Alnylam Establishes Human RSV Infection Model, Inks Research Deal with MIT
Alnylam Pharmaceuticals this week that it has been able to safely and reliably establish respiratory syncytial virus infections in the upper respiratory tract of adult volunteers, opening the door to begin a phase II safety and efficacy study of its RNAi-based RSV treatment in the second quarter.
The company also said this week that it has agreed to sponsor a five-year RNAi delivery research program at the Massachusetts Institute of Technology.
According to Alnylam, the RSV infections were established in the healthy volunteers in order to create a model in which to evaluate viral infectivity of RSV administered intranasally. A total of 36 patients were divided into five cohorts and were exposed to RSV in escalating doses.
The company said that 72 percent of the subjects were infected, and no significant adverse events were observed.
Alnylam said that its planned phase II study of its RSV treatment, called ALN-RSV01, will assess the safety and tolerability of the intranasally delivered drug compared with placebo in healthy adult volunteers experimentally inoculated with RSV. The trial is expected to enroll 90 subjects.
As for the research arrangement with MIT, Alnylam said that it would provide funding for approximately ten postdocs in the labs of Robert Langer and Daniel Anderson over five years.
The arrangement provides Alnylam with an exclusive option to license future RNAi technology resulting from the research sponsorship. The company said it has also broadened a license for the exclusive rights to use a so-called lipidoid delivery technology developed by the Langer lab for RNAi therapeutics.
Bristol-Myers, Isis to Develop Antisense-Based Drugs for Cardiovascular Disease
Bristol-Myers Squibb said this week that it has formed a collaboration with Isis Pharmaceuticals to discover, develop, and commercialize antisense-based therapeutics for the prevention and treatment of cardiovascular disease.
The partnership will focus on proprotein convertase subtilisin kexin 9, a protease that degrades the cell-surface receptor for low-density lipoprotein. Data have shown suppression of PCSK9 can significantly cut cholesterol levels.
Alnylam Pharmaceuticals recently announced that it had added a PCSK9 program to its pipeline of RNAi-based drug candidates (see RNAi News, 12/7/2006).
Bristol-Myers Squibb will pay Isis a $15 million upfront payment and will provide the antisense firm with at least $9 million in research funding over three years. Isis also stands to receive up to $168 million in milestones, plus royalties on product sales.
Bristol-Myers Squibb will also fund all activities under the partnership, although both firms would handle preclinical development, and will handle clinical, regulatory, and commercialization activities.
Additional terms were not disclosed.
Calando Delivery Tech Gets European Patent
Arrowhead Research said this week that a European patent has been issued on drug delivery technology licensed to its RNAi drugs subsidiary Calando Pharmaceuticals.
The patent, No. 1093469, is entitled “Linear Cyclodextrin Copolymers” and claims polymers containing repeating units of cyclodextrin molecules and various co-monomers, linked together in a linear chain, according to Arrowhead.
The patent was issued to the California Institute of Technology and has been exclusively licensed to Insert Therapeutics, another Arrowhead subsidiary. Insert licensed a portion of the intellectual property to Calando.
Nastech Q1 Loss Rises on Lower Revenues, Higher R&D Costs
Nastech Pharmaceuticals said this week that its first-quarter loss rose on lower revenues and increased research and development spending.
According to the company, its net loss climbed to $11.5 million, or $0.47 per share, from a year-ago net loss of $7.8 million, or $0.38 per share.
Revenues in the period dropped to $5 million from $6.7 million in the first quarter of 2006, while R&D costs edged up $1.1 million to $12.9 million. Nastech’s R&D expenses from the first quarter last year included a $4.1 million charge related to the company’s acquisition of the RNAi assets of Galenea (see RNAi News, 2/23/2006).
Nastech ended the first quarter of this year with about $81.4 million in cash, cash equivalents, and short-term investments.
Qiagen's Q1 Revenues up 18 Percent on Organic Growth and Asian Demand
Qiagen this week said first-quarter revenue rose 18 percent as R&D spending increased 13 percent and net income was up 13 percent.
Total revenues for the three months ended March 31, 2007, rose to $127.9 million from $108.7 million year over year.
Qiagen said that the strong sales were fuelled in part by an 11 percent increase in organic growth and a 2 percent contribution from acquisitions.
Sales of consumables made up 89 percent of the company's revenue for the quarter and added 15 percent of the growth. Instruments sales contributed 10 percent of total revenue and “other” revenue accounted for 1 percent.
The company saw a 48 percent increase in quarterly net sales to Asia, driven largely by demand in China, and by the company's expansion into Singapore and Korea.
R&D spending increased to $11.5 million from $10.2 million year over year.
The company said profit increased to $19.9 million from $17.6 million in the year-ago period.
Qiagen said it had around $386.1 million in cash and equivalents and $98.9 million in short-term investments as of March 31.
Bio-Rad Revenue Up 5 Percent, R&D Spending Hits Profit
Bio-Rad Laboratories last week said first-quarter revenues increased 5 percent as R&D spending rose 17 percent and profit fell 13 percent.
Total receipts for the three months ended March 31 increased to $322.5 million from $308.3 million year over year.
R&D spending rose to $32.8 million from $28.1 million year over year.
The company said first-quarter profit fell to $27 million from $31.2 million in the year-ago period.
Bio-Rad said it had around $230.3 million in cash, cash equivalents, and $241.4 million in short-term investments as of March 31.