding and familiarity with biotechnology drugs is surprisingly deficient. This suggests that PhD-trained life scientists, who are outgoing and don’t have problems “selling”, may want to consider careers in biotechnology sales or marketing.

Until next time…

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

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Carl Ichan, the billionaire, activist investor notified Genzyme that he will seek shareholder approval to seat four handpicked directors including himself to be appointed to the company’s board of directors in an attempt to remove embattled Chairman and CEO Henri Termeer who has led the company for the past 25 years.

The move was widely anticipated by industry analysts because Icahn own one percent of outstanding shares of Genzyme’s stock.  Icahn and other large shareholders believe the company would be better off under new leadership. Termeer has publicly stated that he has no intention of resigning.

Until recently, Genzyme’s standing and reputation in the biopharmaceutical and orphan drug industry was second-to-none. However, the company’s inability to quickly correct ongoing manufacturing problems at its biomanufacturing facilities for the past year has been extremely embarrassing and costly. Sloppy manufacturing and quality control problems this past year led to major shortages of two main products, Cerezyme and Fabrazyme. Consequently, in 2009 sales revenues dropped and company earnings were almost flat. Further, Genzyme shares lost 26% of their value in 2009, sinking to a five-year low.

Icahn is no stranger to hostile corporate takeovers and company sales. In spring of 2008, he unsuccessfully tried to gain control of the Biogen/Idec board to force the sale of the company (Ichan owns 5.6% of Biogen/Idec’s outstanding shares). Later that year, Icahn engineered the sale of ImClone to Eli Lilly for $7.0 billion; after getting into a very public and often acrimonious fight with Bristol-Myers Squibb CEO Jim Cornelius who tendered a “low-ball offer” (according to Icahn) to purchase ImClone.

According to my calculations, Icahn is batting .500 for his recent corporate takeover attempts. Do you think he will be able to go 2-for-3? I bet Henri Termeer is hoping that he can’t!

Until next time...

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

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As many of you may recall, in 2001, Sam Waksal, founder and former CEO of the biotechnology company ImClone was convicted (along with his good friend Martha Stewart) for fraud and insider trading of ImClone stock. Waksal, who was released from prison in late 2008 and lived in a half way house for several months had kept a relatively low profile until earlier this month. Rumor has it that Sam along with Richard Mulligan, PhD a Harvard professor and former ImClone director and Dr. Larry Witte, a current executive vice president in the ImClone division of Eli Lilly are attempting raise about $50 million for the privately-held new venture called Kadmon. Other reports indicate that Waksal and other members of the Kadmon team are putting up $50 million as well. 

According to insider reports the company will ostensibly focus on cancer and infectious disease targets and—taking a page out of the Cubist, Celgene and Sepracor play books—re-purpose once promising drug candidates discarded by other companies. To that end, according an article in TheStreet, the company's drug research programs include a "statin inhibitor for influenza" from a "leading Ivy League university" along with a variety of monoclonal antibodies for use as targeted cancer treatments, similar to Erbitux. Kadmon is also eyeing several existing cancer-focused drug companies, one of which already has a marketed product, as acquisition targets, according to the prospectus. For those of you who may be wondering about whether or not Waksal can legally start another biotechnology company, an agreement with the Securities and Exchange Commission bars Waksal from serving as an officer in a publicly traded company, but as previously mentioned, Kadmon is a private venture.

Whether you like Waksal or not, his track record in the biotechnology industry speaks for itself. Unlike the vast majority of his rivals, Waksal shepherded a molecule from discovery through commercialization. That molecule, a monoclonal antibody called Erbitux, became a multibillion dollar a year treatment for certain forms of colorectal cancer. More importantly, Waksal was one of the first to recognize that humanized monoclonal antibodies directed against certain cellular receptors could be used to treat a variety of oncology indications—a concept that is driving a large portion of discovery and product development in the oncology space. For those of you who may not know, Eli Lilly purchased ImClone two years ago for $7.0 billion dollars after a very public and acrimonious fight over the sale price of ImClone erupted between Carl Icahn, ImClone’s Chairman, and Jim Cornelius, CEO of Bristol-Myers Squibb (BMS). ImClone and BMS co-marketed Eribitux prior to the sale.

Waksal has been in and around the biotechnology industry for over 30 years and many consider him to be one of the early industry pioneers. Unfortunately, despite his dubious past, Waksal represents a dying breed of visionaries whose entrepreneurial spirit and unorthodox approach to new drug development is largely responsible the biotechnology industry’s current largess. Like other ex-felons Waksal did his time and like all Americans he is entitled to a second chance.

Let’s hope that Sam learned a few things during his incarceration and is smarter and wiser for his second and possibly final act. I wish Waksal success in his new venture and I hope that he and his team still possess the insight, creativity and tenacity required to discover and develop innovative oncology and infectious diseases drugs.

Until next time....

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

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Pfizer today announced that it’s looking to increase its sales force in China to 3,200 by the end of next year, up from about 2,300. The company expects to have sales representatives in about 250 Chinese cities by the end of 2011. It presently has a sales presence in about 185 cities. Previously, Pfizer it will cut nearly 20,000 jobs as part of the Wyeth merger. Over the pass several years more than 50,000 US pharma sales reps have lost their jobs.

Eli Lilly said last fall that it would continue to hire in China, even as it cuts jobs in the U.S. and other developed markets. Novartis is also making a big push into China, hiring hundreds of workers and spending $1 billion to expand a research center in Shanghai.

With business tough in developed markets, drug makers are counting on the developing world for growth and are expanding into biotechnology and generic drug manufacturing.

Like it or not, the emerging markets in China, India, Brazil and elsewhere represent a substantial upside whereas markets in the developing world are becoming less profitable. Drug companies, like most other large multinational companies, always will follow the profit stream not matter where it takes them or at what cost to the folks at home.

Until next time...

 Good Luck and Good Job Hunting (Try China, I hear they are looking for sales reps)

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The New York Times reported today that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain.                     

AstraZeneca joins a growing list of pharmaceutical companies that have been penalized for off label promotion and misleading advertising. Earlier this year Eli Lilly & Co paid $1.4 billion over its marketing of another antipsychotic drug Zyprexa and Pfizer announced that it would pay $2.3 billion including a record-breaking criminal fine of $1.195 billion mostly for its painkiller Bextra which was withdrawn from the market.

Despite the size of the fines and settlement figures for these recent cases, they are a drop in the bucket when compared with the amount of money generated by illicit marketing and advertising. For example, the $520 million that AstraZeneca has agreed to pay to settle the Seroquel case pales in comparison to the $17 billion that the drug has generated in US sales since 2004. The same was true for Zyprexa and Bextra.

While these settlements cannot repair much of the damage that has been done to unknowing patients, it signals that the US government is beginning to live up to its pledge to provide safe and efficacious medicines to the American public.

Until next time...

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

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Eli Lilly & Co announced today that it is eliminating another 5,500 jobs or roughly 14% of its global workforce over the next two years. This would reduce to size of Lilly’s worldwide workforce from 40,500 to 35,000 by 2011. In addition to the job cuts, the company is reorganizing itself into 5 business units and hopes to save about $1.0 billion in annual costs.

These newly announced job cuts come after the company eliminated 4,000 sales representative jobs this past August and restructured its sale force. Also, prior to the recent cuts, Lilly launched the Lilly Phenotypic Drug Discovery Initiative or PD² a new program to ostensibly strengthen relationships with academic institutions to speed drug discovery and thereby reduce its reliance on internal drug discovery efforts to keep its pipeline full.

Unlike other major pharmaceutical companies that conducted massive layoffs over the past two years, Lilly was content, until the past few months, to lay off small numbers of employees and offer others retirement packages. Unfortunately, the loss of patent protection on several of its blockbuster drugs coupled with generic encroachment on several brands and impending health care reform, forced Lilly to take more draconian action.

Layoffs have been something of rarity in the life sciences sector over the past eight months or so, but this is usually the time that marks the beginning of the corporate “layoff season.” Don’t be surprised if other large life sciences companies announce similar layoffs in the coming months. Luckily, the economy seems to be improving and there are signs that hiring is beginning to ramp up in the pharmaceutical, biotechnology and devices industries.

Speaking of pink slips, those of you who have been downsized or find yourself out of a life sciences job may be interested in a new organization called Pink Slip mixers. According to a description on the group’s website:

“Our Pink Slip Mixers are about hundreds of professional, mid- to upper-level executives who are (might be) victims of the "economic downturn" of 2008. Our parties are about banding together, networking and bonding with the recently "Pinked". We will share our experiences of why we were let off, what companies are hiring, and the "buzz words" that specific hiring managers want to hear. Aside from the usual imbibing, commiseration and fun that every pink slip party brings, headhunters, direct-hire companies, and recruiting firms will also on-hand to learn a little bit more about what you do. Maybe you'll meet a new contact, or find a new job!” 

Sounds like these mixers might be good networking opportunities and a place to kick back and commiserate with others who are no longer gainfully employed. I am planning to attend a Pink Slip Mixer when one is organized in the NYC metropolitan area. Like many of you, I lost my full time contract copywriting job over a year ago!

Until next time...

Good Luck and Good Job Hunting!!!!

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Eli Lilly & Co. is offering buyouts to 4,000 U.S. sales representatives to eliminate several hundred jobs and restructure its operations. Sales representatives will be offered four months' pay in addition to the typical Eli Lilly severance package, which ranges from two to 18 months' salary depending on seniority. The company had a total of 40,500 employees at the end of 2008.

Lilly’s best-selling drugs include Zyprexa for schizophrenia and bipolar disorder, Cymbalta for depression, Byetta for type 2 diabetes, and Evista for osteoporosis. The patent supporting Zyprexa, which bought in $4.7 billion in revenue last year, will expire in 2011. The patents on the company's next three top drugs —Cymbalta, Humalog insulin, and cancer drug Gemzar —are set to expire in 2013.

The restructuring is expected to start in mid-November and take effect in January.

Sales reps and R&D scientists have suffered the most during pharma’s recent three year downsizing binge. While many R&D jobs have been shipped overseas, pharma sales reps might consider a new career in biotechnology drug sales. Growth in biotechnology and personalized medicine drugs is expected to increase for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Bristol-Myers Squibb (BMS) announced late yesterday that it intends to purchase Princeton, NJ-based Medarex for $2.1 billion. BMS and Medarex were working collaboratively to develop a monoclonal antibody called Ipilimumab as a treatment for late stage melanoma.

The acquisition represents BMS’s public commitment to transform itself into a “next generation pharmaceutical company” with both pharmaceutical and biotechnology products in its arsenal. Last year, BMS bought Kosan Biosciences, Inc a California-based biotechnology company developing novel cancer treatments. Also, as you may recall, BMS lost ImClone to Lilly in a bidding war over Erbitux—a monoclonal antibody-based colorectal cancer treatment that was co-marketed by BMS. 

Medarex was one of the last independent, public, late stage monoclonal antibody development companies in the biotechnology industry. Many of its competitors, like ImClone and Cambridge Antibody Technologies, had already been acquired by big pharma and I was wondering when Medarex would be acquired. I have always held Medarex in high regard and it is a solid and well position company. To that end, I recommended that my mother purchase Medarex stock several years ago telling her that I thought it had a huge upside. Not surprisingly, the stock has been soaring since the announcement; so much so that my mother called me today to tell me how smart I was—go figure.

It is not clear, at present, what effect, if any, the Medarex acquisition will have on the employment situation in New Jersey. Although BMS is headquartered in NYC, it has two large sites in New Jersey, one in Lawrenceville and the other in Plainsboro. As mentioned above Medarex is based in Princeton, NJ. BMS has been steadily downsizing over the past three years and I suspect that there may be more layoffs after the Medarex deal closes.  If there are layoffs, more are likely to occur on the Medarex side of the business.

While I have been critical of some of BMS’ strategic moves in the past, I think the Medarex acquisition is an outstanding one and BMS will likely benefit from it!

Until next time...

Good Luck and Good Job Hunting!!!

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The drug maker Eli Lilly and Co quietly launched a new website today for a program dubbed Lilly Phenotypic Drug Discovery Initiative or PD². According to the company, “The PD² initiative is a unique opportunity for investigators from external institutions to submit proprietary compounds for potential screening in Lilly's phenotypic assay panel. This highly collaborative process is enabled by a web-based application that facilitates efficient transfer of information between Lilly and the investigator. The PD² screening panel is currently comprised of five modules which are relevant to therapeutic areas of long-term strategic interest, including oncology, neurological disorders, and metabolic diseases. This panel may change over time to reflect additional research interests.”

Company officials believe that program will allow it to evaluate and possibly license treatments from biotech companies and academic institutions "that are never fully evaluated as potential drug candidates." The launch of the PD² website—perhaps the first of its kind—clearly sends a signal that pharmaceutical companies are reducing their reliance on internal discovery programs to identify prospective new molecular entities and are eager to enter into licensing deals to find and acquire them. 

Membership in the PD² requires that a legal representative from the investigator's academic institution or biotech company executes a Material Transfer Agreement (MTA). Once the MTA is reviewed and approved by Lilly officials, the institution can create an account. Until that time, use of the site is limited to browsing only. I have no doubt that technology transfer offices at most major universities will be signing up for membership in short order.

I think the PD² initiative is an innovative and timely one given the massive reductions in R&D jobs that have taken place at many pharma companies over the past two years. Expect other pharma companies to follow Lilly’s lead.

Until next time....

Good Luck and Good Job Hunting!!!!!

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Carl Icahn, former corporate raider, hedge fund owner and activist investor, is still trying to exert his influence at Biogen/IDEC a biotechnology company in which he owns 5.6 percent of its outstanding shares of stock.  As you may recall, last year, Mr. Icahn tried to wrest control of the Biogen/IDEC board to force the company to put itself up for sale. That attempt failed but yesterday Mr. Icahn was managed to get two of his allies appointed to the Biogen/IDEC board of directors at the company's annual shareholder meeting.

Mr Icahn has long contended that Biogen/IDEC's management team is inhibiting growth and squandering shareholder value. Wall Street analysts predict that Carl will push hard to split the company into two separate entities: one focused on neurobiology (Biogen/IDEC is a market leader for drugs designed to treat Multiple Sclerosis) and the other on cancer.  Another scenario suggests that he will leave the company intact and find a buyer for it--similar to the plan that he attempted to implement last year.

The Biogen/IDEC news follows quickly on the heels of a management coup that he orchestrated at Amylin Pharmaceuticals earlier in the week. On Tuesday, Mr Icahn, along with the hedge fund Eastbourne Capital management, were successful in ousting Amylin's Chairman Joseph C. Cook, Jr. and director James N. Wilson. Mr. Icahn exerted his influence at Amylin because he felt that sales of its key diabetes drug Byetta were too low.  Others believe that he is preparing the company for sale to Eli Lilly which co-markets Byetta with Amylin.

Mr Icahn is certainly no stranger when it comes to maximizing shareholder value at biotechnology companies where he holds substantial stock positions.  Last year, he orchestrated the sale of ImClone to Eli Lilly after getting into a protracted bidding war with Bristol Myers Squibb (BMS) over the cancer drug Erbitux.  At that time, BMS had an exclusive marketing agreement with Imclone for US sales of Erbitux.

Whether or not you like Carl, he is very good at what he does. And, in the end, he has a gift for maximixing shareholder value of companies that he and others have invested in!

Until next time...

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

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Today's New York Times reported that the US Food and Drug Administration (FDA) issued warning letters and ordered 14 pharmaceutical and biotechnology companies to stop running what it calls misleading ads on internet search pages displayed by search engines like Google. The agency faulted the companies for failing to identify product names (brand) and not listing potential side effects (only benefits) for the drugs. In other words, the ads lacked “fair balance” something that FDA stresses and that all drug makers are very familiar with. 

Drug makers and other interest groups pay search engines like Google to place ads on search result pages after someone types in a related search word. The sidebar ads typically contain a eye-catching headline about a relevant medical condition or product and links to websites promoting certain products. The companies receiving warning letters included: Bayer, Biogen Idec, Boehringer Ingelheim, Cephalon, Eli Lilly, Forrest Laboratories, Genentech, GlaxoSmithKline, Johnson and Johnson, Merck, Novartis, Pfizer, Roche, and Sanofi-Aventis. Not surprisingly, most of the world’s largest and most profitable were guilty of running misleading Internet search engine ads.

Historically, drug companies and FDA have engaged in a cat and mouse approach when it comes to advertising and marketing drug and medical devices and diagnostics. This is because FDA’s existing regulations that guide marketing and advertising practices are relatively lax and it provides drug makers with the opportunity to see how far they can push the agency before “they get caught.” While this practice may have been acceptable for print and television advertising, it may no longer be appropriate for Internet advertising— which potentially has a much broader and larger reach than traditional media because there are not national borders on the Web. Unfortunately, FDA has been slow (reluctant?) to react to digital media and is even more perplexed about social media and the drug industry. Rather than continue to play cat and mouse, I think it would be in the best interest of consumers if FDA and drug makers would sit down and craft new guidance on regulating Internet advertising and marketing practices. It is becoming increasingly apparent that the old rules are no longer sufficient as digital and social media continue to evolve.

Until next time....

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

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The Pharmalot blog reported today that Pfizer will likely layoff large numbers of R&D personnel over the next few weeks and months. This should not come as a surprise to Pfizer employees because the company recently announced that it would eliminate research in certain therapeutic areas including heart disease and obesity as part of a global reorganization plan. According to the company, the reorganization is expected to be completed by year’s end and operational in 2009. Inside sources say that the job losses should be significant and far reaching.

In other news, BioJobBlog learned today that Bristol Myers Squibb plans to announce company-wide layoffs by December 1, 2008. As previously reported by BioJobBlog, BMS has been quietly downsizing since last spring because of the impending patent expiry (in 2011) of its blockbuster anticlotting drug Plavix. BMS, unlike Pfizer, has been extremely circumspect about its impending layoffs which is causing a great deal of anxiety among its employees. The recent sale of ImClone, BMS’s partner for the cancer drug Erbitux, to Eli Lilly will undoubtedly contribute to additional layoffs at BMS in the future. Currently, Erbitux is BMS’s top selling biopharmaceutical product.

It goes without saying that it is not a good time to be a pharma employee. Unfortunately, as the old adage goes “things are likely to get worse before they get better”. 

Until next time…

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

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Beginning in 2009, Eli Lilly and Merck will post in online databases all payments made to doctors for speaking and consulting services. According to an article in today’s New York Times, the postings will “likely include” the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments.

The lack of disclosure by physicians about their relationships with drug and medical devices companies have  plagued medical journals and continuing medical education programs for many years. For those of you who may not know commercial and business relationships (including consulting and speaker fees) are common between leading medical thought leaders and drug companies. In the last two decades alone, drug and device makers have made payments to tens of thousands of doctors and researchers in all medical specialties and areas of research. Critics of these practices (including the US Congress) are worried that this money could taint doctors’ research plans or clinical judgment when it comes to new drug/device approval. These concerns have prompted government agencies, medical journals and universities to look more closely at the deals. Many medical journals and granting agencies now require that physicians disclose all of their relationships to drug and device companies before their manuscripts and grants are reviewed.

Lilly and Merck’s decision to publicly disclose which physicians are on their payrolls is a step in the right direction. Full disclose and more transparency about the relationships between physicians and drug/devices makers is an important first step to limit subjectivity and conflict of interest issues when it comes to new drug/device approvals.

Until next time….

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

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Indianapolis-based Eli Lilly & Co announced today that it will transfer its clinical trial monitoring and data management operations to Quintiles and i3.  About half of the affected 265 Eli Lilly employees will lose their jobs.

Like other pharma companies, Lilly is looking at ways to cut costs. And as everyone knows, the best way to save money is to outsource operations and lay-off full time employees who are expensive because of high salaries and benefits.

Until next time….

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

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Eli Lilly & Co. announced today that it will eliminate 500 jobs at its manufacturing facility in Indianapolis, IN. The cuts will affect sites that manufacture active pharmaceutical ingredients for Lilly’s insulin products Humalog® and Humulin® and its osteoporosis medicine Forteo®.

Lilly is offering incentive packages for those employees who voluntarily leave the company. The company has already reduced its global headcount by twelve percent or about 5,500 people since 2004.

Times are tough and getting tougher each day in pharma land. Buckle up–its going to be a rough ride for jobseekers in the pharmaceutical and biotechnology industries.

Until next time….

Good Luck and Good Job Hunting (avoid Indianapolis, who wants to be a Hoosier anyway?)

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Cambridge, MA-based Alkermes announced today that it is restructuring its operations following the termination by Eli Lilly and Company of its inhalable AIR Insulin program (Alkermes manufactured the inhaler delivery device). The company is reducing its workforce by approximately 150 employees and closing its AIR commercial manufacturing facility in Chelsea, MA. The company is taking these actions based on its current expectations of the financial impact of Lilly's termination of the AIR Insulin program.

The job cuts, effective this week, represent almost 18% of Alkermes’ total workforce. Employees affected by the restructuring will be eligible for a severance package that includes severance pay, continuation of benefits and outplacement services. The company expects cost savings from the restructuring in the range of $15 million to $20 million in fiscal 2009.

In other news from across the pond, the trade group, the Association of the British Pharmaceutical Industry (ABPI), reported today that the UK pharmaceutical industry lost about 8.000 pharmaceutical jobs or about 10% of its workforce over the past three years. The ABPI asserts that there is a direct link between job cuts and changes to the British government’s pricing mechanisms for medicines. A spokesperson for the group said “Every time a new PPRS (Pharmaceutical Price Regulation Scheme) comes into force there is a decline in the number of jobs”. Not surprisingly, the group is urging the government to not make any changes in the PPRS.

The UK pharmaceutical workforce has taken a number of big hits of late– Pfizer recently closed a manufacturing plant in Kent, while British drug makers AstraZeneca and GlaxoSmithKline both announced substantial global job cuts many of which were located in Britain.

Until next time….

Good Luck and Good Job Hunting!!!!

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As the cost of prescription drugs continues to spiral upward, the affordability and accessibility to prescription drugs and healthcare will likely be fiercely debated and may influence the outcome of the presidential election next November. Despite growing public concern over the cost of prescription drugs in the US, Eli Lilly has vowed to fight federal legislation that will allow Americans to import lower-priced prescription drugs from Canada, Japan, Australia and many European nations. Lilly spokespeople and their lobbyists in Washington DC argue that the policy would put consumers at huge risk of consuming dangerous and unsafe counterfeit drugs. Big pharma has been using the drug safety argument for the past decade or so to stifle drug importation legislation. That said, blocking prescription drug importation legislation has very little to do with drug safety and everything to do with profit margins and corporate stock prices.

The stakes of prescription drug importation are high for drug makers. In contrast with the US, most other countries keep drug prices low through government distribution programs and strict price controls. Because the US government does not control prescription drug prices, American typically pay two-thirds more than Canadians, 80% more than Germans and 100 per cent more than French residents for identical prescription drugs. Lilly and other big pharma companies contend that price controls for prescription drugs stifle innovation and competition (tell that to the European and Japanese drug companies). Currently, according to government and industry surveillance data only a tiny fraction of counterfeit drugs (about 5 per cent) actually enter the US market. But Lilly and other pharmaceutical companies argue that there could be enormous increases in the number of counterfeit drugs that enter the US annually if Congress relaxes the federal ban on imported prescription drugs.

Pharma’s counterfeit drug argument is a convenient scare tactic that it has been using to lobby against relaxing current drug importation legislation. What the drug makers don’t tell you is that they routinely import and sell drugs in America that are manufactured in foreign production facilities. Further, many of drugs that are sold in Canada, Europe, Japan and Australia are manufactured in the same production facilities that supply drugs that are sold in the US. This begs the question —if drugs are manufactured in the same foreign production facilities and one lot is sold in the US and the other in Canada, would American consumers really be at a greater risk if they bought a Company’s drug in Canada or the US? The answer to the question is a resounding NO–unless you believe that the Canadian Regulatory Agency is less competent at monitoring and approving drugs than the US FDA The real story is this–.counterfeiters stand to make much more money selling bogus prescription drugs in the US than in other countries because there are no price controls in the US (which means much larger profit margins for the counterfeiters–duh!)

Let me propose a solution to the prescription drug counterfeiting that is plaguing and threatening the safety of American–reduce the price of American prescription drugs to prices that are consistent with prescription drug prices in the rest of the world. This would provide greater access of prescription drugs to all Americans and reduce the need for some Americans to purchase prescription drugs from dubious sources because they can’t afford to buy them at their local pharmacies. Further, price controls would certainly reduce the incidence of counterfeit drugs in American because counterfeiters would no longer be able to command high prices for their products which, in turn, would seriously cut into their profit margins.

Despite the logic and simplicity of my proposal, don’t expect there to be any changes in prescription drug importation policies any time soon! Profits not drug safety or open access to life-saving drugs is what drives big pharma-this is American after all!!!

Until next time….

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

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The Danish drug maker Novo Nordisk announced today that it was halting further clinical development of its inhalable insulin product called AERx. AERx was in Phase 3 clinical testing as a short-term diabetes treatment. In a press release the company stated that it was halting development of its inhaled insulin compound because the drug was "unlikely to offer significant clinical or convenience benefits" versus current diabetes treatments.” AERx joins Exubera (Nektar Therapeutics/ Pfizer) on the inhalable insulin scrap heap. This leavesEli Lilly and Alkermes’ IR insulin system as the only inhalable short-acting diabetes treatment in Phase 3 clinical development.

Interestingly, Novo didn't say that it was giving up on developing inhalable insulins— only that it was halting its current late-stage AERx program. The company did announce that it plans to pursue a Glucagon_Like Protein (GLP-1) inhalable diabetes treatment which is similar to a product being developed by California-based MannKind. Its product in Phase 1 clinical testing. Unlike Nektar, which partnered with Pfizer to develop Exubera, MannKind, a small startup, is developing its inhalable insulin product alone. Novo also disclosed plans to develop a longer-acting injectable form of insulin which would eliminate the need for daily injections by patients with diabetes.

In theory, inhalable insulins make sense—many people hate daily injections. That said, inhalable insulins may create other problems that obviate their usefulness as alternatives to daily insulin injections-just ask Pfizer and Nektar about that!

Until next time….

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

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As many of you know, the pharmaceutical industry has been trending downward for the past year or so. Weak pipelines, uncontrolled corporate expansion and soaring drug prices have been offered to explain the recent down turn. However, the real back story to the downturn is the loss of  future revenues that is expected to occur starting in 2010 when many current blockbuster pharmaceutical products, e.g., Lipitor (Pfizer), Plavix (Sanofi Aventis), Avandia (GlaxoSmithKline), Zyprexa (Lilly), and others lose patent protection.

The loss of patent protection of branded blockbuster products is almost always accompanied by the development and subsequent, regulatory approval of lower cost, generic versions of the drugs. The Hatch Waxman Act permits generic manufacturers to begin to develop generic versions of branded products five years prior to patent expiry. This allows generic manufacturers to develop and gain regulatory approval of their products well in advance of a patent expiry date. Further, generic manufacturers usually launch their products (and flood the market) with generic versions of a branded product on the same day that its patent lapses. To induce and hasten generic development, Hatch Waxman grants market exclusivity for 180-days (6 month) to the first company that gains US regulatory approval for a generic version of a branded product that has lost patent protection.

Revenue generation and a company’s market share of branded drug products generally fall precipitously following introduction of less costly, generic versions of the drugs. From a financial standpoint, this is not surprising—why would anybody chose to pay more for a branded product when there is a cheaper and therapeutically efficacious generic alternative available?  In the past, most pharmaceutical companies chose to neglect (and ultimately abandon) blockbuster products after generic versions were introduced.  Many companies chose this strategy because, in the past, there was always another blockbuster in the pipeline that would replace the lost revenues caused by generic competition.

Unfortunately, as we all know, the days of the billon-dollar-a year blockbuster drug are long gone! This realization has caused many pharmaceutical companies to rethink their business strategies when a blockbuster drugs lose patent expiry. Many pharmaceutical companies are experimenting with a relatively new kind of product called an authorized generic–a copycat version of a company’s branded drug that is sold through a licensing agreement between the innovator company and a generic-drug manufacturer. This type of arrangement allows the innovator company to hold on to a larger share of a revenue stream from the drug once it loses patent protection and it falls prey to generic manufacturers.

Authorized generics have always made sense to me–who knows how to manufacture, market and distribute a drug better than the company that originally created it? Further, why would a company choose to give up on a revenue stream simply because a product can no longer generate billions each year due to generic encroachment– wouldn’t hundreds or even tens of millions suffice? Much to my surprise, late last week, Merck & Co announced that it had inked a deal for an authorized generic form of its blockbuster osteoporosis drug  Fosamax after the US patent expires on February 6. Merck did not disclose the terms of the deal or the identity of it generic manufacturing partner.

Industry analysts have suggested that cheaper generics will not only batter sales of Merck’s Fosomax but could also hurt rival Actonel (Proctor & Gamble Co/Sanofi-Aventis) and Boniva (Roche/GalxoSmithKline). Generic manufacturers.  Barr Laboratories and TEVA are expected to launch their own generic versions on February 6 and share the 180-day market exclusivity for their respective products.

Merck, once a champion of the old pharma blockbuster model, is slowing emerging as an industry innovator. The company’s recent decision to authorize a generic version of one of its former blockbuster drugs may be a harbinger of things to come in the pharmaceutical industry. That said, I don’t understand why big biotechnology companies like Amgen, Biogen/IDEC and Genentech are unwilling to consider the authorized generic model to stave off generic competition for blockbuster biotechnology products like EPO, Avonex and Rituxan. Whether these companies like it or not, I believe that biogenerics aka follow-on biologics will be a reality in the US in the next five years. Maybe Amgen can bolster is rapidly falling stock price by inking an authorized generic deal for EPO—rather than spending hundreds of millions on patent litigation—“whadda ya think?”

Until next time…

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

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The New York times reported today

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A sharp drop in sales of its blockbuster diabetes medication Avandia has forced GlaxoSmithKline (GSK) to embark on a major cost cutting campaign that includes job cuts. It is not clear where the cuts will take place or how many jobs will be lost. The company said it would close some of its manufacturing plants, including a plant in Puerto Rico which employs around 900 workers and has been a target of regulatory scrutiny because of ongoing quality control issues.

Although this is the first official public announcement of layoffs at GSK, my inside sources tell me that several hundred employees have already lost their jobs at GSK’s Collegeville, PA facility.

GSK’s announcement coupled with a sharp drop in Amgen’s third quarter profits and Lilly’s problems with clinical development of prasugrel (its highly anticipated anti-clotting drug) indicate that the road will be rather bumpy for the biopharmaceutical sector in the near future.

Until next time…

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

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