Cannabis-Derived Pharmaceuticals: The Next Generation?

Posted in BioBusiness, Uncategorized

My colleagues AJ Fabrizio and Evan Nison of TerraTech Corp and I just published an article in the July 2015 issue of the Journal of Commercial Biotechnology entitled “Cannabis-Derived Pharmaceuticals

The paper details the emerging field of Cannabis-derived pharmaceuticals, the companies that are developing these products and an up-to-date review of US clinical trials that are being conducted to garner FDA-approval of this new class of therapeutics.

Check it out!!!!!!!!!

Until next time,

Good Luck and Good Job Hunting (there is a future in the Cannabis industry!)

Even Generics Companies Are Not Immune: Teva to Slash 5,000 Jobs!

Posted in BioBusiness, BioJobBuzz

Despite the fact that over 80% of the drugs sold in the US are now generic, Teva, the world’s largest generic drug manufacture (based in Israel) announced yesterday that it will eliminate 5,000 jobs (about 10% of its global workforce) by the end of 2014. According to the company, this action is part of Teva’s worldwide restructuring plan which was introduced in December 2012.

While Teva is generally known as a generic drug manufacturer, it does generate a substantial part of its sales revenue for a branded injectable multiple sclerosis drug called Copaxone lost patent protection.  According to a post at the Pharmalot Blog

The move comes less than three months after a US court invalidated the 2015 patent on its Copaxone multiple sclerosis drug. The decision means patent protection for the drug, which generates about half of company earnings and dominates the MS market, may prevent rivals from selling lower-cost versions of the injectable drug only until next year.

In recent years, Teva has made major investments into biosimilar drugs and presently has two approved product –( Lonquex (XM22 lipegfilgrastim) and Tevagrastim (filigrastim)–on the market.  At present, while Congress passed legislation to allow biosimilars to be approved and sold in the US, the Food and Drug Administration has been extremely slow in translating the legislation into a functional and understandable legal regulatory pathway for approval of biosimilars.

Look for job cuts in the pharmaceutical industry (Lilly ?) in the next few months as we are entering prime layoff announcement season.

Until next time…

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

 

What's Up At Bayer Healthcare?

Posted in BioBusiness

Several weeks ago 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.

Today, the company announced that by 2013 it would outsource the entire production of its blockbuster MS treatment Betaferon to its German arch rival Boehringer Ingelheim. At present, Betaferon sold in the US is manufactured at Bayer’s production facility in Emeryville, CA. Bayer will close that facility and about 540 jobs will be lost.

Boehringer already manufactures Betaferon sold in Europe and it recently received US Food and Drug Administration approval to also sell it in the US. A Bayer spokesperson said that “It is important for us that we can offer the product from a single source.” While that makes sense from a regulatory standpoint, the decision also suggests that Bayer Healthcare may indeed be positioning itself for sale. It also suggests that Bayer may be abandoning the US market for “greener pastures” in the emerging BRIC markets (Brazil, Russia, India and China).

For more insights into Bayer Healthcare check us this article in Life Science Leader.

Until next time…

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

 

It's Almost Official: Sanofi and Genzyme Reach An Agreement…In Principle!

Posted in BioBusiness

Reuters reported today that Sanofi Aventis has reached an agreement in principle to purchase Genzyme for $19 billion in cash and future payments based on the performance of Lemtrada, Genzyme’s experimental treatment for multiple sclerosis.                     

The $19 billion dollar deal translates into $74 per share in cash plus a contingent value right for Lemada that Genzyme investors will receive. Interestingly, the $74 per share stock price is the original amount that Genzyme’s board asked for when the saga to purchase the company began last August. Go figure…..

The deal is the second biggest in biotech history (second to Roche’s acquisition of Genentech) two years ago. I don’t know about you but I am glad that the deal is almost done and we don’t have to hear about it anymore. That said, I hope that Sanofi gets what it paid for! And, if I were a Genzyme employee (especially Henry Termeer, Genzyme’s embattled CEO) I would dust off the old resume or CV as quickly as possible. 

Until next time…

Good Luck and Good Job Hunting!!!!!

 

At Long Last: Sanofi and Genzyme May Be Close to a Deal!

Posted in BioBusiness

After a five month-long series of  very public and often acrimonious negotiations, it appears that Sanofi-Aventis and Genzyme may be close to deal that would enable the French drug maker to acquire one of the world’s largest public biotechnology companies.

According to the NY Times and a number of life sciences blogs, both companies have agreed in principle on a framework for a takeover deal. The major sticking point in the negotiations is Sanofi’s tender offer of $69 per share of Genzyme stock. Genzyme executives and industry analysts view the offer as “too low” and believe that a stock share price in the mid-70s is more reasonable and likely in the end. Another sticking point is the success of Genzyme’s leukemia treatment Campath (alemtuzumab, which is in clinical development to treat multiple sclerosis but will be marketed under the brand name Lemtrada if approved). Genzyme believes that Campath will likely be a winner whereas Sanofi executives are not so sure. Consequently, the deal will likely include additional payments to Genzyme if the drug meets or exceeds certain sale targets for either or both indications.

Persons with knowledge of the negotiations suggest that the specifics of a deal will likely be worked out of the next week or so. This is because, on Monday, Sanofi signed a nondisclosure agreement with Genzyme to conduct due diligence for the deal. Really? What has Sanofi been doing for the past 5 months?

The Genzyme deal is critical for Sanofi which desperately needs to quickly get into the biotechnology game, particularly in the areas of oncology and neurological disorders. Last week, Sanofi’s experimental drug to treat breast cancer, iniparib failed to meet clinical endpoints in a late stage clinical trial. Also, Plavix, Sanofi’s top-selling anti-clotting drug will lose patent protection in May 2012 (FDA recently gave Sanofi an additional six months of marketing exclusivity based on a newly awarded pediatric indication). Plavix is the world’s second best selling prescription medication.

I don’t know about you, but I hope that this deal gets done soon! From the outset, it was apparent to most life sciences pundits and industry insiders that Sanofi would prevail and ultimately acquire Genzyme. Unfortunately, Genzyme’s ongoing manufacturing woes provided Sanofi with an excuse to “lowball” its initial offers. And, surprisingly, Genzyme’s management team had the chutzpah and wherewithal to push back hard.  The bottom line: it is a great deal for both companies—“Just Do It.”

Until next time…

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

 

Online Biotechnology Training

Posted in BioEducation

In case you haven’t heard by now, biotechnology is no longer one of the best kept secrets of the pharmaceutical industry. Because small molecule blockbuster drugs are few and far between, every major pharmaceutical company in the world has announced plans to increase the percentage of protein-based drugs in their development pipeline. 

As strange as this may sound, most people working at pharmaceutical companies have little or no understanding of the science behind the biotechnology industry, its products and the skill sets required to compete in the industry. I learned this while working as a contract writer at a pharmaceutical company that was trying to transition from an emphasis on small molecules to biotechnology drugs. Shortly after management publicly announced its intention, signs began appearing in the building where I worked with messages like “Are you biotech to the core” or “Got biotech.” Not surprisingly, I found myself explaining the different between small molecules and biotechnology products to large numbers of colleagues during group lunches. Their lack of understanding about biotechnology was both surprising and troubling. I mean where have these people been for the past 35 years? 

While I thought that this phenomenon was unique to the company where I was working, it turns out —based on many conversations with employees at other companies—that it is pervasive in the pharmaceutical industry! Put simply, there are large numbers of pharmaceutical employees (and aspiring students for that matter) who know little about biotechnology and must quickly learn about an industry that they are being forced to work in so that they can keep their jobs! This presents time and logistical issues for many full time pharmaceutical employees—they simply don’t have the time or where-with-all to learn about biotechnology via traditional bricks and mortar training opportunities, e.g. undergraduate, graduate or certificate programs.

Recognizing a growing need, several academic institutions now offer online biotechnology courses and degree programs for undergraduate and graduate students. While these programs may not enable participants to work as bench scientists at life sciences companies (this requires hands-on wet laboratory training), they certainly provide students with the fundamental scientific and business underpinnings of the biotechnology industry.

Below you will find descriptions of a couple of online degree biotechnology programs and links to online undergraduate and graduate level biotechnology courses.

Online Biotechnology Degree Programs

The Johns Hopkins University – a prestigious brick-and-mortar research university – offers three online degree programs in advanced biotechnology: the M.S. in Bioinformatics, the M.S. in Bioscience Regulatory Affairs, and the M.S. in Biotechnology. (The M.S. in Biotech may involve a limited amount of on-campus instruction in Baltimore.) Students have up to five years to complete their degrees, but those who enroll for full-time study typically finish in two years.

The University of Maryland University College (UMUC) is among America’s largest providers of distance education. UMUC’s Biotechnology Studies Program has been designated a “Professional Science Master’s Degree Program” by the Council of Graduate Schools. The program’s three specialization areas include: bioinformatics, biotechnology management, and biosecurity/biodefense. A dual online degree option is also available: students can earn an MBA in addition to the Master’s in Biotechnology by completing just a few additional courses.

Online Biotechnology Courses

Purdue University’s Department of Continuing Education frequently features online courses in horticulture and related fields that can help students prepare for careers in biotechnology. New choices are offered every semester.

MiraCosta College, a community college in Southern California, offers a number of online courses in biotechnology. The school’s website includes a five-year projection of course offerings.

While the current list of online biotechnology offerings is short, expect the number of online courses and degree programs to continue to grow in the future. If you are aware of or participate in other online biotechnology courses and degree programs, please feel free contact me about them.

Hat tip and thanks to Chesca and her colleagues at OnlineDegreeReviews.org for research and writing of this post!

Until next time,

Good luck and Good learning!

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Carl Icahn Is At It Again!

Posted in Career Advice

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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