The Big Red Biotech Blog

Sanofi: "My GLP-1 Can Beat Your GLP-1 (Byetta)"

Sanofi reported that its GLP-1, lixisenatide, bested the GLP-1 Byetta, exenatide, in a head to head trial of type 2 diabetes patients.  The lixisenatide arm experienced many fewer hypoglycemia events (about 6-fold fewer). 

Sanofi's GLP-1 drug when approved will take on Novo Nordisk's Victoza and Amylin/Lilly's Byetta.  It's being billed as a blockbuster candidate by many analysts.  This is especially true with the world's diabetic population expected to explode from 285 million to more than 435 million in the next 20 years - keep eating that quality Western diet. 

Sanofi is playing catch up with its GLP-1 version so this type of result with a putative direct competitor product is a good shot in the arm.

 

 

 

 

 

 Posted by Bruce Lehr Feb 2nd 2011.

Vertex Urges CDC to Adopt Hep C Screening to Spur New Wave of Patients

Now that Vertex has convinced the FDA to give its Hepatitis C drug, telaprevir, expedited review, it is now working on convincing the CDC to help it get more patients. Xconomy reports that Vertex is lobbying the CDC to recommend that most people over 50 get blood tests for hepatitis C infection.

Vertex Urges CDC to Recommend Hep C Screening, To Nudge Second Tsunami of Patients.

Vertex is working with other companies in the Viral Hepatitis Action Coalition to fund a $3.6 M research study to assess whether this type of screening program would be cost effective.  There are currently 600,000 patients in the US who are expected to seek treatment for hepatitis C from either Vertex's telaprevir or Merck's similar drug (also receiving expedited review).  However, the screening program envisioned could generate an additional 1 M patients for both companies - out of an estimated 3 to 3.9 M persons in the US with chronic hepatitis C infections.

With such an untapped patient market, and a better therapy to boot, analysts are predicting that Vertex's telaprevir could be a more than $2 B blockbuster at annual peak sales. To make sure it gets there, Vertex is spending money on a public awareness campaign for hepatitis C and also is working hard to get the CDC's support for screening. 

 

Posted by Bruce Lehr Feb 2nd 2011.

 

Roche Swallows Bitter Pill - Cuts Taspoglutide

As reported in Fierce Biotech, Roche has decided to cut its losses and kill the taspoglutide development program.  The drug experienced a publicized late stage failure last year.  Roche's decision to cut the program leaves its development partner Ipsen with a 500 M euro bill for the costs of phase III development and trials. OUCH!  Ipsen may be tempted to engage in a last ditch effort to save the drug -- although analysts believe this to be unlikley.

 

Time for that spoonful of sugar.

Posted by Bruce Lehr Feb 1st 2011.

 

 

GSK and Actelion Do Not Have the Perfect Sleeper

Again as reported in Fierce Biotech, GSK and Actelion have pulled the development plug on their insomnia drug, almorexant over patient tolerance conerns. This after GSK had signed a deal with Actelion in 2008 for up to $3.25 B in upfronts and milestones.

Almorexant was targeted to treat insomnia and also Alzheimer's and insomnia-related depression (it is likely inducing some of this now!).  The drug had been projected by [very] eager analysts to hit peak sales of as much as $6 B annually - that's quite a Mother's little helper.

But now due to safety concerns, instead of putting people to sleep the drug itself will be laid to rest.

Goodnight Gracie.

 
Posted by Bruce Lehr Jan 28th 2011.

Sanofi PARP Inhibitor Fails Phase III Breast Cancer Trial

As reported in Fierce Biotech, Sanofi's late stage breast cancer drug, iniparib, failed to meet its endpoints in a phase III trial of triple negative breast cancer patients. Sanofi had spent $500 M to acquire BiPar and its new PARP inhibitor drug and had hoped to apply it to difficult to treat triple-negative breast cancer patients.  The drug failed to work.

This is bad news for Sanofi and its CEO Chris Viehbacher as iniparib had been projected to reach peak annual sales in excess of $1 B.  Iniparib, among the first of Viehbacher's acquisitions at Sanofi, was projected to offset some of the lost revenues the company expects when Lovenox and Plavix lose patent protection soon.

In the usual corporate refrain in such situations, Sanofi will further analyze its results before reporting its options. The drug is in other late stage trials for squamous NSCLC and in phase II trials for other lung and breast cancers.

 

 

Posted by Bruce Lehr Jan 28th 2011.

Eisai Blockbuster Candidate Dies in Phase III

Eisai announced that its potential blockbuster anti-sepsis drug, Eritoran, is being dumped due to poor results in a pivotal phase III trial.  The drug failed to outperform the placebo in the study. Thus, Eisai halts a program that had been targetting a regulatory submission only two months from now.

This is a bitter setback as Eritoran had been projected to deliver more than $1 B in annual sales when approved in both the USA and Europe, and peak sales were projected as high as $2 B per year by some industry analysts. This is particularly troubling for the company as its lead Alzheimer's drug Aricept is losing share and dollars to generic competition. Eisai said it would continue to study its options with Eritoran as it quietly retreats for now. See Fierce Biotech.

 

 

Posted by Bruce Lehr Jan 25th 2011.

Lilly Alzheimer's Diagnostic Expected to Get FDA Approval

Seeking Alpha says it is only a matter of time before Eli Lilly's newly-acquired Alzheimer’s disease diagnostic, florbetapir, wins FDA approval.  Lilly purchased florbetapir last November for $300 M from Avid Radiopharmaceuticals. 

Florbetapir, also known as AV-45 and which Eli Lilly has branded Amyvid, is an imaging agent which binds to the characteristic beta-amyloid plaques found in the brains of Alzheimer’s patients. This essentially dyes the plaques, which can then be seen on a PET scan.  Amyvid will help doctors rule out the degenerative brain disease if there is an absence of plaques.

Amyvid, and other Alzheimer’s and dementia diagnostics, will really come into their own when therapies become available and early diagnosis becomes more important, although it is possible that simpler tools will be available by then. In the meantime, with a lot of research into therapies that target beta-amyloid, Amyvid could well find an important role in clinical trials. Eli Lilly has one of the most advanced agents pursuing this avenue, solanezumab, which breaks up the beta-amyloid clumps. Amyvid should be able to track this happening.

This will be interesting to watch. The industry seems to strongly believe that companion diagnostic tests will become very important  in the future with these more complex diseases in establishing treatment effectiveness or even identifying which patient classes should receive a given therapy.

 

 

Posted by Bruce Lehr Jan 23rd 2011.

EMA Committee Backs Novartis' Gilenya MS Pill

The WSJ reports that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended that oral MS drug, Gilenya, be approved for the treatment of patients with highly active relapsing-remitting multiple sclerosis.

The news should pave the way for EMA approval and give Novartis the chance to launch this purported blockbuster in 2011.  The EMA final announcement is expected in about 3 months.  An approval will give Novartis a further leg up on its competitor Merck KGaA's cladribine which failed to get market approval in Europe. Biogen Idec also failed (coincidentally) on Friday to gain EU approval for its oral MS drug, Fampyra.  Novartis will soon be able to go after its share of the $10 B MS market.

Novartis will present a strong challenge to the others MS drug players including Biogen, Bayer and Teva. Teva's Copaxone had $2.8 B in sales in 2009 and Biogen's Avonex added accounted for another $2 B.  Because Gilenya is a pill and not a daily injection, analysts believe Gilenya can vault to sales of $3.5 B or more.  Patient groups welcomed the news.  There are about a half-million MS patients in Europe.

 

 

Posted by Bruce Lehr Jan 23rd 2011.

 

Biogen Reports 6 New PML Cases with Tysabri

As reported in Reuter's on Friday, Biogen acknowledged that 6 new cases of progressive multifocal leukoencephalopathy (or PML) occurred in December bringing the total now to 85 reported cases.  Of the 85 cases of PML reported, 16 patients have died, while 69 are still alive with varying degrees of disability.  

Biogen temporarily withdrew Tysabri from the market in 2005 after it was first associated with the condition; it was brought back, with stricter safety warnings, in 2006.The drug is widely considered the most effective on the market, but its sales have been crimped by concerns over PML. The risk of the condition increases with the length of treatment.After two years of monthly infusions, the incidence of PML is now 2.13 per 1,000 patients.

The overall rate of PML in clinical trials was 1 in 1000, a benchmark that has now been exceeded.  Biogen is developing a test that it hopes will allow doctors to screen patients to identify which might be more likely to develop PML.  Biogen shares were down $2.02 or 2.9 percent on the news. 

 

 

Posted by Bruce Lehr Jan 23rd 2011.

 

 

Ariad Pharma Stock Up 25 Percent on Phase III Data

Ariad reported very positive results with its drug, ridaforolimus, in a phase III trial with patients with soft-tissue and bone tumors. The study showed patients' median progression-free survival increased by 21% to 17.7 weeks as compared to a placebo.

Ariad Pharma Stock Up More than 25 Percent on Positive Phase III Data.

Merck, which paid Ariad $50 M upfront plus $19 M in R&D funding in May, plans to file for approval this year.  Merck could pay Ariad an additional $514 M in milestones if the drug is commercially successful. Merck also plans to develop the drug toward other cancers. Ariad's stock rose more than 25% on the basis of the positive phase III news.

 

 

Posted by Bruce Lehr January 20th 2011.

CEO Witty Outlines GSK's Plan

This from a Forbes interview with GSK's CEO Andrew Witty discussing the Company's plans to grow sales in the wake of its ssuess with patent expirations and its pipeline and Avandia problems. Says Witty, "Drug companies became complacent in the 1990s. They were slow to react when insurers rebelled against me-too drugs and regulators became more worried about side effects."

He's decided that GSK will shun megamergers and shift its resources toward emerging markets that are eager to get access to Western drugs, and to stable markets like vaccines and consumer products.  Only 23% of GSK's $44 billion in annual sales now come from selling drugs in big Western markets, down from 40% in 2007, and 24% come from emerging markets. 

Through such a strategy, Witty hopes to stabilize GSK's revenues until its R&D can come through with new breakthrough medicines.  He needs the R&D breakthrough too as GSK's shares have declined 20% since late 2005, and its sales are stagnant. 

GSK cleared the me-too drugs out of its pipeline.  Glaxo now has projects on everything from stem cells to gene therapy for rare immune diseases to an emerging area called epigenetics, which looks at how genes are modified.   Almost all of the 18 new drugs in late-stage trials are totally new classes of medicines -- including the first treatment to delay the progression of Type 1 diabetes, a vaccine to prevent lung cancer from recurring, and the first drug in a new class to prevent heart attacks by stabilizing plaque in arteries. The latter could hit $10 billion in sales if it works.

Glaxo's first big success may come early next year, if its new lupus drug, Benlysta, is approved by regulators. It would be the first new drug for the autoimmune disease in 50 years. While GSK's partner Human Genome Sciences invented the drug, Glaxo invested in HGS' gene-hunting technology back in 1993 and stayed the course even after murky early results. With little competition, it could reap $5 billion in sales despite its modest effectiveness.  Based on this, some analysts predict Glaxo's sales will grow at a 7% clip over the next five years, versus 3% or 4% for the rest the industry.

One naysayer, Harvard Business School professor Gary Pisano, doubts the R&D reorganization will make a big difference. The core problem afflicting drug firms isn't bureaucracy but a "lack of deep understanding of disease biology. How you organize it isn't going to solve that," he says.  "Unless a company can develop world-class science, these units will have the same poor track record as biotech [in developing drugs]."

GSK's Witty is placing a big bet on the success of his plan.

 

 

 

 

Posted by Bruce Lehr Jan 4th 2011

 

 

New Drugs 2010 - Fewest FDA Approvals since 2007

Here's a piece republished in its entirety from Bloomberg. 

Twenty-one new drugs were approved in the U.S. this year, the fewest since 2007, as the Food and Drug Administration showed more willingness to delay or reject medicines with potential safety risks.

The tally, compiled by Bloomberg from an FDA database, compares with 25 approvals last year and 24 in 2008, according to the FDA’s website. Nineteen new drugs were cleared in 2007, the fewest in 24 years.

Today marks the last regular work day of 2010 for the U.S. government. This year, the FDA also restricted the use of London-based GlaxoSmithKline Plc’s diabetes pill Avandia and withdrew from the market the weight-loss drug Meridia made by Abbott Park, Illinois-based Abbott Laboratories. The agency citied heart complications in both actions.

“There’s a sense that the FDA is being more cautious,” said Les Funtleyder, a fund manager at Miller Tabak & Co. in New York, in a telephone interview. “If the rules get too onerous, it could potentially keep innovative drugs out of U.S. hands.”

My comments is that the drug makers and agency still need to work harder at collaboration during the drug development process and in defining data needed from clinical trials and designs needed to generate same.  The industry is struggling enough with a withering R&D pipeline. It really cannot afford to have drugs go down as frequently as has been the case in the past few years in phase III.  Also, there needs to be a reality check by industry to NOT put drugs into late stage clinicals that do not have a chance to better the results of products that are already out there.  In many cases, we simply need to be testing better drugs that are designed to deliver better benefits. 

 

 

 

Posted by Bruce Lehr December 31st 2010.

 

Cancer Drugs in Combination - A New Testing Trend?

This piece comes from Xconomy and notes that Merck and Sanofi are joining forces to test new cancer drugs in combination - a trend that appears to be gaining traction with other players in the oncology field as well.  Combination therapies are often used in cancer.  However, historically the combinations weren't tested together until each drug separately reached a fairly late stage (or was already approved).  Now we have companies developing philosophies to test drugs in combination at an early stage of clinical trials.  This is particularly popular in the treatment of cancer as frequently several signalling pathways that could affect the disease may be simultaneously attacked.

Previously, Merck and AZ have teamed up with their respective AKT  and MET inhibitors.  Now Merck and Sanofi plan to test their SAR245408 and SAR245409 inhibitors of the PI3K/mTOR pathway. Both partners will test each other's drug in combination with their own in Phase I trials.

The FDA issued draft guidelines designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses. In addressing the new guidelines, FDA commissioner Margaret Hamburg said they are the result of a growing understanding that experimental therapies may need to be used together in order to be more effective or to prevent drug resistance.

Despite the excitement, efforts to study investigational drugs in combination are still in their infancy. Phase I is the first stage of clinical testing, so these new drug “cocktails” are still several years from reaching the market. Scientific, clinical, regulatory and intellectual property hurdles all must all be overcome if these novel combinations are to provide breakthrough cancer therapies for the patients who desperately need them.

 

 

Posted by Bruce Lehr December 30th 2010.

Seattle Genetics Gets Glowing Review of Prospects

Seeking Alpha's Michael Bryant waxes positively about Seattle Genetics prospects for the next few years and recommends it as an investment candidate.  This is largely based on the Company's success with SGN-35 and its promising collaboration with Millenium (Takeda) with the phase III drug for the treatment of relapsing Hodgkin's lymphoma. 

SGN appears to be in good cash position, has a late stage candidate which looks like it will gain approval, is managing its burn rate -- and has promising "empowered antibody" technology for oncology -- a hot area.  It may also be an attractive acquisition candidate given its promise and the faltering pipelines of many in Big Pharma -- who have the cash but no pipeline candidates and a dire revenue need in the short term.

 

Posted by Bruce Lehr December 30th 2010.

AstraZeneca drops drug, takes $445 mln charge

AstraZeneca axed its RSV drug motavizumab and with it took a $445 M write off.  What's more?  This kills its chance to bring to market a successor to its blockbuster Syngaxis. Woe is me!

PharmaGossip: AstraZeneca drops drug, takes $445 mln charge | Reuters.

Ultimately, the new therapy failed to show improvement over Syngaxis and also exhibited significant side effects. So far as a result, AZ's acquisition of MedImmune for $15.6 B has been a complete bust in terms of delivering new licensed biotherapeutics to market - and the old ones are losing patent protection.

This is a GIANT lump of coal this Christmas.

 
 
Posted by Bruce Lehr December 21st 2010.

Lilly on a Roll! 4th Drug Down in 4 Months

A dozen deaths in a phase III trial apparently is not a good sign.  Lilly suspended the current trial on its melanoma drug, tasisulam after just such a result.  This follows failures with teplizumab for diabetes, Bydureon for diabetes, and semagacesta for Alzheimer's in just the past four months.  See Fierce Biotech. What do you do for an encore from here?

CEO John Lechleiter earlier in the year was crowing about Lilly's strong pipeline and used that as one of his main reasons the company was NOT going to be involved in the acquisiiton frenzy -- at least for a major-sized company.  Now what?  Anybody got the M&A team on speed dial? 

Posted by Bruce Lehr December 14th 2010.

EMA Does No Better than FDA with Clinical Trial Site Inspections

According to this analysis published in Outsourcing-Pharma.com, the EMA inspects fewer than 1% of clinical trial sites included in marketing authorization application (MAA) submissions that it is meant to regulate. Of course, this is resource related as claimed by almost every other regulatory agency in the world, including the FDA.  See here for post where GAO criticized FDA in November for poor implementation of foreign clinical trial inspections.

The Outsourcing Pharma post created an interactive map showing GCP inspections of a country’s trial sites as a percentage of its sites included in MAA submissions. The map can be filtered to show the percentage of inspections in any year from 2005 to 2009. Furthermore, clicking on a region in the graph below filters the map to show data from countries in that part of the world.

Posted by Bruce Lehr December 13th 2010.

Genentech: Sometime Two mAbs Better than One for Breast Cancer

As reported in Xconomy, Genentech's pertuzumab may be making a comeback - albeit somewhat limited - as a second antibody used in combination with trastuzumab (Herceptin) in some breast cancer patients. This is good news for an antibody that many thought dead and buried in 2005.

Genentech's Old Antibody Shows New Life, as Part of Combo Therapy Vs. Breast Cancer.

Pertuzumab targets a different portion of the HER2 receptor than Herceptin and has surprisingly, perhaps, been shown to offer greater clinical benefits to some patients when used in combination with Herceptin and standard chemotherapy.  In a trial of 417 newly diagnosed patients, tumors disappered in 45.8 percent receiving the two antibodies as compared to 29 percent for those receiving Herceptin alone.

Phase III trials will now be conducted by Genentech and the possibility exists for pertuzumab to join trastuzumab as an enhanced treatment regime for HER2 positive breast cancer.

 

Posted by Bruce Lehr December 10th 2010.

Seattle Genetics Reports Groundbreaking Results With SGN-35 for Hodgkin's

Seattle Genetics will report results today at ASH Meetings of its clinical trials with SGN-35 (brentuximab vedotin) on relapsing Hodgkin's disease patients.  In the latest clinical trial, 94 percent of the patents had at least some observable tumor shrinkage - 75% saw at least 50% shrinkage and 34% went into complete remission. Side effects were mostly mild compared to conventional chemotherapy.

Seattle Genetics Report Groundbreaking Results With Drug for Hodgkin's.

The results are being hailed as groundbreaking by company officials and some clinicians involved in the clinical trials. This is the first success of a so-called empowered antibody (antibody drug conjugate) and is being closely watched in the industry. Seattle Genetics plans to file an application with the FDA by the end of March seeking approval.  About 1/3 of the 8500 patients diagnosed with Hodgkin's will relapse at some point during their treatment. Seattle Genentics is aready talking about testing the hypothesis that the drug has the potential to be the standard of care with chemotherapy for 100% of newly diagnosed Hodgkin's patients.

Seattle Genetics controls 100% of the commercial rights in the US.If approved, Seattle Genetics will have its first product on the market and will begin to transform itself from and R&D organization to a more fully integrated commercial one. By the end of 2011, the company expects to add a commercial team numbering 110 and overall staffing could grow to 475-500 employees in the next 12 months.

"We want to be the next Celgene, the next Genzyme, the next really important biotech company," said Clay Siegall, Seattle Genetics CEO.

 

Posted by Bruce Lehr December 6th 2010.

Seattle Genetics Nears Finish Line with SGN-35

As reported by Bloomberg, Seattle Genetics and its partner Takeda are expecting to apply for approval of their antibody drug conjugate, SGN-35, for the treatment of lymphoma when the latest clinical data is reported next week.  SGN-35 will then be able to beat Roche's own ADC, known asT-DM1, to market (albeit for a different clinical application) and become the only ADC approved by the FDA at that point.  A previous ADC, Mylotarg, was withdrawn from the market earlier this year by Pfizer. SGN-35 is expected to generate as much as $420 M annually by 2015 if approved.

Seattle Genetics, which has no marketed products, plans to apply to the U.S. Food and Drug Administration for conditional approval of SGN-35 in the first half of 2011, said Chairman and Chief Executive Officer Clay Siegall. That process would allow the drug to be used while the company conducts confirmatory studies. If the agency agrees, SGN-35 may be in doctors’ hands by the end of 2011, Siegall said in an interview.

The industry has been anxiously watching both SGN-35 and Roche's T-DM1 as these new class of drugs promise to make a large impact on the treatment of various cancers by allowing the targetted delivery of high-potent toxins to cancer cells.  When these drugs are approved and prove themselves in the clinic, analysts expect a new wave of further therapies to follow using this strategy. 

Seattle Genetics and other partners are also testing different antibody-drug combinations for treating cancers of the kidney, prostate, pancreas and other organs. The allies include Roche’s Genentech unit; Bayer AG of Leverkusen, Germany; Celldex Therapeutics Inc. of Needham, Massachusetts; Daiichi Sankyo Co. of Tokyo; GlaxoSmithKline Plc of London; AstraZeneca Plc of London, and Astellas Pharma Inc. of Tokyo.

 

Posted by Bruce Lehr December 4th 2010.

Idenix Pharmaceuticals Gets $20 Million Payment From ViiV for HIV Trial

A few days ago, I posted a piece quoting GSK's Chief Strategy Officer, David Redfern, on possibility that GSK and Pfizer might well spin off its jont venture ViiV Healthcare sometime in the future.  ViiV was formed in November 2009 by the two companies as an independent compnay focused on research, development and commercialization of HIV medicines.

Idenix Pharmaceuticals Announces $20 Million Milestone Payment From ViiV Healthcare For Initiation Of Phase IIb Trial Of '761.

Today, ViiV is paying a $20 M milestone payment to Idenix as its treatment known as '761 is moving into a Phase IIb trial in HIV-infected patients.

 

 

Posted by Bruce Lehr November 24th 2010.

GSK files IND using Vivalis EB66 cell line to produce Flu Vaccine

GSK and its partner Vivalis (France) received clearance from the FDA to begin testing an influenza vaccine in a Phse I trial in humans that will be produced in the Vivalis EB66 duck stem cell line. This is the first trial for the line as an alternative and better technology than chicken eggs for producing vaccines. The flu vaccine could be marketed as soon as 2015 if it progresses through its trials according to plan.

VIVALIS' EB66^® platform, which was used to develop the EB66^® cell line, uses a revolutionary technology to derive avian-based stem cells for vaccine production. EB66^® cells are non-genetically modified and represent the closest cell-based substrate for chicken egg substitution. Unlike many other cell lines, the EB66^® cell line does not require the use of viral genes to enable continuous and stable growth.  

Vivalis issued a press release that further states:

"This achievement supports the regulatory review of the EB66^® cell line by the US FDA and the corresponding Biologics Master File submitted to the agency in 2008.  Evaluation or development programs for EB66^® cells are being conducted by over 75% of the world's leading vaccine developers in human and animal health, with over 25 license and commercial agreements in place to date. Influenza is the largest and fastest growth sector in the vaccine field, having sales of $2.8 billion in seven major markets. This milestone is shared not only by VIVALIS but also our dedicated partners and shareholders.  We continue in our commitment to advancing innovative technologies in markets where commercial success is defined by safety, efficacy, and efficiency," said Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS.  

SAFC collaborated with Vivalis on the creation of serum-free cell culture growth and viral production media to be used specifically with the EB66 cell line.  See here for more information on EBx Media and Feeds on the SAFC website.  

Posted by Bruce Lehr November 24th 2010.

 

 

Vertex Seeks FDA Green Light for Hepatitis C Drug; Seeks Expedited Review

As reported in Xconomy, Vertex has filed an NDA for its new treatment, telaprevir, for hepatitis C infection.  The company is asking the FDA for Priority Review which generally occurs in 6 months instead of the normal 10 months.

Vertex Seeks FDA Green Light for Hepatitis C Drug; Chomps at the Bit For Fast Review.

The priority review request is based on the results of three Phase III trials with over 2000 patients.  The three trials established the following in Vertex's point of view:

• Telaprevir in combination with standard meds coudl cure 3/4 of patients getting their initial round of therapy
• Telaprevir can shorten the standard treatment by 50%
• Telaprevir could cure 2/3 of patients who failed to respond in a prior round of therapy

Taken together, Vertex expects to introduce a new treatment regimen that will roughly double the cure rate of the existing regimen while also delivering fewer side-effects.  There are an estimated 6 million patients in the US and Europe, with another 170 million worldwide.  Vertex could experience annual sales of more than $2 B per year in the US alone due to pent up demand for a more effective hepatitis C treatment.

 

Posted by Bruce Lehr November 23rd 2010.

 

 

Merck Scores Coup with its CETP Inhibitor at AHA Meeting

 

According to Fierce Biotech, Merck greatly impressed an audience at the American Heart Association meetings with "jaw-dropping" data on its new CETP inhibitor, anacetrapib.  Remarkably, in a small clinical trial, the drug increased the "good cholesterol" HDL by 140% and decreased the "bad cholesterol" LDL by 40 percent.  The study's lead investigator indicated the results were wildly unexpected in both directions.

Analysts think Merck may have a mega-blockbuster on its hands with this brand new class of drug - some have predicted that anacetrapib could rack up numbers like Pfizer's Lipitor someday. Merck is anxiously trying to avoid the catastrophic failure Pfizer experienced with torcetrapib, another CETP inhibitor. Four years ago Pfizer had to halt its pivotal study after finding that the drug arm was experiencing a higher death rate.  Merck designed this initial smaller trial to look at both the therapeutic effects and at patient safety as a result.  In this trial, no significant adverse effects were noted.  Now Merck will move on to another larger trial.

In a related post in the Forbes blog, Harlan Krumholz lauds Merck for "doing the right thing" with its trial design - given Pfizer's safety disaster with torcetrapib in late stage clinicals.  Torcetrapib was anticipated to be a sure blockbuster but was found to increase deaths and heart disease events in a large clinical trial. The results surprised most observers as the drug seemed sure to be a great success.

This Merck's DEFINE study, presented to a plenary session at the meeting, confirmed the drug’s powerful effect on laboratory values. It also showed that the drug did not have a major harm or benefit – though it was too small to detect modest harms or benefits. Nevertheless, the drug has passed an important test with this trial – and Merck is now proceeding with the next step, a large clinical trial. Merck did the right thing in looking at the safety aspects too in this early stage with an appropriately designed study.  Anacetrapib will not reach the market until at least 2015, but it has passed the latest step in a way that takes patient safety in mind, as well as clinical results.

 

 

Posted by Bruce Lehr November 18th 2010.

 

Insider Trading on HGS Clinical Trial Info?

As reported in the WSJ Health blog yesterday, the SEC has charged a French physician, who served on the clinical trial committee for a Human Genome Sciences' (HGS) hepatitis C drug, with one count of conspiracy to commit securities fraud and one count of securities fraud.

The good doctor is alleged to have tipped off hedge fund managers about adverse effects of HGS albuferon in ongoing hepatitis C trials in 2007-08. Six fund mangers subsequnetly dumped their position in HGS stock prior to any public announcment of problems with the drug for this indication.  This resulted in stopping losses of nearly $30 M after they sold their 6 million plus shares.

The good doctor, Yves M. Benhamou, might give Sam Waksal a call to ask about prison food, appropriate attire and etiquette.   Besides, with Yves expertise in hepatitis C - Sam's new Kadmon group may be in need of consultant help with their hep C trials.

Posted by Bruce Lehr November 3rd 2010.