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News Breaks
May 19, 2014
16:10 EDTNVS, OPHTOphthotech, 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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August 3, 2015
08:56 EDTOPHTRegeneron price target raised to $630 from $559 at Leerink
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08:46 EDTOPHTOphthotech price target raised to $92 from $69 at Leerink
Leerink analyst Joseph Schwartz upped his price target for Ophthotech to $92 to reflect a higher pool of patients that may be targeted by the company's wet AMD treatment Fovista. The analyst expects 2016 to be the year that combination therapy is validated in wet AMD. Schwartz's base case model has estimated an 80% probability that Fovista succeeds in Phase III and is approved by the FDA, leading to peak U.S. sales of $1.5B in 2027. Ophthotech could be fairly valued up to $205 per share based on the strength of the data, the analyst writes. He keeps an Outperform rating on the stock.
July 29, 2015
05:28 EDTNVSNovartis announces equity stake in Mereo BioPharma Group
Novartis announced a swap of clinical assets for equity with Mereo BioPharma Group. The deal involves compounds in areas of unmet medical need including BPS-804, to improve bone density in brittle bone syndrome, an orphan disease; BCT-197 for acute exacerbations in COPD, and BGS-649 for obese men with hypogonadotrophic hypogonadism to normalize testosterone levels. Under the terms of the agreement, Novartis will have an equity stake in Mereo and will share in the success of the development of these compounds, including a share on milestones and royalties on future commercial sales.
July 24, 2015
10:56 EDTNVSNovartis announces FDA approval of Odomzo
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09:02 EDTNVSLigand says Revolade recommended by CHMP for EU approval for SAA
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07:17 EDTNVSNovartis combination therapy Tafinlar, Mekinist achieves regulatory milestones
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July 22, 2015
07:03 EDTNVSIgnyta names Bernard Parker as Chief Commercial Officer
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July 21, 2015
11:49 EDTNVSNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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07:05 EDTOPHTOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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05:20 EDTNVSNovartis backs FY15 revenue guidance of up mid-single digit
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05:17 EDTNVSNovartis reports Q2 core EPS $1.27, consensus $1.24
Reports Q2 revenue $12.7B, consensus $12.44B. Further strengthening of USD impacted sales by -11% and core operating income by -13%. Growth Products, an indicator of the rejuvenation of the portfolio, contributed 35% of continuing operations net sales in Q2, and were up 24%. In Pharmaceuticals, Growth Products contributed 44% of division net sales in the quarter, and sales for these products were up 38%.

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