seattle times

CellCyte in 'precarious' shape after shares collapse

Tue, 15 Apr 2008 06:59:57 -0400

After a brief period as a high-flying stem cell company, CellCyte Genetics' share price has fallen back to earth, wiping out much of the $440 million market valuation achieved last fall and leaving it in "precarious" financial shape. The Seattle Times is reporting that CellCyte has about five months worth of working capital on hand with shares trading at 45 cents each, down from a high of $10.01 hit last year after an intense period of stock promotion. The stem cell company now faces shareholder lawsuits and an investigation by German regulators of its stock promotion work. Documents filed with regulators on Monday say the company has raised $400,000 from investors since the end of the year. CellCyte had discussed plans of starting clinical trials of stem cell therapies this year at a cost of $7 million in 2008.

- read the report in the Seattle Times

Related Articles:
Report: CellCyte stock up after promoter touts shares. Cellcyte Report
Falling dollar, falling drugmaker prices. Stock report

Fledgling Recodagen gets first venture round

Fri, 14 Mar 2008 07:59:54 -0400

Seattle's Accelerator has a new fledgling biotech company on its hands. Recodagen is taking flight with an undisclosed amount of money from a Series A venture round. The cash is coming from Alexandria Real Estate Equities, Amgen Ventures, ARCH Venture Partners, OVP Venture Partners and WRF Capital. The biotech start-up will work out of an Accelerator facility with technology licensed from Washington State University. It will focus on the genetic mechanism involved in metastasis and the technology developed at Washington State by J. Suzanne Lindsey, who will move to Seattle and become research chief at the company. Recodagen is starting out with three workers.

- read the report from the Seattle Times

ALSO NOTED: ZymoGenetics to chop jobs; Evotec extends collaboration; Iomai touts results for vaccine patch; and much more...

Thu, 14 Feb 2008 06:59:50 -0500

> ZymoGenetics is chopping 80 jobs--mostly in R&D--after facing some tough reviews for the potential of its newly released drug Recothrom--a genetically engineered form of thrombin to prevent surgical bleeding. Several analysts have cast doubt on the future of the drug, which was independently released, as well as ZymoGenetics other lines of research. Those prognostications have weighed heavily on the company's stock at a time the stock market has been roiled by speculation of a looming recession. The Seattle Times also notes that the cutbacks reflect the difficulty biotech companies face when moving from pure research to a combination of R&D and marketing. Release | Report

> Evotec stands to gain up to $37 million through the extension of its collaboration with the CHDA Foundation for new therapies to fight Huntington's disease. Release

> Officials in West Virginia are highlighting a new report that calls for an investment in new drug research, noting that the state is near the bottom of the 50 states in research funding and venture capital. Report

> Iomai is touting the results of a mid-stage study of its vaccine patch for traveler's diarrhea. Report

> Sanofi Pasteur has struck a licensing deal with the Statens Serum Institut of Denmark covering the use of its technology for a new tuberculosis vaccine. Report

> A Chinese plant never inspected by the FDA turned out an active ingredient in the heparin vials recalled last month. The Baxter-made blood thinner has been implicated in hundreds of adverse reactions and four deaths. Now, the FDA is investigating, planning an expedited examination of that plant and its records. Report

> The feds are accusing Cephalon of bribing drug makers to keep copycat Provigil off the market. Report

> Biogen Idec and Cardiokine have launched a late-stage trial of Lixivaptan for congestive heart failure patients suffering from hyponatremia. Release

> Alex Gorsky has left the building. As Novartis' U.S. pharma CEO, Gorsky (photo) had been with the company four years; he's now "pursuing opportunities outside of the company." Report

> It's not personal, it's political. When the Republicans were in charge on Capitol Hill, drugmakers were in favor--or so it appeared to the minority party. Now that the Dems run Congress, they're turning the tables. Report

And Finally… Generic drug makers are enthusiastic about the Bush administration's decision to back a regulatory pathway for follow-on biologics. Article

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

Omeros lays plans for $115M stock offering

Thu, 10 Jan 2008 06:59:56 -0500

Seattle-based Omeros has blueprinted plans for an IPO to raise $115 million. Omeros is betting that its experimental therapies for inflammation and CNS disorders can snag investors' dollars to complete a late-stage study of its lead drug. Omeros has burned through $72 million since it started in 1994 and had $27 million on hand as of last September. The Seattle Times notes that the filing comes after a rough year for IPOs, with more filings withdrawn last year than completed.

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

Related Articles:
Omeros to buy Nura in cash/stock deal. Report
Omeros gets new funding. Report

Report: CellCyte stock up after promoter touts shares

Mon, 10 Dec 2007 06:59:56 -0500

After struggling for years to survive on angel investments, the Seattle Times reports that CellCyte Genetics has ridden a wave of hype this fall to push its market value to $440 million. And the biotech's share price rose following a flood of glossy brochures and spam faxes from an outside investor who had been barred from the securities business in British Columbia.

The spike occurred after CellCyte bought an inactive shell company and went public while a Canadian promoter acquired millions of shares. That attracted the attention of regulators, who say they've been guarding against "pump-and-dump" schemes. CellCyte CEO Gary Reys says that the spike in the company's share price simply shows investor confidence in the company's ability to manipulate stem cells.

- check out the article from the Seattle Times

Related Articles:
Repeat after me: Stock prices will grow in autumn. Report
FDA designation turns into fast track to nowhere. Report
Stock pickers like Big Biotech for '07. Report
Biotech lags Pharma stocks in first half of 2007. Report

Gene therapy trial to resume after patient's death

Mon, 26 Nov 2007 06:59:58 -0500

The gene therapy field is breathing a mighty sigh of relief after Targeted Genetics announced that it has received a green light to resume a clinical trial suspended after the death of a participant. The FDA made its decision after concluding that the gene-therapy study for rheumatoid arthritis did not contribute to the death of 36-year-old Jolee Mohr. A post mortem found that the experimental therapy did not spread in her body and did not greatly increase the immune suppression caused by another RA drug the patient was taking. Gene therapy has been seriously hampered in past years by unexpected trial deaths. Another safety fiasco now may well have put the research field back into slow motion.

- see the company's release
- read the report from the Seattle Times

Related Articles:
Biotech co. defends gene therapy trial standards. Report
Trial death spurs questions about gene therapy. Report
Targeted Genetics study on hold. Report
Targeted Genetics cuts staff. Report

Seattle start-up gains $30M in second venture round

Fri, 26 Oct 2007 06:59:56 -0400

Another biotech graduate of the Seattle incubator Accelerator Corp. has won a significant round of venture backing. Allozyne says that it has garnered a $30 million Series B, enough money to take a preclinical candidate for multiple sclerosis through Phase I. In an interview with the Seattle Times, CEO Meenu Chhabra says that early-stage data should be available around 2010, making it ripe for a partnership with a big pharma company. If so, that would make it one exceptionally promising compound. Most of the significant partnership money doesn't become available until Phase II is well underway or completed. Allozyne is also studying a new therapy for diabetes and is looking for its own headquarters facility, which will allow the biotech to double its 10-person payroll. MPM Capital led the round with participation by OVP Venture Partners, Amgen Ventures, ARCH Venture Partners and Alexandria Real Estate Equities.

- here's the article on Allozyne from the Seattle Times

Expert panel rejects pleas for Hemopure trial

Thu, 14 Dec 2006 19:01:38 -0500

Rejecting the strenuous pleas of the U.S. Navy, an FDA advisory panel has rejected Biopure's bid to test the blood substitute Hemopure on civilian trauma patients. Voting 11 to eight against the move, the experts concluded that the risks exceeded the potential benefits of the trial. Blood substitutes are a highly controversial therapy, in large part because they need to be tested on trauma victims without their consent. The Navy has been backing Biopure's program, though, saying that a blood substitute would save soldiers' lives in wartime. The FDA is not bound by the panel's vote, but it rarely overrules the experts who advise the agency. The agency has already blocked Hemopure trials on three separate occasions.

The rejection is a bad blow for Biopure. The developer already expects its accountants to raise questions about its ability to continue as a viable concern and has told investors that it will burn through its current cash reserves sometime next summer. Biopure needs new capital to go on, but may find that particularly difficult without the FDA's approval for a trial.

- check out the Biopure press release
- read the report on Hemopure from the Seattle Times
- and here's the Wall Street Journal's take (sub. req.)

Related Articles:
FDA cancels hearing on Hemopure. Report
FDA puts Hemopure trial on hold as it reviews safety. Report
FDA reconsiders non-consent trial of Hemopure. Report

Study shows that Alzheimer's drugs don't work

Wed, 11 Oct 2006 20:01:37 -0400

The primary drugs used to treat a wide range of symptoms of Alzheimer's--including agitation, aggression and hallucinations--are no better than placebos. That's the conclusion of researchers involved in a 33-site study of Zyprexa, Seroquel and Risperdal. Up to half of the patients in the study stopped taking the drugs because they weren't working and up to 24 percent stopped because of side effects. Scientists said the data showed that a new generation of therapies need to be developed which can work for the millions of people who suffer from Alzheimer's.

- read the report on the study from the Seattle Times

Trubion outlines plans to gin $69M in IPO

Mon, 02 Oct 2006 20:01:35 -0400

Seattle-based Trubion Pharmaceuticals outlined plans to raise $69 million in an upcoming IPO. Trubion officials say they plan to sell 4.6 million shares at $13 to $15 apiece. Morgan Stanley, Banc of America Securities, Pacific Growth Equities and Lazard Capital Markets are underwriting the offering. Another regional biotech, Light Sciences Oncology, is reportedly planning to finish its IPO as early as this week. Trubion was tapped as a 2006 Fierce 15 company after striking an $800 million collaboration deal with Wyeth to advance its work with small modular immunopharmaceuticals, or SMIPs.

- here's the report on Trubion from the Seattle Times

Pivotal Thrombin trial a success for ZymoGenetics

Tue, 05 Sep 2006 20:01:38 -0400

Seattle-based ZymoGenetics announced that a pivotal Phase III study of Thrombin showed that it was as effective in stopping surgical bleeding as the standard therapy while also proving safer. A total of 1.5 percent of the patients taking Thrombin among the 411 volunteers in the trial developed antibodies against Thrombin compared to 22 percent of volunteers taking a cow-blood based therapy. An antibody reaction can trigger bleeding.

Thrombin is a protein made through gene-splicing that mimics a human clotting protein. ZymoGenetics CEO Bruce Carter said that the company is on schedule to ask for FDA approval later this year and bring a product to market in 2007. Recent surveys have indicated that doctors prefer engineered proteins over proteins derived from either humans or animals. If so, ZymoGenetics would be well positioned to grab a commanding share of the market. The company's shares were buoyed by the news in overnight trading.

- read this article on the trial from the Seattle Times

Nastech to push ahead with obesity spray trial

Wed, 07 Jun 2006 20:01:35 -0400

Nastech Pharmaceutical has requested FDA approval to begin human trials of PYY3-36 spray to treat obesity. The spray delivers a hormone--the YY peptide--that researchers say plays a role in regulating the body's eating habits. Nastech shares were hammered earlier this year when Merck announced that a preliminary study of the hormone demonstrated no effect and was pulling out of a collaboration to develop the therapy. Nastech, however, says the study shows that the hormone is safe and noted that other developers are researching injectable forms of the YY peptide.

- here's the report on Nastech from the Seattle Times

PLUS: Nastech pocketed a $7 million milestone fee from P&G. Report

Trubion announces plans for IPO

Sun, 04 Jun 2006 20:01:37 -0400

Trubion Pharmaceuticals, a 2006 Fierce 15 biotech, has filed an IPO designed to raise up to $86.25 million. Wyeth, which is co-developing TRU-015, has agreed to buy 20 percent of the new shares at the IPO price. Wyeth was drawn by Trubion's work with small modular immunopharmaceuticals, or SMIPs. If Trubion is right, SMIPs represent a new class of immunotherapeutics with distinct advantages over current therapies. Due to their smaller size, SMIPs have shown an ability to reach areas of the body antibodies can't hit. Researchers have touted their selective binding capacity and stability, which should help a body metabolize the drug and lower dosage requirements. Several of Trubion's top staffers came from Immunex. The Seattle-based biotech says it is planning to hire about 27 new staffers by the end of this year.

- read this Seattle Times report on Trubion

SPOTLIGHT: Gottlieb outlines FDA's pharmacogenomic plans

Mon, 20 Mar 2006 19:01:33 -0500

Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, talks to the Seattle Times about the agency's focus on pharmacogenomics, the development of new guidelines for proteomic data and the need for drug developers to follow through on plans for post-marketing studies. Report

Cyclacel to go public in reverse merger with Xcyte

Thu, 15 Dec 2005 19:01:36 -0500

In a reverse merger, Seattle-based Xcyte Therapies is taking over Scotland's Cyclacel Pharmaceuticals in a deal that will allow Cyclacel to emerge as a public company in the US. Xcyte shareholders will wind up with 20 percent of the new company, which will be based in Short Hills, NJ. Xcyte was reduced to a mere shell company earlier this year after the FDA raised objections to its design of a major clinical trial of technology designed to arouse the immune system to ward off disease. Facing a major delay, Xcyte reduced its workforce from 100 to 5 and began to look for someone to come in and take over. The remaining employees will be dismissed and Xcyte's Seattle operations will be closed. Cyclacel will focus on two trials for experimental oncology therapies.

- read this article from The Seattle Times for more information

ALSO: Xcyte sold its T-cell expansion technology to Invitrogen for $5 million. Report

Dendreon plans to raise $59M to market Provenge

Mon, 28 Nov 2005 19:01:37 -0500

Dendreon plans to sell 10 million shares of common stock in a deal aimed at raising $59 million before expenses. The Seattle-based drug developer will use much of the money to commercialize its experimental prostate-cancer drug Provenge, which it plans to file an application on next year.

- read this article from the Seattle Times for more information

ALSO: Dendreon has agreed to a special protocol assessment amendment for its ongoing Phase III trial of Provenge. Release

Chutes & Ladders: Newly-appointed FDA deputy draws fire

Wed, 24 Aug 2005 20:01:37 -0400

Dr. Scott Gottlieb is perhaps best known as the editor of the Forbes/Gottlieb Medical Technology Investor, picking hot biotech stocks and touting his track record for investors. However, in late July he was appointed the No. 2 regulator at the FDA and a chorus of critics has emerged to question the selection, raising potential conflicts of interest and wondering why the Bush administration would tap someone who has called for a faster review process and fewer drug warnings at a time when the agency is attempting to appear more sensitive to safety issues. Gottlieb says he has stopped writing the newsletter and cut his ties to Wall Street and doesn't see any conflicts in his new role.

- read this story from the Seattle Times for more

Sen. demands probe of early access to trial data

Mon, 08 Aug 2005 20:01:38 -0400

A weekend report in the Seattle Times that medical researchers are accepting large fees to deliver early news on the outcomes of clinical research trials has touched off a furor in Washington, DC. Senator Charles Grassley (R-Iowa), who has headed Senate probes of the pharmaceutical industry, has called for a formal investigation of 26 reported cases where early data on research trials were delivered to Wall Street research firms.

According to the report, Gerson Lehrman Group has 60,000 doctors available to discuss research information with clients who pay as much as $1 million per year for the information. But the research group denies any wrongdoing, saying that doctors are paid upwards of $500 per hour even if they cut off discussions when it involves confidential information.

- read this story from the San Francisco Chronicle