Cell Therapeutics

Cell Therapeutics gets crucial cash infusion

John Carroll — Thu, 24 Jul 2008 11:19:23 -0400

Seattle-based Cell Therapeutics got a much-needed financial shot in the arm just days after filing SEC papers that indicated CTI needed new money to continue operations. Cell Therapeutics announced that a single institutional investor--who was not named--has agreed to purchase $44.5 million worth of newly issued 18.33 percent convertible senior notes that are due 2011. The deal comes with a conversion price of $0.79 per share and a warrant to purchase approximately 28.2 million shares of common stock with an exercise price of $0.79 per share. The company says that $22.25 million will be funded this week and the remaining $22.25 million must be funded prior to August 25, 2008. Further funding could be arranged as well.

In regulatory filings last week CTI said that "We have an immediate need to raise additional capital in the next thirty days in order to meet our operation needs." And its travails may not be over.

In today's announcement CTI stated: "The Company continues to have a substantial amount of debt outstanding and the quarterly interest expense associated with the debt is significant; the Company's operating expenses continue to exceed its net revenues and the Company will continue to need to raise capital to fund its operating expenses."

- read the release

Cell Therapeutics running out of cash

John Carroll — Mon, 21 Jul 2008 11:23:34 -0400

Seattle-based Cell Therapeutics is sending out an SOS signal to investors. "We have an immediate need to raise additional capital in the next thirty days in order to meet our operation needs," the company said in SEC documents. Cell Therapeutics also said that it does not have enough money to get through the current quarter. The biotech, which has yet to file its quarterly statement through June 30, stated that it ended the first quarter with $15.3 million in cash and $47.9 million in liabilities. The Seattle Times notes that CTI "subsequently raised a net $40 million in two financings."

- read the story in the Seattle Times

Limerick raises $15M; Icahn offered $15B for Biogen; Neogen expands R&D

John Carroll — Thu, 12 Jun 2008 10:27:38 -0400

> Limerick BioPharma has ginned $11 million in venture funds and borrowed $4 million more to advance its work on the bioavailability of drugs. Arch Venture Partners, Sevin Rosen Funds and Altitude Funds are all listed as investors. Report

> Researchers have presented new data backing Cimzia over competitors for the rheumatoid arthritis category. Report

> Carl Icahn offered to pay up to $15 billion for Biogen Idec last October. Report

> Idenix reported positive phase I/II data on IDX899, which is being developed to treat HIV-1. Report

> Neogen says it intends to double its research and development efforts for its new fiscal year by hiring 23 additional R&D personnel by early fall. Neogen release

> Opexa Therapeutics announced favorable safety and efficacy data for Tovaxin, a T-cell vaccination therapy for multiple sclerosis, in the second year of open-label clinical re-treatment studies in patients with MS. Opexa release

> OPKO Health has acquired exclusive worldwide rights in the field of ophthalmology to a novel small molecule agent in Phase II clinical development for the treatment of viral conjunctivitis and other viral infections. OPKO release

> Vical has received $6.3 million from AnGes under a previously announced collaborative agreement for continued funding of the company's ongoing Allovectin-7 Phase III metastatic melanoma trial. Vical release

> Cell Therapeutics has sold $23 million in senior convertible notes. Report

And Finally... Baxter International says that a human trial of its Celvapan bird flu vaccine demonstrated that it spurred an immune response against three strains of the lethal virus. This is the first time that researchers have developed a flu vaccine using a virus grown in cell cultures rather than eggs. Vaccine report

C&L: PDL BioPharma's L. Patrick Gage resigns

Wed, 04 Jun 2008 06:59:52 -0400

PDL BioPharma director and interim Chief Executive L. Patrick Gage resigned due to differences among the board about prioritizing company goals.

Histogenics has named F. Ken Andrews president and CEO. Andrews is a former vice president of marketing and sales of the tissue repair division of Genzyme.

Epix Pharmaceuticals announced the resignation of Dr. Andrew Uprichard from his position as president and head of research and development.

Alexza Pharmaceuticals announced that Jeffrey S. Williams has rejoined the company in a part-time position as president, Alexza Singapore, a wholly owned subsidiary of Alexza.

Biogen Idec has promoted Hans Peter Hasler to chief operating officer. He had been executive vice president, global neurology.

Etrials Worldwide said James W. Clark, Jr. has resigned his position as secretary, treasurer and chief financial officer.

Genmab AS said it has appointed David Eatwell as new chief financial officer of the group.

Amazon Biotech announced that Dr. Michael Silver has been appointed as the company's new scientific director.

ImClone Systems has appointed Bernhard Ehmer, M.D. as senior vice president and managing director, international operations.

Adolor Corporation has promoted Lee Techner, DPM to vice president, medical affairs and medical director.

MAP Pharmaceuticals has appointed Marco F. Rosa to the newly created position of vice president of human resources.

Stem Cell Therapeutics Corp. has appointed Thomas Franck as vice president of commercial planning.

BioChemics has named Dr. R. Rox Anderson, professor at Harvard Medical School, as a member of the company's Scientific Advisory Board.

DermTech announced that Herbert A. Fritsche, Ph.D., has joined DermTech's Scientific Advisory Board.

Avantogen Ltd welcomed Professor Ian Frazer to the Scientific Advisory Board of Hawaii Biotech Inc.

Provectus Pharmaceuticals has announced that Kelly M. McMasters MD, PhD, has agreed to serve as a member of the corporate board of directors. Additionally, Dr. McMasters will head the scientific advisory board.

TOPIGEN Pharmaceuticals has named Jeremy Curnock Cook, MA, to its board of directors.

Trius Therapeutics announced the appointment of Paul Truex to its board of directors.

NanoBio announced the appointment of David M. Stout to its board of directors.

Enzon Pharmaceuticals announced that Dr. Jack Geltosky has been appointed to the company's board of directors

ALSO NOTED: Shire nabs orphan product; New prez at Cell Therapeutics; and much more...

Thu, 24 Apr 2008 06:59:50 -0400

> Shire has acquired arylsulfatase, an orphan enzyme replacement therapy in Phase I/II for Metachromatic Leukodystrophy, from the Danish company Zymenex. Release

> Sepragen and Neugenesis are collaborate to develop a high-throughput, low-cost production platform for mAbs and vaccines for pandemic flu. Release

> Chutes & Ladders: Cell Therapeutics has named Craig W. Philips, the former vice president and general manager of Bayer Healthcare Oncology, as president. Report

> Are fault lines in the Merck/Schering-Plough joint venture beginning to open up? Report

> We love it when pharma CEOs depart from their usual talking points about financial results and restructurings and pipelines, to wax philosophical on their place in the word. This week, we heard an entire trio musing on the state of the industry: Merck chief Richard Clark, GlaxoSmithKline's putative chief Andrew Witty, and Pfizer's Jeff Kindler. Report

> Big Pharma is dragging its feet on conducting promised post-marketing studies. Report

> Schering-Plough CEO Fred Hassan got a $30M pay package. Report

And Finally... It may not be an ideal topic for polite conversation, but human beings are swarming with bacteria: Even the average healthy adult plays host to about 100 trillion microscopic organisms. Infection takes place when the bacteria get out of hand. Release

Cell Therapeutics reorganizes, scales back R&D

Thu, 31 Jan 2008 06:59:58 -0500

Cell Therapeutics is scaling back its research plans for Xyotax and pixantrone, cutting one group of staffers and beefing up on the sales side as it concentrates on marketing its recently-acquired Zevalin cancer therapy. The move--designed to reduce operating expenses by 35 percent--leaves 31 staffers out of jobs, reducing its headcount to 133 after it fills 13 sales and marketing posts. The biotech says that they are still on track to file for European approval of Xyotax and evaluate pivotal data for pizantrone.

"We believe the best way to maximize shareholder value now is to focus our resources on our marketed and late-stage products," said James Bianco, president and CEO. "It is with great disappointment that we must reduce head count elsewhere in order to meet these goals."

- see this release
- read the report from the Seattle Times

Related Articles:
Cell Therapeutics inks deal to buy cancer drug developer. Report
Cell Therapeutics inks deal for Xyotax. Report
Bayer Schering touts Zevalin study. Report
Cell Therapeutics makes bid to buy DOR. Report

ALSO NOTED: Osiris inks $224M contract; Baxter and Nektar to collaborate;and much more...

Mon, 07 Jan 2008 06:59:50 -0500

> Osiris Therapeutics has inked a deal with the U.S. Defense Department to supply a potential $224 million worth of Prochymal for use in treating military personnel exposed to radiation. Release

> Osiris also regained all worldwide rights to Prochymal. Release

> Baxter International and Nektar Therapeutics are teaming up to investigate new therapies for a rare form of hemophilia. Report

> BrainStorm Cell Therapeutics has expanded its collaboration with Rutgers University aimed at curing spinal cord injuries through adult stem cell research. Release

> Jazz Pharmaceuticals has received orphan drug designation for an experimental epilepsy therapy. Report

> Waltham, MA-based Magen BioSciences has acquired the rights to dermatology compounds from Eli Lilly. Report

> Making a living off pharmaceutical companies suddenly isn't so lucrative: IMS Health, the market research company responsible for so much of the hard data on drug sales, is laying off about 10 percent of its work force. Report

> Celgene announced that it expects fiscal 2007 profits to double to $1.05 per share, as sales of its cancer drug Revlimid skyrocket. Report

> As if Amgen didn't have enough to worry about with its anemia drugs under fire. The company is defending itself against charges of bull-whipping sales reps into marketing drugs off label and violating patients' privacy. Report

And Finally... A pharma nightmare with an English accent: The UK government wants to slash prices for prescription drugs by 10 percent. Report

ALSO NOTED: AstraZeneca completes cancer study enrollment; Smallpox vaccine success triggers milestone; and much more...

Fri, 30 Nov 2007 06:59:50 -0500

> Here's a good estimate of how much it costs when a drug goes into free-fall: $440 million. That's how much Johnson & Johnson is writing off on Natrecor, a heart failure treatment that went into a downward spiral when medical researchers suggested that it might boost the risk of kidney problems and death. Report

> AstraZeneca says that it has completed patient enrollment in a study of Zactima (vandetanib), an oral anti-cancer drug. It's the first of four planned studies of the drug, and data from the trial is expected in 2008. Release

> Bavarian Nordic has successfully completed a Phase II trial of its next-generation smallpox vaccine candidate Imvamune. The trial completion has triggered a $25 million milestone payment from the Department of Health and Human Services. Release

> Cell Therapeutics has entered into agreements to sell approximately $6.5 million of its 7 percent convertible preferred stock and warrants in a registered offering to several institutional investors. Release

> According to TheScientist.com, a former University of Washington researcher who was discovered to have faked data in a number of instances, is now working at Schering Plough. Post

> An FDA advisory panel gave its backing to Abbott's new Xience stent, albeit an endorsement tinged with caution. The committee said Xience should be cleared for sale on one condition--that Abbott conduct post-marketing research on the product. Report

> Herceptin has become a lightning rod for debate over cancer treatment in England. Radiotherapists--including the specialty's chief at the National Health Service--are saying that cancer treatment is weighted too heavily toward expensive drugs and not enough toward more cost-effective radiation treatments. Report

And Finally... Wondering what Jean-Pierre Garnier will do with his free time when he steps down as GSK's head honcho in May? Wonder no more. Report

ALSO NOTED: Zingo data lifts Anesiva stock; Two chemo drugs win approvals; BrainStorm plans trials; and much more...

Wed, 17 Oct 2007 06:59:50 -0400

> Shares of Anesiva jumped after the company announced positive top-line data from a late-stage study of Zingo, its drug candidate for reducing venous procedural pain. Report

> Bristol-Myers Squibb has won the FDA's approval for the chemo drug Ixempra for breast cancer. Report

> The FDA has approved Abraxis Pharmaceutical's chemotherapy drug Epirubicin hydrochloride injection in four dosage forms. Report

> Israel's BrainStorm Cell Therapeutics says it's likely to do clinical trials of its adult stem cell therapies in New York City. Report

> Sorry, Amgen and Johnson & Johnson. So says the FDA, which is backing up Medicare's new limits on using the companies' anemia drugs Aranesp, Epogen, and Procrit. Report

> You can't accuse pharma companies of failing to think ahead. They begin to forge links with future doctors before they even start med school. Report

And Finally... In what is likely to provide a big push for antibiotic developers, a new study by the CDC shows that almost 19,000 Americans were killed by the MRSA superbug last year, making it more lethal than AIDS. Report

ALSO NOTED: Cell Therapeutics to bypass interim analysis; Nabi reports NicVAX data; Chinese see value in scientific failure; an

Thu, 06 Sep 2007 06:59:50 -0400

> Cell Therapeutics has decided to bypass an interim analysis of its non-Hodglin's lymphoma drug candidate Pixantrone. Instead, researchers say they will conduct a full analysis after the trial is completed later this year. Report

> Nabi reports positive results from nine-month results for NicVAX. Report

> Chinese officials are mulling a new law that will officially sanction the value of scientific failure. FierceBioResearcher

> Innocoll is selling its CollaRx Gentamicin surgical implant and European sales and marketing infrastructure to EUSA Pharma. Release

> Pfizer announced results from a new trial that showed statin-switching isn't such a good idea. Lipitor patients who switched to simvastatin saw their risk of cardio events and death rise by almost a third. FiercePharma

> AstraZeneca announced it has issued $6.9 billion in bonds on the U.S. market, planning to use the proceeds to retire a chunk of the short-term debt it took on for the $15 billion MedImmune buyout. Report

And Finally... It's tough enough worrying that the fellow in the next desk will beat you to that promotion--and now, Pfizerites have to worry about a colleague stealing their identities, too. Report

ALSO NOTED: What to expect from Pfizer's new CFO; BrainStorm plans stem cell trials; Phoenix biotech plans San Diego move; and

Thu, 23 Aug 2007 06:59:50 -0400

> Newtown, PA-based CollaGenex says that it has reaped positive data from a mid-stage study of Col-118 for the treatment of erythema. Release

> BrainStorm Cell Therapeutics says it's on track to become the first developer to win approval for clinical trials on a new Parkinson's therapy that uses adult stem cells extracted from the patient. Report

> Ribomed Biotechnologies says the loss of its Phoenix lab space is forcing a move to San Diego. Report

> Cephalon says it is buying the North American rights to Amrix, a muscle relaxing drug, from ECR Pharmaceuticals for $100 million. Report

> Clinical Data is building its biomarker business with the $11.84 million acquisition of Epidauros Biotechnologie. Release

> Nucryst Pharmaceuticals has named Thomas Gardner as chairman, president and CEO. Release

> Alltracel plans to buy Synpart, an oral care business. Report

> It might sound like a candidate for the So What? award, but the FDA's approval of the "atypical" antipsychotic Risperdal for use in children and adolescents is a landmark decision. Report

> As Frank D'Amelio takes over as Pfizer's financial fix-it guy, what changes are in store for the company? FiercePharma

And Finally… Scientists are deeply skeptical, but China's Beike Biotechnology has been touting miracle cures spurred by stem cell therapies that are still years away from approval in most other countries. Article

SPOTLIGHT: Cell Therapeutics buys cancer drug

Thu, 16 Aug 2007 06:59:53 -0400

Cell Therapeutics has agreed to shell out $10 million up front and up to $20 million in milestones for the marketing and development rights of Biogen Idec's Zevalin, a cancer drug. The milestones kick in with the drug's approval as a first-line treatment for non-Hodgkin's lymphoma. Release

Cell Therapeutics inks deal to buy cancer drug developer

Thu, 26 Jul 2007 06:59:54 -0400

Cell Therapeutics has struck a deal to buy Systems Medicine, a cancer drug developer, for $20 million down and up to $15 million for milestones. Tucson-based Systems Medicine is developing a genetically engineered drug called Brostallicin, which Cell Therapeutics believes is a "perfect fit" for its pipeline. Cell Therapeutics CEO James Bianco told investors that the company is also close to acquiring a product with $15 million to $18 million in annual revenue. That would be a first for Cell Therapeutics, which hasn't pushed any drugs through the approval process yet. Its experimental therapy Xyotax has failed several trials.

- check out the release
- read the report on the deal from the Seattle Times

Related Articles:
Cell Therapeutics sees fewer side effects in NHL trial. Report
Cell Therapeutics spins off new protein tech company. Report
Cell Therapeutics makes bid to buy DOR. Report
Cell Therapeutics pays $10.5M to settle kickback claims. Report

Cell Therapeutics sees fewer side effects in NHL trial

Wed, 11 Jul 2007 06:59:55 -0400

Seattle-based Cell Therapeutics says that interim data from a Phase II/III trial of pixantrone demonstrated fewer severe side effects than the standard care for non-Hodkin's lymphoma. Compared with a group of patients receiving doxorubicin, researchers say that both arms of the trial achieved similar efficacy results with complete or partial tumor response among virtually all patients.

"We are excited by these results demonstrating that pixantrone is living up to the promise of preventing the severe cardiac damage that accompanies the use of standard doxorubicin treatment while retaining the potent anti-lymphoma activity of this class of drug," said James A. Bianco, M.D., President and CEO of CTI. "Pending results from this and other studies, these findings could have major implications for treating patients with breast cancer, lymphoma, and leukemia, where debilitating cardiac damage from doxorubicin might be prevented."

- read the report for more information

Related Articles:
Cell Therapeutics spins off new protein tech company. Report
Cell Therapeutics inks deal for Xyotax. Report
Cell Therapeutics makes bid to buy DOR. Report
Cell Therapeutics pays $10.5M to settle kickback claims. Report

SPOTLIGHT: Cell Therapeutics makes bid to buy DOR

Sun, 21 Jan 2007 19:01:33 -0500

Shares of DOR BioPharma soared on Friday afternoon after the company announced it had received an unsolicited buyout offer from Cell Therapeutics. CTI offered to issue 29 million shares to complete the deal, valuing the offer at $50 million. DOR, though, says it has to resolve a letter of intent on a partnership deal for its lead program with Sigma-Tau Pharmaceuticals before it can consider the offer. Press release | Report

ALSO NOTED: Cell Therapeutics suspends enrollment; Morphotek wins orphan drug status; and much more...

Mon, 06 Nov 2006 19:01:30 -0500

> Cell Therapeutics announced on Friday that it was suspending enrollment in its clinical trial for Xyotax so it could study new data on recently enrolled patients. Following a meeting with the FDA. Cell Therapeutics is also amending the study to focus on the survival in women with normal estrogen levels. Release

> The FDA has granted orphan drug status to Morphotek's MORAb-009, a monoclonal antibody for pancreatic cancer. Release

> Amgen is reporting itself well satisfied with Phase II data on its cancer drug AMG-706. One analyst, though, called the results disappointing. Report

> U.S. investors have agreed to pay $524 million for Egypt's Amoun Pharmaceuticals, which manufactures and markets drugs under license. Report

> Targeted Genetics has restructured its debt to Biogen Idec. Report

> Novartis AG's anti-inflammatory drug Prexige has been cleared for EU approval. Report

> Melior Discovery in Exton, PA has inked a research pact with Merck. Release

And Finally… Despite a series of disappointments, researchers say they're exploring some promising new approaches to male contraception. Report

Cell Therapeutics inks deal for Xyotax

Sun, 17 Sep 2006 20:01:37 -0400

Seattle-based Cell Therapeutics has inked a licensing deal with Novartis worth up to $285 million for the cancer therapy Xyotax. Currently in Phase III trials, Cell Therapeutics will retain an option to co-detail the therapy in the U.S. And its executives say the deal, which includes a $15 million equity investment and up to $270 million in milestones, also opens up new opportunities for acquisitions.

"This collaboration takes CTI one step closer to rebuilding its commercial presence in the United States and its goal of becoming a profitable cancer focused company. It also allows us to continue our growth through an acquisition strategy looking for other novel targeted agents to add to our development pipeline and into our future commercial infrastructure," said CTI CEO James A. Bianco, M.D.

- see the release on the Xyotax pact

SPOTLIGHT: Report questions stem cell treatments

Wed, 30 Aug 2006 20:01:33 -0400

BBC Two has run an investigative report saying that employees for Advanced Cell Therapeutics have been injecting stem cells into patients in South Africa which are not suitable for human use. The report states that the majority of patients are seeking treatment for multiple sclerosis. The cord blood stem cells were reportedly obtained from AllCells in California, which says that they are to be used exclusively for research purposes. Report

ALSO NOTED: Generic Plavix to arrive soon;Alzheimer's drug effective against poisoning; and much more...

Mon, 07 Aug 2006 20:00:50 -0400

> Bristol-Myers Squibb says that it expects Apotex to quickly begin delivering a generic version of its blockbuster anti-blood clotting drug Plavix. Apotex had agreed to delay rolling out a generic Plavix until 2011, but a group of state attorneys general rejected that agreement and a federal judge has refused BMS' request for a temporary restraining order. Plavix provides about a third of BMS' revenue. Its stock plunged 7.5 percent on Friday after Medco projected the likely arrival of a generic Plavix later this year. Article

> New treatments like Cytoxan offer patients with scleroderma, or hard skin, new options, says this feature in The New York Times. Stem cell transplants are considered experimental. They're not covered by insurance and can cost $37,000 per treatment. Article

> The Alzheimer's drug galantamine appeared effective in protecting guinea pigs from the effects of poisoning from pesticides and nerve agents, according to researchers at the University of Maryland School of Medicine. Article

> Genizon BioSciences has inked a licensing and collaboration deal with Genentech, granting the South San Francisco biotech giant an exclusive license to Genizon's GeneMap of disease-associated genes generated from a whole genome association study of Crohn's disease patients from the Quebec Founder Population. Release

> One of the participants in the disastrous TeGenero clinical trial in London says he has developed cancer. Report

> Chutes & Ladders: Cipher Pharmaceuticals has promoted its president, Larry Andrews, as CEO. He replaces, John Mull, who will stay on as chairman. Report

> Cell Therapeutics reported today that based on preliminary, encouraging complete response rates observed among the first 40 patients with aggressive non-Hodgkin's lymphoma treated in its Phase III trial of pixantrone, the data monitoring committee recommended that the study continue. Release

> Germany's Epigenomics has entered into an R&D collaboration with Johnson & Johnson Pharmaceutical Research & Development to identify and analyze potential biomarkers for use in J&JPRD's oncology program. Release

And Finally… Severely depressed patients taking a powerful anesthetic called ketamine reported that the drug significantly alleviated feelings of despair. Researchers caution that the drug has severe side effects. Article

Cell Therapeutics inks $72M finance deal

Tue, 20 Jun 2006 20:01:35 -0400

French banking group Societe Generale has reached a deal to buy up to $72 million in new Cell Therapeutics stock to sell on the Italian market. Cell Therapeutics says the actual amount of stock that Societe Generale will deal in will depend on the developer's financing needs.

- read this AP report on Cell Therapeutics