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Alnylam Pharmaceuticals, Kyowa Hakko, Intradigm, SiRNAsense, Polyplus-Transfection, Invitrogen, Applied Biosystems, Millipore, Scripps Research Institute

Kyowa Hakko Licenses Alnylam RSV Drug Candidate for Asian Market
Alnylam Pharmaceuticals this week announced that it has formed an exclusive alliance with Japanese drug maker Kyowa Hakko Kogyo to develop and commercialize the RNAi shop’s phase II respiratory syncytial virus drug ALN-RSV01 in Japan and other Asian markets.
Under the terms of deal, Kyowa Hakko will pay Alnylam $15 million in an upfront cash payment and up to an additional $78 million in development and sales milestone payments. Should ALN-RSV01 be commercialized in Asia, Alnylam will receive double-digit royalties on product sales.
Alnylam noted that it will also work with Kyowa Hakko on the development of additional RNAi drugs against RSV, but that it retains the full rights to all products covered in the arrangement outside of Asia.
Additional terms were not disclosed.
Currently, ALN-RSV01 is being tested in a phase II trial of adult lung-transplant patients naturally infected with RSV (see RNAi News, 4/10/2008). Alnylam plans to begin a second phase II trial in a pediatric population later this year.

USPTO Allows Claims in RNAi Patent Application Licensed to Intradigm
Intradigm announced this week that the US Patent and Trademark Office has issued a notice of allowance for a patent application covering methods of enhancing the RNA silencing activity of an RNAi agent in a mammalian or plant cell and licensed exclusively to the company by the University of Massachusetts.
The patent application, No. 20050037988, claims “rules … for determining, for example, the degree of complementarity required between an RNAi-mediating agent and its target, i.e., whether mismatches are tolerated, the number of mismatches tolerated, the effect of the position of the mismatches, etc.,” according to its abstract. “Such rules are useful, in particular, in the design of improved RNAi-mediating agents [that] allow for more exact control of the efficacy of RNA silencing.”
“The USPTO’s allowance of these patent claims represents an important milestone for Intradigm as it will allow us to incorporate novel enhanced RNAi sequences into our proprietary RNAi delivery systems to create potent and efficacious therapeutics,” Mohammad Azab, president and CEO of Intradigm, said in a statement.

SiRNAsense to Use Polyplus Delivery System with Cancer Drug Candidate
Norwegian RNAi drug shop SiRNAsense said last week that it has signed a deal to use Polyplus-Transfection’s in vivo-jetPEI delivery system with its investigational siRNA-based therapy for melanoma.
“We have chosen the Polyplusdelivery system because we found it to be well suited for systemic delivery of our drug candidate against melanoma metastasis,” Hanne Mette Kristensen, CEO of SiRNAsense, said in a statement. “Following encouraging efficacy data in a mouse model of metastasis, we are now proceeding with preclinical studies in mice and primates to further develop our drug candidate using Polyplus’ delivery system.”
Financial terms of the arrangement were not disclosed.

Invitrogen to Acquire Applied Biosystems for $6.7B
Invitrogen and Applied Biosystems announced last week that Invitrogen will acquire all of the outstanding shares of ABI in a cash and stock deal valued at $6.7 billion.
The acquisition combines Invitrogen’s portfolio of reagents and low-cost instruments focused on the molecular and cell biology and protein research markets with ABI’s vast array of consumables and instruments for applications such as DNA sequencing, proteomics, RNAi, gene expression, and applied testing.
“There are some very compelling macrotrends that make this combination very attractive,” Invitrogen Chairman and CEO Greg Lucier, who will retain that position with the combined firm, said during a conference call last week. “It gives both of our companies access to high-growth markets, opening up opportunities for accelerated revenue growth.
“The promise of this combination is, when joined, we are the best positioned company in the industry to achieve reagent-instrumentation optimization across many of the key workflows in the laboratory,” he added.
The deal comes following a review conducted by Morgan Stanley that began last August, in which the bank was to give an opinion on a restructuring of ABI and its sister company Celera, both of which are traded as tracking stocks of parent firm Applera. That review led to a recent decision to split ABI and Celera, with the latter filing a registration statement to effect the change.
Applera Chairman and CEO Tony White said during the call that the split with Celera is proceeding, and ABI officials hope to get it done by the planned date of July 1. However, the split could be delayed depending on how quickly the SEC reviews and approves amended filings related to the split, said White.
He also noted that ABI had direct contact with other interested parties but narrowed its focus about five or six weeks ago to a merger with Invitrogen.
The deal would be the largest in the life sciences tools market since Thermo Electron bought Fisher Scientific for $10.6 billion in 2006. Similar to that deal, the combined operations of Invitrogen and ABI would create a nearly one-stop shop for life science research customers focused on end-to-end workflows.
“I think it is a very positive move for both entities,” Harry Glorikian, managing partner of Boston-based life sciences consulting firm Scientia Advisors, told GenomeWeb Daily News, an RNAi News sister publication.
“They essentially become somewhat of a category killer if they have the right combinations of technology and solutions,” he said. “There are, however, some very capable and nimble companies out there today that in niche markets” will remain competitive.
The combined company, which will retain the Applied Biosystems name but will be based at Invitrogen’s headquarters in Carlsbad, Calif., will have approximately $3.5 billion in revenue, of which roughly 70 percent will come from consumables and services.
“Invitrogen has capabilities — antibodies, beads, labels, enzymes, and assay development and kits assembly competencies — to significantly enhance AB’s product offerings and to leverage our systems capabilities to create new applied market systems,” ABI President and COO Mark Stevenson, who will maintain that title with the merged firm, said during the call. 
Lucier said that although the firm will carry the ABI name, the Invitrogen brand name will remain for the reagents it already sells. “It’s important that both brands be maintained,” he said.
The board of directors of the combined firm will include nine current Invitrogen board members and three ABI board members, though the firms did not disclose the names of those directors.
The merged entity will boast a sales and service force of approximately 3,000 employees and have customers in more than 100 countries. Lucier noted that the firm would spend more than $300 million annually on R&D, and employ over 1,000 scientists.
Following the first full year after close of the transaction, the firm expects to report mid-single digit organic revenue growth, and neutral to slightly accretive to earnings per share, said Invitrogen CFO David Hoffmeister, who will hold the same post with the combined company.
Under terms of the deal, ABI shareholders will receive $38 for each share they own in the form of Invitrogen stock and cash, with cash accounting for 45 percent of the split. The purchase price represents a 12 percent premium to ABI’s average closing price for the previous 30 trading days.
Invitrogen will pay for the transaction with cash on hand and roughly $2 million of new debt, Lucier said during the call. The debt is being financed by Banc of America, UBS Investment Bank, and Morgan Stanley.
The firms expect the transaction to close in the fall, pending regulatory and shareholder approval.
The break-up fee, should one of the parties pull out of the deal, is roughly $150 million, ABI officials said during the call.

Millipore Gives $150K to Scripps' Loring to Study miRNA-Induced Stem Cell Pluripotency
Millipore said this week that it has awarded Jeanne Loring, a prominent stem cell researcher at the Scripps Research Institute, a $150,000 grant to support her research in the area of microRNA-based induction of pluripotency in stem cells.
The award was made through the Millipore Foundation, a Millipore program that offers grants for K–12 science education, bioscience research, and local community support.
Millipore Chairman and CEO Martin Madaus made the award presentation this week at the BIO International Conference in San Diego.
Under the terms of the agreement, Millipore will provide Loring’s lab increments of $50,000 a year for three years with the option to renew the funding each year at its discretion, the company said.
According to Loring, the grant differs from traditional sponsored research in that she was allowed to choose the research topic, and there are no intellectual property or milestone obligations associated with the award.
“Even though it is for a particular project, there aren’t any strings attached,” Loring told Biotech Transfer Week, an RNAi News sister publication. “I see this more as a gift to promote the research, rather than a grant to do something for them, because there are no obligations.”
Loring added that “in both our minds, I think this is no-strings attached support for research in an area [Millipore] feels very strongly needs to be developed.”
In a statement, Madaus said that “through this grant, we are able to support innovative stem cell research projects that we believe may be the key to solving a number of human health issues.”
Specifically, Loring said that her proposed project would seek to discover a way to treat cells with miRNAs “that either directs them to differentiate in a particular way, or to induce pluripotency. A lot of people are interested in miRNAs for a lot of applications,” Loring said. “This is certainly one of them and Millipore is aware of it.”