It’s Layoff Season

Posted in BioBusiness

Yes–it is that time of year again–layoff season!  To that point, Amgen announced today that it was laying off an additional 1,200 jobs above the 2,900 the company announced it would layoff this past July.   Together, these layoffs represent about 20% of Amgen’s global workforce.  Amgen joins other life sciences companies including Novartis, Sanofi, Pfizer, AstraZeneca and others that have announced layoffs in 2014.

Companies like to announce layoffs in the Fall, to let employees who may be affected by the downsizing to not expect their bonuses this year (which are typically paid at years end).  While this is strictly business, it does kind of put a damper on holiday season joy.  And, because corporations are considered to be “people” –at least according to the US Supreme Court–they ought to show a little more sensitivity and compassion when announcing downsizing and layoffs before the holiday season.

Until next time…

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

Looking for a Job? These Pharma Companies Are “Hiring”!!!!

Posted in BioBusiness

Genetic Engineering and Biotechnology News (GEN) perused the corporate websites of 10 major pharma companies to determine the number of available jobs at those companies for the week of June 17-21, 2013.  While this was a laudable exercise, it is important to note that jobs listed on corporate websites usually do not reflect the actual job openings at the companies that post them. That said, although the results offered byGENsurvey may seem encouraging to jobseekers, I would not put much faith in the conclusions that they draw. For example, the author of the piece wrote:

The results show both the U.S.’ continuing dominance of the industry, since nine of 10 companies hired the highest numbers of employees Stateside—as well as significant hiring overseas, especially in China (which dominated Eli Lilly’s listings of available jobs) and Europe.

Anybody looking for a pharmaceutical job in theUSwill tell you that it is one of the worst job markets inUShistory and that the number of new employees being hired is negligible.  Nevertheless, it is fun to rank big pharma companies when there is nothing else to do. To that end, here is the list of big pharma companies that are “hiring”

1.  Novartis

2,740 total worldwide jobs listed on website

Top nation:U.S., with 1,096 jobs listed on website

Next five countries:Switzerland(500 jobs);Germany(224);U.K.(127);India(113);Austria(109)

2.  Roche

1,450 total worldwide jobs listed on website

Top nation:U.S., with 591 jobs listed on website

Next five countries:Switzerland(240 jobs);Germany(192);China(148);PolandandSingapore(40 each)

3.  Sanofi

1,427 total worldwide jobs listed on website

Top nation:U.S., with 744 jobs listed on website

Next five countries:China(465 jobs);France(68);Germany(51);Canada(45);U.K.(18)

4.  Pfizer

815 total worldwide jobs listed on website

Top nation:U.S., with 332 jobs listed on website

Next five countries:China(249 jobs);U.K.(26);Mexico(18);Taiwan(17);Ukraine(16)

5.  GlaxoSmithKline

733 total worldwide jobs listed on website

Top nation:U.S., with 223 jobs listed on website

Next five countries:Belgium(174 jobs);U.K.(114);Singapore(55);AustraliaandGermany(33 each)

6.  Johnson & Johnson/Janssen Pharmaceuticals

655 total worldwide jobs listed on website

Top nation:U.S., with 232 jobs listed on website

Next five countries:Belgium(81 jobs);China(63); The Netherlands (40);Mexico(30);France(26)

7.  AbbVie (formerly Abbott Labs pharmaceutical division)

555 total worldwide jobs listed on website

Top nation:U.S., with 367 jobs listed on website

Next five countries:Germany(68 jobs);China(28);France(20);U.K.(16); The Netherlands (14)

8.  AstraZeneca

544 total worldwide jobs listed on website

Top nation: U.S., with 259 jobs listed on website3

Next five countries: China(202 jobs); U.K.(55)3;France (11);Turkey (8);Sweden (7)

9.  Eli Lilly

484 total worldwide jobs listed on website

Top nation:China, with 319 jobs listed on website

Next four countries2:U.S. (146 jobs);Canada (16);Australia (2);U.K. (1) 

10.  Bristol-Myers Squibb

368 total worldwide jobs listed on website

Top nation:U.S., with 318 jobs listed on website

Next five countries: Irelandand United Kingdom(12 jobs each); France(9)1;Belgium (7);Spain (5)

A quick perusal of the list indicates that Novartis, Roche and Sanofi, arguably the best positioned and well financed of the companies have the most open jobs listed on their corporate sites.  Pfizer, the world’s largest pharma company has a paltry 815 open jobs worldwide.

The remaining 6 companies on the list have had their share of misfortunes lately, most notably Eli Lilly and AstraZeneca whose development pipelines are thin. Maybe that is why Eli Lilly is aggressively expanding its operations inChinawhere it has made substantial R&D investments.

Johnson & Johnson has been rocked by highly publicized problems with its consumer products whereas Bristol-Myers Squibb has undergone significant restructuring in its executive suite of late.

Interestingly, the top three pharma companies in the world are European not US-owned. Maybe that explains why the US life sciences job market is so bad….go figure. Also, it is important to remember that roughly 300,000 pharmaceutical employees have lost their jobs since 2001.

Until next time…

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

 

FDA Finally Issues Some Biosimilar Guidance Documents

Posted in BioEducation

The US Food and Drug Administration finally released portions of the long-awaited guidance documents that will help to implement the development and approval of biosimilar molecules under the Biologics Price Competition and Innovation Act of 2009 (BPCIA)

Yesterday the agency issued three guidance documents which represent only a small portion of the total guidance package that will be necessary to develop and commercialize biosimilar products in the US

They are:

  1. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  2. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
  3. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

For a more detailed analysis of the guidance documents please check out a post by James N. Czaban. According to Czaban (and many other in the biosimilar space) these first three guidance documents represent “baby steps” towards implementing the specifics of BPCIA. To that point, Czaban suggests that:

“These Guidances, while helpful in expressing some of the FDA’s general approaches, but will be of limited specific value with respect to any particular product”

Stay tuned for more updates.

Until next time…

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

 

Sandoz Moves Its Biosimilar Development Strategy Forward

Posted in BioEducation

Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 

As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.

The filgrastim study is designed to evaluate the efficacy and safety of Sandoz’s biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.

Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.

Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.

The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.

Until next time…

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

 

An Analysis: Big Pharma and Social Media Usage

Posted in Social Media

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 54th 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)

 

A Commentary: Pharma's Ongoing PR Problem

Posted in BioBusiness

Not a day goes by without some report about pharma’s ongoing problems with illegal drug promotions, class action suits against blockbuster medications or civil or criminal settlements with state and federal governments. A quick perusal of articles posted to the Pharmalot Blog in November alone revealed no fewer than eight big pharma companies including Lilly, Merck, GlaxoSmithKline, Bayer, Pfizer, Novartis and Amgen that were involved in some sort of legal action regarding inappropriate marketing claims or failure to disclose potential side effects of blockbuster drugs. To make matters worse, a larger than usual number of pharma companies have experienced manufacturing problems that have resulted in drug recalls or shortages. This list includes companies such as Genzyme, Baxter, Johnson & Johnson, GlaxoSmithKline and most recently Boehringer Ingelheim. While chronic legal and manufacturing problems are extremely troubling (some assert it is just the cost of doing “business”), I believe that the amount of money spent lobbying Congress for legislation favorable to the industry is even more egregious.

According to a recent post on Knowledge Ecology International, the pharma industry has so far spent $115,571,832 on lobbying in 2011 (this number is sure to go higher by the end of this fiscal year). Interestingly, the biggest year for pharmaceutical industry lobbying was in 2009—a year after the Affordable Health Care Bill was passed—with totals in excess of $186,000,000. Just think about how many jobs could have been saved if companies reinvested the money into R&D rather than greasing the palms of lobbyists to induce Congress to pass laws to continue to get favorable tax rates, improve ROI and bolster the stock prices of those companies! To wit, Newt Gingrich, a Republican Presidential candidate and Former Speaker of the House has been accused of lobbying former congressional colleagues to vote for a Medicare drug subsidy while he was a paid consultant to AstraZeneca. Gingrich vehemently denies these allegations; probably because he realizes that most Americans don’t like big pharma and may vote against him if the claims are proven to be true and he wins the Republican presidential nomination.

Not withstanding the legal issues and unnecessary lobbying, what is really hurting the pharmaceutical industry is its lack of communication and transparency with patients and its unfailing practice of putting profits before healthcare. While every big pharma company I know always talks about fulfilling unmet medical needs, meeting those needs always comes at great costs (literally) to patients. Sadly, many patients can no longer afford the costs of potentially lifesaving medicines and treatments. Unless pharma begins to change the way it presents itself to the American public, it will continue to suffer the lost of confidence and trust of the American people. And, if the industry is unable to regain the public’s trust, its inability  will ultimately result in legislation that allows the US government to control drug prices: something that exists in most other countries in the world and big pharma has been desperately trying to prevent for the past 50 years!

Until next time…

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

 

Occupy Wall Street Protest Targets Pharmaceutical Giant Pfizer

Posted in BioBusiness

The Pharmalot Blog today reported that a group of protesters aligned with the Occupy Wall Street movement will conduct a vigil at Pfizer’s Groton,CT R&D facility to protests recent job cuts made by the company. 

Pfizer was targeted because it took tens of millions of dollars in local and state government subsidies to build an R&D facility in New London, Connecticut. But earlier this year, the company abandoned the facility and decided to transfer about 1,100 R&D job from Groton to Cambridge, Massachusetts.Also, the company jettisoned its antibacterial drug discovery efforts at the Groton facility and shipped those jobs overseas to China.  Roughly, 2,500 Pfizer jobs are leaving Connecticut which will likely have a negative impact on the state.

One protest leader quipped “When huge companies like Pfizer take tens or hundreds of millions of dollars in public money, and then pull up stakes as soon as the money disappears, that’s what wrong with our economy”

Also, Pfizer is one of the top US ten companies to shed employees despite an estimated $48.2 billion in offshore funds that the company does not pay any taxes on. Between 2004 and 2011, the company  laid off  58,071.

Don’t be surprised if the Occupy Wall Street Movement spreads from the banking to the pharmaceutical industry.  At this point there appears to be little distinction between the two!

Until next time…

Good Luck and Good Job Hunting

Why Big Mergers Are Never Good For Pharmaceutical Company Employees

Posted in BioJobBuzz

The Pharmalot Blog today reported that a Wall Street Journal article indicated that Pfizer is planning to cut $1.0 billion from its operating budget by 2012. As many of you may recall (especially those who lost their jobs) the world’s largest pharmaceutical company cut 1,100 earlier this year at its research facilities in Groton CT. The new cuts are aimed at reducing Pfizer’s R&D expenses by up to $2.9 billion annually.

The $1.0 billion in cuts is primarily aimed at reducing administrative and management duplications at Pfizer’s headquarters in NYC and worldwide. Other expenses to be trimmed include those related to promotions, travel, entertainment, consultants, print materials and supplies and electronic equipment. While there is no doubt that these cuts will help to control costs, I suspect that substantially more money could be saved if pharma executive salaries and bonuses were also trimmed.

While it is unclear what the additional $1.0 billion in cuts will have on scientists, I suspect it won’t be good. In case you have not noticed by now, Pfizer like many of its competitors are getting out of the R&D business. This means that R&D jobs will continue to dwindle and scientists will continue to struggle to find jobs in a highly competitive job market.

Since Pfizer purchased rival Wyeth Pharmaceuticals in 2009, the company has shed over 20,000 jobs. The reason for the job cuts and massive cost cutting measures at Pfizer is the loss of patent protection in 2012 for its top selling cholesterol medication Lipitor ($10.7 billion in sales) and its ED drug Viagra ($1.9 billion in sales). Last year Pfizer lost patent protection the antidepressant Effexor (peak sales of $3.8 billion) and the Alzheimer’s drug Aricept ($417 million in sales). Also, when mergers take place there is much overlap and duplication of effort that takes several years to sort out.

Don’t be surprised if new Pfizer job cuts are announced late next fall! Now, would be a good time for Pfizer scientists to remove the dust from their CVs; if it is not already too late!

Until next time…

Good Luck and Good Job Hunting!!!!!

 

In Case You Haven't Been Paying Attention: The Indian and Chinese Life Sciences Markets Are Poised For Expansive Growth

Posted in BioBusiness

Over the past week or so there have been daily snippets on various media platforms about business deals and opportunities in the Indian and Chinese life sciences market. While it is not news that many life sciences companies are expanding operations into these markets, the growing frequency of news items about the “goings on” in both markets are noteworthy.

The first bit of news that started the Indian and Chinese life sciences news avalanche, was a note on May 29 that appeared on The Economic Times’ website that reported that New Delhi-based JB Chemical and Pharmaceuticals planned to double the size of its medical sales reps to 1,500 over the next two years to increase its penetration into rural Indian markets. The company had previously divested it over-the-counter consumer business in Russia and other Commonwealth Independent States (CIS; composed of countries from the former Soviet Union) to start up new divisions in gynecology and dental products.

The same day, another New Delhi-based drugmaker called Lupin that specializes in generic drugs, announced that it plans to launch 50 new products by FY12; twelve of which will be generic drugs launched in the US. Both bits of information suggest that new previously untapped commercial opportunities are rapidly beginning to emerge in India and that Indian drug makers are looking to compete in the US and Western European markets that were previously dominated by American, Western European and Japanese companies.

In other India-related pharmaceutical news, an article appeared on June 2 at the Online Pharma Times website that reported that Shlomo Yanai, CEO of the Israeli generic pharmaceutical giant Teva, had flown to India to discuss potential collaborations with pharmaceutical companies there. While most analysts do not think that an acquisition is likely—Teva agreed to buy US-based Cephalon in May for $6.8 billion and also paid $460 million to acquire a controlling stake in Japanese generics group Taiyo Pharmaceuticals—it signals a growing interest by foreign companies to do deals in India to establish a presence it that market.

Like the Indian market, the Chinese market is beginning to heat up. An article at Bloomberg.com published on June 1 reported that Novo Nordisk will boosts its investment in China to preserve its dominance in the diabetes market after rival Sanofi announced a new foray into the Chinese market.

According to a report issued last fall by the International Market Analysis Research and Consulting Group, the Chinese diabetes market is expected to grow from $642 million in 2009 to more that $2.8 billion in 2015. The reason for the increase is attributed to the trend of more people moving from rural areas to cities and changes in eating habits and lifestyles that are contributing to a growing Chinese obesity problem. At present the US Centers for Disease Control in Atlanta estimates that roughly 8.3 percent of the U.S. population and 6.6 percent of the global population has diabetes

Novo first entered the Chinese market about 15 years ago and in 2002 created a diabetes research center and in 2007, in association with the Chinese Academy of Sciences established a foundation to fight diabetes. This year, the company plans on expanding its insulin packaging plant in China becoming the world’s largest insulin packaging facility.

Likewise, in 2005 Sanofi created a diabetes clinic. Three years later is expanded the clinics operations, established a clinical trial center and entered into a partnership with the Shanghai Institutes for Biological Sciences to develop treatments for diabetes, cancer and neurological diseases.

On Jun 3, Pfizer, the world’s largest drugmaker (for now) announced that it plans to partner in a joint venture with China’s Zhejian Hisun Pharmaceutical Company to produce generic drugs for the emerging Chinese market. According to the post on Bloomberg.com

“Pfizer is looking for new sources of revenue before it loses U.S. patent protection in November for Lipitor, the cholesterol medication that was the world’s best-selling drug last year with $10.7 billion in sales. Off-patent medicines, including branded generics, are one of the fastest growing segments in the global pharmaceutical market, Pfizer and Hisun said in a joint press release.”

At present, Pfizer is the top drug company in China (by sales) followed by AstraZeneca and Sanofi according to information supplied by the prescription drug intelligence firm IMS. The size of the Chinese drug market is project to grow by 25 percent this year and rough 60% of the existing market is dominated by generic drugs.

Finally, Chinese pharmaceutical companies are also beginning to invest in the US market. Late last week, the Tianjin Tasly Pharmaceutical Group signed an agreement with the State of Maryland to invest $40 million to build a tradition Chinese medicine (TCM) facility to provide TCM training and information. According to a press release:

“Tasly Pharmaceutical is currently preparing materials for approval by America’s Food and Drug Administration and plans to sell compound danshen drip pills in US and European markets. The medicine’s primary ingredient is obtained from the salvia miltiorrhiza species and is used to treat cardiovascular and cerebrovascular diseases. Danshen is also known colloquially as red sage or Chinese sage.”

I think it is time to pay more attentions to the ebb and flow of the Indian and Chinese markets!

Until next time,

Good Luck and Good Job Hunting (try India and China)!!!!!!

 

More Evidence That Big Pharma's Investment in R&D Will Continue to Wane

Posted in BioBusiness

There is no longer any doubt that big pharma companies are beginning to reduce their emphasis on internal R&D activities. Instead the companies will increasingly rely on outsourcing, partnerships, closer collaborations with academia, public private partnerships and M&A to keep their drug development pipelines full

Therefore it was not surprising when Merck’s new CEO, Kenneth Frazier recently mentioned in a conference call to financial analysts and investors that its multi-billion spending on new drug R & D will likely decline as a percentage of overall sales in the coming years. Merck is one of the largest pharmaceutical companies in the world

According to an article on Nasdaq.com, in 2010, Merck spent $11 billion on R&D, or 24% of total sales. Adjusted to exclude certain acquisition-related and other costs, R&D spending was $8.1 billion. Merck has predicted 2011 adjusted R&D spending would be $8.1 billion to $8.5 billion for 2011.

Frazier, the first African American CEO of a major pharmaceutical company, came under pressure earlier this year after he decided to not substantially cut R&D as many of Merck’s rivals, most notably Pfizer, did. He noted that cuts in R&D spending would have jeopardized Merck’s long term product development pipeline.

While rumors persist that Merck may be seeking to jettison its non-pharmaceutical consumer health and animal health businesses, Frazier insisted that the two units are complementary to its core pharmaceutical and vaccine focus and are not for sale. That said, if I was a Merck employee in either of those divisions, I would be updating my resume just about now.

Until next time…

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