The Cross-Border Biotech Blog

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

Tag Archives: AstraZeneca

Biotech Trends Update: Costs Savings from Personalized Medicine Sought by PBMs, Employers, Pharma Face Legal and Privacy Hurdles

When AstraZeneca announced a companion diagnostics collaboration recently, their head of oncology development said the goal was to get “the right treatment, to the right patient, the first time,” a nice turn of phrase* that is becoming a chorus in the healthcare industry.

This week, giant PBM Medco purchased DNA Direct, saying “[o]ur whole thing at Medco is to get people on the right drug the first time.”  DNA Direct uses its research on 2,000 available tests to help physicians, health insurance companies and patients understand how to use personalized medicine.  This is a good move — we said last month that education is key to expanding the personalized medicine market

AstraZeneca, Medco and other providers, employers and insurers would all like to use information on individuals’ health risks in order to reduce their costs, and as the Wall Street Journal reports, they are willing to provide incentives to their employees to mitigate those risks.  However, some of these efforts conflict with barriers put in place by the Genetic Information Nondiscrimination Act (GINA), which prohibits the intentional acquisition of genetic information about applicants and employees, and imposes strict confidentiality requirements on data that is acquired. (H/T @genomicslawyer)

In addition to legal barriers (some still being erected), AMA and other advocacy groups have also reportedly expressed concern.  I agree there is risk inherent in putting the decision of what the “right drug” is in the hands of manufacturers or payors, neither of whom is neutral in the outcome.  Medco, in particular, does not seem a neutral player here (at least based on their approach to Plavix and Effient, though I invite comments if I’m misinterpreting that study).

Still, a solution is required.  As I have been saying for over a year, personalized approaches to treatment have the potential to benefit all participants in the healthcare system, as the KRAS-Erbitux story has proven.  As Procter & Gamble said when investing in Navigenics’ funding round this week, “Personalized genetic testing can have significant meaning in helping consumers focused on prevention and wellness live better, healthier lives.” 

My bottom line:  A large part of the problem here is the low level of trust from the public, which even limits governments’ ability to act.  That’s particularly unfortunate, because government is the closest thing we have to a neutral funding source for comparative effectiveness and personalized medicine research (despite also being a payor). This is a problem much bigger than just personalized medicine, but until trust is restored, valuable cost savings and health benefits will go unrealized.

Bookmark and Share

* A concept I’ve been trying to call “personalized effectiveness” — tell your friends.

Biotech Trends Update: Jubilant’s R&D Success Continues Drive Toward Innovation in Asia

world_map_2002One of the biotech trends we’re following in 2010 is the increasing innovative activity in India and China.  Both are booming not only as low cost manufacturing centers but also as innovative hubs adding R&D expertise and specialized know-how.

This week, the Indian company Jubilant and Endo Pharmaceuticals announced that they are expanding thier partnership following early and rapid success by Jubliant’s team.  Jubilant has been developing pre-clinical candidates for Endo’s oncology pipeline.  As Endo’s R&D VP says, they are executing on a “strategy of building Endo’s pipeline using a virtual discovery approach” as a complement to their in-licensing strategy.

Jubilant has been running with these types of “virtual discovery” deals, including its collaboration with AstraZeneca that we noted at the time (even as AZ is shedding in-house capacity today), a successful partnership with Lilly and tie-ups with academic institutions including Duke University and UAB.

FierceBiotech reports that Biocon’s Kiran Mazumdar-Shaw predicts a $5 billion Indian biotech business in 2011 that will “double to $10 billion by 2015″ based on “opportunities in clinical trials, manufacturing and more.” 

The greater the contribution R&D makes to India’s growth, the better positioned the country (and the region) will be in the coming years to lead the global industry forward.

Bookmark and Share

Biotech Trends Update — Personalized Medicine: The Case for Diagnostics Focuses on Cost and Effectiveness

A report in FierceBiotech today distilled the views of three life science VCs on trends to watch in 2010.  Along with other worthwhile observations (and I’d encourage you to read the whole thing) was this bullet pointing out the value of personalized medicine in addressing comparative effectiveness concerns:

“Interest in molecular diagnostics is heating up. It’s one of the most attractive areas because physicians are increasingly demanding test that can tell them which treatments have the best chance of working before expensive medicines are issued. And diagnostics fit well with the healthcare reform efforts. Bloch adds that any technology that improves the efficacy of how care is delivered will be attractive to investors.”

The business case is eminently obvious.  Earlier this week AstraZeneca announced a collaboration with Dako Denmark A/S that will see Dako developing companion diagnostics for products in AstraZeneca’s oncology pipeline.  Key quotes from the announcement highlight the companies’ focus on “health care costs” and “reimbursable products”:

“Targeted treatment with personalized medicine is the future, and … is also a significant contributive factor in cutting health care costs” (Dako CEO)

“This agreement … will enable us to develop novel, reimbursable products that … predict which patients are most likely to respond to treatment, ensuring that we are giving the right treatment, to the right patient, the first time.” (AZ Head of Oncology Development)

The economic case for personalized medicine was one of this blog’s top biotech trends in 2009 and looks to continue at a strong pace through 2010.  To reach its full potential, though, the industry will have to convince policy makers and clinicians that personalized medicine can live up to its promise.

Bookmark and Share

No Preemption No Problem: State Courts Step Up

For anyone following the U.S. Supreme Court’s emerging case law on FDA approval and preemption (as we have been here, here, here, and here), it looks like the next frontier is going to be state law. With the Supreme Court’s ruling that drug manufacturers are subject to state tort claims even if they have undergone a full FDA review, liability depends on individual decisions by state legislatures and courts, which still have the power to exempt FDA approved drugs and 510(k) medical devices from tort liability in their states.

A recent decision by the Supreme Court of Arkansas has done just that. In DePriest v. AstraZeneca, the court dismissed claims brought under Arkansas’ Deceptive Trade Practices Act, holding that the Act contains a safe harbor that:

“specifically permits drug manufacturers to promote their drugs to consumers in a manner that is consistent with and supported by the labelling approved by the Food and Drug Administration.”

The court also dismissed the common law claims against the manufacturer on the grounds that FDA approval was sufficient to show that the manufacturer’s statements were not false or misleading.

Read the full opinion here (pdf).

Bookmark and Share

Novel Deal Structures Becoming More Common

Outside the BoxAt the RIC/OCETA talk I participated in last month, one of the trends in deal-making that I mentioned was novel structures.  At the time, examples included option deals and new ways to split rights and territories. 

More recently, we’ve seen GSK and Pfizer form a joint venture to develop HIV treatments, and two more interesting ideas came up this week:

  1. Index Ventures, a VC firm, is forming a joint venture with Amunix Inc., a biotech company.  The idea is, according to the WSJ Venture Capital Dispatch blog, to focus entirely on drug development, not research, and advance three candidates quickly through Phase I proof-of-concept.
  2. AstraZeneca and Merck are teaming up for what FierceBiotech calls an “unusual, early-stage clinical program” where each company is contributing an experimental cancer drug candidate that, in combination, should attack complementary pathways.  From the joint press release:

    Under the terms of the agreement, AstraZeneca and Merck will work together to evaluate co-administration of the compounds in a Phase I clinical trial for the treatment of solid cancer tumors. All development costs will be shared jointly. Following the Phase I trial, the companies will consider opportunities for further clinical development.

Bookmark and Share

Trends Update — Comparative Effectiveness: To Head-to-Head or Not To Head-to-Head?

Goats_butting_heads_in_GermanyOne of the challenges of comparative effectiveness implementation is figuring out when to look for comparative data. Two developments this week shed light on current comparative effectiveness thinking by regulators and pharma:

  1. Vanda’s new antipsychotic, iloperidone (Fanapt) was approved by the FDA last week without any head-to-head comparison against competitors (Zyprexa, Risperidol).  This approval indicates that so far, as the In Vivo Blog points out, the FDA is sticking to the view expresed by Bob Temple last year to the RPM Report that “[i]n most settings, especially for symptomatic treatments, we [the FDA] do not get or ask for comparative data and are perfectly willing to approve a drug that is shown effective.” (emphasis added).
  2. Nevertheless, reports today indicate that AstraZeneca decided to find out at Phase III whether its heart drug Brilinta is more effective than Plavix.  AZ conducted one of the largest head-to-head studies ever undertaken before regulatory approval.  FierceBiotech says that “offers a clear indication of the path developers will be more willing to take as they angle for market share among increasingly cost-conscious payers.”

Would Vanda have had an easier time if it had done a head-to-head trial? Could they have sustained the company long enough to find out? Maybe the only moral of these two trials is to look for comparative data as soon as you can afford to.

Bookmark and Share

Trends Update — Shifting IP Constituencies: AstraZeneca’s R&D Investment in India’s Jubilant

world_map_2002One of our trends in 2009 series is following the increasing innovative activity in India and China, which has the potential to reshape WTO debates around IP protection.

Yesterday, FierceBiotech picked up a Reuters report that AstraZeneca will be funding five years’ work in neuroscience R&D at India’s Jubilant Organosys.  Jubilant was… well … very happy about the deal, which could lead to up to $200 million in milestone payments.  Jubilant also works with Eli Lilly on drug discovery and partnered drug development.  Interestingly, the article juxtaposes Jubilant’s R&D deal with its Monday FDA approval for a generic product.

Bookmark and Share

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)

Bookmark and Share

Follow

Get every new post delivered to your Inbox.

Join 131 other followers