Monday, May 19, 2014

Stop Worrying About Drug Prices and Other Biotech News (ITMN, BIIB, ALXN, UTHR & TNIB)

The biotech sector may have lost some favor on Wall Street, but there is still plenty of interesting or overlooked news about the sector and/or biotech stocks like InterMune Inc (NASDAQ: ITMN), Biogen Idec Inc (NASDAQ: BIIB), Alexion Pharmaceuticals, Inc (NASDAQ: ALXN), United Therapeutics Corporation (NASDAQ: UTHR) and TNI BioTech, Inc (OTCMKTS: TNIB):

Are Concerns About Drug Prices Overblown? Credit Suisse analyst Ravi Mehrotra believes a rally in large-cap biotech stocks can be resurrected in part because concerns about drug prices might be overblown:

"We DO think drug pricing remains an very active debate in the press, politically and in the stock market. The US also works on (2) Competition and (3) Freedom of choice – that includes drugs! Basic laws of economics will play through, bigger picture pricing debates WILL happen. The drug market WILL change. Truly innovative drugs, with clear pharmacoeconomic benefit, and little competition will retain premium pricing…"

Three Reasons (Along with Three Stocks) to Like in Biotech. Oppenheimer's Ari Wald recently appeared on Yahoo! Finance's Breakout Program with Jeff Macke to say that the sector has held its uptrend and:

"There are three things I like about (the sector): It's oversold. It's stabilizing on support and it's still in an uptrend."

He then cited Biogen Idec Inc, Alexion Pharmaceuticals, Inc and United Therapeutics Corporation for their 200-day moving averages: 

Different Biotech Strategies Being Pursued in Europe. In the wake of the controverisial Pfizer Inc (NYSE: PFE) pursuit of AstraZeneca plc (NYSE: AZN), FierceBiotech has a detailed article about the different biotech strategies they along with Johnson & Johnson (NYSE: JNJ) and Bayer AG (OTCMKTS: BAYRY) are pursuing in Europe. Specifically, AstraZeneca is setting aside £5 million ($8.4 million) to fund startups at the Alderley Edge site it is vacating as part of its relocation to Cambridge; Johnson & Johnson has an office in Britain that has inked 16 deals with European biotechs and academic centers last year; and Bayer is inviting biotechs into a new incubator with three startups housed so far.

InterMune Inc's Big Week Next Week. Next week will be important for InterMune Inc and privately held Boehringer Ingelheim as both companies will be presenting Phase III results from their respective (and competing) idiopathic pulmonary fibrosis (IPF) drugs at the American Thoracic Society annual meeting. InterMune Inc itself will give important presentations of data regarding pirfenidone in IPF patients on both Sunday, May 18 and Tuesday, May 20. There will also be live webcasts on each of those days. In early May, Oppenheimer had recommended buying InterMune Inc shares ahead of the American Thoracic Society meeting albeit the real winners have been anyone holding the stock before February 24th when shares doubled on late-stage clinical trial results.

ZS Pharma Files for an IPO. Small cap Texas-based ZS Pharma raised $55 million from venture groups just a few weeks ago and is now planning an $86 million IPO (the S-1 can be found here). ZS Pharma's ZS-9, a hyperkalemia (a condition characterized by high levels of potassium in the blood that can lead to cardiac arrhythmias and sudden cardiac death) drug in a late-stage research program designed to get it into the hands of US and European regulators next year, is the company's main program. However, there is competition from Relypsa Inc (NASDAQ: RLYP) which is also focused on hyperkalemia.

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Marinus Pharmaceuticals Files for an IPO. Small cap Connecticut based Marinus Pharmaceuticals has filed an S-1 outlining plans to raise $63 million on Nasdaq after already burning through $64 million. Marinus Pharmaceuticals' ganaxolone is being put through a successful Phase II study for epilepsy with the groundwork being laid for a Phase IIb trial that can be expanded later into a pivotal study for regulatory submissions.

Small Cap TNI BioTech's Spinoff. Small cap biotech TNI BioTech, which is focused on the development, marketing and distribution of opioid-related immunotherapies, has just posted a Form 10-Q, but the big announcement came earlier in the month about how its board of directors had approved a plan to spin off wholly-owned subsidiary, Cytocom, Inc - an entity established to operate TNIB's drug development business. After the spin off, Cytocom will initially focus on developing low dose naltrexone (LDN) and methionine-enkephalin (MENK) while TNI BioTech will continue to retain the rights to certain assets and will focus on manufacturing, distribution and marketing of these LDN and MENK therapies for the treatment of both humans and animals in certain territories. TNI BioTech shareholders will receive one common share of Cytocom for every one share of TNIB common stock held as of 5:00 p.m., Eastern Time, on July 15, 2014. The company spent last year developing a manufacturing and distribution network for the sale of LDN into emerging nations and had discussions with the FDA and EMA to begin clinical trials in the United States.

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