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Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Abbott

Monday Biotech Deal Review: June 25, 2012

Welcome to your Monday Biotech Deal Review for June 25, 2012.  Highlights from the previous week include the closing of the second tranche of Medifocus’ private placement for gross proceeds of $3.3 million.  Read on to learn more. Read more of this post

Patent Cliff Will Not Save Biotech: Abbott Buys Indian Generics Company Piramal Healthcare

I often hear how the upcoming loss of patent protection for current blockbusters creates an insatiable demand at pharma companies for new pipeline products from biotechs. Here’s an example from 2007. Here’s one from last week. This is not true. Upcoming loss of patent protection creates a insatiable demand for revenue, but new products are not the only source of new revenue.

Abbott’s $3.7 billion deal for a unit of India’s Piramal Healthcare last week is a perfect case in point. This deal, which follows Abbott’s license of a slew of products from Zydus Cadila, will feed the company’s new “established products division.” Abbott’s purchase of Solvay in February also built its emerging markets revenue, which now accounts for over 20% of the company’s business.

Abbott is far from alone: Sanofi is the biggest generics manufacturer in Latin America, Pfizer also has an established products division, Novartis is diversifying into eyecare and has long sold generics, Merck is into follow-on biologics and GSK tapped South Africa’s Aspen Pharma for emerging markets growth through branded generics. These alternatives look even better as payors worldwide are setting more demanding standards for reimbursement, the placebo effect is mysteriously strong, and personalized medicine makes clinical trials even more expensive.

My bottom line? Emerging markets and generics opportunities create plenty of growth, thank you very much, with a far lower risk profile than most product in-licenses or biotech acquisitions (even the option deals). As big pharma gets more comfortable with “established products” and biosimilars, biotechs are going to have to demonstrate even higher value. Plenty of companies are being built and funded with that in mind; but anyone counting on pharma’s desperation will be disappointed.

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No Company is an Island: More Pharma and Biotech Collaboration

Island Nihoa_aerialTwo deals this week showcase collaborative efforts between major pharma players:

 

 

These follow last month’s earlier-stage collaborations between GSK and Pfizer for HIV treatments and betwen AstraZeneca and Merck for cancer treatments.

Why are we seeing these collaborations?  I have a couple of thoughts:

  1. This is a tough regulatory environment and companies are going to reach for every advantage they can get … maybe putting more effort into initial approvals that they might otherwise dole out over time.
  2. I think it’s notable that these projects are all aimed at HIV and cancer, two complex and incredibly tenacious diseases.  The low hanging fruit is (a) gone, and (b) not finishing the jobs. 

Is this the end of magic bullets and the beginning of biotech patent pools?  Too soon to say.

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Abbott’s ABT-888 Guinea Pig: First Phase 0 Clinical Trial Completed

A press release from the National Cancer Institute yesterday (picked up today by BIO SmartBrief and FierceBiotech) touts a successful first:

The first phase 0 clinical trial of a drug in cancer treatment, involving 13 patients with advanced cancers, showed that the drug, ABT-888, affected its target and was well tolerated. Most importantly, this trial showed that it is possible to enroll a small number of patients, treat them with a low dose of a new drug, identify whether the desired target of the drug was affected, and obtain all of this critical information relatively quickly.

The point of a “phase 0″ (phase zero) trial is to focus “primarily on tolerance and the ability of the drug to hit a target.”  The advantage of phase 0 trials is that they:

involve nontoxic drug doses that are administered for short periods of time to small numbers of patients, [so] the preclinical toxicology data required … are less than those required to support a phase I trial; thus, these first-in-human trials can be initiated earlier in the drug development process than traditional phase I studies.

Phase 0 trials come with their own statistical evaluation scheme and endpoints, and although more long-term data is needed on the impact of this approach on timetables and success rates, “phase 0 trials will be a key part of a new approach” in the NCI Experimental Therapeutics (NExT) program.

Here’s NCI’s FAQ from the 2007 introduction of the program, with more info on NExT and phase 0 trials.

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Wednesday Brain Dump: Deal-O-Rama Edition

There’s still plenty of deal activity in the pharma and biotech sector this week, even outside Canada, so here’s a roundup of what’s done, what’s pending and what’s in the rumor mill:

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Wednesday Brain Dump: February 4, 2009

Some good news on the gene therapy front in adenosine deaminase-deficient SCID patients and in rheumatoid arthritis.

But mostly bad news on the job front at GSK, AstraZenecaAbbott,  GenVecPatheon, and others.

Other good news on the approvals front for Parusgel (despite process concerns), KapidexLamictalGelnique and Taxus Liberte.

Really small news: Nanomaterials may be heading for increased regulation in Canada, with a mandatory reporting program reportedly pending and a new guide from IRSST in Quebec (pdf) (although the IRSST guide doesn’t mention bio-materials).

Just NICE news: Comparative Effectiveness may be headed for some changes in the UK, where NICE is working on a review.

Positively Biblical news: The lion lies down with the lamb (or something equally unlikely)

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