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Ono - plans U.S. acquisitions
http://asia.nikkei.com/Business/Deals/Ono-Pharmaceutical-readies-heavy-dose-of-US-acquisitions
February 4, 2017 5:00 am JST
Ono Pharmaceutical readies heavy dose of US acquisitions
Japanese drugmaker could spend over $3bn in next five years
OSAKA -- Ono Pharmaceutical plans to spend 400 billion yen to 500 billion yen ($3.55 billion to $4.44 billion) on acquisitions in the U.S. over the next five years, President and CEO Gyo Sagara told The Nikkei on Friday.
The Osaka-based drugmaker continues to grow on the success of its Opdivo cancer medicine. The company previously has made no major acquisitions, but is changing its stance as part of a long-term strategy abroad. Ono Pharmaceutical is focusing on midsize drugmakers that can serve as a foothold into the U.S. market.
The American pharmaceutical market "has some negative aspects, but also has enough appeal to make up for that," Sagara said. "In addition to the cash we have on hand, we are considering taking out loans to fund the acquisitions."
U.S. President Donald Trump has discussed potentially lowering drug prices, but also has proposed shortening the approval process for new treatments. Ono considers local companies a key help in navigating the world's largest drug market.
Strong domestic demand for Opdivo has put Ono on track for a 110% boost in net profit for the fiscal year ending in March to a record 52.3 billion yen. The price of the drug will be slashed by half in Japan starting this month, and the company sees a big drop in sales next fiscal year.
But Japanese authorities are expected to clear Opdivo as a treatment for stomach cancer, the second-deadliest type in the country after lung cancer. Ono projects at least 10,000 patients will newly qualify to use the drug.
"This could make up for the drop in revenue, and, like when the drug became a treatment for lung cancer, become an opportunity for us to grow significantly," Sagara said.
AMGN/(ESPR) -
TRIL - 2017 milestones PR
http://trilliumtherapeutics.com/investors/news/Press-Release-Details/2017/Trillium-Therapeutics-Outlines-Anticipated-Activities-and-Milestones-for-2017/default.aspx
Feb 02, 2017
TRILLIUM THERAPEUTICS OUTLINES ANTICIPATED ACTIVITIES AND MILESTONES FOR 2017
Download this Press Release (PDF 260 KB)
Advancing the two ongoing clinical trials with TTI-621, an IgG1 SIRPaFc fusion protein targeting CD47; updated data anticipated in 2H/2017
Expanding the CD47 franchise with TTI-622, an IgG4 SIRPaFc fusion protein with IND submission planned by end of year; targeting combination therapies
Reporting preclinical data throughout the year at various international scientific conferences
Executing plans for small molecule pipeline and commencing IO discovery program
TORONTO, Feb. 2, 2017 – Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, today outlined its expected 2017 activities and milestones.
Phase 1 trials of TTI-621:
During the year, Trillium expects to make progress in the Phase 1b TTI-621-01 study (NCT02663518) of its anti-CD47 checkpoint inhibitor TTI-621 (SIRPaFc), which is designed to evaluate safety, pharmacokinetics and preliminary anti-tumor activity across a broad range of hematologic malignancies. One cohort of lymphoma patients is receiving TTI-621 in combination with rituximab, and the company will consider additional combination cohorts based on emerging preclinical data. Furthermore, given the good safety profile of the agent, further dose intensification is planned with the goal of achieving increased blockade of CD47.
In a second Phase 1 trial, TTI-621-02 (NCT02890368), patients with percutaneously accessible solid tumors are receiving intratumoral injections of TTI-621 with the goal of achieving a high level of localized CD47 blockade. The company expects to complete the dose escalation phase, and potentially begin an expansion phase in 2017. This trial provides a unique opportunity to closely characterize local anti-tumor immune responses and to assess the impact of TTI-621 treatment on the tumor microenvironment. Combination cohorts are also under consideration for this trial.
“We are aggressively advancing the TTI-621 clinical program through multiple efforts. After completing the phase 1a dose escalation trial in patients with lymphoma, where we observed preliminary evidence of anti-tumor activity at well-tolerated doses, we finished the year with robust enrollment in the 10-cohort expansion phase and recruitment continues to progress well. As our data mature, we intend to explore the addition of other cohorts to this trial. The TTI-621-02 solid tumor trial has enrolled its first patient and we expect this study to provide key scientific data for charting the course of our clinical development program, especially as it relates to combination therapies,” said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. “In TTI-621 we believe that we have a potent CD47-targeting agent, and we aim to identify cancers that depend upon the CD47 ‘do not eat’ signal to evade the immune system.”
Trillium intends to provide an update on both ongoing TTI-621 trials by year-end. There may be additional opportunities to report on individual cohorts in both trials throughout the year.
Expanding the CD47 Franchise with TTI-622:
In 2017, Trillium is also planning to advance its second SIRPaFc fusion protein, TTI-622, into clinical testing. TTI-622 contains an IgG4 Fc region and is thus anticipated to have a different pharmacologic profile and enable greater exposures in patients than TTI-621 (IgG1 Fc). Like TTI-621, TTI-622 does not bind erythrocytes, and the company believes that this property could give TTI-622 best-in-class status among IgG4-based CD47 blocking agents currently in development. The company plans to submit an IND by the end of 2017 and begin enrolling patients in early 2018, with the goal of rapidly advancing this agent into combination studies.
“With the introduction of TTI-622, we are specifically targeting opportunities for drug combinations that are complementary to TTI-621. Our two SIRPaFc fusion proteins allow us to block CD47 and achieve different levels of Fc receptor engagement on macrophages, which we believe represents a diversified approach to targeting the CD47 axis in the treatment of cancer,” said Dr. Bob Uger, Trillium’s Chief Scientific Officer. “CD47 is in its infancy as a therapeutic cancer target and we have chosen to apply a broad, science-driven investigative approach to maximize our chances of defining patient populations that will derive clinical benefit from TTI-621 or TTI-622 therapy.”
Additional Preclinical Data and Small Molecule Pipeline:
In 2017 Trillium intends to continue investigating SIRPaFc in relevant preclinical models, focusing on combination strategies and mechanism of action studies. The company expects to report data at the 2017 American Association for Cancer Research (AACR) annual meeting in Washington D.C., as well as at other international scientific conferences throughout the year.
The company is actively investigating the competitive advantages and positioning of its orally available small molecule bromodomain and EGFR inhibitor programs and expects to provide guidance on the next steps in the first half of 2017. In addition, Trillium recently launched a discovery program against an undisclosed immuno-oncology target using its proprietary fluorine-based chemistry platform.
Trillium’s cash balance at the end of 2016 was approximately $50 million. A major component of the company’s business strategy continues to be a focus on evaluating potential partnering opportunities across all programs, which may help fund future growth.
The company also announced that its ticker symbol on the Toronto Stock Exchange changed to “TRIL” effective Feb. 1, 2017.
SOBI/BIVV - new Elocta/Alprolix data at EAHAD
http://www.sobi.com/en/Investors--Media/News/RSS/?RSS=http://publish.ne.cision.com/Release/GetDetailInLegacyFormat/101A56A5CA016245
Sobi and Bioverativ to reveal new long-term safety and efficacy data of Elocta® and Alprolix® at EAHAD
2017-02-01
Swedish Orphan Biovitrum AB (publ) (Sobi™) and Bioverativ Inc. (NASDAQ: BIVVV) will present new haemophilia data at the 10th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), taking place in Paris, France, 1-3 February 2017. Nine abstracts from Sobi- and Bioverativ[1]-led studies have been accepted for presentation during EAHAD, reflecting the companies’ commitment to the haemophilia community.
The nine posters include data on the long-term safety and efficacy of the companies’ extended half-life therapies, Elocta® (efmoroctocog alfa), marketed as ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the United States, Japan and Canada, and Alprolix® (eftrenonacog alfa), in people of all ages with haemophilia A and B, respectively, providing an updated analysis of long-term data from the registration studies ASPIRE and B-YOND.
“Sobi and Bioverativ are committed to supporting the haemophilia community to better understand the potential of extended half-life factor treatments,” says Krassimir Mitchev, MD, PhD, vice president and medical therapeutic area head of Haemophilia at Sobi. “These data present how to individualise dosing and consumption in order to gain a comprehensive protection beyond prevention of bleeds.”
“These data provide additional insights for physicians and people living with haemophilia, and reinforce the well-characterised safety and efficacy profile for Elocta/ELOCTATE and Alprolix. These are the only haemophilia therapies utilizing Fc fusion technology, which uses the body’s natural pathway to prolong the time the therapy remains in the body,” said Maha Radhakrishnan, MD, senior vice president of medical at Bioverativ.
Elocta/ELOCTATE – Long-term safety and efficacy data across all age groups
Poster P023: Dosing Regimens Before and During Long-Term Treatment With Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Children With Severe Haemophilia A: An Updated Analysis of the ASPIRE Study
Poster P100: Dosing Regimens Before and During Long-Term Treatment With Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Adults and Adolescents With Severe Haemophilia A: An Updated Analysis of the ASPIRE Study
Alprolix – Long-term safety and efficacy data across all age groups
Poster P108: Individualised Prophylaxis in Children With Haemophilia B Treated Long Term With Recombinant Factor IX Fc Fusion Protein (rFIXFc): Updated Interim Results of the B-YOND Extension Study
Poster P094: Individualised Prophylaxis With Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Adults/Adolescents With Haemophilia B: Updated Interim Results of the B-YOND Extension Study
Poster P069: Long-Term Safety and Efficacy of Recombinant Factor IX Fc (rFIXFc) For Treatment of Severe Haemophilia B: European Subgroup Interim Analysis of the B-Yond Study
Poster P088: Impact of Adherence On Outcomes of Prophylactic Treatment in Severe Haemophilia Patients
Further the understanding of the potential with the haemophilia treatments
Poster P195: The Cost-Utility Analysis of ELOCTA® (Efmoroctocog Alfa) in the Swedish Setting
Poster P098: Utilisations and Costs of Bypass Therapies For the Management of Haemophilia A Patients With Inhibitors
Poster P086: Burden of Illness in Haemophilia Across the Life Course
Abstracts are available through the EAHAD 2017 web site, http://eahad2017.com/ .
SMMT - ridinilazole P3 plan
http://www.summitplc.com/wp-content/uploads/2017/02/2017_RNS_03-CDI-clinical-plan-outline-FINAL.pdf
SUMMIT OUTLINES PHASE 3 PROGRAMME FOR NOVEL CDI ANTIBIOTIC RIDINILAZOLE FOLLOWING FDA AND EMA REGULATORY MEETINGS
Oxford, UK, 1 February 2017 – Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection (‘CDI’), today outlines its Phase 3 programme for its novel antibiotic, ridinilazole, following recent regulatory meetings with the US Food and Drug Administration (‘FDA’) and European Medicines Agency (‘EMA’). With input from the FDA and EMA, Summit intends to design the Phase 3 clinical programme to evaluate superiority of ridinilazole over standard of care in the treatment of CDI. A positive Phase 3 result on superiority has the potential to support the commercial launch of ridinilazole as a differentiated therapy that can both treat initial CDI and reduce disease recurrence.
Mr Glyn Edwards, Chief Executive Officer of Summit commented: “The constructive end of Phase 2 meetings with the US and European regulators have enabled us to design a Phase 3 programme that focuses on evaluating ridinilazole’s superiority over standard of care. This is something we believe would help differentiate our novel class antibiotic from currently marketed CDI treatments and those in late-stage development. Superiority in the combined measure of treatment of initial infection and importantly, reduction in recurrence, could position ridinilazole for front-line treatment of CDI.”
Summit discussed its Phase 3 development programme with the FDA at an End of Phase 2 meeting and through a scientific advice process with EMA. With input from both agencies, the Phase 3 programme is expected to include two trials evaluating ridinilazole as compared to the standard of care, vancomycin, each of which would enrol approximately 700 patients with CDI with the primary endpoint being superiority in sustained clinical response (‘SCR’). Other planned endpoints will include health economic outcome measures. The Phase 3 trial designs are consistent with the successful proof of concept Phase 2 trial, CoDIFy, in which ridinilazole achieved statistical superiority over vancomycin in SCR. SCR is a combined endpoint that measures cure at the end of treatment and a lack of recurrence in the 30 days after treatment. FDA also confirmed that ridinilazole would be eligible for Priority Review based on its QIDP designation.
Mr Edwards continued: “As we continue to evaluate our options to maximise the value of ridinilazole, our stronger financial position following the DMD programme partnership with Sarepta Therapeutics, Inc. means Summit has more time to fully explore all options. These include potentially entering into a collaboration with a third party or securing meaningful non-dilutive funding from government and charitable organisations. In parallel, activities to prepare ridinilazole for Phase 3 trials continue with these anticipated to start in the first half of 2018.”
CALA/INCY CC notes -
CD47/TRIL -
Eisai/AD -
IONS -
RGNX -
Re: MOLN.SW
Looks like our last exchange on MOLN.SW was way back in 2014. Have you looked at this company at all since then? I would think the failures of the anti-PDGF drugs from REGN and OPHT for wet AMD are a net positive for MOLN as it presumably entrenches anti-VEGF alone as the gold standard for wet AMD for the foreseeable future. Recall that MOLN has an anti-VEGF now in P3 partnered with AGN that is set to read out in 2018 (goal is fewer injections than Eylea/Avastin/Lucentis with similar, or even possibly better, efficacy). Per AGN's recent JPM presentation (http://www.allergan.com/investors/events-presentations/events/allergan-plc-at-the-35th-annual-j-p-morgan-healthc ), they identified abicipar as one of six "stars" in P3. AGN also projects peak annual sales of $1.5B - $3B starting in 2020 (assuming both wet AMD and DME indications are successful).
I was looking at P3 trial design for abicipar. See: https://clinicaltrials.gov/ct2/show/NCT02462928?term=abicipar&rank=3 . In arm A, it looks like this design essentially mirrors that of Eylea in one injection every 4 weeks for first 3 months then once every other month thereafter. For arm B, this is presumably where they are trying to differentiate as this shows injection once every 4 weeks for first 2 months, then another injection in 2 months, then an injection every 3 months thereafter. Do you think, if successful (at least comparable efficacy) that this would differentiate abicipar enough from Eylea to make this a successful drug?
I know you like drugs where MoA is proven and anti-VEGF for wet AMD certainly fits the bill. Just a matter of if abicipar can distinguish itself from the comp. Market cap is currently about ~$400M and MOLN gets double-digit royalties from AGN if drug successful so doesn't strike me as expensive if you have belief in the drug.
FWIW, worth keeping an eye on the GT comp down the road. I know RGNX, ADVM, and AGTC all have pre-clinical programs targeting the space but obviously way behind and who knows how much those can differentiate down the road.
Re: HD landscape -
ADOC.PA - LLY terminates collaboration
BMY/(FPRX) -
Re: ADOC.PA
ADOC.PA is down about 40% in the last month on no obvious news that I can tell. Do you have any idea? I know the very big potential overhang is that LLY is weighing whether they want to advance ADOC.PA's ultra-rapid acting insulin into P3 or whether they will advance their own candidate in to P3. Has LLY given any guidance in the last month on this decision? I am wondering if this could be part of the huge recent decline for ADOC.PA.
FWIW, I view this situation as I did the prior situation involving GLPG and ABBV wherein ABBV ultimately chose to advance their own JAK1 into P3 at the expense of GLPG's JAK1 (#msg-117269306 ).
INFI -
INCY/MRK/IOmet/CALA -
OMER (prior P2 aHUS data) -
RARX/OMER -
RARX/OMER -
JAKs/alopecia -