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As many of you may recall, in 2001, Sam Waksal, founder and former CEO of the biotechnology company ImClone was convicted (along with his good friend Martha Stewart) for fraud and insider trading of ImClone stock. Waksal, who was released from prison in late 2008 and lived in a half way house for several months had kept a relatively low profile until earlier this month. Rumor has it that Sam along with Richard Mulligan, PhD a Harvard professor and former ImClone director and Dr. Larry Witte, a current executive vice president in the ImClone division of Eli Lilly are attempting raise about $50 million for the privately-held new venture called Kadmon. Other reports indicate that Waksal and other members of the Kadmon team are putting up $50 million as well. 

According to insider reports the company will ostensibly focus on cancer and infectious disease targets and—taking a page out of the Cubist, Celgene and Sepracor play books—re-purpose once promising drug candidates discarded by other companies. To that end, according an article in TheStreet, the company's drug research programs include a "statin inhibitor for influenza" from a "leading Ivy League university" along with a variety of monoclonal antibodies for use as targeted cancer treatments, similar to Erbitux. Kadmon is also eyeing several existing cancer-focused drug companies, one of which already has a marketed product, as acquisition targets, according to the prospectus. For those of you who may be wondering about whether or not Waksal can legally start another biotechnology company, an agreement with the Securities and Exchange Commission bars Waksal from serving as an officer in a publicly traded company, but as previously mentioned, Kadmon is a private venture.

Whether you like Waksal or not, his track record in the biotechnology industry speaks for itself. Unlike the vast majority of his rivals, Waksal shepherded a molecule from discovery through commercialization. That molecule, a monoclonal antibody called Erbitux, became a multibillion dollar a year treatment for certain forms of colorectal cancer. More importantly, Waksal was one of the first to recognize that humanized monoclonal antibodies directed against certain cellular receptors could be used to treat a variety of oncology indications—a concept that is driving a large portion of discovery and product development in the oncology space. For those of you who may not know, Eli Lilly purchased ImClone two years ago for $7.0 billion dollars after a very public and acrimonious fight over the sale price of ImClone erupted between Carl Icahn, ImClone’s Chairman, and Jim Cornelius, CEO of Bristol-Myers Squibb (BMS). ImClone and BMS co-marketed Eribitux prior to the sale.

Waksal has been in and around the biotechnology industry for over 30 years and many consider him to be one of the early industry pioneers. Unfortunately, despite his dubious past, Waksal represents a dying breed of visionaries whose entrepreneurial spirit and unorthodox approach to new drug development is largely responsible the biotechnology industry’s current largess. Like other ex-felons Waksal did his time and like all Americans he is entitled to a second chance.

Let’s hope that Sam learned a few things during his incarceration and is smarter and wiser for his second and possibly final act. I wish Waksal success in his new venture and I hope that he and his team still possess the insight, creativity and tenacity required to discover and develop innovative oncology and infectious diseases drugs.

Until next time....

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

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At long last, marijuana for medical use is legal in New Jersey. As one of his more courageous acts while in office, outgoing Governor John Corzine signed the act into law late yesterday making New Jersey the fourteenth state to legalize medical pot. Four more states and the District of Columbia are expected to follow suit by year's end.

Many things are driving this sea change. The federal government last year announced that it would no longer prosecute medical marijuana smokers in states where it is legal, while the National Institutes of Health has begun funding research on medicinal use in a reversal of a long-standing policy.

Gallup Polls show a solid majority of Americans sympathetic to therapeutic marijuana use.

Unlike California's medical marijuana law which allows the use, possession, and cultivation of marijuana by anyone who possess a "written or oral recommendation" from their physician that he or she "would benefit from medical marijuana," New Jersey's version requires patient identification cards and state-monitored dispensaries -- easing fears that medical use will fuel illegal sales and teenage substance abuse.

While cannabis preparations have been used to relieve nausea and pain since ancient times, research involving medical uses of marijuana was under funded and in many instances discouraged according to an article in today’s New York Times. But over the last 15 years, research on the body's cannabinoid receptors has begun to decipher the chemistry and biology of the positive effects of cannabinoids especially in the areas of glaucoma and chemotherapy induced nausea and vomiting experienced by patients being treated for cancer. More recently, clinical trials have shown that these benefits outweigh the concerns about addiction, heart and respiratory diseases, cancers, and psychoses -- at least, with short-term use.

Marinol, a synthetic cannabinoid pill, is approved by the Food and Drug Administration for treating AIDS-related wasting and chemotherapy-related nausea. But many patients say choking down a slow-acting pill simply doesn't provide the convenient and immediate relief of inhaling marijuana smoke. A new drug, Sativex, made by GW Pharmaceuticals, may renew the debate. A cannabinoid-based oral spray, Sativex is approved in Canada for treating pain in multiple sclerosis and advanced cancer. The company is now completing the clinical testing needed for approval in Europe and the United States.

While I don’t endorse or use illegal drugs (any more), there is no question that medical marijuana helps patients deal with chronic and, in some instances, severely debilitating conditions that impact the overall quality of their lives. I have long contended that just because a substance is deemed illegal it doesn’t negate potential medically-beneficial properties. An example of legal drugs that don’t have any therapeutic benefits and cause much more morbidity and mortality than marijuana are cigarettes and alcohol. Need I say more?

All I gotta say is that we have come a long way since I saw the film Refer Madness while growing up and coming of age in the late 60s. For those of you who haven’t seen the film it is funny whether you are straight or high! object width="445" height="364">

I guess the nation—well NJ anyway—is finally going to pot!

Until next time...

Good Luck and Good Toking (only for medicinal purposes of course)!!!!!!!!!!!

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For the past month or so I have been working on a piece about chemotherapy induced nausea and vomiting (CINV) that is common among patients being treated for cancer. While not a pleasant topic, it is a reality for many patients who undergo cancer chemotherapy treatment.  Although CINV is less common with some of the newly-developed anti-cancer monoclonal antibody treatments, it is still a troublesome and debilitating problem that must be managed during conventional cancer chemotherapy treatment regimens. 

There is a growing body of evidence that marijuana (delta-9-tetrahydrocannabinol is the active ingredient) and related cannabinoid-like agents may help to effectively manage and control CINV in certain patients who are undergoing cancer chemotherapy. Recognizing this, 14 states have already legalized marijuana for medicinal purposes. Interestingly, according to Newsweek Magazine (November 2, 2009), the US government could save as much as $13.5 billion annually if it stopped enforcing laws against marijuana. To that end, the Justice Department says it will no longer prosecute people who use if for medicinal purposes in the 14 states where that's legal.

While I am not advocating illegal drug use, it seems silly to me that the inherent, medically-beneficial properties of  marijuana haven't been fully utilized to treat patients who are suffering from potentially life-threatening illnesses like cancer.  Further, there are legal and medical precedents for the use of illegal drugs that offer medical benefits. For example, while opium use is illegal in the US but morphine and related products (which are derived from opium and poppy plants) are legal prescription drugs that are regularly used to control acute and chronic pain in millions of Americans. Unfortunately, research on development of cannabinoid-like drugs to treat CINV has been stifled because of the illegality of marijuana.

The number of patients being treated for cancer rises each year. Isn't it time to start offering patients the best and most effective medical treatments available to them rather than continuing to adhere to out dated and unevenly enforced US drug laws?

Until next time...

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

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Late last week, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s cervical cancer vaccine Cervarix for use in girls and women ages 10 to 25 and also approved Gardasil —Merck’s cervical cancer vaccine previously approved in 2006 for use in girls and women—for boys and men ages 9 to 26. For those of you who may not know, over 99% of human cervical cancers are caused by infections with cancer-causing strains of the human papilloma virus (HPV) which also causes venereal warts. Vaccination with Cervarix protects against cervical cancer by inducing immunity against HPV 16 and 18 (which cause most cervical cancers in developed nations) whereas Gardasil affords protection against HPV 16 and 18 as well as HPV 6 and 11, strains that cause venereal warts (which don’t lead to cancer).

Despite FDA’s approval to vaccinate boys with Gardasil to prevent HPV infections, the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP)— which guides national policy on use of vaccines—decided yesterday to recommend the use of the vaccine in girls and women but didn’t fully endorse its use in males. Typically, ACIP recommendations are adopted by professional medical associations and set the standards of practice for physicians. Also, its recommendations play a major role in determining whether or not insurers and third party payors will reimburse patients who are vaccinated. The new recommendations mean, in effect, that physicians and clinics may now administer the vaccine at their discretion to boys and men ages 9 to 26, but they are not expected to offer it. In contrast, vaccination of girls and women ages 10 to 25 will be strongly recommended, readily available and reimbursable. This means that parents may consider the vaccine as an option for their sons, but some health insurers may choose not to cover the shots—an option which is sure to severely limit the numbers of boys and men who are vaccinated with Gardasil.

The ACIP committee decided not to include Gardasil immunization for boys and men on its recommended list because several members, most notably a medical economist, questioned whether vaccinating boys would be cost effective in the long run. At the heart of the debate was whether or not it was appropriate and cost-effective to vaccinate boys for a problem (venereal warts) that can be embarrassing and uncomfortable but is not life-threatening. For those of you who may not know, Gardasil immunization is expensive and requires a series of three injections that cost $130 each ($390 total).  Cervarix, which also requires a series of three injections, is planned to be offered for $385.

Last year in the United States, about 37 percent of girls ages 13 to 17 started the Gardasil vaccine series, a national immunization survey showed, and about half of them completed it. Not a great track record for a vaccine demonstrated to prevent cervical cancer and dramatically reduce the transmission of venereal warts. Nevertheless, yesterday’s decision to recommend vaccination for girls and women but not boys and men makes no sense to me from a public health perspective and it almost smacks of gender bias. Let me explain.

Like all other sexually transmitted diseases (STDs), HPV is transmitted from men to women and visa versa. Based on years of epidemiological studies, the only effective way to reduce the overall incidence of STDs is to implement strategies that prevent infections in both females and males. While boys and men can’t develop cervical cancer, they do contract venereal warts and perhaps, more importantly, can serve as carriers or reservoirs of HPV infection in the population. In other words, infected males (who may or may not show symptoms of HPV infection) still possess the potential to transmit it to sexually-active, unvaccinated girls and women. Consequently, while the incidence of HPV infections may begin to decrease among women after immunization, it will never be completely eliminated and the possibility of developing cervical cancer will continue to be a public health concern.

While the ACIP’s understanding of the transmission of STDs is tragically flawed, its willingness to publicly disclose cost effectiveness as a reason to not endorse HPV vaccination for males is even more egregious! The agency’s decision begs the question: Which is more costly; 10,000 American women developing cervical cancer each year (and countless others going for unnecessary cervical biopsies because of “bad” Pap smears) or a heads up to insurance companies that they ought to cover the costs of male HPV immunizations? 

The ACIP’s reluctance to recommend male HPV vaccination based on economic and health care cost concerns rather than on public health implications is yet another example of how broken the US healthcare system is and how drastically it needs to be reformed. Allowing 3,700 women to die each year in the US from cervical cancer when there is a safe and effective way to prevent these deaths is, in my opinion, unconscionable!

Until next time...

Good Luck and Good Job Hunting!!!!!

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Without fanfare, GlaxoSmithKline (GSK) quietly announced today that the US Food and Drug Administration (FDA) granted approval for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

It has taken GSK over three years to garner US regulatory approval for CERVARIX® which has been approved and used in over 100 other countries in the world. Early "unspecified concerns" delayed approval and, as recently as two weeks, FDA delayed a decision despite recommendations from an advisory panel to approve the vaccine. Coincidentally, a week before the agency was expected to announce approval for the vaccine, a British girl died after she was vaccinated with Cervarix. While FDA spokespersons claimed that the girl’s death following vaccination had nothing to do with the delaying a decision on Cervarix, many industry pundits believe that the FDA was reluctant to approve the vaccine in light of the sensational media coverage in the UK surrounding the incident. After an autopsy was performed on the girl, British authorities announced that a massive cardiac tumor that had infiltrated one of her lungs, not Cervarix was responsible for her death.

Today’s approval of Cervarix provides American consumers with an alterative to Gardasil, Merck’s cervical cancer vaccine that was approved about two years ago. That said, the ability to protect girls and young women from the possibility of developing cervical cancer is more important than which of the two vaccines is used to induce immunity. I plan on immunizing my daughter when she is old enough!

Until next time...

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

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My son, who is a 9^th grader, was recently asked to write an essay for his social studies class about the application of Machiavellian principles to modern day rulers and governments. One of Machiavelli’s ideas that he chose to write about was the notion that a good ruler or government must do it’s very best to insure the safety and health of its subjects or constituents. While this may seem altruistic or philanthropic don’t be fooled—workers who are afraid, unhealthy or regularly ill aren’t productive and can threaten the economic well-being and stability of a society. In any event, he asked me to help with a modern day example of how safety can be reconciled with the Machiavellian principle; “the end justifies the means.” As an infectious disease professional, I quickly realized that mandatory vaccination of newborns and school-aged children against viral and bacterial diseases is a great example.

Prior to the development and subsequent worldwide use of childhood vaccines, epidemics and pandemics of smallpox, measles, polio, diphtheria and other serious diseases routinely ravaged the planet with impunity. During the recurring outbreaks, large numbers of people became ill, and while some sustained life-long debilitating injuries, many others suffered long, painful and excruciating deaths. The recognition that often devastating and regularly occurring outbreaks and epidemics could threaten the well being— and possibly destabilize monarchies and democratically elected governments—  led to the development of  20^th century vaccines against many bacterial and viral childhood diseases. However, it is important to note, while most vaccines are safe and offer protection for many individuals (typically 90% or higher), a small percentage (usually 1% to 5%) of those vaccinated, may experience side effects ranging from mild to severe and possibly life threatening. I believe that vaccination is a polemic for the “ends justify the means” principle because while some vaccinated individual may suffer serious side effects or death greater numbers will benefit from the protection and safety afforded by most vaccines. In other words, governments must be willing to risk harm and possibly death to some of its citizens to insure the productivity, well being and ultimately the safety of the majority.

Despite the medical and health benefits of vaccines, the anti-vaccine movement in the US has steadily been gaining strength of late. Vaccine opponents’ fears have been stoked and promulgated by bogus clinical data offered by fraudulent scientists (which have subsequently been discredited and refuted) and media outlets seeking sensational stories to sell magazines and newspapers. Last week, a 14 year old British girl died shortly after being vaccinated with Cervarix, GlaxoSmithKline’s (GSK) cervical cancer vaccine. This story was quickly pounced upon by the British tabloids and widely circulated.  In the end, the safety of the Cervarix—a vaccine administered to 1.8 million girls without a single death similar to the one that had occurred—became suspect. Almost immediately, anti-vaccine advocates publicized this unfortunate incident as another other reason why parents shouldn’t vaccinate their children. The girl’s death prompted UK officials to immediately suspend all nationwide Cervarix vaccinations; even though an autopsy hadn’t been performed to determine the actual cause of the girl’s death. After an autopsy was finally performed, British health officials announced that the girl had a large cardiac tumor that had infiltrated one of her lungs and that it was likely cancer not Cervarix that caused her death. Unfortunately, the media’s feeding frenzy fanned by the anti-vaccine lobby’s loud voice may have cost GSK US FDA approval of  Cervarix—a product approved and safely used in over 100 countries! 

About three weeks prior to the British girl’s death, an FDA advisory committee unanimously recommended approval of Cervarix. Generally, the agency follows recommendations of its advisory committees. Ironically, the girl’s death occurred several day’s prior to an FDA decision on whether or not to approve Cervarix. Much to the surprise of many industry experts, this past Tuesday, FDA delayed its decision on Cervarix’s approval. FDA spokespeople claimed that the girl’s death had no bearing on its decision to delay Cervarix’s approval (if you believe that, would any of you be interested in some land in Florida?).

It is no secret that GSK has struggled to get Cervarix approved in the US —a decision on its approval has been delayed three times over the past several years. In the interim, the company has managed to successfully address all of the agency’s concerns over Cervarix’s safety and efficacy.

FDA’s decision to delay Cervarix’s approval is great news and something of a victory for Merck, the manufacturer of Gardasil— the ONLY cervical cancer vaccine approved in the US and Cervarix’s main competitor. Failure of Cervarix to win FDA approval will undoubtedly help Merck to bolster Gardasil sales and help it maintain its stranglehold on the US anti-cervical cancer market for the foreseeable future!

Until next time...

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

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A spokesperson at the US Food and Drug Administration (FDA) announced today that it decided to delay its decision whether or not to approve GlaxoSmithKline’s (GSK) anti-cervical cancer vaccine Cervarix. The agency was scheduled to announce its ruling Tuesday on whether to approve Cervarix, but a GSK spokeswoman said the review will continue. An agency spokesperson failed to disclose any reasons for the delay because FDA doesn’t comment on ongoing product reviews. This is the second regulatory delay for Cervarix in the past two years.

The delay comes as something of a surprise because earlier this Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25. The FDA is not required to follow the group's advice, though it usually does. Cervarix already is approved in nearly 100 other countries, but has been delayed in the U.S. since 2007, when the FDA said it needed additional safety data.

An approval from FDA would allow London-based GSK to compete against Merck's blockbuster vaccine Gardasil, which has been on the US market following its approval in 2006. Based on all available published reports, Cervarix has a similar safety profile and efficacy profile as compared with Gardasil.

One of the issues with Cervarix may be the adjuvant use to formulate the vaccine to bolster anti-HPV immunity. While Merck's Gardasil uses an aluminum salt adjuvant, Cervarix uses a novel adjuvant known as AS04. The agency’s lack of familiarity with AS04 and possible concerns about its safety may be what is delaying the Cervarix decision. 

Stay tuned for further details!

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The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.

In a press release, the company announced that “Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of  Cervarix against additional cancer-causing virus types.”

The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine.

In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.

Cervarix® has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.

The likely approval will provide girls and women with an alternative to Merck’s cervical cancer vaccine Gardasil which has been on the market for almost two years. Gardasil has recently come under fire by religious and anti-vaccine groups and sales have been lackluster lately. It will be interesting what effect if any Cervarix will have on the US anti-HPV/cervical cancer market. That said, I doubt whether Merck executives will be sleeping as well as they have been prior to today’s advisory panel recommendation!

For a great comparison of the two vaccines check out an article in today's New York Time business section.

Until next time...

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

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According to a recent report issued by the Pharmaceutical Manufacturers of America (PhRMA), a record 861 new cancer treatments are being developed by pharmaceutical and biotechnology companies. Many of these treatments, which include vaccines and immunomodulators, are in clinical development or awaiting regulatory approval.

The breakdown of the treatments based on therapeutic areas is: 122 for lung cancer, 107 for breast cancer, 70 for colorectal cancer and 103 for prostate cancer. Additional treatments target brain, kidney, pancreatic and other forms of cancer.

While there are many other unmet medical needs that must be addressed by the life sciences industry, the burgeoning and ever-increasing numbers of cancer patients suggests that there is a dire need for development of improved anti-cancer treatments. To that end, if you are contemplating graduate school, already enrolled or trying to determine what therapeutic area makes sense for a postdoctoral fellowship, I highly recommend that you consider oncology. Job opportunities in this field (and neuroscience) will continue to outstrip all others in the near future.

Until next time...

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

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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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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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The New York Times reported today that Genentech’s blockbuster cancer treatment, Avastin, failed to show a significant effect on preventing the recurrence of colon cancer, limiting its utility as an adjunct treatment to treat primary colorectal cancer. While Avastin is already a best-selling cancer treatment, success in this closely watched and highly visible clinical trial could have paved the way to a new uses of the drug, potentially increasing sales by billions of dollars a year.

Avastin had sales of $2.7 billion in the United States alone last year. But it is currently approved only for late-stage colon, breast and lung cancers. For those indications, patient’s lives have been prolonged for up to a few months. The new trial was designed to determine whether or not Avastin could be used earlier in the course of the disease, right after surgery to remove the tumor. The hope of such so-called adjuvant therapy is to prevent the cancer from coming back at all, effectively curing the patient.

While the Avastin failure will have little or no effect on Genentech’s financial outlook, it does call into question whether or not Roche paid too much last month to buy the 44 percent of Genentech it did not already own. Roche has long insisted that its desire to own all of Genentech did not hinge on the results of this trial. And yet, the trial appeared to play a major role in Roche’s months-long negotiations with Genentech.  It appeared that Roche, which had started those discussions last summer, wanted to complete the deal before results of the Avastin trial were announced — on the assumption that a successful trial would have sent Genentech’s stock soaring, possibly putting the takeover price it offered out of reach.  A failed trial, on the other hand, could have pushed down the value of Genentech’s stock. So it now looks as if Roche could have paid less had the results of the Avastin trial come out before it completed the deal.

Art Levinson, Genentech’s former CEO who played hardball with Roche over the course of negotiations, needs to be recognized for his outstanding business acumen. He and other Genentech executives convinced Roche that Avastin sales could quadruple, to $10 billion, by 2015 if the drug could be used for early-stage colon, lung and breast cancers. This possibility induced Roche to raise its bid for Genentech’s outstanding shares from $86.50 to $95 per share. Although Dr. Levinson wasn’t able to fend off Roche’s takeover and is no longer Genetech's CEO, he is likely “laughing all the way to the bank” as the expression goes. And, who said that PhDs aren’t any good at business?

Roche shares were down more than 10 percent on Wednesday, closing at $29.54.

Until next time...

Good Luck and Good Job Hunting!!!!!

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After months of melodrama and acrimonious exchanges between Jim Cornelius and Carl Icahn, Eli Lilly, not Bristol-Myers Squibb, will acquire ImClone and gain access to the multibillion Erbitux franchise. In the end, Carl Icahn, ImClone’s Chairman, got the $70 per share that he wanted for ImClone stock.

BMS’s reluctance to purchase ImClone at the $70 per share price is puzzling. The Pharmalot blog reported that Jim Cornelius, BMS’s CEO, released the following statement after the ImClone/Lilly deal was finalized “We are pleased to have initiated a process that has resulted in the substantial increase of ImClone’s value for all of its stockholders. Perhaps Bristol-Myers has made a comfortable bid for ImClone which would be, in our view, very attractive to the company. If however, it did not succeed then it can liquidate its stake at a premium.” This makes about as much sense as Sarah Palin’s explanation of the factors responsible for global warming—the amount of money that BMS would garner if it liquidates its 16% stake in ImClone would pale in comparison to revenues that would annually accrue from Erbitux sales. Apparently I am not alone in my thinking. According to a financial analyst “the stake’s value independent of full ownership of IMCL is NOT strategic, and gets BMY nothing,”

In my opinion, Jim Cornelius’s failure to acquire ImClone (at any cost) has jeopardized BMS’s future. He had the opportunity to right the wrongheaded licensing deal that his predecessor Peter Dolan entered into with ImClone. The inability of BMS to retain at least partial ownership of its flagship biotechnology product doesn’t bode well for a company that is trying to reinvent itself as a “next generation biopharma company”—if there is a next generation at BMS.

 Until next time…

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

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 On the surface, you wouldn’t think that the Human Papilloma Virus (HPV, the causative agent of venereal warts and cervical cancer) and US Homeland Security have much in common. However, they have more in common than you think as reported in yesterday's Pharmalot blog.

According to a report by the TheStreet.com , Homeland Security’s US Citizenship and Immigration Services (USCIS) is the first government agency to mandate that all female immigrants’ ages 11 to 26 years old be vaccinated against HPV. Because Gardasil is the only cervical cancer (HPV) vaccine that is approved for use in the US it will the vaccine used for the mandatory immunizations. Surprisingly, there is no HPV vaccination requirement for US visa holders or American citizens.

Since the policy was begun, an estimated 233,000 females aged 11 to 26 who entered the US as prospective citizens paid a combined $52 million or so for the vaccinations according to the Street.com article. Curiously, the USCIS is requiring only a single injection for females who receive the vaccine—the Gardasil label indicates that three injections are required for full anti-HPV effectiveness.

As you may recall, more than 20 states rejected plans backed by Merck to make Gardasil vaccination mandatory. Merck abandoned its campaign after parents and medical experts expressed concern about safety and effectiveness. While Gardasil vaccination is optional for American citizens, there is apparently no opt-out provision for females who simply want to immigrate to the US. The confusion may like lie in a document issued by the US State Department called form DS-3025, or “vaccination documentation worksheet which says vaccination against “Human Papillomavirus is required for US immigrant visa applicants.” Here is the form.

John Abramson, the former chairman of the CDC’s Advisory Committee for Immunization Practices when the HPV requirement began in April 2007, and an opponent of mandatory vaccination said “This is not a disease that is communicable like SARS or pandemic flu or even measles.” “I am stunned. It was not the intention of the policy to mandate vaccination of immigrants,”

Ironically, Merck which has been pushing as hard as it can to promote Gardasil use isn’t aware of the Homeland Security policy, according to a Merck spokeswoman. It just goes to show how effective unregulated pharmaceutical lobbying can be!!!

Until next time…

Good Luck and Good Job Hunting

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The Pharmalot blog reported today that Merck received approval from the US Food and Drug Administration to use Gardasil to prevent vaginal and vulval cancer in addition to cervical cancer.

Of late, Gardasil has been a lightening rod for controversy—mostly because of Merck’s unrelenting marketing campaigns (and the behind-the-scenes lobbying for the vaccine to be placed on the US mandatory vaccination list)  coupled with the Christian right’s moral machinations about premarital sex and sexually transmitted diseases in general. Also, let’s not forget the brouhaha surrounding FDA’s decision to delay approval of GlaxoSmithKline’s competing cervical cancer vaccine called Cervarix. Finally, about a month ago, there was study published in the New England Journal of Medicine questioning the cost effectiveness of Gardasil vaccination of women after the age of 18.

Regardless of your moral, ethical or business concerns about Gardasil, the bottom line is this: girls/women vaccinated with Gardasil are much less likely to develop cervical cancer as compared with those who are not vaccinated.

As I have mentioned before, all approved and marketed drugs have side effects and possible safety/tolerability issues. More importantly, the decision to approve a particular drug is always based on a careful risks/benefits assessment by government healthcare regulators. Whether or not a person uses a drug or vaccine is ultimately a personal choice. With the exception of mandatory childhood vaccines (children can be exempted for moral or religious reasons), every American has the right to decide whether or not to use a medication or undergo a treatment recommend by a healthcare professional. Based on everything that I have read about Gardasil, it appears to be a safe and effective vaccine to prevent cervical cancer. When FDA finally approves Cervarix (probably sometime in late 2009), it will offer women who may have concerns about Gardasil with an alternate vaccine to protect them against developing cervical cancer.

The funny thing about the Gardasil firestorm is that cervical cancer isn’t a major healthcare problem in the US. This is because a majority of American women undergo annual routine gynecological examinations (that include pap smears, the current gold standard for cervical cancer detection). In contrast, cervical cancer is a major healthcare problem and economic concern in Asia, most notably in China and India. This begs the question—why are Merck and GSK so intent on selling their cervical cancer vaccines in the US? Put simply, there is still much more money to be made in the US than in Asia. Look for approval of Gardasil and Cervarix in China and India when the middle class of both countries reach a critical mass.

Until next time…

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

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The recent bad press about Gardasil, Merck’s anti-cervical cancer vaccine, must have been keeping its marketing and advertising executives up at night because the company recently launched a marketing campaign called Charm4Life—a line of jewelry designed to raise awareness about cervical cancer. According to a post at the Pharmalot Blog, women (or concerned men) can pay $32 for any of four “limited edition” bangles designed by Carolyn Rafaelian, a designer with Alex and Ani.  The Charm4Life campaign could also be in response to the likely approval early next year of Cervarix, GlaxoSmithKline’s anti-HPV vaccine.

Merck insists that the campaign is to promote awareness about cervical cancer and that all proceeds from sale of the bangles will go to the Prevent Cancer Foundation. Of course, the real goal of the campaign is to promote Gardasil vaccination by raising their awareness of cervical cancer.  

The $32 price tag for the bangles is way cheaper than the $365 it costs for the Gardasil vaccination series. That said, I hope women don’t buy the bangles and forego Gardasil vaccination.

Hat tip to Ed at Pharmalot

Until next time…

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

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After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, Amgen was ordered by the US Food and Drug Administration (FDA) yesterday to change the labels for its EPO drugs (Epogen and Aranesp) that will likely further restrict their use in treating patients with cancer.

The label changes ordered by FDA represent the first time that the agency has invoked its power to change prescribing information for drugs that it previously approved. In the past, FDA could only negotiate with drug manufacturers about changes to labels and prescribing information. In my opinion, it’s about time that FDA has been empowered to unilaterally order these types of changes. I have long contended that negotiations between the agency and drug makers about labeling and prescribing information is not in the best interests of Americans who use prescription drugs. To that end, it was negotiations between FDA and Merck about whether the serious cardiovascular risks associated Vioxx should appear on the Vioxx label (they didn’t) that lead to the misuse, safety problems and ultimate recall of the drug.

While the ordered label changes are not good news for Amgen and its partner Johnson and Johnson which sells Procrit (EPO manufactured by Amgen and sold by J&J), they are in the best interests of all Americans who use these drugs to treat anemia caused by cancer chemotherapy and kidney disease.

Until next time….

Good Luck and Good Job Hunting (avoid A Thousand Oaks, CA)!!!!!!!!!!

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A post at the Pharmalot blog said that the US FDA and the Centers for Disease Control issued a statement today indicating, that after reviewing side effect reports, Merck’s anti-HPV (cervical cancer) vaccine Gardasil is safe and effective, and its benefits continue to outweigh its risks.

According to the statement, the joint agency review determined that 94 percent of  all side effects reported after Gardasil vaccination were not serious. The most commonly reported adverse events fainting, pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted.

Although there have been 20 reported deaths following vaccination, there was no common pattern or tend that would suggest they were caused by the vaccine itself. The statement went on to say that in cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.

The statement was likely issued in response to highly publicized and widely circulated adverse events reports issued by the ultraconservative Judicial Watch which is morally opposed to HPV vaccination. It is extremely unfortunate that a small but vocal group of conservative Christians are willing to risk the health of their daughters because they are morally opposed to premarital sex and birth control. 

Until next time….

Good Luck and Good Job Hunting!!!

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At lunch the other day, I was telling a bunch of people about how brilliant Roche’s biotechnology strategy has been for the past 20 years or so. All of this changed for me on Monday, when Roche announced that it wanted to buy the remaining shares of Genentech that it already doesn’t own for $ 43.7 billion —Roche currently owns 56% of Genentech’s stock. More importantly, Roche doesn’t have control of Genentech’s board of directors nor does it influence corporate strategy or product development.

Unlike many other pharma companies who have historically purchased  biotechnology companies and then integrated them into existing corporate structures, Roche previously opted to buy controlling interests in companies and then allowed them to continue to operate independently with little corporate input or guidance. Unlike pharma culture, which is very structured and inherently conservative, the most successful biotechnology companies have been built on cultures that promote creativity and “thinking outside the box”.   If Roche buys Genentech and attempts to integrate it into the existing Roche family of companies, I suspect that all of this will change dramatically.

For the past 30 years or so, Genentech has been one of the brightest stars in the biotechnology universe.  Genentech’s management team worked long and hard to implement and maintain a vision that was formulated way back in the late 1970s when the company was first formed. Even though it is the world’s largest and most financially successful biotechnology company, Genentech has steadfastly resisted the temptation to go “corporate” and has worked diligently to maintain its “biotechnology identity” —symbolized by innovation, creativity and employee-centric policies.

I have no doubt that if the Roche-Genentech deal is approved, there will be a mass exodus of talent from the company. Based on my experience, a publicly-treaded biotechnology employee’s greatest fear is the dreaded corporate takeover! I have yet to meet a biotechnology company employee who is willing to sacrifice freedom and creativity (despite a possible financial upside) for more structure, discipline and an endless plethora of rules! 

In my opinion, the deal makes sense for Roche—competition in the cancer space is intense and they want to hedge their future success on Genentech’s oncology franchise. In the best case scenario, Roche will buy Genentech but allow it to operate as a wholly owned subsidiary with an independent management team that spends as little time in Basel as possible. I think the old adage “If it ain’t broke, don’t fix it” is particularly apt here!

Until next time….

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

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The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

Before anybody puts a nail in Gardasil’s coffin, it is important to point out who started the recent firestorm about the vaccine. It was none other than the conservative-funded public interest group Judicial Watch. It is no secret that this group advocates abstinence over condom usage and other methods to prevent sexually transmitted diseases. Further,  I suspect that a majority of Judicial Watch’s members don’t believe sex education or pre-marital sex for that matter. Finally, I have no doubt that Judicial Watch received some support (financial, spiritual or otherwise) from the anti-vaccination lobby that is unfortunately gaining strength in the US and elsewhere.

From a scientific standpoint, it is difficult to get a real measure of the safety of a vaccine until it has been widely used by large numbers of people. Although pivotal Phase III trials are required for all vaccine approvals, the number of people studied in these trials (sometimes in the tens of thousands) is not sufficient to predict all possible safety problems that may emerge when the vaccine gains widespread use. For this reason, regulatory agencies typically require vaccine manufacturers to conduct mandatory post marketing Phase IV clinical trials that are designed to address the seriousness of any possible safety concerns that may have emerged after a vaccine has been on the market for several years. Because all vaccine makers know this, it is still not clear to me why Merck, a company which has been in the vaccine business for a very long time, embarked on its failed lobbying campaign to get Gardasil on the mandatory US vaccination schedule shortly after it was approved. 

As I have said in the past, ALL pharmaceutical and biotechnology drugs have side effects and their occurrence and severity varies from person to person. Generally speaking, most drugs are approved by regulatory agencies because their potential benefits outweigh real or presumed safety risks. That said, the question facing all parents who have daughters is: Does protection against cervical cancer outweigh any adverse events or potential safety risks associated with Gardasil or Cervarix vaccination? It is a tough question but one that my wife and I and others will have to answer for our daughters!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station, NJ)!!!!!!!!!

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Monoclonal antibodies (MAbs) directed against vascular endothelial growth factor (VEGF) receptors on cancer cells, have been found to slow the growth of a variety of cancers including colorectal, breast and lung.  While a number of blockbuster biotechnology products( based on these MAbs (Avastin by Genentech/Roche and Eribitux by Bristol-Myers Squibb/ImClone/Merck KGA) have been approved to treat a variety of different cancers their effectiveness as cancer treatments has been the subject of intense debate since their approvals.

Although numerous human clinical trials have shown that VEGF inhibitors slow the growth and development of tumors, they, as a class, don’t seem to significantly increase the survival time for most cancer patients. Further, Avastin and Erbitux are generally not used as stand alone treatments but are used in combination with more tradition anti-cancer chemotherapies. The high costs of these drugs, (Avastin’s worldwide sales hit $ 3.5 billion last year) and their variable effectiveness have caused many to question the usefulness of this class of drugs to treat cancer patients.

The well-publicized use of these drugs as cancer treatments coupled with anecdotal evidence about their effectiveness has put practicing oncologists between a rock and a hard place when it comes to treating patietns with cancer. In an article in Sunday’s New York Times one prominent oncologist said that depsite the controversy,  “I still use Avastin routinely. It’s not a slam dunk and, in fact, the incremental benefit may be more modest than we want to admit.” Others are more sanguine about VEGF inhibitors as cancer treatments “Even when these drugs ‘work,’ what kind of impact are you talking about?” said Fran Visco, president of the National Breast Cancer Coalition. But we market them and give them to everybody.”  

Nevertheless, most oncologists find it difficult to withhold Avastin or Erbitux from cancer patients seeking hope. As one oncologist put it “ When I am not sitting in front of a patient, I think about whether drugs like Avastin are worth it to society. But when facing a seriously ill patient, who, based on clinical trial results, might benefit — even if only a little — from Avastin, I think about the patient’s needs.” 

Regardless of their therapeutic value, the main issue with this class of anti-cancer drugs is cost. Avastin treatment costs patients about $4000-$9000 per month— Eribitux treatment is even more costly! While Medicare and most private insurers cover 80% of the cost, patients can be responsible for 20% or more of treatmetn costs.  As posited in the Times article “If Avastin were inexpensive or if it cured cancer or even held it at bay, as the drug Gleevec does for blood cancer, few might care.”

Are anti-VEGF drugs real cancer treatments or expensive red herrings? Clearly, the jury is still out on that one. That said, I think that only cancer patients can truly provide an accurate response to that question!

Until next time…

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

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As many of you may recall, Merck tried unsuccessfully last year to lobby state and federal officials to pass legislation that would require mandatory vaccination of girls aged 9-26 with Gardasil, its anti-HPV, cervical cancer vaccine. Merck came under fire for its efforts (which seemed ethically disingenuous to many). Consequently, the company’s image took a hit and its stock price started to tumble. Although Merck stopped its lobbying campaign (mostly because of bad press and a flagging stock price), Gardasil ads continued to run and went largely unnoticed.

Because GlaxoSmithKline may be close to launching Cervarix^Tm—its cervical cancer vaccine—  the company recently decided that it was time to ramp up its Gardasil advertising efforts. Starting this past Saturday and continuing through June 26, Gardasil ads will be gracing the screens of a theater  near you. The ads will be shown with films like “Sex and the City” (hmmm, clever wouldn’t you say?), “Get Smart” (who doesn’t remember Barbara Feldon), “The Happening” (what woman doesn’t love a scary movie), “You Don’t Mess with the Zohan” (Adam Sandler is hot) and several others. I want to thank Ed Silverman over at Pharmalot for the heads up on this story!  I don't know about you, but I think that showing commercials at the movies, especially those hawking pharmaceutical products, is just plain wrong!!!!!!!!

This isn’t the first appearance of Gardasil ads at the cinema—I recall seeing an ad for Gardasil the last time I went to the movies (I don’t remember the movie but I clearly can recall the ad!). According to a Merck spokeswoman (aren’t pharmaceutical companies clever?), “We purchased advertised space that is relevant for our older female target audiences; specifically for the summer movies that are relevant to those aged 19 through 26.” 

As Ed so eloquently stated in his Pharmalot post: “Of course, plenty of teenagers will be seeing some of these flicks, too. Zohan and Get Smart are rated PG-13. And Sex and The Happening are rated R, but the restrictions only apply for kids under 17– some of whom will, no doubt, see them anyway.  In any event, Gardasil is unlikely to be available as a value pack that includes soda and popcorn. But we (Pharmalot) are curious to know whether the Gardasil beach towel is about to make a comeback.”

 Until next time….

Good Luck and Good Movie Watching!!!!!!!!!!

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Bristol-Myers Squibb announced today that it will purchase California-based Kosan Biosciences for approximately $190 million. Kosan has been developing two classes of oncology drugs known as heat shock protein 90 (Hsp90) and epothilones. One of Kosan's Hsp90 compounds is currently in Phase III clinical testing for the treatment of multiple myeloma.

Kosan’s epothilone program will complement existing BMS programs designed to develop novel chemotherapy-based oncology products. The Hsp90 clinical program will help to sure up BMS’s push to become a next generation biopharma company.

Kosan was originally founded as an antimicrobial drug development company based on a novel combinatorial drug development (polyketide) platform but eventually morphed into a cancer-focused business. In addition to Kosan’s pipeline, BMS will inherit a small GMP biomanufacturing facility.

The acquisition is good news for Kosan which has been struggling of late. Unlike most other companies, BMS usually retains the employees of companies that it acquires. That said, only time will tell.

Until next time…

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

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Pfizer the world’s largest and least innovative pharmaceutical company  announced yesterday that its profits dropped by 18% last year. The company attributed the loss to reductions in the sale of its blockbuster anti-cholesterol drug Lipitor, which is slated to lose patent protection in the next few years.

Pfizer, which has about $25 billion in cash, has been on something of a buying spree the past couple of years. The company is desperately trying get into biotechnology (too little, too late?) and believes, as it always has, that the best way to enter a new therapeutic area is to buy its way into it! To that end, Pfizer has already purchased two “biotech” companies in 2007 (more purchases are likely on the way) and entered into financially-lucrative, long term research collaborations with several others. Although this strategy has previously worked for Pfizer in the short term, it has proved to be financially disastrous for the company in the long term. Nevertheless, Pfizer said it still expects earnings this year to grow about 11%, due largely to a cost-cutting program that has eliminated 25,000 jobs, or 23% of its work force since 2004.

Until Pfizer executives realize that a robust internal drug discovery and development program is the key to success, Pfizer will continue to be the world’s biggest pharmaceutical company with a constantly flagging stock price.

Until next time….

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

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According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy.

The advisor panel voted 13-1 to keep Amgen's Aranesp and J&J's on the market for use with chemotherapy. The recommendation was very surprising because over the last year FDA has scrutinized the drugs because of safety concerns and recently added new warnings to the labels. Many analysts expected further recommendations for restrictions. Although the advisory panel vote is non-binding, FDA usually follows the advice of its panels when making regulatory decisions. However, it is important to note that FDA has not followed the advice of several advisory panels in the recent past.

The positive advisory panel vote is good news for J& J and Amgen because billions of dollars in revenue are at risk for the cancer indication.  I bet that J & J and Amgen executives breathed a collective sigh of relief after hearing the news!  Maybe that loud noise I heard earlier today was the popping of champagne corks at J & J corporate headquarters in New Brunswick, NJ.  

To quote Mark Twain: “The rumors of my death have been greatly exaggerated” is particularly apt for Amgen and J &J after today’s decision.

Until next time….

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

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Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

Amgen believes that the increased trial deaths among EPO-treated patients resulted from blood clots rather than by promoting tumor progression or growth. The company contends that the amounts of EPO used in the trials exceeded what is recommended in the drug label and, at those levels, blood clots are a known common side effect. On the other hand, there is a growing body of evidence from a variety of sources which suggests that some types of human tumors express EPO receptors, which when stimulated by EPO binding, induces tumor cell proliferation. To make matters worse, when Procrit was first approved to treat chemotherapy-induced anemia, FDA regulators suggested in briefing documents that there may be a “hypothetical risk” that EPO could stimulate tumor cell growth. Nevertheless, neither FDA nor most EPO experts believe at this time that a direct link between EPO use and tumor growth has been established. Everyone agrees that more research must be conducted to verify or refute this idea.

Tomorrow, an advisory committee to FDA will consider placing further safety restrictions on the use of EPO drugs.  If they feel that blood clots were responsible for increased death among EPO-treated cancer patients then the recommendation would be relatively simple–only use the recommended modest levels of EPO to treat cancer patients as indicated on the product label.  However, if they believe that EPO directly stimulates tumor growth then even the currently recommended modest doses of the drug may be too risky to treat cancer patients. Regardless of the outcome of the tomorrow’s FDA advisory meeting, it is clear that Amgen’s flagship EPO franchise may be in serious jeopardy.

Until next time….

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

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Amgen announced today that US regulators added black box warnings to its erythropoietin drugs, Epogen and Aranesp. Similar warnings were also added to Johnson and Johnson’s Procrit which is licensed from Amgen. For those of you who don’t know, getting a black box warning on a drug label is like getting the “kiss of death” from a marketing and sales perspective. It certainly will not help sales of these products!

The new warnings approved by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling warned of similar risks in other types of cancers.

The actions taken by the agency were not unexpected but suffice it to say there are a lot of unhappy Amgen and Johnson & Johnson employees in a Thousand Oaks, CA and New Brunswick, NJ

Until next time….

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

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Sometimes things just seem to occur randomly or by cosmic convergence. Yesterday, my good friend Pete learned that he had prostate cancer. His prostate specific antigen (PSA) levels were slightly elevated over the past few years (they were in a gray zone that made a definitive diagnosis difficult without doing a biopsy). After being urged by his wife and urologist, he had the biopsy performed and, unfortunately, a diagnosis of prostate cancer was made. Hopefully, his cancer is localized to the prostate and will be easily treated via conventional therapies. As many of you may know, prostate cancer is easily treat and the cure rates high if it is detected early.

The use of PSA levels to diagnosis prostate cancer is notoriously unreliable and inaccurate.Today, a group of Swedish scientists announced that they developed a DNA-based test that showed that men carrying a combination of known risk genes run a four to five time higher risk of developing prostate cancer. They envision that this test could be used in tandem with PSA monitoring to more accurately diagnose prostate cancer. I hope that they are right!

Unfortunately, the new test wasn't developed in time to help Pete; but perhaps it can be used in the future to more accurately assess the risk and diagnose prostate cancer quickly so that treatment begins as soon as possible!

Until next time…

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

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Remember the Sam Waksal-Martha Stewart insider trading scandal that rocked the financial world in the late 90s and early 2000s? What about Peter Dolan, the former BMS CEO, who plunked down $2.0 billion for an unproven colon cancer fighting drug Erbitux being developed by ImClone, a dubious biotechnology company?

Well, guess what? . At years end, ImClone’s stock price had spiked 65 percent! This is because Wall Street remained bullish on the company’s only product Erbitux, which has been approved to treat colon and some head and neck cancers. ImClone’s gains are in marked contrast with Amgen and Genentech losses, two of the world’s largest biotechnology companies, whose share prices declined 31 and 17 percent respectively in 2007.

Big biotech companies like Amgen and Genentech better watch their backs— much smaller and nimble companies like Gilead Sciences and OSI Pharmaceuticals also posted large gains in 2007.

As always, good science begets large profits. Despite BMS’s recent troubles, it executives certainly know how to recognize good science to create products that fulfill unmet medical needs!

Until next time….

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

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All good things must come to an end. Yesterday, FDA regulatory reviewers suggested that Avastin, Genentech’s anti-cancer drug, may not be an effective treatment for breast cancer. FDA reviewers determined that Avastin did not help women with breast cancer live significantly longer, and it caused serious side effects, including a few deaths.

An advisory committee to the F.D.A. will meet tomorrow to discuss whether Avastin, already a blockbuster drug for colon and lung cancer, will win an additional approval for breast cancer. The drug had $1.7 billion in United States sales in the first nine months of 2007.

It is unlikely that the advisory panel (composed of practicing physicians, other healthcare professionals and community advocates) will recommend approval of Avastin given the analysis provided by agency reviewers. That said, stranger things have happened at FDA over the past 9 years or so! My sources at FDA tell me that agency reviewers recommended against approval for Vioxx (Merck’s Cox-2 inhibitor that was subsequently withdrawn from the market) but the recommendation was not heeded by agency administrators.

The analysis by the agency’s staff appeared to dim the prospects that Avastin would win an approval as a treatment for breast cancer. Genentech’s stock fell $2.75, or 3.6 percent, yesterday, closing at $73.50.

Until next time....

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

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