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%)
Wed, Feb. 25, 9:42 AM
- The FDA accepts for review the New Drug Application (NDA) from Teva Pharmaceutical Industries (TEVA -0.6%) for CEP-33237, its hydrocodone bitartrate extended release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- The product is formulated with its proprietary abuse-deterrent technology, although it does not specify the nature of the technology or how it works. In an oral human abuse liability study (HAL) in nondependent recreational opioid users, the abuse potential of finely crushed CEP-33237 powder was significantly lower based on peak at-the-moment drug liking. An intranasal HAL study produced the same result.
- Related tickers: (ZGNX -0.6%)(EGLT)(OTCQB:ELTP)(PFE -0.7%)(ACUR)(MNK -0.6%)(ACT +0.7%)(ABBV -0.6%)(LCI +1%)(ALKS -1.7%)
Wed, Feb. 25, 7:36 AM
- The long-anticipated major debut of biosimilars is underway in Europe. South Korean biopharmaceutical firm Celltrion's biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab) will be launched in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden under the brand name Inflectra by commercial partner Hospira (NYSE:HSP) (NYSE:PFE) and in Germany, Italy, Britain, the Netherlands, Belgium and Luxembourg under the brand name Remsima by privately-held Indian drug firm Mundipharma.
- Biosimilars to Remicade have been available in certain smaller markets in Europe for several months, but this is the first move into major markets so the results will closely watched from the global biotech industry.
- Remicade generated almost $6.9B in sales for J&J the past four quarters, including ~$2.3B in Europe.
- Remsima was approved by the European Medicines Agency in 2013. The FDA's Arthritis Advisory Committee will meet on March 17 to discuss Celltrion's biologics license application (BLA) for clearance in the U.S.
Tue, Feb. 24, 8:14 AM
- Merck (NYSE:MRK) extends a royalty-free license to the Medicines Patent Pool (MPP) for its pediatric formulations of raltegravir (marketed as Isentress in the U.S.) for the treatment of HIV-1 infection in infants and children from four weeks to under 12 years of age in developing countries. This is the MPP's first agreement that provides access to an HIV integrase inhibitor for use in combination HIV therapy for patients in this age range.
- Raltegravir is the only integrase inhibitor cleared for use in infants and children as young as four weeks in the U.S. and European Union. Pediatric formulations are available as chewable tablets (25 mg and 100 mg) and granules for oral suspension (single-use 100 mg packets).
- There are ~3.2M children infected with HIV worldwide.
- The MPP, founded in 2010, is a United Nations-backed organization that aims to increase access to HIV medicines and technologies to people in developing countries. It has agreements with AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY), Gilead Sciences (NASDAQ:GILD), Roche (OTCQX:RHHBY), NIH and ViiV Healthcare (NYSE:PFE) (NYSE:GSK).
Fri, Feb. 20, 11:41 AM
- The FDA accepts under Priority Review Pfizer's (PFE -0.5%) supplemental New Drug Application (sNDA) for the use of Rapamune (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive lung disease in women of childbearing age that is characterized by the proliferation of disorderly smooth muscle growth (leiomyoma) throughout the lungs. It is often fatal. If cleared, it will be the first approved treatment for the disease. It is estimated that LAM affects 30K - 50K women worldwide.
- Priority Review shortens the review clock to six months from the normal ten. The agency's decision should happen by June, based on the sNDA submission date.
- Rapamune is currently cleared for the prevention of organ rejection in kidney transplant patients aged 13 years and older.
Thu, Feb. 19, 12:21 PM
- On the recommendation of the academic executive committee, Eli Lilly (LLY +0.1%) extends the Phase 3 study of evacetrapib by ~six months. Results remain blinded to both the company and academic committee so the extension is not based on data, but the belief that longer treatment will allow appropriate testing of the hypothesis that evacetrapib added to statins can reduce major adverse cardiovascular events (MACE) compared to statins alone in patients with high-risk atherosclerotic cardiovascular disease (ASCVD).
- The futility analysis, previously planned for this quarter, will now occur in Q3.
- Evacetrapib is cholesterylester transfer protein (CETP) inhibitor which increases high-density lipoprotein and lowers low-density lipoprotein.
- Pfizer (PFE -0.5%) attempted to develop its own CETP inhibitor, torcetrapib, but abandoned it in 2006 after Phase 3 studies showed excessive all-cause mortality.
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Tue, Feb. 17, 10:06 PM
- Elite Pharmaceuticals (OTCQB:ELTP) plans to commence a Phase 3 study in late March evaluating its abuse-deterrent opioid product candidate, ELI-200. The company has submitted a study protocol to the FDA and expects to receive its comments by mid-March. Patient dosing should start shortly thereafter.
- The multi-center, randomized, double-blind, placebo-controlled, parallel group clinical trial will assess the safety and efficacy of abuse-deterrent ELI-200 for the treatment of adult patients with moderate-to-severe pain following surgery. The study will enroll ~150 patients and will take ~eight weeks to complete.
- Elite projects submitting a New Drug Application (NDA) in Q3 and achieving regulatory clearance by early 2016.
- The company's abuse-deterrent technology is a multi-particulate capsule that contains an opioid agonist in addition to the opioid antagonist, naltrexone. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the effects of the opioid. The technology is the firm's top priority, expected to add considerably to its modest revenues to date. Fiscal Q3's top line was only $1.4M.
- Related tickers: (NYSE:PFE) (NASDAQ:ACUR) (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
Tue, Feb. 17, 1:03 PM
- Teva Pharmaceutical Industries (TEVA +0.4%) launches its generic version of Sanofi's (SNY -0.6%) Lovenox (enoxaparin sodium injection) for the prophylaxis of deep vein thrombosis (DVT) and treatment of acute DVT. Lovenox generates ~$1.8B in U.S. sales.
- It also launches a generic version of Pfizer's (PFE -0.2%) Zyvox (linezolid) for the treatment of infections caused by Gram-positive bacteria. Zynox generates ~$465M in U.S. sales.
- As of January 22, Teva had 120 product registrations pending FDA approval, representing U.S. sales of over $86B.
Tue, Feb. 17, 8:40 AM
- The FDA accepts for review the New Drug Application (NDA) from privately-held Canton, MA-based Collegium Pharmaceuticals for Xtampza ER, its abuse-deterrent extended-release oxycodone formulation for the treatment of chronic pain.
- Its abuse-deterrent technology is called DETERx, which preserves the extended-release properties following common methods of tampering. It also avoids the use of antagonists (Pfizer's (NYSE:PFE) ALO-02 and Embeda) and aversive agents (Acura's (NASDAQ:ACUR) AVERSION), thereby minimizing the risks to legitimate patients.
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
Fri, Feb. 13, 11:22 AM
- The FDA accepts for review Pfizer's (PFE -0.1%) New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- ALO-02 incorporates abuse-deterrent technology. The capsules contain pellets consisting of the opioid, oxycodone, surrounding sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, patients receive oxycodone in an extended release manner with no effect from the naltrexone. If the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released, counteracting the effects of oxycodone.
- Related tickers: (ZGNX +1.8%)(MNK +1.8%)(ACT +1.1%)(TEVA -0.6%)(ABBV +1%)(LCI -1%)(ALKS -3.7%)
Thu, Feb. 12, 5:33 PM
- Impax Laboratories (NASDAQ:IPXL) receives three Civil Investigative Demands (CIDs) from the Office of the Attorney General of the State of Alaska concerning its investigation into whether the company violated Alaskan state law by entering into settlement agreements with the respective brand name maker to delay the entry of generic versions of the products Adderall XR (NASDAQ:SHPG), Effexor XR (NYSE:PFE) and Opana ER (NASDAQ:ENDP).
- Such transactions are called "pay-to-delay" deals because the generic firm accepts a cash payment in exchange to delay the commercial launch of a lower-priced generic version to the branded product. This enables the branded manufacturer to maintain higher prices for an extended period.
- A CID is beefed-up subpoena which can require the recipient to produce documents, answer interrogatories or give testimony under oath.
- Impax plans to cooperate fully with the Alaska AG.
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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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