Isis Pharmaceuticals

Genzyme and Isis - Billion-dollar deals

Maureen Martino — Wed, 23 Jul 2008 08:33:10 -0400

Who: Genzyme
With: Isis Pharmaceuticals
What: $1.9 billion deal

Scoop: Genzyme agreed to fork over up to $1.9 billion for rights to Isis Pharmaceutical's flagship program mipomersen, a cholesterol drug candidate. The company reportedly survived a bidding war for the drug that involved 10 companies. Mipomersen blocks a gene that opens the gate to cholesterol in the blood. It's now about to enter Phase III trials after posting some impressive data for lowering bad cholesterol.

Cholesterol drug delay signals new FDA standards

Mon, 28 Apr 2008 06:59:58 -0400

In what may signal a major shift in FDA standards, Isis and Genzyme say that they expect to add another year to the development timeline for a closely watched cholesterol therapy in order to produce data demonstrating a reduced risk of heart attacks and related diseases rather than just an ability to lower levels of cholesterol. Researchers for the two companies say they now plan to file for approval in 2010. Shares of both companies were hurt by the announcement, with Isis shares dropping 29 percent Friday.

Genzyme agreed to buy $150 million of Isis shares and provide $175 million in a large upfront fee last January. The two companies planned to file for approval of mipomersen as a therapy targeted against a rare genetic disease. The decision, though, could have a wide ranging impact on drug developers if the FDA will no longer approve a drug based simply on its ability to lower cholesterol. And that could be a direct result of the brouhaha over data showing that Vytorin--while effective in lowering cholesterol--was no better than a generic in preventing thickening of the arteries.

- see this Genzyme/Isis release
- read the story in the Wall Street Journal

ALSO NOTED: MAP touts IIa data; Isis pockets $2M milestone;and much more...

Tue, 08 Apr 2008 06:59:50 -0400

> A surge of hopeful research reports on the potential of stem cells has helped fatten profits at Cryo-Save. The company says its stem cell storage work jumped 41 percent last year. Demand is particularly strong in Spain and Hungary. Report

> MAP Pharmaceuticals says that a Phase IIa trial demonstrated positive results for MAP0005, a combination of budesonide, a corticosteroid, and formoterol, a long-acting beta2-agonist. Release

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OncoGenex, Isis report Phase II success

Fri, 15 Feb 2008 06:59:57 -0500

OncoGenex and collaborator Isis Pharmaceuticals say that in a Phase II trial, OGX-011, in combination with either docetaxel or mitoxantrone, was well-tolerated as a second-line treatment for patients with prostate cancer. In addition, the trials demonstrated ongoing survival rates better than results published with chemotherapy alone.

"These data show that the combination of OGX-011 with docetaxel or mitoxantrone may improve treatment outcomes in second-line prostate cancer," said Dr. Fred Saad, the primary investigator in the study. "The data also suggests that re-treatment with docetaxel when combined with OGX-011 may reverse chemotherapy resistance in second-line docetaxel re-treatment." The results were presented at the 2008 Genitourinary Cancers Symposium. Planning is underway for a Phase III study utilizing chemotherapy plus OGX-011 as second-line therapy in patients progressing after a first-line docetaxel regimen.

- see OncoGenex's release for more

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DEALS: Genzyme, Isis ink $1.9B pact

Thu, 17 Jan 2008 06:59:52 -0500

Genzyme, Isis ink $1.9B pact

DEALS
WHO	WITH	WHAT	SCOOP
Genzyme	Isis Pharmaceuticals	$1.9B deal	The deal is for Isis' promising cardiovascular drug mipomersen, its flagship product. Genzyme is paying $175 million in an upfront fee and will buy five percent of the company.
Merck	Addex Pharmaceuticals	$702M licensing deal	Merck is paying $22 million up front and up to $455 million more for regulatory, sales and development milestones for ADX63365, a schizophrenia drug candidate.
Pfizer	Scil Technology	$250M licensing deal	Pfizer gains worldwide to an experimental osteoarthritis therapy under development at Germany's Scil Technology. Scil has been developing a cartilage specific growth factor--CD-RAP--to regenerate tissue in degenerative joints.
WuXi PharmaTech	Apptec	$151M buyout	WuXi gains Apptec's biologics capabilities along with U.S. market presence.
Invitrogen	CellzDirect	$57M buyout	CellzDirect provides R&D operations hepatocyte-based cell products and other services used to test new drugs.
Pfizer	Taisho	$22M deal	Japan's Taisho has granted all commercial rights to its preclinical schizophrenia drug outside of Japan to Pfizer for $22 million up front.
Ipsen	Salk Institute	$10M	Over the next three to five years, Ipsen will pay Salk $10 million dollars to research three disease areas: cancer biology, degenerative diseases and maladies associated with metabolic syndrome.

Genzyme wins Isis pact with $1.9B bid

Tue, 08 Jan 2008 06:59:58 -0500

Shares of Isis Pharmaceuticals rocketed up 45 percent after the biotech announced that Genzyme had signed on as a partner to develop the promising cardiovascular drug mipomersen, its flagship product. Genzyme is paying a whopping $175 million in an upfront fee and will buy five percent of the company. Potential milestone payments could make the deal worth more than $1.9 billion. Genzyme survived a bidding war that involved 10 companies interested in mipomersen, according to Isis.

The drug blocks a gene that opens the gate to cholesterol in the blood. It's now about to enter Phase III trials after posting some impressive data for lowering bad cholesterol. Isis can now budget a maximum of $75 million in new discovery costs for the program with Genzyme shouldering the rest of the load. Genzyme, which has emerged as an aggressive biotech powerhouse, also gets "preferred access" to other Isis therapies in the future.

- see this release on the deal
- here's the article from The San Diego Union-Tribune

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ALSO NOTED: FDA panelist rails against lax enforcement; Micromet's CFO resigns;and much more...

Fri, 14 Dec 2007 06:59:50 -0500

> Remember that scathing report from the FDA's own Subcommittee on Science and Technology a couple of weeks ago? One of the Advisory Board members aired his opinion in a written report, and the DrugWonks blog has published it. Report

> Chutes & Ladders: Micromet's CFO Christopher Schnittker has resigned. Donald A. Zelm, Executive Director Finance, will assume the responsibilities as principal financial officer of the Company and as its interim chief financial officer. Release

> Chutes & Ladders: Isis Pharmaceuticals has promoted B. Lynne Parshall, J.D. to COO. Release

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> Little did Pfizer know what it was getting into when it signed an exclusive distribution deal with UniChem in the U.K. The U.S.-based drug maker thought the deal would help it better control supplies, reduce its wholesale discount, and build relationships with pharmacies. Report

> Novartis was hit with two safety-related jabs yesterday. First, the company warned healthcare professionals that its drug Exjade has caused liver failure in some patients. Also, drug watchdogs in the EU want to withdraw all drugs containing the Cox-2 inhibitor Lumiracoxib. Report

And Finally... An FDA advisory panel voted overwhelmingly against allowing Merck to sell its statin Mevacor without a prescription. Report

SPOTLIGHT: Regulus gets CEO

Tue, 04 Dec 2007 06:59:53 -0500

Alnylam Pharmaceuticals and Isis Pharmaceuticals have named Kleanthis G. Xanthopoulos as president and chief executive of their joint venture--Regulus Therapeutics. Xanthopoulos is the former CEO of Anadys. Release

ALSO NOTED: Antigenics releases positive cancer results; NovaBay raises $24M; Bionovo wraps stock offering; and much more...

Fri, 26 Oct 2007 06:59:50 -0400

> Antigenics says that a Phase I/II trial of cancer vaccine Oncophage delivered positive results, with 11 out of 12 patients exceeding median benchmarks on survival from time of recurrence. Researchers also said that all patients demonstrated an immune response. The company launched a Phase II trial of Oncophage earlier this month to evaluate overall survival in glioma patients. Report

> San Francisco-based Exelixis has announced positive Phase II data for XL647 for non-small cell lung cancer. The company also revealed interim Phase II data for XL880, a renal cell cancer drug. Release | Release

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> Isis Pharmaceuticals will receive $9.9 million from the non-profit CHDI to develop a therapy for Huntington's disease. Report

And Finally...Are you hearing messages in white noise? That could be an early sign of schizophrenia. Release

ALSO NOTED: Novartis cuts 1,260 jobs; Nektar hammered on Exubera decision; and much more...

Thu, 18 Oct 2007 06:59:50 -0400

> Slammed by weak sales last quarter, Novartis announced that it will lay off 1,260 in the U.S. and rearrange its management. Report

> Pfizer wasn't the only casualty in today's announcement that Exubera was being dropped after disappointing sales. Nektar, which garnered a 15 percent sales royalty on the drug, say its shares plunge on the news. Nektar gets the rights back. Report

> Isis Pharmaceuticals has added a new diabetes drug targeting the sodium dependent glucose transporter type 2 (SGLT2) to its development pipeline. Release

> An Indian state is planning a new biotech research center. Report

> Microban international is expanding with 45 new jobs. Report

> In yet another blow to the embattled diabetes drug Avandia, the Department of Veterans Affairs is severely restricting its use. Until now, the VA accounted for about 8 percent of Avandia sales. Report

> Amgen is playing hardball to protect its anemia drugs as Roche prepares to launch a competing product, Mircera, next month. Report

> In a sort of good news/bad news move, the FDA is allowing Merck to expand marketing of the diabetes drug Januvia--but it's also expanding the warnings on Januvia's label. Report

> Acclaimed Australian stem cell scientist Alan Trounson, who was recently appointed to head up California's $3 billion stem cell institute, has been questioned in an investigation related to "anomalies" in interim results presented for an aborted $1 million lung regeneration research project. Report

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More good news from RNAi company Isis

Fri, 05 Oct 2007 06:59:56 -0400

Isis has been on a good-news roll lately, and today is no exception. The company announced positive results from a Phase II open-label extension trial of of ISIS 301012, a cholesterol-lowering drug for with familial hypercholesterolemia. The study included 16 patients who had participated in an earlier Phase II study of the drug. These patients received weekly doses of ISIS 301012 for as long as six months and didn't experience any new or worsening adverse events.

"We are particularly pleased to have had such an uneventful experience with patients in the long-term study. Until now, the longest exposures to ISIS 301012 had been three months, and now to have patients dosed for a total of more than six months without any tolerability issues is quite reassuring," stated John J.P. Kastelein, M.D., Ph.D., a principal investigator for the studies. "Of course, we will all be eager to see more patients and longer exposure times to strengthen our confidence that ISIS 301012 could truly be a transformational new drug for the treatment of refractory high cholesterol."

- see the release from Isis for more

Related Articles:
Isis touts positive cholesterol data in LDL study. Report
RNAi leaders Isis, Alnylam form new company. Report
Isis acquires Symphony GenIsis. Report
Isis gains from big RNAi deal. Report
Mid-stage cholesterol data sends Isis stock soaring. Report

ALSO NOTED: Renovis' CEO steps down; Isis gains $5M milestone; and much more...

Tue, 02 Oct 2007 06:59:50 -0400

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> NicOx is touting the results of its collaboration with Spain's Ferrer Grupo International. In particular, the company is crowing about Phase I results for NCX 1022, a potential dermatology product. Release

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> Using mesenchymal stem cells taken from bone marrow, researchers at Massachusetts General Hospital have been able to spur the livers of rats to generate new tissue, raising the possibility that they can repair liver damage without resorting to a transplant. Report

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Isis acquires Symphony GenIsis

Fri, 28 Sep 2007 06:59:55 -0400

Isis Pharmaceuticals today announced its purchase of all of the equity of Symphony GenIsis at the pre-negotiated price of $120 million. The purchase was prompted by Isis's recently announced collaboration with J&J's Ortho-McNeil, in which the companies agreed to develop four antisense drugs. The collaboration includes licensing of two of the drugs previously held by Symphony GenIsis, ISIS 325568 and ISIS 377131, which target glucagon receptor and glucocorticoid receptor.

"We have been very satisfied with our Symphony GenIsis financing. It provided us with the capital to advance the two diabetes programs, and with the Symphony funding we have been able to assemble a full Phase 2 and supportive toxicology profile for ISIS 301012, upon which we are now basing our licensing discussions for that drug. Because all three of the programs appreciated in value so rapidly, we were able to purchase the Symphony GenIsis equity early in the four-year collaboration term, saving ourselves $75 million in additional capital."

- see the release from Isis for more

Related Articles:
Isis pockets $45M in pact with J&J subsidiary. Report
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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

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Isis pockets $45M in pact with J&J subsidiary

Thu, 13 Sep 2007 06:59:58 -0400

Isis Pharmaceuticals is pocketing an upfront payment of $45 million after forging a licensing and commercialization deal with Ortho-McNeil, a J&J company. The pact includes a potential payout of $230 million for the successful development of new diabetes drugs. Ortho-McNeil gets the worldwide rights to ISIS 325568 and ISIS 377131 while Isis gets a deep-pocket partner to fund additional research into therapies for metabolic disorders like diabetes and obesity. This is the kind of big payout that thrills biotech investors. Isis shares surged 11 percent in pre-market trading. Prior to closing the transaction, Isis said it plans to purchase the equity in Symphony GenIsis and reacquire the intellectual property related to the GCGR and GCCR programs as well as regain full ownership of ISIS 301012, the company's lipid-lowering drug targeting Apolipoprotein B-100.

"We look forward to working with Ortho-McNeil and J&JPRD to advance our glucagon receptor and glucocorticoid receptor drugs through the clinic and to develop additional drugs against other promising targets," said Lynne Parshall, J.D., Isis' CFO.

- see the release from Isis for more

Related Articles:
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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

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ALSO NOTED: Archemix and Isis to collaborate; WuXi PharmaTech sees successful IPO; FDA ruling soon on Wyeth drug; and much more

Thu, 09 Aug 2007 06:59:50 -0400

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> An FDA ruling is looming for Wyeth's schizophrenia drug bifeprunox. Report

> A team of investigators says a new trial of an experimental stroke drug has demonstrated no effect. Report

> Jordan's Hikma Pharmaceuticals is buying Alkan Pharma in Egypt for $60.5 million. Report

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SPOTLIGHT: New cancer data from Isis

Tue, 31 Jul 2007 06:59:53 -0400

OncoGenex Technologies and Isis Pharmaceuticals announced encouraging preliminary data from an ongoing Phase II clinical trial of OGX-011 in combination with second-line chemotherapy in patients with metastatic hormone refractory prostate cancer. All patients had progressive disease on or within six months of first-line docetaxel therapy. Patients receiving the combination of OGX-011 and re-treatment with docetaxel in the second-line setting are achieving longer survival, longer progression-free survival and more frequent prostate-specific antigen decreases than patients treated with OGX-011 in combination with mitoxantrone, a standard second-line chemotherapeutic agent. Release

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

C&L: Alexandre to leave NC Biotech Center

Tue, 23 Jan 2007 19:01:32 -0500

Saying she's ready for a break, Leslie Alexandre is stepping down as CEO of the North Carolina Biotechnology Center.

Trellis Bioscience has appointed Brian C. Cunningham as CEO.

NitroMed has named CFO Kenneth Bate as CEO, succeeding interim CEO Jerry Karabelas. The company also named James Ham CFO.

BioProcessors has appointed Jonathan Rennert as president and CEO.

Takeda Global Research & Development Center has named Mehmood Khan, M.D., president.

Mazal Plant Pharmaceuticals has appointed Stanley Fass as interim president and director.

Jeffrey M. Jonas, M.D. will join Isis Pharmaceuticals on February 1 as executive vice president.

Pharmasset has named M. Michelle Berrey, MD, as chief medical officer and William T. Symonds, PharmD as vice president, clinical pharmacology.

Synta Pharmaceuticals announced the following appointments: Art McMahon has been named vice president of human resources; Andrew Sonderfan has been appointed vice president, pre-clinical safety assessment and Rob Kloppenburg has joined the company as vice president, investor relations and corporate communications.

Kirk T. Williamson joined ViaCell as vice president of marketing.

Neuroptix announced that Evan Sherr has signed on as vice president, product management, and Vincent Valvo is the new vice president, engineering and product development.

Oncolytics Biotech has named Mary Ann Dillahunty as vice president, intellectual property.

OMRIX Biopharmaceuticals has appointed Kevin Rakin and Philippe Romagnoli as new members of the board of directors; promoted Mike Burshtine to executive vice president and CFO and Nissim Mashiach to executive vice president and COO.

CytoCore has added Dr. Stephen Raab to its medical advisory board.

Transgenomic has accepted Collin J. D'Silva's resignation as a member of the board of directors, including his position as chairman of the board and secretary of the company.

Carla A. Hills has been appointed to Gilead Science's board of directors, bringing the number of directors to 10.

Biomira announced that Eric E. Baker retired from the company's board of directors.

Senesco Technologies has named Jack van Hulst to the board.