FDA Approves Hyperion's RAVICITI; Seattle Genetics' ADCETRIS Approved by Health Canada Print E-mail
By Staff and Wire Reports   
Friday, 01 February 2013 20:00
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 1, 2013.

Hyperion Therapeutics, Inc. (Nasdaq: HPTX)
announced the U.S. FDA has approved RAVICTI for the treatment of Urea Cycle Disorders (UCD) in patients two years of age and older. The drug is expected to be commercially available by the end of April 2013.  

Separately, Hyperion announced it has received notification from the U.S. Patent & Trademark Office (USPTO) of the allowance of the claims of patent application number 13/417,137 entitled, METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS, which discloses optimal measurement timing and target levels for blood ammonia in UCD patients. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires in March 2032. After issuance, Hyperion plans to list this patent in FDA's Approved Drug Products with Therapeutic Equivalence, or Orange Book.   

 "With FDA approval of RAVICTI, we are now in a position to commercialize Hyperion's first product. Furthermore we believe that the allowed claims, once issued, will provide important protection for the use of RAVICTI to treat UCD," said Donald J. Santel, Hyperion's chief executive officer. "We thank our clinical trial patients, their families, our investigators and study coordinators, the UCD Consortium, and the National Urea Cycle Disorders Foundation – in particular NUCDF Executive Director Cynthia Le Mons – for their collaboration and support of our development efforts."

The FDA approval of RAVICTI was based on a New Drug Application (NDA) that included data from 10 clinical trials, including six in UCD patients, that involved 23 sites, over 50 investigators and sub-investigators, and approximately a dozen referring metabolic specialists throughout North America. As part of FDA approval, Hyperion agreed to post-marketing requirements that include: studies of RAVICTI safety, ammonia control, and pharmacokinetics in pediatric UCD patients in the first two months of life and from two months to two years of age; studies in healthy adults to examine drug-drug interaction and whether RAVICTI metabolites are present in breast milk; a randomized controlled clinical trial to assess the safety and efficacy of RAVICTI in treatment-naïve patients with UCD; and a UCD registry of approximately 10 years duration. Importantly, the FDA did not require a Risk Evaluation and Mitigation Strategy (REMS) program.


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Seattle Genetics, Inc. (Nasdaq: SGEN)
announced Health Canada has issued a Notice of Compliance with conditions (NOC/c), authorizing marketing of ADCETRIS for two lymphoma indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen. The indications for ADCETRIS were authorized based on promising response rates demonstrated in single-arm trials. No data demonstrate increased survival with ADCETRIS.

“We are focused on making ADCETRIS available globally to all eligible patients with relapsed HL and sALCL. The approval of ADCETRIS in Canada, as well as the recent approval in the European Union, are important milestones to accomplish this goal,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Now that Health Canada has approved ADCETRIS, we are committed to working closely with public and private insurers to secure reimbursement coverage for patients in Canada.”

“The approval of ADCETRIS in Canada marks a significant milestone for patients with relapsed HL or sALCL who have had few new treatment options in several decades,” Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada.

Health Canada grants NOC/c, a form of market approval, on the basis of promising evidence of clinical effectiveness, for products intended for the treatment of serious, life-threatening or severely debilitating illnesses that meet a serious unmet medical need or demonstrate a significant improvement in the benefit/risk profile over existing therapies. Conditions associated with market authorization under the NOC/c policy include a requirement that Seattle Genetics conduct clinical trials designed to confirm the anticipated clinical benefit of ADCETRIS in these patients. Two confirmatory phase III clinical trials evaluating ADCETRIS in the front-line treatment setting of HL and mature T-cell lymphoma (MTCL), including sALCL, are currently underway and enrolling patients.

ADCETRIS (brentuximab vedotin) was issued marketing authorization under the NOC/c policy based on results from a single-arm, phase II pivotal trial in HL patients with relapsed or refractory disease following an ASCT and a single-arm, phase II pivotal trial in relapsed or refractory sALCL patients. ADCETRIS is administered in hospitals through IV infusion over 30 minutes every three weeks and patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately one year).


Also Friday:




Affymax, Inc. (Nasdaq: AFFY)
today announced the promotion of Christine Conroy, Pharm.D., to senior vice president, Regulatory Affairs and Quality Assurance, as well as Tim Varacek to vice president, Sales and Account Management.

Arrowhead Research Corporation (NASDAQ: ARWR)
, a targeted therapeutics company, today announced that academic collaborators and scientists from the company will present data on the Dynamic PolyConjugate™ (DPC) siRNA delivery system, the ARC-520 hepatitis B drug candidate, and the Homing Peptide™ platform at upcoming scientific conferences.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL)
, a specialty biopharmaceutical company, today announced that The Journal of Urology has electronically published the uncorrected proof of the Company's pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, in-office, biologic for the potential treatment of Peyronie's disease (PD) on its website www.jurology.com.

Covidien plc (NYSE: COV)
today announced the initial filing by Mallinckrodt plc of a Form 10 Registration Statement with the U.S. Securities and Exchange Commission (SEC) in connection with Covidien’s previously announced plan to spin off its Pharmaceuticals business.

Emergent BioSolutions Inc. (NYSE: EBS)
announced today that it will report financial results for the fourth quarter and full year 2012 on Thursday, March 7, 2013, after market close.

EasyMed Services, Inc. (CNSX:EZM) (OTCBB:EMYSF)
today announced that following up on an investor event presentation hosted by the Company in Toronto on January 24, the presentation provided at the event has been made available on the Company's website.

Healthpoint Biotherapeutics, a Smith & Nephew business  (LSE: SN, NYSE: SNN), today announced the introduction of a Copay Assistance Program for patients who have been prescribed Collagenase SANTYL® Ointment and pay more than $50 out-of-pocket for their prescription.

iBio, Inc. (NYSE MKT: IBIO)
entered into an "At-the-Market" (ATM) equity offering sales agreement with the Donjon Group, a division of Further Lane Securities, L.P. on January 31, 2013, under which iBio may, from time to time, offer and sell shares of its common stock having an aggregate offering price of up to $10 million through Donjon

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2012.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX)
announced today that the Company will report its fourth quarter and year-end 2012 financial results before the Nasdaq market opens on Friday,  February 8, 2013.

Pfizer Inc. (NYSE: PFE)
today announced that its former animal health business unit, now a standalone company named ZoetisTM, began trading on the New York Stock Exchange under the ticker symbol “ZTS.”

TNI BioTech, Inc. (OTCPINK: TNIB)
has signed an exclusive licensing agreement for all of the intellectual property developed at Pennsylvania State by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer.

VIVUS, Inc. (Nasdaq: VVUS)
announced today the publication of a study concluding that weight loss resulting from treatment with QsymiaTM (phentermine and topiramate extended-release) capsules CIV led to significant improvements in cholesterol, blood pressure and triglycerides in obese and overweight patients experiencing one or more of these associated conditions.



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