The Life Sciences in New York State

Biotechnology Business Development - Book Available Now

I'm honored to have made a small contribution to this excellent collection of articles and essays on biotech business development. Do check it out and let me know if it is helpful.

Best Practices in Biotechnology Business Development

Experts from a wide range of disciplines have composed best practices
based on their experiences and expertise, creating a vital toolbox
covering a broad spectrum of topics. These best practices will enable
you develop a better understanding of the key elements in these
operations and empower you to better manage their implementation.

Dismal, indeed

Once again, FDA approvals are down. This is old news, of course. The question really is, why? And what can we do about it?

"FDA's official tally will probably be 18, including two therapeutic biologics approved by the Center for Drug Evaluation & Research. FDA began including biologics in its total in 2004, so that makes historical comparisons difficult. But even if you count all 18, this was still the worst year since 1983"

F.D.A. Is Unable to Ensure Drugs Are Safe

This is rather frightening, no?

The Food and Drug Administration cannot guarantee the safety of the nation’s drug supply because it inspects few foreign drug manufacturers and the inspections it does carry out abroad are less rigorous than those performed in this country, witnesses told a Congressional subcommittee yesterday.

Emisphere Technologies, Inc. Moves Into New Corporate Headquarters

OK, but I’m still calling them a Tarrytown-based company.

Emisphere Technologies, Inc. today announced it will move its corporate headquarters from Tarrytown, New York to Cedar Knolls, New Jersey

Emisphere Technologies, Inc. Moves Into New Corporate Headquarters.

Inhaled insulin: make or break?

Fair question. I don’t blame Lilly for taking the stance that they are taking. In fact, I don’t think Lilly has much of a choice at this point. It’s interesting that Novo is already lowering expectations with their product by stating that inhaled insulin may not be a blockbuster product.

 

Eli Lilly is remaining optimistic about its yet-to-be-approved inhaled insulin despite the dramatic downfall of Pfizer's Exubera. But is Exubera's fall from grace an indication of things to come for inhaled diabetes treatments?
Eli Lilly is remaining optimistic about its yet-to-be-approved inhaled insulin despite the dramatic downfall of Pfizer's Exubera. But is Exubera's fall from grace an indication of things to come for inhaled diabetes treatments?

 

Inhaled insulin: make or break?.

Polypharmacy...a problem that keeps getting worse

This is correct. Multiple diseases are being treated by multiple doctors writing multiple prescriptions being filled (and this is key) at multiple pharmacies. Nobody can keep track of all this.

The ‘Poisonous Cocktail’ of Multiple Drugs

In addition to seeing several doctors, many older people use multiple pharmacies to buy prescriptions. There may be no single health professional who knows what they are taking and could alert them to dangerous combinations. This is especially true in places where chain stores have replaced independent pharmacies or when the patient’s drug plan requires that medications be ordered by mail.

Pfizer suddenly discovers biotech

Normally a story like this would be greeted with a yawn. However, with Pfizer, they have suffered the double whammy of Lipitor's impending genericization and the failure of torcetrapib. So to make Wall Street happy, they announce their new willingness to be more of a biotech company.

I've never bought into this argument that pharma and biotech - which I define as parenteral peptides and proteins - are so different. Yes we're talking about different ways to manufacture and deliver these drugs. But at the end of the day, it's about having an organization that can develop and commercialize an innovative product.

Lipitor was the fifth statin to market, with a marginally better efficacy profile versus competitors. Yet Lipitor is a $9 billion product. Compare this with Exubera, which is by all accounts a flop. My point here is that if Pfizer gets their hands (likely through major acquisition) on an innovative "biotech" product, they will likely succeed with it. Hence, the last sentence in the quote below is key.

I wouldn't be surprised if there were an army of analysts at Pfizer HQ on 42nd Street analyzing M&A opportunities. Pfizer will acquire the successful developer, then use their proven skills to successfully commercialize any "biotech" product they acquire.



Pfizer's future rests with biotech

Pfizer has already announced a plan to invest $10 million a year for the next five years to help start-up biotechs in San Diego. Expect to see Pfizer snapping up biologics from smaller drug developers and investing more money in biotech companies in the months and years to come.

Generic epo about to hit the market in Europe

Novartis wins the race to bet a generic version of epo approved in Europe. Truly a watershed day in biotech, in my view. Will we ever see generic epo in the US? That's the question...

Bloomberg.com: Germany

Novartis is first in a race among generic companies including Germany's Stada Arzneimittel AG to enter the $7 billion market dominated by Johnson & Johnson and Amgen Inc's branded versions of the drug. Sandoz sued U.S. regulators last year to win approval to copy the human growth hormone.

Other than that, it's a fine product

What strikes me about this is that there doesn't seem to be anything positive about Exubera.

Great idea + poor design = unsuccessful product

Exubera becoming a big disappointment for Pfizers

With patients put off by Exubera's difficult dosing device, insurers reluctant to foot the bill and doctors concerned about its long-term impact on patients' health, sales of Pfizer's inhaled-insulin diabetes therapy have fallen dramatically behind initial projections.

Company moves to New York

Welcome to Delcath Systems.

Delcath Systems, Inc. Moves Headquarters to New York

Delcath Systems is the developer of percutaneous perfusion technology for organ- or region-specific delivery of therapeutic and chemotherapeutic agents. The Delcath system is currently being tested with the drug melphalan in a Phase III trial of patients with metastatic ocular and cutaneous melanoma in the liver, and a Phase II trial of patients with primary liver cancers and metastatic tumors in the liver from neuroendocrine cancers and adenocarcinomas, as well as patients with melanoma who previously received isolated perfusion.