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.

BioSpecifics Financing

More news from New York, this time from Long Island. BioSpecifics received fresh cash of $2+ million.

BioSpecifics is an interesting company, and their history is summarized here. Basically, they developed a topical collagenase product, which was then sold. The company then focused on developing parenteral collagenase products for a wide array of indications.

I always find it interesting when a company that appears to have a narrow focus is able to identify seemingly obscure applications and actually move these applications forward in the clinic. That takes diligent research and thought leader insight to identify and assess the ideas, but that's the easy part. The tough part is to then move these into and through trials, especially in indications where there are no products, and hence no "pathways" for companies like this to follow.

Progenics Initiates Phase II in HIV

Tarrytown-based Progenics Pharmaceuticals announced that it is entering Phase II for PRO 140, an antibody that blocks HIV viral entry by blocking the CCR5 receptor.

What I find interesting is that they are looking to study this antibody in patients who have not received oral anti-retrovirals during the previous three months. Even more interesting is their attempt to develop a self-injectable, subcutaneous formulation.

So in theory, an HIV positive patient could undergo a shorter-term course of oral anti-retrovirals, then self-inject with PRO 140. If this pans out, it would be a substantially different way of attacking HIV and delaying disease progression.

This may also address some of the safety concerns that have emerged with oral CCR5 inhibitors. I'm specifically thinking of GSK's decision a few years ago to drop aplaviroc in Phase III due to hepatotoxicity issues.

Wine…in pill form

I'm all for drug development in diabetes. But I still prefer taking my resveratrol by the glass, preferably in the form of a pinot noir…

 

Some day, if all goes well in the lab, you may be able to take a pill instead. And Sirtris Pharmaceuticals, a pioneer of the approach, just reported results from an early study in diabetic patients. The company's drug, code-named SRT501, is based on resveratrol — a chemical found in red wine.

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"

Marketing $ >> R&D $

Drug industry spends nearly twice as much on marketing than on research and development

 

I'm shocked…shocked to learn that this is a marketing-driven industry!

 

    "In their analysis of data from two market research companies, IMS and CAM, Marc-André Gagnon and Joel Lexchin (York University, Toronto, Canada) found that US drug companies spent US$57.5 billion on promotional activities in 2004, the latest year for which figures were available.

In comparison, the National Science Foundation reported that in 2004 the amount of industrial pharmaceutical research and development (including public funds for industrial research and development) was US$31.5 billion in the United States. "

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.

OSI Pharmaceuticals Rises on 3Q Results: Financial News - Yahoo! Finance

NEW YORK (AP) -- Shares of OSI Pharmaceuticals Inc. rose Friday after it raised its 2007 guidance on better-than-expected third-quarter results, and analysts predicted renewed growth for the biotechnology company's flagship drug.

OSI Pharmaceuticals Rises on 3Q Results: Financial News - Yahoo! Finance.

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?.