http://www.straightstocks.com Leading Stock Market News, Opinions and Commentary Wed, 25 Nov 2009 18:35:47 +0000 http://wordpress.org/?v=2.8.5 en hourly 1 http://www.straightstocks.com/stock-watch/sanofi-drags-hospira-and-apotex-nysesny/ http://www.straightstocks.com/stock-watch/sanofi-drags-hospira-and-apotex-nysesny/#comments Tue, 27 Oct 2009 16:54:31 +0000 Jyotsna Ramani http://www.favstocks.com/?p=1525 http://www.straightstocks.com/stock-watch/sanofi-drags-hospira-and-apotex-nysesny/feed/ 0 http://www.straightstocks.com/stock-watch/fda-recommends-2-new-drugs-analyst-blog/ http://www.straightstocks.com/stock-watch/fda-recommends-2-new-drugs-analyst-blog/#comments Fri, 20 Mar 2009 18:41:56 +0000 Zacks Market Commentaries http://www.zacks.com/stock/news/18402/FDA+Recommends+2+New+Drugs+-+Analyst+Blog Highlights include Sanofi-Aventis SA (SNY) and Johnson & Johnson (JNJ).

On March 18th and 19th, the FDA advisory panels recommended approval of 2 important cardiovascular product candidates. The FDA does not have to follow the recommendations of the panels but usually does.

On Wednesday, the 18th of March, an FDA advisory panel recommended approval of Sanofi-Aventis' (SNY) heart drug Multaq. Multaq (dronedarone) is a new class III anti-arrhythmic drug developed for atrial fibrillation (AF).

On Thursday the 19th, an FDA review panel voted 15 to 2 in favor of approving Johnson & Johnson's (JNJ) anticoagulant rivaroxaban. Rivaroxaban, which will be sold under the brand name Xarelto upon approval, will be marketed in the U.S. by J&J and is already sold partner Bayer AG outside of the U.S. Multaq was initially submitted to the FDA for approval in 2006 but the FDA responded with a "not-approvable" letter.

Sanofi continued with development and presented results of the phase III ATHENA trial in May 2008 at the World Congress of Cardiology conference. Results showed that Multaq met its endpoint by significantly reducing the risk of cardiovascular hospitalizations or death from any cause by 24% compared to placebo.

Multaq also significantly reduced the risk of arrhythmic death by 45% and the risk of cardiovascular death by 30% on top of standard therapy compared to placebo. It failed, however, to show a statistically significant benefit in reducing death from any cause, a secondary endpoint.

A retrospective analysis of ATHENA discovered that Multaq also significantly reduced the risk of stroke by 34% in AF patients already being treated with standard therapy including anti-thrombotics. The FDA advisory panel clearly believed that the data was compelling enough to warrant recommending Multaq for approval.

The advisory panel recommendation means that FDA approval is very likely, which is very good news for Sanofi, as we believe Multaq could post sales of EUR400 million by 2012 and eventually achieve blockbuster sales status. We have viewed Multaq as Sanofi's most promising late-stage pipeline compound.

Sanofi, like many large-cap pharmaceutical companies, will be contending with significant patent expirations over the next few years and needs to rely on new products such as Multaq to replenish its coffers.

Patent expirations of Taxotere (cancer), Plavix (anti-clotting) and Avapro (hypertension) will contribute to significantly slower companywide revenue growth at Sanofi over the next few years. We estimate almost EUR8 billion of Sanofi's sales will be exposed to patent cliffs through 2012, representing about 26% of the company's expected revenue in 2009.

Meanwhile, rivaroxaban, a factor Xa inhibitor for anti-coagulation, is J&J's most promising late-stage pipeline candidate, in our opinion. The FDA panel recommended approval for the prevention of blood-clots in the legs of patients undergoing hip or knee replacement surgery.

Phase III data showed rivaroxaban significantly reduced the incidence of blood clots compared to Sanofi-Aventis' blockbuster drug Lovenox. Major bleeding was numerically higher in rivaroxaban patients but not statistically significant. Despite the bleeding concerns, as well as concerns over liver toxicity levels in patients given rivaroxaban, the FDA panel recommended approval. We expect the FDA to make a decision by the end of May.

Upon FDA approval we believe the strong efficacy data will allow rivaroxaban to gain significant market share from Lovenox, which posted sales of EUR2.7 billion ($3.8 billion) in 2008. Rivaroxaban, which is given orally in pill form, should also benefit from ease of administration versus Lovenox which must be injected.

Rivaroxaban is also being studied for the prevention of acute coronary syndrome (ACS), a potentially very lucrative indication. Eventual FDA approval for this indication could push peak sales of rivaroxaban to $2 billion or more.

Gaining final approval for both Multaq and Xarelto will be two important events for big pharma investors to keep an eye on. The FDA has been a significant wildcard in drug company investing over the past several years. With new leadership in charge, investors are clearly hoping for a change.

If the FDA follows the advice of the panel on both Multaq and Xarelto it could provide some confidence and much needed consistency in FDA decisions that would certainly fare well for all big pharmaceutical companies in the future.

Read the full analyst report on "SNY"
Read the full analyst report on "JNJ"
Zacks Investment Research
]]> http://www.straightstocks.com/stock-watch/fda-recommends-2-new-drugs-analyst-blog/feed/ 0 http://www.straightstocks.com/stock-watch/sanofi-poised-for-eventful-year-analyst-blog/ http://www.straightstocks.com/stock-watch/sanofi-poised-for-eventful-year-analyst-blog/#comments Thu, 12 Feb 2009 09:33:31 +0000 Zacks Market Commentaries http://www.zacks.com/stock/news/17368/Sanofi+Poised+for+Eventful+Year+-+Analyst+Blog Highlighted stocks include Sanofi-Aventis (SNY) and Biogen-Idec (BIIB).

On February 11, 2009, Sanofi-Aventis (SNY) announced financial results for the 4th quarter 2008. Revenue of EUR7,456 million increased by 3% from the 4th quarter of 2007, and was ahead of our estimate of EUR7,101 million. Revenue benefitted from strong sales of Lantus, Lovenox, Plavix and Ambien CR.

Revenue was also positively impacted by foreign exchange translation. EPS, adjusted for non-recurring charges, was EUR1.25 in the 4th quarter, compared to our estimate of EUR1.24. Relative to our expectations, EPS was negatively impacted by higher R&D and SG&A spend and a slightly tighter-than-expected gross margin, partially offset by a lower tax rate.

For the full-year 2008, revenue of EUR28.8 billion was down 1% from 2007, while EPS increased by 2% to EUR5.36. Foreign exchange negatively impacted sales and EPS by 5% and 8%, respectively, for the full-year. The company has been aggressively paying down debt during 2008 and exited the year with net debt of only EUR1.8 billion, down from EUR4.2 billion at the end of 2007.

Management's EPS guidance for 2009 is for an increase of at least 7%, assuming that the average exchange rate in 2009 is equal to the average rate throughout 2008.

On the earnings conference call with analysts, Chris Viehbacher, Sanofi's newly appointed Chief Executive Officer, outlined several new planned initiatives in order to rationalize costs and help accelerate revenue growth. The company will conduct an extensive review of its research and development (R&D) operations in order to reallocate resources to the highest growth and most promising development programs.

A new operating model will be implemented which is expected to target cost-cutting in R&D and SG&A to further improve the company's already strong operating margins. The company also expects to be more focused on growing through new partnership arrangements as well as through "disciplined" acquisitions. In order to accelerate business development activities, the company created a Chief Strategic Officer.

We believe Sanofi has a growing concern over significant patent expirations and slowing growth of key drugs in the next few years. A number of Sanofi's blockbuster products will soon be exposed to generic competition, including Plavix (anticoagulant), Taxotere (cancer) and Avapro (hypertension). We believe Sanofi is very likely to make a small-to-mid sized acquisition in order to help address these patent issues.

While Mr. Viehbacher did not rule out a large acquisition, he clearly feels that this is not where Sanofi should be focusing their efforts. We expect Sanofi to be looking to the high-growth biotech space and believe Biogen-Idec (BIIB) makes the most sense as an acquisition candidate.

Biogen fits the "mid-size" definition and would help diversify the company's product base and geographical reach -- key aspects of Viehbacher's new vision for growth. Biogen would bring with it blockbusters Rituxan (non-Hodgkin's lymphoma), Avonex and Tysabri (both for multiple sclerosis) and would expand opportunities for licensing deals as well as development outsourcing.

We have previous comments on Sanofi and a potential tie-up with Biogen here: http://www.zacks.com/stock/news/17153/Sanofi+Eyeing+Major+Acquisition. Our case for why investors should own Biogen-Idec, regardless of an acquisition by Sanofi-Aventis, or anyone for that matter, can be found here: http://www.zacks.com/stock/news/17266/Biogen+Too+Attractive+to+Ignore.

Read the full analyst report on SNY

Read the full analyst report on BIIB



"SNY" Free Stock Analysis: Buy? Sell? Hold?
"BIIB" Free Stock Analysis: Buy? Sell? Hold?
Zacks Investment Research
]]> http://www.straightstocks.com/stock-watch/sanofi-poised-for-eventful-year-analyst-blog/feed/ 0 http://www.straightstocks.com/small-cap-and-micro-cap-stocks/cell-genesys-inc-cege-receives-expected-fda-halt-on-clinical-prostate-cancer/ http://www.straightstocks.com/small-cap-and-micro-cap-stocks/cell-genesys-inc-cege-receives-expected-fda-halt-on-clinical-prostate-cancer/#comments Thu, 11 Sep 2008 20:24:04 +0000 QualityStocks http://Blog.QualityStocks.net/?p=12315 http://www.straightstocks.com/small-cap-and-micro-cap-stocks/cell-genesys-inc-cege-receives-expected-fda-halt-on-clinical-prostate-cancer/feed/ 0 http://www.straightstocks.com/small-cap-and-micro-cap-stocks/cell-genesys-inc-cege-halts-cancer-treatment-trial-to-ensure-patient-safety/ http://www.straightstocks.com/small-cap-and-micro-cap-stocks/cell-genesys-inc-cege-halts-cancer-treatment-trial-to-ensure-patient-safety/#comments Wed, 27 Aug 2008 16:49:48 +0000 QualityStocks http://Blog.QualityStocks.net/?p=11996 http://www.straightstocks.com/small-cap-and-micro-cap-stocks/cell-genesys-inc-cege-halts-cancer-treatment-trial-to-ensure-patient-safety/feed/ 0