This post from Patent Docs blog is self-explanatory. Suffice it to say that any hoo-haw over the exhorbitant price of a BRCA diagnostic test at $3000 is -- shall we say overblown. Assertions of this sort couldn't be more wrong-headed. If you want to blame somebody on this front, it is likely more apt to blame a particular insurer for NOT covering the test cost.
Posed by Bruce Lehr May 3rd 2013
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Xconomy published today on Qiagen's recent application to the FDA for the approval of a diagnostic test that looks at a mutation in the EGF receptor. The test is useful in the diagnosis of the speed of disease spread in non-small cell lung cancers (NSCLC) -- 10 to 15 percent of Caucasions and 40 percent of Asians carry the mutation. The test was developed in conjunction with Boehringer Ingelheim's cancer therapy, afatinib that targets the mutation -- and they've asked the FDA to approve both products simultaneously.
This type of "companion diagnostic" has long been talked about, particularly with cancers, as being advantageous to define the target patient population that will respond to the drug. This helps recruitment for clinical trials and to better ensure the drug will actually be effective in the trial. The proto-type for this concept is Roche's combination Herceptin and the HER2 positive breast cancer from the late 90's. But not much else has really reached the market since then.
With Qiagen's/BI's application, we expect to see a new surge in companion diagnostics-therapeutic combination being developed and brought forth. In fact, co-development of the therapy and the diagnostic is the major difference in these programs now compared to what may have been done in the past where a test was typically developed sometime well after the therapy was available. The result is that the tests didn't work particularly well and only 1% of drugs in the US actually have a companion diagnostic -- most in cancer area.
That's changing as the FDA has encouraged this approach. Qiagen says it now has 15 programs in progress -- including with not only BI -- but with big companies like Pfizer and AZ. Last year, Roche had a companion diagnostic it developed with its Zelboraf treatment for melanoma. Pfizer's Xalkori has a companion diagnostic developed by Abbott. Other drug-companion diagnostic programs in progress include the following companies:
The industry and FDA are looking for more of these to be successful -- and would expect clinical trials to flow more smoothly and result in more approved drug applications. It remains to be seen if this will translate into reality -- though the promise is clearly there.
Posted by Bruce Lehr Jan 31st 2013.
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As expected, the Supreme Court remanded the Myriad case back to the lower Circuit Court to review its previous finding in lieu of the new ruling in the very recent Prometheus case. As explained in the blog post, the Supreme Court would like to make sure the lower court vets all the issues.
Myriad Will Return To Supreme Court: Rod Explains // Pharmalot.
This case as you may remember essentially is deciding whether gene sequences (genes) are patentable. Most of the biotech industry and the BIO organization have certainly backed Myriad claiming that a denial of these patents would chill innovation and investment in the industry.
Opponents see patenting genes as goign against the patent doctrine prohibiting patents "on the underlying laws of nature." Prometheus was cited as being in violation of this concept as its patent was thrown out last week. Opponents also see the Myriad BRCA patents as potentially limiting access to potentially life-saving genetic tests if it is deemed to be the only provider.
Many observers expect the Circuit Court to reaffirm its original ruling (in Myriad's favor) and then we'll end back up at the Supreme Court anyway. The drama unfolds.
Posted by Bruce Lehr Apr 2nd 2012.
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There's no doubt where the writer of the IN VIVO blog stand on the wisdom of the Supreme Court's ruling against the Prometheus' patent. The logical extension of the ruling (according to the writer) would be the denial of patent rights to a myriad (get it) of personalized diagnostic tests.
The IN VIVO Blog: Supremes' Prometheus Ruling Has Dire Consequences for Personalized Medicine.
Not only would the analysis of small differences in gene sequences (as embodied by the Myriad case) potentially be covered by this ruling, but any tests that attempt to figure out why certain individuals respond better to one drug over another and how much drug should be administered should be covered. At least, if the logic exhibited in Prometheus were extended to other cases.
But then again, who ever accused the Supreme Court or most of the legal system to actually be bound by logic? Until another case comes along that will allow a reversal, I guess we're left with hanging chad in the biotech industry.
Posted by Bruce Lehr Mar 26th 2012.
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Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, is hot. Several Big Pharma players continue to invest in this emerging field as evidenced by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics. Look out for whole genome sequencing - some folks idea of the Holy Grail in enabling personalized medicine.
PharmTech Talk » Roche Makes Bid to Advance Position in Personalized Medicine.
Roche, perhaps, more than any other pharmaceutical company, is banking heavily on the combination of diagnostics and drug development to drive pharmaceutical innovation. Roche is uniquely positioned in that regard as it is ONE of the leading diagnostics and pharmaceutical companies. Roche has 6 personalized NMEs and companion diagnostics in its commercial or late-stage pipeline. These include Zelboraf/BRAF companion for metastatic melanoma, and Tarceva/cobas EGR companion for non-small cell lung cancer.
Drug-companion diagnostics are a hot area in cancer treatment, and surely are ushering in a new era of personalized medicine.
Posted by Bruce Lehr Jan 30th 2012.
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Plexxikon says it has agreed to be purchased by Daiichi Sankyo. The reported price tag is $805 M upfront and another $130 M in potential milestones. Daiichi will acquire Plexxikon's drug candidates for the treatment of certain cancers - based on a personalized medicine approach. Plexxicon already has one such apparent success story in the making with its Roche-partnered melanoma therapy, PLX4032, that has shown exciting clinical results.
Plexxikon, Creator of Hot Melanoma Drug, Bought by Daiichi Sankyo for $805M Upfront.
Plexxikon's CEO Peter Hirth said that his company was proud that Daiichi Sankyo recognized the value of their robust pipeline of personalized medicine drugs and their discovery engine.
Posted by Bruce Lehr March 2nd 2011.
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Novartis will acquire Genoptix for $470 M representing a 39% premium over its current stock price of $17.98 per share. It's a tender offer which means the majority of Genoptix shareholders will need to agree to surrender their shares.
Genoptix Agrees to $470M Takeover by Novartis.
The acquisition of Genoptix, a company specializing in diagnosing cancers in bone marrow, blood and lymph nodes, will help Novartis in its pursuit of personalized cancer treatment programs. Novartis currently is the world's second biggest maker of cancer drugs - with 2009 sales of more than $9 B. The fact that Genoptix is a profitable company doesn't hurt the deal. Genoptix will become part of Novartis' Molecular Diagnostics unit.
Posted by Bruce Lehr Jan 24th 2011.
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via www.pharmastrategyblog.com
Sally Church, while adjusting to the high altitude of Denver at the American Association of Cancer Research (AACR) meeting on molecular diagnostics and cancer therapeutics, penned this item about new cutting edge ideas from the show.
She mentions the need for closer and more collaborative relationships between basic and clinical research in order to translate the knowledge and ideas into practice in the clinic more quickly. Essentially, better collaboration between academia, industry, between labs and between companies, even between what some may seem as competitors. Sounds a lot like a cry for more open innovation.
A second theme she called out is the need to put more emphasis on systems biology - to look at "pathwayness" - that is trying to understand the complex pathways involved in cancer and devising strategies against the pathway versus attacking individual receptors that may only shut off portions of the pathway that can be bypassed by the cancer.
By taking the more open innovation route, and by picking up the tools we already have to more coherently apply to the pathways approach, we can potentially target more effective treatments for the individual patient -- and get there more rapidly. It again highlights a need for more work to identify biomarkers that can be used to assess successful outcomes in clinical trials within patient subpopulations - so we can apply the best treatments to the patient populations most likley to respond favorably.
Posted by Bruce Lehr September 30th 2010.
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Another story from Fierce Biotech highlights Merck's new deal with China's BGI, a leading genomic research Institute in Shezhen province. BGI will help Merck with drug discovery efforts aimed at the personalized medicine market that is expected to develop big over the next decade and beyond.
Specifically, BGI will lend its genomic sequencing and bioinformatics expertise to Merck's drug discovery efforts. Personalized medicine is seen as the future according to Yin Ye, vice president of BGI's Research and Cooperation Department. He believes that genetic differences between Europeans and Asians will lead to the development of unique therapeutics for each group.
Merck also sees having a footprint in China as being important. Michael Vounatsos, chief of Merck's China operations, indicates that he believes the market can expand there by more than 25% next year and that it will be among Merck's top 5 markets within the decade.
Posted by Bruce Lehr September 17th 2010.
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Over the past year, several market reports have predicted that in the new world of pharmaceuticals - post-patent cliff, post-blockbusters, post-biosimilar onset -- much more attention will be spent on developing drugs for orphan or rare disease applications. As further evidence of this trend, several Big Pharma companies have in fact announced their investment into these areas. See examples from Pfizer and Sanofi. Both the FDA and the NIH have discussed how they see their support increasing in this area. And, the Senate passed a new bill that looks to spur funding and development in the rare disease arena.
With this backdrop, we have a report this morning, in Medical News Today, that molecular scientists at Max Planck and at Charite Universitatsmedizin Berlin have succeeded in a whole genome screening process to - in this case - identify disease genes for Mabry Syndrome in 3 patients. They were able to track down individual mutations in the genome and connect these with the disease. The researchers relied on high throughput sequencing technology to identify the defect.
"It was like the proverbial search for a needle in a haystack. We fished out solely the 22,000 genes from the entire genome, decoded their sequence and examined them for mutations. Using new bioinformatic analyses, we were able to limit the number of mutation candidates to two, one of which is ultimately responsible for Mabry Syndrome" explains Michal Ruth Schweiger from Max Planck.
The methods developed here enable the identification of mutations even in very rare diseases and could help speed our introduction to the era of personalized medicine. Certainly, these type of diagnostic tests will aid in drug discovery and development as well -- and will complement efforts by the other players described above.
Posted by Bruce Lehr September 7th 2010.
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