Jun. 12, 2014, 7:51 AM
- In the next several weeks, the Supreme Court is expected to rule on a case involving a shareholders' class action lawsuit against Haliburton (HAL). If it rules in favor of the company, it will set a higher bar for plaintiffs to achieve class certification. Currently, a judge holds a certification hearing to decide whether class status is appropriate. One criterion is that the people must have common issues. If HAL prevails, then the defendants will be able to file a brief with the court demanding that the shareholders have to again seek court approval for class status under a new, tougher standard. If they fail the gain the approval, the case ends.
- HAL is trying to overturn a 1988 decision, Basic v. Levinson, which is based on "fraud on the market theory," which postulates that a defendant's material misrepresentation that affects the price of publicly traded securities is assumed to have been relied upon by a buyer who suffered a loss. In HAL's case, shareholders alleged that it understated its asbestos liabilities while overstating revenues and the benefits of its merger with Dresser Industries.
- Other firms facing class action suits that would benefit from a favorable ruling are Pfizer (PFE), Merck (MRK), HSBC Holdings Plc (HSBC), Regions Financial (RF) and Las Vegas Sands (LVS).
Jun. 10, 2014, 11:39 AM
- RBC's Michael Yee believes that Gilead's (GILD +0.6%) 4% drop yesterday in response to Merck's (MRK +0.4%) buy of Idenix (IDIX -0.3%) creates a nice buying opportunity. He says Sovaldi sales could hit $12B in 2015 driving EPS to $8 - 10 meaning the firm would likely sport a modest earnings multiple of only 8 - 10.
- Mr. Yee states that the consensus view is that the U.S. HCV market will begin to deteriorate by 2016 but other long-term markets (ex-U.S.) are sustainable.
Jun. 9, 2014, 2:11 PM
- Right on cue, legal troll Rigrodsky & Long announces its investigation (and shareholder recruitment) into whether the Idenix (IDIX +231.8%) BOD breached its fiduciary duty by not shopping the company around before agreeing to Merck's (MRK -0.1%) $24.50/share offer. Apparently, a ~240% premium isn't enough.
Jun. 9, 2014, 11:41 AM
- Boston-base Baupost Group LLC, the hedge fund run by highly-respected value investor Seth Klarman, stands to reap a hefty $900M profit from its 53.3M share stake in Idenix Pharmaceuticals (IDIX +234%) in light of Merck's (MRK -0.1%) $3.85B offer ($24.50/share). This is a superb example of why he runs $27B in institutional money. Since 1983, his fund's average annual gain has been 17% versus the S&P 500's 11%.
Jun. 9, 2014, 7:59 AM
Jun. 6, 2014, 9:55 AM
- The online edition of Lancet Infectious Diseases publishes the results of Cubist Pharmaceuticals' (CBST +1.9%) Phase 3 clinical trial of its investigational antibiotic Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections ((ABSSSI)) and complicated skin and soft tissue infections ((cSSTI)). The company is developing the once-daily oxazolidinone as an IV and oral therapy for the treatment of serious Gram-positive infections such as those caused by methicillin-resistant Staphylococcus aureus (MRSA).
- Study results showed that a daily dose of 200 mg of Sivextro given IV over six days was non-inferior (no worse than) compared to a ten-day regimen of twice-daily IV 600 mg of linezolid for the treatment of ABSSSI.
- The FDA's Anti-Infective Drugs Advisory Committee unanimously voted (14-0) in favor of approving Sivextro for ABSSSI infections on March 31, 2014.
Jun. 2, 2014, 4:14 PM
- Fresenius Kabi USA sends Cubist Pharmaceuticals (CBST +0.1%) a letter notifying it that it has submitted an ANDA for a generic version of Cubicin (daptomycin for injection) which, according to Cubist, is protected by six Orange Book-listed patents expiring between 2016 and 2028. Fresenius alleges that five of the patents are invalid and unenforceable. Cubist intends to file a complaint with the FDA within 45 days. Once it files its lawsuit, the FDA will institute an automatic 30-month stay on its approval decision.
Jun. 2, 2014, 8:01 AM
- At this week's American Society of Clinical Oncology meeting in Chicago, cancer immunotherapies are all the rage. Using the body's immune system to battle cancer is significantly extending survival times for a variety of cancers and has created the next frontier for blockbusters. Bristol-Myers Squibb (BMY), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are all racing to bring their offerings to market.
- Some caution is warranted, however. The drugs work for only a minority of patients and they frequently have significant side effects, especially when a combination of therapies is used. For example, in a trial of BMY's Yervoy for advanced lung cancer, half of the 46 patients in the trial suffered serious side effects and three died from the drugs themselves.
May 27, 2014, 12:49 PM
May 23, 2014, 4:35 PM
- Durata Therapeutics (DRTX) says the FDA has approved its Dalvance antibiotic for the treatment of patients with acute bacterial skin and skin structure infections.
- Dalvance is the first drug with the qualified infectious disease product designation to receive FDA approval.
- A March FDA advisory panel approval also had given a favorable review to a rival product from Cubist Pharmaceuticals (CBST); the FDA is set to rule on the CBST drug shortly.
- DRTX shares halted.
May 20, 2014, 8:25 AM| 1 Comment
May 19, 2014, 5:20 PM
- Merck (MRK +0.9%) and development partner Endocyte (ECYT -0.5%) withdraw their conditional marketing authorization applications from the European Medicines Agency for vintafolide and companion imaging components, imaging agent etarfolatide and IV folic acid, for the treatment of adults with folate receptor-positive , platinim-resistant ovarian cancer, in combination with pegylated liposomal doxorubicin. The companies' action is based on further analyses of interim data from the Proceed clinical trial. Earlier this month, The Data Safety Monitoring Board recommended stopping the trial due to the lack of efficacy.
May 16, 2014, 8:55 AM
- The European Commission approves J&J (JNJ) unit Janssen Pharmaceuticals' Olysio (simeprivir) for the treatment of Hepatitis C genotype 1 and 4 infection in combination with other medicines.
- Olysio is already approved for sale in the U.S., Japan, Canada and Russia. It will be available in the EU in 2H 2014.
- Related tickers: (GILD) (ABBV) (BMY) (MRK)
May 13, 2014, 8:00 AM
- Merck (MRK) has agreed to sell some ophthalmology products to Santen Pharmaceutical (SNPHY) for $600M upfront plus milestone payments.
- The deal covers Japan, as well as "key markets" in Europe and Asia Pacific, with the products generating $400M in annual sales in those regions.
- The transaction follows Merck's sale of its U.S. ophthalmology business to Akorn Pharmaceuticals.
- Merck will continue to sell ophthalmology products in various markets, including Latin America, Canada, Australia, and EMEA. (PR)
May 12, 2014, 9:26 AM
- Certain traders are apparently swinging from trees this morning as they pop shares of Alnylam (ALNY) 8% on modest volume in premarket action in response to its announcement of a significant reduction in HBV surface antigen in preclinical testing on four monkeys with its RNAi therapeutic ALN-HBV product candidate. The product reduced HBsAg as much as 2.3 log10 compared to 0.5 log10 which is the generally accepted minimum reduction indicating immunologic cure. While encouraging, a colossal amount of work and time remains before any such product will reach the market.
- Alnylam purchased the assets from Merck (MRK) in January for $175M ($25M cash + stock). Merck acquired the assets via its acquisition of Sirna Therapeutics in 2006 for $1.1B. Merck's exit at a significant loss is a clear signal that the road to commercialization will be long and arduous.
- Alnylam hopes to file an IND by the end of 2015.
May 8, 2014, 4:16 PM
- The FDA approves Merck's (MRK -1.8%) Zontivity (vorapaxar) as a treatment to reduce the risk of heart attack, stroke and cardiovascular events and urgent procedures to restore blood flow to the heart in patients who have had a heart attack or peripheral artery blockage in the legs. Vorapaxar is a new class of drug called a protease-activated receptor-1 (PAR-1) antagonist. It reduces the ability of platelets to clump together.
- Zontivity will have a boxed warning against prescribing the product to patients who have had a stroke, transient ischemic attack or bleeding in the head due to the heightened risk of bleeding in that area.
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