Key Developments: Bayer AG (BAYRY.PK)
112.75USD
18 Jun 2013
$1.35 (+1.21%)
$111.40
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Latest Key Developments (Source: Significant Developments)
Regeneron Pharmaceuticals Inc And Bayer AG's Bayer HealthCare Reports Positive Phase 3 Results For EYLEA (aflibercept) Injection In Myopic Choroidal Neovascularization (mCNV)
Regeneron Pharmaceuticals Inc and Bayer HealthCare announced positive top-line results for EYLEA (aflibercept) Injection from the Phase 3 MYRROR study in myopic choroidal neovascularization (mCNV). In this trial, patients receiving EYLEA at an initial dose of 2 milligrams (mg), followed by treatment on an as-needed (PRN) basis, had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, compared to a loss of 2.0 letters in patients receiving sham injections (p <0.0001). The common adverse events observed in the MYRROR trial that occurred with a frequency of 2% or more were conjunctival hemorrhage, dry eye, eye pain, headache and nasopharyngitis. Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of EYLEA, except for Japan where Regeneron will receive a royalty on net sales. Full Article
Bayer AG's Subsidiary Acquires Majority Interest In Conceptus, Inc For USD1.1 Billion
Bayer AG announced that the Bayer Group has successfully completed tender offer for the outstanding shares of Conceptus, Inc., Mountain View, California. As of the expiration of the offer period last night, 31,983,536 shares were validly tendered and not withdrawn in the tender offer, representing approximately 96.4% of the currently outstanding shares - including 2,198,177 shares delivered through notices of guaranteed delivery, representing approximately 6.6% of the currently outstanding shares. Bayer has accepted for payment all shares validly tendered into and not withdrawn from the tender offer and will promptly make payment for such shares. As a result of the purchase of shares in the tender offer, a merger between Conceptus and a Bayer subsidiary is planned to be effected imminently, giving Bayer full ownership of Conceptus. The total value of the transaction amounts to approximately USD1.1 billion (equivalent to EUR852 million). Full Article
Bayer AG’s Bayer HealthCare Pharmaceuticals And Onyx Pharmaceuticals, Inc. Present Positive Phase III Data On Sorafenib
Bayer AG announced that its unit, Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced positive data from the Phase III DECISION trial investigating the use of sorafenib (Nexavar) tablets in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. Sorafenib extended progression-free survival (PFS) compared to placebo, which represents a 41% reduction in the risk of progression or death for patients who received sorafenib compared to placebo treated patients. Bayer AG plans to submit the Phase III DECISION data as the basis to apply for marketing authorization of sorafenib in the treatment of RAI-refractory differentiated thyroid cancer. Full Article
France Will Back Down Over Bayer AG's Acne Pill-Reuters
Reuters reported that France's health regulator said on May 30, 2013 it would comply with the European Commission if it ruled that Bayer AG's acne pill Diane 35 and its generic versions were safe to use in some cases. However, it added it would keep sales of the treatment on hold until then. Full Article
Antitrust Clearance Obtained For Bayer AG's Bayer HealthCare LLC Acquisition Of Conceptus Inc
Conceptus, Inc announced that the Antitrust clearance from the US Federal Trade Commission (FTC) was obtained with respect to Bayer's acquisition of Conceptus, Inc., Mountain View, California. The FTC raised no objection to the transaction within the relevant waiting period under US antitrust law, which expired yesterday. The antitrust clearance marks an important step toward Bayer's intended acquisition of Conceptus. The transaction remains conditioned upon a minimum tender of at least a majority of the outstanding shares of Conceptus. On May 7, 2013, Evelyn Acquisition Company, a subsidiary established by Bayer HealthCare LLC, Tarrytown, N.Y., for the purpose of the acquisition, commenced a cash tender offer for all the shares of Conceptus, Inc. at a price of US$31 per share. The total value of the transaction amounts to approximately US$1.1 billion (equivalent to EUR 852 million). The board of directors of Conceptus has unanimously recommended that its stockholders accept the offer, which expires on June 5, 2013 (one minute after 11:59 p.m., New York City time, on June 4, 2013), unless the tender offer is extended or earlier terminated by Bayer in accordance with the Merger Agreement. Following the acquisition, Bayer will be able to offer a complete range of short-term, long-term and permanent contraceptive choices for women. Full Article
Bayer AG’s Bayer HealthCare’s Xarelto Approved In EU For Secondary Prevention After Acute Coronary Syndrome
Bayer AG announced that Bayer HealthCare’s (the Company’s unit) oral anticoagulant Xarelto (rivaroxaban) has been approved by the European Commission for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome (ACS) in adult patients with elevated cardiac biomarkers at a dose of 2.5 mg twice-daily (BID) in combination with standard antiplatelet therapy. This approval makes rivaroxaban the only oral anticoagulant approved to protect patients with elevated cardiac biomarkers following an ACS event. Full Article
Bayer AG’s Bayer HealthCare Presents Positive Interim Results From Long-Term Extension Study PATENT-2 With Riociguat
Bayer AG’s Bayer HealthCare announced positive data from the interim analysis of the on-going PATENT-2 trial with riociguat, the openlabel long-term extension of the pivotal Phase III study PATENT-1, at the American Thoracic Society International Conference, Philadelphia, USA. The results support the positive data of the pivotal PATENT-1 trial, showing long-term safety and sustained clinical benefits in patients with pulmonary arterial hypertension (PAH). Full Article
Bayer AG Asks Japan to Approve Riociguat For Pulmonary Hypertension-DJ
Dow Jones reported that Bayer AG has filed its Riociguat drug for the treatment of chronic thromboembolic pulmonary hypertension for regulatory approval in Japan. The Company submitted Riociguat in early February 2013 for regulatory approval in the United States and the European Union. Full Article
Bayer AG To Acquire Herbal Medicine Maker Steigerwald Arzneimittelwerk GmbH-Reuters
Reuters reported that Bayer AG said it agreed to buy privately held Steigerwald Arzneimittelwerk GmbH (Steigerwald), a maker of herbal treatments. The Company added that Steigerwald generated sales of EUR 61.3 million (USD 78.8 million) in 2012 with 180 staff. It did not disclose financial terms of the takeover. Full Article
Bayer AG Gets FDA Approval For Advanced Prostate Cancer Drug; Bayer AG And Algeta ASA To Co-Promote Xofigo in United States-DJ
Dow Jones reported that Federal regulators approved a new drug from Bayer AG to treat certain types of advanced prostate cancer. The drug, which will be sold with the brand name Xofigo, is meant to treat prostate cancer that has spread to the bones, but not other organs, in men who have previously received separate therapy designed to lower testosterone. Testosterone is a hormone that can stimulate prostate cancer growth. The drug will cost USD 69,000 for a complete course of therapy, which would be six injections given at four-week intervals. Xofigo was initially under development by Algeta ASA. In 2009 Bayer AG entered into an agreement with Algeta ASA to get the drug to the marketplace. Bayer AG and Algeta ASA will co-promote Xofigo in the United States. Algeta ASA in a statement said the drug's production is underway and is expected to be available in a few weeks. Full Article
Europe shares dip as Chinese data hits miners
PARIS, June 10 - European stocks ended slightly lower on Monday as China's unexpectedly weak imports data prompted investors to dump cyclical miners and pick up defensive companies such as Deutsche Telekom and Bayer .
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