Alnylam

Takeda and Alnylam - Billion-dollar deals

Maureen Martino — Wed, 23 Jul 2008 08:37:23 -0400

Who: Takeda
With: Alnylam
What: $1 billion licensing deal

Scoop: In May, Takeda continued its expansion in the U.S. with a $1 billion move into the RNAi field. In an alliance with RNAi powerhouse Alnylam, Takeda gained RNAi therapeutics in the fields of oncology and metabolic disease with the option to expand to additional therapeutic areas in the future. Alnylam landed $100 million in up-front cash and an additional $50 million in near-term technology transfer payments. Takeda can expand the partnership in the future to include additional fields, with a payment of $50 million to Alnylam for each additional field. Finally, Alnylam will receive $171 million in milestones, along with royalties, for each product developed as part of the deal.

Novartis extends $700M Alnylam pact

Maureen Martino — Wed, 16 Jul 2008 09:39:19 -0400

Novartis has extended its pact with Alnylam through October 2009. The deal, which is worth up to $700 million should the collaboration produce results, was first forged in 2005 and is focused on the development, and commercialization of RNAi therapeutics. As part of the extended alliance, Novartis will continue to fund Alnylam's research efforts. The company also retains rights to exercise a non-exclusive platform license from Alnylam in exchange for an undisclosed payment and future milestones and royalties. In addition, Novartis has the option to extend the collaboration for an additional one-year term through 2010. Finally, Novartis retains certain rights to purchase Alnylam equity up to 19.9 percent; current Novartis ownership is approximately 13.4 percent.

"Our efforts with Novartis have been very productive over the past three years, and we are delighted that Novartis has elected to extend our alliance for another year," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. Alnylam is one of the biggest names in the hot RNAi field.

- see the release on the deal

Alnylam inks another Japanese development pact

John Carroll — Thu, 19 Jun 2008 11:07:32 -0400

Cambridge, MA-based Alnylam Pharmaceuticals has signed on to a $93 million pact with Japan's Kyowa Hakko Kogyo to develop an Respiratory Syncytial Virus therapy for Asian markets. Alnylam gets $15 million of that up front with a lineup of $78 million in milestones. Alnylam will also get double-digit royalties from Kyowa Hakko based on the sales of ALN-RSV01 in Asia. The partnership also includes additional RSV-specific RNAi therapeutic compounds that comprise the ALN-RSV program. Alnylam retains all development and commercialization rights worldwide excluding Asia.

"This new collaboration is yet another example of Alnylam's commitment to work with leading biotechnology and pharmaceutical companies to advance RNAi therapeutics to patients on a global basis," said Alnylam CEO John Maraganore. This is Alnylam's second deal with a Japanese pharma company in a matter of weeks.

- see Alnylam's release
- read the report from the Boston Globe

Takeda gains RNAi tech with $1B Alnylam deal

Tue, 27 May 2008 06:59:58 -0400

Takeda's quest to expand in the U.S. market--and off-set expiring patents on big drugs--continues. The Japanese company announced today a $1 billion alliance with RNAi company Alnylam. The deal covers RNAi therapeutics in the fields of oncology and metabolic disease with the option to expand to additional therapeutic areas in the future. Alnylam gets $100 million in up-front and additional $50 million in near-term technology transfer payments. Takeda can expand the partnership in the future to include additional fields, with a payment of $50 million to Alnylam for each additional field. Finally, Alnylam will receive $171 million in milestones, along with royalties, for each product developed as part of the deal.

"We believe this alliance will accelerate our initiatives to establish the foundation for RNAi drug discovery supported by Alnylam's platform technologies and know-how. We expect that our product portfolio will be enhanced by the addition of RNAi therapeutics to our current small molecule and anti-body research platforms," said Takeda's president Yasuchika Hasegawa. Just two months ago Takeda forked over $8.8 billion dollars to buy Millennium Pharmaceuticals, bolstering its oncology pipeline.

- here's Takeda's release
- read the Wall Street Journal article for more

GSK tests the miRNA waters with $600M deal

Thu, 17 Apr 2008 06:59:58 -0400

Further solidifying RNA's "next big thing" status, GlaxoSmithKline and Regulus Therapeutics today announced a $600 million alliance to discover, develop and market microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Regulus is the offspring of two RNAi leaders, Isis and Alnylam. The companies teamed up September 2007 to form Regulus, which focuses on developing new drugs based on micro-RNA. MicroRNA is one of two types of RNAi found in all human cells and affects how genes are turned off and on (siRNA is the other).

GSK will have the option to license product candidates directed at four different microRNA targets for inflammatory disease. Regulus will receive $20 million in upfront payments from GSK, including a $15 million option fee and a $5 million note that will convert into Regulus stock. The company is also eligible for $144.5 million in milestones for each drug developed with GSK; in addition, the company could earn royalties on any marketed products stemming from the deal.

"When associated with an aberrant inflammatory response, microRNAs represent disease targets whose therapeutic modulation could revolutionize the way we treat immune diseases and provide benefits not readily achievable with today's medicines," said Kleanthis Xanthopoulos, CEO of Regulus. This isn't Glaxo's first foray into the RNA space. Back in December, the company signed another RNA deal with Santaris Pharma.

- see GSK's release

Related Articles:
RNAi leaders Isis, Alnylam form new company. Regulus report
A billion-dollar lesson in RNAi economics. RNAi report
Shares slip as developers see RNAi doubts. RNAi report

Shares slip as developers see RNAi doubts

Wed, 02 Apr 2008 07:59:55 -0400

Shares of Opko and Alnylam have slid since a new study published in late March concluded that experimental drugs developed with the hot new science of RNA interference may work by activating the human immune system rather than by silencing select genes. That conclusion, notes New York Times biotech writer Andrew Pollack, suggests that the entire field could be much less precise than previously imagined, with unexpected consequences for patients' health that could threaten a variety of clinical programs. For now, the companies involved say that they have data demonstrating that their drugs are safe and work as intended. There are at least five RNAi therapies in clinical development now consisting of short sequences of double-stranded RNA.

- check out the New York Times article

Related Articles:
Alnylam trial shows RNAi works in humans. Report
Alnylam's makes progress with RNAi program. Report
Is Alnylam Roche's 'second Genentech'? Report
OPKO acquires rights Phase III drug. Report

Alnylam trial shows RNAi works in humans

Fri, 29 Feb 2008 06:59:57 -0500

Alnylam is offering up the first signs that RNAi therapy may work in humans. In a small Phase II trial, Alnylam's ALN-RSV01 for respiratory syncytial virus showed statistically significant anti-viral efficacy. Subjects receiving ALN-RSV01 experienced a 38 percent reduction in infection rate, proving that the therapy was effective in humans. Gene silencing is one of the most promising new technologies in drug development and drug developers large and small are pouring money into researching its applications for various diseases

"With the positive results from GEMINI, we believe that Alnylam has demonstrated the first ever human proof of concept with an RNAi therapeutic," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "As such, these new data represent a key milestone and a major 'de-risking' event for the advancement of RNAi therapeutics, as well as important progress for our RSV program." Another Phase II trial of the drug is planned this year.

- see this Alnylam release
- read TheStreet report

Alnylam's makes progress with RNAi program

Fri, 08 Feb 2008 06:59:54 -0500

RNAi trailblazer Alnylam has published a paper in the journal Human Molecular Genetics that details RNAi's ability to silence a gene implicated in early onset torsion dystonia. Dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal posture. According to Dinah Sah, Ph.D., Senior Director of Research at Alnylam, the data demonstrates RNAi therapeutics can discriminate between a disease target of interest and a closely related gene, which could help treat genetic disorders.

"We are encouraged by these results, as well as results we have seen to date with our other neurological RNAi therapeutic programs, such as Huntington's disease, Parkinson's disease, and others," added Sah.

- read the release

Related Articles:
Alnylam gains on positive mid-stage RSV data. Report
Is Alnylam Roche's 'second Genentech'? Report
Roche harnesses Alnylam's RNAi tech in $1B deal. Report
RNAi leaders Isis, Alnylam form new company. Report

Alnylam gains on positive mid-stage RSV data

Wed, 23 Jan 2008 06:59:54 -0500

Shares of Alnylam surged this morning on the news that mid-stage data for its experimental respiratory drug demonstrated a positive response with statistically significant anti-viral activity. Researchers were testing ALN-RSV01 against respiratory syncytial virus, or RSV, the most common cause of bronchiolitis and pneumonia among infants and children under 1 year of age

"We are very pleased with the results of [the study] and look forward to advancing this program to its next stage of development, a Phase II study in naturally infected adult patients which we expect to initiate in the first half of this year," Chief Executive John Maraganore said.

- see this release for more

Related Articles:
Is Alnylam Roche's 'second Genentech'? Report
Roche harnesses Alnylam's RNAi tech in $1B deal. Report
RNAi leaders Isis, Alnylam form new company. Report

Alnylam, Merck dump RNAi deal

Wed, 19 Sep 2007 06:59:57 -0400

A little more than a year after revising their RNAi development deal to include $120 million in milestone payments, Alnylam says it is fundamentally in its best interests to terminate the pact with Merck. After they amended that deal last summer, Merck bought Sirna Therapeutics for $1.1 billion, which put Merck directly into the RNAi space. Alnylam has other partnerships still in the works with Novartis and Biogen Idec, and it recently formed a new company with Isis Pharmaceuticals to focus on developing new drugs based on micro-RNA. Investors and analysts alike were quick to applaud the move, sending Alnylam's shares up sharply.

- check out Alnylam's release on the decision
- read the report from MassHighTech

Related Articles:
Merck, Alnylam recalibrate development pact. Report
Roche harnesses Alnylam's RNAi tech in $1B deal. Report
RNAi leaders Isis, Alnylam form new company. Report
A billion-dollar lesson in RNAi economics. Report

DEALS: Isis, Alnylam form RNAi company

Thu, 13 Sep 2007 06:59:52 -0400

Isis, Alnylam form RNAi company

DEALS
WHO	WITH	WHAT	SCOOP
Alpharma	IDEA	$202 licensing deal	Alpharma has agreed to pay Germany's IDEA up to $202 million in upfront fees and milestones for the U.S. rights to the late-stage pain drug Diractin, a prescription topical NSAID.
Nabi Biopharmaceuticals	Biotest	$185M sale	Nabi Biopharmaceuticals plans to sell its biologics unit to Germany's Biotest for $185 million.
Boehringer Ingelheim	Ablynx	$103.5M partnership	Boehringer has signed a second agreement with Ablynx to develop and commercialize up to 10 different Nanobody therapeutics.
Medivation	Azimuth Opportunity	$100M stock deal	VC firm Azimuth Opportunity will purchase $100 million of Medivation's stock over the next 18 months as the drug developer pushes through a late-stage trial of an experimental Alzheimer's drug.
Meda	BioDelivery Sciences	$90M licensing deal	Meda will pay BioDelivery up to $90 million in exchange for a licensing deal covering the North American rights to BEMA Fentanyl, a new pain patch for cancer patients.
Ventana Medical Systems	Spring BioScience	$31M acquisition	Ventana Medical Systems has inked a deal to acquire Spring BioScience, which makes rabbit monoclonal antibodies and other reagents.
Isis Pharmaceuticals	Alnylam Pharmaceuticals	Company formation	Isis and Alnylam have teamed up to form Regulus Therapeutics, a company that will focus on developing new drugs based on micro-RNA.

RNAi leaders Isis, Alnylam form new company

Fri, 07 Sep 2007 06:59:58 -0400

Isis Pharmaceuticals and Alnylam Pharmaceuticals--two leaders in the hot field of RNA--have teamed up to form Regulus Therapeutics, a company that will focus on developing new drugs based on micro-RNA. Micro-RNA is one of two types of RNA interference found in all human cells and affects how genes are turned off and on. MiRNAs regulate whole networks of genes; therefore therapeutics based on this technology represent a new approach to target the pathways of disease, according to the companies.

Both companies will grant Regulus licenses to their IP for miRNA therapeutic applications, as well as certain early fundamental patents in the miRNA field. Alnylam will make an initial investment of $10 million to balance venture ownership; thereafter Isis and Alnylam will share funding of Regulus. Regulus will be operated as an independent company with an independent Board of Directors and management team, which will include Nobel laureate David Baltimore.

"The emerging biology of microRNAs points to a completely new understanding of cellular mechanisms for regulation of gene expression," noted Baltimore. "I believe that microRNAs represent previously unexplored disease targets where pharmacological approaches could lead to the emergence of novel therapies for many human disorders. "

- see this release for more

Related Articles:
A billion-dollar lesson in RNAi economics. Report
Isis gains from big RNAi deal. Report
Roche harnesses Alnylam's RNAi tech in $1B deal. Report

Is Alnylam Roche's 'second Genentech'?

Mon, 23 Jul 2007 06:59:58 -0400

The incoming CEO of Roche says he hopes that the company's partnership with Alnylam will create a "second Genentech" in the U.S. for the pharma giant. Alnylam opens up a "new front" in biotech, says Severin Schwan. Roche is paying $331 million up front to gain access to Alnylam's drug discovery technology. It's another sign of the steady convergence of biotech and pharma, with a product-hungry pharma world looking to biotechnology companies to supply the products of the future. It's also a key indicator of the thriving market for new deals.

- read the AFX report for more information

Relate Articles:
Roche shakes up R&D, eyes new buyouts. Report
Roche harnesses Alnylam's RNAi tech in $1B deal. Report
Genentech touts pipeline as doubts fester. Report

SPOTLIGHT: Isis gains from big RNAi deal

Tue, 10 Jul 2007 00:01:33 -0400

Alnylam wasn't the only biotech company to score on Wall Street after the announcement of its rich RNAi deal with Roche. Isis Pharmaceuticals stands to gain $26.6 million along with milestones and royalties in the deal, and investors bid up its stock price by 17 percent. Isis licensed its RNAi tech to Alnylam in 2004. Report

A billion-dollar lesson in RNAi economics

Mon, 09 Jul 2007 00:01:39 -0400

Roche's billion-dollar deal for gene-silencing technology (below) underscores once again what a hot commodity RNAi tech has become. And prices are rocketing up fast. Merck paid $1.1 billion to buy Sirna, leaving CytRx and Alnylam in an incredibly influential position to dictate prices. A nonexclusive deal like Roche's shows just how influential that position has become. The reason for all the positive attention, of course, is that gene silencing is shaping up as a game changer in healthcare. For an outside observer, the premiums in this field are looking stratospheric. But big bets in biotech can be rewarded with even bigger global markets. With a wide variety of diseases triggered by the activity of specific genes, a mechanism to turn them off is worth every bit of the Nobel Prize handed out for the basic research last year. Barring a significant stumble in R&D, look for new work in the field to grow aggressively. And don't expect the buy-in price to go down anytime soon. - John Carroll

Roche harnesses Alnylam's RNAi tech in $1B deal

Mon, 09 Jul 2007 00:01:38 -0400

Demonstrating once again the powerful pull of RNAi, Roche has agreed to pay $331 million up front--including an equity payment--and up to a billion dollars overall for the nonexclusive licensing rights to Alnylam's gene silencing technology. Roche winds up with a 5 percent stake in the company. It's a huge deal for Alnylam, which recorded about $27 million in revenue last year. Alnylam's stock soared 61.6 percent on the news. The package includes a $15 million payout to acquire Alnylam's German research center, which employs some 40 people.

"This technology has the potential of fundamentally treating disease in a new way," said Alnylam CEO John Maraganore. "That type of option, given the level and significance of human disease that is unsatisfactory today, that level of impact is profound."

- see the release on the deal
- here's the AP report
- and check out the Wall Street Journal's report (WSJ sub. req.)

Related Articles:
Calando inks RNAi pact with Alnylam. Report
Alnylam wins $23M biodefense contract. Report
Merck, Alnylam recalibrate development pact. Report
Collaboration gives Novartis gains 20% stake in Alnylam. Report
Sirna pushing RNAi field. Report

CytRx spins off RNAi assets into new company

Mon, 08 Jan 2007 19:01:38 -0500

CytRx has set up a subsidiary devoted to RNAi, or gene silencing, and gathered a stellar group of advisers for it that includes the Nobel Prize-winning Craig Mellow. Tod Woolf, the former CEO at Sequitir, will run the operation, dubbed RXi Pharmaceuticals. Other advisers are: Gregory J. Hannon, Tariq M. Rana and Michael P. Czech. CytRx will own 85 percent of the new company and the advisers will share 15 percent.

"The clinical potential of RNAi technology is garnering strong attention from the pharmaceutical industry, making the timing excellent to acquire these RNAi assets from CytRx," Woolf said in a statement.

- check out the press release
- here's the AP report on the new company

Related Articles:
Calando inks RNAi pact with Alnylam Report
Sirna posts positive data on RNAi therapy. Report

ALSO NOTED: Cancer vaccine market to soar; Point Therapeutics cuts staff; and much more...

Thu, 09 Nov 2006 19:01:30 -0500

> Analysts say that the cancer vaccine market will soar to $8 billion by 2012. Report

> Fledgling Point Therapeutics has cut its workforce by 15 percent, with most of the cuts focused on its preclinical development group. "In our ongoing efforts to further talabostat's clinical development, particularly our Phase III program, it became necessary for Point to undertake measures to reduce our costs," said CEO Don Kiepert. The company announced positive preclinical data on talabostat at the end of October. Release

> Australia's pSivida has inked a deal with an investment fund for $33.7 million in funds to advance its macular edema therapy. Report

> Dendreon is touting positive preliminary data from a new trial of Provenge that demonstrated its effect in boosting the immune response to fight prostate cancer. Almost half of the patients in the study benefited from the drug. Report

> The wrinkle treatment company Thermage raised $42 million in its IPO, significantly under its original expectations. Report

> Cambridge, MA-based Immunogen says its Phase I trial of its anticancer therapy huN901-DM1 shows it was well tolerated and produced evidence of efficacy that included a complete remission for one of the patients enrolled. Release

> Boehringer Ingelheim has received the FDA's approval to market Mirapex for restless leg syndrome. Mirapex has long been on the market as a therapy for Parkinson's symptoms. Release

> Alnylam has filed a shelf registration with the SEC to periodically sell up to $150 million in stock. Alnylam is focused on RNAi, a hot prospect in the biotech world. Report

And Finally… A new class of sirtuin activators are being pursued by biotechs who see big potential in the anti-aging therapies. Article

Senetek, Nastech strike deals for RNAi technology

Tue, 07 Nov 2006 19:01:34 -0500

Senetek has struck a deal to acquire RNAi technology for brain tumors from the Institute of Bioorganic Chemistry of the Polish Academy of Sciences. The deal includes the rights to three anti-aging compounds for skin. The brain tumor technology is designed to inhibit the production of tenascin-C, which is linked to malignancy. "This new technology works not only to prolong the survival of patients suffering from brain tumors, but possibly to cure them as well," said CEO Frank Massino. RNAi technology has turned red-hot in the wake of this year's Nobel Prize for the field's pioneers.

- check out the UPI report on Senetek

ALSO: Nastech struck a licensing deal with City of Hope for RNAi technology. Release

Related Articles:
Calando inks RNAi pact with Alnylam. Report
Sirna posts positive data on RNAi therapy. Report
Nastech to push ahead with obesity spray trial. Report

Acquisition deals in biotech keep getting richer

Wed, 01 Nov 2006 19:01:35 -0500

The post-deal analysis on Merck's acquisition of Sirna for $1.1 billion, which includes a hefty premium for stockholders, left analysts somewhat agog over the numbers. And with that kind of money on the table for RNAi technology--which holds huge promise but is still years away from commercialization--other players in the field like Alnylam and Nastech saw their stock prices surge. With licensing deals and acquisitions looking increasingly fat for biotech companies, the analysts are betting that the Sirna deal will push other big pharma companies into signing some rich deals for the independent players in the market. Of course, now that the pioneers of RNAi have won the Nobel Prize, it makes the whole field look like a smart play.

- read the BusinessWeek report on the latest buyout trends

ALSO: In an interview with MarketWatch, Schering-Plough CEO Fred Hassan called the recent amounts being paid in takeovers "breathtaking" and indicative of how hard it is to gain control of major new drug candidates. Report

Related Articles:
Calando inks RNAi pact with Alnylam Report
Sirna posts positive data on RNAi therapy. Report
SR Pharma inks $95M licensing pact. Report