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.
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.
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)
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.
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.
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. Continue reading →
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.
Interestingly, the portfolio companies page at OETF lists four “conditionally approved” investments, so perhaps we should stay tuned for two more announcements.
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.
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.
“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.”
“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)
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 Continue reading →
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.
Johnson & Johnson’s Animas Corp. unit (responsible for insulin pumps), and glucose monitor maker DexCom will work together on a device about the size of a cell phone that would be worn outside the body, with initial patient testing potentially beginning in less than a year.
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.”
The biggest development I’d cite is Pfizer’s deal to sell 40 generics made by India’s Strides Arcolab and South Africa’s Aspen. This deal seems to go a step farther than other innovator/branded deals with generics in that it treads on U.S. soil. The Pfizer Established Products Business Unit has in-licensed more than 200 products and has an overall portfolio of approximately 600.
“Generics” companies are not sticking to their traditional role either. Noting Teva’s projected growth and market cap, Jacob Goldstein says that “[i]t’s no longer correct to think of generics manufacturers as scrappy little competitors nipping at the heels of big pharma,” especially where 30% of their revenue comes from branded drugs.
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 Continue reading →
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.
In Canada, the Patented Medicine Prices Review Board (PMPRB)’s mandate is to (1) “ensure that prices charged by patentees for patented medicines sold in Canada are not excessive,” and (2) “report on pharmaceutical trends of all medicines, and on the R&D spending by pharmaceutical patentees. ” It has jurisdiction over any patented medicine “sold in any market in Canada.”
In a recent case, Canada (Attorney General) v. Celgene Corporation (A-177-09), the Federal Court of Appeal restored the PMPRB’s order that a patented medicine sold by a U.S. company and shipped F.O.B. the U.S.A. to physicians in Canada was nevertheless ”sold in any market in Canada” and subject to the jurisdiction of the Board, despite shipment, invoicing and payment all occuring directly to the U.S. in U.S. currency. In this case, Celgene was shipping THALOMID to Canadians under Health Canada’s Special Access Programme (“SAP”).
This decision means that SAP drugs will be subject to the PMPRB’s jurisdiction whether they’re manufactured in Canada or not.
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.
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.
None other than our very own Jeremy Grushcow is featured in the Law Pages of the Globe & Mail today in a story about lawyers and social media. Go look for yourself – it’s really true. The story was also picked up by @stevematthews on Twitter and by the à l’avant garde blog at lesaffaires.com.
A Popular Mechanics article in the January issue is entitled “How to Create a Designer Baby.” It is an interesting and seemingly accurate view of the state of the art, but when it says
“women undergoing in vitro fertilization (IVF) could one day choose to have a baby boy with perfect vision, an aptitude for sports and a virtual lock on avoiding colon cancer,”
it doesn’t go far enough. The problem is the first clause: “women undergoing IVF.” If you could guarantee any one of those traits, and could afford it, wouldn’t you choose IVF regardless of whether you needed it?
The moral of the story? To make informed ELSI (Ethical, Legal and Social) decisions, we need to look farther into the future, as the Genomics Law Report is starting to do. Want to know what having a baby will be like in 20 years? Take a look back at this scene from the 1997 movie GATTACA:
If you’re not thinking of that when you’re thinking of reproductive genomics, you’re not thinking far enough ahead.
Similarly, check out the UPI Article “Personalized Medicine Advancing” that describes a new chip designed by Georgetown Georgetown Lombardi Comprehensive Cancer Center in to look for mutations in as many as 170 genes that affect drug metabolism. Interesting and cost-effective for now, but shortly after someone wins the Archon X Prize for Genome Sequencing, these intermediate approaches will become moot.
As we head into another budget cycle here in Ontario, there has been a flood of news showing that other jurisdictions are investing heavily in recruitment and stimulus for biotech companies. Each one of these investments raises the bar for what has to be done in Ontario to build our own companies and capitalize effectively on our R&D resource base:
Across the border in the U.S., things have been even busier. The Senate version of the health care reform bill includes the famous (/infamous) 12-year exclusivity period for biologics, but according to a BioWorld article the bill also includes ”a therapeutic discovery project tax credit.” Sen. Arlen Specter (D-Pa.) also reportedly offered a measure that would create a translational science grant program through the National Institutes of Health, called the Cures Acceleration Network, and that would aid in expediting the FDA review.
Add to the federal stimulus an array of state-level initiatives:
Even the traditional U.S. biotech hotbeds are not standing still: North Carolina’s $250 million innovation fund is almost up and running, with an RFP out for a fund manager. (h/t @GenomicsLawyer)
Welcome back, and happy 2010! If you’ve been away for a couple of weeks, check out the winners and losers from our 2009 Trends, and the year’s top posts.
If you’re just here for the deals, don’t fret, we have those too: a busy bunch of closings ended 2009, with almost $12 million flowing into the coffers of Canadian biotech companies from December investors over the past two weeks. But don’t expect a quiet January in the Biotech Deal Review — Med BioGene has filed for its U.S. IPO, Agrium continues its push for CF Industries and Prism has engaged a Special Committee. Details of those and all the other goodies you missed while you were voting in IVB’s year-end round up after the jump…
We’ve put up posts with our top the winners and losers from our 2009 Trends, but that was just subjective. Here’s an emprical sort of the year’s top posts (excluding Swine Flu items):
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