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Dennis Crouch's Patently-O on Bilski
Bilski v. Kappos and the Anti-State-Street-Majority
http://www.patentlyo.com/
Posted: 28 Jun 2010 02:11 PM PDT
The 1998 Federal Circuit decision in State Street Bank opened the door to patent protection on a wider variety of innovations — especially in the fields of business methods and software. State Street held that an invention should be patent eligible under 35 U.S.C. §101 if it involves some practical application and “it produces a useful, concrete and tangible result.”
Although not rejected by the majority opinion, it is clear that the broad “useful, concrete, and tangible result” test is dead. That test is conclusively rejected by what I term the Anti-State-Street Majority — a majority created by the combining the two concurring opinions in Bilski and their five-justice majority. The result is that the scope of patentable subject matter is certainly narrowed from its 1998 high-water-mark.
* * * * *
In Bilski v. Kappos (2010), the majority opinion neither endorses nor rejects State Street — writing instead that “nothing in today’s opinion should be read as endorsing interpretations of §101 that the Court of Appeals for the Federal Circuit has used in the past. See, e.g., State Street, 149 F. 3d, at 1373; AT&T Corp., 172 F. 3d, at 1357.”
The two concurring opinions in Bilski (2010) both explicitly reject the Useful-Concrete-And-Tangible-Result test of State Street. Justice Stevens writes that “it would be a grave mistake to assume that anything with a ‘useful, concrete and tangible result,’ may be patented. (Justice Stevens concurrence at FN 1). Justice Breyer reiterated his prior statement that “if taken literally, the statement [that anything which produces a useful, concrete, and tangible result, is patentable] would cover instances where this court has held the contrary.” (Justice Breyer concurrence). The two concurrences are in agreement on this point and are signed by five Supreme Court Justices — leading to a second majority on that particular point.
Of course, in its In re Bilksi decision, the Federal Circuit already repudiated State Street as inadequate and "insufficient to determine whether a claim is patent-eligible under § 101."
Cumulatively, this means that the broadest notion of patentable subject matter as represented by State Street is not the law. Although not "the test" it appears that the USPTO will continue to use the machine-or-transformation test as a "tool" for determining whether particular process claims fit within Section 101. A recent Post-Bilski notice to examiners indicated as much:
Examiners should continue to examine patent applications for compliance with section 101 using the existing guidance concerning the machine-or-transformation test as a tool for determining whether the claimed invention is a process under section 101. If a claimed method meets the machine-or-transformation test, the method is likely patent eligible under section 101 unless there is a clear indication that the method is directed to an abstract idea. If a claimed method does not meet the machine-or-transformation test, the examiner should reject the claim under section 101 unless there is a clear indication that the method is not directed to an abstract idea. If a claim is rejected under section 101 on the basis that it is drawn to an abstract idea, the applicant then has the opportunity to explain why the claimed method is not drawn to an abstract idea.
I'm sure that our notion of the law will continue to develop as the Bilski decision makes its way into daily practice.
The FDA approved Venlafaxine HCl ER Capsules, Teva's generic version of Wyeth's antidepressant Effexor XR®. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth.
As the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
The brand product had annual sales of approximately $2.75 billion in the United States, based on IMS sales data.
http://www.tevapharm.com/pr/2010/pr_945.asp
The Court stated that its previous decisions – e.g., the Benson, Flook, and Diehr decisions – are the controlling law. Seems to me The Supreme Court rolled back the law of what is patentable subject matter to the days before the Bilski decision.
The “machine-or-transformation” test is not dead - Justice Steven’s concurrence states that this test is “a critical clue.” However, what we are left with after the Supreme Court’s decision is a collection of past statements that alone or taken as a whole provide no clear boundaries as to subject matter patentability under 35 USC § 101. The Supreme Court, in simply removing the layer of law added by the Federal Circuit, and not providing further analysis, seems to be inviting the Federal Circuit to try again: “we by no means foreclose the Federal Circuit’s development of other limiting criteria that further the purposes of the Patent Act …” (slip opinion at 16).
Unfortunately, the Supreme Court’s opinion does not clarify what is patentable subject matter under 35 USC § 101. It appears likely that some business method patent claims (such as Myriad's) and a majority of software method patent claims are now patentable subject matter under section 101, but determining which ones are patentable will be difficult. I expect that further court opinions at the level of district courts and the Court of Appeals for the Federal Circuit will attempt to make some sense of this.
I would not read too much into it. PLX will probably hear from the FDA early next week. I have checked again and PLX has announced that manufacturing data were submitted on April 27 (so the FDA should respond by June 27):
http://www.protalix.com/filings.html (see the 8-K from 4/27)
GILD said on Friday it agreed to acquire privately held drug discovery company CGI Pharmaceuticals Inc for up to $120M.
http://www.reuters.com/article/idCNN2511086720100625?rpc=44
The European Medicines Agency recommended approval of Shire's Vpriv an alternative to Genzyme's Cerezyme.
http://www.reuters.com/article/idCNLDE65O0FB20100625?rpc=44
The CHMP issued positive opinion for i.v vernakalant, for acute AF.
http://finance.yahoo.com/news/Investigational-BRINAVESS-bw-3082803584.html?x=0&.v=1
And another one: The European Medicines Agency recommended approval of Shire's Vpriv an alternative to Genzyme's Cerezyme.
http://www.reuters.com/article/idCNLDE65O0FB20100625?rpc=44
Or brought them the nicest bouquet
FRX/Savella
Your CYPB Call notes
That's pretty much what BiolineRx said with a few more details on:
1. Their view of the next trial - a bigger and longer (6-month) phase II/III, probably 3 doses, powered to validate data of phase IIb, could start before yearend. If succeeds - think one phase III will be needed.
2. On cognitive endpoints - BACS is only about 30 min test and MATRICS takes about 2 hours, very long time for a psychotic patient during the first 6 weeks of treatment while in hospital. CYPB will negotiate for an SPA with combined endpoint, perhaps the shorter test during the first month or so and the longer one later.
3. Why CYPB - perhaps this sounds like an excuse but they felt that a smaller and a hungrier company will do a better job developing this drug.
I have asked again about the trend seen with the lower dose and as I remembered the trend was there. I believe cognitive effect should be a lot better when correlates with BMI at the 10mg dose as it is underdose for heavier patients. I cannot say if they did such an analysis but my hunch is positive.
This must be bad news for anti-NGF mAb programs. SNY/REGN have an anti-NGF mAb in phase II for osteoarthritis pain.
CYPB
Hi M,
BiolineRx management did say it wants to IPO at NASDAQ but until then this is the best I could find in English:
http://www.tase.co.il/TASEEng/General/Company/companyDetails.htm?subDataType=0&companyID=001394&shareID=01101518
If you keep track of the list of shareholders you will be able to notice changes. The system in Hebrew shows all inside transactions in real time as you suspected but it's a terribly difficult language, some kind of a punishment if you ask me
And BiolineRx former CEO sold about one third of his shares on the news.
Oppenheimer MS survey:
Yes, this week PLX is expecting the issuance of a PDUFA date (manufacturing data were submitted on 4/24 so the FDA should respond by 6/24).
I haven't seen any data on the cognitive endpoint, in the 10mg dose either, but have been told it showed a trend. I believe CYPB did see all data before taking such a big decision. I thought the data were good since the study was powered to show statistical significance vs placebo and not Risperidone. BiolineRx investors weren't so happy with the deal as they were hoping for a big pharma partner (but then they were not happy when PLX partnered with a big pharma cause they were hoping the company will be bought...)
PLX - FDA decision on their drug is expected in October not this week (this week they only expect to have the date).
Transient transformation by agroinfiltration using vacuum infiltration is no big deal and inserting gene into the expression cassette is also something any grad student did at my time (and that was long ago). The viral vector is the most critical compound and I'm certain iBio's vector is not as good as they are saying (never take what the company people are telling you for granted). I'm sure it is suitable for small antigens such as vaccines but with large proteins, expression will be a problem. Icon for example are using similar tech but has a better viral vector so I don't see anything special about iBio. When comparing iBio to PLX you can try to value each system's advantages/disadvantages but saying iBio is much more versatile just because iBio people told you so, well, I think I should quit here.
CYPB-1020
Re Oppenheimer MS survey
73% of neurologists thought use of Copaxone could
decrease. On ave. Copaxone use could decline by 18.6% if gilenia is approved. They estimate Teva's 2011 EPS could drop 6.5% if gilenia is approved.
Meanwhile, I saw a piece by Yoram Gabizon in an Israeli paper about a survey conducted by Oppenheimer in which 26 neurologists treating more than 100 MS patients were asked how Gilenia will change treatment paradigm. I'm too tired to translate now and hopefully there will be an English version tomorrow in http://www.haaretz.com/
The hard and timely part in this game is designing the expression cassette that contains the vector and cDNA of interest. This part is pretty much the same for all players GENZ,PLX or iBio. Inserting this construct into agrobacteria and then infecting plants instead of inserting directly to cell culture might be a bit more rapid but then extracting from a whole plant instead of cells is longer. So, every system has its own pros and cons but saying iBio's is more versatile simply isn't correct.
Cypress Bioscience In-Licenses BioLineRx's Novel Antipsychotic
http://www.streetinsider.com/Press+Releases/Cypress+Bioscience+In-Licenses+BioLineRxs+Novel+Antipsychotic/5744253.html
SAN DIEGO, CA -- (MARKET WIRE) -- 06/20/10 -- Cypress Bioscience, Inc. (NASDAQ: CYPB) announced that Cypress has entered into an exclusive North American license for the development and commercialization of BioLineRx's novel antipsychotic (BL-1020, hereafter, CYP-1020), a potential breakthrough treatment for schizophrenia. Specific terms of the transaction were not disclosed, but the total upfront payment to BioLineRx was $30 million, with total potential clinical and regulatory milestones of up to $160 million through to approval in the United States (the majority of which are related to improvement in cognition), potential commercial milestones of $85 million, and a potential additional $90 million associated with approval for additional indications in the United States or for approval in other countries in North America. In addition, Cypress will fund all continuing development activities and pay BioLineRx a royalty based on applicable sales.
"This agreement reflects our renewed strategic focus on R&D, where we have successfully demonstrated leadership, creativity and a competitive advantage," said Jay D Kranzler, MD, PhD, Chairman and Chief Executive Officer of Cypress Bioscience. "This transaction represents a step down a path that we have successfully navigated before -- late stage, innovative drug development of a novel compound to address a significant unmet medical need. From fibromyalgia, and our success with Savella?, we believe Cypress has the experience and expertise required to successfully continue the development of CYP-1020, a novel antipsychotic that has the potential to address both the psychotic symptoms and cognitive deficits associated with schizophrenia. CYP-1020's data to date is compelling and we believe that it has the potential to set a new standard in the field as a first-line antipsychotic."
"This licensing agreement is a reflection of BioLineRx's proven business model, which focuses on conducting high-quality proof of concept programs with novel compounds and then partnering with companies which have the clinical and commercial expertise to help fully realize their potential. We believe that CYP-1020 is especially exciting, insofar as the cognitive impairments associated with schizophrenia reflect such a dramatic unmet medical need," said Kinneret Savitsky, PhD, Chief Executive Officer of BioLineRx.
Carol Tamminga MD, Professor of Psychiatry at the University of Texas Southwestern, a specialist in schizophrenia and translational neuroscience, and a BioLineRx consultant, said, "Patients with schizophrenia demonstrate symptoms in several functional domains, including psychosis and cognitive impairment. While antipsychotic therapies improve psychosis, there are no medications that affect cognition. CYP-1020 is a new antipsychotic drug candidate designed to reduce psychosis and augment cognition. Importantly, a recent proof of concept trial showed that CYP-1020 not only reduced psychosis compared to placebo, but it also improved cognition as compared to both placebo and an active control. This is a remarkable finding and will generate enormous enthusiasm in the field, if it can be replicated and its implications for psychosocial function demonstrated."
As a result of funds received from the Office of Chief Scientist of the Ministry of Industry, Trade and Labor of the State of Israel, or the OCS, in respect to BioLineRx's preclinical and clinical program related to CYP-1020, the effectiveness of the license agreement is subject to the consent of the OCS and OCS may condition providing its consent on the parties' agreeing to modifications in the license agreement. Cypress and BioLineRx have agreed to work together to attempt to secure OCS approval on terms that minimize financial and non-financial obligations on the parties that may be imposed as a condition to receipt of the OCS consent. Cypress is not required to agree to any modifications to the license agreement that would have, or would be likely to have, a material adverse impact on its rights and obligations under the license agreement, and whether OCS provides its consent on terms acceptable to Cypress, and the timing of any such consent, cannot be estimated at this time. BioLineRx has agreed that it will assume sole responsibility for any financial obligations imposed by the OCS. In addition, the upfront payment was placed into an escrow account pending receipt of a satisfactory OCS consent and effectiveness of the license agreement.
CYP-1020 Phase 2b Trial Design
BioLineRx designed and conducted a six week, double blind, placebo and active-comparator (risperidone) controlled multisite phase 2b clinical trial. The phase 2b EAGLE (Effective Antipsychosis via GABA Level Enhancement) study was conducted under a U.S. Food and Drug Administration Investigational New Drug Application (IND) at 40 sites in the U.S., Europe and India and included patients suffering from acute exacerbation of schizophrenia. In this six week study, 363 patients were randomized equally to treatment with low (10 mg/day) or high (20-30mg/day) dose of CYP-1020, risperidone (2-8mg/day) or placebo.
The study was designed to demonstrate statistically significant superiority of CYP-1020 to placebo on the primary efficacy measure, the change from baseline in the total score of the Positive and Negative Symptoms of Schizophrenia (PANSS). Risperidone at a dose of 2-8 mg was included as a positive control to validate the trial results.
Cognitive function in the EAGLE trial was measured by the Brief Assessment of Cognition in Schizophrenia (BACS) neuropsychological battery. The BACS test battery assesses a variety of aspects of cognition, including: verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing, and executive functioning. All of these functions are significantly impaired in patients with schizophrenia(1).
CYP-1020 Phase 2b Data
Results of the phase 2b EAGLE study demonstrated that CYP-1020 at the 20-30mg dose range exhibited clinically relevant and statistically significant improvement on the cognition endpoint assessed using the BACS neuropsychological test battery. The 20-30mg dose range of CYP-1020 was superior to both risperidone and placebo at endpoint on the BACS total score (p=0.027 for both), with positive trends in all subsets within the BACS.
CYP-1020 was also effective as a treatment for the other symptoms of acute schizophrenia exacerbation, as measured by the Positive and Negative Symptom Scale (PANSS). The CYP-1020 high dose group (20-30mg/day) experienced a statistically significant reduction in the PANSS from baseline versus placebo (LS mean -23.6 vs. -14.4; p=0.002). The superiority of CYP-1020 (20-30mg/day) over placebo was also supported by additional secondary efficacy measures such as the clinical global impression of severity (CGI-S) and change (CGI-C).
The incidence of serious adverse events was low in the CYP-1020 (20-30mg/day) group (0%) compared to risperidone (3.3%) and placebo (6.5%). Discontinuations due to adverse events (AEs) were similar in the CYP-1020 (20-30mg/day) group and in the placebo group (4.3%) but higher in the risperidone group (8.8%). There were no statistically significant or clinically relevant metabolic related AEs including body weight gain, glucose increases, or changes in lipids. The incidence of cardiovascular, sexual, psychiatric, autonomic and gastrointestinal AEs was low and did not increase compared to placebo. There were no statistically significant or clinically relevant changes in subject electrocardiography (ECG), laboratory or vital signs (blood pressure, heart rate, temperature).
Recent results from an extension trial showed that patients receiving CYP-1020 (20-30mg/day) for six additional weeks maintained the improvements on the PANSS and CGI that had been observed after the initial six weeks of treatment and, more importantly, showed continuing improvement in cognitive function as assessed by the BACS. The 12 weeks of treatment were not associated with any increased toxicities.
About CYP-1020
CYP-1020 (formerly BL-1020) is a first-in-class GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. CYP-1020's dopamine antagonism reflects a well-established pathway to improve the psychotic symptoms of schizophrenia. Furthermore, both preclinical and clinical data suggest that CYP-1020's GABA enhancement may provide the basis for improved cognition
About Schizophrenia...snip
Agree that waiting for the results of the ARISTOTLE trial before submitting an NDA for Apixaban in AF/stroke prevention is the more likely scenario.
Cypress Bioscience In-Licenses BioLineRx's Novel Antipsychotic
http://www.streetinsider.com/Press+Releases/Cypress+Bioscience+In-Licenses+BioLineRxs+Novel+Antipsychotic/5744253.html
SAN DIEGO, CA -- (MARKET WIRE) -- 06/20/10 -- Cypress Bioscience, Inc. (NASDAQ: CYPB) announced that Cypress has entered into an exclusive North American license for the development and commercialization of BioLineRx's novel antipsychotic (BL-1020, hereafter, CYP-1020), a potential breakthrough treatment for schizophrenia. Specific terms of the transaction were not disclosed, but the total upfront payment to BioLineRx was $30 million, with total potential clinical and regulatory milestones of up to $160 million through to approval in the United States (the majority of which are related to improvement in cognition), potential commercial milestones of $85 million, and a potential additional $90 million associated with approval for additional indications in the United States or for approval in other countries in North America. In addition, Cypress will fund all continuing development activities and pay BioLineRx a royalty based on applicable sales.
"This agreement reflects our renewed strategic focus on R&D, where we have successfully demonstrated leadership, creativity and a competitive advantage," said Jay D Kranzler, MD, PhD, Chairman and Chief Executive Officer of Cypress Bioscience. "This transaction represents a step down a path that we have successfully navigated before -- late stage, innovative drug development of a novel compound to address a significant unmet medical need. From fibromyalgia, and our success with Savella?, we believe Cypress has the experience and expertise required to successfully continue the development of CYP-1020, a novel antipsychotic that has the potential to address both the psychotic symptoms and cognitive deficits associated with schizophrenia. CYP-1020's data to date is compelling and we believe that it has the potential to set a new standard in the field as a first-line antipsychotic."
"This licensing agreement is a reflection of BioLineRx's proven business model, which focuses on conducting high-quality proof of concept programs with novel compounds and then partnering with companies which have the clinical and commercial expertise to help fully realize their potential. We believe that CYP-1020 is especially exciting, insofar as the cognitive impairments associated with schizophrenia reflect such a dramatic unmet medical need," said Kinneret Savitsky, PhD, Chief Executive Officer of BioLineRx.
Carol Tamminga MD, Professor of Psychiatry at the University of Texas Southwestern, a specialist in schizophrenia and translational neuroscience, and a BioLineRx consultant, said, "Patients with schizophrenia demonstrate symptoms in several functional domains, including psychosis and cognitive impairment. While antipsychotic therapies improve psychosis, there are no medications that affect cognition. CYP-1020 is a new antipsychotic drug candidate designed to reduce psychosis and augment cognition. Importantly, a recent proof of concept trial showed that CYP-1020 not only reduced psychosis compared to placebo, but it also improved cognition as compared to both placebo and an active control. This is a remarkable finding and will generate enormous enthusiasm in the field, if it can be replicated and its implications for psychosocial function demonstrated."
As a result of funds received from the Office of Chief Scientist of the Ministry of Industry, Trade and Labor of the State of Israel, or the OCS, in respect to BioLineRx's preclinical and clinical program related to CYP-1020, the effectiveness of the license agreement is subject to the consent of the OCS and OCS may condition providing its consent on the parties' agreeing to modifications in the license agreement. Cypress and BioLineRx have agreed to work together to attempt to secure OCS approval on terms that minimize financial and non-financial obligations on the parties that may be imposed as a condition to receipt of the OCS consent. Cypress is not required to agree to any modifications to the license agreement that would have, or would be likely to have, a material adverse impact on its rights and obligations under the license agreement, and whether OCS provides its consent on terms acceptable to Cypress, and the timing of any such consent, cannot be estimated at this time. BioLineRx has agreed that it will assume sole responsibility for any financial obligations imposed by the OCS. In addition, the upfront payment was placed into an escrow account pending receipt of a satisfactory OCS consent and effectiveness of the license agreement.
CYP-1020 Phase 2b Trial Design
BioLineRx designed and conducted a six week, double blind, placebo and active-comparator (risperidone) controlled multisite phase 2b clinical trial. The phase 2b EAGLE (Effective Antipsychosis via GABA Level Enhancement) study was conducted under a U.S. Food and Drug Administration Investigational New Drug Application (IND) at 40 sites in the U.S., Europe and India and included patients suffering from acute exacerbation of schizophrenia. In this six week study, 363 patients were randomized equally to treatment with low (10 mg/day) or high (20-30mg/day) dose of CYP-1020, risperidone (2-8mg/day) or placebo.
The study was designed to demonstrate statistically significant superiority of CYP-1020 to placebo on the primary efficacy measure, the change from baseline in the total score of the Positive and Negative Symptoms of Schizophrenia (PANSS). Risperidone at a dose of 2-8 mg was included as a positive control to validate the trial results.
Cognitive function in the EAGLE trial was measured by the Brief Assessment of Cognition in Schizophrenia (BACS) neuropsychological battery. The BACS test battery assesses a variety of aspects of cognition, including: verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing, and executive functioning. All of these functions are significantly impaired in patients with schizophrenia(1).
CYP-1020 Phase 2b Data
Results of the phase 2b EAGLE study demonstrated that CYP-1020 at the 20-30mg dose range exhibited clinically relevant and statistically significant improvement on the cognition endpoint assessed using the BACS neuropsychological test battery. The 20-30mg dose range of CYP-1020 was superior to both risperidone and placebo at endpoint on the BACS total score (p=0.027 for both), with positive trends in all subsets within the BACS.
CYP-1020 was also effective as a treatment for the other symptoms of acute schizophrenia exacerbation, as measured by the Positive and Negative Symptom Scale (PANSS). The CYP-1020 high dose group (20-30mg/day) experienced a statistically significant reduction in the PANSS from baseline versus placebo (LS mean -23.6 vs. -14.4; p=0.002). The superiority of CYP-1020 (20-30mg/day) over placebo was also supported by additional secondary efficacy measures such as the clinical global impression of severity (CGI-S) and change (CGI-C).
The incidence of serious adverse events was low in the CYP-1020 (20-30mg/day) group (0%) compared to risperidone (3.3%) and placebo (6.5%). Discontinuations due to adverse events (AEs) were similar in the CYP-1020 (20-30mg/day) group and in the placebo group (4.3%) but higher in the risperidone group (8.8%). There were no statistically significant or clinically relevant metabolic related AEs including body weight gain, glucose increases, or changes in lipids. The incidence of cardiovascular, sexual, psychiatric, autonomic and gastrointestinal AEs was low and did not increase compared to placebo. There were no statistically significant or clinically relevant changes in subject electrocardiography (ECG), laboratory or vital signs (blood pressure, heart rate, temperature).
Recent results from an extension trial showed that patients receiving CYP-1020 (20-30mg/day) for six additional weeks maintained the improvements on the PANSS and CGI that had been observed after the initial six weeks of treatment and, more importantly, showed continuing improvement in cognitive function as assessed by the BACS. The 12 weeks of treatment were not associated with any increased toxicities.
About CYP-1020
CYP-1020 (formerly BL-1020) is a first-in-class GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. CYP-1020's dopamine antagonism reflects a well-established pathway to improve the psychotic symptoms of schizophrenia. Furthermore, both preclinical and clinical data suggest that CYP-1020's GABA enhancement may provide the basis for improved cognition
About Schizophrenia...snip
No coincidence. They are working on a way to milk carrots. Still couldn't find which ones are the females and where the heck their udders are :)
Perhaps BMY will try to file based on this trial alone although I think they know the FDA would probably want to wait for data from the ARISTOTLE trial.
Just curious, what makes you think that constructing cDNA sequence into a plant viral gene expression vector, then introducing the vector into agrobacteria, then infecting plants with the bacteria, then extracting the recombinant protein from plants tissue, is a more versatile technology than Protalix'?
Tasigna’s sales will rise of course but I think short term more on the expanse of Sprycel in 2nd line. Anyhow NVS has time to move Tasigna into 1st line before Gleevec goes off patent in 2015.
Lantus and association with an increased cancer risk - there were also a few posts here at the time #msg-39064911 and the editorial from this link http://webcast.easd.org/press/glargine/glargine.htm is a good read (the abs. you posted is in its ref.)
Gen-Probe has made a $50 million strategic investment in Pacific Biosciences, a private sequencing company. In addition, the companies will work together to explore co-development of new integrated clinical diagnostics systems based on Pacific Biosciences' Single Molecule Real Time (SMRT) platform and Gen-Probe's expertise in diagnostics.
http://www.biospace.com/news_story.aspx?StoryID=184632&full=1
I expect that Gleevec will remain the tyrosine kinase inhibitor of choicee in first-line CML until data from Tasigna and or Sprycel will show superiority in OS.