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News Breaks
May 19, 2014
16:10 EDTOPHT, NVSOphthotech, Novartis enter into ex-U.S. licensing, commercialization agreement
Ophthotech (OPHT) announced that the company has entered into an ex-US licensing and commercialization agreement with Novartis Pharmaceuticals (NVS) focused on the treatment of wet age-related macular degeneration, or AMD. Under the agreement, Ophthotech grants Novartis exclusive rights to commercialize Ophthotech’s lead product candidate, Fovista, in markets outside the United States while Ophthotech retains sole rights to commercialize Fovista in the U.S. Potential payments to Ophthotech under the agreement could total over $1B in upfront and milestone payments, not including future royalties. Ophthotech will continue to lead the global Fovista Phase 3 wet AMD pivotal clinical program which is expected to have initial, topline data available in 2016. Ophthotech will continue its lead role in the potential registration of Fovista in the U.S., while Ophthotech and Novartis will collaborate to seek regulatory approvals outside the U.S. This collaboration continues the Fovista development strategy to remain agnostic with respect to the choice of the anti-VEGF agent administered in combination with Fovista. Separate injections of the anti-VEGF agent and Fovista would allow physicians to choose their preferred anti-VEGF agent for the combination therapy. The collaboration also provides for the potential development of a fixed combination delivery of a co-formulation of Fovista with a Novartis proprietary anti-VEGF product which would result in additional flexibility for physicians. Novartis will also seek to develop and commercialize alternative innovative delivery technologies such as a Fovista pre-filled syringe as part of this collaboration.
News For OPHT;NVS From The Last 14 Days
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October 21, 2014
07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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October 16, 2014
07:23 EDTOPHTIBF Conferences to hold a summit
Ophthalmology Innovation Summit is being held in Chicago on October 16.
October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
October 14, 2014
11:23 EDTNVSBIND Therapeutics and The Conference Forum hold a conference
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October 10, 2014
05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
October 8, 2014
11:05 EDTNVSLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses congestive heart failure and the prospects for LCZ696 in HF-PEF on an Analyst/Industry conference call to be held on October 9 at 3 pm.
07:19 EDTNVSCBI to hold a conference
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06:11 EDTNVSNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.

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