Advent, Carlyle and KKR reportedly are among P-E firms, as well as sovereign wealth funds and pension funds, considering MaterialScience after Bayer said in September that it planned to spin off the division through a stock listing.
Market conditions for IPOs have weakened in recent weeks, forcing a number of companies to pull their listings and potentially heightening the attractiveness of a sale to P-E firms.
Privately-held Boehringer Ingelheim commences patient enrollment in a Phase 3 clinical trial evaluating the safety and efficacy of nintedanib in patients with colorectal cancer refractory to standard treatments. The double-blind randomized, placebo-controlled study will enroll more that 750 patients at 150 sites worldwide.
The FDA accepts and grants priority review of Roche unit Genentech's (OTCQX:RHHBY +0.1%) supplemental Biologics License Application (sBLA) of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy. The PDUFA date is February 6, 2015.
Lucentis is currently cleared for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
In Phase 1 and 2 studies, PER977 showed that it directly binds to heparin as well as circulating direct factor Xa- and IIa-inhibitors reversing their anticoagulant effect. PER977 does not bind to blood coagulation factors or other blood proteins. In healthy volunteers, it reverses anticoagulant activity after a single IV dose of 100 mg - 300 mg and does not require an extended infusion in order to maintain the reversal.
Under the terms of the agreement, Perosphere will seek FDA and EMA approval of PER977 to reverse anticoagulant activity of edoxaban and commercialize PER977 in the U.S. and EU. It retains full worldwide commercial rights to PER977. Perosphere will receive an upfront payment from Daiichi Sankyo as well as clinical development-related milestones. It plans to submit an NDA to the FDA by June 2015.
Plandai Biotechnology (OTCQB:PLPL -3%) plans to develop and test an all-natural product for erectile dysfunction (ED). The compound, called icariin, is an extract from the plant Epimedium, also called the horny goat weed. Icariin is a phosphodiesterase type 5 (PDE5) inhibitor similar to sildenafil, the active ingredient in Viagra.
The company has begun cultivating and cloning epimedium and expects to begin testing on a potential ED product in mid-2015. Icariin is less potent than sildenafil, but Plandai believes its extraction process will enhance epimedium's absorption and retention in the bloodstream to a sufficient degree that it will be a viable all-natural ED treatment alternative.
The Japanese Ministry of Health, Labour and Welfare approves the use of Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) injection for the treatment of choroidal neovascularization (myopic CNV).
Eylea is already approved for sale for neovascular age-related macular degeneration (wet AMD) and macular edema secondary to central vein occlusion (CRVO).
Eylea is marketed in Japan by Bayer Healthcare's (OTCPK:BAYRY) (OTCPK:BAYZF) Japanese subsidiary Bayer Yakuhin, Ltd.
Bayer could announce as soon as tomorrow a plan to shed the MaterialsScience unit, but the company reportedly has not decided what form the separation would ultimately take - an outright sale, IPO or spin off.
The unit, which makes polycarbonate, polyurethane and other polymers had sales last year of €11.2B ($14.4B), down 2.2% Y/Y, and analysts have valued it at ~€10B, but in terms of growth, the business has underperformed Bayer's prescription drug and other life sciences operations.
The European Commission approves Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) for the treatment of visual impairment caused by diabetic macular edema (DME). The new indication complements its current approvals for wet age-related macular degeneration (AMD) and macular edema following central retinal vein occulsion (CRVO).
Bayer HealthCare Pharmaceuticals (OTCPK:BAYRY -2.4%) (OTCPK:BAYZF -1.7%) and development partner Onyx Pharmaceuticals (AMGN -0.3%) report that the 537-patient Phase 3 clinical trial evaluating the safety and efficacy of Nexavar (sorafenib) plus capecitabine for the treatment of advanced breast cancer failed to achieve its primary endpoint of improving progression-free survival (PFS). Nexavar is currently approved in over 100 countries for other cancers.
The companies are evaluating Nexavar in a variety of different cancers. Bayer has exclusive marketing rights to the product ex. U.S. and Japan. They co-promote it in America and share profits globally.
Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. At the same time Bayer creates value through innovation, growth and improved earning power. <br /> <br />Bayer HealthCare AG researches, develops, manufactures and markets...More