Vical

Vical cuts jobs, closes research facility

Calisha Myers — Fri, 21 Nov 2008 10:50:11 -0500

Many companies are scrambling to find ways to cut costs and preserve cash before year's end. The latest to announce restructuring and layoffs is San Diego-based Vical. In order to preserve capital and focus on its most advanced development programs, the biotech will reduce its workforce by 29 employees, approximately 20 percent of its total staff. Vical will also close one of its research facilities. Although the company will incur Q4 charges of about $0.8 million for the layoffs and another $0.5 million in early 2009 for the facility closure, this will reduce future net losses and cash burn by about $4 million a year, according to the company's statement.

"Vical is fortunate to have sufficient capital for its near-term needs," said Vijay Samant, Vical's President and CEO, "but in the current economic climate, we needed to reduce spending and focus our efforts on advancing our two late-stage product development programs toward the achievement of key milestones."

According to an RTTNews report, Vical's Q3 earnings did not meet analysts' expectations. On average, analysts expected the company to narrow its losses over last year by $0.03, but Q3 net losses remained stagnate at $0.24 per share. Despite doubling revenue, Vical also failed to meet those expectations. Earnings for the Q3 2008 were $0.8 million, compared with $0.4 million during 2007's Q3. Wall Street analysts survey by RTTNews expected revenues of $2.46 million.

- read Vical's release
- check Vical's Q3 financial report
- take a look at the Top 5 layoffs of 2008

Vical reports bird flu success

John Carroll — Thu, 17 Jul 2008 11:12:14 -0400

San Diego-based Vical is reporting early-stage success with a new bird flu vaccine that relies on engineered bacteria to produce genes of the H5N1 virus. The DNA is combined with an adjuvant in a new manufacturing process that will be considerably swifter than the egg-based process now commonly in use. And as one of the gene ingredients in this vaccine stays in every strain of bird flu that evolves, it may also have much broader applicability in the event of a pandemic. Vical report

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

ALSO NOTED: Visiomed, Clinical Cell Culture to merge; Genzyme wants to reopen merger vote; Vical touts adjuvant data; and much

Wed, 10 Oct 2007 06:59:50 -0400

> Visiomed Group and Clinical Cell Culture are merging into a $27 million biotech company. Release

> Bioenvision and Genzyme want to reopen the vote on a proposed merger, despite the opposition of a big shareholder. Release

> Vical announced that data from a study in mice demonstrated the potential of its patented Vaxfectin adjuvant to be used as a dose-sparing agent with a protein-based H5N1 pandemic influenza vaccine. Release

> Roche is still confident that the company's $3 billion takeover bid for Ventana will be accepted. Report

> What do you call a migraine drug that could help alcoholics quit drinking? A big-time marketing opportunity--if it weren't going off patent next year. Report

> Say the Pfizer/Sanofi-Aventis rumors are true: Would merging with the French drug maker boost Pfizer's fortunes? Not so much, say some observers. Report

And Finally... A team of Australian scientists has found an enzyme in diabetics that prevents them from producing insulin. Report

Bird flu vaccine effective in animal trial

Thu, 19 Oct 2006 20:01:34 -0400

Vical says its bird flu vaccine proved 100 percent effective in protecting ferrets from bird flu. Vical announced earlier that two doses of DNA vaccine was effective in protecting mice and ferrets. Vical's vaccine candidate is mixed with Vaxfectin adjuvant and viral proteins. Vical says it wants to begin human trials as soon as possible.

- here's the AP report on Vical

Related Articles:
Sanofi vaccine effective against new bird flu strains. Report
Switzerland to stockpile GSK's bird flu vaccine. Report
PowderMed touts data for new flu vaccine. Report
Low-dose bird flu vaccine effective in trial. Report

ALSO NOTED: Voyager ends Phase III early; Allegra cleared for use in children; and much more...

Wed, 18 Oct 2006 20:01:30 -0400

> DURECT announced that Voyager Pharmaceutical had told the company that it was ending a Phase III trial of Memryte for Alzheimer's disease in order to get a possibly earlier look at efficacy data. Memryte uses DURECT's DURIN technology to provide sustained release of the peptide leuprolide acetate and is based on Voyager's patented method of treatment of Alzheimer's disease. Release

> Sanofi-aventis' allergy drug Allegra has been cleared for use in children as young as two. Report

> J&J has gained FDA approval for another indication for Remicade. Report

> Vical is selling $25 million in stock to Singapore-based Temasek Holding. Report

> SIGA Technologies has arranged for a $9 million private placement. Report

And Finally... Buoyed by the response to its new $4 generic drug program, Wal-Mart is accelerating plans to roll it out around the country. Article

C&L: Dr. David Kaslow exits Vical

Tue, 25 Jul 2006 20:01:32 -0400

David Kaslow, M.D. has announced plans to leave his job as chief scientific officer at Vical. He is returning to Merck & Co. Vical says it does not plan to replace Dr. Kaslow.

Neurologix has named John Mordock to the post of chief executive officer. Mordock, a partner of Red Bird Capital, is replacing Michael Sorell.

MonoSolRx announced the hiring of Keith J. Kendall as its new senior vice president and chief financial officer.

Ray "Rui" Zhong has joined China Biopharmaceuticals as senior vice president, finance and business development.

VaxGen announced that Kathrin U. Jansen, Ph.D., the company's senior vice president, research and development and chief scientific officer, has accepted the position of senior vice president of vaccine research at Wyeth, and has resigned from VaxGen.

Antigenics announced that Shalini Sharp, currently senior director of strategic planning and corporate development, will be appointed as the company's chief financial officer and vice president as of September 30. Peter Thornton plans to return to Ireland with his family.

Immtech Pharmaceuticals has named Carol Ann Olson, M.D., Ph.D., senior vice president of pharmaceutical development and chief medical officer.

Poniard Pharmaceuticals has appointed Alan B. Glassberg, M.D., as chief medical officer.

Exagen Diagnostics has named Luc Van Hove, M.D., PhD, CSSBB, as vice president, quality, regulatory, medical affairs and chief medical officer.

Halozyme Therapeutics has named Robert Little vice president and chief commercial officer.

Novo Nordisk, has appointed Howard Levy, M.D., Ph.D., executive director of clinical research-hemostasis in the company's clinical development, medical, and regulatory affairs department. The company also named Henry Cortina associate vice president of information technology in the United States.

EntreMed has named the following people to its new scientific advisory board: Tak W. Mak, S. Gail Eckhardt, M.D., Michael E. Weinblatt, M.D., Hans Wigzell, M.D., Ph.D.

Phytopharm plc has appointed Peter Robin Blower, M.D., former director of new neuroscience products at SmithKline Beecham, as a non-executive board director of Phytopharm.

Portola Pharmaceuticals has appointed Peggy V. Phillips, former chief operating officer at Immunex, to the company's board of directors.

Jerome Groopman, M.D., has submitted his resignation from Genta's board of directors due to personal health reasons.

Magellan Biosciences has named Michael E. Woehler, Ph.D., to the company's board of directors.

Clarient has named Dennis Morgan Smith Jr., M.D., as member of the board and James A. Datin to chairman of the board of directors.

Zelos Therapeutics has added Colin Goddard, Ph.D., to its board of directors.

Argolyn Bioscience announced that James R. McNab, Jr. has been appointed to the position of executive chairman of the board of directors.

MGI PHARMA has named James O. Armitage, M.D., F.A.C.P., F.R.C.P., to its board.

DEALS: Novartis signs two major licensing deals

Wed, 07 Jun 2006 20:01:32 -0400

Novartis signs two major licensing deals

DEALS
WHO	WITH	WHAT	SCOOP
Novartis	Human Genome Sciences	$552.2M licensing deal	Novartis has licensed HGS's hepatitis C drug Albuferon for an upfront payment of $45 million and milestones of up to $507.5 million for the development of the therapy.
Novartis	Cytopia	$274 licensing deal	Novartis will pay Cytopia $13M in up front fees as part of a $274M package that includes major milestones on new therapies to prevent transplant rejection and to treat auto-immune diseases.
AnGes	Vical	$100M licensing deal	Japan's AnGes has agreed to pay up to $100 million in research funding and milestone fees in a licensing deal for Vical's Allovectin-7 cancer therapy.
BioLineRx	Gevys Pharmaceuticals	Licensing deal	The deal is for worldwide rights to Gevys Pharmaceuticals' experimental pain drug BL-3010.
Novartis	NeuTec Pharma	$569M acquisition	Novartis has bid $569 million to acquire NeuTec Pharma, a British drug developer with several late-stage candidates in the pipeline. NeuTec's board has backed the takeover.
Covance	Signet Laboratories	$8.95M asset acquisition	Covance has acquired most of the assets of Signet Laboratories for $8.95 million.
Biogen Idec	Fumapharm	Acquisition	The companies will continue to collaborate BG-12 for MS and psoriasis and Biogen Idec will expand its European operations.
PerkinElmer	Clinical & Analytical Service Solutions	Acquisition	PerkinElmer has acquired Clinical & Analytical Service Solutions for an undisclosed sum.
Gilead Sciences	Raylo Chemicals	$147.8M buyout	Gilead says it needs Raylo, a subsidiary of Germany's Degussa, for its experience as a chemical and manufacturing experience.
Angiotech Pharmaceuticals	Quill Medical	$40M buyout	Quill Medical makes the Contour Threads surgical suture product.
Bristol-Myers Squibb	Lexicon Genetics	$20M alliance	Bristol-Myers Squibb has extended its alliance with Lexicon Genetics on psychiatry and neurology therapies by two years, adding another $20 million in new research funds.
Parata Systems	McKesson'	Sale	Parata Systems has inked a deal to buy virtually all of the assets in McKesson's automated prescriptions systems division. McKesson becomes Parata's sole third-party distributor in the U.S.
CombinatoRx	Cystic Fibrosis Foundation Therapeutics	$13.8M collaboration	The companies will collaborate to find new drug combination therapies for cystic fibrosis.
Highland Clan	Raptor Pharmaceutical	Reverse takeover	Raptor will become a wholly owned subsidiary of Highland and Highland will focus solely on the development of Raptor's RAP technology.

AnGes inks $100M licensing deal with Vical

Mon, 29 May 2006 20:01:39 -0400

Japan's AnGes has agreed to pay up to $100 million in research funding and milestone fees in a licensing deal for Vical's Allovectin-7 cancer therapy. In exchange for the marketing rights in several Asian countries, AnGes will provide more than $22 million in cash and equity payments, including an initial $6.9 million equity payment. Vical will conduct the Phase III trial for Allovectin-7 in the U.S. and has begun recruitment for the study at the ASCO meeting this week in Atlanta.

"We established a mutually beneficial relationship last year with AnGes in the angiogenesis field," said Vijay Samant, president and CEO of Vical," and we believe the Allovectin-7 agreement expands our opportunities for success."

- here's the release on the licensing deal

U.S. to buy 95 million flu drug doses

Tue, 02 May 2006 20:01:38 -0400

The federal government plans to stockpile 75 million doses of antiviral drugs and 20 million doses of an experimental vaccine to help combat a potential bird flu pandemic. The plan is expected to be released later today, but The New York Times was briefed on the essential outlines of the government's response. In addition, the government has outlined plans to have police and the National Guard maintain public order, with help from the military as needed. And businesses are being encouraged to develop plans that would factor a 40 percent absenteeism rate during successive waves of bird flu outbreaks.

- here's the New York Times report on the plan

ALSO: Shares of Vical, meanwhile, soared 31 percent after the drug developer announced promising results from an animal study of its experimental bird flu vaccine. The vaccine completely protected mice and ferrets exposed to the virus. Investors were particularly enthused by signs that the vaccine could work against multiple strains of the virus. Any human pandemic requires a viral mutation that can significantly alter the way it works, and change its response to more narrowly targeted therapeutics. Report

Antigen Express gets guidance on vaccine trial

Sun, 26 Mar 2006 19:01:36 -0500

Antigen Express says that the FDA clearly spelled out a road map for testing an experimental synthetic peptide vaccine that could play a role in combating avian flu. Executives at the company, a subsidiary of Generex, said that they may be just weeks away from filing an IND on the vaccine. Earlier this month the FDA outlined the kind of data that it would expect to see from anyone working on a new vaccine. The agency said that the move clearly reflected the priority that was being given to finding new therapies to manage a potential human outbreak. Vical is working on another experimental therapy that relies on bacteria to produce DNA vaccine.

- read the article from the Boston Business Journal

PLUS: The rapid spread of the bird flu virus around the globe has forced scientists to take another look at strategies used to contain viral diseases. "We cannot contain this thing anymore. Nature is in control," Robert G. Webster, a virologist at St. Jude Children's Research Hospital, told the Los Angeles Times. Article

Potential pandemic lures biotech with prospects of major market

Sun, 04 Dec 2005 19:01:36 -0500

Despite all the hype and the prospect of billions of dollars in federal spending, many biotech companies--and stock analysts--are warily eyeing the market for new avian flu drugs. The Los Angeles Times brings up the case of Vical, which was developing a vaccine for a SARS epidemic that never happened. But despite the extremely difficult process of developing a vaccine for a virus that currently doesn't exist and may never appear, a lineup of biotech companies are plunging ahead. That lineup also includes Vical.

- read this report from the Los Angeles Times for more

Vical wins orphan drug status

Mon, 13 Jun 2005 20:01:35 -0400

The FDA has granted orphan drug status to Vical's vaccine for the herpes virus cytomegalovirus. A mid-stage trial is planned for the second part of the year among bone marrow donors and recipients. The virus occurs in about 30 percent to 60 percent of bone marrow and solid organ transplant patients.

- read this article from the AP for more

ALSO NOTED: Endo wins patent suit; Judge rules against trial patients; Biota shares surge on discovery; and much more...

Tue, 07 Jun 2005 20:00:50 -0400

> Shares of Endo surged yesterday afternoon after the company reported it had won a patent suit allowing it to market a generic version of the extended release form of Oxycontin. Story

> A judge has ruled against two patients who tried to force Amgen to continue to supply them with an experimental Parkinson's drug. Amgen had suspended the trial after determining that GDNF was no better than a placebo and could be dangerous. The judge ruled that the biotech giant was under no contractual obligation to continue to provide the drug. Article

> Shares of Australia's Biota Holdings surged after the company announced it had found a novel class of antivirals. Story

> Nymox of Maywood, New Jersey, is reporting positive data for its experimental drug for benign prostatic hyperplasia. Release

> Tracleer is gaining a new market in Japan, where it will be sold for $60,000, well above the $35,000 price tag found in the US. Story

> Vical has licensed three cancer vaccine targets to Merck. Release

> Novavax of Malvern, Pennsylvania, has announced preclinical results for two compounds. Release

And Finally... Doctors are trying to create a "firewall" to separate them from drug company freebies, but the close ties have proved hard to unravel. Article