|Eli Lilly Shares Rise on Alzheimer’s Drug Hopes; FDA Sets PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone|
|By Staff and Wire Reports|
|Tuesday, 06 December 2011 20:34|
Eli Lilly & Co. (NYSE:LLY) rose to a one-month high after an analyst said success of the company’s experimental Alzheimer’s drug could double the share price.
Lilly, based in Indianapolis, gained 3.9 percent to $38.86 at 4 p.m. New York time. Expectations have been “extraordinarily low” for the success of Alzheimer’s drugs, so a Lilly success with solanezumab could boost the shares 50 to 100 percent, Tim Anderson, an analyst with Sanford C. Bernstein, said in a note.
“Eli Lilly and several of its competitors are willing to spend hundreds of millions of dollars on what is essentially a massive lottery ticket,” Anderson said. “If their drugs are successful in delaying the progression of Alzheimer’s disease, they could end up making Lipitor look like a mid-sized product,” he said in a note to clients sent yesterday. Sales of solanezumab could reach $9 billion by 2020, he said.
Solanezumab is an antibody designed to clear protein fragments called beta amyloid that clutter the brains of patients with Alzheimer’s disease. Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE:JNJ) and Elan (OTC:ELAN) are testing bapineuzumab, a similar drug.
Anderson cautioned that the drug’s chances of success are only 10 percent to 20 percent. Because of the large potential payoff, drugmakers have been willing to gamble on the medicines.
A leading theory of the disease is that amyloid causes the disease by harming brain cells. Debate over whether the theory is correct has increased as other drugs that target the protein have failed or shown murky results in trials. In August 2010, Lilly stopped development of a pill, semagacestat, that blocked amyloid by another mechanism, after trials found it didn’t slow disease progression.
Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) today announced that the U.S. Food and Drug Administration's ("FDA") Division of Oncology Products 1 ("DOP1") has notified CTI that CTI's October 2011 resubmitted New Drug Application ("NDA") is considered a complete, Class 2 response to the FDA's April 2010 complete response letter ("CRL"). The FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of April 24, 2012 for a decision on the NDA. The NDA seeks accelerated approval of pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") in patients who failed two or more lines of prior therapy.
Pixantrone is also under review for marketing approval in Europe with a Committee for Human Medicinal Products ("CHMP") opinion on the application tentatively scheduled on January 19, 2012.
"We look forward to working with the FDA and the European Medicines Agency ("EMA") to bring this drug to patients for whom there are currently no approved therapies," James A. Bianco, M.D. Chief Executive Officer stated.
CTI appealed the CRL for the pixantrone NDA based on the results of the PIX301 clinical trial. The FDA's Office of New Drugs ("OND") responded to CTI's appeal by providing CTI with an opportunity to resubmit the NDA with additional information, but without conducting an additional clinical trial. In June 2011, CTI met with the DOP1 to review CTI's plans for responding to the items noted in the CRL including CTI's plans for addressing the items noted by the OND in response to the appeal.
Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has modified the requirements of the Nplate® (romiplostim) Risk Evaluation and Mitigation Strategy (REMS) Program.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the Oppenheimer 22nd Annual Healthcare Conference in New York City.
BioLife Solutions Inc. (OTCBB: BLFS), a leading developer, manufacturer, and marketer of proprietary biopreservation media products for cells, tissues, and organs, today announced the launch of its new corporate website that includes the following features: Mike Rice, BioLife Chief Executive Officer, commented on the launch of the Company's new website by stating, "Our new site has been designed to increase awareness and adoption of our high-quality cGMP HypoThermosol, CryoStor, and BloodStor® biopreservation media products.
BioLineRx (NASDAQ:BLRX) (TASE:BLRX) announced today the final results of the Phase Ia study of BL-1021, an orally available small molecule for neuropathic pain.
Celsion Corporation (the "Company") (NASDAQ: CLSN) today announced the closing of its previously announced sale of $15 million of the Company's securities to leading life science institutional investors in a private placement offering.
Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the Company will be presenting at Oppenheimer & Company’s 22nd Annual Healthcare Conferenceat 3:55 p.m. EST on Tuesday, December 13, 2011, in New York City.
Dendreon Corporation (NASDAQ:DNDN) today announced that it has agreed to sell for $125 million in cash its royalty interest related to intellectual property licensed to Schering-Plough Ltd. and Schering Corporation (collectively Schering, each now a wholly owned subsidiary of Merck & Co., Inc.) and associated with VICTRELIS™ (boceprevir), a treatment for chronic hepatitis C.
Discovery Laboratories, Inc. (Nasdaq: DSCO) today released new data showing that use of AFECTAIR® resulted in as much as a 70 percent reduction in the amount of nitric oxide required to deliver the desired dose of the therapeutic gas when compared with current standard of care (SoC) (p < 0.001).
Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude® SkinPrep System for transdermal drug delivery, today announced positive results from its clinical study of its Symphony tCGM System in patients with type 1 and type 2 diabetes.
GenVec, Inc. (Nasdaq: GNVC) today announced that it has achieved the second milestone in its collaboration with Novartis (NYSE: NVS), related to the development of treatments for hearing loss and balance disorders.
The board directors of Health Enhancement Products, Inc. (OTCBB: HEPI) an Arizona-based food ingredients and nutraceutical enterprise, has accepted a $2 million convertible debt agreement to fund the Company's R&D efforts going forward.
In support of our new Mission and Strategy, IGEN Networks Corporation (OTCBB:IGEN) is pleased to announce an exclusive distribution agreement with the Gogiro Internet Group to expand regional office coverage across North America by an additional 30 cities by Q1-2013 along with an option to purchase up to 9.5% of the Gogiro Internet Group during the same period.
Nuvilex, Inc. (OTCQB:NVLX) announced today their affiliate SG Austria and partners have successfully treated diabetes in an established, recognized animal model utilizing live encapsulated cells.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company primarily focused on the pediatric market, today announced the appointments of David Becker as Chief Financial Officer, Charles (“Chuck”) Hrushka as Vice President of Sales & Marketing, and Leslie White as Director of Regulatory Affairs & Quality Assurance.
Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.
Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) announced today that executive management will present at the Oppenheimer Healthcare Conference to be held on December 13-14, 2011 in New York.
Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE AMEX: SNT) announced today that it will deliver a poster presentation at the 53rd Annual Meeting of ASH, the American Society of Hematology.
ViroPharma Incorporated (Nasdaq: VPHM) and Halozyme Therapeutics (Nasdaq: HALO) today announced positive top line data from ViroPharma's open-label, multiple dose Phase 2 clinical trial designed to evaluate the safety, pharmacokinetics and pharmacodynamics of subcutaneous administration of Cinryze® (C1 esterase inhibitor [human)] in combination with Halozyme's Enhanze™ technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), in subjects with hereditary angioedema (HAE), a rare, debilitating and potentially fatal genetic disease.