Actelion Ltd., of Allschwil, Switzerland, said the European Union’s Committee for Proprietary Medicinal Products issued a positive opinion on Tracleer tablets, an orally active endothelin receptor antagonist for pulmonary arterial hypertension. The opinion is the result of a centralized EU-wide procedure and will now be considered by the European Commission, which is expected to issue its final decision in 90 to 120 days. The CPMP recommended the approval of Tracleer for PAH to improve exercise capacity and symptoms in patients with Grade III functional status. Efficacy has been shown in primary pulmonary hypertension and pulmonary arterial hypertension secondary to scleroderma, without significant interstitial pulmonary disease.
Amgen Inc., of Thousand Oaks, Calif., agreed to the sale of 30-year zero-coupon senior notes convertible into shares of Amgen common stock, with anticipated gross proceeds of $2.5 billion. Amgen disclosed the proposed sale Thursday and said Friday it agreed to the sale. Amgen expects to use proceeds to fund the purchase of approximately $650 million of its common stock and for general corporate purposes, including acquisitions, additional share repurchases, capital expenditures and working capital. The initial purchaser of the 30-year zero-coupon senior notes has a 13-day option to purchase an additional $321 million notes. Terms of the notes include a yield-to-maturity of 1.125 percent and an initial conversion premium of 40 percent, or about $80.62, based on Thursday’s closing price of $57.59. Holders may convert each of the notes into 8.8601 shares of Amgen common stock at any time on or before the maturity date. The notes are convertible into about 31 million common shares, or 35 million common if the overallotment option is exercised. The notes may not be redeemed by Amgen for five years but are redeemable at any time thereafter at accreted value. Or, holders may convert their notes called for redemption into common stock. Holders of the notes will have the option to require Amgen to purchase their notes at accreted value in years three, five, 10 and 15. Amgen may choose to pay the redemption purchase price in cash and/or common shares. Amgen’s stock (NASDAQ:AMGN) fell 4 cents Friday to close at $57.55.
Beyond Genomics Inc., of Waltham, Mass., formed a partnership with Micromass UK Ltd., of Manchester, UK, a subsidiary of Waters Corp., under which Micromass will supply its mass spectrometry technologies to Beyond Genomics for use in its Systems Biology drug discovery platform. Waters will make an equity investment in Beyond Genomics. Micromass will have the opportunity to license certain Beyond Genomics intellectual property. Also, Beyond Genomics may purchase Micromass products. Further financial details were not disclosed.
Calcigen Corp., of Bethlehem, Pa., said it is relocating and expanding its offices through a move to the Ben Franklin Technology Partners of Northeastern Pennsylvania Business Incubator in Bethlehem. Calcigen’s CEO said the company chose to relocate to the mountaintop incubator on the campus of Lehigh University because it liked the facility and the facility staff support for start-up companies. Calcigen is pursuing applications in the field of homeland defense, as well as therapeutics in osteoarthritis and drug delivery.
Devgen NV, of Ghent, Belgium, said it developed the first C. elegans genome-wide RNAi feeding library as a tool for high-throughput identification and validation of drug targets. The library will be used to suppress, individually or as subsets, the activity of each of the 19,000 genes in the C. elegans genome. The selective in vivo suppression of gene activity provides a tool for drug identification and functional validation.
Neurobiological Technologies Inc., of Richmond, Calif., said its partner, Merz Pharma KgaA, of Frankfurt, Germany, was granted approvable status from regulatory authorities in the European Union for memantine for Alzheimer’s disease. The president and CEO of NTI said the approvable status validates the safety and the efficacy of the drug.
Orchid BioSciences Inc., of Princeton, N.J., granted an option to Beckman Coulter Inc., of Fullerton, Calif., to license Orchid’s SNP-IT primer extension technology for molecular diagnostic SNP applications on multiple platforms. Beckman Coulter also obtained a license to make and sell certain analyte-specific reagents for use on the platforms. Beckman Coulter may obtain a nonexclusive license to develop and sell diagnostic kits and systems incorporating Orchid’s SNP-IT technology for performing DNA diagnostic tests on capillary electrophoresis systems, microarray plates and flow cytometers. Beckman has three years to exercise the option.
Pain Therapeutics Inc., of South San Francisco, said it adopted the name MorViva for its painkiller formerly known as PTI-555/501 and OxyTrex for its painkiller formerly known as PTI-801. Both products are in trials with patients suffering from moderate to severe pain, the company said.
Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., initiated a Phase IIb trial of the investigational drug methylnaltrexone (MNTX) for the reversal of narcotic-induced constipation, a debilitating problem for many patients treated with opioid pain medication. MNTX is designed to reverse the side effects of opioids without interfering with pain relief. The trial using subcutaneous doses of MNTX is being conducted with patients who are being treated with opioids and suffering from constipation.