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Piscataway, NJ-based Enzon Pharmaceuticals, the once venerable biotechnology that was the first to successfully commercialize protein PEGylation, yesterday announced that it plans to lay off nearly half its employees by the second quarter of next year.

The layoffs will leave Enzon with 47 employees. The company said that the layoffs are intended to align resources with the company's research and development activities. Enzon, once with a market valuation greater than Merck pharmaceuticals, has been steadily losing revenue over the past 10 years and had essentially abandoned R&D in the protein PEGylation field that it had pioneered. Over the same time period, the company had a succession of CEOs, each of whom had a different vision and strategic plan forward.

Enzon was founded in 1982 by Abe Abuchowski, PhD, who validated the commercial possibilities for protein PEGylation while a graduate student at Rutgers University. Abuchowski licensed the rights to protein PEGylation and formed Enzon several years after receiving his PhD degree. He took the company public in 1985 (a feat that was not easy to accomplish back in those days) and went on to use protein PEGylation to develop two products with orphan drug designations (Adagen and Oncospar) and PEG-Intron a second generation biopharmaceutical used to treat Hepatitis C infections.

Abuchowski was CEO and Chairmen of Enzon until 1996. He left the company that he created because its board decided that PEGylated small molecules rather than proteins ought to be the future focus of the company. Enzon abandoned its biopharmaceutical focus in favor of small molecules in the late 1990s. Although in recent years the company tried to resuscitate its protein PEGylation programs, the PEGylation industry had essentially passed the company by and they were no longer competitive.

Abuchowski is currently CEO and Chairman of Prolong Pharmaceuticals, a South Plainfield, NJ-based, company developing products targeting the treatment of anemia resulting from oxygen deficiency. Not surprisingly, many of the products in the company’s pipeline were developed using protein PEGylation technology. While others have contributed to the protein PEGylation field, Abuchowski is generally recognized as the first person to commercialize the technology. He has received numerous awards for his work in protein PEGylation; a technology that generates roughly $30 billion in drug sales annually.

Until next time...

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

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The conversation about follow-on biologics became extremely muted after passage of the US Healthcare Reform Act which included a 12 year period of data exclusivity for innovator company products. This provision inhibits biosimilar manufacturers from introducing generic versions of branded biologics for 12 years from the date the US Food and Drug Administration granted a license for the branded product. While this may effectively limit activity in the follow-on biologics space in the US, it didn’t stop Merck from launching its BioVentures Division (dedicated to follow-on biologics development) almost two years ago.

At the time of the announcement Merck executives in charge of the BioVentures Division divulged that its first product would be a PEGylated version of Amgen’s anemia drug Epogen (EPO). Unfortunately, a PEGylated version of EPO doesn’t qualify as a follow-on biologics because PEGylated proteins are considered new molecular entities (NMEs) by regulatory agencies. Nevertheless, Merck also said it would develop other follow-on products and that its efforts would be based primarily on the proprietary humanized yeast biomanufacturing platform it acquired after purchasing Glycofi, a New Hampshire-based biopharmaceutical company that developed the technology. Interestingly, two weeks ago Merck announced that it was abandoning the PEGylated-EPO product that it mentioned two years ago at the BioVentures kick off press conference.

It isn’t clear whether or not Merck jettisoned the project because of patent infringement litigation, regulatory concerns or possibly because of the increasingly fierce competition in the EPO space. Another possibility is that pharmaceutical companies have finally realized that biologically-active proteins are costly to manufacture and have limited therapeutic applicability as compared with monoclonal antibodies (MAbs) which are taking the biopharmaceutical industry by storm. At last count, there were over 300 MAbs in various phases of pre-clinical development with and about 125 in late stage clinical development. Last week, Teva and Lonza announced plans to develop a biosimilar version of Roche’s anti-inflammatory and cancer MAb Rituxan (rituximab)—kicking off a new era in the biosimilar industry.

For those of you who are unfamiliar with or remain interested in the follow-on biologics debate, I came across a nice PowerPoint presentation given by Teruhide Yamaguchi at the Division of Biological Chemistry and Biologicals at the National Institutes of Health.

Quality Safety and Efficacy of Follow-on Biologics

Until next time...

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

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Back in 1993 when I was looking for an industrial job, I came across an ad for a research scientist at a Philadelphia-based biopharmaceutical company called Neose. Unlike most other biotechnology companies at the time, the company was focused on identifying and discovering drugs against carbohydrate-based targets—a novel idea at the time. Because I had spent the previous seven years working on carbohydrate biochemistry, I applied for the job and I was invited to interview for the position. At the time, Neose was a small, marginally-funded biotech company that was started in 1993 by a cell biologist from the University of Pennsylvania. 

I was very impressed with the company and thought that my background was consistent with the company’s long-term goals. Unfortunately, they never made me an offer and I went to work for one of Neose’s main competitors, a small, start-up company called Transcell Technologies. Plagued by poor management and a weak technology platform, Transcell Technologies was sold and liquidated in 1999.

Neose ultimately went public and had to reinvent itself several times over the past 14 years. At one point, it had developed a novel carbohydrate-based PEGylation technology for recombinant therapeutic proteins and monoclonal antibodies, which appeared to be gaining traction in the biogenerics market space. Unfortunately, it was “too little, too late” and like most other companies focused on carbohydrate drug discovery, Neose couldn’t sustain itself. Consequently, Neose recently inked separate deals with Novo Nordisk and BiogeneriX to liquidate most of its assets for cash deals worth only $43 million. Both companies had been collaborating separately with Neose on it clinical development programs.

Neose reported that it would retain certain intellectual property rights including those related to producing glycolipids. Like Pharmacopeia, another biopharmaceutical pioneer that recently sold its assets, Neose had a solid 15 year run—something that most biotechnology companies can only dream about!

Until next time…

Good Luck and Good Job Hunting!!!!

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

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

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

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

Until next time….

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

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There are currently two injectable products on the market that are used to treat chronic Hepatitis C infections. Both products, PEG-INTRON (Schering Plough) and Pegasys (Roche) are PEGylated versions of the cytokine interferon-alpha that are used in combination with ribavarin (an orally-delivered small molecule drug) to treat patients infected with Hepatitis C virus.  

PEG-INTRON (peginterferon alpha-2b) was co-developed by Schering Plough and Enzon in the early 1990s and brought to market in 2000. Pegasys (peginterferon alpha-2a) , which use a different chemistry to attach PEG to interferon-alpha, was approved in early 2002 and quickly supplanted PEG-INTRON as a treatment of choice for Hepatitis C infections. Pegasys also gained approval in 2005 to treat chronic Hepatitis B infections.

The knock on PEG-INTRON was that it appeared to lose potency in liquid form (a claim that has always been denied by Schering and Enzon). Nevertheless, PEG-INTRON was supplied to patients as a sterile powder which had to be reconstituted prior to injection. In contrast, Pegasys was supplied in liquid form in pre-filled self injection pens to infected patients. This was possible because the PEG chemistry used to create Pegasys was found to be extremely stable (as compared with PEG-Intron?) in liquid form. Although there appeared to be no real differences in efficacy between PEG-INTRON and Pegasys to treat Hepatitis C infections, patients tended to prefer Pegasys over PEG-INTRON because it was easier and more convenient to use.

Schering Plough has been struggling for the past 5 years or so to recapture the market share that it lost following Pegasys’ introduction in late 2002. To that end, in 2003 the company received FDA approval for a pre-filled injection pen to administer PEG-INTRON. Further, to dispel any rumors regarding PEG-Intron’s efficacy relative to Pegasys, Schering decided to conduct two large head-to-head clinical studies that compared PEG-Intron or Pegasys in combination with ribavarin as treatments for Hepatitis C patients. Today, Schering-Plough announced the results of the first of these two large scale clinical studies called IDEAL. The results from the IDEAL study showed that PEG-Intron was just as effective as Pegasys for treating patients with Hepatitis C. Further, it appeared that fewer patients taking PEG-INTRON relapsed after treatment.

It is not clear whether Schering will win the war but the company certainly appears to have won this most recent skirmish!

Until next time…

Good Luck and Good Job Hunting (try Schering Plough)!!!!!!!!!

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I was reading a post about the Exubera deal that Pfizer cut with Nektar the other day and I stumbled upon this tidbit–“The two companies will continue to jointly develop an inhaled formulation of PEGylated recombinant human growth hormone (rHGH) to treat growth problems”.

For those of you who may not know, protein PEGylation–developed about 30 years ago by Frank Davis and Abe Abuchowski at Rutgers University– involves chemically attaching polyethylene glycol (PEG) to proteins. PEGylated proteins are less immunogenic and circulate longer in the bloodstream than native, unPEGylated proteins. Protein PEGylation has revolutionized the biopharmaceutical industry because it reduces immunological side effects, improves clinical efficacy and enhances patient compliance (by reducing the number of injections that are required) for many protein-based drugs. Several companies including Schering Plough, Roche and Amgen have used protein PEGylation to create multibillion blockbuster a year biotechnology products like PEG-Intron, Pegasys and Neulasta.

Like most protein-based products, rHGH needs to be injected daily to achieve its desired clinical effects. At present, there are no fewer than 8 rHGH products on the market that are used to treat pediatric and adult growth hormone deficiencies. The holy grail of the growth hormone market is to develop a sustained-release version of rHGH so that daily injections are no longer necessary. To that end, several companies, including Nektar, have developed PEGylated versions of rHGH which are in various stages of clinical development. These products should hit the markets in Europe and the US within the next few years.

Although Pfizer is in the rHGH biz, it is puzzling (to me) why any company would consider developing an inhaled form of PEGylated rHGH –given all of the regulatory hurdles and exhorbitant development costs-when an injectable form of PEGylated rHGH would be far superior and offer greater patient benefits than any of the currently marketed rHGH products? Maybe I am missing something here. That said, the larger question is: Why hasn’t Pfizer learned that the inhaled protein market is a dicey one at best?  Maybe that's why Pfizer is still Pfizer!

Until next time….

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

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