| Merck's Busy Road Ahead The Burrill Report submits: By Michael FitzhughMerck (MRK) outlined a pipeline stuffed with more than 20 late-stage candidates in a bid to show investors just how rewarding the spoils of its acquisition of Schering-Plough might be. The slate of new drugs could be a lifeline for Merck as it hustles to replace revenue from medicines that have recently gone off patent, such as the hypertension drugs Cozaar and Hyzaar and the company's best-selling drug, Singulair for asthma. The hypertension drugs contributed 8 percent of Merck’s pharmaceutical revenue in the first quarter of 2010 and Singulair for asthma contributed 12 percent of first quarter revenue. It loses patent protection in August 2012. Merck will submit five new drugs for U.S. Food and Drug Administration approval in 2010, including treatments for Hepatitis C and diabetes, and plans five additional major market filings to gain approval of new indications or formulations of its existing drugs during 2010, says Peter Kim, executive vice president and president, Merck Research Laboratories. Merck anticipates having five late-stage biosimilar programs by 2012 and “anticipates access to an accelerated development pathway for biosimilar candidates that employ the same biologic expression platform used for manufacturing the originator molecule, which will be the focus of Merck BioVentures,” says Kim. The company is putting $1.5 billion into R&D projects in that unit through 2015. The news wasn't all good for biosimilars. The company will drop what was expected to be its first biosimilar product, the pegylated erythropoietin MK-2578, to avoid the hassle and cost of proving its safety in the face of FDA concern about the safety of erythopoeitin stimulating agents. In the U.S., Merck will file for approval of boceprevir for chronic hepatitis C; Janumet XR, a combination of the cholesterol drug Zocor and the diabetes treatment Januvia; NOMAC/E2 for contraception; MK-0431D for diabetes and ridaforolimus for sarcoma. Merck also detailed the status of its new products in the European Union, saying it has four new molecular entities under regulatory review there, including the mometasone/formoterol combination for asthma, Brinavess for atrial fibrillation, NOMAC/E2, and asenapine for schizophrenia and bipolar disorder. The company also provided updates on drugs for cardiovascular indications, oncology, vaccines, bone, respiratory, immunology, dermatology, neuroscience, ophthalmology and endocrinology. Merck’s late-stage pipeline as of April 30, 2010 Drug Indication Stage DULERA8 (SCH 418131) (US/EU) Asthma Under Review BRINAVESS (MK-6621) ((EU))7 Atrial Fibrillation Under Review NOMAC/E2 (SCH 900121) ((EU)) Contraception Under Review SYCREST0 (SCH 900274) ((EU)) Schizophrenia, Bipolar Disorder Under Review SCH 697243 Allergy, Grass Pollen Phase III SCH 039641 Allergy, Ragweed Phase III MK-0524A ((US)) ER niacin/laropiprant Atherosclerosis Phase III MK-0524B ER niacin/laropiprant/ simvastatin Atherosclerosis Phase III anacetrapib (MK-0859) Atherosclerosis Phase III ridaforolimus (MK-8669) Cancer Phase III V503 HPV vaccine (9 valent) Cervical Cancer Phase III NOMAC/E2 (SCH 900121) ((US)) Contraception Phase III sitagliptlin/pioglitazone (MK-0431C) Diabetes Phase III corifollitropin alfa injection (SCH 900962) ((US)) Fertility Phase III SAFLUTAN (MK-2452) ((US)) Glaucoma Phase III boceprevir (SCH 503034) Hepatitis C Phase III MK-4305 Insomnia Phase III acadesine (SCH 900395) Ischemia-Reperfusion Injury Phase III telcagepant (MK-0974) Migraine Phase III sugammadex4 (SCH 900616) ((US)) Cyclodextrin Neuromuscular Blockade Reversa Phase III odanacatib (MK-0822) Osteoporosis Phase III daptomycin for injection (MK-3009) Staph Infection Phase III vorapaxar (SCH 530348) Thrombosis Phase III Complete Story » seekingalpha.com |
Sales Boost Novartis Results Novartis reported a sharp rise in second-quarter net profit on healthy drug sales and cost cuts, prompting the Swiss drug giant to lift its full-year sales guidance. online.wsj.com |
Teva: Evolution of a Generics Company Jason Chew submits: It is difficult to characterize Teva (TEVA) - is it a generics company or a biopharmaceutical? It would appear it is the best of both worlds, a hybrid of the two. For the year 2009, Teva derived 67% of its revenue from the sale of generics and the rest from novel drugs and specialty products. Low margin generics were balanced by high margin branded drugs. It spends relatively little on research - around 6% of sales - improving operating margins significantly. In fact, at 27%, its operating margins are in-line with those of the largest pharmaceutical companies. Teva had $13.9 billion in net revenue in 2009, up 25% from 2008, due in large part to the acquisition of Barr Laboratories. The company’s stated goal is an annual 15% growth rate through 2015 with revenue of $31 billion in that year, while at the same time maintaining a product mix of 70% generics and 30% branded and specialty drugs. That would make it one of the fastest growing companies in the large cap pharmaceutical space. Only Celgene is currently growing faster, but no one’s prediction mid-teen growth rates into 2015. Investors appear to believe; Teva has a trailing P/E of about 17, only Celgene’s incredible P/E of 30 is higher.Complete Story » seekingalpha.com |
Why People Can't Make Decisions Researchers have been investigating how people's view of the world affects their lives, and how they might be able to make better decisions. online.wsj.com |
A Food Fight Over Nutraceuticals Investment U submits: By Tony D’AltorioAt first glance, the food and drug industries have very little in common. One is a relatively slow and safe business, the other a high-risk, high-reward venture. Yet these days, they seem to be moving in a common direction… straight towards the clinical nutrition and nutraceuticals business.Complete Story » seekingalpha.com |