Acorda Therapeutics

ALSO NOTED: Ambrilia touts data; Amarin raises $60M; and much more...

Wed, 14 May 2008 06:59:50 -0400

> Ambrilia Biopharma reported positive 24-week Phase III top-line results for prolonged-release formulation of Octreotide. Release

> Amarin is raising $60 million through a stock placement. Release

> Acorda Therapeutics CEO Ron Cohen has exercised stock options for 31,432 shares. Report

> A federal proposal requiring drug and device makers to disclose payments to doctors got a boost yesterday when Eli Lilly became the first Big Pharma to back it. Lilly report

> In an interesting twist on the usual generics news, it's the copycat makers who are predicted to suffer as competitors undercut their products. The source of this competition? None other than China. Generics report

> The NIH's Avastin/Lucentis trial could fundamentally reshape relations between payers and pharma, according to IMS Health. Report

> After weeks of pressure from Congress to request more money for the agency--and weeks of refusals to specify a figure for beefing up FDA's safety operations-FDA commissioner Andrew von Eschenbach has asked lawmakers for $275 million. FDA report

And Finally... South Korean officials have wiped out the poultry population of Seoul in an effort to combat the spread of the avian flu virus. Report

C&L: Peacock tapped to run Alba

Wed, 09 Apr 2008 06:59:52 -0400

Dr. Blake Paterson has been replaced as chief executive of Alba Therapeutics. Bruce Peacock, a venture partner with SV Life Sciences Advisors LLC, will take over for Paterson, who founded the company.

Dr. Iain Chessell, former worldwide head of pain research at GlaxoSmithKline, has commenced work as CEO of NeuroDiscovery.

DiaMedica has appointed Thomas Wellner to the board of directors, and announced the resignation of Dr. Albert Friesen from board. Rick Pauls was named chairman, interim president and CEO following the resignation of Dr. Karl-Gunnar Hidinger as president.

Cylex has named Brad Stewart president of the company.

PPD chief medical officer Dr. Paul Covington is retiring from the clinical research organization in June.

Stiefel Laboratories has promoted Dr. Gavin Corcoran to the newly created position of chief scientific officer.

The Immune Tolerance Institute has added Aaron Kantor, Ph.D. as chief scientific officer.

SciClone Pharmaceuticals announced that Executive Vice President and Chief Financial Officer Richard Waldron has resigned to pursue another professional opportunity.

Caliper Life Sciences has named Peter McAree as senior vice president and chief financial officer.

Nucryst Pharmaceuticals said that Eliot Lurier plans to step down as chief financial officer.

John Librie has been named senior vice president of sales and marketing at Acorda Therapeutics.

NuGEN Technologies has hired Dr. Douglas Amorese to serve as the company's vice president of research and development.

Adventrx Pharmaceuticals has appointed Jose Hechavarria to the new position of vice president of manufacturing.

Mark Day has been named senior director of cognitive neuroscience at PsychoGenics.

BrainStorm Cell Therapeutics has appointed former U.S. Assistant Surgeon General, Rear Admiral Roscoe Moore, Jr. (USPHS, Ret) to the company's advisory board.

Egenix has named Daniel Petrylak, MD chairman of the company's scientific advisory board.

Asterand has named Dr. Peter Coggins as a non-executive director.

EntreMed announced the retirement of Ronald Cape, Ph.D. as director.

IDM Pharma has named Gregory Tibbitts to its board of directors.

Senomyx has appointed Roger Billingsley, Ph.D., as a director and a member of the corporate governance and nominating committee. Senomyx also announced that Kent Snyder has been named to assume the role of chairman of the board.

ALSO NOTED: Galenica share surge on committee approval; Progen to acquire CellGate; and much more...

Mon, 04 Feb 2008 06:59:50 -0500

> Shares of Galenica jumped 15 percent this morning after the company announced that an FDA advisory committee has endorsed its iron replacement therapy Ferinject/Injectafer. A formal decision is expected in mid-March. Report

> Australia's Progen has inked a deal to acquire CellGate, a U.S. cancer therapy developer, for $1.5 million in shares and the assumption of $1 million in liabilities. In addition to its pipeline candidates Progen also gains the help of CellGate CSO Dr. Laurence Marton. Report

> Acorda Therapeutics has acquired certain assets of Neurorecovery, which focuses on the development and commercialization of neurological drugs that target inflammatory diseases of the peripheral nerves. Release

> Chutes & Ladders: Valeant Pharmaceuticals CEO Timothy Tyson has hit the exit and will be replaced by Michael Pearson. Chairman Robert Ingram will step down as well but remains as a director. Prior to joining Valeant, Pearson had been a director at McKinsey & Company. Release

> BioLineRx has produced positive data from a Phase IIa trial of its schizophrenia drug BL-1020. Thirty-six treatment refractory patients took part in the study, registering statistically significant responses during the six-week study. No side effects like weight gain or motor difficulty were reported. Report

> Pre-emption handed GlaxoSmithKline the victory in a lawsuit over a 13-year-old who committed suicide while taking the antidepressant Paxil. A California judge cited the pre-emption rule in dismissing the suit, saying that the case created a direct conflict between federal labeling requirements and state tort law. Report

> The FDA says it's "increasingly likely" that Pfizer's stop-smoking pill Chantix may cause psychiatric symptoms in some patients, including suicidal thoughts and actual suicide. Report

> Pony up, Congress. Stop whipping the FDA for its failures and fork over the cash necessary to fix the problem. That's what editorial writers at the Boston Globe and New York Times said over the weekend. Report

And Finally... For anyone out there who may think that quality does not matter in healthcare: Patients treated at top-rated hospitals nationwide are nearly one-third less likely to die, on average, than those admitted to all other hospitals. Study

C&L: NovaDel's Egberts quits CEO post

Wed, 25 Jul 2007 06:59:52 -0400

NovaDel CEO Jan Egberts, M.D., has resigned and Board Chairman Steven B. Ratoff will serve as interim president and CEO.

Ambrx has named Stephen Kaldor, Ph.D., as president and CEO.

Genstruct has appointed Christopher Z. Thomajan as its new CFO.

Acorda Therapeutics announced that COO Mary Fisher resigned to pursue other interests.

Peter Benton joins eTrials as COO on an interim basis.

Merrimack Pharmaceuticals has named William Slichenmyer, M.D. senior vice president and chief medical officer.

Micromet has promoted Carsten Reinhardt, M.D. from senior vice president of clinical development to senior vice president and chief medical officer.

PS Pharmaceuticals has named Andrew Rackear as associate general counsel, succeeding Val Antczak as general counsel.

Auriga Laboratories has appointed Lisa Tripodi vice president of trade relations.

Panacea Pharmaceuticals has named Steven A. Fuller, Ph.D. as vice president, product development, and Billie Jo Wood as director, clinical laboratory services.

Pacific Biometrics has named Richard J. Gordon, M.S., as its new vice president of business development and sales and marketing.

WuXi PharmaTech has named Dr. Deepak Hegde vice president of formulation development services.

Alnylam Pharmaceuticals has appointed Philip Chase to the position of vice president, legal; Eric Raichle to the position of vice president, human resources; and Jason Rhodes to the position of vice president, business development.

Alexza Pharmaceuticals has named Nasrat Hakim as vice president, quality.

Eastern Biotech & Life Sciences has named Pankaj Sohaney as a manager-marketing and business development for the Middle East region.

MonoGen has reported that Frank Leo has been appointed to its board of directors and Laurence Hootnick has resigned as a director.

Bioniche Life Sciences has named Dr. Lorne Babiuk as a member of its board of directors.

ProtoKinetix has elected Max Arella, PhD, to their board.

Phenomix Corporation has named James Harper and William Harris to the board.

Lorus Therapeutics has appointed Herbert Abramson to the board.

Auxilium Pharmaceuticals has named Dr. Dennis Langer as an independent director.

AerovectRx Corporation announced the founding members of its Scientific Advisory Board: Kenneth Brigham, M.D. (Chair)--Emory University School of Medicine; Robert Aris, M.D.--University of North Carolina School of Medicine; James J. Barry, Ph.D.--Creare, Inc.; Beth L. Laube, Ph.D.--Johns Hopkins University School of Medicine; Ralph Tripp, Ph.D.--University of Georgia; Gerald Smaldone, M.D., Ph.D.--State University of New York at Stony; Arlene Stecenko, M.D.--Emory University School of Medicine.

SPOTLIGHT: Acorda announces added trial

Thu, 07 Dec 2006 19:01:33 -0500

Acorda Therapeutics has announced an additional late-stage trial of Fampridine-SR for multiple sclerosis. Researchers are working with the FDA to design a new Phase III study of the same or shorter duration as the recently completed trial. That study demonstrated that volunteers taking the drug experienced significantly improved walking speed. Report

The best (and worst) biotech stocks of 2006

Maureen Martino — Fri, 01 Dec 2006 10:35:55 -0500

As we all know by now, pharma biotech investment is risky
at best and disasterous at worst. “No other sector produces as such huge gains or such steep losses in such short periods of time,” notes The Motley Fool’s Brian Lawler. Below is a year-end round-up of the five best and five worst performing biotech and pharma stocks. Of course, this list doesn’t include larger biotechs such as Genentech or Amgen since these established companies are less prone to major stock market swings. But it does provide a look into which companies and technologies investors found appealing, and those that might that might want to re-examine their approach.

The Best

> Medivation: The San Francisco-based company saw its shares surge after the company announced announced that its Alzheimer's therapy Dimebon hit all five primary endpoints for efficacy in a Phase II trial. The drug also appeared to be safe and well tolerated. Further results are expected in the second quarter of next year.

> Sirna Therapeutics: In the wake of Andrew Fire and Craig Mello’s Nobel Prize for their work on RNAi, the promising technology has garnered significant attention from the biotech industry. Drug giant Merck took note and decided to buy San-Francisco-based Sirna Therapeutics for a hefty $1.1 billion. Sirna's lead drug candidate, Sirna-027, is being developed as a treatment for wet, age-related macular degeneration.

> Acorda Therapeutics: Shares of Acorda skyrocketed after the company reported a successful outcome of its Phase III trial of Fampridine-SR for multiple sclerosis. Researchers found that a statistically significant number of patients in the trial reported improvements in walking speed, the primary endpoint in the trial. Hawthorne, NY-based company plans to seek talks with the FDA on how to proceed with the drug.

> Auxilium Pharmaceuticals: A trial of AA4500--an injectable enzyme product for patients with Dupuytren's Disease—proved that the drug was highly effective in the treatment of the disease. The Malvern, PA-based company also turned in positive results for its topical testosterone gel demonstrated for men with Type 2 diabetes

> Allos Therapeutics: Allos--which is developing small molecule therapeutics for the treatment of cancer--gained orphan drug status for an experimental cancer therapy. Investors are also anticipating favorable results from tow of the company’s lead products--Efaproxyn and PDX--early this month.

The Worst

> Neurocrine Biosciences: In May, Neurocrine stunned the market with its announcement that the FDA had approved two low-dose versions of indiplon and issued a non-approvable letter for a 15 mg dose that is considered vital for its success. In the wake of this news, Pfizer decided to pull out of its co-development pact for the sleep drug. Things only got worse from there, as Neurocrine was forced to reduce its workforce to save money. Shares of the company’s stock took another hit in November as the company announced that it would delay a resubmission of its FDA application for indiplon while reporting third quarter losses.

> Cardiovascular BioTherapeutics: CardioVascular BioTherapeutics headquartered in Las Vegas, Nevada, is focused on developing treatments for cardiovascular disease. After a promising $15 million IPO in 2005, stock dropped from a high of $9.15 in February to $1.80 in December.

> CV Therapeutics: Palo Alto, CA-based CV has seen it’s stock tumble from a high of $27.90 a share in January--when the FDA approved the company’s drug Ranexa for angina--to a low of $9.40 in mid-August. It appears higher costs related to marketing expenses for the new drug are to blame for the company’s $63 million loss in the third quarter of this year.

> Idenix Pharmaceuticals: Idenix took a hit earlier this year when the company announced that it would modify an ongoing phase IIb clinical trial of valopicitabine for hepatitis C. The dosing levels of the drug were adjusted from 800 mg/day to 200 mg/day or 400 mg/day as a result of dose-related gastrointestinal side effects observed in study subjects. Just days later Novartis—which owns 56 percent of the company-- inked a licensing deal to pay Idenix up to $525 million for the rights the drug. Some analysts saw the deal as a way for Novartis to display its confidence in the program at a critical point.

> SkyePharma: SkyePharma started off the year with the loss of chairman Ian Gowrie-Smith, who handed in his resignation in January. Then, when the company inked a long-awaited $165 million licensing deal with Kos Pharmaceuticals for the U.S. marketing rights to Flutiform for asthma, several analysts complained because the drug developer couldn't link up with a bigger name in pharma. And in August the company was stumped as to why SkyePharma stock had dropped to near record lows.

For more on the year’s best and worst performers:
- read this Motley Fool article

ALSO NOTED: Acorda gains $10M in funds; Supreme Court debates patent law; and much more...

Tue, 28 Nov 2006 19:01:30 -0500

> Acorda Therapeutics has amended its deal with Paul Capital Healthcare to gain up to $10 million in additional funds. Release

> Pain Therapeutics says its painkiller PTI-202 successfully completed a Phase I trial. Release

> The U.S. Supreme Court debated a critical test of U.S. patent law in a case that has broad implications for the biotech industry. Report

> While citing progress in containing bird flu in Asia, the UN's bird flu chief says it will need another $1.3 billion to fight the spread of H5N1 in Africa and other countries. Report

> Novartis is mulling over the sale of the baby food company Gerber. It's already in talks to sell a medical nutrition subsidiary to Nestle. Report (WSJ sub. req.)

> Auxilium Pharmaceuticals has amended its manufacturing agreement with UK-based Cobra Biologics. Under the amended agreement, Cobra will complete only one BLA batch of the active ingredient for AA4500, its injectable enzyme. Release

> Arena Pharmaceuticals plans to sell eight million shares in a public offering. Report

> Zila says it has completed its transition to a cancer detection company. Release

And Finally… Confronted by the embarrassing scandal surrounding the fraudulent Korean stem cell study in 2004, Science magazine has devised new methods to scrutinize research findings. Article

Press Release: Acorda Therapeutics to Receive Up to $10 Million from Paul Capital Healthcare

Maureen Martino — Tue, 28 Nov 2006 12:40:46 -0500

Acorda Therapeutics to Receive Up to $10 Million from Paul Capital Healthcare

Proceeds to Finance Zanaflex Capsules Salesforce Expansion and Promotion

HAWTHORNE, N.Y. & NEW YORK -- Acorda Therapeutics (NASDAQ: ACOR) today announced that it has amended its December 2005 agreement with an affiliate of Paul Capital Healthcare (formerly Paul Royalty Fund) to revise the triggers to receive up to $10 million in additional funding. The Company previously received $15 million to fund the initial expansion of its salesforce from 14 to 32 professionals, as well as other Zanaflex Capsules operations. The current proceeds will fund the recently-announced salesforce expansion to 65 and other Zanaflex Capsules commercialization activities.

Under the terms of the amendment, the Company will receive $5 million at closing with the potential for an additional $5 million if it achieves a 2006 sales milestone.

"Acorda's salesforce has shown impressive performance in marketing Zanaflex Capsules over the past year. We are pleased to be able to expand our existing agreement with the company to fund their recently-announced salesforce expansion initiative," said Lionel Leventhal, Partner, Paul Capital Healthcare.

“We are very pleased with our partnership with Paul Capital Healthcare. This agreement has enabled us to expand our business through a financing that is non-dilutive to our shareholders,” said Mary Fisher, Chief Operating Officer of Acorda Therapeutics. “The salesforce expansion will allow us to address more specialists and primary care physicians who are high prescribers of tizanidine.”

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

About Paul Capital Partners and Paul Capital Healthcare

Paul Capital Partners manages nearly $5 billion in equity capital commitments for its three investment platforms that include Healthcare Direct Investments (including royalty and revenue interests), Private Equity Secondaries and Top Tier Fund-of-Funds. The firm has offices in New York, San Francisco, Paris, London and Toronto. Paul Capital Healthcare is one of the largest dedicated healthcare funds globally, with $1.4 billion in equity capital commitments and debt facilities under management. Paul Capital Healthcare has made investments in the pharmaceutical, biotechnology, and medical device sectors valued at more than $850 million. These investments are focused on commercial stage companies and products, and consist of investments in the form of royalties, revenue interests, debt and equity. For more information, visit www.paulcapital.com.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules™ (tizanidine hydrochloride), a short-acting drug for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. Acorda’s lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

ALSO NOTED: Wyeth releases Tygacil data; Eurand inks deal with GSK; and much more...

Tue, 03 Oct 2006 20:01:30 -0400

> Wyeth has released data from a Phase III trial of Tygacil that shows a statistically similar ability to treat community acquired pneumonia as an existing therapy. Tygacil cured 89.7 percent of patients compared to 86.3 percent for levofloxacin. One infectious disease expert says that new therapies for CAP are needed as antibiotic-resistant strains emerge. Report

> Eurand has inked a licensing deal with GlaxoSmithKline to use its tablet technology in the development of a new formulation of an existing GSK drug. Eurand stands to earn up to $42 million in milestone payments. Their goal is to be ready with an FDA application by the end of 2007. Report

> UCB has expanded its licensing deal with Jazz Pharmaceuticals for the narcolepsy drug Xyrem, doubling the number of countries it has marketing rights to and adding an indication for chronic pain characterized by widespread musculoskeletal aches. Xyrem is in Phase III pain studies. Report

> SkyePharma announced positive late-stage results for a reformulated version of Lodotra for rheumatoid arthritis. Report

> Canadian regulators have approved Tysabri for multiple sclerosis. Report

> Keryx Biopharmaceuticals has struck a licensing agreement with Japan's Kyowa Hakko Kogyo to develop Kyowa's mid-stage cancer therapy, UCN-01, in markets outside of Japan. Report

> Nanogen will pocket $20 million from a deal to sell five years of royalties from its MGB technology to Drug Royalty. Report

> Baxter International is touting the latest preliminary data for its experimental H5N1 vaccine. Report

> Shares of Quest Diagnostics were hammered after the company announced the loss of a contract with UnitedHealthcare. Report

> Acorda Therapeutics announced plans to raise $31.5 million in a private placement. The money is earmarked for pipeline development and sales and marketing. Release

> Schering and Biogen Idec have launched a late-stage trial of their lymphoma drug, Zevalin. Report

> Dynavax Technologies is raising $27 million in a private offering. Report

> Isotechnika says its immunosuppressive therapy ISA247 has won a European patent. Report

And Finally… After seizing more than 40,000 packages of prescription drugs bound for the U.S., Customs says it will stop its program of confiscating the drugs. Article

C&L: Doyle picked as new Syntaxin CEO

Tue, 08 Aug 2006 20:01:32 -0400

Syntaxin has named Patrick James Doyle CEO. Doyle joins Syntaxin from Metabolex, California, where he held the post of chief corporate development.

Cipher Pharmaceuticals has promoted its president, Larry Andrews, to CEO. He replaces, John Mull, who will stay on as chairman.

MGI PHARMA has named Mary Lynne Hedley, Ph.D., Eric P. Loukas, Esq., and William F. Spengler to executive vice president and appointed Loukas as COO.

BioSyntech has named Francois Michaud C.A., C.M.A., as CFO and Richard Lacombe Ph.D., M.B.A., as vice-president clinical affairs.

Neopharm named Ronald Pauli as CFO, effective Sept. 1. He replaces Lawrence Kenyon.

Celator Pharmaceuticals has named Arthur C. Louie, M.D., as chief medical officer.

Callisto Pharmaceuticals has named Robert C. Shepard, M.D., F.A.C.P. as its chief medical officer.

NSP advises that Vincenzo Guerrieri and Marc Greenberger have resigned as directors of NSP. Henry Evans had resigned as secretary of NSP and executive vice-president of Naturale Science Pharma Inc. NSPI did not renew the consulting agreement for Philip Antunes, COO, which terminated July 31, 2006.

Inspire Pharmaceuticals has hired two new vice presidents: Bart J. Dunn as vice president, business development and Raymond W. Hines as vice president, associate general counsel.

AVANIR Pharmaceuticals has hired Theresa Hope-Reese as vice president of human resources.

John Friedman has stepped down from the board of directors of Acorda Therapeutics.

Icagen has appointed Adeoye Y. Olukotun, M.D., MPH, FACC to its board of directors.

Dr. Gerald Batist, the director of the McGill Center for Translational Research in Cancer based at the Jewish General Hospital in Montreal, has joined Chemokine Therapeutics' clinical advisory board.

C&L: Karl-Ludwig Kley tapped as Merck KGaA chief

Tue, 14 Mar 2006 19:01:32 -0500

Merck KGaA's advisory board has named Karl-Ludwig Kley, the current CFO of Lufthansa, as its new CEO.

Orchid Cellmark has appointed Thomas A. Bologna as the company's new president and CEO.

Perlan Therapeutics named Sterling Johnson president and a director.

Morphotek has named Robert Radie chief business officer and promoted Dr. Luigi Grasso to senior vice president of research and development.

Amarillo Biosciences has appointed Gary W. Coy as CFO.

Inotek Pharmaceuticals has hired Emma Reeve as vice president and CFO.

Nabi Biopharmaceuticals has named Adam E. Logal interim CFO, chief accounting officer and treasurer. He replaces Mark Smith, who resigned.

Acorda Therapeutics has announced that Lorin J. Randall, senior vice president and CFO for Eximias Pharmaceutical, has become a member of the Acorda board of directors and will serve as the Chairman of Acorda's audit committee.

Seattle Genetics named Daniel F. Hoth, M.D., to the company's board of directors.

Callisto Pharmaceuticals announced that Dr. Arthur Sytkowski, associate professor of medicine at Harvard University, has agreed to serve as Callisto's clinical trial advisor and medical safety monitor.

Ventaira Pharmaceuticals has named Phyllis Gardner to its board of directors.

BioMimetic files for $50M IPO

Thu, 09 Feb 2006 19:01:38 -0500

BioMimetic Therapeutics has filed for an IPO designed to raise up to $50 million. The Franklin, TN-based drug device company makes products for musculoskeletal diseases. The FDA handed the company its first approval last year for a product that treats periodontal bone ailments.

- read this release for more

PLUS: Shares of Acorda Therapeutics jumped to $6.40 this morning after debuting at $6. Acorda had initially forecast a share price of $11 to $13. Report

Acorda Therapeutics plans $86M IPO

Wed, 05 Oct 2005 20:01:36 -0400

Acorda Therapeutics of Hawthorne, New York, has outlined plans to raise $86 million in an IPO. Details of the offering weren't released. Acorda has been developing therapies for multiple sclerosis, spinal cord injuries and other conditions of the central nervous system.

- read this Dow Jones report for more