Adapted from a bulletin by my colleagues Evan Cobb and Brad Newman:
In the U.S., Section 365(n) of the bankruptcy code provides protection to licensees in the event their licensor becomes insolvent. Canadian law has not historically had that protection, forcing licensors to set up dedicated IP holding companies or other bankruptcy-remote structures to protect their licensees. However, recent amendments to Canada’s insolvency legislation provide a solution for licensees, at least in the case of intellectual property licensors that are restructuring under the Companies’ Creditors Arrangement Act (“CCAA”) or Bankruptcy and Insolvency Act (“BIA”) proposal regime.
Under the amendments, even if an intellectual property license has been successfully disclaimed by an insolvent licensor, the licensee’s right to use, or its ability to enforce a right of exclusive use of, the licensed intellectual property is not affected for the duration of the license agreement (which includes any rights of renewal). The right to continued use is conditional upon the licensee’s continued performance of its obligations under the license agreement in relation to that usage.
Some cautionary notes regarding the Canadian amendments:
- The amendments do not provide protection to licensees in a standard bankruptcy or receivership scenario. If a receiver or bankruptcy trustee of the licensor were to sell the licensed intellectual property and terminate the license associated therewith, licensees would generally be left only with an unsecured claim against the assets of the licensor.
- The exact definition of “intellectual property” is uncertain. Under the U.S. Bankruptcy Code, “intellectual property” is defined specifically (and excludes trademarks). A similar definition may be adopted in Canada, but at the moment the application could be quite broad.
- Obligations “in relation to” use of the intellectual property that the licensee has to comply with may be uncertain in some circumstances. License fees that aggregate payments for all usage, exclusivity rights and maintenance services may be problematic in light of the amendments. Precise delineation of obligations under a license agreement that are attributable to use of the licensed intellectual property would be a prudent drafting response to the amendments.
Read the whole bulletin for more analysis of the amendments’ implications for IP licensors and licensees.
Categories: Jeremy Grushcow · News
Tagged: Bankruptcy and Insolvency Act, Bankruptcy Code, BIA, CCAA, Companies’ Creditors Arrangement Act, intellectual property, license agreement, Section 365(n)
February 8, 2010 · 1 Comment
This week’s Canadian biotech deals feature a new private placement, two medical device acquisitions, a truly dedicated CEO, some HIV funding from Merck. Seeking redemption? Keep reading →
Categories: Jeremy Grushcow · Monday Deal Review
Tagged: BC Centre for Excellence in HIV-AIDS, Concord Elevator, IMRIS, MacDonald Dettwiler, Merck, NeuroArm Surgical, Nuvo Research, Protox Therapeutics, Quest PharmaTech, Savaria Corporation, SOLABS, Titan Medical
Several neurological related stories this week and quantum biology?
Glial Cells – They’ll turn against you: An unusual molecule can turn glial cells, which normally surround neurons, into killer cells that attack the neurons they are suppose to protect. Researchers made the surprising discovery of proNGF’s role while trying to figure out its function in the eye. They found that it can activate glial cells to turn against retinal neurons and potentially cause vision impairment or loss. Some of the molecular details were also worked out and they describe the significance of TNFalpha and p75NTR proteins in this cell death process. These results shed light on potential routes for therapeutic targets to prevent certain cases of vision loss. The study, published in the early on-line edition of the Proceedings of the National Academy of Sciences, is a collaboration involving Dr. Adriana Di Polo at Université de Montreal and Dr. Philip Barker at the Montreal Neurological Institute.
Unexpected Heart Failure and Treatment: Researchers studying mouse models for neuronal diseases, such as Alzheimer’s, noticed progressive abnormalities in the rodent’s heart function. The mice had slower heart rates (as expected) but they also had difficulty pumping blood and researchers soon realized that they may have stumbled upon a possible mechanism of human heart failure. The genetic modification in these mice resulted in decreased levels of the neurotransmitter, acetylcholine. In contrast to previous reports on heart failure, this is the first study suggesting that slower heart rates may lead to cardiac dysfunction. Furthermore, the administration of the drug Pyridostigmine, which increases acetylcholine levels and is approved for treating muscle weakness, corrected the cardiac dysfunction. The research team of Drs. Marco Prado and Vania Prado at the Robarts Research Institute at The University of Western Ontario describe their findings in the latest edition of Molecular and Cellular Biology.
Early Stages of Huntington’s: Insight into the cellular mechanisms in the brain that causes Huntington’s disease is described in this article appearing in the journal Neuron. Using mouse models expressing the gene mutations causing the disease, scientists discovered increased numbers of NMDA receptors surrounding the synaptic connections between neurons. The increased NMDA receptor activity also diminishes survival signals leading to brain cell death. In other words, the neurons become confused and triggers cell death (excitotoxicity). Although it is not known why the receptors accumulate outside of the neuron, a therapeutic drug is already available (for Alzheimer’s) to treat the early stages of the disease. Memantine can control the abnormal NMDA receptor signaling specifically outside the synapses and not disrupt the normal activity within the synapse, thereby reducing side effects. Clinical trials are underway. Dr. Lynn Raymond at the University of British Columbia led the research team.
Algae + Quantum Biology?: It appears that algae, a very simple organism, figured out quantum mechanics nearly two billion years ago. During the process of photosynthesis, antenna proteins in the light-harvesting complexes absorb light and transmit the energy between molecules to proteins in the reaction centre. Researchers at the University of Toronto decided to study this energy transfer and discovered quantum mechanics at play in this photosynthetic process. This is just a bit beyond the scope of our blog but you can read Drs. Greg Scholes and Paul Brumer’s commentary here or enrich yourself with the detailed study here in the journal Nature.
Categories: Friday Science Review · Richard Chan
Tagged: acetylcholine, Alzheimers, glial cells, heart disease, Huntington's, neurons, NMDA receptor, photosynthesis, quantum mechanics, synapse
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.
* A concept I’ve been trying to call “personalized effectiveness” — tell your friends.
Categories: Biotech Trends in 2010 · Jeremy Grushcow · News
Tagged: AMA, American Medical Association, AstraZeneca, Comparative Effectiveness, DNA Direct, Genetic Information Nondiscrimination Act, GINA, Medco, Navigenics, Personalized Effectiveness, Personalized Medicine, Procter & Gamble
Teva’s decision last year to submit a full biologic license application (BLA) for Neupoval looks positively prescient today. Teva’s product is already sold in the EU as a biosimilar to Amgen’s Neupogen, but a U.S. biosimilars pathway is stalled along with the rest of health reform and today, the FDA accepted Teva’s BLA, clearing the way for a review of Teva’s clinical data and potentially for approval of the product.
FDA approval isn’t Teva’s only hurdle, though. Amgen’s U.S. patents on Neupogen don’t expire until 2013, and the two companies are currently litigating the issue of whether Teva’s product infringes those patents. Furthermore, the Dow Jones article quotes Credit Suisse analyst Michael Aberman who points out that in the EU Teva’s product only has 5% market share, competing against both the original Neupogen and Amgen’s longer-acting Neulasta.
Investors’ reaction? Teva shares were up 1.4 percent, Amgen shares were off minutely.
My bottom line: If you want to read tea-leaves to predict the approach other biosimilar products will take (and I do), watch the Neupoval BLA closely. The calculus undertaken by other potential market entrants will weigh Teva’s success and costs with this approach against the costs of any Congressional requirement for data exclusivity period and any FDA requirement for clinical trials in an eventual biosimilars regime.
Follow our coverage of North American biosimilars news on this Biotech Trends in 2010 page.
Categories: Biotech Trends in 2010 · Jeremy Grushcow · News
Tagged: Amgen, Biosimilars, BLA, FDA, Follow-On Biologics, Neulasta, Neupogen, Neupoval, Teva, TevaGrastim
Canadian biotech companies were busy making and closing deals this week, with $44 million raised, four new licensing and collaboration deals, and particularly big weeks for Ospens and the MDS/Dahaner transaction. Keep reading →
Categories: Jeremy Grushcow · Monday Deal Review
Tagged: Abiomed, Aeterna Zentaris, Afexa Life Sciences, Athena Diagnostics, CAMH, Chemaphor, CK Life Sciences International, Danaher, FTC, ImmunoVaccine Technologies, IntelGenx Technologies, LMS Medical Systems, M Partners, MDS Analytical Technologies, MDS Inc., Neovasc, Ontario Hospital Association, Ospens, Pacgen Biopharmaceuticals, PerkinElmer, PharmaTrust, Resverlogix, Thermo Fisher Scientific, WEX Pharmaceuticals
A productive week of international collaborations leading to new drugs or targets…
Genetic Map of Yeast: A large-scale, genome-wide interaction map of yeast genes was constructed in an international study. The extensive network of genetic interactions lays out a functional map of the cell where similar biological processes can be grouped together. Yeast has been studied in the past and present because their molecular signaling is similar to human cells and is easy to manipulate. The detailed “genetic atlas” in this project, a first for any organism, provides important information to better understand genetic functions in relation to diseases. Their technique also allowed the scientists to map interactions between genes and chemicals, which will aid in choosing drug targets by predicting the extent of the interaction with other genes and how it may affect the cell. The multi-national project was led by University of Toronto researchers Drs. Brenda Andrews and Charles Boone. Details of the yeast map study appear in the prestigious journal, Science.
Mutations in Lymphomas: The identity of new mutations associated with specific types of lymphomas is described in this latest Nature Genetics article. Sequencing of genes involved in the NF-kappaB signalling pathway led to the identification of recurrent mutations affecting the EZH2 histone methyltransferase enzyme. The oncogene is the second member of this enzyme group found to be mutated in different types of cancer. Mutations were found in over 21% of a lymphoma subtype, affecting amino acid Tyrosine 641 that renders the enzyme with lower activity. Dr. Marco Marra at the Michael Smith Genome Sciences Centre (BC Cancer Agency) conducted the sequencing project.
Stopping Alzheimer’s Disease: Inhibition of ACAT1, an enzyme directly involved in cholesterol metabolism, significantly decreases the accumulation of amyloid plaques when tested in a mouse model of Alzheimer. To gain deeper knowledge of how this works, researchers deleted the ACAT1 gene in mice predisposed to develop Alzheimer’s disease. The brains of these mice had fewer amyloid plaques with improved cognitive function. The key finding is that without ACAT1 function, cholesterol accumulates in a subcellular compartment of the cell where it is converted and no longer available to be involved in amyloid plaque formation. These data supports the use of ACAT1 inhibitors in the battle against Alzheimer’s disease and lends insight into future improvement. Dr. Nabil Seidah at the Institut de Recherches Cliniques de Montréal collaborated with researchers in the U.S. and published the study in the Proceedings of the National Academy of Sciences.
New Treatment to Stop Malaria: Two enzymes important to the survival of Plasmodium falciparum, the parasite causing malaria, have been discovered in an international collaboration aimed at stopping the drug-resistant parasite. Malaria parasites invade red blood cells and digest the proteins for fuel to grow and divide until they burst out of the red blood cell and repeat the process again. The discovery of the parasitic enzymes, PfA-M1 and PfA-M17, which are keys to the digestive process in red blood cells, was the first step in designing therapeutic drugs. Building three-dimensional structures of the enzymes was the next step in determining how best to target and inhibit the enzyme. The study suggests that blocking PfA-M1 and Pfa-M17 would prevent the parasite from feasting on the red blood cell and represents a new wave of promising anti-malarial drugs. McGill University’s Dr. John Dalton led the international research project and is reported in this week’s The Proceedings of the National Academy of Sciences.
Vitamin D fights Crohn’s Disease: Vitamin D deficiency in individuals may contribute to the development of Crohn’s disease, as suggested in this new research report. Mismanagement of intestinal bacteria triggers an inflammatory response that develops into the autoimmune disorder. The action of Vitamin D, as the study suggests, is to directly promote the expression of NOD2, which signals to the body of a microbial invasion. NOD2 then activates NF-kappaB to induce expression of DEFB2 (defensin beta2), an anti-microbial peptide. To further support Vitamin D’s role, both DEFB2 and NOD2 have been linked to Crohn’s disease in earlier studies. This is significant to the management of the disease because Vitamin D deficiency is easy to test for through a simple blood test and Vitamin D supplements (and sunlight!) are readily available. Dr. John White and his team at McGill University and the Université de Montréal published their study in the Journal of Biological Chemistry.
Categories: Friday Science Review · Richard Chan
Tagged: Alzheimers, amyloid, cholesterol, Crohn's Disease, Genetics, genome, inflammatory bowel disease, lymphoma, malaria, Plasmodium, vitamin D, yeast
Categories: Biotech Trends in 2010 · Jeremy Grushcow · News
Tagged: AstraZeneca, Biocon, China, Duke University, Eli Lilly, Endo Pharmaceuticals, India, Jubilant Biosys, Singapore, UAB, University of Alabama at Birmingham
Equicom published a report recently that takes a comprehensive look back at 2009 at the Canadian public healthcare sector. Here’s the link to the press release, which has the headline numbers and a link to the full report. If I use “therapeutics” as a rough proxy for “biotech,” here’s where we stood at the end of 2009:
- The average stock price change in public Canadian therapeutics companies was up 53% in 2009 — better than the TSX composite index (+31%) and the NASDAQ Biotechnology index (+16%) — despite some notable declines following clinical trial failures
- Therapeutics companies raised $257.5 million, with $6.3 million of that coming in as convertible debt and the remainder as equity (mostly incentvized by warrants)
- The study notes 10 licensing deals totaling $212 million in up-front payments with the potential for almost $2 billion in future milestone payments (among the 8 that disclosed financial information)
Read the whole thing (pdf), and you’ll see some reason for optimism.
In fact, BIOTECanada released some data from an updated survey this week that also shows increasing optimism in the sector heading into 2010. Whereas the data in July showed 70% of companies with under 12 months’ cash, the new results show the converse percentage — over 70% of companies now report at least 12 months’ cash on hand.
Categories: Jeremy Grushcow · News
Tagged: BIOTECanada, biotechnology, Equicom
Alex Philippidis ran a great story at GenomeWeb last week on the OICR’s plans for 2010, which include hiring 40 more staff, growing informatics capabilities and providing additional support for its Intellectual Property Development and Commercialization program.
On the commercialization front, the news is particularly exciting. OICR has already been willing to participate in novel initiatives like POP-CURE, and has now hired two executives with extensive industry experience:
Franklin Stonebanks, the new chief commercial officer, ”founded global life-science advisory firm Blackcomb Advisors; served as president and CEO of Cynvec; and held managerial positions in the venture funds of Johnson & Johnson and IBM, where he also led its healthcare and life science mergers-and-acquisitions effort.”
Nicole Onetto, the new deputy director, was “senior VP and chief medical officer of ZymoGenetics, and earlier served as executive VP and chief medical officer of OSI Pharmaceuticals. She was international project leader for Taxol, and led the clinical development of Tarceva (erlotinib) for non-small cell lung cancer and pancreatic cancer in collaboration with the National Cancer Institute of Canada.”
The OICR team has already invested over $5 million in 12 startups, three of which have since been acquired. The funded projects include imaging technologies, biomarkers and new therapeutics. These two should be great additions, and together with Rafi Hofstein, are raising the international profile of Canadian innovation.
Categories: Jeremy Grushcow · News
Tagged: Frank Stonebanks, Intellectual Property Development and Commercialization Program, Nicole Onetto, OICR, Ontario Institute for Cancer Research
January 25, 2010 · 1 Comment
Everyone’s looking to the future in this week’s deal review: two special committees, 225,000 options, two royalty streams, a delisting notice and the first income trust/tax loss deal of 2010. Keep reading →
Categories: Jeremy Grushcow · Monday Deal Review
Tagged: Aeterna Zentaris, Arcadia Biosciences, BioSyent, ConjuChem, Dragon Pharmaceutical, IntelGenx Technologies, Kane Biotech, Notlers, SemBioSys Genetics Inc., Sonomax Hearing Healthcare
January 22, 2010 · 1 Comment
Some really exciting research in this week’s review…
Special (RNAi) Delivery: One of the obstacles for RNAi based therapeutics is the difficulty in getting the RNAi into the cells efficiently to invoke a positive response. Vancouver based Tekmira Pharmaceuticals (TSX: TKM.TO), in partnership with Alnylam Pharmaceuticals (Nasdaq: ALNY) and researchers at the University of British Columbia, Drs. Pieter Cullis and Marco Ciufolini, developed a new and improved RNAi delivery method that is 10X better than their standard delivery platform. Using their knowledge of lipid structure and how specific features influences delivery into cells, they used a rational design approach to develop a new cationic lipid, DLin-KC2-DMA (KC2), that is used with their current SNALP system (stable nucleic acid-lipid particles) to achieve the remarkable results. Details of the study are reported in this week’s issue of Nature Biotechnology.
Resolving Stem Cell Populations: The differentiation of stem cells is a complex multi-step process that is not fully understood. With each step, the potential of that stem cell becomes more and more restricted. Researchers performed a series of intricate detailed studies on cell populations to resolve distinct Intermediate Term Reconstituting Hematopoietic Stem Cells or ITRC (versus long- and short-term populations). The significance of this key finding is that researchers who are interested in harnessing the potential of long-term reconstituting hematopoietic stem cells can more accurately study a pure population of true, self-renewing stem cells with homogeneous characteristics. Prior to this new “intermediate-term” identification, the majority of “long-term” cells were actually comprised of intermediate-term cells. Dr. Norman Iscove and his team at the University Health Network describe their work in the latest issue of Cell Stem Cell.
Fishing for New Drugs: A high-throughput behavioural monitoring system to observe the response of Zebrafish to neuroactive chemical compounds should help expedite the discovery of new drugs for neurological disorders. Researchers setup a video system and applied “behavioural barcodes” that they say can track the effects of 14,000 chemicals on zebrafish behaviour. The capacity of this large-scale screen is unique and the use of zebrafish is quite informative because they are transparent, genetically tractable, and more similar to humans than you might think. In this platform, response to two strong light pulses after exposure to chemicals is monitored and the observations are translated into barcodes that make data analysis of this magnitude a lot more manageable. Drs. Jennifer Bryan and Rick White at UBC collaborated with Harvard researchers and published their study in Nature Chemical Biology.
Intrinsic Stimulator of Muscle Regeneration: A new subpopulation of cells in muscle tissue that contribute to muscle injury repair has been identified. The surprise is that these cells, called fibro/adipogenic progenitors (FAPs), are derived from a different developmental lineage as muscle cells. These fat-lineage cells, which are resident in muscle tissue, are ‘activated’ in response to muscle damage but they do not become muscle cells. Instead, they release factors that promote and enhance muscle progenitors in the myogenesis repair process. The conundrum, however, is that too much of these FAPs can lead to fibrosis and contribute to muscle disorders. The study, reported in Nature Cell Biology, was led by Dr. Fabio Rossi at the University of British Columbia.
Pharmacoviral Therapy for Gliomas: Oncolytic viruses (VSVs) are used in the treatment against malignant gliomas but are limited in efficacy due to the viral induced IFN (interferon) response – one of our body’s natural defense mechanism. Knowledge of the molecular mechanisms involving the mTOR pathway in IFN production led researchers to investigate the use of rapamycin, an mTOR inhibitor, in conjunction with the VSVs. This “pharmacoviral” combinatorial approach was very successful when tested in rats with malignant gliomas and represents a potentially new therapeutic strategy. Dr. Nahum Sonenberg and his team at McGill University are experts in the mTOR pathway and describe their work in the Proceedings of the National Academy of Sciences.
Categories: Friday Science Review · Richard Chan
Tagged: Alnylam Pharmaceuticals, blood stem cells, glioma, interferon, mTOR, muscle, myogenesis, neuroactive chemicals, pluripotent stem cells, rapamycin, regenerative medicine, RNAi, Tekmira, zebrafish
January 22, 2010 · 1 Comment
Ontario’s $250 million Emerging Technologies Fund has closed its first two investments, participating in a $6.73 million round from smart grid company ecobee and a Series A round of undisclosed size from location-based ad company Bering Media. I am proud to report that Ogilvy Renault, led by Senior Partner Jay Lefton, acted for ecobee in connection with its financing.
Interestingly, the portfolio companies page at OETF lists four “conditionally approved” investments, so perhaps we should stay tuned for two more announcements.
More tidbits: the Qualified Investors page now lists Celtic House (no OETF deal yet?), JLA Ventures (the QI for the ecobee deal), Tech Capital (the QI for the Bering deal and an ecobee investor) and XPV Capital (no OETF deal yet?).
The OETF mandate includes (1) clean technology, (2) life sciences and advanced health technologies, and (3) digital media and information and communications, with (1) and (3) covered by these first two deals. Look forward to seeing (and working on) some life sciences deals from the OETF.
Categories: Jeremy Grushcow · News
Tagged: Bering Media, Celtic House, Cleantech, ecobee, JLA Ventures, OETF, Ontario Emerging Technologies Fund, Tech Capital, XPV Capital
January 21, 2010 · 1 Comment
Governments want to create jobs. Not just any jobs, “creativity-oriented jobs” and ”knowledge economy jobs.” But what does it cost government to create one of these jobs? We don’t really know, but on this blog we’ve been tracking data points all year to try to get some sense of how to invest effectively to attract the workers who will keep our economy competitive into the next century.
This week, a report from Florida’s legislature created what appears to be a new high-water mark: $1.4 million for each new biotech job. $759 million investment in eight biotech campuses over the last six years, with about equal amounts coming from other levels of government, resulting in a total of 1,100 jobs. However, as the report points out, not that much time has elapsed. This also seems like a count of only the most direct jobs, and these have a high leverage ratio, each one supporting 5-7 additional jobs.
One valuable conclusion from the report: creating a cluster takes a multifaceted approach. The biotech campuses were of limited help because early stage capital was not available.
Photo of meat grinder from flickr user gpiper under a Creative Commons license.
Categories: Bailout · Jeremy Grushcow · News
Tagged: biotech, biotech campus, biotechnology jobs, Florida, Jobs
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.
Categories: Biotech Trends in 2010 · Jeremy Grushcow · News
Tagged: AstraZeneca, Comparative Effectiveness, Dako, Health Care Reform, Personalized Medicine, reimbursement, venture capital
January 18, 2010 · 1 Comment
Another strong week for Canadian deals. Light on securities, but heavy on M&A, licensing and partnerships. MedGenesis and Cyplasin brought assets in, Canada and Australia are doing a do-sa-do (Topigen-Pharmaxis, YM-Cytopia), and Trillium Therapeutics signed an out-license to Biogen, while Medicure is shopping its lead program around. Less good news for Haemacure and Forbes Medi-Tech, but plenty of other deal info, including 7 HTX investments, to be found Keep reading →
Categories: Jeremy Grushcow · Monday Deal Review
Tagged: Angiotech, Biogen-Idec, Certo Labs, Colibri Technologies, Cyplasin Biomedical, DVS Sciences, eSight, Forbes Medi-Tech, Haemacure, Health Technologies Exchange, HTX, MedGenesis Therapeutix, Medicure Inc., Microbix Biosystems, NexJ Systems, Patheon, Pharmaxis, Sanofi-Aventis, Sentinelle Medical, Therapure, TOPIGEN, Trillium Therapeutics, Virionics, WordQ, YM Biosciences
A little sunflower power to brighten up a quiet week…
Understanding Cancer Therapy Resistance: A molecular contribution to resistance to cancer treatments is from the cellular protein Clusterin (CLU). This cell survival protein is targeted by the antisense based OGX-011, one of OncoGenex Pharmaceutical’s leading compounds currently in phase 2 trials for prostate, lung and breast cancers. In this recent research project, the mechanism of clusterin mediated treatment resistance was investigated by Dr. Martin Gleave’s team at the University of British Columbia. They found that CLU enhances the degradation of two proteins, COMMD and I-kappaB, which in turn leads to an increase in the transcriptional activity of NF-kappaB to support cell survival. These findings surely provide additional potential drug targets for Dr. Gleave, who is the founder of OncoGenex and currently serves as the Chief Scientific Officer. The study is reported in Molecular Cancer Research.
Sunflower Genome: This is an award announcement to fund the $10.5M (USD) “Genomics of Sunflower” Project. The contributions are from a ‘cross-border’ consortium including Genome Canada, Genome BC, the US Departments of Energy and Agriculture, and France’s INRA (National Institute for Agricultural Research). An international team including University of British Columbia researchers and led by Dr. Loren Rieseberg will generate the reference genome that is approximately 3.5 billion bases long for the sunflower family, which includes 24,000 different species. This agri-biotech project will support the future of the sunflower industry (its seed industry alone is worth $14B) by trying to identify genes that are responsible for agriculturally important traits such as seed-oil content, flowering, seed-dormancy, and wood producing-capacity as well as adapt to today’s changing environment and consumer tastes.
Categories: Friday Science Review · Richard Chan
Tagged: agri-biotech, cancer treatment, clusterin, Genome BC, Genome Canda, genome sequencing, Oncogenex, sunflower
January 13, 2010 · 1 Comment
The U.S. Federal Trade Commission published a report today (subtly) entitled “Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions” claiming that settlements between patentees and potential generic entrants where the generic manufacturer is compensated result in delays averaging 17 months longer than the delays in settlements where no compensation is paid.
“Pay for Delay” is the top “Hot Topic” on the FTC’s homepage, and appears to be getting a lot of attention from Bureau of Competition Director Richard Feinstein: this is is the FTC’s second report on the topic since 2009, and the reports have been accompanied by Congressional testimony, two active cases and “multiple” investigations.
Add to this the announcement by the European Commission this week that it is also investigating these deals, with GSK and AstraZeneca confirming requests for information, and it’s clear the global regulatory heat on these settlements in being turned up. So far, though, the EU statements are more moderate, with European Competition Commissioner Neelie Kroes reportedly saying only: “We need to monitor this type of agreement in order to better understand why, by whom and under which conditions they are concluded.”
Some more details from the reports:
- The FTC study looked at 218 final settlements between 2004 and 2009, of which 66 involved “some form of compensation” (the FTC counts non-cash consideration, like agreement not to launch authorized generics, in this group).
- The EU cites a similar 25% of 200 examined cases where payments were made.
- The latest FTC report doesn’t provide the primary data, but their analysis shows that “there is less than a 1% chance that this large a difference in average time to entry would be observed if the amount of delay from the two types of agreements were drawn from the same statistical distribution.”
- The FTC report weights the analysis by the amounts of the annual sales of the applicable drugs, but it says that the “distribution of annual sales figures for drugs covered by these pay-for-delay agreements is not discernibly different from the distribution of annual sales figures for drugs covered by agreements that restrict generic entry with no payment to the generic.”
Categories: Jeremy Grushcow · News
Tagged: European Commission, Federal Trade Commission, FTC, pay-for-delay
January 11, 2010 · 1 Comment
The busy pace for Canadian biotech deals set at the end of 2009 continues into 2010. After the jump, 3 licensing agreements, 6 securities deals (though it’s 5 closing, one launching) and a PMA. You may even find redemption if you Keep reading →
Categories: Jeremy Grushcow · Monday Deal Review
Tagged: Abraxis Bioscience, BioSyntech, Canadian Patient Access, delisting, Haemacure, Heart Force Medical, Inverness Medical Innovations, Labopharm, Miraculins, Mount Sinai, Neovasc, Nightingale Informatix Corporation, Ondine Biopharma, ProMetric Life Sciences, Resverlogix
I am starting the new year and decade by recognizing the accomplishments of two distinguished scientists…
Two outstanding Canadian scientists were recognized for their valuable contributions to the global research community.
Dr. Andras Nagy’s innovative technique to reprogram mature body cells into stem cells – called induced pluripotent stem cells or iPS cells – was named Method of the Year by the prestigious journal Nature Methods. Earlier in the year, Dr. Nagy was selected as one of Scientific American magazine’s top 10 – Guiding Science for Humanity.
Dr. Tony Pawson was honoured as one of ten “Nation Builders of the Decade” by the Globe and Mail. His breakthrough research over the past decade and beyond has propelled our understanding of the intricate communication that goes on within a cell and between cells. Dr. Pawson was also awarded the Kyoto Prize this year.
Bypassing PTEN Mutants in Cancer Cells: The discovery of a novel link between the proteins PTEN and PKR may lead to new approaches forncer treatments. Dr. Antonis Koromilas’ research at McGill University identified that the tumour suppressor function of PTEN requires it to activate the PKR-eIF2alpha pathway, which applies an inhibitory control on protein synthesis. In a cancer cell where PTEN is mutated, PKR also loses its ability to control protein synthesis and the cell continues growing into a tumour. The significance of this is that they can now try to bypass the PTEN mutation and find alternate ways to activate PKR and regain control of cell growth. The research is reported in the journal Science Signaling.
Distinguishing Sister Chromatids: In studying cell division, scientists have long desired to follow the fate of sister chromatids – the identical chromosome copies that is distributed to each cell during the process of cell division. Researchers used the CO-FISH (chromosome orientation fluorescence in situ hybridization) technique with unidirectional probes. When they observed the process in different cell types, they found that the chromatids segregated randomly in some cell types but not in others. The non-randomness may be a mechanism to direct cells to be slightly different from its sister cell and is one of many layers of complexity in developing higher organisms. The solution to this biological phenomenon by Dr. Peter Lansdorp at the BC Cancer Agency deserves the recognition in the prestigious journal Nature.
Prognostic Marker for Bone Cancer Survival: Genetic deletion mutations in a specific chromosome region called osteo3q13.31 may be predictive of a poor prognosis for osteosarcoma patients. The copy number alteration (CNA) marker was identified in subsets (80%) of osteosarcoma patients where their bone cancers appeared to be more difficult to treat. With this genetic marker, patients may be screened to identify candidates who should be treated more aggressively from the onset of diagnosis. Furthermore, the osteo3q13.31 region contains 3 genes that were not previously associated with the disease and requires further investigation that may lead to additional therapeutic options. The study was conducted by Dr. David Malkin’s team at The Hospital for Sick Children and is published in Cancer Research.
Categories: Friday Science Review · Richard Chan
Tagged: bone cancer, cancer, cell division, chromatids, iPS Stem Cells, mitosis, Nagy, osteosarcoma, Pawson, pluripotent stem cells, PTEN, Scientific American
Late last year, a PwC report made the rounds with a big headline number — $232 billion — as the size of the personalized medicine market. FierceBiotech called it a “tipping point,” for personalized medicine. George Church called us “the first genomic generation” in Newsweek, and Francis Collins’ new book ”offers practical advice on how to utilize these discoveries for you and your family’s current and future health and well-being” (at least according to its publisher).
And this isn’t just idle speculation, it’s being reflected in real investments. Cancer Research UK, the Medical Research Council, University College London, and the Wellcome Trust are developing a £500 million new home for their partnership, called the UK Centre for Medical Research and Innovation (UKCMRI), where “genomic technologies will play a key role in the array of research its partners plan to pursue there.”
However, there are real challenges to realizing the 11% annual growth rate PwC predicts.
- Health care providers need to learn a whole new language and a whole new set of tools and approaches. A new year-long project at Valparaiso University aims to meet the new criteria of the nursing curriculum essentials in genetics that are set by the American Association of Colleges of Nursing (AACN), but this is just the tip of the iceberg. (h/t @mikesgene)
- Even when health care providers are educated, it doesn’t mean that the market will grow. For example, there is high awareness (80-90%) of a new genetic test designed to reveal a breast cancer patient’s sensitivity to tamoxifen. However, according to research from Duke University Medical Center, “[a] greater awareness of the emerging data for this new test corresponded to less likelihood of ordering the test and lower likelihood of changing practice based on test results.” (emphasis added) (h/t @DukeIGSP)
- The Genetic Information Nondiscrimiation Act loopholes are still intimidating. GINA does not expressly cover long-term care and other types of insurance and is focused to some extent on prohibitions on requiring genetic tests (which will be moot when everyone’s full genome is sequenced). Some efforts to remedy or mitigate GINA loopholes are underway, including:
However, many patients (and, anecdotally, everyone in the insurance industry) are vociferously refusing genetic testing and sequencing.
- FierceBiotech notes that the PwC report itself identifies another caveat: “Big Pharma will have to bury its blockbuster business model in favor of a more “collaborative model.”
My bottom line: Those who are counting on seeing the growth predicted by PwC will have to make an unprecedented investment in educational and regulatory changes to sychronize with the unquestionably giant strides in product innovation that are occuring daily.
For more on personalized medicine, check out the Biotech Trends in 2010 page.
Categories: Biotech Trends in 2010 · Jeremy Grushcow · Trends in 2009
Tagged: AACN, American Association of Colleges of Nursing, Duke University Medical Centre, Francis Collins, Genetic Information Nondiscrimination Act, George Church, GINA, HHS, OCR, Office of Civil Rights, Personal Genomes Project, Personalized Medicine, PwC, tamoxifen, UK Centre for Medical Research and Innovation, UKCMRI, Valparaiso University
Two interesting Tweets appeared this morning:
Biotech drug approvals spiked in 2009. http://is.gd/5O2KD
followed shortly by
#FDA Drug Approvals Mostly Flat in 2009 http://bit.ly/5sAGF6
The actual numbers, which are based on analysis by investment research group Washington Analysis, are that 2009 saw 26 total approvals compared to 25 in 2008 and of those, seven were for biotech drugs compared to four in 2008.
Is that a spike for biotech? Ira Loss (from Washington Analytics) tells FierceBiotech maybe, but wants to see if the increase holds in subsequent years. Fisher’s exact test gives a p-value of 0.499, indicating that seven out of 26 is not a statistically significant increase over four out of 25; but as the Pharmaceutical Processing article says, “[t]he FDA can’t approve drugs that aren’t submitted.”
So, we can’t really reach an answer without a real denominator — I’d suggest using the number of drugs with a PDUFA deadline during the calendar year; but even then it would be very hard to control for NDA quality or other possibly confounding factors.
Bottom line? Seven is better than four; and as FierceBiotech points out, fears that the Obama FDA would ratchet back approvals have not been substantiated.
Categories: Jeremy Grushcow · News
Tagged: biotech drugs, drug approvals, FDA, Food and Drug Administration, PDUFA
Adapted from a bulletin by my colleagues Evan Cobb and Brad Newman:
