Tue, Mar. 24, 5:34 PM
- A Phase 2a clinical trial evaluating Lpath's (NASDAQ:LPTN) candidate for advanced renal cell carcinoma (RCC), ASONEP, failed to achieve its primary efficacy endpoint of a statistically significant improvement in progression-free survival (PFS). The study enrolled RCC patients who had previously failed treatment with at least one anti-vascular endothelial factor (VEGF) agent and no more than one mTOR inhibitor. This patient population is considered "last line."
- To meet the endpoint, 25 of 39 patients needed to be progression-free at Month 2 of treatment, but the overall median time to progression was less than that. Seven patients were progression-free at least six months and three were progression-free for more than 29 months.
- ASONEP is an anti-S1P antibody formulated for systemic use. S1P is sphingosine-1-phosphate, a blood-borne lipid mediator that is a key regulator of vascular and immune systems. It is upregulated (there is more of it) in certain cancers so binding to it may potentially inhibit progression.
- The company will assess its options with a partner to explore areas that present the greatest chance of success for ASONEP. Another Phase 2 study is evaluating the ocular version, iSONEP, in wet age-related macular degeneration. Data readout should happen in Q2. Pfizer (NYSE:PFE) has an exclusive option for a global license. Pfizer has a time-limited right of first refusal for a license for ASONEP.
- LPTN is down 27% after hours on robust volume.
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Mon, Mar. 23, 1:55 PM
- Jeffries raises it price target on Pfizer (PFE +3.3%) to $45 citing improved prospects for the launch of Ibrance, higher growth in GEP driven by the Hospira acquisition and potential M&A deals.
- According to a survey of oncologists, peak sales of Ibrance could reach $13B, based on the assumption that it will be used in ~half of first-line hormonal therapy within one year.
- Based on the Hospira upside and evolving shift to emerging markets, GEP's revenues and earnings are trending ~14% above consensus by 2018.
- M&A will continue to be a potential catalyst considering the $117B it was prepared to spent for AstraZeneca.
Mon, Mar. 23, 12:38 PM
- The Federal Trade Commission grants early termination under the HSR Act of the waiting period of Pfenex's (PFNX -1.4%) exclusive collaboration deal with Hospira (PFE +3.2%) to develop and commercialize PF582, a biosimilar to Roche's (OTCQX:RHHBY +0.7%) Lucentis (ranibizumab). The action clears the way for Hospira's initial payment of $51M to Pfenex.
- Previously: Pfenex up on Hospira biosimilar deal (Feb. 10)
Mon, Mar. 23, 9:35 AM
- Pfizer (PFE +1.3%) and collaboration partner Eli Lilly (LLY +0.1%) plan to resume the Phase 3 clinical program for tanezumab for the treatment of chronic pain. The action will trigger a $200M payment from Lilly to Pfizer as stipulated in their agreement.
- The FDA instituted a partial clinical hold on tanezumab in December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed. The regulator lifted the partial hold after reviewing nonclinical data submitted in February 2015 characterizing the sympathetic nervous system response to tanezumab.
- Tanezumab is a humanized monoclonal antibody that inhibits (binds to) nerve growth factor (NGF), a regulator of pain processing and sensitivity. Pfizer was developing it for the treatment of osteoarthritis a few years ago, but stopped amid indications that it was associated with joint destruction. The pain med worked so well that a group of patients blew out joints that needed replacing. Pfizer shelved the program in light of the safety risk but rekindled it after a panel of outside experts recommended that a more specific patient population could benefit from anti-NGF therapies. It partnered with Lilly in 2013 to advance the program and share the risk.
Fri, Mar. 20, 1:02 PM
- According to Bloomberg, AstraZeneca's (AZN +2.6%) previously stated plan to increase revenue 75% by 2023 is looking a bit wobbly. In cancer, for example, it trails three competitors in immunotherapies for lung cancer. The FDA approved Bristol-Myers Squibb's (BMY +0.2%) Opdivo for the indication on March 4. AZN's candidate, MEDI4736, is still in clinical development with an NDA filing on tap for next year. Being late to the party means modest sales unless there is a profound advantage, something that MEDI4736 may not have unless combined with other drugs.
- If the company's sales growth fails to ramp, its valuation could slump and encourage another takeover bid. AZN currently sports a P/E of 79 versus the industry average of 25 (per msn money).
- Last year, CEO Pascal Soriot fought off a $117B bid from Pfizer (PFE +0.2%) telling investors that the firm could increase revenues to $45B by 2023. The company remains bullish, though. Spokesperson Esra Erkal-Paler says that the firm is making significant progress and that oncology drugs could represent 25% of sales by 2023, up from 12% in 2014. It is currently running clinical studies of AZD9291, a non-immune therapy, in lung cancer patients with a specific mutation who have relapsed after prior treatment. If it can beat rival Clovis Oncology (CLVS -2.4%) to the market, it could be worth as much as $3B per year.
- Mirabaud analyst Nick Turner says that even if all the drugs in the pipeline make it to the market, AZN will have to stretch to reach $45B in 2023 because two of its biggest sellers, Crestor (ttm sales=$5.5B) and Nexium (ttm sales=$3.7B), face declining sales from the loss of patent protection.
Wed, Mar. 18, 10:42 AM
- Paris, France-based Cellectis (Pending:CLLS) is set for its U.S. debut of 3.5M American Depositary Shares (ADSs) representing 3.5M ordinary shares at $36.83 per ADS. The company's stock currently trades on the Alternext market of Euronext in Paris under the symbol "ALCLS."
- The gene-editing firm develops CAR-T cancer immunotherapies, currently the "next big thing" in the treatment of cancer. Other emerging biotechs in the field sport valuations of $3B+ (NASDAQ:KITE) (NASDAQ:JUNO) (NASDAQ:BLCM) (NASDAQ:BLUE). In June 2014 it inked a deal with Pfizer (NYSE:PFE) to develop CAR-T therapies which included establishing a 10% stake in Cellectis.
- Cellectis' gene-editing technology allows it to create T-cells that express chimeric antigen receptors (CARs) that harness the immune system's power to target and kill cancer cells. Its uniqueness is the capability to create allogeneic CAR-T cells from healthy donors instead from the patients themselves. This creates the opportunity to develop "off-the-shelf" products that can be stored and distributed worldwide.
- Gene editing is a form of genetic engineering in which DNA is manipulated (inserted, deleted, repaired or replaced) from a precise location in the genome. Cellectis' technology and expertise enables it to edit any gene with a high degree of precision.
- 2014 financial performance (€M): Revenues: 26.5 (+108.7%); Operating Loss: (5.2) (+80.4%); Net Loss: (1.0) (+98.2%); CF Ops: 42.5 (+322.5%).
Thu, Mar. 12, 5:03 PM
- A post-market 107-patient Phase 4 study evaluating Pfizer's (NYSE:PFE) Lyrica (pregabalin) in adolescents, aged 12 - 17 years, with fibromyalgia (FM) failed to demonstrate a statistically significant difference in pain score versus placebo. The treatment difference was 0.66 points, which was an improvement of 1.60 points from baseline for pregabalin-treated patients and 0.94 for placebo (p=0.121). The company intends to submit the full results for publication.
- Lyrica is approved for five indications in the U.S., four of which address pain, including FM.
- FM is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue and disruptions to sleep, memory and mood. The specific cause is unknown and there is no cure. It affects almost 6M Americans.
Wed, Mar. 11, 10:01 AM
- Based on feedback from the FDA, Egalet (EGLT) now plans to submit a New Drug Application (NDA) for its abuse-deterrent, extended-release oral morphine product, Egalet-001, by the end of the year.
- The company will initiate a pivotal bioequivalence study comparing the 60 mg dose to Purdue's MS Contin later this month. Bioequivalence to MS Contin has already been demonstrated at the 15 mg and 30 mg doses.
- Egalet-001 incorporates the company's Guardian Technology to deter abuse. It utilizes injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
- Related tickers: (ZGNX -23.4%)(ACUR)(ALKS +0.5%)(PFE +0.6%)(ABBV +0.7%)(LCI +1.6%)(ACT +1.7%)(MNK +1.6%)(TEVA +2.6%)
Tue, Mar. 10, 8:01 AM
- Privately-held Collegium Pharmaceutical raises $50M from institutional investors to fund the advancement of its abuse-deterrent product candidate, Xtampa ER (oxycodone extended-release capsules) through FDA clearance and commercial launch as well as fund operational growth and other pipeline programs.
- The FDA accepted the company's New Drug Application (NDA) for Xtampa ER in February. Its abuse-deterrent technology is called DETERx, which combines oxycodone with fatty acid and waxes to form small spherical beads which resist particle size reduction and dose dumping when subjected to breaking, crushing, chewing and dissolving.
- Previously: FDA accepts Collegium's NDA for abuse-deterrent opioid (Feb. 17)
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT) (NYSE:PFE) (NASDAQ:ACUR)
Tue, Mar. 10, 3:55 AM
- Prescription drug spending rose by a record 13% in the U.S. last year, the biggest annual increase in over a decade.
- "For the past several years, annual drug spending increases have been below the annual rate of overall health-care inflation in the U.S.," said Glen Stettin, senior vice president at Express Scripts. "But that paradigm is shifting dramatically as prices for medications increase at an unsustainable rate."
- Spending on specialty medicines, such as those for inflammatory diseases, multiple sclerosis, cancer and hepatitis C rose an unprecedented 31%.
Tue, Mar. 3, 9:16 AM
- The European Commission approves a revised label for Pfizer's (NYSE:PFE) Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, absorbed]) to include efficacy data from the company's Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease (IPD) in adults aged 65 and older.
- Three out of four cases of pneumococcal pneumonia are non-invasive, but the invasive types are generally more severe.
- The company conducted the CAPiTA study as part of its regulatory commitments to global regulatory authorities.
- Prevenar 13 is approved for the prevention of pneumococcal pneumonia and invasive disease caused by 13 strains of Streptococcus pneumoniae in children and adults.
Tue, Mar. 3, 7:25 AM
- Privately-held Boehringer Ingelheim files applications for marketing approval in the U.S., Europe and Canada for idarucizumab, a rapid reversal agent for its anticoagulant, dabigatran, the active ingredient in Pradaxa, a prescription blood thinner.
- The FDA designated idarucizumab a Breakthrough Therapy in June of last year. The company will pursue accelerated reviews with all three regulators.
- Blood thinner-related tickers: (NYSE:JNJ) (OTCPK:BAYRY) (NYSE:PFE) (NYSE:BMY)
Mon, Mar. 2, 12:33 PM
- A Phase 1b study evaluating Tracon Pharmaceuticals' (TCON +29.3%) TRC105 in combination with Pfizer's (PFE +1.1%) Inlyta (axitinib) for the treatment of patients with advanced or metastatic renal cell carcinoma (RCC) showed an objective response rate of 29% (n=5/17) and median progression-free survival (PFS) of 8.4 months (11.3 months in the clear cell RCC subgroup). This beat Acceleron Pharma's (XLRN -3.9%) preliminary results of 25.0% and 8.3 months, respectively, for dalantercept.
- A Phase 2b study in now underway.
- TRC105 is an antibody to endoglin, a protein that is over-expressed on endothelial cells and is essential for angiogenesis, the process of new blood vessel formation. Angiogenesis characterizes the transition of a tumor from a benign state to a malignant one. TRC105 binds to endoglin thereby inhibiting angiogenesis and "starving" the tumor.
- The data were presented at the American Society of Clinical Oncology (ASCO) 2015 Genitourinary Cancers Symposium in Orlando, FL.
- Previously: Acceleron Pharma cancer drug shows encouraging results in Phase 2 study, but not quite as encouraging as Tracon Pharma's (March 2)
Mon, Mar. 2, 12:08 PMAcceleron Pharma cancer drug shows encouraging results in Phase 2 study, but not quite as encouraging as Tracon Pharma's
- Preliminary data from an ongoing Phase 2 trial evaluating Acceleron Pharma's (XLRN -4.6%) activin receptor-like kinase (ALK1) inhibitor, dalantercept, in patients with advanced renal cell carcinoma (RCC) show encouraging response rates and improved progression-free survival (PFS) when administered with Pfizer's (PFE +1%) vascular endothelial growth factor (VEGFR) inhibitor, Inlyta (axitinib), compared to VEGFR inhibitor therapy alone.
- The objective response rate for the combination therapy was 25.0% (n=7/28) compared to 11.3% for single agent axitinib in a Phase 3 study. Median PFS was 8.3 months compared to 4.8 months in the same Phase 3.
- The data were presented at the American Society of Clinical Oncology (ASCO) 2015 Genitourinary Cancers Symposium in Orlando, FL.
Fri, Feb. 27, 9:59 AM
- Biogen Idec (BIIB -0.5%) and collaboration partner Swedish Orphan Biovitrum AB announce positive top-line results from a Phase 3 trial evaluating Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) in children under age 12 with severe hemophilia B.
- Medical professionals recommend prophylactic treatment in children with severe hemophilia in order to manage and/or prevent bleeding episodes, but frequent administration schedules can be burdensome for patients and caregivers. Alprolix is administered once every 7 - 10 days for routine prophylaxis (prevention).
- In the study, children treated with Alprolix experienced an overall median annualized bleeding rate (ABR) of 1.97, while the median ABR for spontaneous joint bleeds was zero. About one third of the participants had no bleeding episodes at all. Overall, 91.7% of bleeding episodes were controlled by one or two infusions of Alprolix. None of the patients produced inhibitors (antibodies) to Alprolix in the study, which was the most significant potential complication of treatment.
- The European Medicines Agency requires the inclusion of pediatric study data in the initial Marketing Authorization Application (MAA) for a new hemophilia treatment. Interim data were used in the U.S. New Drug Application (NDA).
- Alprolix is the only approved hemophilia B therapy with prolonged circulation in the body. The FDA cleared it in March of last year. It generated $25.3M and $40.3M in sales for Biogen in Q3 and Q4, respectively.
- Related tickers: (BAX +0.3%)(OPK -0.8%)(SGMO -1.9%)(ALNY -1.9%)(ONCE +3%)(PFE -0.2%)(SHPG -1.6%)
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Pfizer Inc is a research-based biopharmaceutical company. The Company has five operating segments: Primary Care; Specialty Care and Oncology; Established Products and Emerging Markets; Animal Health; and Consumer Healthcare.
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