Pharma edges its political contributions between Dems and Republicans

According to the Center for Responsive Politics, Pharma edges its 2008 political contributions between Democrats and Republicans. This is a departure from the last 15 years where Republicans have always been favored. It is interesting to note that GSK, Abbott, Schering Plough and Novartis in that order continue to lean Republican while Johnson & Johnson and Roche make 2/3 of their contributions to Democrats.

While pro-business, former Bain Capital top exec, Matt Romney was an early favorite, McCain ambiguous statements toward Pharma, have had the industry hedge its bets toward Democrats. Obama slightly leads Clinton among Democrats.

Healthcare Policy will clearly continue to be high on the agenda of candidates in a year where recession fears and reality make voters very responsive to promises of better health coverage. We shoud therefore expect the debate to heat up and hope the industry can be pro-active in supporting realistic solutions.

How much damage did ENHANCE cause for Merck and Schering Plough’s Vytorin?

After much delays and controversy due to attempts to re-consider the study ENHANCE end point, top line results have been released according to the initial design. Bottom line: Vytorin, a fixed combination of 10 mg of ezetimide, a cholesterol absorption inhibitor, and 80 mg simvastatin did not due better than 80 mg simvastatin alone in reducing Intima Media Thickness (IMT) or atherosclerotic plaque at 3 sites in the carotid arteries in patients with Familial Hypercholesterolemia. Meanwhile, LDL-C, a key marker of heart disease, was down 68% at 24 months in the Vytorin group versus 41% in the simvastatin group. What can we conclude? Atherosclerosis is multi-faceted and particularly difficult to study. Statins anti-inflammatory effect – in addition to LDL-C lowering- may be a significant contributor to their efficacy. Inflammation is a key component of atherosclerosis and heart disease. Vytorin remains a safe and superior efficacy drug to agressively reduce LDL-C.  Dr Steven Nissen, a leading cardiologist from the Cleveland Clinic and often critic of the industry, recommended to limit the use of Vytorin to patients not responding to simvastatin. We believe hat this is an over-reaction since LDL-C remains the best marker of heart disease prevention and  the consensus is that “lower is always better”.

More definitive conclusions will determine the long term future of Vytorin when the results of three larger cardiovascular end pont studies are available in 2010-11.

Merck & Co  (NYSE:MRK) and Schering Plough (NYSE:SGP) have been down 1.3% and 8% respectively on January 14 upon release of the unfavorable news. Negative publicity for Vytorin may have a short term impact on sales but long term Vytorin remains a winner and a major revenue contributor for both Merck and Schering Plough.

Schering Plough’s CEO showed his confidence by personally purchasing $ 2 million of Schering Plough stock on the open market.

JP Morgan Update:Can Celgene become a “Niche Buster” Factory?

Sol Barer, PhD, CEO of Celgene (NASDAQ:CELG) announced at the JP Morgan Conference in San Francisco, exciting developments in in label expanding clinical trials for Revlimid including in the treatment of newly diagnosed multiple myeloma patients. Along with oral TNFalpha inhibitor for the treatment of psoriasis in the research pipeline, Celgene is demonstrating its ability to create and develop more drugs in the immunology/oncoloy sector. Dr Barer announced the goal for Celgene to become a major pharmaceutical company. Hopefully, Celgene will remain nimble, delivering multiple ”niche busters’ , just like Genentech has done, rather than grow into a Big Pharma with a mediocre R&D productivity.

In the mean time, Celgene is trading at around $ 50 a share, 33% below its peak level in 2007. 2008 will a transition year with the digestion of the $ 2.9 billion Pharmion acquisition and continued pressure to grow Revlimid sales over 30 % in face of competition from Millenium’s Velcade.

JP Morgan Update: Scandinavian company BioVitrum develops long lasting Hemophilia Treatment

At the JP Morgan Conference in San Francisco, former executive director of Astra Zeneca, newly appointed CEO of BioVitrum, Martin Nicklasson announces launching of clinical trials for a fusion Factor IX Fc molecule with extended product life time allowing a one a week drug administration, thus improving considerably patient quality of life. Phase I & II clinical trials are due to being launched in the US early 2008.

BioVitrum (BVT:SS) is a $536 million market cap biopharmaceutical company.

BioVitrum is currently awaiting results for two Phase II clinical trials for primary care products for the treatment of Glaucoma (retinal hypotension inducer) and for the treatment of Diabetic Neuropathic Pain, for which it claims to be the sole player involved. 

The outcome of these trials will determine the future development of the company and surely deserves undivided attention…

JP Morgan Update: Alnylam Pharm. (NASDAQ:ALNY) starts Phase II RSV study

At the JP Morgan Annual Healthcare Conference in San Francisco, Alnylam Pharmaeuticals’ CEO John Maraganore detailed the steady development of the clinical indications for their RNAi technology and announced Phase II clinical trials of ALN-RSV01 for human Respiratory Syncytial Virus (RSV) infection, based on the microRNA silencing technology.

Major developments include usage of the RNAi silencing into Hypercholesterolemia, Liver Cancer and Huntington’s Disease, the latter being developed in partnership with Medtronic.

Alnylam claims possession of the majority of exclusive patents on RNAi technology and continuing successes in partnership building. After a historical deal on a non-exclusive plateform alliance with Roche in July 2007, with an upfront cash payment of $ 331 millions, and a product alliance with Medtronic, Alnylam is looking at extending its RNAi technology and receiving its first POC in Q1 of this year.

Alnylam (NASDAQ:ALNY) was up 4.35% today in after hours trading, reaching a Market Cap of $1.25 billion. Alnylam breakthrough technology and strong product portfolio make it certainly a company to be kept on the radar screen in months and years to come.

Amgen and J&J under Pressure on New Risks Associated with Aranesp and Procrit

The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn’t receive the anemia drug.

“This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

“FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients.”

Amgen (NASDAQ:AMGN) and Johnson & Johnson (NYSE:JNJ) continue to experience a rapid sales slide for their blockbuster anemia drugs, as the FDA and payors are attempting to promote more cautious use of ESAs.

Merck & Co in $ 700 million Schizophrenia Deal with Swiss Biotech Addex

According to Reuters, US Pharmaceutical Giant Merck & Co (NYSE:MRK) licensed ADX63365 for the treatment of schizophrenia from Geneva, Switzerland based Addex SA (Swiss:ADXN). Addex will receive $ 22 million upfront and up to $680 million in milestone payments. Piper Jaffray analysts suggests an additional 5-15% royalty on sales and co-promotion rights in certain European markets.

Private Equity Firm Bain Capital New Lead Investor in CRO Quintiles

JP Morgan Chase Private Equity arm, One Equity Partners, is selling its stake in Quintiles for $ 3 billion. Bain Capital will be the new lead investor, along with UK based 3i Group become a significant investor, and existing investor Texas Pacific Group (TPG) increasing its stake.

Quintiles, the largest Clinical Research Organization (CRO), with a market share of 14%, went private in 2003 through a $1.7 billion buy-out led by CEO Dennis Gillings. The market for CRO services is estimated at $14 billion and is expected to grow to $ 24 billion by 2010. The top five CROs, including Quintiles, PPD and Covance, hold a 45% share of the market.

Cephalon submits NDA for Treanda in Lymphoma

Cephalon (NASDAQ:CEPH) has submitted a New Drug Application to the FDA requesting approval of Treanda for injection for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma who have progressed during or following treatment with rituximab or a rituximab-containing regimen.

Lesley Russell, executive vice president, worldwide medical and regulatory operations of Cephalon, said: “Treanda is the lead product in our oncology pipeline and with this second NDA submission for the product in 2007 we have achieved a significant milestone for our business.”

Theravance and Astellas close to FDA review for Telavancin

According to Reuters, Drug developer Theravance Inc (NASDAQ:THRX) said the FDA’s anti-infective drugs advisory committee may soon meet to review the marketing application for telavancin, an antibiotic for the treatment of Gram Positive infections. Telavancin is partnered with Astellas Pharma.

Forbes comments on the recent investor anxiety and Theravance stock slide as a result of delays in the FDA review.

Most analysts are skeptical but not  Rachel McMinn of Cowen : ”The FDA is now required to refer all new molecular entities for advisory review prior to approval or explain why not in an action letter,” said McMinn, who added that the telavancin review may be “nothing more than what will become routine for the industry.”