Friday, April 24, 2015
- The FDA approves a fourth indication for Eli Lilly's (NYSE:LLY) Cyramza (ramucirumab), for the treatment, in combination with FOLFIRI chemotherapy, of patients with metastatic colorectal cancer with disease progression on or after therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
- Cyramza was previously cleared for the treatment, in specific circumstances, of advanced gastric (stomach) cancer, gastroesophageal junction adenocarcinoma (April 2014) and advanced lung cancer (December 2014).
- Ramucirumab is an antiangiogenic therapy. It inhibits the formation of new blood vessels in a tumor which inhibits its growth.
- Akorn (NASDAQ:AKRX) will restate its 2014 annual financial statements as well as its statements for the second, third and fourth quarters of 2014 due to errors found during the Q1 2015 financial review process pertaining to the understatement of rebates and other sales allowances. This overstated net revenue. Most of the errors are related to companies and products that Akorn acquired in 2014, the formation of purchasing alliances among several of the company's customers and a changing competitive landscape for selected products that were acquired last year.
- Management believes that the impact of the errors to net revenue and pretax income from continuing ops will be $20M - 35M for the year.
- The company affirms its 2015 non-GAAP EPS guidance of $1.88 - 1.98.
- Shares are down 13% after hours on robust volume.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Valeant Pharmaceuticals' (NYSE:VRX) Relistor (methylnaltrexone bromide) for the treatment of adult patients with opioid-induced constipation (OIC) when response to laxative therapy has not been sufficient. This is a larger population than the one allowed under the current label. The Committee also recommends a one-year extension of data/marketing protection for Relistor to 11 years from the date of approval, citing its benefits compared to existing therapies.
- Relistor is currently cleared for the treatment of OIC in adult patients with advanced illness who are receiving palliative care when response to laxative therapy has been insufficient.
- Relistor was developed by Progenics Pharmaceuticals (NASDAQ:PGNX) which licensed it to Salix Pharmaceuticals which was acquired by Valeant in February.
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)
- Cambridge, MA-based blueprint Medicines (Pending:BPMC) is set for its IPO of 7,187,500 shares of common stock at $15 - 17.
- The biopharmaceutical firm focuses on genomically-defined diseases driven by abnormal kinase activation. Kinases are enzymes that play an essential role in cell behavior. Its drug development platform combines the company's genomics expertise with a novel library of kinase inhibitors against ~200 kinases. It identifies drug targets by sequencing unexplored cancers and mining public data with new genome analysis algorithms.
- One of its lead product candidates is BLU-285, which targets KIT Exon 17 and PDGFRalphaD842V, abnormally active receptor tyrosine kinase mutants that play key roles in cancer and proliferative disorders. It will be initially developed for the treatment of systemic mastocytosis, a disorder in which the body produces too many mast cells, and defined subtypes of gastrointestinal stromal tumor. Another product candidate, BLU-554, which targets the kinase FGFR4, is being developed for a defined subset of patients with hepatocellular carcinoma. Both products will enter Phase 1 development after the company files the INDs with the FDA mid-year.
- 2014 financials ($M): Operating expenses: 39.7 (+89.0%); Net Loss: (40.3) (-92.8%); CF Ops: (35.4) (-86.3%).
- Privately-held French biotech medDay Pharmaceuticals reports results from a Phase 3 clinical trial (MS-SPI) evaluating MD1003, a pharmaceutical-grade biotin, for the treatment of primary and secondary progressive multiple sclerosis. The study met its primary endpoint in the intent-to-treat population with 12.6% of patients treated with MD1003 showing an improvement in EDSS (Expanded Disability Status Scale) or TW25 (a timed 25-foot walk) at Month 9 compared to 0% for placebo (p=0.0051).
- Secondary analyses showed evidence of a decrease in the risk of disease progression. Mean EDSS scores in the treatment group between the start of treatment and Month 12 decreased (-0.03) compared to progression (+0.13) in the placebo cohort (p=0.015). Four percent of patients in the MD1003 group showed EDSS progression at Month 9 confirmed at Month 12 compared to 13% for placebo (p=0.07).
- Biotin is a B-vitamin known as vitamin H or coenzyme R. It plays a key role in cell growth, the production of fatty acids and the metabolism of fats and amino acids.
- The data were presented at the American Academy of Neurology Annual Meeting in Washington, DC. Full results will be submitted for publication in a peer-reviewed journal.
- MS-related tickers: (BIIB -5.9%)(SNY +0.3%)(NVS -0.9%)(TEVA +1.4%)(FWP -0.3%)(OPXA)(RCPT +0.1%)(CHRS -3.3%)(ABBV +1.7%)
12:02 PM| Comment!
- StemCells (STEM -28.4%) prices its public offering of common stock and warrants at $0.70 for the combination. The exercise price of the five-year warrants is $0.85. The number of shares is not disclosed but the expected gross proceeds of ~$25M implies 35.7M.
- Underwriters over-allotment is an additional 5,357,250 shares and warrants to purchase an additional 4,017,938 shares. Closing date is April 29.
- As part of its plan to proactively manage its cash and debt, Invacare (IVC +2.4%) sells five properties for $23M and enters into long-term leases with the new owners. The annual rent for the first year will be $2.275M. Net proceeds will be used to reduce debt on the company's revolving asset-based credit facility.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Vanda Pharmaceuticals' (VNDA -0.8%) Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults. The final decision by the European Commission (EC) usually takes ~60 days.
- Non-24 is circadian rhythm disorder that occurs frequently people who are totally blind. It causes nighttime sleep problems and creates an overwhelming urge to nap during the day which negatively affects everyday tasks and activities.
- Tasimelteon is a melatonin receptor agonist that acts as a circadian regulator that resets the body's clock in the area of the brain called the suprachiasmatic nucleus (located in the hypothalamus). Melatonin is a hormone that plays a key role in the body's circadian rhythm, rising as night falls (creating drowsiness) and lowering in the early morning.
- The EC designated Hetlioz an Orphan Drug in 2011. If approved, it will have a 10-year period of market exclusivity for the indication in the EU. The FDA approved it in January 2014.
- AstraZeneca (AZN -2%) and Innate Pharma SA (OTCPK:IPHYF) establish a collaboration to accelerate and broaden the development of Innate's proprietary anti-NKG2A antibody, IPH2201, including the combination with MEDI4736, a PD-L1 checkpoint inhibitor.
- The initial plan includes Phase 2 studies of the combination in solid tumors, multiple Phase 2s involving IPH2201 as monotherapy and in combination with currently approved treatments across a range of cancers and the development of associated biomarkers.
- Under the terms of the agreement, Innate will receive an initial payment of $250M, $100M prior to the initiation of Phase 3 development, regulatory- and sales-based milestones and double digit royalties. Innate has the right to co-promote in Europe for a 50% profit share. AstraZeneca will have exclusive global rights to commercialize IPH2201 in combination with MEDI4736 as well as access to IPH2201 in monotherapy and other combinations in certain treatment areas.
- IPH2201 is a humanized IgG4 antibody, an immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic NK (natural killer) and CD8 T lymphocytes. Blocking the inhibitory function of CD94/NKG2A enhances the ability of NK and T cells to kill cancer cells.
- MEDI4736 is a human monoclonal antibody that binds to PD-L1, a protein found on the surface of cancer cells that allows them to avoid detection by the immune system. Binding to PD-L1 enables T cells to recognize and kill cancer cells.
10:27 AM| 28 Comments
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Bristol-Myers Squibb's (BMY -0.2%) Opdivo (nivolumab) for both treatment-naive and treatment-experienced patients with advanced (unresectable or metastatic) melanoma. The final decision by the European Commission usually takes ~60 days.
- Opdivo is a PD-1 immune checkpoint inhibitor. PD-1 (programmed cell death protein 1), found on the surface of cancer cells, enables them to avoid detection by the immune system. Binding to PD-1 enables T cells to recognize and kill cancer cells.
- Opdivo was cleared in Japan in July 2014 followed by the U.S. in December for the treatment of melanoma. The FDA approved a label expansion last month for lung cancer.
- Previously: European approval of Bristol-Myers' Opdivo remains elusive (March 27)
- Under Irish Takeover Rules, Mylan (MYL +1%) issues a Rule 2.4 announcement setting forth its legally-binding commitment to acquire Perrigo (PRGO -1.8%) for $205 in cash and stock. Under the terms of the offer, PRGO shareholders will receive US$60 in cash plus 2.2 ordinary shares of MYL for each PRGO share.
- The cash portion will be financed by a new bridge credit facility arranged by Goldman Sachs.
- Perrigo's Board of Directors rejected Mylan's bid several days ago.
- Previously: Perrigo unanimously rejects Mylan bid (April 21)
- Previously: Mylan preparing new bid for Perrigo (April 22)
9:39 AM| Comment!
- In results published in The Lancet, GlaxoSmithKline's (GSK -0.2%) investigational malaria vaccine, RTS,S, demonstrated a statistically significant reduction in malaria in children who received RTS,S followed by a booster shot of the vaccine at 18 months.
- RTS,S reduced the number of clinical malaria cases in young children (aged 5 - 17 months at first vaccination) by 36% and in infants (aged 6 - 12 weeks) by 26%, over an average follow-up period of 48 months.
- The vaccine incorporates Agenus' adjuvant, QS-21 Stimulon, which boosts the immune system's response to antigens in the vaccine.
- Trial data were submitted to the European Medicines Agency in June 2014 for review by its Committee for Medicinal Products for Human Use (CHMP). A positive opinion together with a recommendation from the World Health Organization (WHO) would support licensure applications to regulatory authorities in sub-Saharan African countries.
- Healthways (HWAY +2.7%) Q1 results: Revenues: $189.9M (+7.4%); COGS: $161.5M (+9.0%); SG&A: $16M (-2.4%); Operating Loss: ($0.2M) (+98.1%); Net Loss: ($2.9M) (+69.8%); Loss Per Share: ($0.08) (+70.4%); Quick Assets: $3.8M (+111.1%)CF Ops: $1.8M (-80.2%).
- 2015 Guidance: Revenues: $800M - 825M; GAAP EPS: $0.23 - 0.35; Adjusted EPS: $0.35 - 0.47; Adjusted CF Ops: $80M - 90M; GAAP CF Ops: $66M - 76M; CAPEX: $37M - 42M.
- At the Liver Meeting in Europe, Merck (NYSE:MRK) presented data from its ongoing C-EDGE pivotal Phase 3 study evaluating its HCV combination of grazoprevir/elbasvir (100mg/50mg) in patients with genotypes 1, 4 or 6.
- Overall, treatment-naive patients treated with the combo for 12 weeks without ribavirin (RBV) showed a cure rate (sustained virologic response 12 weeks after therapy or SVR12) of 95% (n=299/316). Treatment-naive patients co-infected with HIV treated for 12 weeks, without RBV, also showed a cure rate of 95% (n=207/218).
- Treatment-experienced HCV patients treated with the combo, with and without RBV showed cure rates of 94% (n=98/104) and 92% (n=97/105), respectively. Treatment-experienced HCV patients treated for 16 weeks, with and without RBV, showed cure rates of 97% (n=103/106) and 92% (n=07/105), respectively.
- Cure rates in cirrhotic patients ranged from 89 - 100%; non-cirrhotic: 93 - 97%; genotype 1a: 90 - 95%; genotype 1b or other g-1: 96 - 100%; genotype 4: 60 - 100% and genotype 6: 75 - 100%.
- The results were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY)
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