|Chelsea Resubmits NDA for Northera; Intuitive Surgical Plunging after Negative Pre-Announcement (ISRG)|
|By Staff and Wire Reports|
|Tuesday, 09 July 2013 23:34|
Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced that it resubmitted a New Drug Application (NDA) to the U.S. FDA seeking approval to market NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The NDA resubmission includes data from Study 306B, a large phase 3 study which confirms findings from Study 301 demonstrating improvement in dizziness/lightheadedness, the cardinal symptom of NOH. Under the Prescription Drug User Fee Act, or PDUFA, the FDA is expected to review and act on the NDA six months from the date of resubmission.
"The resubmission of our Northera NDA marks a critical step in our effort to bring an important new therapeutic option to patients living with this debilitating condition," said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea. "We now have two large randomized placebo-controlled clinical studies which show that treatment with Northera results in consistent and statistically significant improvements in the symptoms of NOH, and a greatly expanded database supporting the safety of Northera. We look forward to working closely with the FDA as they review our application and, in parallel, planning for commercialization."
In addition to Study 306B, the filing also includes three smaller supportive randomized controlled trials, two long-term open-label extension studies, a dedicated thorough QTc study, a 24-hour ambulatory blood pressure monitoring study and a bioequivalence study for the 300 mg dose form of droxidopa. The bioequivalence study showed comparable pharmacokinetics between the 300 mg dose form of droxidopa and the 100 mg and 200 mg combination dose form.
As previously disclosed, FDA has indicated that the revised Northera NDA may be reviewed by the Cardiovascular and Renal Drug Advisory Committee, or CRDAC. The FDA has also raised the possibility of accelerated approval for Northera, where it has indicated that endpoints measuring short-term clinical benefits can be used as valid surrogates reasonably likely to predict long-term clinical benefits under accelerated approval. FDA also noted that the Company may be required to verify the durability of effect of Northera in a post-marketing study. Chelsea continues to work with the FDA on the design of such a study, which it intends to initiate in the fourth quarter of 2013. The study is expected to include short-term clinical endpoints should the Agency require an additional clinical trial for the approval of Northera.
Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.
In a pre-announcement Monday evening, Intuitive Surgical (NASDAQ: ISRG) said that it expects to report net income of $160 million and revenue of $575 million--a catastrophic miss versus analyst expectations of $177.7 million and $630.4 million respectively.
The company developed the da Vinci Surgical System which allows a surgeon to make tiny incisions where small instruments are inserted for control by the surgeon. Although it’s called a robot, the surgeon retains complete control.
It’s supposed to be minimally invasive and can move in a more precise manner than the human hand. The company says that about 1.5 million surgeries have been performed using the system and according to the release, the number of surgeries is up 18 percent.
The company will still show year over year net income growth of 3 percent and 6 percent growth in revenue but that’s where the good news ends.
Chief Executive Officer Gary Guthart in the statement, “While we are disappointed in our performance this quarter, particularly with respect to our capital sales in the U.S., overall procedure performance was solid in a difficult environment.”
The release goes on to provide reasons for the slow growth. First, budget crunches are forcing hospitals to cut back on purchases. The company sold 143 systems totaling $215 million compared to 150 totaling $229 million one year prior.
It also said that the system was being used less in benign gynecology procedures because of reduced hospital admissions and more conservative decisions by insurance companies.
What the company failed to mention were the lawsuits filed where patients alleged they were injured during surgeries with the device. It also failed to mention that U.S. regulators were surveying surgeons about the use of the system after 70 deaths were reported since 2009 and a rise in adverse events was reported in conjunction with the system.
Then there are the doctors who question the need for the machine. Robotic surgery costs significantly more than traditional surgeries and doctors point out that there is a lack of large-scale studies to prove the benefits of the system.
All of this has caused the stock to plummet more than 17 percent in early trading Tuesday and 30 percent since late January.
Actinium Pharmaceuticals Inc. (OTCQB: ATNM), a biopharmaceutical company that develops innovative targeted payload immunotherapeutics for treatment of advanced cancers, announced that the Actinium Pharmaceuticals' clinical programs and platform technology were presented in Vienna, Austria, at a technical meeting at the International Atomic Energy Agency (IAEA).
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that it resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that aldoxorubicin, its more potent version of the widely used chemotherapeutic agent doxorubicin, demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals.
eHealth, Inc. (NASDAQ: EHTH), parent company of eHealthInsurance, the nation's first and largest private online health insurance exchange, released answers to questions about the impact of recent Supreme Court decisions on health insurance options for same-sex couples.
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) today reported results for the fourth quarter and year ended April 30, 2013.
Illumina, Inc. (NASDAQ:ILMN) today announced that it will issue results for second quarter 2013 following the close of market on Tuesday, July 23, 2013.
Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that the Company will release its second quarter 2013 financial results on Thursday, August 8, 2013, after the close of the U.S. financial markets.
Mallinckrodt plc (NYSE: MNK) will report third quarter results on August 9, 2013, before trading opens for the day on the New York Stock Exchange.
Medifocus, Inc. (OTCQX: MDFZF) (TSX VENTURE: MFS) announced today the Company's common shares have been granted eligibility status by the Depository Trust Company (DTC), subsidiary of the Depository Trust & Clearing Corporation (DTCC).
Merus Labs International Inc. (TSX:MSL)(NASDAQ:MSLI) is pleased to announce that it has appointed Mr. Michael Cloutier to the Company's Board of Directors, effective immediately.
Milestone Scientific Inc. (OTCQB: MLSS), a leading medical research and development company that designs and patents innovative injection technology, announced today that it has entered into a strategic partnership with Tri-anim Health Services, Inc. ("Tri-anim"), the nation's largest provider of specialty sales and distribution solutions for healthcare, with core competencies in respiratory medicine, anesthesia, NICU, ICU and the OR. Tri-anim is a unit of Sarnova Inc., a specialty distributor of healthcare products.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) will be holding a conference call on Tuesday July 16, at 9:00 am ET to present its results for the first quarter ended May 31, 2013.
When Nuvilex, Inc. (OTCQB: NVLX) enters its pivotal Phase III clinical trial using its cell encapsulation technology combined with the anti-cancer drug ifosfamide for the treatment of late stage, inoperable pancreatic cancer, the company will do so with a number of distinct advantages.
Prestige Brands Holdings, Inc. (NYSE:PBH) today announced its acquisition of Care Pharmaceuticals Pty Ltd. (“Care”) of Bondi Junction, New South Wales, Australia, a privately-held marketer and distributor of over-the-counter (OTC) healthcare brands for children and adults.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the formation of an international, multi-disciplinary, clinical advisory board to help maximize the commercial opportunity for Androxal.
Steiner Leisure Limited (Nasdaq:STNR), announced today that it will release its Second Quarter 2013 earnings on Wednesday, July 31, 2013, after market close.
Synergetics Surgical EU Ltd., an indirect subsidiary of Synergetics USA (NASDAQ: SURG), announced today that it has acquired M.I.S.S. Ophthalmics Limited ("M.I.S.S."), a private ophthalmology distribution company incorporated in England and Wales, for net cash consideration of $2.8 million.
VIVUS, Inc. (Nasdaq:VVUS), a pharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today responded to First Manhattan Co.'s (FMC) July 2, 2013 open letter to VIVUS stockholders.