Merck Inks a Deal with Sinopharm to Bolster Its Vaccine (and Biosimilar ?) Business in China

Merck & Co today announced that is reached an agreement with Sinopharm Group Co Ltd one of China’s largest biopharmaceutical companies to market its cervical cancer vaccine Gardasil and other protein-based products in China. While the terms of the deal were not disclosed, it is Merck’s first attempt to expand its vaccine and biotechnology business in the rapidly emerging Chinese biopharmaceutical market. Merck, like many other American pharmaceutical companies, now recognize that a Chinese marketing and distribution partner is required to successfully penetrate and compete in China.

Like other big pharma companies, Merck recognizes that its future growth lies in making inroads into emerging markets like Asia, Africa and South America.  Merck executives project that more than 25 percent of the companies pharmaceutical and vaccine sales will come from emerging markets by 2013 (currently 17 percent of revenues are derived from emerging markets). Last May, Merck indicated that it already had 3,000 sales representatives in China which represents a 90 percent increase since 2007.

Cancer is a major problem in China and it is putting a lot of financial pressure on the Chinese government. Moreover, the cervical cancer rate is inordinately high in China mainly because there is no formal screening program similar to those found in the US and Europe. 

Interestingly, the Human Papilloma Virus (HPV) types that cause cervical and other cancers in China are somewhat different than those that cause disease in Western countries. For example in addition to HPV 16 and HPV 18, HPV 58, 52 and 33 have also been associated with a high incidence of cervical cancer in China. This suggests that Merck will have to reformulate Gardasil (which contains HPV 6, 11, 16 and 18) to be effective for the Chinese market.

Until next time...

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

 

Bristol-Myers Squibb Board Okays $3.0 Billion Stock Repurchase Program; Is BMS Preparing Itself for Sale?

Bristol-Myers Squibb (BMS) announced Tuesday that its board authorized the repurchase of up to $3 billion of its common stock.

The company said the buyback program has no expiration date and will take place over the next few years. Company spokespersons said the decision reflects Bristol-Myers' strong financial position, which included $9.8 billion in cash and marketable securities at the end of the first quarter.

While stock repurchase programs are common, BMS is steeling itself for the expected loss of substantial revenues beginning in 2011 due to patent expiry of its top selling anti-clotting medication Plavix. In the past year or so, the company has sold off a profitable medical device subsidiary (Convatec) and a consumer products company (Meade Johnson) to sure up its finances and improve stock share price. 

Long be rumored to be a takeover target, BMS has attempted to reinvent itself over the past few years as a “next generation biopharmaceutical company” through licensing agreements and acquisition of smaller biotechnology companies with promising technology platforms and near term new biotechnology products (Medarex). However, the loss of Imclone—the biotechnology company that developed the one of the top-selling colon cancer drugs called Erbitux—to rival drug maker Eli Lilly has significantly slowed the next generation initiative.

Stay tuned for all late-breaking events.

Until next time…

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

 

Merger Mania Continues in the Life Sciences Sector

Merck of Germany announced on Sunday that it had agreed to purchase Millipore, an American supplier of laboratory products and reagents for biotechnology companies for $7.2 billion. The offer comes in the wake of the $6.0 billion offer made last week by Thermo Fisher Scientific one of the largest supplier in the world of laboratory reagents, supplies and equipment. While somewhat of an unconventional move for a healthcare company, Merck executives hailed the acquisition as a strategic move for customers, stakeholders and share holders of both companies.

In other news, Astellas Pharmaceuticals, Japan’s second largest pharmaceutical company said today that it tendered an offer to acquire all outstanding shares of Long Island, NY-based OSI Pharmaceuticals for $52.00 per share or approximately $3.5 billion in cash. OSI, which manufactures and sells Tarceva (erlontinib) a treatment for non-small cell lung and pancreatic cancer (which it co-markets by Genentech in the US and globally with Roche), has a strong oncology pipeline and is also developing treatments for diabetes and obesity. Despite early success with Tarceva, cash-starved OSI has been struggling of late. The acquisition of OSI provides Astellas with a strong pipeline and entrée into the growing US oncology market. OSI would also complement Astellas’ existing strength and franchises in urology and immunology.

While mergers and acquisitions were largely anticipated in the US biopharmaceutical sector over the past few years, the acquisition of American companies like Millipore and OSI Pharmaceuticals by foreign companies suggests that there may be chinks in the armor of once dominant US biotechnology companies. The economic crisis coupled with America’s waning innovation in the life sciences sector suggests that other US-based biopharmaceutical companies may be at risk. Although most foreign governments stumbled when attempting to develop the own internal biotechnology expertise, many cash-rich foreign companies recognize that purchasing US companies with marketed products offers them an opportunity to quickly and strategically gain a foothold in the ever-expanding biotechnology market.

Until next time....

Good Luck and Good Buying!!!!!!!!!

 

The New Bacterial Threat

For the past decade or more multiple drug resistant strains of bacteria such as methicillin resistant Staphylococcus aureus (MRSA), enterococci and other Gram positive cocci have been highlighted and showcased in the medical and lay press. While the incidence of infections caused by MRSA and other Gram positive cocci has steadily risen, antibacterial drug discovery experts have long known that the greatest disease threat in the future will be from emerging multiple antibiotic resistant strains of Gram negative bacteria including Acinetobacter baumannii, Klebsiella pneumoniae, Serratia marcescens and Pseudomonas aeruginosa.

Last Spring, in an interview that I conducted with Barry Eisenstein, MD, Senior Vice President of Scientific Affairs at Cubist Pharmaceuticals and an antibacterial drug discovery expert, he indicated that there are currently no drugs in development to treat infections caused by antibiotic resistant Gram negative bacteria. He warned that this, coupled with the loss of interest in antibiotic development by large pharmaceutical companies, will cause infections caused by multiple drug resistant Gram negative bacteria to become a serious unmet medical need in the not so distant future. The appearance of an article in the New York Times this past Saturday chronicling the rise of infections caused by antibiotic resistant Gram negative bacterial suggests that the not so distant future may have already arrived! For the record: would newspaper and television reporters please refrain from identifying bacteria as “germs.” It is an anachronistic term which was coined in the 19th century before bacteria and viruses were conclusively identified as the cause of most infectious diseases.

Despite the media hype about antibiotic resistant Gram positive bacteria, a variety of new drugs have been developed to treat infections caused by these bacteria. Interestingly, because of greater public awareness about MRSA infections and improved hospital infection control and surveillance programs, the incidence of disease caused by MRSA and other Gram positive bacteria is finally beginning to wane. Unfortunately, the same is not true for infections caused by antibiotic resistance Gram negative bacteria.

For those of you who may not know, the cell wall architecture of Gram negative bacteria (and a multitude of antibiotic resistance mechanisms) makes it much more difficult and costly to develop new antibiotics to treat Gram negative infections. Consequently, research in this area has been largely ignored for the past 15 years or so. This means that in the future the morbidity and mortality associated with infections caused by antibiotic resistant Gram negative bacteria is certain to rise. With this in mind, persons at the greatest risk of developing these infections include patients in hospitals and long term care facilities and individuals receiving implantable medical devices.

Because most large pharmaceutical companies abandoned antibiotic drug discovery in the mid to late 1990s, it is unlikely that new Gram negative antibiotics will come from the pharmaceutical sector. While there are several small biopharmaceutical start ups working on antibiotics for Gram negative bacteria (KaloBios Pharmaceuticals, Calixa Therapeutics and Novexel) the increasing regulatory scrutiny and rising development costs suggests that these companies may have trouble bringing new antibiotics to market. Sadly, this places the onus of new Gram negative antibiotic discovery squarely on the shoulders of the US government. To that end, as much as it pains me to say this, it will likely take the death of government official or family member before sufficient resources are allocated to address this rapidly growing unmet medical need. Maybe the Obama Administration ought to think about allocating stimulus monies to begin to address the problem!

Until next time...

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

 

Economic Recovery: US Contract Biomanufacturing Companies Are Experiencing an Upswing

For the past decade or more, small to mid-sized biotechnology companies had been outsourcing production of their preclinical and clinical protein-based products to Asian contract manufacturing organizations (CMOs). This was because manufacturing and labor costs were lower and product quality was consistent with Western standards and requirements. However, the recent economic down turn coupled with rising prices at Asian CMOs (mainly driven by increasing labor and project management costs) has forced many small to mid-sized companies to rely again on American CMOs to manufacture their products. Unlike cash-rich, larger companies, US small to midsize companies generally lack the financial resources and personnel to effectively manage operations in Asia. Many industry analysts contend that the lower initial costs of Asia-based companies are usually offset by the money and resources need to oversee a project.

While business returning from Asia improved the financial outlook for some American CMOs, 2009 was a bad year for most firms that service small to mid-sized pharma and biotech companies. However, industry analysts expect 2010 to be better than 2009. More importantly, the return of biomanufacturing to the US may signal the beginning of a new trend in the biomanufacturing outsourcing industry.

Until next time....

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

 

Science Magazine Survey: American Life Sciences Companies are Some of the Best to Work for in the World

An annual survey conducted by Science magazine and the American Association has identified the 2008 top twenty life sciences employers in the world. The rankings were based on a company’s leadership, stability, social responsibility and treatment of its employees. Six of the top 10— Genentech, Gilead Sciences, Genzyme Corp., Schering-Plough Corp., Gilead Sciences are based in the US whereas the remaining four—Boehringer Ingelheim, Roche Pharmaceuticals, EMD Serono, and Millennium are headquartered outside of the US. For the first time, eight of the top 20 are located outside the United States.

In case you were wondering, Genentech was ranked number 1. This is the fifth time out of the past 6 years that the San-Francisco based company made it to the number one slot (it fell to second last year). Another notable is Massachusetts-based Genzyme which made it to the number 3 spot (out of 575 companies) for the second consecutive year. Surprisingly, Monsanto, the company that makes genetically modified seed crops, was number 2—this despite all of the negative press about genetically modified foods. Let see whether or not Genentech can retain its number 1 ranking after the Roche takeover of the company is completed.

Until next time....

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

 

Bristol-Myers Squibb to Buy Monoclonal Antibody Maker Medarex

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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What Not To Say in Your Resume

Back in the day—when the economy was sound and jobs were plentiful—an adequately written resume with a sprinkling of keywords and strategically-placed human resources clichés were sufficient to get your foot in the door at most companies. However, in today’s troubled economy where unemployment is rampant, there are certain buzz words and phrases that no longer resonate with hiring managers. According to Liz Ryan, an experienced  corporate career advisor who writes for Yahoo Hot Jobs, the following phrases must never appear in a resume if you are a job seeker in today’s market. 

  • Results-oriented professional
  • Cross-functional teams
  • More than [x] years of progressively responsible experience
  • Superior (or excellent) communication skills
  • Strong work ethic
  • Met or exceeded expectations
  • Proven track record of success
  • Works well with all levels of staff
  • Team player
  • Bottom-line orientation

She contends (and rightfully so) if old and tired phrases (like the ones mentioned above) appear in you resume you run the risk of being marked as “uncreative and vocabulary challenged.” Further Ms. Ryan suggests that you “can make your resume more compelling and human-sounding by rooting out and replacing the boring corporate-speak phrases that litter it, and replacing them with human language— things that people like you or I would actually say.” 

This language change is being driven by the informal nature of social media and a growing emphasis on truthfulness and transparency in the business. Nevertheless, well written resumes—with or without buzz words or key phrases—have always been and remain the first step in the sometimes long and tedius process of landing a new job!

Until next time...

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

 

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Looking to Improve Your Business Acumen?--A New Mini-MBA for Biotech

I am frequently asked by life sciences PhDs whether an MBA would improve their chances of finding a job in industry. And, my response is always “maybe— because it depends. I don’t think that getting a traditional MBA really gives you that much of an edge especially if you are an established PhD looking for career advancement or change.  However, if you are a graduate student or postdoc who has already decided that academia is not for you, then getting a certificate or M.S. through an established graduate program in biotechnology (Georgetown University’s M.S. in biotechnology or The New York Center for Biotechnology's  Fundamentals of Bioscience Program) may increase the likelihood of winning a job in industry. This is because hiring managers recognize that in addition to a job candidate’s technical competency, they possess an understanding of the business aspects of the industry—something that is vital for scientists to be successful in the biotech biz.

Recognizing this, Rutgers University recently created a program that they call ‘a mini-MBA for the biopharmaceutical industry’. In contrast with traditional MBA or M.S. programs, the mini-MBA is a 12 week long, degree-granting program that was designed to familiarize students with the nuances and intricacies of the business aspects of the biopharmaceutical program. The good news is that they are actively recruiting students to fill the slots available in their inaugural class. The bad news is that it costs $4,995 to enroll. That said, it may be worth the time to check it out because—in the end—the investment may be worth it!

Until next time…

Good Luck and Good Job Hunting!!!!!

 

The FDA New Drug Approval Conundrum Revealed

FDA approvals of biopharmaceutical products have decreased in recent years. This includes recombinant proteins and monoclonal antibodies and cancer therapeutics. In the decade from 1996-2005, an average of 16.6 new drugs were approved each year. In marked contrast, there were only 11 and 12 new medications approved in 2006 and 2007, respectively.

Last year was an unusually unproductive year for the pharmaceutical and biotechnology industry. The combined sales for products approved in 2007 are projected to be less than $1.0 billion dollars–the benchmark for drugs that receives blockbuster status. Further, most or the approved drugs were similar to ones that were previously approved (so called “me too” drugs) and none will significantly improve healthcare for large numbers of patients.  Finally, only two recombinant protein drugs were approved in 2007–a level more representative of the 1980s.

Most analysts agree that it is unclear why FDA approval of new drugs has decreased over the past few years and who, if anybody (FDA and/or industry), deserves the blame for the approval drop-off. Regulatory filings for a number of new products are either expected or currently pending. To that end, it is likely that there will be more new approvals in 2008 and 2009 as compared with previous years. To learn more about the drug approval conundrum please read this article recently written by Ronald A Radar.

The rate of new approvals must increase in order for the biopharmaceutical and pharmaceutical industries to remain economically healthy and viable. Industry and the FDA must work more closely with one another to continue to insure that the American public has ready access to innovative, safe and efficacious, new biopharmaceutical and pharmaceutical products.