Gilead Sciences

FDA rejects Gilead's CF drug

Maureen Martino — Wed, 17 Sep 2008 07:58:48 -0400

The FDA has rejected aztreonam lysine for inhalation, Gilead's investigational therapy for cystic fibrosis patients who have Pseudomonas aeruginosa. The agency stated that they cannot approve the application in its current form and an additional clinical study will be required. Gilead said that it will work with the FDA to determine if further analyses of the data could lead to approval, or if the company will need to conduct another study as stated in the letter. Release

Gilead doubles jobs, space to boost development

Calisha Myers — Fri, 22 Aug 2008 11:46:58 -0400

While many biotech and pharma companies are planning layoffs and restructuring to reduce costs, Gilead Sciences plans to double its campus at its Foster City headquarters--swelling from 629,154 square feet to 1.2 million to make way for a big expansion of its workforce. The developer says it needs to accommodate an additional 1,900 jobs over the next ten years. The company will also double its workforce in Seattle and Durham over the next ten years, Gilead President John Milligan told the San Francisco Business Times.

Gilead's expansion plans don't end there. The increase in staff and space is part of an overall effort to boost the funding and resources allocated for R&D. The company currently has over 20 compounds in different stages of development, said Milligan. The anti-viral drug maker, which claimed a $999 million profit in the first half of this year, is also building a portfolio of pulmonary and cardiovascular drugs, according to the SFBT.

- read the San Francisco Business Times article

Gilead numbers ‘uninspiring’

John Carroll — Fri, 18 Jul 2008 10:48:39 -0400

TheStreet's Adam Feuerstein rated Gilead Science's second quarter numbers "uninspiring," with strong top-line results and a disappointment in earnings. As one of the few profitable biotechs in the market, though, the analysts concluded that a record of strong results would likely entice investors willing to overlook any short-term weakness. Report

C&L: Una Ryan leaves Avant

Wed, 14 May 2008 06:59:52 -0400

Avant Immunotherapeutics today announced the departure of Una Ryan, Ph.D, President and CEO, effective immediately.

Watson Pharmaceuticals announced that co-founder and Chairman Allen Chao has resigned from the board of directors to pursue other business activities. Board member Andrew Turner will become nonexecutive chairman.

Ardea Biosciences has named John Beck senior vice president, finance and operations and chief financial officer.

Encorium Group has appointed Philip Calamia as its interim chief financial officer.

PregLem has named Sven Zimmermann, a biotech analyst at UBS Investment Bank, as its new chief financial officer.

Nucryst Pharmaceuticals revealed the appointment of David Holtz as vice president and chief financial officer.

Kendle has appointed Patricia Williams to the position of vice president, commercial operations.

Adnavance Technologies has appointed Christian P. Valcke, Ph.D., to its scientific advisory board.

Gilead Sciences on Wednesday said that Chief Executive Officer John C. Martin was named chairman of the biotechnology company's board of directors.

Vyteris named John E. Burrows and Susan Guerin to the company's board of directors,

Nventa Biopharmaceuticals Corporation has named John Varian to the company's board of directors.

DOR BioPharma announced that its President and Chief Executive Officer Christopher Schaber, PhD, has joined the board of directors of the Alliance for Biosecurity.

Inovio Biomedical announced that Patrick Gan was elected as the company's eighth director at Inovio's annual general meeting.

Human Genome Sciences announced that John LaMattina, Ph.D., who retired in late 2007 as president of Pfizer Global Research and Development, has been appointed to the HGS board of directors.

Robert Hill has joined the Biothera board of directors.

C&L: Wells named Biovail CEO

Wed, 23 Apr 2008 06:59:52 -0400

Biovail has named William Wells, Loblaw Cos. Ltd.'s chief financial officer, as its new chief executive, replacing Douglas Squires, who will become Biovail's chairman.

ARUP Laboratories co-founder Carl R. Kjeldsberg, MD, will retire as chief executive officer at the end of June 2009.

Bioniche Life Sciences announced late last week that its chairman, Hy Isenbaum, has died.

DUSA Pharmaceuticals announced that the role of D. Geoffrey Shulman, MD, chairman of the board and chief strategic officer, is expected to change as a result of a serious health condition.

US Oncology's CFO Rick McCook is resigning to explore opportunities in a retail or manufacturing business.

MannKind Corporation announced that Matthew J. Pfeffer will join the company as corporate vice president and CFO, effective April 21.

Gilead Sciences announced that Robin L. Washington will join the company in May 2008 as senior vice president and chief financial officer.

Medicago announced the return of Pierre Labbé as chief financial officer on a full-time basis.

Advanced Life Sciences Holdings says that R. Richard Wieland II, executive vice president and chief financial officer, has resigned to pursue other opportunities.

BioReliance Corporation has named John Ludwig Kolman, PhD, senior director, research and development.

Eisai has named Robert Laverty to the newly created position of vice president of U.S. communications.

Speedel has named Dr. Harald Schafer the new head of corporate communications and investor relations.

Encorium Group announced the resignation of Lawrence R. Hoffman, the company's chief financial officer, effective May 2.

ProGenTech has made several executive management appointments. They are: Dr. Paul Richardson, vice president for R&D; Dr. Jesus Ching, chief scientist; Sarah Wenning, VP of U.S. operations; Dylan Bird, director of business development; David Hu, VP of engineering.

Zogenix has named Cynthia "Candy" Robinson as chief development officer and Mark Thompson as vice president, sales and managed markets.

Addex Pharmaceuticals has named Laurent Massuyeau as head of business development.

Spherix named Randy Brown as chief of operations.

Ovation Pharmaceuticals has named Samuel Yonren, M.D. as vice president, patient safety with responsibility for global drug safety for all Ovation products.

Migenix has appointed Pieter Dorsman to its board of directors.

VIVUS has named Charles J. Casamento to the board of directors.

Resolvyx Pharmaceuticals has named Timothy J. Barberich and George M. Milne, Jr., Ph.D, to the board of directors.

Avexa Ltd has named Nathan Drona a non-executive director of the company.

Introgen Therapeutics has appointed Robert "Bob" Pearson to its board of directors.

Edwards Lifesciences announced that Vernon R. Loucks Jr. is retiring from the company's board of directors.

Oncolin Therapeutics has added Sandra Silberman, M.D., Ph.D. to its Scientific Advisory Board.

Gilead Sciences - Big Biotech's Stock Report

Maureen Martino — Wed, 26 Mar 2008 09:07:13 -0400

Company: Gilead Sciences
Starting stock price: $32.16
Ending stock price: $46.01
Percent Change: 43.06%

Scoop: Gilead's big achievement of '07 was the FDA approval of Letairis, a hypertension drug that marked the company's entry into the lucrative cardiovascular space. The company reported strong Phase III results for aztreonam lysine for cystic fibrosis, and Gilead's late-stage hepatitis B treatment Viread is closing in on FDA approval. Booming sales and an EU approval of HIV treatment Atripla rounded out a great year for Gilead.

Current stock price (3/25): $51.01

Big Biotech's Stock Report

Maureen Martino — Wed, 26 Mar 2008 08:53:23 -0400

2007 was a big year for Big Biotech, and while some of the top companies shined, other industry leaders took a beating. Biotech five biggest players--Amgen (1), Genentech (2), Biogen Idec (3), Genzyme (4) and Gilead Sciences (5)--are among the oldest and most established companies in the industry. Drug safety concerns, buyout talks, layoffs, and the ongoing struggle to produce cutting-edge technologies all made for an eventful year for these industry giants.

Gilead, Biogen Idec and Genzyme were the stock market winners in '07, gaining 43 percent, 16 percent and 13 percent respectively. On the other hand Genentech was down 18 percent, and Amgen dropped a whopping 34 percent. Click below for full stock performance details on Big Biotech's 2007 winners and losers.

1. Gilead
2. Biogen Idec
3. Genzyme
4. Genentech
5. Amgen

ALSO NOTED: Genta inks licensing deal on oncology program; Abbott, et al, target Tarceva gene test; Gilead submits marketing ap

Fri, 07 Mar 2008 06:59:50 -0500

> Genta has entered into an exclusive worldwide licensing agreement with Daiichi Sankyo for the development and commercialization of tesetaxel
(formerly known as DJ-927), a late Phase II oncology therapy. Release

> Millipore has inked a deal with Solabia to market materials used in manufacturing biologics. Release

> Abbott Laboratories' molecular diagnostics unit has joined with Genentech, OSI Pharmaceuticals and Roche to develop a gene test for Tarceva. Release

> Gilead Sciences has submitted a Marketing Authorization Application for marketing approval of aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the European Union. Release

> Hovione has purchased 75 percent of Hisyn Pharmaceutical, a Chinese plant that manufactures drug substances. Story

> Novartis will use biomarker detection technology developed by Singulex for its drug development work. Report

> Shareholders have approved the sale of Pharmion to Celgene. Release

This week's most popular story: Pfizer snaps up Serenex in buyout. Report

And Finally... Genetic mutations involving insulin-like growth factor explain why short women live longer. Report

ALSO NOTED: Sirtris, NCI collaborate on cancer models; Kylin expands in Indiana; and much more...

Thu, 21 Feb 2008 06:59:50 -0500

> Sirtris announced a collaboration with the National Cancer Institute to its enzyme activators in cancer models. Report

> Kylin Therapeutics in Indiana has been expanding with the help of funds provided by the state's Economic Development Corp. Report

> The Los Angeles Times reports on the growing profitability of the HIV drug sector, which has been particularly beneficial to Gilead Sciences. Article

> Sirion Therapeutics has licensed rights to develop eye therapies using a anti-inflammatory agent developed by Bridge Pharma. Release

> LA-based ImmunoCellular Therapeutics announced today that Manish Singh, Ph.D., MBA has taken on the full-time position of president and CEO. Release

> Eurand has been granted a priority review by the FDA for Zentase--EUR-1008. Release

> Forest Laboratories and Cypress Biosciences say the FDA has agreed to review their NDA application for milnacipran, a treatment for fibromyalgia. Report

> Medical device makers got some supreme protection yesterday. The highest court raised a partial shield against lawsuits, saying that devices that passed the FDA's most stringent premarketing review are exempt from consumer lawsuits. Report

> A Nobel Prize-winning biologist says that researchers are no closer to developing a vaccine against HIV than they were 20 years ago, when the scientific quest began. Report

> Can a vaccine control high blood pressure? Report

> There's growing evidence around the U.S. that the flu jab offers only marginal protection against the seasonal ailment. Report

> In 2007, drugmakers jacked prescription prices up 7.8 percent. Report

And Finally…The CDC says the U.S. has made enormous efforts to prepare for a health crisis, like a flu pandemic, but cautions that an enormous amount of work remains to be done. Article

ALSO NOTED: Stalevo posts positive Parkinson's data; Genzyme applauded for aggressive strategy; Philogen pulls IPO; and much mo

Thu, 24 Jan 2008 06:59:50 -0500

> Novartis has told Orion Corp.--which put out a press release--that Stalevo has produced positive data in a late-stage Parkinson's trial. Release

> Analysts are bullish about Genzyme's aggressive position in the orphan drug market. Its approach has paid off with a 22 percent increase in sales during the fourth quarter. Article

> Italy's Philogen has decided against getting on the public market roller coaster. The developer is postponing its IPO, citing "market conditions." Report

> In a pipeline update, BioCryst says that it is now "planning to initiate a Phase II clinical trial that will evaluate the 300mg dose and a higher dose of peramivir later this year. As a result, BioCryst will not continue to pursue a pivotal Phase III program for i.m. peramivir in the current influenza season." Release

> Italy's Gentium says that an interim analysis of late-stage data on Defibrotide for veno-occlusive disease demonstrated no safety concerns. Release

> When Johnson & Johnson announced that it would create a so-called "Office of Strategy and Growth," there wasn't much detail to be had. Now, the new chief of that office, Nick Valeriani, has spoken to the Star-Ledger about his new task. Report

> Remember how the American Heart Association rushed to the defense of Vytorin after the results of the Enhance study were released last week? Well, now several news outlets are pointing out that the association gets almost $2 million annually from Merck and Schering-Plough. Report

> Yesterday, Gilead Sciences saw its four key patents on its anti-HIV med Viread (tenofovir disoproxil fumarate, also found in the Atripla combo pill) declared invalid. Report

> Researchers have made a key breakthrough in the quest to discover a vaccine or therapy to cure the deadly ebola virus. Report

And Finally… By transplanting stem cells from donors' bone marrow, kidney recipients were able to live without needing to take a steady regimen of immunosuppressive drugs. The new approach could revolutionize the entire field. Article

Letairis - 2007 FDA approvals

Maureen Martino — Wed, 09 Jan 2008 10:10:19 -0500

Drug: Letairis (ambrisentan)
Indication: Pulmonary arterial hypertension
Company: Gilead Sciences
Approval Date: June 15, 2007

Scoop: Letairis is a once-daily endothelin receptor antagonist (ERA). The approval marked Gilead's entry into the lucrative cardiovascular space. Gilead is taking a conservative approach in marketing Letairis due to the potential for serious side effects. The company will only allow someone to gain a prescription for the drug after they have taken an education course into risk factors such as liver damage and birth defects.

More news:
Gilead shares surge on Letairis approval. Report
Gilead's NDA for ambrisentan damages Encysive shares. Report

Press Release: Phase III Study Evaluating Gilead’s Viread Meets Primary Endpoint

Maureen Martino — Mon, 25 Jun 2007 11:53:02 -0400

Second Phase III Study Evaluating Gilead’s Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint

FOSTER CITY, Calif. -- Gilead Sciences today announced that Study 103, a Phase III clinical trial evaluating the company’s once-daily anti-HIV drug Viread® (tenofovir disoproxil fumarate or tenofovir DF) 300 mg as a potential treatment for chronic hepatitis B virus (HBV) infection, met its primary efficacy endpoint. The data show that Viread is non-inferior to the company’s once-daily antiviral drug Hepsera® (adefovir dipivoxil) among patients with “e” antigen (HBeAg)-positive chronic hepatitis B. The primary efficacy endpoint, the proportion of patients with a complete response at week 48, was defined by serum HBV DNA levels below 400 copies/mL and histologic improvement characterized by at least a two point reduction in the Knodell necroinflammatory score (a measure of necro-inflammation – an inflammatory process in the liver including or leading to death of liver cells) with no concurrent worsening of fibrosis (scarring of liver tissue).

At 48 weeks, 66.5 percent of patients in the Viread arm (n=176) had a complete response compared to 12.2 percent in the Hepsera arm (n=90; p<0.001). The most commonly observed treatment-emergent adverse events of moderate intensity or higher were abdominal pain, back pain, headache, respiratory infections and transaminase elevations. The incidence of these events was comparable between the Viread and Hepsera arms of the study. In addition, the most frequently observed grade 3 or 4 laboratory abnormalities were elevations in transaminase and serum amylase and were comparable between the two arms. Full study results will be submitted for presentation at an upcoming scientific meeting.

Study 103 is the second of two Phase III pivotal studies evaluating the efficacy, safety and tolerability of Viread for the treatment of chronic hepatitis B to have met its primary efficacy endpoint. Earlier this month, the company announced that the first study (Study 102) met its primary 48-week efficacy endpoint showing that Viread is non-inferior to Hepsera among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic hepatitis B.

“The preliminary data observed in both Phase III trials evaluating Viread as a potential treatment option for chronic hepatitis B are very encouraging,” said Franck Rousseau, MD, Vice President, Clinical Research, Gilead Sciences. “We look forward to reviewing these data with regulatory authorities and are working quickly to file a New Drug Application in the United States and Marketing Authorisation Application in Europe in the fourth quarter of this year.”

The active ingredient in Viread, tenofovir DF, is currently the most prescribed molecule in the United States for combination HIV therapy. Viread received approval as an anti-HIV medication from the U.S. Food and Drug Administration (FDA) in October 2001 and from the European Commission in February 2002. Viread is not approved as a treatment for chronic hepatitis B, and data from this analysis have not been reviewed by the FDA.

Study Design

Study 103 is a multi-center, randomized, double-blind Phase III clinical trial that compares the efficacy, safety and tolerability of Viread and Hepsera over 48 weeks among patients with HBeAg-positive chronic hepatitis B. Two hundred and sixty-six patients were randomized in a 2:1 ratio to receive either Viread (300 mg once daily; n=176) or Hepsera (10 mg once daily; n=90).

About Viread (tenofovir disoproxil fumarate)

In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Viread should not be used in combination with the fixed-dose combination products Truvada® or Atripla™ because they already contain Viread.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Viread is not approved for the treatment of chronic hepatitis B and the safety and efficacy of Viread have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV and HBV and discontinue Viread. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of Viread. It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy with Viread and as clinically appropriate during therapy. Coadministration of Viread and didanosine should be undertaken with caution. Patients should be monitored closely for didanosine-associated adverse events, and didanosine should be discontinued if these occur. Patients on atazanavir and lopinavir/ritonavir plus Viread should be monitored for Viread-associated adverse events, and Viread should be discontinued if these occur. When co-administered with Viread, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Viread.

Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk are unknown. Changes in body fat have been observed in patients taking anti-HIV medicines. The cause and long-term health effect of these changes are unknown. Immune Reconstitution Syndrome has been reported in patients treated with combination therapy, including Viread.

The most common adverse events among patients receiving Viread with other antiretroviral agents in a pivotal clinical study (Study 903) were mild to moderate gastrointestinal events and dizziness. Moderate to severe adverse events occurring in more than 5 percent of patients receiving Viread included rash (rash, pruritis, maculopapular rash, urticaria, vesiculobullous rash and pustular rash), headache, pain, diarrhea, depression, back pain, fever, nausea, abdominal pain, asthenia (weakness) and anxiety. In another pivotal study (Study 907), less than 1 percent of patients discontinued participation because of gastrointestinal events.

It is important for patients to be aware that anti-HIV medicines including Viread do not cure HIV infection or AIDS and do not reduce the risk of transmitting HIV to others. Full prescribing information is available at www.GileadHIV.com.

The parent compound of Viread was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research, Katholic University in Leuven, Belgium.

About Hepsera

Hepsera, a nucleotide analogue for the treatment of chronic hepatitis B, works by inhibiting HBV DNA polymerase, an enzyme involved in the replication of the virus in the body.

In the United States, Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The adverse reactions considered at least possibly related to treatment reported in 3 percent or greater of patients in the first 48 weeks in Hepsera pivotal clinical studies were asthenia, headache, abdominal pain, nausea, flatulence, diarrhea and dyspepsia. With extended treatment, mild to moderate increases in serum creatinine were observed uncommonly in patients with chronic hepatitis B and compensated liver disease treated with Hepsera for a median of 49 weeks up to a maximum of 240 weeks. Changes in serum creatinine were observed very commonly in patients pre- and post-transplantation with lamivudine-resistant liver disease and multiple risk factors for changes in renal function who were treated with Hepsera for up to 129 weeks, with a median time on treatment of 19 and 56 weeks, respectively. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with antiviral therapies for hepatitis B, including Hepsera. Special warnings and precautions for use are included in the package insert regarding monitoring of renal function, post-treatment exacerbations of hepatitis, and the occurrence of lactic acidosis and severe hepatomegaly with steatosis. Dosing instructions for patients with underlying renal impairment and for patients co-infected with HIV are also provided in the package insert, which is available for download online at www.hepsera.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to Gilead's ability to successfully commercialize tenofovir DF for chronic hepatitis B. For example, safety and efficacy data from additional clinical studies may not warrant further development of this compound for the treatment of chronic hepatitis B and completing our clinical studies may take longer or cost more than expected. In addition, feedback from regulatory authorities or results from clinical trials might require modifications or delays in later stage clinical trials or additional trials to be performed. Further, the FDA and other regulatory authorities may not approve tenofovir DF for the treatment of chronic hepatitis B, and marketing approval, if granted, may have significant limitations on its use and physicians and may not see advantages of tenofovir DF over other treatment options and may therefore be reluctant to prescribe tenofovir DF for chronic hepatitis B. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2006 and its Quarterly Report on Form 10-Q for the first quarter of 2007, filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Gilead touts Phase III Hep B results

Mon, 25 Jun 2007 00:01:36 -0400

Gilead is reporting that a Phase III trial of its HIV drug Viread was more effective at reducing amounts of the hepatitis B virus than the company's other antiviral drug, Hepsera. At 48 weeks, 66.5 percent receiving Viread had a complete response compared to 12.2 percent in the Hepsera arm. "The preliminary data observed in both Phase III trials evaluating Viread as a potential treatment option for chronic hepatitis B are very encouraging," said Franck Rousseau, MD, Vice President, Clinical Research, Gilead Sciences. "We look forward to reviewing these data with regulatory authorities and are working quickly to file a New Drug Application in the United States and Marketing Authorization Application in Europe in the fourth quarter of this year."

- read the release

Related Articles:
Viread data points to role in HIV prevention. Report
Viread program mired in controversy. Report

C&L: Bradbury takes reins at Amylin

Tue, 30 Jan 2007 19:01:32 -0500

Amylin Pharmaceuticals President and COO Daniel Bradbury is taking over as CEO from Ginger L. Graham on March 1. Bradbury has been president and COO since last June.

Jitendra N. Doshi is leaving his positions as COO and CFO of Caraco Pharmaceutical Laboratories to devote his efforts to managing and overseeing Sun Pharmaceutical's development projects and overall operations at its New Jersey and Ohio facilities.

Bernard Poussot has been promoted to the position of president, COO and vice chairman at Wyeth.

Jacques van Kimmenaede has been appointed president of Diosynth Biotechnology.

Gilead Sciences has promoted Jim Meyers to senior vice president, commercial operations, North America.

Metabolon has added these three members to its executive staff: Tim Germann, the new vice president of sales; Dr. Bruce McCreedy has been appointed vice president of strategic development; and Dr. Dan Stevens is the new director of marketing. MonoGen has hired James D. Cureton for the position of vice president, sales and marketing.

Archimedes Pharma has appointed Simon Collins as U.K. country manager.

Aize Smink has joined Chiltern International as global head of project management.

BioVerdant has named Dr. Berkeley W. Cue to its scientific advisory board.

Exelixis has named Jose Baselga, M.D., to its scientific advisory board.

John Leo has resigned from his position as a member of the China Aoxing board of directors.

NexMed has named David S. Tierney, M.D. to the board of directors.

Somaxon Pharmaceuticals has appointed Robert Jones as vice president, human resources.

J. Michael Millis, M.D., has been appointed to the board of Vital Therapies.

CuraGen has appointed James Noble, M.A., C.F.A. to its board of directors.

Dr. Andrew Pecora, FACP, has joined TetraLogic Pharmaceuticals board.

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

Related Articles:
The 10 Commandments of biotech investing. Part 1 | Part 2
The best (and worst) biotech stocks of 2006. Report

ALSO NOTED: Kosan forges deal with Pfizer; Genta cuts staff; and much more...

Tue, 19 Dec 2006 19:01:30 -0500

> Kosan stock surged on the news that it had inked a deal with Pfizer to develop a therapy for gastrointestinal diseases. Kosan gets $12.5 million up front and up to $72.5 million in milestones. Pfizer gains worldwide rights to KOS-2187, a compound that helps spur production of a hormone that promotes movement in the gastrointestinal tract. Release

> Fast on the heels of its announcement that the FDA did not approve its cancer therapy Genasense, Genta has laid off 34 workers, or about a third of its staff. Genta is still awaiting word on its European application for Genasense as a therapy for advanced myeloma. Report

> Shares of Panacos were slashed this morning after it announced that an experimental HIV therapy, bevirimat, proved disappointing in a Phase IIb trial. Patient data indicated a lower than expected response rate. Release

> Gilead Sciences announced that its Phase III AIR-CF2 (CP-AI-005) study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa met its primary efficacy endpoint. Release

> Germany's MorphoSys says it has extended its development pact with Pfizer, bringing its total potential value to more than $100 million in research support and milestone payments. Report

> The FDA has approved Johnson & Johnson's Invega, a therapy for schizophrenia. Release

> Repros Therapeutics has announced that preliminary trial data for the testosterone therapy Androxal demonstrates that it is not inferior to Androgel, which is sold by Solvay. Release

> Medigene has acquired the European rights to the dermatology product Oracea for €400 million plus milestones. Report

> Labopharm says it has made a complete response to the FDA's request for more information on the once-daily painkiller tramadol. Report

> Wyeth and Progenics have begun their second Phase III trial of intravenous methylnaltrexone for temporary gastrointestinal impairment. Report

> Serono and ZymoGenetics have begun a mid-stage trial Atacicept for rheumatoid arthritis. Report

> RheoGene, a gene and cell therapy company based in Norristown, PA, and Intrexon Corporation, a biotechnology company based in Blacksburg, VA, have announced plans to merge the two firms. Release

And Finally... The Bill & Melinda Gates Foundation is giving $47 million for a coordiated assault on a group of diseases. Release | Article

ALSO NOTED: Encysive shares climb as trial resumes; Donors support bird flu fight; and much more...

Thu, 07 Dec 2006 19:01:30 -0500

> Shares of Encysive were climbing this morning on the news that the FDA had cleared its researchers to resume a trial on TBC3711, the company's next-generation endothelin receptor antagonist. Report

> International donors have pledged $476 million in additional support to fight the spread of bird flu. Report

> Innovive Pharmaceuticals has acquired exclusive North American rights to develop and commercialize Tamibarotene, a synthetic retinoid for the treatment of acute promyelocytic leukemia, a type of acute myeloid leukemia. Release

> DOV Pharmaceutical announced today that the license agreement with Merck for DOV 21,947 and DOV 216,303, has been terminated by the parties. DOV regains all rights to the compounds. Release

> Canada's Millenium Biologix has laid off 20 staffers as it looks for new financing. Release

> Chutes & Ladders: Novacea CEO Bradford Goodwin has resigned for personal reasons. Report

> Gilead Sciences has been subpoenaed by federal prosecutors investigating its marketing efforts behind three HIV therapies. Report

> Crucell has announced a new $20 million contract for its Quinvaxem vaccine. Report

> Actelion moved on its earlier announced plans to acquire CoTherix by launching a $13.50 a share tender offer. Report

> Economic development: Malaysia plays catch-up for biotech business. Report

And Finally… The NIH has been steadily ratcheting down the amount of money that is available to researchers whose studies are considered risky. Article (WSJ sub. req.)

DEALS: Gilead Sciences acquires Myogen for $2.5B

Wed, 11 Oct 2006 20:01:32 -0400

Gilead Sciences acquires Myogen for $2.5B

DEALS
WHO	WITH	WHAT	SCOOP
Gilead Sciences	Myogen	$2.5B buyout	Gilead Sciences announced that it will acquire Myogen for $2.5 billion in a move designed to bolster Gilead's pulmonary program.
Sigma Pharmaceuticals	Australian Pharmaceutical Industries	$422M buyout	The buyout bid would create a company that controls two thirds of the Australian market.
Genentech	CGI Pharmaceuticals	$525M development deal	Genentech has agreed to pay CGI Pharmaceuticals $25 million up front and up to $500 million in milestones for the rights to collaborate on the development and commercialization of therapeutics for an unidentified target for the treatment of multiple cancer and autoimmune indications.
Biogen Idec	UCB	$200M development pact	Biogen Idec and Belgium-based UCB have signed a pact to develop UCB's CDP323, a small molecule alpha4-integrin inhibitor being developed as a treatment for multiple sclerosis.
Plexxikon	Servier	$100M collaboration deal	Plexxikon and France's Servier have struck a collaboration deal to discover non-peptidic renin inhibitors.
Wyeth	Biotica Technology	$195M licensing deal	Wyeth gains rights to Biotica's advanced drug candidates, a portfolio of additional rapamycin analogs, and the technology to discover new compounds.
Takeda	Xenon Pharmaceuticals	$75.5 licensing deal	Canada's Xenon Pharmaceuticals has agreed to license out the rights to its lead product for pain, XEN401, for Japan and certain Asian markets to Takeda.
Roche	Plexxikon	$40M deal	Roche and Plexxikon have signed a deal to develop and commercialize PLX4032, a therapy for cancer that selectively inhibits B-Raf(V600E).
Pfizer	PowderMed	Development deal	Pfizer has struck a deal to buy the UK's PowderMed, a company that has been developing a new generation of DNA-based vaccines.
Starpharma	Dendritic	Acquisition	Starpharma has struck a deal to buy all the stock of Dendritic Nanotechnologies it doesn't already own for about $7 million in Starpharma shares.
Barr Pharmaceuticals	Pliva	Acquisition	Barr Pharmaceuticals announced that it has acquired more than 70 percent of Pliva's stock.
Valentis	Urigen	Merger	Burlingame, CA-based Valentis announced that it would merge with Urigen through a stock swap.

Gilead shares surge on $2.5B Myogen buyout

Sun, 01 Oct 2006 20:01:38 -0400

Continuing the recent string of biotech buyouts, Forest City, CA-based Gilead Sciences announced that it will acquire Myogen for $2.5 billion in a move designed to bolster Gilead's pulmonary program. Last month Myogen kicked off a Phase III trial of ambrisentan, a pulmonary arterial hypertension treatment and an NDA for the drug is expected later this year. This is the second recent acquisition for Gilead, which recently exercised its option to buy Seattle-based Corus Pharma, a company that focuses on respiratory and infectious diseases, for $365 million.

"Myogen represents a unique scientific and strategic fit with our company, bringing to Gilead a late-stage product candidate that addresses an area of significant unmet medical need and further enhances our growing focus on pulmonology," said Gilead CEO John C. Martin in a press release. "We are excited about the potential of ambrisentan, which we believe could have important clinical benefit over existing therapies for pulmonary arterial hypertension." Myogen's shares surged sharply on the news.

- read the report on the buyout from TheStreet.com

ALSO NOTED: Sirion completes Sytera merger; BioMS to pursue pivotal trial; and much more...

Tue, 15 Aug 2006 20:00:50 -0400

> Sirion Therapeutics has completed a merger with Sytera, a La Jolla, CA-based biopharmaceutical firm working on new treatments for dry AMD. Release

> BioMS has won the approval of its data monitoring committee to continue its pivotal study of MBP8298 for the treatment of secondary progressive multiple sclerosis. Release

> Evotec has won its second €1 million milestone in its collaboration with Takeda Pharmaceuticals. Report

> Algeta and Affibody, which are building a pipeline of products based on tumor-targeting affinity molecules, today announced a research collaboration agreement to develop novel targeted radiotherapeutics. Release

> India's Strides Arcolab has inked a deal with Gilead Sciences to distribute generic versions of Truvada and Viread. Report

> A new report says that the FDA's drug directory is woefully outdated. Report

> Switzerland's Speedel has retained all commercialization rights to the blood clotting drug SPP200, citing positive data. Report

And Finally… Don't put down that cup of java. Four to six cups of coffee a day can be a healthful tonic for most people, say researchers. Article