Bwt12102010.indd

B I O T E C H ’ S M O S T R E S P E C T E D N E W S S O U R C E F O R 2 0 Y E A R S
Competition for MS Therapies Heats Up Teva’s MS Drug Nails Primary
XenoPort Prices Public
Endpoints – and Then Some
Offering of 4M Shares
BioWorld Today Contributing Writer Teva Pharmaceutical Industries Ltd. has reported that its Shares of XenoPort Inc. tumbled 6.4 percent after oral laquinimod for relapsing-remitting multiple sclerosis the biotech priced a public offering of 4 million common (RRMS) hit the primary endpoint in its two-year Phase III shares at $7. 15 per share, which was about 7.9 percent ALLEGRO study, demonstrating signifi cant reduction in annualized relapse rate compared to placebo. Shares of XenoPort (NASDAQ:XNPT) closed at $7.26 The drug is being developed in partnership with Active Biotech, of Lund, Sweden. In 2004, Jerusalem-based Teva In a fi ling with the SEC, the Santa Clara, Calif.- acquired from Active the exclusive worldwide rights to based company, which develops drugs for restless legs develop, register, manufacture and commercialize the syndrome (RLS), post-herpetic neuralgia, migraines and other pain-related conditions, said it plans to use the In a potentially game-changing development, the expected proceeds of $26.6 million, or $30.6 million if companies reported that laquinimod achieved additional the underwriters exercise in full their option to purchase clinical endpoints, including signifi cant reduction in disability 600,000 additional shares of common stock, for general progression as measured by the Expanded Disability Severity corporate purposes, including trials, manufacturing, R&D Israeli Biotech Sector Maturing,
Promoting Attachment is Good
Seeking U.S. Investors
For Fighting Biofilm Infections
BioWorld Today Contributing Writer NEW YORK – In spite of having the world’s highest Not just curmudgeons will admit that people can exit the number of life science patents per capita, a highly hospital with bigger problems than they came in with. One developed academic research infrastructure, and example is hospital-acquired infections, which can form so- entrepreneurial know-how, Israel still has trouble called biofi lms, often on medical devices such as catheters. commercializing its discoveries due to a number of New research shows how bacteria can break out of such factors, mostly fi nancing. But the Israeli biotech industry biofi lms to seed new fi lms or become a source of recurrent is fi nally coming of age, according to 14 company presentations at this week’s Tel Aviv Stock Exchange When bacteria band together in biofi lms, they become (TASE)-NASDAQ Biomed Conference held at NASDAQ’s much more diffi cult to treat. For one thing, sticking together forms something of a mechanical barrier: not all antibiotics Representing a broad swath of drugs and technologies in various stages of development, the 14 are jointly listed In addition, bacteria in a biofi lm are in a dormant state: on the TASE and NASDAQ. Monday’s meeting served as a “They are not actively proliferating . . . so it is diffi cult to formal introduction to U.S. investors, said Ester Levanon, attack them with anything that targets dividing cells,” OTHER NEWS TO NOTE: AMICUS, ARGOS, BIONOVO, CYTOS, CYTRX, ICO .2 INSIDE: CLINIC ROUNDUP: ACORDA, NOVELOS, SPHERIX, SYNDAX, TALECRIS .7
To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com Other News To Note
Stock Movers
• Amicus Therapeutics Inc., of Cranbury, N.J., was awarded a $500,000 grant over 24 months from the Michael J. Fox Foundation for Parkinson’s Research for the development of a next-generation pharmacological chaperone for the treatment of Parkinson’s disease. Amicus’ studies will be conducted in collaboration with the David Geffen School of Medicine at University of California, Los Angeles Department of Neurobiology. • Argos Therapeutics Inc. reported that AGS- 004, an HIV immunotherapy, was able to generate fully functional dendritic cells from viremic patients. AGS- (Biotechs showing signifi cant stock changes Thursday) 004 is an RNA-loaded dendritic cell immunotherapy. The Durham, N.C.-based company will pursue Phase I trials in patients who are naïve to antiretroviral therapy. The data were presented at the HIV DART Conference in Los Cabos, Mexico.
supply agreement with GP Pharm SA, of Barcelona, • Bionovo Inc., of Emeryville, Calif., said data Spain, to immediately include Mexico. Under the published in Breast Cancer Research and Treatment new terms, GP Pharm will be responsible for gaining demonstrated that ERb causes cancer cell growth arrest regulatory approval for and commercializing Ampligen, by inactivating critical genes and enzymes responsible an experimental therapeutic, to treat chronic fatigue for cell growth, which the company said provide evidence syndrome in Mexico. The deal also expands the rights that drugs that stimulate the production of or activate to sell the drug in other Latin America countries if GP ERb are potential new therapies to prevent breast cancer. Pharm achieves certain performance milestones.
• Cytos Biotechnology Ltd., of Schlieren, • iCo Therapeutics Inc., of Vancouver, British Switzerland, reported that its investigational influenza Columbia, granted Immune Pharmaceuticals, of Israel, vaccine, Qb-Flu, induced high levels of virus neutralizing an option to an exclusive license for the development antibodies after a single injection in ferrets. Cytos and commercialization rights to the systemic uses of compared Qb-Flu to Panvax and no immunization, and iCo-008, iCo’s human monoclonal antibody targeting found that the animals immunized with QB-Flu and eotaxin-1 , in inflammatory bowel disease and severe Panvax were almost completely protected from disease.
asthma, with iCo retaining worldwide exclusive rights • CytRx Corp., of Los Angeles, was notified that it to all ocular applications. IMPH will pay iCo a non- had met the compliance requirements with all NASDAQ refundable option fee creditable upon conversion listing qualifications after its consolidated closing bid against an up-front license fee payment of $1 million. price exceeded $1 for 10 consecutive days.
iCo may receive up to an additional $32 million in • Hemispherx Biopharma Inc., of Philadelphia, milestone payments, in addition to royalties on net amended its June 2010 sales, marketing, distribution and BioWorld® Today (ISSN# 1541-0595) is published every business day by AHC Media LLC, 3525 Piedmont Road, Building Six, Suite 400, Atlanta, GA 30305 U.S.A. Opinions expressed are not necessarily those Please call (800) 688-2421 to subscribe or if
of this publication. Mention of products or services does not constitute endorsement. BioWorld® and Bio- you have fax transmission problems. Outside World® Today are trademarks of AHC Media LLC, a Thompson Publishing Group company. Copyright U.S. and Canada, call (404) 262-5476. Our
2009 AHC Media LLC. All Rights Reserved. No part of this publication may be reproduced without the customer service hours are 8:30 a.m. to 6:00 written consent of AHC Media LLC. (GST Registration Number R128870672).
ATLANTA NEWSROOM: Managing
Editor: Lynn Yoffee. Assistant Managing Editor: Jennifer Boggs.
Lynn Yoffee, (404) 262-5408
Karen Pihl-Carey. Senior Production Editor: Ann Duncan.
Jennifer Boggs, (404) 262-5427
Staff Writer: Tom Wall.
Anette Breindl, (518) 595-4041
Trista Morrison, (858) 901-4785
ASHINGTON BUREAU: Washington
Donna Young.
Donna Young, (301) 216-2433
WEST COAST BUREAU: Staff
Trista Morrison.
Tom Wall, (404) 262-5417
EAST COAST BUREAU: Science
Anette Breindl.
BUSINESS OFFICE:
Senior Vice President/Group Publisher: Donald R. Johnston.
Director of Product Management: Jane Cazzorla.
Donald R. Johnston, (404) 262-5439
Marketing Manager: Sarah Cross.
Matt Hartzog, Chris Wiley, Scott Robinson.
DISPLAY ADVERTISING:
For ad rates and information, please call Stephen Vance at (404) 262-5511
or email him at [email protected].
REPRINTS:
For photocopy rights or reprints, call our reprints department at (404) 262-5479.
PRESS MATERIALS:
Send all press releases and related information to [email protected].
daily oral laquinimod over placebo and performing a comparative risk-benefi t assessment between laquinimod and interferon beta-1a. BRAVO study results are expected in Scale (EDSS) – the gold standard in treating RRMS. Hitting the EDSS is “a higher hurdle than the primary Bret Holley, senior analyst of biotechnology equity endpoint of reduction” in the annual MS relapse rate, research at Oppenheimer & Co., Inc., in New York, is waiting according to Mark Schoenebaum, biotechnology and for Teva to provide “greater clarity” on laquinimod’s effi cacy pharmaceuticals analyst and head of health care research and detailed safety profi le. Nevertheless, “the top-line [Teva] at ISI Group, Inc., in New York. “The fact that the drug hit data signals the emergence of yet another oral competitor the EDSS endpoint raises the possibility that it’s a more which could threaten [Biogen]’s MS franchise in the long effective agent than we had previously thought,” he wrote term,” he wrote in a Biogen research update. “We believe [Biogen] has become signifi cantly Company offi cials did not respond to requests for an overvalued following announced intentions to restructure, and its valuation does not adequately refl ect the competitive The progress by Teva could represent new hurdles for threat near term from Gilenya and long term from multiple biotechs with a competing MS pipeline – especially Biogen Idec Inc., which has four MS drugs under development, Biogen shares took a hit in September, after the FDA including BG-12 (dimethyl fumarate), an oral immune approved Gilenya (fi ngolimod), the fi rst oral disease- modulator currently in two Phase III clinical trials; PEG- modifying agent for MS, developed by Basel, Switzerland- based Novartis AG. (See BioWorld Today, Sept. 23, 2010.) version of its Avonex (interferon beta-1a) RRMS treatment Yesterday, analyst Robyn Karnauskas with Deutsch now in a placebo-controlled Phase III study; and daclizumab, Bank Equity Research added that Teva’s Phase III laquinimod a humanized monoclonal antibody that binds the CD25 results represent an “incremental negative” for Biogen.
alpha subunit of the high-affi nity IL-2 receptor with the “While we, and the Street, already model signifi cant goal of selectively targeting activated T cells. Daclizumab erosion from oral MS therapies, we view the [Teva] is being developed under a collaboration agreement with announcement as an incremental negative for [Biogen’s] Abbott. (See BioWorld Today, May 25, 2010.) stock as another competitor moves closer to the market,” The fourth is ocrelizumab, a humanized monoclonal antibody specifi c for CD20, which is being developed in On Thursday, Biogen closed at $66.37, down 99 cents. collaboration with Genentech Inc., a unit of F. Hoffmann- Not all analysts were quick to jump on Teva’s LaRoche Ltd., of Basel, Switzerland. (See BioWorld Today, bandwagon. “Given investor concerns over the sustainability of Copaxone, laquinimod is a key piece to Coincidentally, Roche reported progress in Phase II the future of Teva’s highly profi table multiple sclerosis studies of ocrelizumab for RRMS during an investor event franchise,” Corey Davis, specialty pharmaceuticals analyst in London. The company plans to move the compound into for Jefferies & Company Inc., wrote in a research update. Phase III studies early next year, both for RRMS and primary- “Positive Phase III data comes as a welcome relief, and a bit progressive MS (PPMS), representing a potential bright spot earlier than we expected, but we don’t see it really moving Three other potential competitors in various stages of Davis maintained his “hold” recommendation on Teva’s development include Merck Serono’s oral formulation of stock (NASDAQ:TEVA), which closed Thursday at $52.63, cladribine; Genzyme’s alemtuzumab, already licensed in the up $3.36, noting that Teva “has largely disappointed U.S. as a single agent for treating B-cell chronic lymphocytic leukemia and granted FDA fast-track status for RRMS last June; Teva also faces potential competition on its lead and Sanofi Aventis’ terifl unomide, a once-daily oral drug in product Copaxone (glatiramer acetate) from Momenta ongoing Phase III studies. (See BioWorld Today, Oct. 15, 2010.) Pharmaceuticals Inc., which has partnered with Sandoz, Laquinimod, which also received fast-track status in the generic unit of Novartis, to develop a generic version of February 2009, is a once-daily oral immunomodulatory the drug. In July 2008, Cambridge, Mass.-based Momenta compound that is being evaluated in two studies. ALLEGRO and Sandoz fi led an abbreviated new drug application is a two-year multi-national, multi-center randomized, double-blind, placebo-controlled study to evaluate effi cacy, safety and tolerability. The study was conducted at 139 sites in 24 countries and enrolled 1 , 106 MS patients, who BioWorld is now on Twitter!
were randomized to a once-daily oral dose of 0.6 mg of laquinimod or matching placebo.
Stay Connected, Follow Us on Twitter!
The second study, BRAVO, with similar design protocols, www.twitter.com/bioworld
is comparing the safety, effi cacy and tolerability of once- To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com Financings Roundup
Horizant was dealt another blow after top-line results from a Phase IIb trial showed the drug failed to demonstrate and general and administrative expenses.
XenoPort said it also may use a portion of the proceeds migraines over placebo. (See BioWorld Today, July 8, 2010.) for the potential acquisition of, or investment in, companies, GSK also is evaluating Horizant for the potential products or technologies that complement its business, treatment of post-herpetic neuralgia, a chronic type of although the fi rm acknowledged that it currently had no neuropathic pain that can follow the resolution of shingles. understandings, commitments or agreements to do so. XenoPort’s pipeline also includes arbaclofen placarbil XenoPort has been developing its lead product XP13512 (XP19986), which the company is evaluating as a potential (gabapentin enacarbil) with its partners Astellas Pharma treatment for gastroesophageal refl ux disease (GERD) in Inc. and GlaxoSmithKline plc, although the road to approval patients who do not experience complete relief of GERD symptoms while being treated with proton-pump inhibitors. The FDA in February unexpectedly issued a complete The company in September 2009 determined that response letter for GSK’s new drug application (NDA) for it would no longer be pursuing further development of XP13512 in RLS, which the companies plan to market in the U.S. arbaclofen placarbil for acute back spasms after a Phase II of under the brand name Horizant, after the agency concluded the drug in acute moderate to severe muscle spasms in the that a preclinical fi nding of pancreatic acinar cell tumors lumbar region failed to demonstrate effi cacy over placebo.
in rats precluded approval of the drug for the treatment of The fi rm is continuing to develop the drug as a potential RLS – resulting in a collapse of XenoPort’s shares and the treatment for spasticity, a condition in which certain muscles fi rm trimming its work force in half the next month. (See are continuously contracted, interfering with movement or BioWorld Today, Feb. 19, 2010, and March 8, 2010.) speech, although it has delayed any other trials until 2011 . The Horizant application had been plagued from the XenoPort’s product candidates also include XP21279, a beginning. GSK initially had submitted its NDA for the drug transported prodrug of L-Dopa, as a potential treatment for in RLS in September 2008, but withdrew it two months later after regulators requested the fi rm reformat data from a single Morgan Stanley & Co. Inc. acted as bookrunner for study. The company resubmitted the NDA in February 2009. the offering, while RBC Capital Markets LLC and Wedbush But last month, London-based GSK provided new PacGrow Life Sciences acted as co-managers.
data from nonclinical studies of Horizant to the FDA in a As of Sept. 30, XenoPort had 30.57 million shares of resubmission, along with epidemiology data exploring The Horizant NDA resubmission also included a fi nal • Geron Corp., of Menlo Park, Calif., said its underwriters safety update, which provided updated and new safety have exercised in full their option to purchase 2,608,695 information on patients in clinical studies who have been additional shares of the company’s common stock at $5 per share, with expected gross proceeds of $100 million. Geron The FDA designated the resubmission as a Class 2 said it plans to use the net proceeds for R&D, including clinical response and set a new Prescription Drug User Fee Act trials for its product candidates, development activities for in-licensed products and other general corporate purposes. XenoPort’s other partner, Tokyo-based Astellas, has fi led J.P. Morgan Securities LLC and Lazard Capital Markets LLC an NDA for approval of XP13512 as a treatment for RLS in Japan. acted as the joint book-running managers, while Rodman & GSK also is developing Horizant as a prophylactic Renshaw LLC, Roth Capital Partners LLC and WBB Securities treatment for migraine headaches. But this past July, LLC acted as co-managers of the offering. „ competition for Copaxone and called laquinimod “an under-the-radar” long-term growth driver for Teva. „ Teva subsequently fi led a citizen petition with the FDA arguing that Copaxone contains trillions of polypeptide sequences that have not been fully characterized, making it impossible for a generic version to establish that is has the same active ingredients. In May, the FDA denied that petition. (See BioWorld Today, May 14, 2010.) . . . and reach high-level biotech professionals every day! In the meantime, Momenta and Sandoz have sought to invalidate Teva’s patents on Copaxone with a paragraph IV For advertising opportunities in BioWorld Today, fi ling. (See BioWorld Today, Dec. 8, 2010.) please contact Stephen Vance at (404) 262-5511 But David Amsellem, senior research analyst at Piper Jaffray & Co. in New York, downplayed near-term generic To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com Biofilms
bonds, Otto said. Most maturators act as detergents to disrupt those interactions, allowing bacteria to escape. They also share being under the control of quorum-sensing molecules. Michael Otto told BioWorld Today.
But in other ways, they are very different. Genetically, And the real problem, he added, can come not when the there does not appear to be a whole lot of similarities between biofi lm develops, but when it matures. “It can be a source for biofi lm maturation molecules from different bacterial species; infections that are not necessarily biofi lm infections anymore,” and chemically, too, they appear to be very different from each he said. The process is in some ways similar to a metastasizing cancer – and like metastasis, it spells bad news for the patient. This diversity means that although biofi lms are clearly a “Once they disseminate, they can do much more harm.” clinical problem, the results described in the JCI article do not Otto, who is a senior investigator at the National Institute suggest therapeutic approaches. If anything, their diversity of Allergy and Infectious Diseases, and his colleagues have makes biofi lm maturators pretty clearly unsuited as targets.
identifi ed a mechanism by which bacteria get out of the “In principle this might be a target,” Otto said. “But you biofi lm: by secreting a surfactant peptide that goes by the are never going to get a broad-spectrum small molecule” name phenol-soluble modulin beta, or PSM-beta.
that is active against all, or even most, biofi lm maturation Phenol soluble modulins in general, Otto said, were “identifi ed fi rst because they have proinfl ammatory features.” In previous studies, Otto and his colleagues had shown that another PSM peptide, PSM-alpha, is important for turning Coming Monday
community-acquired Methicillin-resistant Staphylococcus in BioWorld Insight
aureus strains virulent. (See BioWorld Today, Nov. 13, 2007.) PSM-beta, he said, “has a little bit different approach to virulence. It causes chronic infections and so it doesn’t really ‘want to’ do much damage to the host, so to speak.” While technical risk was once the biggest threat to In their current work, which was published in the Dec. many biotechs, regulatory and commercial risks have 6, 2010, issue of the Journal of Clinical Investigation, Otto moved front and center. And no one – not VCs, not the and his colleagues showed that in animal studies, PSM-beta public markets and not potential partners – wants to helps bacteria break off of established biofi lms to enter the tackle those heightened risks, which creates additional bloodstream and become a source of recurrent infections, fi nancing risk. What’s a biotech to do? a process known as maturation. Treating the animals with antibodies to PSM-beta could inhibit the spread of bacteria.
The authors began by identifying conditions that encouraged biofi lm versus so-called planktonic growth, and Celgene Corp. shocked investors this week with found that PSM-beta was produced when bacteria were in a data from three separate Phase III trials demonstrating an increase in secondary malignancies in multiple Biofi lm is a bit of a misnomer. Actually, bacteria growing myeloma patients taking Revlimid (lenalidomide). But is in a biofi lm are part of a more or less mushroom-shaped the observed effect even real? And if it is, how much will structure. Under the control of so-called quorum sensing gene it affect Revlimid sales, considering that plenty of cancer expression programs, bacteria can begin to produce PSM drugs have been known to cause the illness they’re trying that essentially forms channels in the mushroom, eventually to treat? BioWorld Insight takes a deeper dive.
disrupting the fi lm enough to allow bacteria to escape.
Biofi lm research is heavily conducted in vitro, Otto said, which can have its pitfalls. So in his opinion, an important aspect of the study is that “we took [our work] to the in vivo Streamlining the clinical trial process is a top priority for all drug developers, and the Multiple Myeloma The authors implanted mice with catheters and tested Research Consortium seems to have hit upon a strategy whether cells were more likely to spread from biofi lms if they that works. The nonprofi t presented data at last week’s came from regular bacteria, or from those engineered to lack American Society of Hematology annual meeting PSM-beta. They found that engineered bacteria were far less showing its trials open faster, enroll faster and attract able to spread out from biofi lms on the catheters, suggesting more patients than average. BioWorld Insight provides that PSM-beta plays an important role in enabling bacteria to spread. Antibodies to the peptide also blocked the spread of infection. Take BioWorld Insight for a test drive. Call (404) In some ways, PSM-beta seems to be similar to other 262-5476 or (800) 688-2421 and mention Editor Trista biofi lm maturation proteins. “The forces that hold the biofi lm Morrison for a free trial subscription.
together . . . are electrostatic interactions” rather than covalent To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com is the fi rst Israeli company to receive FDA approval for a biologic (produced in its FDA-approved facility in Israel). Israel’s biotech industry is one of the country’s fastest (See BioWorld Today, Aug. 25, 2010.) growing sectors, Levanon said. “Our goal is to have a critical And Protalix Biotherapeutics Ltd., of Carmiel, signed mass of companies in order to attract more local and foreign a $115 million licensing deal in December 2009 with Pfi zer Inc., of New York, for its Gaucher’s disease drug Uplyso About 50 percent of Israeli biomed companies are (taliglucerase alfa). (See BioWorld Today, Dec. 2, 2009.) relatively early stage, according to Jerusalem’s Hadasit More recently, BioLineRx Ltd., of Jerusalem, moved into BioHoldings Ltd.’s (HBL) CEO Ophir Shahaf. the black as a result of its deal with Cypress Bioscience In Israel, high tech has traditionally drawn more Inc., of San Diego, for BL-1020, a schizophrenia drug. (See investments than biotech both internally and overseas. And in biomed, more capital has traditionally been available for Hadasit Bio-Holdings Ltd., a publicly traded holding device companies, which account for over half of all Israeli company, has a portfolio of eight companies, four of which are now in Phase I/II, and four will enter Phase I/II in the And while internal venture capital and strong government support of biomed start-ups have been “Our business model is to secure agreements with invaluable for early ventures, there has been a huge strategic partners at the end of Phase I/II, as deals at this fi nancing gap for mid-stage companies until relatively stage have increased in value over the past number of years,” Shahaf told BioWorld Today.
Change is afoot now, with a new cadre of recently trained One of its companies, Cell Cure Neurosciences Ltd., biotech business leaders, like New York University-MBA- of Jerusalem, was started in 2005 by Benjamin Reubinoff, trained Shahaf, more late-stage clinical trials and increasing chief investigator of one of the two initial groups to isolate foreign investment – all helping the sector to mature.
embryonic stem cells in 1999. Unlike the U.S. and much of In 2005 Jonathan Silverstein, general partner in the Europe, Israel’s stem cell policy has been extremely liberal biotech venture capital fi rm OrbiMed Advisors LLC, predicted from the start, giving it a strong competitive advantage it would take about fi ve years for the biotech (in contrast to for research, and benefi ting Cell Cure, a majority-owned device) sector to reach critical mass and become attractive subsidiary of BioTime Inc., of Alameda, Calif.
to foreign investors. OrbiMed has invested in Israeli biotech Initially, Cell Cure’s focus was neurodegenerative for 10 years, and more recently, has been joined by a number diseases, but on advice from the FDA, it is fi rst developing of other foreign VC funds. In April, OrbiMed expanded its embryonic stem cell-derived retinal pigmented epithelial presence in Israel by adding four full-time partners there. cells therapy, OpRegen for age-related macular degeneration “What attracted the VC fi rm to the country? Israel has for safety reasons. These cells will be a localized treatment, the highest percentage of [biomedical] R&D per capita, 1 ,000 new companies, and about 70 start-ups per year,” said Clal Biotechnology Industries Ltd., of Tel Aviv, an older holding company with $60 million in cash, was started in Overall, $11 billion has been invested in Israeli biomed 1998, and now has 15 biotechs in its portfolio: fi ve in Phase which has created $30 billion in value, he added. III trials, four in Phase II, and three in Phase I, covering “Thirty exits to date include mergers and acquisitions, cancer, central nervous system disorders, wound care and initial public offerings [IPO], reverse mergers, IPOs on autoimmune diseases as well as medical devices. NASDAQ, and a steady clip of acquisitions, such as “Seven of our companies have strategic agreements Johnson & Johnson’s November 2008 purchase of Omrix with international pharmas,” said CEO Ruben Krupik.
Biopharmaceuticals Ltd. for $438 million,” he said. (See One of its companies, D-Pharm Ltd., of Rehovot, is focusing on CNS diseases, with its lead product, DP-b99 now in Phase Today, many companies are seeking deals that will III for ischemic stroke, and DP-VPA in Phase II for epilepsy, enable them to retain more rights in licensing agreements migraine and bipolar disease. It has three other products now than in the past, and are also forging agreements for drugs in development. (See BioWorld Today, Aug. 18, 2009.) „ in later-stage development, Silverstein said. Like in the U.S., many Israeli biotechs are pursuing For example, Baxter International Inc. (BAX), of Promote it on your website or in your investor kit! Deerfi eld, Ill. last August entered a manufacturing, supply and marketing agreement with Kamada Ltd. (KMDA), of Ness For high-quality reprints of articles about your
Ziona, for Glassia, an intravenous form of alpha1-proteinase company, please contact Stephen Vance at (404)
Inhibitor, which was approved in July by the FDA as an 262-5511, or [email protected]
orphan drug and launched in the U.S. in October. Kamada To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com the highly anticipated trial with SIGA Technologies Inc., Other News To Note
of New York, on Jan. 3, 2011 , in a case where PharmAthene is claiming a portion of a smallpox contract worth $2.8 million. • PharmAthene Inc., of Annapolis, Md., said the FDA Shares of PharmAthene (AMEX:PIP) rose 14 cents, to close at lifted the partial clinical hold imposed last year on Valortim, $3.69. (See BioWorld Today, Nov. 9, 2010, and Nov. 22, 2010.) a fully human anti-toxin monoclonal antibody being • Zealand Pharma AS, of Copenhagen, Denmark, developed for the prevention and treatment of inhalational received a €500,000 (US$662,055) milestone payment from anthrax, clearing the company to move forward with a Phase Helsinn Healthcare SA, of Lugano, Switzerland, as part I intravenous dose-escalation study in the coming weeks, of the fi rms’ November 2008 license agreement to develop which Roth Capital Partners analyst Joseph Pantginis called ZP1846, potent and selective glucagon-like-peptide-2 an “encouraging event” for the company. Coming off of the analog, as a treatment for chemotherapy-induced diarrhea. hold, Pantginis added, will be instrumental in moving further Under the terms of the agreement, Zealand Pharma is funding discussions forward with the Biomedical Advanced eligible to receive development and sales based milestone Research and Development Authority for Valortim. He noted payments of up to €140 million, of which €10 million has that the next upcoming catalyst for the company will be g doses producing similar responses to one another, while Clinic Roundup
the 7.5 g dose produced a greater response. In addition, by the end of the six-month trial, the 7.5 g dose reduced serum triglycerides vs. the 2.5 g dose by -42 mg/dl from a mean of • Acorda Therapeutics Inc., of Hawthorne, N.Y., 180 mg/dl in the evaluable effi cacy population. The reduction initiated a randomized, double-blind Phase I trial of Glial in serum triglycerides became statistically signifi cant in the Growth Factor 2 (GGF2) in heart failure. GGF2 previously intent-to-treat population at three months of treatment, -31 restored heart muscle integrity and improved function in mg/dl, p=0.03, and the reduction essentially held steady at the six-month end-of-study visit, -29 mg/dl.
• BioDelivery Sciences International Inc., of • Results from a Phase III study of Latuda (lurasidone HCL) Raleigh, N.C., enrolled and dosed the fi rst patient in its Phase tablets once-daily atypical antipsychotic for schizophrenia III trial of BEMA buprenorphine for chronic pain. Results are by Sunovion Pharmaceuticals Inc., of Marlborough, Mass., showed statistically signifi cant improvement • GeoVax Labs Inc., of Atlanta, reported that in a compared to placebo. The study included 2,900 people with Phase IIa trial its recombinant DNA-vectored vaccines for schizophrenia. Latuda was given at 80 and 160 mg doses.
HIV showed cellular immune response rates similar to those • Syndax Pharmaceuticals Inc., of Waltham, Mass., observed in a Phase I trial. The safety results were also said results from its double-blind, placebo-controlled Phase consistent with previous Phase I results and revealed no II ENCORE 401 showed there was a 9.4 month median survival in the subset of patients with advanced non-small-cell lung • Neurokine Pharmaceuticals Inc., of Vancouver, cancer with elevated E-cadherin, a molecular marker of British Columbia, is initiating a Phase II trial program for epithelial tumors, who received entinostat in combination NK-001 in patients with Alzheimer’s type memory loss with Tarceva (erlotinib), which is marketed by Genentech undergoing coronary artery bypass graft surgery. NK-001 is Inc., of South San Francisco, and OSI Pharmaceuticals an encapsulated formulation of Enbrel (etanercept, Amgen Inc., of Melville, N.Y., vs. 5.4 months who received Tarceva Inc.) designed to cross the blood-brain barrier.
• Novelos Therapeutics Inc., of Newton, Mass., • Talecris Biotherapeutics Inc., of Research Triangle presented open-label Phase II data showing that NOV-002 Park, N.C., initiated a trial evaluating the safety and the plus chemotherapy doubled the rate of pathologic complete pharmacokinetic profi le of 120 mg/kg weekly vs. the responses (pCR) compared to a historical control. Of 38 licensed dose of 60mg/kg weekly of Prolastin-C (alpha1- patients in the trial, 15 achieved confi rmed pCRs. The data proteinase inhibitor [human]), a therapy indicated for chronic were presented at the AACR Breast Cancer Symposium in augmentation and maintenance in adults with emphysema San Antonio, TX. NOV-002 is an immune modulator that due to alpha-1-antitrypsin defi ciency, a rare, genetic disorder previously failed a Phase III lung cancer trial. (See BioWorld in which low levels of the alpha-1 protein circulating in the lungs can increase an individual’s risk of developing • Spherix Inc., of Bethesda, Md., said results of its Phase emphysema. Subjects in the study will be randomized to II diabetes trial found that the minimum dose of D-tagatose receive either the 120 mg/kg dose or the 60 mg/kg dose for capable of affecting HbA1c was 7.5 g three-times daily and eight weeks, and then will be crossed over to the alternate was within the range of doses tested, with the 2.5 g and 5.0 To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com

Source: http://www.hbl.co.il/files/BioWorld%20Dec%2010%202010.pdf