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

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

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

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

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

Until next time...

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

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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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There is a growing worldwide shortage of nurses and other typically female-dominated medical professionals. The acute shortage of nurses in Europe has induced at least one Czechoslovakian clinic to develop a novel—albeit somewhat controversial— approach to retain and recruit hospital personnel. According to an article in today’s New York Times (which was also reported on NPR several weeks ago) “When Petra Kalivodova, a 31-year-old Czechoslovakian nurse, was considering whether to renew her contract at a private health clinic special perks helped clinch the deal: free German lessons, five weeks of vacation, and a range of plastic-surgery options, including complimentary silicone-enhanced breasts.” She opted for cosmetic breast surgery (which normally cost about $3,500) and also had liposuction on her thighs and stomach citing that she her appearance is important to her and her patients.  Perhaps, more importantly, she could never have afforded to have the procedures done on her current salary which is lower than most bus drivers. Of the 50 nurses working at the clinic, 10 opted for plastic surgery, while several more were considering it. And, at least one male employee is seriously considering liposuction.

While offering plastic surgery as an inducement to recruit and retain hospital employees is somewhat controversial, it highlights the need to improve the salaries and benefits of nursing and other medical care professionals. In many places in Europe, nurses and other hospital employees make considerably less than bus, truck drivers and other non-technical workers. The same is true in the US which has also been experiencing ongoing nursing shortages. But, hospitals and clinics here have yet to offer plastic surgery options to recruit or retain medical and support staff personnel. Unlike Europe, where cosmetic surgery is booming, plastic surgery procedures have dropped about 9 per cent this year as compared with years past.

Like it or not, cosmetic surgery is an option in today’s world and, accordingly, people ought to have the right to choose whether or not it is right for them. However, it is important to remember that cosmetic surgery is invasive and potentially serious medical complications including infection, disfiguration and death can occur. The fact that 20 per cent of the Czech nurses chose cosmetic surgery over more vacation time or free German lessons may be indicative of the growing pressure placed on both women and men to look young, vibrant and remain sexy. Further, there are marketing and employment studies which suggest that younger more attractive people get hired more easily and advance their careers more rapidly than average, older-looking ones.

When Petra Kalivodova, the 31-year-old Czechoslovakian nurse who opted for breast augmentation and liposuction was asked about her choice she said “People of my mother’s generation look down on me for getting the surgery—“I see it in their eyes. But I don’t care. I did this because I wanted to and I didn’t ask anyone’s permission, including my boyfriend.” I think her comments reflect a changing and growing attitude among women 35 and under who believe that personal choice, feminine beauty and pursuing professional careers are no longer mutually exclusive.

Until next time.

Good Luck and Good Job Hunting!!!!

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Late yesterday, drug maker and consumer healthcare giant Johnson and Johnson announced that it was buying Mentor, a Santa Barbara, CA maker of skin care products, liposuction equipment and MemoryGel breast implants. According to industry analyst the $1.07 billion that J&J will spend to purchase the company “represents a giant premium for Mentor.” Mentor will become a stand-alone unit of J&J’s Ethicon a leading supplier of sutures, mesh and other surgical products. The cosmetic surgery and anti-aging markets are huge and are expected t to grow as the baby boomer generation continues to age.

J&J is on something of a buying spree and will continue to buy specialty companies to to offset possible losses that may from a weak drug pipeline of its pharmaceutical division. In November, the company purchased Omrix for $438 million, a biopharmaceutical that develops biosurgical and passive immunity products. The deal is expected to close this month.

Unlike most other pharmaceutical companies, J&J has been able to successfully run a diversified conglomerate company that specializes in both pharmaceutical and consumer healthcare products. It is a cash rich company that has a reputation for treating its employees very well! Who said that “beauty is only skin deep?”

Until next time

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

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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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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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