Sanofi Aventis

EMEA issues host of decisions

Maureen Martino — Fri, 25 Jul 2008 10:54:29 -0400

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has been busy. The drug regulator released a host of decisions today, so here's the round-up:

The Committee for Medicinal Products in Human Use (CHMP) recommended approval of Bayer's blood-thinning pill Xarelto. The drugs, which Bayer hopes will generate €2 billion in sales, prevents thrombosis in patients bedridden after major orthopaedic surgery. Report
Sanofi-Aventis' Taxotere got shot down, as the agency recommended against using the drug to treat HER2 positive breast cancer. Report
The EMEA restricting the use of antibiotics based on moxifloxacin--marketed by Bayer under the name Avelox--because of the potential risk of liver damage, and also wants strengthened warnings. Report
A positive opinion was issued on marketing authorization for Ceplene for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia. Release
Novartis' osteoporosis drug Aclasta was recommended to treat the disease in men who are at increased risk of fractures. Release

Sanofi: Acomplia demonstrates better glucose control

John Carroll — Tue, 10 Jun 2008 11:56:48 -0400

Sanofi-Aventis said that a trial of Acomplia showed a significant improvement in glucose control in comparison to insulin among patients with type 2 diabetes. Glucose control was three times more pronounced among the Acomplia group compared to volunteers who received insulin and lifestyle advice.

The drug has been approved in Europe but faces a lengthy delay in the U.S. as regulators shift through data that the drug may raise the risk of depression. In the trial, 14 percent of the Acomplia drug reported symptoms of anxiety compared to five percent in the control group and 14 percent reported symptoms of depression compared to 7.5 percent in the control arm.

- check out the AFX report

ALSO NOTED: ASCO news; Acorda shares surge on data; Genentech, Exelixis and Celgene win kudos; and much more...

Mon, 02 Jun 2008 06:59:50 -0400

> Shares of Acorda Therapeutics shot up after researchers released new late-stage data demonstrating that Fampridine consistently improved the walking speeds of MS patients. Release

> Japan's Santen Pharmaceutical and MacuSight have forged a research and development collaboration and license agreement for the Japanese and Asian development and commercialization of sirolimus for ocular diseases and conditions including wet age related macular degeneration and diabetic macular edema. MacuSight gains $50 million upfront. Release

ASCO news:

> Celgene reported that a group of patients with non-Hodgkin's lymphoma responded to Revlimid. Report

> TheStreet put together an interesting scorecard on the top news coming out of the conference. Genentech, Exelixis and Celgene all get a pat on the back for their data. Story

> Poniard is hoping its chemotherapy data will win the attention of a collaborator. Report

> Novartis touted data indicating that RAD001 could be effective against breast cancer. Release

> Antisoma presented positive data for ASA404. Story

> Talk about an image being worth a thousand words. A Wall Street Journal chart tracking new Chantix prescriptions since January shows the kind of downward slope you only want to see on a double black diamond ski run. Report

> To your list of patent-lawsuits-to-watch, add a set of cases over TriCor, the Abbott Laboratories cholesterol med. TriCor is 33 years old, but it's still on patent, thanks to a series of formulation and other tweaks Abbot made along the way. That's no small thing, either: TriCor snared $1.2 billion in 2007 sales. Abbott report

> The European Commission announced it's investigating Sanofi-Aventis for obstructing its big probe of anticompetitive tactics in the drug industry. Report

> Just as the heparin hoopla was starting to settle down, now China is reporting that six patients in Jiangxi province have died after injections of immunoglobulins. Report

And Finally... A new study suggests that children in the Northeastern U.S. suffer from a high rate of cancer. Article

Aflibercept misses endpoint in mid-stage study

Wed, 21 May 2008 06:59:55 -0400

Regeneron and Sanofi-Aventis announced that their experimental therapy aflibercept missed a mid-stage goal for an ovarian cancer trial. The primary goal was a five percent response for established criteria at two dosages. At the higher dose, researchers tracked a 4.5 percent response and a 0.9 percent response at the lower dose.

Aflibercept is also being tested in late-stage trials for prostate, colorectal, pancreatic and non-small cell lung cancers. Both companies say they're now evaluating how to proceed developing the therapy.

- take a look at the announcement
- read the AP story

GSK bird flu vaccine wins race for European OK

Mon, 19 May 2008 06:59:58 -0400

After investing about $2 billion in development efforts, GlaxoSmithKline has won European approval for the first bird flu vaccine that can be used either in advance of or in the early days of a human pandemic. Glaxo is clearly expecting to see orders for Prepandrix shoot up after regulators for the European Commission firmly placed the vaccine well in the lead in the heated race to develop an antidote designed to protect populations against H5N1. Switzerland has already ordered 8 million doses, enough to inoculate its entire population. And the U.S. has ordered 27.5 million doses.

"It's clear that some governments are more proactive than others," said Emmanuel Hanon, vice president of the Influenza Vaccine Franchise at Glaxo. "The policy is evolving, and I'm looking for some kind of alignment in terms of what governments are going to do. Governments are concerned by the real medical and economic threat of a pandemic."

Sanofi Aventis and Novartis are also in the race to gain approvals for a new vaccine, anxious to capture a market that may total about $1 billion a year.

- read the story from the International Herald Tribune

ALSO: South Korea, meanwhile, mobilized soldiers for a second time to help cull millions of poultry in the face of an outbreak of H5N1 in the country's bird population. Report

ALSO NOTED: AMA joins DTC advertising fray; U.K. toughening up on pharma promos; and much more...

Fri, 09 May 2008 06:59:50 -0400

> We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. What we didn't expect was for the American Medical Association to join the fray. DTC report

> U.S. lawmakers aren't the only ones toughening up on pharma promos. In the U.K., the industry itself is strengthening its code. Report

> Sanofi-Aventis and Bristol-Myers Squibb may have squashed copycat Plavix in the U.S., but competition is now popping up in Europe. Plavix report

> We've all heard the safety warnings about the Ortho-Evra birth control patch and its link to life-threatening blood clots. Public Citizen is now campaigning to have the patch taken off the market completely. Ortho-Evra report

> Researchers are touting the early results from a study of a new brain cancer vaccine that combines protein antigens extracted from a patient's tumor and matches them with white cells also drawn from the patient. Vaccine report

And Finally... The headlines may have died down in recent months, but bird flu experts say that the threat of a global pandemic has actually been growing. Report

ALSO NOTED: AIDS vaccine researchers years away from success; Amgen reports earnings; and much more...

Fri, 25 Apr 2008 06:59:50 -0400

> Following a series of major setbacks trying to develop a vaccine for AIDS, pessimistic researchers say they're years away from success. Report

> AstraZeneca and Amgen have posted their earnings. Earnings report

> FDA inspectors found 49 problems at Merck's West Point, PA, vaccine plant--problems independent experts called "serious concerns." Merck report

> Sanofi-Aventis announced that small amounts of an impurity have been found in batches of its heparin injection Lovenox. Sanofi report

> You can't say Takeda Pharmaceutical is unwilling to take risks. The Japanese drugmaker went out on an $8.8 billion limb in bidding for the U.S. biotech Millennium Pharmaceuticals. Investors weren't impressed; they dragged share prices down by 8 percent almost immediately. Report

> After more than a decade of attempts, it looks like Congress might finally pass a bill that would block health insurers from denying coverage to otherwise healthy persons based on their genetic predisposition to come down with a particular disease. Report

> GSK is confident it can prevail in vaccine battle. Report

> Genocea Biosciences has been recognized as the best vaccine startup company at a meeting of the World Vaccine Congress in Washington D.C. Report

And Finally... The Democratic Party may not have its nominee yet, but Big Pharma apparently does. At a mock election this week at the DTC National Conference, Barack Obama trounced Hillary Clinton with 59 percent of the vote to her 40 percent. Election report

Sanofi Pasteur plans C$100M R&D facility in Canada

Wed, 16 Apr 2008 06:59:56 -0400

Score one win for Ontario province in the field of economic development. Sanofi Pasteur, the vaccine arm of Sanofi-Aventis, will build a C$100 million R&D facility in Toronto with the province chipping in C$13.9 million through its Biopharmaceutical Investment Program.

Researchers will target pediatric combination vaccines, pneumococcal protein vaccines and cancer vaccines. Look for the grand opening in 2010.

- check out the AFX report

Related Articles:
Sanofi licenses technology for new TB vaccine. Sanofi report
Maxygen, Sanofi Pasteur ink $24.5M vaccine deal. Sanofi report
Canada's streamlined approval process raises protests. Canada report
Canada's drug market slowing. Market report

Boehringer wins approval in anti-clotting drug race

Thu, 27 Mar 2008 07:59:56 -0400

Boehringer Ingelheim has stolen a march on arch rival Bayer, winning European marketing approval for a new anti-clotting agent--Pradaxa--that is likely to provide Lovenox with considerable competition. Boehringer's pill formulation is likely to be attractive compared to the injection of Lovenox, which earned €2.6 billion for Sanofi-Aventis last year. Bayer, meanwhile, has been advancing Xarelto for this market, which it forecasts will garner more than $2 billion a year. Pradaxa gets its first rollout in Germany and the UK in the next few weeks.

This first license for Pradaxa "marks an important advance and milestone in anticoagulation therapy and the prevention of potentially fatal thrombi," says Boehringer R&D chief Andreas Barner.

- here's the release on the approval
- read the story in PharmaTimes

Related Articles:
Boehringer anti-clotting drug performs in Phase III. Report
Pfizer, BMS report Phase II clotting trial success. Report
Sanofi loses Lovenox patent protection. Report
Lovenox reduces cardio risks but can cause bleeding. Report
Bayer buoyed by success in late-stage clotting trial. Report

Oxford BioMedica benefits from TroVax results

Wed, 26 Mar 2008 07:59:55 -0400

Oxford BioMedica shares were boosted by the news that its first mid-stage trial of TroVax produced encouraging results for prostate cancer. Disease stabilization in patients currently ranges from two to 10 months. And anti-tumor immune response correlated with the clinical benefit, researchers say. TroVax is Oxford BioMedica's lead cancer immunotherapy product, which is being developed in collaboration with Sanofi-Aventis. The Phase II data were presented by the clinical investigators from the Methodist Hospital in Houston, Texas.

- and check out the press release
- read the report from Hemscott

Related Articles:
Is Sanofi preparing a bid for Oxford BioMedica? Report
Sanofi inks $690M pact for cancer vaccine. Report
Oxford BioMedica says licensing talks heating up. Report
Oxford BioMedica touts mid-stage TroVax trial data. 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

ALSO NOTED: Ablynx pockets upfront fee; Plexxikon publishes cancer data; Solvay drug on fast track; and much more...

Tue, 19 Feb 2008 06:59:50 -0500

> Belgium's Ablynx says it has received an undisclosed milestone payment from Novartis for an exclusive license for a program involved in their alliance on therapeutic nanobodies. Release

> Plexxikon has published data demonstrating that its targeted cancer compound selectively destroys tumor cells which contain the B-RafV600E cancer-causing mutation, a defect present in most melanomas and thyroid tumors and a large number of colorectal and other cancers. Release

> Sanofi-Aventis and UCB have received FDA approval of an oral solution version of the allergy drug Xyzal. Release

> The FDA has accepted Cephalon's NDA for the chemo drug Treanda. Release

> Chelsea Therapeutics says it has reached an accord with the FDA regarding the design of a late-stage trial for Droxidopa, a therapy for neurogenic orthostatic hypotension. Release

> Marshall Edwards has received orphan drug status for NV-196, a treatment for Stage IIB through Stage IV malignant melanoma. Report

> The FDA has put Solvay's Duodopa, the intestinal gel being developed for patients with advanced Parkinson's disease, on its fast track. Report

> Biolex Therapeutics announced that it has entered into an agreement with Merck KGaA to evaluate antibody optimization and production in Biolex' proprietary LEX System. Release

> Behind the scenes at Enhance: Schering-Plough statisticians reviewed some data before the study was complete, according to New Jersey's Star-Ledger. Report

> It was a glitch. That's what the FDA said last week when confronted with the news that it hadn't inspected the Chinese plant that made the main ingredient for Baxter's recalled batches of heparin. Now we know just how big that glitch was: The FDA inspected and approved the wrong plant. Report

> The FDA has finally released proposed rules that would allow pharma to distribute journal articles that support off-label uses of their products--two months after an irate Congressman pulled the veil off the same proposal. Report

And Finally… The Bill & Melinda Gates Foundation has come under a rare attack for its contributions to research efforts targeted at malaria. Report

SPOTLIGHT: Buffett plows money into GSK, Sanofi

Fri, 15 Feb 2008 06:59:53 -0500

Where Warren Buffett goes, others follow--and that's why anyone holding GlaxoSmithKline or Sanofi-Aventis options is smiling today. Report

Sanofi to pay $500M for Dyax antibody program

Tue, 12 Feb 2008 06:59:58 -0500

Sanofi-Aventis has committed up to $500 million for the worldwide rights to Dyax's DX-2240 human monoclonal antibody product. Sanofi also inked a nonexclusive license to Dyax's proprietary antibody phage display technology. Dyax pockets $25 million under the deal this year. Sanofi will be responsible for the ongoing development, commercialization and consolidation of sales of DX-2240. Dyax is retaining co-development and profit sharing rights "for certain other future antibody product candidates discovered by Sanofi-Aventis." DX-2240 is a fully human monoclonal antibody that targets the Tie-1 receptor on tumor blood vessels. In preclinical animal models, DX-2240 has demonstrated activity against a range of solid tumor types.

"These strategic agreements validate Dyax's capabilities to successfully discover novel antibody drug candidates utilizing our proprietary phage display technology and advance the resulting drug candidates into development," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax.

- check out the press release

ALSO: Take a look at Sanofi's pipeline. Report

Related Articles:
Sanofi: We're looking for biotech deals. Report
Sanofi underscores pipeline advances, setbacks. Report
Dyax shares skyrocket on successful Phase III. Report
Dyax pockets $30M in revenue deal. Report

Is Sanofi preparing a bid for Oxford BioMedica?

Tue, 12 Feb 2008 06:59:57 -0500

Investors have focused their attention on Oxford BioMedica, a struggling UK developer that is the hotly rumored takeover target of Sanofi Aventis. Speculation about a possible buyout drove up Oxford BioMedica stock by 27 percent on Monday as analysts did the math on a possible deal. The company right now would probably fetch around $547 million, analysts tell the Financial Times. But a successful development program for the cancer vaccine TroVax would cost Sanofi--which partnered on the therapy--$753 million. Phase III data on TroVax is due next year while with Phase I/II data this year for a gene therapy aimed at Parkinson's.

"Sanofi Aventis has committed about £350 million and if everything is successful they are never going to pay this when the company is so cheap at the moment," says Navid Malik, an analyst at Collins Stewart. The companies, though, aren't saying anything for now.

- check out the article from the Financial Times

Related Articles:
Rumor Mill: Sanofi to buy Oxford BioMedica. Report
Sanofi inks $690M pact for cancer vaccine. Report
Oxford BioMedica says licensing talks heating up. Report
Oxford BioMedica touts mid-stage TroVax trial data. Report

ALSO NOTED: AstraZeneca may shake up R&D with spin-off; Vertex sells stock; and much more...

Tue, 12 Feb 2008 06:59:50 -0500

> AstraZeneca is considering spinning off its GI research institute into a separate company that would go out into the market and hunt for venture capital backing, according to Swedish newspaper reports. The news reports say that the pharma company is looking at spinning off five research projects. Report

> Vertex plans to sell 6 million common shares as well as $250 million in convertible senior subordinated notes due 2013. Report

> Belgium's Innogenetics says it plans to shelve new investments at its therapeutics business Genimmune. Report

> Docs needing blood-thinning drugs may be in a fix. Allergic reactions prompted Baxter to stop making multiple-dose vials of heparin, and the FDA told physicians to stop using them except when absolutely necessary--and then, very carefully. Report

> Finally, someone asked the question we've been wanting to ask ourselves: Even if the Enhance study data remained blinded, could Merck or Schering-Plough have divined its overall sway? Sen. Charles Grassley, who's been shooting out letters to the two companies at the rate of at least two a week, made the query in another round of correspondence yesterday. Report

> Schering-Plough, Sanofi and Teva have announced their earnings. Report

> While they were reporting their earnings, Schering-Plough and Sanofi-Aventis executives both found themselves on a hot seat. Report

> A protein may hold the key to a new vaccine that could effectively target pneumonia, according to Children's Hospital of Pittsburgh of UPMC. Report

> If you can't afford $350,000 to have your genome sequenced, wait awhile. The price is dropping fast. Report

And Finally… The World Health Organization says that without urgent action a billion people will be killed by tobacco this century. Release

Rumor Mill: Sanofi to buy Oxford BioMedica

Mon, 11 Feb 2008 06:59:56 -0500

Rumors are swirling that Sanofi-Aventis may be making a bid for Oxford BioMedica, a U.K.-based developer of gene-based medicines. Oxford's shares have surged in response to a report published in The Mail claiming that a Sanofi bid for the company is imminent. Neither side is sharing details, however; spokespeople for both Sanofi and Oxford declined to comment.

A takeover by Sanofi isn't out of the question, as the drug developer has indicated in recent months that it's looking to acquire a biotech. Additionally, last year Sanofi hopped on the cancer vaccine bandwagon when it inked a $690 million licensing deal for Oxford BioMedica's TroVax. However, another news source reported that the rumors are false and that Sanofi doesn't have plans to change its relationship with the company.

- read this CNN report

Related Articles:
Sanofi: We're looking for biotech deals. Report
Sanofi inks $690M pact for cancer vaccine. Report
Oxford BioMedica says licensing talks heating up. Report
Oxford BioMedica touts mid-stage TroVax trial data. Report

FDA overhauls trial design with new suicide standard

Thu, 24 Jan 2008 06:59:58 -0500

The FDA has quietly engineered the biggest change-up in the way many clinical trials are designed since the early '90s. Developers working in a range of fields including obesity, epilepsy, smoking cessation, depression and more are being required to investigate the added risk of suicide. Merck, Sanofi-Aventis and Eli Lilly are all adding suicide assessments to trials, as the FDA notifies developers of the new trial standard.

The new requirement has been in the works for several years, starting with startling indications four years ago that antidepressants increased suicide risks among children and teenagers. The New York Times adds that fresh alarm bells were rung by Acomplia, an obesity drug from Sanofi-Aventis also linked to psychiatric side effects.

- read the report from The New York Times

IDM outlines big layoff in restructuring plan

Wed, 16 Jan 2008 06:59:57 -0500

Two weeks after it was jilted in a key drug collaboration deal, IDM Pharma filed papers with the SEC saying it will lay off 60 percent of its workers at core facilities in Paris and Irvine, CA. IDM--which is based in Irvine--had already announced plans to restructure as it shelved a development program for the melanoma drug Uvidem and ratcheted back on its work regarding L-MTP-PE for osteosarcoma. The restructuring should be done earlier this year.

There's still no exact figure, though, on how many IDM workers will get a pink slip. IDM announced at the end of December that Sanofi-Aventis had decided to pull out of a partnership on Uvidem, leaving all rights for the drug with IDM.

- check out the AFX report for more info
- see this release for more

Related Articles:
IDM shares plunge on FDA's rejection. Report
IDM Pharma gets new CEO as founder departs. Report

BMS is lead player in patent-approval race

Tue, 15 Jan 2008 06:59:56 -0500

Which biopharma company was granted the most pharma patents last year? Pharmalot asked IFI Patent Intelligence the question and came up with Bristol-Myers Squibb, with 82. Wyeth, Pfizer, Hoffman LaRoche, Merck, AstraZeneca and Eli Lilly followed in due order of innovation. These are all class 514 patents approvals, as distinct from filings. As Pharmalot points out, there is always a hefty backlog of patent filings. Interestingly, Sanofi-Aventis, which has been hammered by the analysts for its thin pipeline, came out near the bottom of the list, behind the University of California. Tech companies put the biopharma industry to shame though. IBM alone filed 3,148 patents last year.

- read the report from Pharmalot

Related Articles:
Patent 'cliff' looms for Big Pharma. Report
Standards on biotech patents get tougher. Report
Sanofi underscores pipeline advances, setbacks. Report