Another Biotech Company Bites the Dust

Posted in BioBusiness

Abbott Laboratories yesterday announced that it will buy Facet Biotech Corp. for about $450 million in cash. Facet, along with its development partner Biogen Idec, had planned on moving a potential monoclonal antibody (MAb) treatment for multiple sclerosis called daclizumab into late stage clinical development in the second quarter of this year. The company is also developing several different cancer treatments with other pharmaceutical partners.

Abbott’s purchase of Facet signals Abbott Laboratories’ ongoing commitment to biotechnology or protein-based drugs. The company launched Humira (a fully human MAb treatment for rheumatoid arthritis and other inflammatory diseases) several years ago and it has managed to glean market share from older competitor’s products including Remicade (Johnson & Johnson) and Enbrel (Amgen/Pfizer) to become a blockbuster drug. MAbs are viewed by many as the “drugs of the future.” At present, there are over 350 MAb-based products in various stages of discovery and clinical development.

Earlier in the year, Biogen Idec offered to purchase Facet for $17.50 per share. Company executives and shareholders rejected the offer citing that they thought it was too low. Abbott offered $27 per share which represented a 67 percent premium to Facet’s closing stock price of $16.21 on Tuesday.  Both companies’ boards of directors have already approved the deal which is expected to close some time in the second quarter. It is not clear how the purchase will affect Facet employees but expect to see layoffs and a mass exodus by company executives.

Look for more cash purchases of biotech firms by pharmaceutical companies as debt continues to accrue and venture money remains scarce and difficult to come by.

Until next time…

Good Luck and Good Job Hunting!!!

 

Simponi–A New Anti-TNF-alpha Monoclonal Antibody–Garners FDA Approval.

Posted in Career Advice

The FDA has approved Johnson and Johnson’s Simponi (golimumab), a new treatment for adults with moderate-to-severe rheumatoid arthritis , psoriatic arthritis, and ankylosing spondylitis. Unlike Enbrel, Remicade and Humira, other anti-TNF-alpha monoclonal antibody products—which require multiple monthly intravenous infusions—Simponi is injected under the skin and requires only a single monthly injection. 

Simponi is intended for use in combination with the immune-suppressing drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Like other anti-TNF-alpha monoclonal antibody products, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and serious fungal infections with use of the drug. The most common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion.

I have no doubt that Simponi will provide much-needed relief to patients suffering from immune arthritis. However, I think that the marketing folks at J& J could have come up with a better name—it reminds me of Spumoni (the Italian ice cream) and The Simpsons television program. But, then again, the name is distinctive and easy to remember!

Until next time…

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

 

Expect More Uneasiness at Pharma Companies This Week

Posted in BioJobBuzz

In the wake of last week’s Pfizer-Wyeth M&A feeding frenzy, I suspect that most analysts were hoping that this week would be a little quieter. Unfortunately for many pharmaceutical company employees, this week may be shaping up to be almost as nerve-wracking as last week!and declared that it was on the hunt for a merger or acquisition partner. A ll of the usual suspects have been cited as possibilities. They include: Bristol Myers Squibb (Plavix, Erbitux, Orencia Abilify) , Amgen (EPO, Aranesp, Neupogen, Neulasta and Enbrel), Biogen-Idec (Avonex, Tsyabri and Rituxan) (Actavis (generics) Ratiopharm (generics) and Crucell (vaccines). The hands on favorite and most likely target would be Bristol Myers Squibb because the two companies co-market Plavix, their top selling drug that is due to lose patent protection in the next year or so. That said, in this environment anything can happen. 

 

In other news, GlaxoSmithKline announced that it will be cutting 6,000 jobs later this week when the company puts out financial results. The company began reorganizing itself in 2007 and will continue to do over the next few years to deal with generic encroachment on several of its top selling drugs. Glaxo employs about 100,000 people worldwide. Analysts suspect that many of the job cuts will occur in the UK and that sales rep may be hit the hardest in this latest round of layoffs.

Until next time…

 Good Luck and Good Job Hunting!!!!!

 

 

 

Why a Pfizer-Wyeth Merger Doesn't Make Sense

Posted in BioJobBuzz

Pfizer is the largest pharmaceutical company in the world. It was able to garner that distinction by going on a decade-long buying spree that began in the mid 1990s. To date, Pfizer has acquired Warner Lambert, Pharmacia and a host of smaller specialty pharmaceutical and biotechnology companies. Despite these acquisitions, which yielded top selling blockbuster drugs like Lipitor and Celebrex, Pfizer’s stock has never performed up to analyst’s expectations. In fact, while it’s smaller and more nimble pharmaceutical competitor’s stock prices were soaring, Pfizer’s stock price was either flat or falling. While conventional wisdoms suggest that “bigger is always better” this has proven not to be the case when companies, like Pfizer, attempt to win greater market share through mergers and acquisition and also loss sight of their core business.

In my opinion, Pfizer’s acquisition of Warner Lambert in the mid 1990s was a well executed, strategic move—the transaction gave Pfizer rights to Lipitor, currently the world’s top selling prescription drug. At that time, Pfizer’s internal drug discovery pipeline was essentially running on empty and it needed a blockbuster to insure its future growth. Despite the benefits of the Warner Lambert deal, it took Pfizer many years and hundreds of millions of dollars to fully integrate the two companies into a fully functional one.

Several years later, Pfizer acquired Pharmacia to gain access to Celebrex, a Cox-2 inhibitor that had the potential of becoming a blockbuster drug to treat inflammation and chronic pain. Unfortunately, Pfizer’s ROI on Celebrex hit a sales-stopping road block when the safety of Cox-2 inhibitors was called into question after Merck withdraw its Cox-2 inhibitor, Vioxx from the market in 2005. While Pfizer directly benefited from Celebrex sales, it again took the company many years, at great expense, to fully integrate Pharmacia into Pfizer’s day-to-day operations.

During its decade long expansion, Pfizer’s internal drug discovery programs were largely ignored and had begun to fail largely because of management’s inexorable focus on acquiring blockbuster drugs rather than developing them internally. In the early 2000s, recognizing that blockbuster drugs were becoming harder to purchase, the company bet its financial future on a new cholesterol-lowering drug called torcetrapib (which, by the way, was developed by Pfizer scientists). The buzz surrounding torcetrapib—a potential blockbuster drug that was expected to replace Lipitor—reached a fever pitch in 2006 as Pfizer’s stock price soared. Unfortunately, Pfizer was forced to abandoned clinical development of torcetrapib in late 2006 because it exhibited potential life-threatening side effects in pivotal Phase 3 clinical trials This failure, coupled with the impending loss of  patent protection for several of its top selling drugs, most notably Lipitor, has placed Pfizer in its current precarious financial situation.

Like many of its competitors, Pfizer believes that biotechnology is the “next big thing” and its executives have publicly disclosed their intentions to get into “protein-based therapeutics.” While this strategy may represent a way for Pfizer to correct its current downward trajectory, the company, as a whole, lacks the requisite biopharmaceutical experience and expertise to commercially compete in this space. To obviate this, Pfizer has hinted that it would consider purchasing a large biotechnology company or a pharmaceutical company that has biotechnology products on the market.  Enter Wyeth—another pharmaceutical company that is trying to reinvent itself as a biopharmaceutical company. However, unlike Pfizer, Wyeth markets and sells two successful biotechnology products—Enbrel, a treatment for rheumatoid and psoriatic arthritis and Prevnar a blockbuster anti-pneumococcal vaccine. However, it is important to note that neither Enbrel nor Prevnar were developed at Wyeth. Further, while Wyeth has achieved commercial success with both Enbrel and Prevnar, several of its non-biotechnology drugs have recently hit regulatory snags and their future approval is uncertain.

On the surface, a Pfizer-Wyeth merger may make sense—both companies are struggling, Pfizer needs an entrée into biotech and Wyeth has marketed biotechnology products and biomanufacturing capability. However, a closer examination of the deal reveals some major flaws. First, Wyeth’s internal biotechnology discovery pipeline is sparse (although it does have a few, niche protein-based products in early stage clinical development). While Enbrel sales are increasing and consistently have topped $1 billion in annual sales in recent years, Wyeth only owns the non-US rights to Enbrel (Amgen owns the US rights). Second, Prevnar is coming off patent soon and GlaxoSmithKline (GSK) has developed a competing vaccine that is expected perform as well or better than Wyeth’s next generation version of Prevnar. Finally, Prevnar has been a huge money maker for Wyeth because there are currently no other approved pneumococcal vaccines on the market. The introduction of GSK’s competing vaccine will undoubtedly have a negative impact on the sale of Prevnar and its successor. If neither company has strong internal drug discovery pipelines and both lack sufficient expertise in biopharmaceutical product development, why are Pfizer and Wyeth actively engaged in M&A discussions?

For the past several months, rumors have been circulating that Pfizer might acquire Amgen. While a Pfizer-Amgen deal makes more sense to me that a Pfizer-Wyeth one, I don’t think that acquiring another large pharmaceutical company is in the best interests of Pfizer shareholders (they are still paying for the past two mergers!). That said, if Pfizer does acquire Wyeth, the combined entity will still hold the distinction of being the world’s largest pharmaceutical company—at least there is that!

Until next time…

 

Good Luck and Good Job Hunting (hope that a merger doesn’t take place—there will be layoffs!)

 

When it Rains it Pours: The State of New Jersey Requests Amgen Documents for Off-Label Marketing of Enbrel

Posted in BioJobBuzz

Still reeling from lawsuits filed last week by ex-sales reps’ alleging improper marking of Enbrel to treat patients with psoriasis, Amgen was subpoenaed on Monday by New Jersey’s attorney general regarding allegations that the company promoted Enbrel for unapproved uses.

In the subpoena served Monday, Attorney General Anne Milgram is seeking "a comprehensive array of documents and information" concerning the marketing and sale of Enbrel from July 2002 to the present.

The subpoena calls for Amgen to deliver the required materials by Feb. 4.

Although doctors are free to prescribe medicines as they see fit, drug companies are only allowed to promote their products for uses that have been approved by the U.S. Food and Drug Administration and appear on product labels.

Until next time…

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

Amgen Gets Sued by Ex-Sales Reps for Improper Marketing Practices

Posted in Career Advice

It goes without saying that Amgen has had a run of bad luck over the past six months. But, just when you thought things couldn’t get much worse, two former Amgen sales representatives are suing the company, alleging it pushed its sales force to search doctor’s confidential medical records for potential patients to boost sales of its blockbuster drug Enbrel.

The ex-employees are seeking lost pay, punitive damages and other compensation totaling more than $15 million apiece. One of the sales representatives, Elena Ferrante of Montvale, N.J., was fired in August 2005, while the other, Mark Engelman of Laguna Niguel, Calif., resigned last year after he received a negative performance review.

A lawyer representing the ex- reps alleges the marketing scheme to increase sales of the drug started in 2005 or sooner, after new drugs competing with Enbrel came on the market. "Amgen stepped up their marketing practices to get all these people who were not indicated for Enbrel" to start taking the drug, she said.

Enbrel which is approved to treat rheumatoid arthritis and moderate to severe cases of psoriasis generated $3.0 billion in sale for Amgen last year. Enbrel treatment can cost as much as $20,000-$50,000 per patient per year depending upon disease severity. 

Stay tuned for the next installment of the ongoing Amgen saga!

Until next time….

Good Luck and Good Job Hunting (not in A Thousand Oaks)!!!

Are Biotech Drugs ALWAYS Better?

Posted in Career Advice

The buzz and promise of biotechnology is the likely cause of the buying frenzy that big pharma has been on lately. Word on the street is that biotechnology products are innovative, have a higher return on investment (ROI) and are generally perceived to be “better” than conventional small molecule drugs. I agree that biotechnology products are certainly innovative and the gargantuan ROIs are titillating. But, are biotechnology products always safer and more efficacious than extant small molecule drugs? According to a recent study–maybe not!

A study conducted at the Agency for Healthcare Research and Quality in the UK evaluated the effectiveness of 11 different drugs to treat rheumatoid arthritis (RA). They analyzed the results of clinical trials that enrolled at least 100 subjects that were conducted between 1980 and 2007. After analyzing 101 studies (50% of which were conducted by or on behalf of drug companies) they were unable to detect a significant difference in efficacy or safety of small molecule and biotechnology medications that are used to treat RA. The drugs that were analyzed included conventional corticosteroids, synthetic disease modifying anti-rheumatic drugs (DMARDS) such as hydroxychloroquine, leflunomide, methotrexate and sulfasalazine and a variety of biotechnology products including Orencia® (abatacept, Bristol Myers Squibb) Humira® (adalimumab, Abbott Laboratories) Kineret® (anakinra, Amgen), Enbrel® (etanercept), Remicade® (infliximab, Johnson & Johnson) and Rituxan® (rituximab, Genentech).

As is the case with all medications, there are substantial patient-to-patient variations in efficacy and side effect profiles and one drug may work better for patient than another– whether it is a protein-based biotechnology product or a small molecule drug. Generally speaking, biotechnology drugs focus on novel targets and may have unique mechanisms of action. That said it is not prudent to assume that new biotechnology drugs are inherently better than pre-existing small molecule treatments. The jury should remain out on any drug, biotechnology or otherwise, Phase IV clinical trials and exhaustive post marketing data are collected, analyzed and evaluated.

Until next time….