FDA panel votes against Xgeva; Nervous GlaxoSmithKline Pulls Cash Out of Eurozone Print E-mail
By Staff and Wire Reports   
Wednesday, 08 February 2012 20:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 8, 2012.

A panel of cancer experts voted against a new use for Amgen Inc.'s (NASDAQ:AMGN) Xgeva in prostate cancer saying the drug's ability to slow the spread of the disease did not translate into meaningful benefits for patients.

The FDA's cancer drug panel voted 12-1 that the benefits of the drug did not outweigh its risks, which included bone disease in about 6 percent of patients. The FDA is not required to follow the group's advice, though it often does.

Xgeva is already approved to prevent fractures in cancerous bones, and for osteoporosis, in a different formulation called Prolia.

Amgen Inc. has asked the FDA to approve the injectable drug as a preventive measure for men with recurring prostate cancer that is at high risk of spreading to the bone. At the public meeting Wednesday, Amgen scientists pointed to results of a company study showing patients taking Xgeva experienced a four-month delay in the spread of cancer to the bones around the prostate.

Panelists termed this a "statistical benefit," but not one that resulted in increased survival or higher quality of life for patients.

"The effect of the studied compound is quite weak with no effect on survival or the overall course of the disease in general," said Dr. Ronald Richardson of the Mayo Clinic. All of the panel's physicians voted against the company's application. The lone patient representative on the panel voted in favor.

Many cancer drugs approved by the FDA do not actually extend survival, but instead slow the growth of tumors or their spread to other parts of the body. In recent years, cancer experts have debated the meaningfulness of these measures. Panel chair Dr. Wyndham Wilson acknowledged that delaying the disease's spread to the bone could be meaningful, but suggested the drug would have to do so for more than four months.

"If it was one year we probably wouldn't even be here today, no one is denying that, but the magnitude here is quite low," said Wilson, a research chief at the National Cancer Institute.

Panelists also raised concerns about exposing patients to the drug's side effects, including osteonecrosis of the jaw, in which the bone dies because of poor blood supply.

Doctors use a variety of treatments and interventions to treat prostate cancer, depending on the speed of the cancer's growth and the patient's age, among other factors. Patients with fast-growing prostate tumors often receive hormone therapy to stop production of testosterone, which fuels cancer growth.

All of the men in Amgen's study had tumors that did not respond well to hormone therapy, but had not yet spread beyond the prostate. While there are multiple drugs for both early and late-stage prostate cancer, Amgen argued "there is a gap in the treatment plan for those patients" enrolled in its study.

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GlaxoSmithKline Plc, (NYSE:GSK)
Britain's biggest drugmaker, has been sweeping cash on a daily basis from euro-zone banks in a bid to protect itself from potential problems in the single currency bloc, its chief executive said.

"We don't leave any cash in most European countries," Andrew Witty told reporters after presenting fourth-quarter results on Tuesday.

"We sweep all of our cash raised during the day out of the local banks and send it to banks here in the UK which we think are robust and secure."

The system has been in place since early last year and involves the movement of "tens of millions of pounds" in cash each day, he added.

In recent months, many business leaders have started to contemplate the possibility of a break-up of the euro, even though this is still viewed as unlikely. For non-financial firms, a key focus is on safeguarding cash and ensuring cash deposits are in the safest possible banks.

The pharmaceuticals industry has already been hit hard by the crisis in the euro zone, which has seen a number of southern European governments slashing prices for medicines. Drug manufacturers also face a growing problem of unpaid bills.

In the case of Greece, drugmakers have been forced to accept government bonds instead of cash for some outstanding debts. Those bonds were either sold immediately at a discount or are still sitting on the companies' books at even lower value today.



Also Wednesday:



Affymax, Inc. (Nasdaq: AFFY)
today announced that John Orwin, the company’s chief executive officer, will present at the 14th Annual BIO CEO & Investor Conference on Tuesday, February 14, 2012 at 3:00 p.m. Eastern Time in New York City.

Affymetrix, Inc., (NASDAQ:AFFX) today reported its operating results for the fourth quarter and fiscal year ended December 31, 2011.

Anacor Pharmaceuticals (Nasdaq:ANAC)
, today announced the sale of 3.25 million shares of its common stock for gross proceeds of $21,450,000 pursuant to an underwriting agreement with Canaccord Genuity acting as the sole bookrunner.

Array BioPharma Inc. (NASDAQ: ARRY)
announced today that it is offering to sell, subject to market and other conditions, shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering.

AstraZeneca (NYSE:AZN)
announced today that it broadened the income eligibility for its AZ&Me™ Prescription Savings programs to enable more people to qualify for free medicines.

Biogen Idec Inc. (NASDAQ: BIIB)
announced today that its presentation at the Leerink Swann Global Healthcare Conference will be webcast live on Wednesday, February 15, 2012 at 8:30 a.m. ET.

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI)
today announced it will introduce Augmatrix™ Biocomposite Bone Graft, a new bone graft substitute product line, to surgeons and distributors at its exhibit booth during the American Academy of Orthopedic Surgeons (AAOS) meeting this week in San Francisco, CA.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
, announced today that the company has entered into a privately-negotiated securities exchange agreement with a holder of BioSante’s 3.125% convertible senior notes due May 1, 2013.

Catalyst Health Solutions, Inc. (NASDAQ: CHSI)
will release its fourth quarter and year-end financial results on Tuesday, February 21, 2012, after the market closes.


EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT)
today announced that Jack Talley, President and Chief Executive Officer, will be presenting at the 14th Annual BIO CEO & Investor Conference on Monday, February 13, 2012 at 3:00 PM Eastern time at The Waldorf=Astoria in New York City.

Exelixis, Inc. (Nasdaq: EXEL)
today reported financial results for the fourth quarter and year ended December 31, 2011.

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY)
, announced today four-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate.

Interleukin Genetics, Inc. (OTCQB: ILIU)
announced today that CEO Lewis H. Bender will present at the 14th Annual BIO CEO & Investor Conference on Tuesday, February 14 at the Waldorf Astoria, in New York City.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
(the “Company”) announced today that it has commenced an underwritten public offering of 5,250,000 shares of its Class A common stock. All of the shares are being offered by Ironwood.

Imaging3™, Inc. (OTCBB: IMGG)
, developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, today announced that the company has added archived appearances of CEO Dean Janes and his interviews on MoneyTV to the Imaging3, Inc. website.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
announced that it was informed this evening that the U.S. Food and Drug Administration (FDA) will not schedule an advisory committee meeting in connection with the its review of the New Drug Application (NDA) for linaclotide proposed for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).

MannKind Corporation (Nasdaq: MNKD)
today announced the completion of an underwritten public offering of 35,937,500 units, including 4,687,500 units sold pursuant to the full exercise of an over-allotment option previously granted to the underwriters (with each unit consisting of one share of its common stock and a warrant to purchase 0.6 of a share of its common stock).

MAXIMUS (NYSE:MMS)
announced today that it has signed a new contract with the Government of Ontario’s Ministry of Health and Long-Term Care to provide administrative services for the Ontario Drug Benefit (ODB) Program.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB)
, a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has opened a business and commercial development office in Andover, MA, just outside of Boston.

NeuroMetrix, Inc. (Nasdaq: NURO)
today announced that it has priced a public offering of up to 10,500,000 Units at a price per Unit of $1.00, for aggregate gross proceeds of up to $10,500,000, pursuant to its previously filed Registration Statement on Form S-1 (Reg. No. 333-178165).

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP)
announced today that it will report its 2011 financial results on Wednesday, February 15, 2012 at approximately 4:30 p.m. ET.

Opexa Therapeutics, Inc. (NASDAQ: OPXA)
, a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, President and Chief Executive Officer, will present at the 14th Annual BIO CEO & Investor Conference on Monday, February 13, 2012, at 11:30 a.m. EST.

pSivida Corp. (NASDAQ: PSDV) (ASX: PVA)
, a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced financial results for its second quarter ended December 31, 2011.

RTI Biologics Inc. (RTI) (Nasdaq: RTIX)
, a leading provider of orthopedic and other biologic implants, is highlighting two new allografts and introducing a public education website at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Francisco this week.

Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced that it will release its financial results for the fourth quarter and year ended December 31, 2011 prior to market open on Wednesday, February 29, 2012.

Synergy Pharmaceuticals, Inc. (Nasdaq: SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced that it has engaged The Trout Group LLC a leading investor relations and strategic advisory firm.

Seattle Genetics, Inc. (NASDAQ:SGEN)
announced today that management will present at the following upcoming investor conference.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that it will release its fourth-quarter and year-end 2011 financial results before the market opens on Wednesday, February 22, 2012.

Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced presentations at several upcoming investment conferences.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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