Seeking Alpha
  • Wednesday, August 20, 2014

  • 5:56 PM
    • Bloomberg reports Allergan (NYSE:AGN) isn't currently in active buyout talks with Salix (NASDAQ:SLXP). Though Allergan approached Salix about a deal in recent months, the talks are currently "dormant," and Allergan is exploring other options to thwart Valeant's hostile bid.
    • SLXP -2.7% AH. Shares rose over 15% yesterday after the WSJ reported Allergan has approached Salix about a potential deal. They fell 2.3% in regular trading today.
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  • 5:07 PM
    • Shares of Kindred Biosciences (NASDAQ:KIN) plummet 34% on robust volume in response to the company's disclosure that its lead product candidate, CereKin (diacerein), an interleukin-1 inhibitor for the control of pain and inflammation associated with osteoarthritis in dogs, failed to achieve its primary endpoint in a clinical trial.
    • The failure was due to a higher-than-expected placebo response rate and statistical variability. In the high dose (20 mg/kg) cohort, the response rate was comparable to human studies but the dropout rate was too high to achieve statistical significance.
    | 1 Comment
  • 4:53 PM
    • Invacare (IVC -3.2%) initiates a restructuring plan that it expects to save $14M - 15M per year when fully implemented in 2015. The move includes a reduction in workforce of 150 associates and 40 temporary associates from the North America/Home Medical Equipment, Institutional Products Group and Asia/Pacific segments.
    • The firm expects to incur ~$6M in pre-tax restructuring charges.
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  • 4:48 PM
    • The FDA designates Supernus Pharmaceuticals' (SUPN -1.2%) product candidate for the treatment of impulsive aggression in attention deficit hyperactivity disorder, SPN-810 (molindone hydrochloride), Fast Track. The product candidate is expected to enter a Phase 3 clinical trial in 2015.
    • Molindone hydrochloride is currently marketed under the brand name Moban for the treatment of schizophrenia.
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  • 4:30 PM
    • Cellectar Biosciences (NASDAQ:CLRB) Q2 results: Operating Expenses: $2.4M (-11.1%); Net Loss: ($2.1M) (unch); Loss Per Share: ($0.73) (-1.4%); Quick Assets: $1.6M (-33.3%).
    • No financial guidance given.
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  • 4:22 PM
    • Covidien (COV +0.4%) debuts its Covidien Center of Innovation (CCI) Brazil. The Sao Paulo-based 3,000 square meter facility will serve as a hub for training health care professionals on the latest medical technology. It has the capacity to offer 120 courses and educate up to 2,000 clinicians per year.
    • It contains a surgical lab equipped for minimally invasive surgeries using electronic and computer simulators in addition to silicone models, a clinical scenario simulation lab equipped with a human patient simulator, a lab for educating in medical and hospital procedures, an Anatomage touchscreen table (study the human body's anatomy in a virtual patient), an R&D lab and a 160-person auditorium.
    • The company also has CCI facilities in China, South Korea, India and Turkey.
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  • 4:18 PM
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  • 3:49 PM
    • The FDA clears GlaxoSmithKline's (GSK +0.9%) Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid for maintenance treatment of asthma as prophylactic therapy in patients as least 12 years old.
    • The fluticasone furoate is delivered to the lungs using the Ellipta inhaler, which is also used in other GSK respiratory medicines. For addressing chronic obstructive pulmonary disease, the treatment is branded Breo Ellipta (fluticasone furoate and vilanterol).
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  • 1:22 PM
    • A federal judge issues a temporary restraining order against the FDA's decision to allow the sale of generic versions of Hospira's (HSP +1.4%) sedative Precedex (dexmedetomidine HCL injection) In its lawsuit filed yesterday, Hospira claims that the agency violated its own rules by allowing generic firms to launch competing products as long as the labeling omitted information about the drug's uses (intensive care unit sedation) covered by Hospira's patent.
    • In his order, Judge Jarrod Hazel says that Hospira would likely win its suit because the FDA's decision as "at odds with relevant authority" and "tantamount to a change of the rules."
    • Generic firm Sandoz (NVS +0.3%) intervened on Hospira's behalf because the ruling would deprive it of the six-month exclusivity it negotiated in its patent infringement settlement with Hospira in December.
    • Related ticker: (MYL +2.8%)
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  • 12:56 PM
    • Valeant Pharmaceuticals (VRX) and Bill Ackman filed a countersuit in California yesterday in response to Allergan's (AGN -0.2%) lawsuit alleging the two pursuers breached insider trading laws.
    • In addition to the well-known argument that their agreement is legal, they assert cloak and dagger-type activities by Allergan such as secretly recorded telephone conversations, "highly unusual" investor road shows to Valeant's home country of Canada and "unusual" executive transitions.
    • With the exception of the lawyers involved, everyone else is most assuredly fatigued over the ongoing acrimony surrounding Valeant's hostile bid.
    | 1 Comment
  • 12:25 PM
    • Nigeria's health ministry says that doctors in Lagos are assessing five new suspected cases of Ebola. The patients were admitted to a hospital yesterday and are being kept in an isolation ward.
    • Yesterday, Health Minister Onyebuchi Chukwu said that Nigeria had only two known cases of Ebola and the county would be free of the disease within a week.
    • The outbreak has sickened 2,240 people to date with 1,229 fatalities.
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  • 11:33 AM
    • The U.K.'s National Institute for Health and Care Excellence reverses its position and now supports the use of Celgene's (CELG +1.9%) Revlimid (lenalidomide) by the National Health Service for the treatment of myelodysplastic syndromes.
    • The healthcare cost and quality of care advisor changed its opinion after the company submitted revised analyses and a proposal to limit the cost of the drug, including agreeing to provide Revlimid free of charge to anyone requiring more than 26 monthly cycles of treatment.
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  • 11:00 AM
    • Emisphere (OTCQB:EMIS +24%) sets up a $20M loan facility with MHR Fund Management (and certain MHR affiliates) to fund the U.S. commercialization of Eligen B12. The facility will mature on December 31, 2019 and bear interest of 13% per year.
    • The company and MHR also consummate an agreement that obligates Emisphere to pay MHR royalties on the sale and licensing of Eligen B12 and related products.
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  • 10:41 AM
    • The USPTO issues a Notice of Allowance to Alnylam Pharmaceuticals (ALNY -0.5%) for claims in the Tuschl et al. patent application 13/725,262. The 262 patent application includes claims directed to compositions that mediate RNAi and compromising a double-stranded molecule with up to 25 base pairs and at least one nucleotide analogue.
    • The patent application broadly covers small interfering RNA (siRNA) molecules of various designs, including dicer substrate RNAi triggers and double-stranded RNAi-mediating molecules containing moieties that include unlocked nucleobase analogs among other naturally or non-naturally occurring nucleotide analogues.
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  • 10:06 AM
    • Novartis (NVS -0.2%) signs a licensing agreement with the Global Alliance for TB Drug Development for its experimental tuberculosis drugs that have been discovered at the Novartis Institutes for Tropical Diseases. Among the product candidates is a class of meds called indolcarboxamides which target drug resistant and multi-resistant strains of TB. One of the compounds, NITD304, works by blocking a protein this is essential for the TB bacterium's survival.
    • The company did not ask for an upfront or milestone payments.
    • The move reflects Novartis' intent to concentrate its research on its core areas of cancer, respiratory, heart failure and dermatology.
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  • 9:35 AM
    • Ipsen (OTCPK:IPSEY) (OTC:IPSEF) names Cynthia Schwalm as President and CEO of Ipsen N.A. responsible for all commercial and medical affairs throughout the region. She joined the firm in February 2014 and is preparing for the launch of the company's first oncology product in 2015. Previously, she was VP of Neurology at Merz.
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  • 9:26 AM
    • Emergent BioSolutions (NYSE:EBS) and MorphoSys AG enter into an agreement to jointly develop and commercialize Emergent's bi-specific antibody, ES414, for the treatment of prostate cancer. Under the terms of the contract, Emergent will receive an upfront payment of $20M and milestone payments of up to $163M. MorphoSys will bear 64% of ES414's development costs and Emergent will bear 36%. Emergent will retain commercialization rights in the U.S. and Canada and pay MorphoSys royalties from mid-single-digit up to 20%. MorphoSys will own commercialization rights for the rest of the world and pay Emergent low-single-digit royalties.
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  • 9:03 AM
    • Pernix Therapeutics Holdings (NASDAQ:PTX) finalizes its acquisition of the U.S. commercial rights to GlaxoSmithKline's (NYSE:GSK) Treximet (sumatriptan/naproxen sodium). Pernix has expanded its sales force to 100 to support the marketing of the product which it plans to launch next month.
    • Under the terms of the deal, Pernix paid GSK an upfront payment of $250M, an additional payment of $17M upon the resolution of the recent supply constraint and royalty payments of 18% of sales (minimum: $4M/qtr). GSK assigned the product development and commercialization agreement (PDC Agreement) between GSK and Pozen (NASDAQ:POZN) to Pernix.
    • Updated 2014 guidance: revenue: $110M - 120M; non-GAAP EBITDA: $22M - 24M.
    • 2015 guidance: revenue: ~$230M; non-GAAP EBITDA: ~$95M.
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  • 8:42 AM
    • Hasco Medical (OTCPK:HASCQ1 results: Revenues: $20.7M (+38.0%); Operating Expenses: $4.6M (+23.6%); Net Income: $194.3K (+197.8%); EPS: $0.00 (unch); Quick Assets: $0.9M (+504.8%).
    • 2014 Guidance: revenues: $75M - 85M; gross margin: 21 - 23%; net income: positive.
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  • 8:29 AM
    • Bristol-Myers Squibb (NYSE:BMY) and Celgene (NASDAQ:CELG) collaborate in a Phase 1 clinical trial to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers' Opdivo (nivolumab) and Celgene's Abraxane (paclitaxel) as a treatment for HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC).
    • Opdivo is a cancer immunotherapeutic that uses the body's own immune system to fight cancer while Abraxane works by interfering with cancer cells' ability to divide. The trial will explore if the combination of the two agents leads to an enhanced anti-tumor response.
    • The clinical trial is slated to begin in Q4 and will be run by Celgene. HER-2 negative breast cancer patients will be treated with Abraxane and Opdivo, pacreatic cancer patients will be treated with the combination plus gemcitabine and NSCLC patients will be treated with the combination plus carboplatin.
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