Sanofi-Aventis

Sanofi discontinues clinical trials for Acomplia

John Carroll — Wed, 05 Nov 2008 11:54:00 -0500

Sanofi-Aventis is discontinuing all ongoing clinical trials for its obesity treatment Acomplia. The pharma giant said it was prompted to halt the trials after the European Medicines Agency concluded that the patients taking Acomplia experienced a doubled risk of psychiatric disorders when compared to the group taking a placebo.

"The decision has been taken in light of recent demands by certain national health authorities," the company said. "This announcement does not change the company's guidance for 2008."

Sanofi says it will notify the healthcare professionals involved in the trials later today.

- check out the report from Dow Jones

Analysts: Look for shake-up at Sanofi

Maureen Martino — Mon, 03 Nov 2008 11:51:13 -0500

As Sanofi-Aventis announced its Q3 earnings today, analysts are looking ahead to December when ex-GSK exec Chris Viehbacher (photo) will take over as CEO. Many anticipate that Viehbacher will institute major changes to help the company cope with a number of challenges, including patent expirations, the withdraw of Acomplia in Europe, and several failed clinical programs. "Sanofi's stock is one of the cheapest in the drug industry, reflecting investor concern that the company doesn't have enough drugs in development to keep sales growing," notes the WSJ.

The drugmaker has already taken some steps to fill the gaps. Sanofi has boosted its generic drug business with the $2.6 billion buyout of Zentiva, and expanded its R&D presence in China. Like many other developers, Sanofi is increasing its focus on biologics. While the drugs only account for about 10 percent of the company's sales, Sanofi wants to up that number to 20 or 30 percent by 2012.

- see the WSJ report

Sanofi-Aventis expands its R&D work in China

Christe Bruderlin-Nelson — Wed, 22 Oct 2008 11:36:12 -0400

Here's one more sign that China is growing as an R&D hub for biopharma. France's Sanofi-Aventis announced it will expand its research and development functionality in Shanghai, China. In a new partnership with the Shanghai Institutes for Biological Sciences, the company will work on drug discovery in the areas of cancer, diabetes and neurological disease, and will put a new biometrics facility in Beijing. The facility in Shanghai has been there since June of 2005 and functions in the full spectrum of drug discovery.

The new facility in Beijing, which it hopes will be in full operation by year's end, will be more specialized, handling specifically data management, study design and statistical analysis.

"A comprehensive development program for vaccines is already on-going in China and we are looking forward to its expansion in the near future," said Dr. Michel DeWilde, Senior Vice President, Sanofi Pasteur R&D.

- read Sanofi's release

Sanofi-Aventis - Biotech Market Share Report

Maureen Martino — Sun, 28 Sep 2008 21:00:39 -0400

Company: Sanofi-Aventis
2007 Sales: $3.2 billion
Market share: 4.3%
CAGR: 37.7%

What they have: Sanofi's top-selling biotech blockbuster is Lantus, a Type 1 and 2 diabetes treatment. The company also markets a host of vaccines through Sanofi Pasteur, the vaccine division of Sanofi-Aventis.

What to look for: Currently, only 10 percent of the drugs Sanofi makes are biologics; in an interview, Senior Vice President, Scientific and Medical Affairs Mark Cluzel said the company wants to boost that number to 20 or 30 percent by 2012. Sanofi is collaborating with Regeneron on its drug Aflibercept (VEGF Trap), a cancer drug in late-stage trials for prostate and lung cancer.

GSK's Viehbacher picked as Sanofi CEO

Maureen Martino — Wed, 10 Sep 2008 10:28:49 -0400

When GlaxoSmithKline's Chris Viehbacher (photo) announced his plans to leave the company, everyone wondered where he would head next. Apparently it's the CEO spot at another company--the position he was passed over for at GSK. As of December 1, Viehbacher will replace Gerard Le Fur as CEO of Sanofi-Aventis. Article

Sanofi-Aventis scores positive data in Multaq trial

John Carroll — Wed, 03 Sep 2008 10:54:49 -0400

The experimental heart drug Multaq, being developed by Sanofi-Aventis, reduced the risk of stroke by a third among elderly patients suffering from atrial fibrillation. The trial pitted Multaq against a placebo.

"These are extraordinarily impressive trial results," said John Cam, professor of clinical cardiology, at St George's Hospital Medical School. "No other anti-arrhythmic drug has had a positive outcome of this nature in atrial fibrillation. The 34 per cent reduction in relative risk of stroke is amazing for a drug that is not an anti-coagulant."

Researchers say that the positive effect of the drug was seen early in the study and was maintained during the 12 to 30-month follow-up. That data helps underscore the drug's potential, with analysts estimating future revenue from an approved product at around $2 billion a year. The trial involved 4,628 patients over the age of 70.

- read the report from the Telegraph

Regeneron licenses tech to Sanofi in $21.5M deal

John Carroll — Tue, 05 Aug 2008 12:34:58 -0400

Sanofi-Aventis has agreed to make five annual payments of at least $4.3 million to Regeneron Pharmaceuticals in exchange for the rights to use its Velocigene technology. Regeneron posted losses of $125 million in the last fiscal year. The technology will be used to develop knock-out and transgenic models of gene function for target genes identified by Sanofi-Aventis. Sanofi-Aventis will use these models for its internal research programs, outside the scope of its antibody collaboration with Regeneron.

- here's the press release
- read the report from Business in the Burbs

Acambis shares soar on $548M buyout deal

John Carroll — Mon, 28 Jul 2008 10:38:33 -0400

Shares of Acambis soared after Sanofi Pasteur, the vaccine division of Sanofi-Aventis, announced that it planned to buy the vaccine developer for $548 million. Aside from the smallpox vaccine ACAM2000, which recently won a 10-year, $425 million contract from the U.S. government, Sanofi-Aventis also gains a slate of experimental vaccines for dengue fever, West Nile disease and clostridium difficile, influenza and genital herpes.

Sanofi Pasteur and Acambis are partnered on a variety of development programs already. And the deal underscores just how attractive vaccine companies have become. Sanofi-Aventis "quite liked what we had in Acambis," said Acambis Chief Executive Ian Garland.

- check out Sanofi's release
- read the Wall Street Journal report
- here's the AP story

4. Sanofi-Aventis - Top 15 R&D Budgets

Maureen Martino — Wed, 28 Nov 2007 09:36:32 -0500

Who: Sanofi-Aventis

Based: France

2006 Pipeline Budget: $6.44 billion (€4.40B)

2007 Pipeline News: Sanofi-Aventis has been thus far unsuccessful in gaining FDA approval for its potential blockbuster Acomplia in the U.S. Additionally, its Alzheimer's drug Xaliproden failed late-stage trials. However, Sanofi’s antidepressant saredutant passed its late-stage trials, setting up a schedule to file for approval in Europe and the U.S. next year, and the company has several promising entries lined up for the hot vaccine market. Sanofi has 48 therapies in late-stage development and expects to file on 31 of them by the end of 2010.

Phase III
> Rimonabant (Acomplia) - Type 2 diabetes
> NV1FGF (fibroblast growth factor) - Critical limb ischemia
> Eplivanserin, Volinanserin (5-HT2A antagonists) - sleep maintenance.
> Saredutant - Major depressive disorders and general anxiety disorders
> Amibegron - Major depressive disorders and general anxiety disorders
> Aflibercept (VEGF Trap): Advanced ovarian cancer, prostate cancer, non-small cell lung cancer
> S-1 - Second-line treatment for pancreatic cancer
> Menactra Toddler - Meningococcal meningitis
> Low-dose H5N1 flu vaccine with adjuvant
> Dianicline - Smoking cessation
> Ilepatril - Blood pressure reduction and long-term cardiovascular and renal protection.

Full Pipeline Site: Link

Big Pharma takes an interest in cancer vaccines

Maureen Martino — Wed, 19 Sep 2007 10:49:50 -0400

For two decades, biotech companies have struggled to develop therapeutic cancer vaccines designed to treat the disease by stimulating the immune system to attack cancer cells without harming normal cells. This approach would be a major step forward for cancer treatment, as current therapies attack both diseased and healthy cells and can result in hair loss, vomiting and infection.

So far, the FDA has yet to approve a single therapeutic cancer vaccine. The issue is that the vaccines must do more than slow tumor growth – they must actually improve patient survival, which can take years to measure, requiring long Phase III trails. But a crop of late-stage cancer vaccines are showing a lot of promise and attracting the attention of large pharma and biotech companies. “There are possibilities here, and now the big companies are starting to be interested, but they haven't had the courage before because it has been too risky for them," noted Haakan Mellstedt, a professor in oncological biotherapy at Karolinska Institutet in Stockholm. Cancer treatment is a $50 billion annual market, and research firm Arrowhead Publishers says that if approved, cancer vaccines could grab $6 billion in annual sales by 2010. Analysts expect the cancer vaccine market will soar to $8 billion by 2012. Here’s a look at some of the late-stage drug candidates that could revolutionize the cancer treatment field:

Earlier this year, Sanovi-aventis bought the rights to TroVax from Oxford BioMedica for $720 million (in fact, it was one of the top 5 deals of the first half of 2007). TroVax is currently in Phase III for renal cancer, but the company is exploring its utility in a range of cancers including colorectal, lung, breast and prostate cancer.
Glaxo said it will be recruiting 2,000 patients for a Phase III trial of its lung-cancer vaccine MAGE-A3, making it the largest cancer vaccine study ever.
Also competing in the lung cancer market, Merck KGaA is recruiting patients for a Phase III study of Stimuvax, bought from Canada's Biomira in January. In the Phase II trial, patients taking Stimuvax lived an average of 30.6 months compared to an average of 13.3 months for patients receiving supportive care alone.
Genitope is developing MyVax for an incurable form of non-Hodgkin's lymphoma. The company plans to wrap up a trial of the vaccine by the end of this year. The developer hoped to end the trial sooner, but last month an independent board recommended that the clinical trial continue.
Antigenics has reported positive data for Oncophage, a brain cancer treatment. Previously, Antigenics took a beating when Oncophage failed late-stage trials for skin and kidney cancer.

For more:
- read the Wall Street Journal article

Related Article:
Vaccine "renaissance" attracts huge new venture investments. Report

Sanofi signs stem cell pact in China

Fri, 14 Sep 2007 06:59:54 -0400

Sanofi-aventis announced that it has signed a deal to collaborate with the Chinese Academy of Medical Sciences on stem cell research. Sanofi hopes to isolate acute myeloid leukemia stem cells and generate of monoclonal antibodies against these cells. New therapeutics could be built from the research.

During a signing ceremony held in Beijing, China, Dr. Qi-Min Zhan, Vice President Research, Chinese Academy of Medical Sciences touted the pact. "This collaboration with a large and well-known pharmaceutical company is a significant progress for the academy; it clearly demonstrates that the work of our scientists on the leading-edge of cancer research is acknowledged. We actively encourage many more such initiatives."

China is becoming an increasingly attractive R&D site for major pharmaceutical companies. While it has already made tremendous inroads as a manufacturing center for the world, it's now making enormous investments in R&D to propel the country into the top ranks of world innovators.

- see Sanofi's release

Related Articles:
China now leads India in ongoing clinical trials. Report
China's pharma market steams ahead. Report
China pushes drug development as R&D soars. Report

4. Sanofi-Aventis and Oxford BioMedica

Maureen Martino — Tue, 11 Sep 2007 09:04:14 -0400

Who: Sanofi-Aventis
With: Oxford BioMedica
What: $690 million licensing deal

Summary: Sanofi-Aventis hopped on the cancer vaccine bandwagon when it inked a $690 million licensing deal for Oxford BioMedica's TroVax. Oxford BioMedica is slated to get $39 million up front and $25 million payments as targets are hit. The deal includes additional payments if TroVax goes on to win approval for multiple indications--TroVax is currently in Phase III for renal cancer, but the company is exploring its utility in a range of cancers including colorectal, lung, breast and prostate cancer. The Sanofi/Oxford BioMedica pact is an example of big pharma's interest in cancer vaccines. Release

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