Hepatitis C

SciClone's hep C drug fails late-stage trial

John Carroll — Wed, 05 Nov 2008 10:52:07 -0500

SciClone Pharmaceuticals' late-stage therapy for hepatitis C failed to hit a primary endpoint in a late-stage trial. The drug, thymalfasin, failed to register a significant response in patients who had not responded to a combination of pegylated interferon alpha and ribavirin--standard treatments in use today. The drug is partnered with Sigma-Tau.

In a smaller portion of the trial, though, researchers said the drug demonstrated efficacy against hepatitis C. For "patients who completed the full course of 48 weeks of treatment with thymalfasin in addition to peg-IFN-2a and RBV, the primary endpoint achieved statistical significance."

"We are disappointed that the study did not reach its primary efficacy endpoint in the intent-to-treat population," said CEO Friedhelm Blobel, Ph.D., in a statement. "Nevertheless, the data seen in the completer population suggest a potential benefit of using thymalfasin in patients who completed the full course of treatment."

"These data suggest that the immunomodulatory activity of thymalfasin may play an important role in maintaining the viral response in patients who completed the full prescribed 48 weeks of treatment," said Israel Rios, MD, chief medical officer of SciClone. "Although the safety analyses are still ongoing, thymalfasin appeared to be well tolerated. During the course of the trial the side effects reported were those usually associated with the use of interferon and ribavirin."

- read SciClone's release
- check out the AP report

Related Article:
SciClone report positive hep C data

GSK buys Genelabs for $57M

Maureen Martino — Thu, 30 Oct 2008 10:22:43 -0400

In a move designed to bolster it's hepatitis C offerings, GlaxoSmithKline is buying Redwood City, CA-based Genelabs Technologies for $57 million. GSK will pay $1.30 per share for outstanding Genelabs stock. Genelabs will become part of GSK's Drug Discovery organization and its HCV programs will be consolidated with its existing pipeline. The deal will likely close in December.

"Genelabs has demonstrated a strong track record in HCV drug discovery and identified numerous novel classes of inhibitors that target unprecedented mechanisms in the virus's life cycle," stated Zhi Hong, SVP of the Infectious Diseases Centre for Excellence in Drug Discovery at GSK. "This arrangement, combined with our other collaborations, will give GSK a broad HCV drug discovery platform addressing novel targets and innovative therapeutic approaches."

- see GSK's release

Vertex readies new Phase 3 trial of telaprevir

John Carroll — Tue, 19 Aug 2008 12:09:56 -0400

Vertex and partner Johnson & Johnson have struck agreements with regulators on both sides of the Atlantic for a new Phase III trial of the closely-watched telaprevir for hepatitis C. This new late-stage study will test the therapy in 650 refractive patients and is intended to build on the data due from a separate trial of telaprevir in treatment naïve patients.

Vertex's share price has been tied to the fate of telaprevir, rising and falling with the drug's prospects. TheStreet notes that the developer isn't likely to file for approval of the drug until the second half of 2010, when it has the data on the treatment naïve group. A smaller study in treatment resistant patients has demonstrated efficacy for attacking the virus.

--see the Vertex release
--read the story from TheStreet.com

Metabasis strikes $203M pact with Roche

John Carroll — Fri, 08 Aug 2008 10:23:07 -0400

San Diego-based Metabasis Therapeutics is getting a $10 million upfront injection from Roche to put its drug technology to work to find a new therapy for hepatitis C virus. In the event they find a drug candidate in the course of the two-year collaboration, Metabasis would be eligible for up to $193 million in milestones and Roche would have global commercialization rights.

"The HepDirect technology has shown significant promise in delivering the activated form of certain antiviral nucleosides to the liver and therefore has the potential to both enhance the antiviral activity of these nucleosides, as well as to lower the effective dose," says Dr. Mark Herion, the CSO at Metabasis. "A partnership with Roche enables Metabasis and Roche to combine their respective strengths in liver-targeting and hepatitis C research with the hope that this combination will lead to a drug candidate for HCV in the near future."

- read the release for more

Schering-Plough posts positive hep C data

John Carroll — Mon, 04 Aug 2008 12:12:20 -0400

Schering-Plough published promising new data for its experimental hepatitis C drug boceprevir, which pushed down the share value of rival Vertex Pharmaceuticals. After 48 weeks of therapy, researchers said, three out of every four patients receiving boceprevir in combination with standard therapy had undetectable levels of the virus. That compares to 38 percent with undetectable viral levels in the standard therapy arm.

None of that Phase II data is likely to sway analysts who pegged Vertex's closely watched telaprevir as the likely winner in the race to an FDA approval. But hepatitis C is a very competitive disease field, and a rival therapy could quickly eat into its revenue. Vertex shares lost 11 percent on the news from Schering-Plough.

- check out Schering-Plough's release
- read the report from StreetInsider

Vertex shares rise on positive data for telaprevir

John Carroll — Mon, 09 Jun 2008 11:52:41 -0400

Vertex Pharmaceuticals saw a significant bump in its share price this morning after researchers released new, mid-stage interim data backing telaprevir for hepatitis C. The company is now penciling in the start of a new late-stage trial for the closely watched drug--enrolling patients who had failed standard therapy--in the third quarter. The new data is from a Phase IIb involving patients who had failed a standard therapy.

In the study, patients received telaprevir in combination with interferon/ribavirin for 12 weeks, then the combination therapy for the next 12 weeks followed by 12 weeks of neither therapy. The control arm received the combination therapy for 36 weeks. Slightly more than half of the telaprevir group had undetectable levels of the virus after 36 weeks compared to 30 percent in the control group. A late stage trial for the hep C drug began in spring with patients who had received no prior therapy.

- check out the press release
- read the AP report

Tercica shares skyrocket following takeover bid

Fri, 06 Jun 2008 06:59:54 -0400

Moving fast, investors swiftly bid up the value of Tercica's stock yesterday afternoon after hearing that France's Ipsen would pay $9 a share to acquire all the stock in the company it didn't already own. That was more than $4 a share above what Tercica has been trading at. One unexpected mover was Vertex, which jumped after an analyst predicted that its closely watched hepatitis C drug telaprevir would be approved earlier than expected.

- read the AP story

First miRNA drug enters human studies

Wed, 28 May 2008 06:59:54 -0400

Denmark's Santaris has kicked off a Phase I study of SPC3649, a potential treatment for hepatitis C infection. The trial marks the first time a microRNA drug has been tested in humans. SPC3649 will be tested for safety in 48 healthy volunteers before being administered to hepatitis patients in a Phase II trial.

MicroRNA is one of two types of RNAi found in all human cells and affects how genes are turned off and on (siRNA is the other). "The mechanism of action of this drug represents a potential breakthrough in medical science. The ability to switch off the functions of particular microRNAs may enable clinicians to modulate entire networks of genes associated with disease or ill-health," said Santaris' CEO.

- check out Santaris' release for more

Valeant chops workforce in restructuring

Fri, 02 May 2008 06:59:57 -0400

In an effort to bring expenses in line with revenues, Valeant is cutting 130 workers in the U.S. and Mexico. In addition, headcount will be further reduced by 1,250 positions as it divests its European subsidiaries. The full effects of the layoffs will be felt within the next year. The layoffs will reduce Valean's staff by about half.

"This is the first step in our plan to right size our company and return it to appropriate levels of profitability," said J. Michael Pearson, chairman and chief executive officer. "We understand the impact these changes will have on our employees and we are committed to treating everyone with respect and dignity. While difficult, these changes are in the best interest of the company to generate meaningful change that will produce long-term value."

- here's Valeant's release

ALSO NOTED: Isotechnika reports psoriasis success; Romark enrolls hep C patients; and much more...

Fri, 18 Apr 2008 06:59:50 -0400

> Isotechnika's ISA247 has demonstrated significant efficacy against psoriasis. Report

> Romark Laboratories has begun enrolling patients in a U.S. clinical trial to evaluate nitazoxanide for the treatment of chronic hepatitis C. Preliminary data from the study is expected in the second half of 2008. Release

> It was inevitable: All the chit-chat about drug safety and the FDA's shortcomings had to result in legislation. Rep. John Dingell's House Energy and Commerce Committee released a "discussion draft" yesterday, planning to convene hearings over the next few weeks and draw up the real bill after that. Report

> Pfizer shares hit a 10-year low yesterday. And who can blame investors who sold, considering the Eeyore tone Wall Street analysts took after the drugmaker announced its falling sales and earnings? Report

> Call it the backlash against the backlash. In the wake of the recent Vytorin and Vioxx marketing scandals, drugmakers are banding together to prevent a Congressional crackdown on their power to promote. Report

And Finally… Researchers at Purdue say they're on to a new bird flu vaccine that offers broader protection over a longer period of time. Article

Vertex shares jump on positive telaprevir data

Tue, 01 Apr 2008 07:59:56 -0400

Vertex Pharmaceuticals got a much-needed boost to its share price after investors responded positively to the latest data analysis on its closely-watched hepatitis C therapy. Vertex stock jumped 28 percent after researchers noted that patients responded to telaprevir in a mid-stage study. The data will be featured in a late-breaker poster presentation during the 43rd Annual Meeting of the European Association for the Study of the Liver in Milan, April 23-27. There's a $3 billion market for hep C drugs in the U.S. and Europe. Schering-Plough is also developing a hep C drug--boceprevir.

- check out the press release
- read the AP report

Related Articles:
Investors disappointed in Vertex despite strong data. Report
Vertex hep C drug impresses in Phase IIb. Report
Vertex inks rich pact with J&J. Report

Vertex drug improves lung function in IIa CF trial

Thu, 27 Mar 2008 07:59:57 -0400

After stumbling on high investor expectations for its experimental hepatitis C therapy, telaprevir, Vertex garnered a dose of good news with the release of positive Phase IIa data on VX-770 for cystic fibrosis. Researchers reported that the small, 20-patient study revealed improved lung function in patients taking the oral drug. There was no discerned improvement in patients taking a placebo. Vertex shares jumped 10 percent on the news.

"While these are early data, it is unprecedented for an investigational oral compound for the treatment of CF to have such a marked effect on multiple measures of CF disease activity. We saw an average improvement in lung function of 10 percent in patients receiving the highest dose, compared to no observed improvement in patients who received placebo," said Frank Accurso, M.D., Director of the Cystic Fibrosis Center and Professor of Pediatrics at the University of Colorado School of Medicine in Denver.

"More than 10 years ago, the Cystic Fibrosis Foundation believed that Vertex's approach to treating CF by directly targeting CFTR function--the underlying mechanism of the disease--was an important opportunity to meaningfully change the course of cystic fibrosis," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation.

- see the release
- read the AP report on the data

Related Articles:
Red tide research points to cystic fibrosis therapy. Report
Investors disappointed in Vertex despite strong data. Report
Vertex refines terms on $300M public offering. Report

C&L: Opexa CEO to retire

Wed, 26 Mar 2008 07:59:52 -0400

GeoVax Labs has added Dr. Robert McNally as president and CEO.

Opexa Therapeutics announced that David McWilliams, president and CEO, will retire following the naming of his successor.

Synthetic Blood International announced the death of interim CEO Robert Larsen. He was 79. Chris J. Stern, DBA, chairman of Synthetic Blood International's board of directors, will take over Larsen's roles.

Icagen has promoted Richard Katz, M.D. to executive vice president, finance and corporate development, and chief financial officer.

Metabolix announced that Joseph Hill has been appointed chief financial officer.

Biophage Pharma announced that Louis Guindon has resigned as chief financial officer.

Acura Pharmaceuticals announced that Robert Jones has been named senior vice president and chief operating officer.

Zelos Therapeutics has appointed David Krause, MD, FACP, as the company's senior vice president of R&D and chief medical officer.

Cubist Pharmaceuticals has named Tamara Joseph as senior vice president.

Monogram Biosciences has promoted Gordon Parry, PhD, to the position of vice president, research and development, oncology.

Conatus Pharmaceuticals has named Anthony "Tony" Fox as part-time chief medical officer to oversee the recently initiated Phase 2 clinical trial of CTS-1027 in Hepatitis C virus-infected patients as well as assisting in the development of the longer-term clinical development plans.

Codexis has named David Anton, Ph.D. to the newly-created position of vice president, bioindustrials research and development.

Kinexum Metabolics has named Peter Damsbo, M.D. to the clinical development team that is designing human trials for INGAP Peptide which are scheduled to begin in 2008.

Sernova Corp. has added Dr. Shinichi Matsumoto, director of the Baylor All Saints Islet Cell Laboratory at the Baylor Research Institute in Fort Worth Texas, to its Scientific Advisory Board.

Micromet has named five leading oncology and immunology researchers to its newly formed panel of BiTE antibody advisors. They are: Richard Flavell (Yale University, New Haven, Connecticut); Michael Keating (MD Anderson Cancer Center, Houston, Texas); Ronald Levy (Stanford University, Stanford, California); Jeffrey Ravetch (Rockefeller University, New York, New York); and Anthony Tolcher (South Texas Accelerated Research Therapeutics, San Antonio, Texas).

Avexa announced that its chairman, Dr. Hugh Niall, has retired from the board of the company.

GlobeImmune has added J. William Freytag, Ph.D. to its board of directors.

Sirtris Pharmaceuticals has named Paul Friedman, M.D., president and CEO of Incyte Corporation, to its board of directors.

Hana Biosciences has named Paul Maier to its board of directors.

H. Ward Wolff has been appointed to the board of Map Pharmaceuticals.

Presidio snags preclinical hep C program for $108M

Thu, 20 Mar 2008 07:59:54 -0400

XTL Biopharmaceuticals is pocketing a $4 million upfront fee and stands to earn another $104 million in milestones after inking a collaboration deal with Presidio Pharmaceuticals for its preclinical hepatitis C program. NS5A is in advanced stages of lead optimization. As part of the license, Presidio obtained rights to several distinct chemical series, including their lead series, which exhibits activity against both the HCV 1a and 1b genotypes. Presidio will assume responsibility for any additional lead optimization, clinical development, and commercialization activities related to the program.

"This license agreement with XTL expands the HCV franchise we created in our ongoing agreements with Stanford and Numerate, and firmly establishes Presidio as a leading developer of medicines for HCV," said Omar K. Haffar, Presidio's president and CEO.

- read the release
- check out the AFX report

Related Articles:
XTL shutters program on early-stage failure. Report
XTL licenses development rights to pain therapy. Report
XTL names Ron Bentsur CEO. Report
Presidio pockets $26M in second VC round. Report

ALSO NOTED: Rumor Mill: AstraZeneca a possible Shire suitor; Cardiome baits hook for partners; Vertex shares keep sliding; and

Tue, 18 Mar 2008 07:59:50 -0400

> Shire is suddenly the talk of the town as investors and investment banks publicly mull a match-up with AstraZeneca. Report

> Cardiome has brought in Merrill Lynch to handle the expected partnership offers for Vernakalant. Cardiome is bullish about its prospects after reporting positive interim Phase IIb data for atrial fibrillation. Release

> Vertex shares have been sliding as analysts assess its prospects for the once red-hot hep C drug telaprevir. Report

> Targacept is starting an early-stage trial of TC-5214 for major depression. A spin-off of RJ Reynolds, its researchers specialize in neuronal nicotinic receptors in the brain. Report

> Pharmacopeia is pocketing a $5 million payment from GlaxoSmithKline for completing early research discovery work. Release

> Fewer reps are knocking on doctors' doors these days. A consulting firm that advises most of Big Pharma says Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb have all culled their herds of reps. And more companies will be following suit soon. Report

> A measure that would force pharmaceutical companies and medical device makers to disclose gifts valued at more than $25 seems to be gathering momentum. Report

> The FDA's Andrew von Eschenbach got peeved during an appearance at the American Enterprise Institute when someone suggested that appointing Janet Woodcock (photo) to her former post at the top of CDER was a return to the "old ways" at the agency. Au contraire, he said. She's "going back as a very, very strong change agent," he responded. Report

And Finally... A UN agency has been alarmed by the 'critical' situation posed by the continued spread of avian flu in Indonesia. Report

Valeant shares jump on epilepsy trial data

Wed, 13 Feb 2008 06:59:54 -0500

Shares of Valeant Pharma jumped yesterday after the developer announced that its experimental epilepsy treatment retigabine met its primary endpoint in reducing the number of seizures by a statistically significant margin. Data from a second late-stage trial is expected in the second quarter of this year with an NDA expected in the U.S. and Europe by the end of this year.

"These data confirm the efficacy seen with retigabine in earlier clinical trials and put Valeant at the forefront of development of neuronal potassium channel openers for the treatment of epilepsy and other central nervous system diseases," says Michael Pearson, Valeant's chairman and chief executive officer.

- here's the release
- read the AP report

Related Articles:
Valeant sells development programs. Report
Valeant hep C drug fails pivotal trial, again. Report
Valeant to out-license programs in restructuring. Report

SciClone report positive hep C data

Mon, 11 Feb 2008 06:59:55 -0500

SciClone Pharmaceuticals and Sigma-Tau are reporting positive interim data from a Phase III trial of Zadaxin for hepatitis C. At the end of 48 weeks, the blinded data show that 171 out of 553 total patients, including both treatment and control group patients, responded to treatment. "These interim HCV data are promising because, although we do not know the breakdown between thymalfasin treated and control group patients who have achieved an SVR, this is already a strong overall response for nonresponder patients," said Mario Rizzetto, M.D., lead investigator of the trial. Full results of the trial will be available in the third quarter.

- see this release for more

Related Article:
SciClone's Zadaxin flunks Phase III trials. Report

Idenix reports success in early-stage HIV drug trial

Thu, 07 Feb 2008 06:59:56 -0500

Idenix Pharmaceuticals says that an early-stage study of its experimental HIV drug demonstrated a significant response in a small group of patients who hadn't been previously treated for the virus. Eight people taking an 800 mg dose of IDX899 saw viral loads drop an average of 99 percent. Researchers plan to test lower doses in future studies. Idenix has been restructured in recent months; about a third of its workers were laid off last September after the FDA rejected its hep C therapy valopicitabine.

"New once-a-day NNRTIs that offer improved resistance and safety profiles over what is currently available would be a valuable asset to HIV-treating physicians," said Dr. Douglas Richman, Professor of Pathology and Medicine, University of California San Diego, and Director of the UCSD Center for AIDS Research. "The early profile of IDX899 shows promise and warrants continued clinical evaluation as a potential HIV therapy."

- check out the release for more data

ALSO: Merck says that Isentress (raltegravir) tablets in combination with other anti-HIV medicines maintained significant HIV-1 viral load suppression and increased CD4 cell counts through 48 weeks of therapy. Release

Related Articles:
Idenix restructures, cuts workforce. Report
Idenix sees little hope for hep C candidate. Report
Idenix shares soar on positive hep C study data. Report
Idenix hep C therapy misses endpoints in two trials. Report

Turbulent market forces Biolex to scrap IPO

Mon, 04 Feb 2008 06:59:54 -0500

The turbulent stock market has claimed another biotech victim. Biolex Therapeutics says it is dropping its bid to go public, the result of some lethal market rip tides that have already spurred more than a dozen companies to surrender their IPOs. Biolex and OctoPlus have been pushing the development of Locteron, an experimental therapy for hepatitis C.

- here's the report from the Charlotte Observer

Related Articles:
Biolex pockets $30M for drug discovery work. Report
Biolex garners $36M in second round. Report
Dealmaking stays big even as the markets tremble. Report

Phenomix outlines its shot at an IPO

Mon, 28 Jan 2008 06:59:57 -0500

Phenomix says now is the time to go public. The San Diego-based drug developer has filed papers with the SEC that outline an initial public offering designed to raise $86 million. Phenomix has development programs for type 2 diabetes as well as hepatitis C. Its lead program is a mid-stage DPP4 inhibitor. Its long list of venture backers include JP Morgan FUnds, Nomura Phase4 Ventures, Delphi Funds, Alta Partners Funds, Sofinnova Funds, Novartis Funds. Morgan Stanley, Credit Suisse, Oppenheimer & Co. and Pacific Growth Equities will underwrite. Phenomix was a 2007 Fierce 15 company.

- see this release
- here's the report from SoCalTech