Aug. 21, 2014, 4:31 PM
- In a regulatory filing, Isis Pharmaceuticals (ISIS -3.1%) discloses that it earned an $18M milestone payment from development partner Biogen Idec (BIIB -1.1%) by virtue of dosing the first infant in the ENDEAR Phase 3 clinical trial evaluating ISIS-SMNrx as a treatment for spinal muscular dystrophy.
Aug. 16, 2014, 9:41 PM
- The FDA approves Biogen Idec's (NASDAQ:BIIB) Plegridy (peginterferon beta-1a) for the treatment of patients with relapsing forms of multiple sclerosis (MS). It is the only pegylated beta interferon approved for this indication. The dosing regimen is once per two weeks subcutaneously.
- The European Commission approved Plegridy for relapsing-remitting MS in late July 2014.
Aug. 1, 2014, 8:32 AM
- Isis Pharmaceuticals (NASDAQ:ISIS) plans to dose the first patient in the next few weeks in a Phase 3 clinical trial evaluating the safety and efficacy of ISIS-SMNrx in infants with spinal muscular atrophy (SMA). This event will trigger an $18M milestone payment from development partner Biogen (NASDAQ:BIIB).
- The primary endpoint of the 110-infant study is survival or permanent ventilation.
Jul. 25, 2014, 10:27 AM
- The EMA's Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion recommending approval for Gilead Sciences' (GILD -0.8%) Zydelig (idelalisib 150 mg film-coated tablets) as a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL).
- CHMP's opinion supports the use of Zydelig in combination with Rituxan (rituximab) (BIIB -0.2%) for the treatment of CLL patients who have received at least one prior therapy or as a first-line treatment in CLL patients with the 17p deletion or TP53 mutation who are unsuitable for chemotherapy. The Committee also supports the use of Zydelig as a monotherapy for the treatment of FL in patients refractory to two prior lines of treatment.
- A final decision from the European Commission typically takes ~3 months.
Jul. 23, 2014, 12:22 PM
- The U.S. regulator grants traditional approval for Gilead Sciences' (GILD +0.4%) Zydelig (idelalisib) as a treatment for chronic lymphocytic leukemia (CLL) that has relapsed. Zydelig is to used with Rituxan (rituximab) (OTCQX:RHHBY +0.3%) (BIIB +11.6%) in cases where Rituxan alone is appropriate therapy. In a Phase 3 clinical trial, patients treated with Zydelig + Rituxan demonstrated mean progression-free survival of 10.7 months compared to 5.5 months for the Rituxan + placebo cohort.
- The agency grants accelerated approval (BTD designation) for Zydelig as a treatment for relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). It is to be used to treat patients who have received at least two prior systemic therapies.
Jul. 23, 2014, 11:57 AM
- The European Commission approves Biogen Idec's (BIIB +11.2%) Plegridy (peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS). It is the only pegylated interferon approved for RRMS.
- Patients dose themselves every two weeks with a subcutaneous injection using a prefilled syringe.
- Plegridy is Biogen's fifth product offering for MS.
Jul. 23, 2014, 9:11 AM
Jul. 23, 2014, 7:17 AM
- Biogen Idec (NASDAQ:BIIB) Q2 results: Net Product Revenues: $2,056.3M (+48.4%), Joint Business: $303.3M (+5.0%), Royalty: $40.3M (+5.9%), Corporate Partner: $21.5M (+101.9%); COGS: $291.9M (+26.5%); R&D Expense: $447.3M (+36.6%); SG&A Expense: $576.6M (+33.8%); Net Income: $723.1M (+47.4%); EPS: $3.01 (+46.1%); Quick Assets: $1,573.1M (+135.6%); Gross Profit: $2,129.6M (+42.7%); COGS: 12.1% (-10.0%); Gross Margin: 87.9% (+1.5%); Operating Profit: $1,105.7M (+50.6%); Operating Earnings Yield: 45.7% (+7.2%); Net Earnings Yield: 29.9% (+4.9%).
- Product Sales: Avonex: $773.8M (+3.9%), Tysabri: $533.4M (+37.9%), Tecfidera: $700.4M (+144.6%), Fampyra: $22.3M (+32.7%), Fumaderm: $16.0M (+1.1%).
- 2014 Guidance: Revenue Growth: 38 - 41% from 26 - 28%; R&D Expense: 20 - 21% of revenue from 20 - 22%; SG&A Expense: 22 - 23% of revenue (unch); EPS: $11.26 - 11.46 from $9.85 - 9.95.
- Shares are up 5% premarket on light volume.
Jul. 23, 2014, 6:47 AM
Jul. 22, 2014, 5:30 PM
Jul. 17, 2014, 8:42 AM
- Alkermes (NASDAQ:ALKS) initiates a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of ALKS 8700, an oral monomethyl fumarate (MMF) in development for the treatment of multiple sclerosis (MS). The randomized double-blind study will compare ALKS 8700 to placebo in 125 healthy subjects.
- ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features compared to Biogen's (NASDAQ:BIIB) Tecfidera.
Jun. 17, 2014, 7:26 AM
Jun. 16, 2014, 9:23 AM
- Joint developers Biogen (BIIB) and AbbVie (ABBV) announce positive top-line results for a Phase 3 clinical trial comparing subcutaneous daclizumab high-yield process (DAC-HYP) to intramuscular interferon beta-1a as a treatment for relapsing-remitting multiple sclerosis (RRMS). DAC-HYP achieved its primary endpoint of a statistically significant 45% reduction in annualized relapse rate.
- It also achieved statistical significance on the first secondary endpoint by demonstrating superiority compared to interferon beta-1a in reducing new or newly-enlarging T2-hyperintense lesions at week 96 by 54%. It did not achieve statistical significance in the second secondary endpoint of reducing the risk of three month disability progression as measured by EDSS.
- The companies plan to work with regulators to determine the appropriate timelines for filings.
Jun. 10, 2014, 7:46 AM
- Yesterday it was Biogen (BIIB). Today it's AstraZeneca (AZN). Isis Pharmaceuticals (ISIS) earns a $15M milestone payment from AZN by virtue of its initiation of a Phase 1 clinical trial for ISIS-ARrx, an antisense drug for the treatment of prostate cancer that works by inhibiting the production of the androgen receptor. Isis has now earned $57M to date on its development and is eligible for additional milestone payments as the product progresses through clinical trials.
Jun. 9, 2014, 9:27 AM| 1 Comment
Jun. 7, 2014, 4:56 PM
- The U.S. regulator clears Biogens' (BIIB) Eloctate (antihemophilic factor (recombinant) Fc fusion protein) for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia A. It is the first recombinant therapy with prolonged circulation in the body and it offers hemophilia patients the potential to extend the interval between prophylactic infusions. The recommended starting prophylactic regimen is 50 IU/kg every four days.
- In a 165-patient Phase 3 clinical trial of males 12 years and older with severe hemophilia A, prophylactic treatment with Eloctate achieved a statistically significant reduction of bleeding episodes compared to on-demand treatment. 98% of bleeding episodes were controlled with one or two Eloctate infusions.
- Biogen expects to launch the product commercially in the U.S. in July.
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