Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

I have been in the business long enough to remember when Amgen was the largest and most successful biotechnology company in the world. During most of the 90s and early 2000s, Amgen was second to none. But, a lack of innovation, questionable marketing practices and an uncreative executive management team forced the once invincible biotech Giant to recently stumble and relinquish its world class status

For those of you who may not be familiar with Amgen, it was founded in 1980 by a team of scientists led by George B. Rathmann. The company’s original name was Applied Molecular Genetics which was officially changed in 1983 to Amgen. Its first product, Epogen (EPO; epoetin-alfa) an erythropoiesis-stimulating hormone was approved in 1989 when Gordon Binder was CEO. 

EPO quickly became the company’s flagship blockbuster product and was largely responsible for Amgen’s early success.  The company’s second blockbuster product Neupogen (Filgrastim) a recombinant-methionyl human granulocyte colony factor (G-CSF)—also under Binder’s leadership—which stimulates neutrophil (white blood cell) production was approved in 1998. In the early 2000s the company—now under the tutelage of its third CEO, Kevin Shearer—introduced a longer acting, second generation EPO product called Aranesp (darbepoetin-alfa) and Neulasta (pegfilgrastim), a second generation, longer-acting PEGylated version of recombinant G-CSF.

The largesse from the EPO and Filgrastim franchises allowed Amgen to rapidly expand in the 2000s and to heavily invest substantial resources into new drug development (both small molecule and biotechnology). Unfortunately, most of these investments did not pan out; with the possible exception of XGEVA (denosumab) and Prolia (denosumab) a monoclonal antibody (MAb) treatment that recently received approval for the treatment of skeletal-related events including pathological faction in patients with bone metastases from solid tumors and postmenopausal osteoporosis respectively.

In the 2000s, Amgen’s went on something of a “buying spree” during Mr Shearer’s 11 year tenure at the company. During this time Amgen acquired eight companies including three high profiles and well known ones; Immunex (2002) a MAb development company; Tularik (2004) a small molecule discovery company and Abgenix (2006) another MAb development entity. The Immunex acquisition, clearly the most profitable one, gave Amgen access to Enbrel (etanercept) a tumor necrosis factor α MAb indicated for the treatment of various forms of arthritis. Enbrel is currently one of the world’s top selling biotechnology products.

Despite its lack of R&D productivity, Amgen was recognized until recently as the world’s largest and most profitable biotechnology company in the world. However, its lack of R& D productivity coupled with a recent, highly publicized regulatory and criminal inquiry into inappropriate marketing associated with its EPO franchise has seriously tarnished the company’s once impeccable reputation. Interestingly, it appears that Amgen is finally attempting to reinvent itself.

Last week, the company announced that its CEO, Kevin Shearer and Dr. Roger M. Perlmutter, head of R&D will retire early next year. Mr. Shearer will be succeeded by Robert Bradway, a former Wall Street executive who is Amgen’s current chief operating officer. Dr. Perlmutter will be replaced by Sean Harper, MD, the company’s chief medical officer. And, last month, Amgen announced that it plans on buying back up to $5 billion shares of its publicly-held stock in an attempt to return profit to shareholders. Finally, today, the company announced that it entered into a deal with Watson Pharmaceuticals, a leading generics company, to develop biosimilar versions of some of its competitor’s blockbuster cancer-fighting biotechnology drugs. The press release made it clear that the deal did not include developing biosimilar versions of any of Amgen’s currently marketed biotechnology products. Nevertheless, today’s announcement strongly suggests that Amgen is willing to use anything at its disposal (in this case its substantial expertise in biomanufacturing rather than new drug development) to generate additional revenue streams for the company.

The recent organizational changes and strategic decisions made by Amgen’s board of directors and management team tends to validate the need for change at the company so that it can remain profitable and possibly restore its reputation as a global biotechnology leader. That said, like most other things in life, only time can tell!

Until next time...

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

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

By now, many of you have received an invitation by e-mail to join someone’s LinkedIn network. While some of you may have heard of LinkedIn, you may not exactly be sure what it is and whether or not you ought to accept the invitation to join your colleague’s network. To that end, watching the video below (sponsored by LinkedIn) may help to answer some questions about the network and whether or not it may be right for you.

It is becoming increasingly obvious that participation at online social networking at sites like LinkedIn, BioCrowd, Twitter and others are necessary to land jobs in today’s competitive job market. Unfortunately, many scientists are still reluctant to join these networks to help to find jobs or advance their careers. Hopefully, this will change in the future as scientists begin to recognize the career benefits of online networking sites.

BTW, LinkedIn, which has 100 million users* and a presence in over 140 countries, is going public. It latest IPO price was today announced at $45 per share; the top of its expected price range! Other social media companies like GroupOn and Facebook are expected to issue IPOs later this year.

* In a previous iteration of this post, I mistakenly published that LinkedIn had over 200 million members. The actual number is about 100 million....Mea Culpa!

Until next time...

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

Addendum: LinkedIN successfully completed its IPO on Thursday. After opening at at $83 — up from its I.P.O. price of $45 — and rose as high as $122.70. The shares closed at $94.25, giving the company a market value of roughly $9 billion

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The NY Times today reported that a 15-year veteran chemist at the US Food and Drug Administration (FDA) has been charged with using confidential and proprietary information about pending drug applications to buy and sell pharmaceutical and biotechnology company stock.

According to a criminal complaint filed by the US Justice Department, Cheng Yi Liang, 57 and his son Andrew made millions trading stocks on inside information since 2007. The criminal lawsuit alleges that the Liangs traded stocks in five pharmaceutical and biotechnology companies that had drug applications under review at the agency. Cheng Yi Liang’s job gave him access to a password protected-database that tracked the progress of new drug applications. Some of the companies leveraged by the Liangs included Vanda Pharmaceuticals, Clinical Data, Momenta Pharmaceuticals, Middlebrook Pharmaceuticals and Progenics. The Securities and Exchange Commission (SEC) simultaneously filed a civil securities fraud lawsuit against Cheng Yi Liang. 

The elder Liang is accused in the criminal complaint of “of using the FDA database to get an early look at F.D.A. decisions on companies developing drugs and then working with his son to trade on that knowledge, buying stock ahead of good news and selling it before bad news was announced. Both complaints assert that the defendants made just under $2.3 million in direct profits and avoided an additional $1.3 million in losses”. Further, the S.E.C. complaint accused FDA employee Liang of illegally trading ahead of more than two dozen F.D.A. announcements involving drug applications by 19 companies.

The case is noteworthy because, according to the Times article “it is uncommon for insider-trading investigations to involve FDA, despite the significant amount of market-moving information that passes through the agency each year. The agency maintains a rigorous ethics code and imposes significant restrictions on stock ownership and trading by its employees.”  The good news is that insider trading at FDA is rare and that a majority of its employee maintain ethical and moral standards that are consistent with the mission of the agency which is to supply the American public with safe and efficacious medicines. However, while the Liangs got caught, it does not mean that other less-than- scrupulous employees at FDA have also not benefited from less sophisticated insider trading schemes than those employed by the defendants. After all, FDA employees are human like the rest of us and the temptation to “get rich quickly” can be overwhelming especially during hard financial times.

Until next time...

Good Luck and Good Job Hunting (try FDA, there is at least one open position that needs to be filled)

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Late last week, Merck appointed Ken Frazier, a lawyer, to be the company’s next CEO. Frazier’s appointment, while expected, was historical because he was the first African American tapped to be the CEO of a major pharmaceutical company. Industry insiders contend that Frazier’s unlikely ascension is a tribute to his affability, PR prowess and ability to successfully use his considerable legal skills to navigate Merck through its troubled Vioxx era. 

On the other hand, industry analysts and Pfizer shareholders have been less enamored of the performance of Jeffrey B. Kindler, another lawyer, who has led the company since 2006 when its former CEO Hank McKinnell Jr tried to single-handedly destroy the world’s largest drug maker. Kindler joined Pfizer in 2002 as its chief counsel after working at General Electric and McDonalds—clearly a man with little or no previous pharmaceutical industry experience. While critics contend that Kindler did a laudable job after stepping into the breech, there was consensus among a majority of Pfizer shareholders that it was time for a change at the top.

In a statement Sunday, Kindler announced that he wanted to “recharge my batteries, spend some rare time with my family and prepare for the next challenge in my career.” During his tenure, Kindler oversaw the acquisition and merger of Pfizer and Wyeth and successfully oversaw a settlement for illegal marketing of the painkiller Bextra which included a $1.3 billion criminal fine: the largest health care fraud case and criminal fine for a pharmaceutical company in US history.

The reason for Kindler’s unexpected and sudden departure is likely the impending patent expiry (2011) for its top selling cholesterol drug Lipitor (Pfizer acquired Lipitor after purchasing Warner Lambert Pharmaceuticals in the mid 1990s). Recent financial reports indicate that Lipitor accounted for $11.4 billion of Pfizer’s $50 billion in sales last year or 23% of its revenue. Most industry analysts agree that navigating Pfizer in a world without Lipitor will require an individual with many years of pharmaceutical industry experience and moxy.

To that end, Pfizer announced that Ian Read, currently head of the company’s biopharmaceutical operations will immediately take over as CEO. According to a profile on Forbes.com, Read is:

Senior Vice President; Group President, Pfizer Biopharmaceutical Businesses since October 2009. Previously, he was President Worldwide Pharmaceutical Operations from August 2006 until October 2009. Mr. Read has held various positions of increasing responsibility in pharmaceutical operations. He previously served as Area President for the Europe, Canada, Africa and Middle East and Latin America regions and Senior Vice President of the Pfizer Pharmaceuticals Group. Mr. Read was elected a Vice President of Pfizer Inc. in April 2001.

Also, Pfizer’s board of directors said that it would elect a new chairman (another position vacated by Kindler’s departure) at a meeting within the next two weeks.

Until next time...

Good Luck and Good Job Hunting!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Beleaguered orphan drug manufacturer Genzyme responded to Carl Icahn’s attempt to remove current board members through a proxy fight by issuing a statement announcing a $2.0 billion stock buyback program. Also, the company announced that it would sell or spin off its underperforming genetic testing, diagnostics and pharmaceutical ingredient manufacturing divisions. Both initiatives were announced in an attempt to fend off Icahn’s current assault on the company.

Genzyme spokespersons stated that the company will repurchase $1.0 billion worth of stock in the near term and finance it with debt. An addition $1.0 billion of stock will be purchased over the next year, Genzyme said. While financial analyst believe that the announcement will please shareholders, it is unlikely to ward off the Icahn plan to wrest control of the company away from embattled CEO Henri Termeer.

Until next time..

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The recent manufacturing woes of orphan drug manufacturer Genzyme have been well documented and widely publicized. These problems resulted in massive shortages of some of its top selling drugs Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) causing many of the patients who depend on these drugs to maintain their quality of life to go without reduced or no treatments for months. 

Because both drugs were approved by the US Food and Drug Administration (FDA) as orphan drugs they enjoy seven years of market exclusivity from the date of regulatory approval which prohibits other companies from seeking approval and selling similar drugs in the US. Consequently, Genzyme is the only commercially-available source for the drugs. Genzyme’s ongoing biomanufacturing created massive shortages of both drugs last summer. Because of this, FDA allowed two other companies, Shire and Protolix Biotherapeutics (both have treatments for Gaucher (Protalix) and Fabry (Shire) disease in late stage clinical development), to make their drugs available (at no charge) to patients prior to regulatory approval. This was a relatively rare and bold move by the agency. But, to be fair, they had little choice because so many patients were suffering.  

In case you may be wondering there are approximately 1500 Cerezyme users and fewer than 1000 Fabrazyme users in the US. Despite the small numbers of patients, the cost of the treatments are extraordinarily high; costing patients as much as $200,000 per year for treatment.

According to an article in today’s NY Times as many a 15 percent of American Cerezyme users have switched to a different drug. Fewer patients with Fabry disease have switched mostly because Shire’s drug for Fabry disease Replagal was less widely available. The almost year-long shortages of both drugs have seriously tarnished Genzyme’s reputation. And previously loyal patients are questioning their almost decade long allegiance to the company. This, coupled with a 26 per cent decline in Genzyme’s stock price last year suggest that Genzyme’s standing as one of the top five biotechnology companies in the world may be in serious jeopardy. 

Despite calls for his resignation (and an attempt by Carl Icahn to wrest control of the company), CEO Henri A. Termeer, who has led Genzyme for over 20 years has vowed not to resign. While manufacturing problems are not uncommon in the biotechnology industry, the severity and ongoing nature of the manufacturing problems at Genzyme’s Allston Landing, MA production facility are unacceptable; especially for a company that specializes and prides itself in developing treatment for orphan disease indications. The FDA recently announced that it would fine Genzyme and place its manufacturing operations under a consent degree for an indefinite period of time.

Genzyme representatives now contend full supplies of Cerezyme will be available after May 1 and those for Fabrazyme possible in the third quarter of this year.

While so-called “copycat” or “me too” drugs developed by pharmaceutical companies tend to be vilified by consumers and patient advocacy groups, the agency prefers to approve more than one treatment option for a given disease indication in case one medication doesn’t deliver the intended therapeutic benefits or induces untoward adverse events. Unfortunately, the seven years of market exclusivity awarded to orphan drugs manufacturers that garner regulatory approval for their products prohibits this. The biomanufacturing fiasco at Genzyme suggests that it may be time to reexamine the Orphan Drug Act and modify some of the financial and regulatory terms that were included to induce drug companies to develop new treatments for orphan disease indications.

Until next time…

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

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Biogen Idec today announced that Dr. Eric K. Rowinsky and Dr. Stephen A. Sherwin have been appointed to its Board of Directors pursuant to an agreement with Icahn Partners. Dr. Rowinsky was proposed as a nominee to the Board by Icahn Partners and Dr. Sherwin was selected by the Company as part of its process to identify new directors.

"Under the terms of the agreement, Icahn Partners has agreed to vote its shares at the 2010 Annual Meeting for Biogen Idec's nominees, who will include current directors Nancy L. Leaming and Brian S. Posner as well as Drs. Rowinsky and Sherwin. In addition, under the terms of the agreement, Icahn Partners will withdraw its notice of nomination of persons for election as directors and its proposal to amend Biogen Idec's Bylaws to limit the size of the Board."

As you may recall, Icahn tried to wrest control of the company from its current management team in an attempt to force the company to sell itself because Icahn believed that its stock price was undervalued. Since that time, it appears that Biogen Idec executives are seeking to appease Icahn rather than publicly fight with him over the value of the company. Don’t be surprised if Biogen Idec is sold to a large pharmaceutical company by the end of this year.

Until next time…

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

It looks as though Enzon Pharmaceuticals, the first company to successfully commercialize protein PEGylation, finally buckled under the pressure exerted by Carl Icahn, one of its major shareholders.  As I mentioned in a previous post, Carl recently started buying large blocks of Enzon stock to gain a controlling interest in the company to maximize shareholder value. To accommodate Icahn’s "vision" and demands, Jeff Buchalter, Enzon’s Chairman and CEO has decided to spin out a new biotechnology company.  According to an Enzon press release, the new company (to be named later) will get Enzon’s core technology (PEGylation) and its entire preclinical pipeline (i.e.; their RNA antagonist oncology portfolio). Enzon will also invest $150m in the new venture.

So, what does Enzon get out of the deal? It retains ownership of a small, aging manufacturing facility and a portfolio of nominally-performing specialty pharma drugs. I think comments made by Eben Tessari, a financial analyst who follows Enzon, sums up of the essence of the proposed spin out.  He writes: “Maybe I’m way off here but it seems to me in analyzing this deal that the new company gets all the goodies while Enzon is left with a manufacturing plant and a stable of marginal drugs (zero out of four therapies have over $50m a year in revenue). Now, I don’t mean to imply that I think Enzon is a bad company - hell, they’ve managed to make more profit this quarter than any pharma company I’ve ever worked for - I’m just saying they are selling their future based on the advice of a man notorious for breaking up companies and wringing every last dime out of a shakeup.”

Not surprisingly, Jeff Buchalter, the brains behind the deal, thinks it will provide Enzon shareholders with the value that they demand. “By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure. Operating separately will allow each company to benefit from greater strategic and managerial focus and appeal to their own unique shareholders. The separation will enable the two businesses to compete more effectively in their respective markets and optimize their business goals, research initiatives and capital requirements. We look forward to creating this opportunity for the shareholders,” said Buchalter.

Jeff, who learned how to turn around failing companies from his former boss Fred Hassan (turn around specialist and current CEO of Schering Plough) ought to know a little something about value. According to SEC filings, last year Jeff made $773,558 (base salary) with $1,162,500 in bonuses for a total cash compensation of about $2 million. In addition, Jeff received just over $3.1 million in equity bringing his total 2007 compensation package to approximately $5.2 million —almost 3 times the amount received by any other Enzon executive.  Not that there is anything wrong with that!!!!!!!!!!!!

Until next time….

Good Luck and Good Job Hunting (try Enzon’s spin out, they are flush with cash)!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

A federal judge ruled that Amgen Inc. must defend itself against charges that it misled investors about safety concerns with its flagship anemia drug, Aranesp.

A US district court judge dismissed charges against five of nine Amgen officers and directors but left plaintiffs 30 days to amend their complaint in order to include those defendants. The investors, led by Connecticut Retirement Plans and Trust Funds, assert that positive statements made by company officials regarding the safety of Amgen's two anemia drugs, Aranesp and Epogen, were knowingly at odds with clinical studies that had raised concerns.

The plaintiffs assert, according to court filings, that they unknowingly purchased artificially inflated shares, between April 2004 and May 2007. In one instance, during its fourth-quarter 2006 conference call, Amgen announced results of a clinical trial that tested Aranesp in 939 patients with anemia from cancer. The Food and Drug Administration, according to court filings, described the study as "demonstrat(ing) significantly shorter survival rate in cancer patients receiving (anemia drugs) as compared with those (sic) receiving transfusion support."

Describing the results of the study during the conference call, Roger Perlmutter, a defendant and executive vice president of research and development, said, "We did not see a statistically significant adverse affect of Aranesp on overall mortality in this patient population, and so we conclude that the risk/benefit ratio for Aranesp in these extremely ill patients with anemia secondary to malignancy is, at best, neutral and perhaps negative."

Sounds misleading to me! It is unfortunate that companies compromise their scientific integrity and corporate reputation simply to boost their stock price in the short term. I think companies are slowly learning that if they are dishonest or disingenuous with the American public that the public will soon lose confidence in them and their products. This, in turn, will lead to a decrease in sales and ironically a reduction in company stock price. As the old adage goes “Honesty is always the best policy!”

Until next time….

Good luck and Good Job Hunting!!!!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link