Celgene

Celgene terminates MethylGene licensing deal

John Carroll — Mon, 27 Oct 2008 11:42:41 -0400

MethylGene announced that Celgene has terminated their licensing agreement for oncology histone deacetylase inhibitors, including MGCD0103. As a result, MethylGene will reacquire the rights to these programs. Furthermore, the company announced that it will implement a strategic initiative to focus its resources on the clinical development of its proprietary pipeline. MethylGene release

FDA puts partial clinical hold on MethylGene program

John Carroll — Mon, 18 Aug 2008 12:14:34 -0400

Canada's MethylGene says that as a result of its voluntary decision to halt enrollment in a new drug study, the FDA has put a partial clinical hold on its lead development program in cancer. The agency says it is waiting to see data and a risk mitigation plan to protect volunteers in the study. MGCD0103 is partnered with Celgene as a therapy for solid tumors and hematological malignancies.

"Under the partial clinical hold, patients currently enrolled in MGCD0103 clinical trials who are confirmed to have no signs or symptoms of pericarditis or pericardial effusion may continue in their respective studies," the company stated in a release. "MethylGene and Celgene are working closely together with the FDA to complete this package and communicate it with the FDA to obtain approval to commence enrollment of new patients as soon as possible."

- read the press release
- check out the report on the Canadian Press

Celgene drops development deal with GPC

Maureen Martino — Wed, 06 Aug 2008 21:48:32 -0400

In another blow to GPC, Celgene has decided to drop out of its co-development and licensing pact for the cancer drug satraplatin. Celgene is returning rights to the drug in Europe, Turkey, the Middle East, Australia and New Zealand. GCP has been on the ropes since satraplatin failed to help prostate cancer patients live longer in a critical late-stage trial. Since then the drug developer has cut staff and is on the hunt for an M&A partner.

GPC CEO Bernd R. Seizinger said, "We are disappointed, but we understand Celgene's decision given their recent withdrawal of the Marketing Authorization Application for satraplatin in Europe. We plan to decide in the near future the next steps regarding the development of satraplatin, and we will continue to focus our other efforts on advancing our RGB-286638 kinase inhibitor into the clinic and exploring various merger and acquisition opportunities."

- here's the GPC release

Acceleron doubles space, hires workers

Maureen Martino — Tue, 17 Jun 2008 02:20:58 -0400

Acceleron Pharma announced plans to increase its headcount by 40 percent and double the size of its administrative, laboratory and manufacturing facilities in Cambridge, MA. "The new space is expected to house the company's second manufacturing facility for Growth and Differentiation Factors-related proteins," notes the Boston Business Journal. The company expects to begin Phase II studies with ACE-011 later this year and also plans to bring its second and third programs into the clinic by the end of 2008. These programs include the ACE-031 program for increasing skeletal muscle mass and strength and the ACE-041 program, which blocks the vessel maturation process.

Acceleron has gained notoriety for its work on therapies that regulate body tissues and systems. Researchers at the company often show a picture of the Belgian blue, a white bull with enormous muscles. The company believes the same kind of genetics at work in the Belgian blue would help repair the harsh physical damage of certain diseases. Back in February Celgene inked a $1.9 billion deal with Acceleron to develop three programs.

- check out the Acceleron release
- see the Boston Business Journal article

Celgene CEO outlines future plans, post-Pharmion buyout

Fri, 14 Mar 2008 07:59:56 -0400

In an interview with the Star-Ledger, Celgene CEO Sol Barer laid out some of the basics in how it will integrate operations with Pharmion, a biotech Celgene paid $2.9 billion for. After some consolidation, he says, the combined company will have operations around the globe. And while he expects some new collaboration deals with other developers, don't look for anything too big in the near term.

"A lot of these (deals) are driven by specific opportunities that often are difficult to predict," says Barer. "There will be a period of time subsequent to the Pharmion acquisition where a lot of integration will go on. While that will not affect the smaller deals, it probably will affect the larger collaborations, which would be a lower priority while we're integrating the new company."

- check out the Q&A from the Star-Ledger

Celgene commits $1.9B to Acceleron

Wed, 20 Feb 2008 06:59:57 -0500

Celgene has agreed to option three development programs at Acceleron and collaborate on the development of its lead bone formation protein in two deals that could be worth upwards of $1.9 billion. Celgene is paying Acceleron $50 million up front and a $5 million equity payment and up to $510 million in milestones for ACE-011--which is in an early-stage trial. On top of that, Celgene will take a minimum $7 million equity stake in Acceleron if it goes public. And there's an additional $1.3 billion in payments for the options on discovery stage programs targeting cancer and cancer-related bone loss. A mid-stage trial of ACE-011 is expected to get underway later this year.

"This collaboration is an excellent strategic fit for Acceleron and the ACE-011 program. Celgene is one of the most successful biotech companies in the world and is the leader in the field of blood cancers, including multiple myeloma, an indication where ACE-011 has great potential," said John Knopf, Ph.D., CEO of Acceleron. Knopf signaled an approaching deal to FierceBiotech last fall, saying it expected to get a collaboration agreement inked in the first quarter. The biotech company delivered right on schedule.

- check out this release on the deal
- read the report from MassHighTech

Related Articles:
Celgene goes global with $2.9B Pharmion buyout. Report
Revlimid fuels Celgene sales rocket. Report
The race is on for muscle-enhancing therapies. Report
Acceleron takes a lesson from the giant Belgian blue. Report
Acceleron garners $30M in venture capital. Report

Celgene touts mid-stage psoriasis results

Tue, 05 Feb 2008 06:59:56 -0500

Researchers for Celgene are changing the dosing and duration of their tests of an experimental psoriasis drug after seeing a significant reduction in severity and symptoms in a mid-stage study. A 260-patient study of CC-10004 demonstrated that 24.4 percent of patients treated with 20 milligrams of CC-10004 every 12 hours had a 75 percent or greater reduction in psoriasis severity and symptoms. A placebo registered a 10.3 percent reduction. Patients can now get doses of 30 mgs for up to six months and Celgene will expand the trial to include related conditions. No serious side effects were reported.

- see this release
- check out the AFX report

Related Articles:
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A race to the finish for blockbuster blood thinners

Mon, 10 Dec 2007 06:59:55 -0500

Several big developers will take the stage at the American Society of Hematology meeting to provide updates on a string of new blood thinners that are in the clinic. Johnson & Johnson, Bristol-Myers Squibb and Pfizer, Eli Lilly, Boehringer Ingelheim and Portola are all testing drugs that may claim a portion of the multibillion-dollar market for blood thinners, according to the Wall Street Journal. Atrial fibrillation is the biggest clinical target with the most money at stake, say analysts. Developers want to provide an alternative to warfarin, a drug with a history of serious side effects that limit its use to about half of all prospective patients.

- read the article from The Wall Street Journal

ALSO: Shares of Germany's Bayer rose on data for its blood thinner. Release

PLUS: Seattle Genetics revealed positive, early-stage data for SGN-33, an experimental therapy for AML. Release

AND: Shares of Celgene plunged 15 percent on disappointing Revlimid data. Report

Related Articles:
Pfizer partners with BMS in $1B deal. Report

ALSO NOTED: BMS hands back drug rights; OncoMethylome in deal with GSK; Celgene shares take a bounce; and much more...

Mon, 26 Nov 2007 06:59:50 -0500

> Bristol-Myers Squibb has returned the rights to vinflunine to Pierre Fabre. The therapy was studied as a treatment for bladder cancer. Release

> Belgium's OncoMethylome Sciences has forged a pact with GlaxoSmithKline to develop DNA methylation biomarkers for use in developing personalized cancer therapies. Release

> Shares of Celgene got a bounce this morning after a Banc of America analyst give a thumb's up to the company's expanded line-up of cancer therapies with its acquisition of Pharmion. Katherine Kim concludes that Revlimid can earn $3.5 billion a year. Report

> Sanofi Pasteur says it's spending about $104 million on a Chinese manufacturing plant in hopes of launching flu shots locally by 2012. Report

> A new regulatory report gives us a peek at the recall of Roche's HIV remedy Viracept--and it's not a pretty picture. Report

> The FDA also plans to review Roche's Tamiflu and GlaxoSmithKline's Relenza at its advisory committee confab Nov. 27-28. At issue: the anti-influenza drugs' potential neurological side effects in kids. Report

The FDA is taking a second look at the safety of three asthma drugs used in kids: GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil. Report

> QRxPharma has begun treating patients as part of the Phase III development program for its lead product candidate Q8003IR, an immediate release dual-opioid pain therapy. Release

> An M.D. and former speaker-on-behalf-of-a-drug tells his story in the New York Times Magazine, and it's an illuminating, behind-the-scenes look at how Dr. Daniel Carlat (photo) became Dr. Drug Rep.

And Finally… In a major study, transcranial magnetic stimulation proved effective in treating major depression. Report

ALSO NOTED: ESC companies unimpressed by latest advance; Delcath shares surge in trial resumption; Pharmion CEO ready to start

Wed, 21 Nov 2007 06:59:50 -0500

> News that scientists had found a way to program skin cells to act like embryonic stem cells has failed to shake the clinical trial plans of the leading developers in the field. Report

> Shares of Delcath Systems surged on the news that the FDA approved resumption of clinical trials of its perfusion delivery technology. Report

> At 44, Pharmion co-founder and CEO Pat Mahaffy says he plans to start a new biotech company after Celgene completes its buyout. Report

> Exelixis has sold an 80 percent stake in Artemis Pharmaceuticals to Taconic Farms for $20 million. Artemis develops and markets genetically engineered mouse models and engineered mouse embryonic stem cells as genetic model systems for use in drug discovery or academic research. Report

> Cerus is spinning off its immunotherapy business. Report

> The FDA has extended its action date on Spectrum Pharmaceuticals' ISO-Vorin or levofolinic acid or LFA for injection NDA by 60 days. Report

And Finally… There's new evidence that the best way to stay mentally tough is to give your brain a regular workout. Release

Celgene goes global with $2.9B Pharmion buyout

Mon, 19 Nov 2007 06:59:58 -0500

Celgene took a big stride toward its goal of becoming a global marketer of blood cancer therapies with the news over the weekend that it is buying Pharmion for $2.9 billion. That buyout amount is 11 times Pharmion's annual revenue and a 46 percent premium for its shares. Pharmion sells Vidaza and Thalomid and has extensive operations in Europe, where Celgene has been particularly interested in expanding. Celgene owns Thalomid and sells the multiple myeloma drug in the U.S. Celgene's lead therapy is Revlimid. The buyout also covers a late-stage therapy for small-cell lung cancer and the mid-stage oncology drug MGCD0103.

"The rationale for the deal is fairly clear," says Celgene CEO Sol Barer. "It's another important step as we evolve to become what we want to become: a global leader in hematology and cancer." Celgene is the seventh largest biotech by sales volume. The deal is expected to close next summer.

- see this release
- read the report on the buyout from TheStreet.com
- and here's the article from Forbes

Related Articles:
Array partners with Celgene, nets $40M upfront. Report
Celgene accelerates program on positive psoriasis data. Report
Pharmion nets cancer therapy in Cabrellis buyout. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

SPOTLIGHT: Here comes the $100B barrier

Tue, 09 Oct 2007 06:59:53 -0400

A recent conference in Philadelphia included some bold projections for biotech as the industry approaches the $100 billion mark for collective revenue. That's up from $10 billion in 1998. Keith Brownlie from Ernst & Young also notes that we're well past the point where Amgen and Genentech dominated the biotech field. Other companies like Celgene and ImClone have made an impact and more biotechs are expected to join the ranks of the Big Leagues in coming years. Report

GlobeImmune lands $41M venture round

Wed, 26 Sep 2007 06:59:57 -0400

With its lead drug in Phase II for pancreatic cancer and a hepatitis C drug slated to forge into a mid-stage study later this year, GlobeImmune has rounded up $41.2 million in its third round of venture financing. That money came from a long list of new and existing investors, which includes Celgene, Boston Life Science Venture, Morgenthaler Ventures and Biogen Idec. Wexford Capital led the round. GlobeImmune has raised a total of $88 million in financing to date.

In an interview with FierceBiotech, GlobeImmune CEO Timothy C. Rodell M.D., noted that the financing would get the company to Phase II data on its two lead programs. By that stage, the company would have a chance to fully evaluate how it would like to push ahead, including potential partnerships or possibly an IPO. GlobeImmune is advancing therapies based on a proprietary platform that offers a new approach to triggering a potent T-cell response to infectious diseases and cancer. We'll have more on the company's plans--and platform--in our Friday profile on emerging biotech companies.

- check out this release on the round

Array partners with Celgene, nets $40M upfront

Mon, 24 Sep 2007 06:59:55 -0400

Tiny Array BioPharma has lined itself up with Celgene in a deal that delivers $40 million in exchange for the marketing rights to two of Array's experimental therapies. But that wasn't a big enough figure to impress analysts, who were looking for a richer deal. Array's stock slipped this morning after the pact was announced.

The way this deal will work, Array and Celgene will identify four products that Array will take through Phase I or Phase IIa. Celgene then gets to gain worldwide marketing rights to two therapies, with Array retaining limited co-promotion rights in the U.S. The deal includes milestone payments of up to $200 million for each therapy and up to $300 million for commercial milestones.

- see this release on the deal

Related Articles:
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Array, Genentech expand research pact Genentech. Report
Celgene accelerates program on positive psoriasis data. Report
Stock pickers like Big Biotech for '07. Report

PTC Therapeutics gains $20M on new tech pact

Thu, 13 Sep 2007 06:59:57 -0400

These are good times for PTC Therapeutics, one of this year's Fierce 15. Just after being profiled in Forbes, PTC's Stuart Peltz announced that Celgene is investing $20 million in the company in exchange for an option for an exclusive R&D deal related to two cancer targets. The deal provides Celgene with the use of PTC's GEMS technology to develop two small molecule drugs.

Peltz learned long ago how to leverage PTC's technology into lucrative partnership deals with other companies. This pact is another sign that PTC can continue to fund much of its own work by hiring out its technology, which is one reason why the company decided to drop a recent move to go public. Pfizer, CV Therapeutics and Schering-Plough have also inked technology pacts with PTC.

- see PTC's release on the deal

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Genetic therapy could cure 1,800 diseases. Report
Schering-Plough, PTC to collaborate. Report
PTC inks deal with CV. Report

Press Release: Cylene Pharmaceuticals Closes $44 Million Series C Financing

Maureen Martino — Tue, 23 Jan 2007 12:03:31 -0500

Cylene Pharmaceuticals Closes $44 Million Series C Financing

Financing Co-Led by HBM BioVentures and Lilly Ventures

SAN DIEGO, Jan. 23 -- Cylene Pharmaceuticals, Inc., a small molecule oncology drug discovery and development company, today announced the closing of a $44 million Series C financing, co-led by HBM BioVentures (Cayman) Ltd. and Lilly Ventures. The Company elected to have the financing commitment paid in two separate tranches, representing approximately 60% and 40% of these fund commitments. Proceeds from the financing will be used to fund human clinical trials for Phase II studies of CX-3543 in several different cancer indications and to advance two more products into development. CX-3543, Cylene's most advanced product for the treatment of multiple cancers, acts as a Ribosomal RNA Biogenesis Inhibitor (RBI) by targeting a Protein:DNA interaction that is amplified in cancer cells during Pol I transcription of the rRNA genes.

In addition to HBM BioVentures (Cayman) Ltd. and Lilly Ventures, other new and returning investors include: Sanderling Ventures, Novartis BioVenture Fund, BioVentures Investors, Research Corporation Technologies, Mitsui & Co. Venture Partners, and Celgene Corporation. Dr. Erich Platzer of HBM Partners (investment advisor to HBM BioVentures), S. Edward Torres of Lilly Ventures, and Reinhard J. Ambros, Ph.D. of Novartis BioVenture Fund have been elected to the Cylene Board of Directors. In addition, Walter Gilbert, Ph.D. and Deborah Widener were previously appointed as Directors. Dr. Gilbert was awarded the 1980 Nobel Prize in Chemistry for his discovery of a method for rapid DNA sequencing, he led a distinguished forty year academic career at Harvard University, and he co-founded and served as the CEO of Biogen. Dr. Gilbert has also served as a Managing Director of BioVentures Investors since 2001. Ms Widener, who earned an M.B.A. from Harvard Business School, has twenty-five years of expertise in financing strategies in both private and public markets. Previously, Ms Widener managed billions of dollars in leveraged investments as President of General Electric Capital Corp.'s Financial Service Group, and she served as an investment banking Managing Director of Robertson, Stephens & Co. and a Managing Director at Adams, Harkness.

"We are very pleased with the level of enthusiasm surrounding our lead compound and our proprietary Ribosomal RNA Biosynthesis Inhibition Technology," said Dr. William G. Rice, President and CEO of Cylene Pharmaceuticals. "This funding should enable us to complete multiple Phase II studies of CX-3543 and to expand our product pipeline with internally- discovered product candidates. Moreover, the financing unified a talented and cohesive Board of Directors that can provide insightful governance and help keep us on the path of success."

"Our firm seeks investments in innovative, clinical-stage companies that offer strong partnership potential with big pharmaceutical companies," said Dr. Erich Platzer, an investment advisor at HBM Partners and formerly Head of Strategic Marketing Oncology at Roche. "Cylene Pharmaceuticals certainly fits these parameters. Cylene's clinical development efforts are led by Dr. Daniel Von Hoff, and Cylene Pharmaceuticals leads the industry in directly targeting the ribosomal RNA biogenesis apparatus."

"Lilly Ventures invests in companies with promising technologies that have the capability of generating multiple product candidates," said S. Edward Torres, Lilly Ventures. "Cylene's RBI technology enables the design of drugs with potential anticancer activity across a broad range of tumor types via novel targets within validated anticancer pathways. These drugs could provide new valuable tools to cancer patients and their doctors."

"As Chairman of the Cylene Board of Directors and as an early investor, I am delighted to have the support and commitment of other top-tier venture capital funds in building a leading oncology company," said Fred A. Middleton, General Partner of Sanderling Ventures.

About Cylene Pharmaceuticals, Inc.

Cylene Pharmaceuticals is a biotech pharmaceutical company dedicated to the discovery, development and commercialization of targeted small-molecule drugs to treat life-threatening cancers. Using its proprietary Ribosomal RNA Biosynthesis Inhibition Technology (RABIT(TM)) to design molecules that combat drug-resistant forms of cancer, Cylene has created multiple product candidates in different stages of development. Cylene's most advanced cancer agent, CX-3543, is a Ribosomal RNA Biogenesis Inhibitor (RBI) in late-stage Phase 1 clinical development. More information can be found at www.cylenepharma.com.

Stock pickers like Big Biotech for '07

Wed, 10 Jan 2007 19:01:34 -0500

Share prices in biotechnology floundered in 2006, but the analysts say that Big Biotech should be a top performer in 2007. The theory: In a softening economy, profitable biotech companies look like a good defensive maneuver, driving share prices higher. Among the most highly touted stocks: Genentech; Amgen; Celgene and Gilead Sciences. It will be interesting to see how good the analysts are at picking biotech stocks, a notoriously tricky sector for investors.

- read the report on biotech stocks from CNNMoney

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C&L: Goodwin resigns from Novacea

Tue, 12 Dec 2006 19:01:32 -0500

Novacea said Bradford Goodwin has resigned as CEO and director of the company for personal reasons.

Triton BioSystems has hired Dr. Donald S. Masters as its president and CEO.

Celgene has named Thomas Daniel to the new position of president of Celgene research.

Sciele Pharma announced the retirement of John N. Kapoor, Ph.D. from the company's board of directors. Dr. Kapoor was a founder of Sciele Pharma and has served as a director since December 1996.

PAREXEL International has created a new, strategic leadership position of CIO and has appointed Christopher Rieder to the role.

Watson Pharmaceuticals has named Thomas R. Giordano as senior vice president, CIO.

Bill Chen is resigning from his position as CFO of Wex Pharmaceuticals.

Micell Technologies has appointed David Dresner to serve as CFO on an interim basis. Dresner replaces the company's current CFO, Jon Kennedy, who is leaving Micell to assume financial management responsibilities with another Raleigh-based company.

Columbia Laboratories announced the appointment of James A. Meer to the position of senior vice president, CFO and treasurer, succeeding David L. Weinberg, who is leaving to pursue other opportunities.

Ilypsa has promoted Gerrit Klaerner, Ph.D., to senior vice president and chief business officer.

INC Research as named Ronald E. Keeney, M.D., as its vice president of pediatric product development.

Recordati has named Gianni Soro to the position of general manager pharmaceuticals Italy.

Elite Pharmaceuticals has begun a strategic alliance with Dr. Veerappan Subramanian under which Dr. Subramanian has joined Elite's board of directors and will serve as strategic advisor to Elite on the research, development and commercialization of Elite's existing pipeline.

Ambit has appointed Brian J. Druker, M.D., and Gordon B. Mills, M.D., Ph.D., as the first members of its clinical oncology advisory board.

Helicos BioSciences has added John Quackenbush, Ph.D. of Dana Farber Cancer Institute, and David Liu, Ph.D. of Harvard University, to its scientific advisory board.

Bionovo announced that Dr. Terry Speed will join the company's scientific advisory board.

NeoStem has appointed Stephen D. Nimer, MD, a prominent authority in hematologic oncology, to the company's scientific advisory board.

Advanced Life Sciences Holdings has named Theron E. Odlaug, Ph.D. to its board of directors.

Dr. Jeffrey M. Leiden, MD, PhD will join the board of Shire as a non executive director.

Norman C. Payson, M.D., former chairman and CFO of Oxford Health Plans, has been elected to Idenix's board of directors.

NGN Capital co-founder Georg Nebgen, Ph.D., was unanimously elected to the board of directors of Javelin Pharmaceuticals. Venture capitalist Peter Morgan Kash has stepped down from the board and will continue to serve with the company under contract.

Biophan Technologies has named Stan Yakatan to its board of directors.

ALSO NOTED: Celgene buys plant; Roche data positive on Xeloda; Merck, Vertex to advance MK-0457; and much more...

Sun, 10 Dec 2006 19:01:30 -0500

> Celgene is buying an active ingredient plant from Switzerland's Siegfried for $46.5 million. Report

> Roche announced that its latest Phase III trial for Xeloda hit its primary endpoint in a study on progression-free cancer survival. Release

> Merck and Vertex announced that MK-0457 will move into Phase II for leukemia after successfully completing a dosing study. Report

> Bristol-Myers Squibb is touting the positive results of a Phase III trial of Sprycel among patients resistant to Gleevec. Report

> AEterna Zentaris has released positive interim data from a mid-stage trial of Perifosine for multiple myeloma. Release

> Biogen Idec released positive Phase I/II data for lumiliximab. Report

> Health Discovery Corporation has executed a license agreement with Pfizer for its pattern recognition technology. Release

> Synerx Pharma has inked an agreement with Teva Pharmaceutical Industries in which Synerx will develop and secure FDA approval for a number of undisclosed products. Release

And Finally… Connecticut is moving aggressively in its support of embryonic stem cell research, handing out $20 million for 21 programs. Report

Revlimid price likely to attract price scrutiny

Sun, 02 Jul 2006 20:01:37 -0400

Celgene says it will sell the newly-approved Revlimid for $6,195 a month to patients with multiple myeloma. Analysts note that each new cancer drug that is approved is coming out with a price higher than competing drugs currently on the market. That's a trend that can be sustained for now, analysts note, but won't be sustainable indefinitely. Morgan Stanley concludes that the drug will garner a 97 percent gross profit, which doesn't include the cost of marketing or administrative overhead. Celgene plans to establish a program to help patients who are uninsured or underinsured. But some analysts note that with Medicare and Medicaid picking up much of the tab, it's only a matter of time before lawmakers step in.

- see the article on Revlimid from The Wall Street Journal (sub. req.)