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EP Vantage submits:The writing had been appearing on the wall in increasingly large red letters over Pfizer’s (PFE) commitment to Celldex Therapeutics’ (CLDX) brain cancer vaccine, rindopepimut (PF-04948568 / CDX-110) for some time now. Despite reporting decent if unspectacular phase IIb data at Asco this summer, Pfizer’s silence ever since over phase III plans was looking ominous (Event - Celldex hoping Asco data will move cancer vaccine into phase III, May 12, 2010).Nevertheless, all break-ups are painful when they finally happen and Celldex’s shares tumbled 26% on Friday to a record low of $3.53, valuing the Massachusetts biotech at just $113m despite it sitting on $65m in cash. Investors, unmoved by Celldex’s ambitious and positively spun response, are naturally more concerned about the reasons why Pfizer decided to ditch the vaccine and Celldex’s determination to go it alone with phase III trials, which will most likely need to be funded by dilutive financing.Complete Story »

EP Vantage submits:To coin a L’Oréal phrase, in the eyes of Astellas Pharma (ALPMF.PK), OSI Pharmaceuticals (OSIP) is definitely ‘worth it’. Having conducted its due diligence of OSI’s private books, Astellas Sunday raised its original hostile offer of $52 cash per share to an accepted bid of $57.50 cash per share, valuing the deal at $4bn, the second biggest overseas acquisition by a Japanese pharma company.Big sighs of relief all round then at Astellas, who failed to land CV Therapeutics last year and adopted a slightly risky approach to bidding for OSI. But it now looks set to increase its presence in the US market and gain a portfolio of marketed and pipeline cancer drugs, most notably lung cancer drug Tarceva. As for OSI, some ambitious shareholders will be disappointed with the price as the stock reached $59.80 on Friday, but given that the offer is a 55% premium overall and equivalent to a five-year high, they should be more than happy.Complete Story »

EP Vantage submits:The developmental and regulatory minefield confronting companies attempting to develop follow-on-biologics (FOBs), or biosimilars, was highlighted again this week with Merck (MRK)'s decision to scrap development of MK-2578, its pegylated form of erythropoietin similar to Amgen’s (AMGN) blockbuster anaemia drug Aranesp. MK-2578 was widely expected to be the first biosimilar erythropoietin-stimulating agent (ESA) onto the US market with a launch pencilled in for 2012. However, the FDA has requested cardiovascular outcome data for the product, which Merck believes will be too onerous and lengthy to be worth it. Perceived by some in the market as good news for Affymax through the removal of a key competitor to its own ESA agent, Hematide, the FDA’s stance on cardiovascular safety for these products could set alarm bells ringing at the Californian biotech ahead of crucial phase III data.Complete Story »

EP Vantage submits:Another weak quarter for kidney and liver cancer treatment Nexavar prompted a 5% drop in Onyx Pharmaceuticals’ (ONXX) shares Thursday and questions about what exactly is driving the disappointing figures. The sales were reported by Onyx’s marketing partner Bayer and when the US biotech reports first quarter figures next week, no doubt the subject will take center stage; some financial analysts have already moved to significantly trim sales forecasts. Just how concerned followers of the US biotech should be remains to be seen, but with competition from newer agents biting in its biggest market, kidney cancer, Onyx needs to demonstrate that demand for Nexavar will pick up.Complete Story »

EP Vantage submits:Certriad has been thrown into a period of uncertainty. The FDA issued a complete response letter for the Abbott Laboratories (ABT)/AstraZeneca (AZN) cholesterol therapy on Tuesday, two weeks after the regulator announced it would be evaluating new data suggesting that diabetic patients treated with a fenofibrate and statin, the ingredients of Certriad, were no less likely to suffer a major cardiovascular event than patients given a statin alone. The letter may delay by at least a year the launch of the drug, a combination of Abbott’s Trilipix with AstraZeneca’s Crestor, analysts said in the wake of the complete response letter. That will surely knock down the value of the drug in both companies’ portfolios - which stood at $2.49bn for Abbott and $1.9bn for Astra before the FDA’s complete response letter, according to EvaluatePharma’s NPV Analyzer.Complete Story »

EP Vantage submits:Bigger is definitely not better for Eisai’s share priceWith patent expiry of its lead drug galloping towards it at high speed, the last thing that Eisai (ESALY.PK) needed was a delay to one of the drugs it had picked as a cornerstone product to help it get over generic competition to Alzheimer’s treatment, Aricept, in November.Complete Story »

EP Vantage submits:The dreaded FDA complete response letter, so often seen as a major setback and perceived negatively by investors in afflicted companies, was Monday welcomed with open arms by shareholders in Amylin Pharmaceuticals (AMLN) and Alkermes (ALKS), sending shares in both companies to 12-month highs; in early morning trading Amylin stock gained 9% to $22 while Alkermes rose 11% to $13.50. Although the FDA has essentially rejected the application to approve Amylin, Alkermes and co-partner Eli Lilly’s (LLY) once-weekly version (Bydureon/Byetta LAR) of the already approved twice-daily diabetes therapy, Byetta, the relatively benign looking response letter appears to have removed significant uncertainty over the product’s approvability, with safety issues a particular concern (Event - Victoza approval could pave the way for Byetta LAR approval, February 4, 2010). Amylin hopes to respond to the FDA’s requests, over labelling, REMS and manufacturing issues, within the next few weeks although the likely classification of the response, Class I or II, remains unclear. Complete Story »

EP Vantage submits:Cadence Pharmaceuticals (CADX) has been dealt a new setback in its quest to get Ofirmev, the intravenous acetaminophen formerly known as Acetavance, to the US market. The FDA has given the California company a complete response letter stating it cannot approve Cadence’s only product because of deficiencies detected at a Mississippi plant operated by its third-party manufacturer, Baxter International (BAX). While the company emphasised that the FDA identified no safety issues and asked for no further studies, the market punished Cadence shares by pushing the price down 8%, to $9.46 at close on Thursday.Complete Story »

EP Vantage submits:Hotly anticipated data from a big trial of Celgene’s (CELG) Revlimid in multiple myeloma were released at the American Society of Hematology (Ash) yesterday and, as is often the case, prompted more questions that answers. This is partly because the study, called MM-015, has not finished yet, meaning the next data read out which will probably happen at the American Society of Clinical Oncology meeting (Asco) in June is now firmly in the calendars of Celgene followers. Although many saw the Ash event as an opportunity to hold the drug up against Johnson & Johnson’s (JNJ) rival myeloma therapy, Velcade, consensus forecasts reveal that analysts are already expecting Revlimid to become a substantially bigger product, as the table below shows. Partly this is because as a pill, compared to Velcade's infusion administration, it is more convenient. Despite this Velcade is still a capable competitor, and further information is needed to determine exactly how big a drug Revlimid can become.Complete Story »

EP Vantage submits:Immunomedics (IMMU) has had an outstanding year. The small New-Jersey based company has produced some of the biggest growth in the microcap sector and has seen its shares more than double since January (Human Genome, OncoGenex Standout Smallcaps So Far in 2009, October 1,).What Immunomedics appears to have got right is the multiple targets it has for hard-to-treat disorders using its proprietary monoclonal antibody technology. However, the shares, which peaked in August on the back of positive phase IIb lupus data for epratuzumab, have in recent weeks lost a little ground as investors, pleased with the so far spectacular results, have hastened to take profits.Complete Story »