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  • Today - Wednesday, August 20, 2014

  • 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.
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  • 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.
    | 1 Comment
  • 8:02 AM
    • Shares of NovaBay Pharmaceuticals (NYSEMKT:NBY) are off 40% premarket on light volume after the company announced that its ophthalmic formulation for viral conjunctivitis, NVC-422, failed to achieve its primary or secondary endpoints in a Phase 2 clinical trial.
    • The global study enrolled patients with adenoviral conjunctivitis in the U.S., India, Sri Lanka and Brazil. The endpoints were: measured clearing of bulbar conjunctival injection (red eye); eradication of adenovirus from tear film; spread of infection to the fellow eye; reduction in sub-epithelial infiltrates; clearing of blurred vision compared to its Vehicle at Test-of-Cure Visit (Day 18).
    • The company has terminated its pursuit of NVC-422 for this indication.
    | 1 Comment
  • 7:43 AM
    • Evogene Ltd. (NYSE:EVGN) Q2 results: Revenues: $3.9M (-10.8%); Operating Expenses: $5.2M (+50.4%); Net Loss: ($3.2M) (-69.6%); Loss Per Share: ($0.13) (-30.0%); Quick Assets: $87.3M (+72.9%); Cash Burn: ($2.0M) (-297.7%).
    • No financial guidance given.
    | 1 Comment
  • 7:27 AM
    • Share of Amicus Therapeutics (NASDAQ:FOLD) are up 37% premarket on light volume in response to its report of positive results for its Fabry disease drug candidate, migalstat HCL, in a Phase 3 clinical trial (Study 012).
    • Study 012 compared oral migalstat to standard-of-care enzyme replacement therapies (ERT), Fabrazyme (agalsidase beta) (NYSE:SNY) and Replagal (agalsidase alfa) (NASDAQ:SHPG), for Fabry disease. The co-primary endpoints were the mean annualized changes in estimated glomerular filtration rate (eGFR) and measured (iohexol) GFR (mGFR) assessed by descriptive comparisons on migalstat and ERT over 18 months.
    • The statistical analysis of the results was based on 54 of the 60 subjects in the study that had GLP HEK-amenable mutations. All patients were treated with ERT for a minimum of 12 months prior to the start of the trial.
    • Migalstat had a comparable effect to ERT on patients' kidney function (measured by the change in eGFR and mGFR). Levels of the biomarker plasma lyso-Gb3 remained low and stable in patients with amenable mutations who switched from ERT to migalstat. Of the 48 patients with GLP HEK-amenable mutations who completed Study 012, 46 (96%) elected to continue with the 12-month treatment extension. 45 remain on migalstat today as their sole treatment for Fabry disease.
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  • 7:10 AM
    • Evogene (NYSE:EVGN): Q2 EPS of -$0.13 misses by $0.02.
    • Revenue of $3.85M (-10.9% Y/Y) misses by $0.81M.
    • Press Release
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  • Tuesday, August 19, 2014

  • 5:17 PM
    • Urologix (ULGX) fiscal Q4 and full year results:
    • Q4: Revenues: $3.3M (-21.3%); Operating Expenses: $5.0M (+56.6%); Net Loss: ($3.5M) (-182.7%); Loss Per Share: ($0.17) (-183.3%); Quick Assets: $0.7M (-68.6%).
    • Fiscal 2014: Revenues: $14.2M (-14.2%); Operating Expenses: $13.0M (+7.6%); Net Loss: ($7.6M) (-77.3%); Loss Per Share: ($0.36) (-71.4%); Cash Burn: ($1.5M) (+21.9%).
    • No financial guidance given.
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  • 5:06 PM
    • CollabRx (CLRX -2.8%fiscal Q1 results: Revenues: $64K (-76.3%); Operating Expenses: $1.3M (+36.9%); Net Loss: ($1.2M) (-56.6%); Loss Per Share: ($.61) (-48.8%); Quick Assets: $2.1M (+44.6%); Cash Burn: ($0.7M) (-20.0%).
    • Fiscal 2015 Guidance: quarterly cash operating expenses: ~$1M.
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  • 4:49 PM
    • The FDA clears Genzyme's (SNY -0.3%) Cerdelga (eliglustat) an oral therapy for the treatment of adult patients with Type 1 Gaucher disease, a rare genetic disorder caused by the underproduction of the enzyme glucocerebrosidase. The enzyme deficiency causes fatty materials to accumulate in the spleen, liver and bone marrow. The drug's mechanism of action slows down the production of the fatty materials by inhibiting the metabolic process that forms them.
    • Genzyme's first drug for Type 1 Gaucher disease was Ceredase (alglucerase injection) which was approved on March 11, 1985.
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  • 4:24 PM
    • Salix Pharmaceuticals (SLXP +15.5%) receives notice of early termination of the waiting period for U.S. antitrust review under the Hart-Scott-Rodino Act of its planned merger with Cosmo Pharmaceuticals. The waiting period was due to expire on August 21, 2014. The removal of the waiting period satisfies a condition of the closing of the transaction.
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