Enzon Pharmaceuticals Redux

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)!!!!!!

Update on the PEGylation Wars: Schering Plough vs Roche

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)!!!!!!!!!

Another Bad Investment for Pfizer -Inhaled PEGylated Human Growth Hormone

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!!!!!!!!!!!