Tis the Season…to Lose Your Job

Posted in BioJobBuzz

It is that time of year again….the layoff season.  Coincidentally, the end of the fiscal year frequently overlaps with the beginning of the holiday season.  This means that profits and losses for the past year have already been tabulated and new budgets have been crafted for the new fiscal year.  Not surprisingly, this is when management has the numbers and metrics it needs to determine upcoming staffing levels and whether or not layoffs are necessary.

To wit, yesterday Bristol Myers Squibb announced that it was laying off 75 workers in its R&D division to realign research priorities and cut costs. Also, Ariad said yesterday that it was reducing its US workforce  following its decision to temporarily suspend the marketing and commercial distribution of Iclusig® (ponatinib) in the U.S. Earlier this week, Novartis indicated that it would slash 500 jobs as it realigns its research efforts and attempts to control costs in both Europe and the US. And Shire announced that is was cutting 180 jobs in a UK facility. Finally, a little over a month ago, Merck announced that it would slash 8,500 R&D and marketing/sales positions worldwide.

Admittedly, getting laid off at the beginning or during the holiday season is a horrible thing. That said, since things are slowing down anyway, it gives persons who received pink slips sufficient time to beef up their resumes/CV and stash their year end bonuses into their IRA or checking account.

Tis the season….

Until next time…

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

The Other Shoe Has Finally Dropped: Merck to Eliminate 8,500 Jobs

Posted in BioBusiness, BioJobBuzz

After Merck rehired Roger Perlmutter to replace Peter Kim as head of R&D (he left Merck about 10 years ago to lead Amgen R&D), it was pretty obvious that reorganization and job cuts were likely. However, it was not clear, until today, how extensive the cuts would be and what exactly what would be changing at Merck.

Today, Merck revealed plans to eliminate about 8,500 jobs–mainly in R&D, marketing and sales–in an attempt to save $2.5 billion by the end of 2015. In addition to the job cuts, R&D focus will be shifting and Merck’s headquarters will be relocated again (it was moved from Whitehouse Station to Summit several years ago) to Kenilworth, NJ (the former headquarters of Schering Plough which Merck purchased for roughly $41 billion in 2009)

According to a post at the Pharmalot Blog, while it is not exactly clear where the job cuts will take place, most industry insiders expect that the majority of them will likely take place in NJ.  The shift in R&D focus is intended to emphasize oncology, diabetes, acute hospital care, vaccines, oncology and a greater effort in biologics. Further the company intends to either license or discontinue research on “selected late-stage compounds” and reduce its investment in “platform technologies.”

Once one of America’s preeminent pharmaceutical companies, Merck has stumbled over the past decade (with the Vioxx scandal and the Vytorin and Zetia controversies) and it continues to struggle with regulatory approval of some of its new medicines. Perlmutter was hired to transform R&D and bring his expertise in oncology to bear at Merck.

Time will tell.

Until next time…

Good Luck and Good Job Hunting!!!!!

Bureaucratic Shakeup and More Layoffs at Merck?

Posted in BioBusiness

The Twitterverse was buzzing with activity late last week about a possible shakeup at Merck as Roger Perlmutter takes control as its new head of R&D.  As many of you may know, Perlmutter used to work at Merck but left to become Amgen’s Executive VP of R&D when Peter Kim, the now former Head of Merck’s R&D, was hired several years

Kim’s tenure at Merck was rife with missteps, misdirection and drug approval failures. So, when Amgen replaced its CEO and Merck fired Kim, Perlmutter saw an opportunity to return to the fold with Merck now under the tutelage of CEO Ken Frazier (the man who engineered the company’s Vioxx legal strategy).

Fierce Biotech substantiated the Twitter rumors that a major shakeup may be underway at Merck. According to an article published early on Friday, a Merck spokesperson confirmed that Perlmutter is indeed shaking things up and reorganizing Merck’s R&D infrastructure.

The spokesperson said

“I can confirm that some members of management, but not all Franchise leadership, are leaving the company but are working to ensure a smooth transition.”

The departure of several senior leaders was later confirmed by the Wall Street Journal.  While not confirmed, rumors suggested that Rupert Vessey will lead Merck’s Discovery and Early Development programs.

While Merck spends close to $8 billion annually on R&D, its late stage development pipeline is thin and Perlmutter was hired to strengthen it. Changes at the top usually mean that other changes will take place among the rank and file. That said, stay tuned for possible additional layoffs among Merck R&D personnel.

Until next time….

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

The Beat Goes On: More Layoffs at Life Science Companies

Posted in BioBusiness

Despite assurances that the economy is improving, many life sciences companies are still continuing to downsize.  According to the Pharmalot Blog New Jersey-based Mylan (a generic drug manufacturer)  is laying off nearly 120 people from its specialty offices in Basking Ridge, New Jersey, as part of a reorganization that will consolidate the specialty operation near its Pittsburgh headquarters. The cuts were disclosed in a state filing. A spokeswoman says some employees may relocate. The company is also closing a specialty pharmaceutical plant in Napa, California, later this year which will result in the lost of 270 additional jobs.

Likewise, Massachusetts-based Alkermes  plans to eliminate up to 130 jobs from a plant in Ireland  and, last week, Bristol-Myers Squibb (BMY) revealed that roughly 300 employees will lose their jobs as part of a plan to close the San Diego headquarters occupied by Amylin Pharmaceuticals, which was acquired by BMS last year.

Today, another New Jersey company Unigene that is investigating delivery of proteins and peptide-based drugs announced that it would cut up to 40%of it workforce as it reorganizes and tries to stay in business.

Finally, Swiss pharmaceutical giant Novartis said Tuesday it is consolidating its U.S.-based eye disease research projects in Cambridge, Mass., and closing the Novartis Institutes for BioMedical Research group on its Alcon Labs campus in Fort Worth. About 120 employees in Fort Worth were told Tuesday their jobs will end June 11, The employees will be allowed to apply for jobs in Cambridge as well as for other positions with Alcon. Novartis acquired Alcon, an ophthalmic drug company in 2011 and has been working for the past few years to consolidate all of Novartis’ eye research centers in one location in Fort Worth.  Alcon currently employees about 4,800 people.

While these layoffs are noteworthy, the size of these layoffs pale in comparison to the carnage that took place in the pharmaceutical industry over the past five years. According to Challenger Gray & Christmas, the recruiting and consulting firm more only 3,100 pharmaceutical employees lost their jobs this year. However, Ed Silverman, who writes the Pharmalot Blog mentioned in a post today that “there is industry speculation that Merck will undergo more job cuts.”

Although the industry is still shedding jobs, it is likely that the worst is over and that new job opportunities will emerge in the US and elsewhere over time.

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)

 

Merck Continues Its Eastward Expansion

Posted in BioBusiness

Merck today announced that it will establish an Asia Research and Development headquarters in Beijing, China as part of a $1.5 billion commitment the company made to invest in China over the next five years.

The new headquarters will be focused on new drug discovery and development. Merck’s Asian commercial operations (known as MSD outside of the US and Canada) are located in Shanghai, China and will remain a separate entity from the new R&D center in Beijing. In addition to these facilities, MSD possesses manufacturing capabilities at many other locations throughout China.

Merck joins a growing list of big pharma companies that are rapidly establishing R&D centers in China and other emerging markets. With this in mind, don’t expect US R&D jobs to return to the US anytime soon! Now, may be a good time for American students to reconsider an anticipated career in life sciences R&D. On the other hand, the future is bright for Chinese life sciences graduate students and postdocs who are training in the US.

While Horace Greeley may have gotten it right in his day, I think the saying “Go East young man/women” may be more apt for the 21st century life sciences industry.

Until next time…

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

 

Biotech Update: Samsung Biologics And Biogen/Idec To Compete In The Global Biosimilar Market

Posted in BioBusiness

While Samsung is mostly know for flat screen televisions and other electronic appliances, one of South Korea’s largest companies has been quietly evaluating a play in the protein engineering and manufacturing space. For those of you who may not know, Korea possesses one of Asia’s most vibrant biotechnology industries. At present, there are over 600 Korean biotechnology companies in existence. In April 2011, Samsung created a business units called Samsung Biologics which specializes in biopharmaceutical manufacturing.

Today, Samsung formally announced that it would create a joint venture with America’s Biogen/Idec to develop market and manufacture biosimilar molecules. Under the terms of the agreement, Samsung will invest $255 million and garner a 85% stake in the venture which will be located in South Korea. Biogen/Idec will invest $45 million for a 15% stake in the joint venture. Samsung will take a leading role in developing and marketing the joint venture’s products whereas Biogen/Idec will contribute expertise in protein engineering and biomanufacturing. The joint venture will not develop biosimilar versions of Biogen/Idec’s proprietary, branded protein-based drugs which include Avonex (MS), Rituxan (oncology) and Tysabri (MS).

Biogen/IDEC is the first “big biotech” company to jump on the biosimilar train. The company joins Merck BioVentures and Sandoz (Novartis) as major players in the biosimilar marketplace. Teva, which began looking at biosimilars about eight years ago, is also widely believed to be a biosimilar player. While the financial fate of biosimilars is still uncertain in the US, these molecules are generally perceived as having a much higher financial upside in large emerging markets such as China, Korea, Brazil and Russia which are susceptible to government pricing controls.

Until next time…

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

 

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!!!!!!