|Pfenex Inc. In Development Pact For Macular Degeneration Drug; KYTHERA Acquires Worldwide Rights to Potential Novel Treatment of Hair Loss|
|By Josh Gee|
|Tuesday, 10 February 2015 20:43|
Pfenex Inc. (NYSX: PFNX) shares gained more than 20 percent after the company disclosed its macular degeneration drug candidate will get collaborative support from Hospira, Inc. HSP 0.01%.
The drug under development is aimed at competing as a so-called biosimilar with Roche Holding Ltd. (ADR)'s RHHBY 0.23% ranibizumab injection, called Lucentis, which had estimated sales last year of $4 billion.
Pfenex and Hospira will share the Phase 3 trial costs and Pfenex will receive "double digit" royalty payment on net sales that may follow. Hospira will be responsible for manufacturing and commercializing the product worldwide.
Under terms of the agreement, Pfenex will receive an upfront payment of $51 million from Chicago-based Hospira, and will be eligible for an additional $291 million over the next five years in a combination of development and sales-based milestone payments.
The collaboration is subject to antitrust approval. Pfenex is currently conducting a safety trial where 24 patients have been randomized to receive monthly intraocular injections of the treatment for three doses and ongoing patient follow-up for 12 months.
San Diego-based Pfenex changed hands recently at $8.25, up $1.35.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced that it has entered into separate license agreements with Actelion Pharmaceuticals Ltd. and the University of Pennsylvania for a novel approach for the treatment of hair loss, which together could enable KYTHERA to bring a new treatment to the very large and still highly unsatisfied hair loss market.
"These two licenses build on KYTHERA's focus on developing and commercializing high-value, self-pay aesthetic products that have the promise to yield high patient satisfaction and enhanced self image," said Keith Leonard, KYTHERA's president and CEO. "Based on several years of research and clinical work already accomplished, we believe we have the possibility of reaching initial proof-of-concept data in a very capital efficient manner."
Under the terms of the agreement with Actelion, KYTHERA Holdings Ltd., a wholly-owned Bermuda subsidiary of KYTHERA Biopharmaceuticals, Inc., licensed the worldwide rights to setipiprant, a clinical-stage selective and potent oral antagonist to the prostaglandin D2 (PGD2) receptor. As part of the agreement, Actelion will be eligible to receive up to $27 million in potential development and regulatory milestones, as well as royalties on sales if setipiprant is successfully commercialized.
Under the terms of the agreement with the University of Pennsylvania, KYTHERA Holdings Ltd., acquired exclusive worldwide rights to certain patent rights owned by the University of Pennsylvania covering the use of PGD2 receptor antagonists for the treatment of hair loss (often presenting as male pattern baldness, or androgenic alopecia) under a license agreement facilitated by the Penn Center for Innovation. The discovery of the relationship between PGD2 and hair loss was made in the laboratory of Dr. George Cotsarelis and published in late 20111. KYTHERA has been supporting research in Dr. Cotsarelis' lab at the University of Pennsylvania over the last two years under sponsored research and option agreements to further develop and elucidate the initial reported observations.
"The University of Pennsylvania's discovery and associated intellectual property assets, combined with access to the PGD2 antagonist setipiprant, provide KYTHERA a strong foundation for this novel approach to hair loss," said Frederick Beddingfield, III, M.D., Ph.D., KYTHERA's Chief Medical Officer. "These observations are potentially the most innovative new thinking in hair loss over the last two decades. Setipiprant is believed to directly affect this hair loss pathway, and our own preclinical and in vitro human hair models confirmed this effect. It is a well-characterized molecule with a large safety database and we believe we can quickly initiate a development program to study it in hair loss. Putting these two pieces of the puzzle together is ideal and represents an example of our approach to scientifically sound and efficient drug development."
KYTHERA plans to conduct a human proof-of-concept study to establish the efficacy of setipiprant in male subjects with androgenic alopecia (AGA).
Alliqua BioMedical, Inc. (Nasdaq:ALQA), a provider of advanced wound care products, today announced plans to release fourth quarter and fiscal year 2014 financial results before the market opens on February 24th.
Amarantus BioSciences Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing diagnostics in neurology, and therapeutic products with the potential for orphan drug designation in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that the publication of the results of a Phase 2a study of eltoprazine in Parkinson's disease levodopa-induced dyskinesias (PD-LID).
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced positive data on pre-specified patient reported outcomes from both of its Phase 3 studies of the oral small molecule pharmacological chaperone migalastat HCl ("migalastat") for Fabry disease at WORLDSymposium™ 2015 in Orlando, Florida.
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today highlighted results from preclinical studies of its next-generation Pompe ERT at WORLDSymposium™ 2015 in Orlando, Florida.
Bio Blast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases, today announced that it will report its results for the fourth quarter and fiscal year ended December 31, 2014 before the market open on Tuesday, February 17, 2015.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced the issuance of U.S. Patent No. 8,951,970 with claims covering the use of its lead clinical compound, CR845, and related compounds of this chemical class for the treatment and prevention of a broad range of pain-related conditions.
Cerner Corporation (Nasdaq:CERN) today announced results for the 2014 fourth quarter and full year that ended January 3, 2015, delivering strong levels of bookings, revenue, earnings and operating cash flow.
Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced unaudited financial results from operations for the first fiscal quarter ended December 31, 2014.
Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced the dosing of the first patient in its HPN-100-009 study in pediatric subjects under two years of age with urea cycle disorders (UCDs).
ImmuDyne, Inc. (OTCQB:IMMD) announced today the hiring of Todd Goldman as Senior Vice President of Marketing and Sales.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, today announced the completion of its previously announced underwritten public offering of 1,000,000 shares of its common stock.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced a strategic collaboration with Emdeon, a leading provider of revenue and payment cycle management and clinical information exchange solutions.
MediciNova, Inc., (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that FDA (U.S. Food and Drug Administration) has approved the protocol for a clinical trial of MN-001 (tipelukast) for the treatment of moderate to severe IPF (idiopathic pulmonary fibrosis).
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that the Company will release fourth quarter 2014 financial results after the close of trading on Tuesday, February 24, 2015.
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced results for the fourth quarter and year-end 2014.
Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, will announce its fourth quarter and full year 2014 financial results on Wednesday, February 25, 2015.
Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, announced today that management will participate in two investor conferences in February.
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a clinical late stage biopharmaceutical company developing and commercializing novel tetracycline based antibiotics to treat serious infections where resistance is of concern, today announced that Evan Loh M.D, President and Chief Medical Officer will present at the 2015 Leerink Global Healthcare Conference on Thursday, February 12 at 8:30 a.m. Eastern Time at the Waldorf Astoria Hotel in New York City.
Precision Optics Corporation, Inc. (OTCQB:PEYE) today announced that it will provide pre-release demonstrations of a micro-camera module that will be available in the near future.
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that its international Diabetes Consortium has met to develop the path forward for the development of a novel treatment for insulin-dependent diabetes and that it has appointed Dr. Eva Maria Brandtner Director of Diabetes Program Development.
Phibro Animal Health Corporation (Nasdaq:PAHC) today announced its financial results for its second quarter ended December 31, 2014.
Prosensa Holding N.V. (Nasdaq:RNA), the biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, announced today that, on February 11, 2015, it will file a Form 25, Notification of Removal from Listing and/or Registration under Section 12(b) of the Securities Exchange Act of 1934 (the "Exchange Act") (the "Form 25"), with the Securities Exchange Commission ("SEC") in order to voluntarily delist the registered shares of the Company, nominal value €0.01 per share (the "Shares") from the NASDAQ Global Select Market ("NASDAQ"), which will become effective 10 days after filing.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced that the Lysosomal Disease Network (LDN) will present Raptor Pharmaceutical with the 2015 New Treatment Award for PROCYSBI® (cysteamine bitartrate) delayed-release capsules on February 12, 2015 at its 11th Annual WORLD Symposium being held in Orlando, Fla. on February 9-13, 2015.
Repligen Corporation (Nasdaq:RGEN) announced today that it has completed an 11,000 square foot expansion of its U.S. manufacturing facility.
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP) announced today that Rick Matros, the Company's Chairman and Chief Executive Officer and Talya Nevo-Hacohen, the Company's Chief Investment Officer, will be participating at the 18th Annual Wells Fargo Real Estate Securities Conference from February 24-25, 2015 at the Plaza Hotel in New York, New York.
T2 Biosystems, Inc. (Nasdaq:TTOO) today announced that it will release its 2014 fourth quarter and year-end financial results after the market closes on Tuesday, February 17, 2015.
Tandem Diabetes Care®, Inc. (Nasdaq:TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps, plans to release its fourth quarter and full year 2014 results after the financial markets close on Tuesday, February 24, 2015.
VeriTeQ Corporation (OTC Markets:VTEQ), a provider of implantable medical device identification and radiation dose measurement technologies, announced today that its Board of Directors and FINRA have approved a reverse split of the Company's common stock at a ratio of 1-for-1000, commencing at the open of trading on February 11, 2015.
Wright Medical Group, Inc. (Nasdaq:WMGI) today announced the pricing of its offering of $550 million aggregate principal amount of cash convertible senior notes due 2020 ("the notes").
ZS Pharma (Nasdaq:ZSPH), a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced that Martin Babler, Chief Executive Officer of Principia Biopharma, has been appointed to the ZS Pharma Board of Directors.