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Monday, Mar 310:20 AM
Monday, Mar 310:20 AM| 1 Comment
- Bayer (BAYRY) has filed for Japanese approval of Regeneron's (REGN) Eylea therapy for treating patients with diabetic macular edema, the companies have said. Bayer has the rights to sell Eyelea outside the U.S.
- The submission is based on Phase 3 clinical trials that proved a statistically significant improvement in best-corrected visual acuity from baseline at 52 weeks compared with laser photcoagulation.
- The companies didn't provide a timetable for marketing approval, although the process is usually slower than with the FDA in the U.S. (PR)
Friday, Feb 287:30 AM
Friday, Feb 287:30 AM| Comment!
- Bayer's (BAYRY) adjusted Q4 EBITDA fell 3.1% to €1.77B and missed expectations of €1.91B, dragged down by currency fluctuations and increased R&D expenses.
- Net profit climbed 24% to €455M, under forecasts of €626M.
- Sales increased 0.3% to €9.89B vs consensus of €9.97B, with revenue boosted by sales of new therapies and strong volumes at Bayer's CropScience segment.
- For 2014, Bayer is targeting sales of €41-42B and expects adjusted EBITDA to increase by a low- to mid-single-digit percentage; however, Bayer also expects forex pressures of around €450M.
- Bayer's most important treatments - Xarelto (blood thinner), Adempas (lung), Stivarga and Xofigo (cancer), and Eylea (eye) - generated sales of €1.52B in 2013.
- Bayer increased its combined peak annual sales forecast for the drugs to at least €7.5B from a prior outlook of €5.5B.
- Bayer believes that Xarelto and Eylea will reach peak revenues in 5-6 years. Bayer holds the license to sell Eylea, which is developed by Regeneron, outside the U.S. Shares are +0.6% in Frankfurt. (PR)
Monday, Feb 248:00 AM
Monday, Feb 248:00 AM| Comment!
- Bayer (BAYZF) is on course to acquire partner Algeta (ALGZF) after the German company received acceptance representing 92.17% of the Norwegian company's stock for its $2.9B bid.
- Bayer has also extended the acceptance deadline of the offer by two days to Wednesday and it expects to close the deal in Q1.
- The acquisition will give Bayer full control of Xofigo, a prostate-cancer treatment that the German drugs and chemicals firm has developed with Algeta since 2009.
- Bayer views Xofigo, which was launched in the U.S. last year, as one of its five most important new medicines. (PR)
Thursday, Feb 204:33 AM
Thursday, Feb 204:33 AM| 1 Comment
- Novartis (NVS) and Bayer (BAYRY) are among the suitors that are exploring an acquisition of Merck's (MRK) consumer-healthcare business, Reuters reports, adding that the unit could be worth $10-12B.
- Reckitt Benckiser (RBGPF) and Procter & Gamble (PG) are also among the companies to have held talks with Merck about a deal. However, GSK (GSK) is not interested.
- Novartis and Merck have considered swapping the latter's consumer-healthcare operations for Novartis' animal-health and human vaccines businesses, although such a deal is looking unlikely.
Wednesday, Feb 128:59 AM
Wednesday, Feb 128:59 AM| Comment!
- An FDA advisory committee has voted 16-9 that there is not enough evidence to assert that the anti-inflammatory painkiller Naproxen, which Bayer (BAYRY) sells as Aleve, is safer for the heart than rival drugs.
- The vote means that Bayer and other sellers of Naproxen won't have a marketing advantage over other painkillers such as Advil, Ibuprofen and Celebrex.
- The FDA had organized the meeting after epidemiologists who work at the agency said there was evidence to show that Naproxen is safer.
Monday, Feb 108:16 AM
Monday, Feb 108:16 AM| 1 Comment
- Regeneron's (REGN +3.15%) Eylea treatment improved vision and maintained that improvement over two years in a Phase III trial of patients with diabetic macular edema (DME).
- DME is a leading cause of blindness in younger and middle-aged adults; Eylea could potentially treat over 6M sufferers globally.
- Regeneron and partner Bayer (BAYRY) are waiting for U.S. and EU approval of Eylea to treat DME; the therapy has already been authorized for other indications, including wet age-related macular edema. (PR)
Tuesday, Feb 42:33 PM
Tuesday, Feb 42:33 PM| Comment!
- Novartis (NVS -0.7%) reportedly is drawing interest for its human vaccines unit as talks to swap its animal health business for assets from Merck (MRK +2.6%) slow down.
- While the vaccines unit was initially on the table with animal health as part of the possible trade for MRK’s over-the-counter drugs business, NVS may now sell the vaccines unit separately in a deal that could be valued at ~$1B.
- NVS and MRK are still talking but agreeing on valuation is proving difficult, so NVS has informally talked to Eli Lilly (LLY -0.1%) and Bayer (BAYRY, BAYZF) about the animal health business, according to the report.
Tuesday, Jan 149:45 AM
Tuesday, Jan 149:45 AM| Comment!
- The FDA expresses skepticism that Johnson & Johnson's (JNJ) anticoagulant Xarelto (rivaroxaban) is effective in cutting the risk of additional heart problems in heart-attack patients.
- J&J has recommended that Xarelto, which is already authorized for other uses, be administered in the 90 days after an attack.
- However, the FDA doesn't see the point. "Not only does the effect of rivaroxaban not appear to be greater earlier, but an effect in the first 90 days or so is not apparent at all," the agency says in a review.
- The FDA's comments come two days before an advisory panel is due to discuss whether to recommend Xarelto for this indication.
- Bayer (BAYRY) co-markets Xarelto.
Tuesday, Jan 147:40 AM
Tuesday, Jan 147:40 AM| Comment!
- Regeneron Pharmaceuticals (REGN) and Bayer (BAYZF) are deepening their relationship with a plan develop a new therapy for wet age-related macular degeneration.
- Bayer will make an upfront payment of $25.5M to Regeneron and up to $40M in options and milestone payments, and it will pay royalties on any product sales outside the U.S.
- Regeneron will retain 100% of U.S. profits.
- Human clinical studies are planned for early this year. (PR)
Thursday, Jan 21:54 PM
Thursday, Jan 21:54 PM| Comment!
- IQWiG, Germany's cost gatekeeper, struck a blow to Regeneron (REGN -0.5%) and Bayer's (BAYZF -4.1%) Eylea Thursday, saying it could not determine whether the drug is superior to Lucentis (NVS -2.1%) in treating macular edema.
- As Reuters notes, the institute's position "could affect the level of reimbursement by public insurers for Eylea in Germany."
Thursday, Dec 192013, 7:25 AM
Thursday, Dec 192013, 7:25 AM| Comment!
- Bayer (BAYZF) has increased its offer for partner Algeta (ALGZF) to $2.9B from an initial bid of $2.41B, with the proposal receiving support from the Norwegian company's board.
- The acquisition would give Bayer full control of Xofigo, a prostate-cancer treatment that the German drugs and chemicals firm has developed with Algeta since 2009.
- Bayer views Xofigo, which was launched in the U.S. this year, as one of its five most important new medicines. (PR)
Wednesday, Dec 182013, 7:46 AM
Tuesday, Dec 102013, 7:16 AM
Tuesday, Dec 102013, 7:16 AM| 1 Comment
- Novartis (NVS) is reportedly considering an attempt to swap its animal-health division with a business owned by Merck (MRK) or another company.
- The Swiss firm, which apparently has little use for the cash that a sale or IPO would bring, has its eye on Merck's over-the-counter drug business, although it's not clear whether the latter would be open to such an exchange.
- Novartis' animal-health unit has drawn interest from German drugmakers Boehringer Ingelheim and Bayer (OTCPK:BAYZF), and from Eli Lilly (LLY).
Tuesday, Dec 32013, 7:16 AM
Tuesday, Dec 32013, 7:16 AM| 1 Comment
- Novartis (NVS) has reportedly opened the books of its animal-health business to Bayer (BAYRY) and other potential suitors so that they can carry out their due diligence.
- Novartis' animal-health unit generates sales of $1.1B and that of Bayer $1.7B, so a combination would create the number three or four company in the sector. Zoetis is the industry leader.
Thursday, Nov 282013, 7:08 AM
Thursday, Nov 282013, 7:08 AM| Comment!
- Bayer (BAYZF) has filed a request in Japan to use Regeneron's (REGN) Eylea to treat Myopic Choroidal Neovascularization (myopic CNV), a common cause of blindness in the country.
- Eylea is already approved in Japan for macular edema following central retinal vein occlusion.
- Regeron is working with Bayer on non-U.S. sales of Eylea.
Tuesday, Nov 262013, 2:13 AM
Tuesday, Nov 262013, 2:13 AM| 2 Comments
- Bayer (BAYZF) has offered 14.76B Norwegian kroner ($2.41B) to acquire partner Algeta (ALGZF), with the bid of 336 kroner a share representing a 27% premium to the latter's last closing price.
- Earlier this month, Bayer and Algeta received EU marketing approval for prostate-cancer treatment Xofigo. (PR)