Today - Friday, November 28, 2014
- According to UBS analyst Matthew Roden, total prescriptions for Gilead Sciences' (GILD +0.3%) Harvoni for the week ending November 21 was 4,366 (+21%). Scripts for Harvoni and Sovaldi were 7,813 (+5%). Bloomberg consensus view for Q4 Harvoni sales is $1.8B.
- RBC's Michael Yee cites a Q4 consensus for Harvoni + Sovaldi of ~$3.6B and, if current momentum continues, a 2015 consensus of ~$12B.
- Bankrupt biotech Affymax (OTCPK:AFFY +127.6%) jumps on an 8x surge in volume as traders move to capture the $0.05 dividend payable to shareholders of record December 2, 2014.
- Previously: Affymax declares cash distribution, names new chief
- Previously: The end for Affymax
- Medtronic (MDT +1.3%) secures EU approval for its $43B acquisition of Covidien plc (COV +1%) contingent on, as expected, Covidien selling Stellarex, its drug-coated angioplasty balloon. Spectranetics (SPNC +1.9%) agreed to purchase Stellarex several weeks ago for $30M. The FTC recently gave its blessing to the transaction as well.
- Previously: FTC clears Medtronic/Covidien marriage
- Previously: Spectranetics buys Covidien's DCB platform
- Dispelling rumors that it might jettison its consumer healthcare unit after acquiring Sigma-Aldrich for $17B, Merck KGaA (OTC:MKGAF) (OTCPK:MKGAY) says that it has no intention of selling the business which is expected to hit the $1B sales mark in 2014.
- The OTC market has consolidated this year led by Bayer's acquisition of U.S. Merck's consumer healthcare unit, Glaxo and Novartis' deal and Perrigo's buy of Omega Pharma.
- Previously: Perrigo buys consumer health products firm
- Previously: FTC gives thumbs up to Glaxo/Novartis transaction
- Previously: Bayer buying Merck consumer care unit for $14.2B
- Pursuant to a Securities Purchase Agreement, Alimera Sciences (ALIM +1.2%) will issue $50M in preferred stock plus a subscription premium of an additional 124.378 shares of preferred to Deerfield Management. The preferred shares will be convertible into 8,416,251 shares ALIM common.
- Proceeds will fund the commercial launch of Iluvien in the U.S., continued marketing activities in Europe and general corporate purposes.
- Lyon, France-based Flamel Technologies (FLML +0.6%) sells its Pessac, France-located manufacturing and development facility to Swedish CDMO (contract development and manufacturing organization) Recipharm for €10.6M as part of a five-year service agreement. Flamel retains access to the capabilities of Pessac as well as other Recipharm facilities for its production and development activities. The sale includes the royalty contract for Coreg CR with GlaxoSmithKline (GSK +0.3%).
- Flamel and Recipharm agree to negotiate an agreement with the objective of incorporating the former's drug delivery technology into the latter's contract development business.
- In a separate transaction, Recipharm will make a €10.5M investment in Flamel's common stock.
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
- In preemptive move, the China Food and Drug Administration (CFDA) drafts a policy that allows for the emergency use of diagnostic products to determine Ebola infection and clinical trials. The regulator approves three Chinese firms, Da An Gene Co Ltd, Shenzhen Pu Rui Kang and Shanghai ZJ Bio-Tech Co Ltd., to manufacture the diagnostic products for emergency use.
- No Ebola cases have been reported in China, but many Chinese nationals live in Africa including ~10,000 in Sierra Leone, Guinea and Liberia.
- ETFs: FXI, EWH, KWEB, PGJ, YINN, GXC, FXP, ASHR, HAO, TAO, YANG, CHIQ, CQQQ, CHIX, MCHI, QQQC, PEK, XPP, YAO, YXI, CHXF, ECNS, FCA, CHII, CN, CHIE, CHIM, EWHS, FCHI, ASHS, KFYP, CNXT, CHNA, KBA, FHK
- The FDA accepts for review Ipsen's (OTCPK:IPSEY) supplemental Biologics License Application (BLA) for Dysport (abobotulinumtoxinA) for the treatment of adult patients with upper limb spasticity.
- Dysport is currently cleared in the U.S. for the treatment of adults with cervical dystonia, a painful condition in which the neck muscles contract involuntarily.
- The product is an injectable form of botulinum toxin type A (BoNT-A) which is isolated and purified from Clostridium BoNT-A bacteria.
- After three people died shortly after receiving Novartis' (NYSE:NVS) Fluad influenza vaccine, Italy's drug regulator AIFA suspends two lots of the product. In an e-mailed statement, Novartis says, "A review of the two batches confirmed that they conform with all production and quality standards and no casual relationship to the vaccine have been established."
- Fluad was approved in 1997 and has an extensive history of safe use.
- The three deaths, and another serious adverse event, all occurred in the southern regions of Sicily and Molise. One of the deaths was a 68-year-old man who died ten minutes after being vaccinated.
- As expected, Avanir Pharmaceuticals (NASDAQ:AVNR) receives a Complete Response Letter (CRL) from the FDA related to its New Drug Application (NDA) for AVP-825, an investigational drug-device combination for the treatment of migraines.
- Consistent with previous feedback, the agency requests that Avanir assess the root cause (s) of device use errors observed in the previously conducted human factors testing. A new validation study to assess the device's usability following improvements to the product will be required. The FDA did not specify any additional trials that need to be conducted prior to approval.
- Avanir Chief Medical Officer Joao Siffert, M.D., says, "We believe the concerns raised by the FDA are fully addressable. Following the receipt of the preliminary feedback we have been working internally and with the FDA toward implementing changes prior to repeating the human factors study. Based on these conversations, we will conduct a new human factors study, with input from the FDA, with a goal to respond to the CRL in the first half of calendar 2015."
- Previously: FDA approval unlikely as PDUFA date approaches for Avanir
- GlaxoSmithKline (NYSE:GSK) declines to exercise its option to license Dynavax's (NASDAQ:DVAX) DV1179, an investigational bifunctional inhibitor of toll-like receptors (TLR) 7 and 9, after it failed to meet its pharmacodynamic endpoints related to the reduction in interferon alpha-regulated genes in a Phase 1b/2a study in patients with active systemic lupus erythematosus.
- Dynavax will now have full global rights to develop DV1179 and other TLR 7/9 inhibitors for all indications.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) grants accelerated assessment to Novartis' (NYSE:NVS) LCZ696, an investigational drug for the treatment of heart failure with reduced ejection fraction. This is the first time CHMP has extended such a review for a cardiovascular medicine. The designation shortens the committee's review period by 60 days (210 to 150) so a decision should be forthcoming in 2015.
- Novartis expects to submit its Marketing Authorization Application (MAA) in early 2015. The basis for the submission is he Paradigm-HF study where LCZ696 demonstrated superiority compared to ACE-inhibitor enalapril.
- The drug candidate is under Fast Track review in the U.S. The company's rolling submission should be complete by the end of next month.
- Previously: Novartis chief says new heart failure drug will be a winner
- Previously: Novartis heart failure drug candidate beats enalapril
- Pfizer's (NYSE:PFE) attempt to gain control of AstraZeneca (NYSE:AZN) through a £69.4B ($110B) takeover bid in May would have collapsed on changes to U.S. tax inversion laws, announced Astrazeneca's chief exec, cooling off speculation of another bid for the U.K. pharmaceutical company.
- "If we had agreed to a deal at the time, probably that deal would have fallen apart by now, just like the AbbVie/Shire deal, and created enormous destruction and disruption in our company," said Pascal Soriot in an interview with CNBC.
Thursday, November 27, 2014
- Britain's National Institute for Health and Care Excellence (NICE), the advisory group for the National Health Service, recommends the commission of Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab) for the treatment of patients with atypical hemolytic uremic syndrome (aHUS), an ultra-rare life-threatening disorder characterized by renal failure and the formation of blood clots in the small blood vessels throughout the body (thrombotic microangiopathy or TMA). In the UK, the total number of potential patients, typically children five years old or less, is only ~25.
- 79% of patients with aHUS die within three years of diagnosis despite plasma exchange or plasma infusion. The majority of patients with aHUS who undergo a kidney transplant experience subsequent systemic TMA and face a 90% transplant failure rate.
- Soliris first achieved regulatory clearance in 2007 in the U.S. and EU for the treatment of another ultra-rare life-threatening blood disorder called paroxysmal nocturnal hemoglobinuria (PNH). It was approved for aHUS in the U.S. and EU in 2011. Soliris is also cleared for sale for both indications in Japan and selected other countries.
- A full regimen of Soliris costs ~$540,000, the world's most expensive drug until UniQure's Glybera (alipogene tiparvovec) leapfrogged it.
- NICE recommended funding for Soliris for aHUS in September.
- Previously: NICE recommends Soliris for aHUS
- Previously: UniQure sets price record with Glybera
- An experimental Ebola vaccine from GlaxoSmithKline (NYSE:GSK) produced an immune response in all 20 healthy volunteers who received it, and did not cause any serious side effects, Reuters reports quoting the New England Journal of Medicine.
- The early-stage clinical trial, which began on Sept. 2, is primarily aimed at assessing how safe the vaccine is and will monitor the volunteers for 48 weeks.
Wednesday, November 26, 2014
6:38 PM| 1 Comment
4:45 PM| Comment!
- Affymax (OTCPK:AFFY) declares a special cash distribution of $0.05 per share to shareholders of record December 2, 2014. Also, The BOD appoints Jonathan M. Couchman as a Class I director and President & CEO of the firm. The remaining members of the board resign.
- The company will continue its evaluation of strategic alternatives.
- Previously: The end for Affymax