BLRX Does A Deal, CRMD Enters Arabia, IG Exceeds Goal, See What's New In GRANIX

Biotechnology 122414

BioCryst Pharmaceuticals Inc.'s (BCRX) investigational drug BCX4161 for the prevention of acute attacks of angioedema in patients with hereditary angioedema has been granted orphan drug designation by the FDA.

BCX4161 is currently under a three-arm, parallel cohort design trial evaluating the efficacy and safety of 300 mg and 500 mg doses of the compound, administered three-times daily compared with placebo. This study, dubbed OPuS-2, which is a 12-week trial, was initiated as recently as December 17, 2014.

A phase 2a clinical trial of BCX4161 in patients with HAE, known as OPuS-1, was successfully completed in May of this year, with the study meeting the primary efficacy endpoint, several secondary endpoints and all other established trial objectives.

BCRX closed Tuesday's trading at $11.07, down 0.54%. In after-hours, the stock was up 2.80% at $11.38.

BioLineRx Ltd. (BLRX) has out-licensed BL-5010, a novel product for the non-surgical removal of benign skin lesions, to Omega Pharma, a Belgian over-the-counter drug maker.

BL-5010 has completed a phase 1/2 pilot clinical study for the removal of seborrheic keratosis (brown warts), which showed excellent efficacy and cosmetic results, and has received confirmation in Europe for the regulatory pathway classification as a medical device Class 2a.

Under the licensing agreement, Omega Pharma will develop BL-5010 for OTC indications in the territory of Europe, Australia and additional selected countries. BioLineRx will retain the rights to BL-5010 in the United States and the rest of the world.
The licensing agreement significantly accelerates the pathway to commercialization for BL-5010, with the first OTC products expected to enter the market in 2016, according to BioLineRx.

BLRX closed Tuesday's trading 1.81% higher at $1.69.

CorMedix Inc. (CRMD) has finalized the first Middle East sales/distribution agreement for its lead product Neutrolin with distributor Arabian Trade House in the Kingdom of Saudi Arabia.

Neutrolin is a broad-spectrum antimicrobial/antifungal and anticoagulant combination that reduces the incidence of catheter-related bloodstream infections (CRBIs) by working as a catheter lock solution.

CRBSI, are common among hemodialysis patients as well as patient population utilizing central venous catheters, such as oncology/chemotherapy, total parenteral nutrition and intensive care unit patients.

Neutrolin is already approved in the EU. Only two months back, the company received approval from the FDA to initiate a pivotal clinical study of Neutrolin in the U.S.

The company's foray into the Middle East marks a new revenue stream.

CRMD closed Tuesday's trading at $1.49, up 4.20%.

Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (ENDP), has submitted a New Drug Application for its lead product candidate Buprenorphine HCl Buccal Film to the FDA.

Buprenorphine HCl Buccal Film is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The drug uses BioDelivery Sciences International Inc.'s (BDSI) patented BioErodible MucoAdhesive, or BEMA, drug delivery technology to efficiently and conveniently deliver buprenorphine across the buccal mucosa (inside lining of the cheek).

Endo and BioDelivery Sciences signed a worldwide license and development agreement for BEMA Buprenorphine in January 2012.

ENDP closed Tuesday's trading at $71.76, down 0.68%.

IGI Laboratories Inc. (IG) has submitted three more additional abbreviated new drug applications to the FDA, which brings the company's total number of ANDA submissions in 2014 to eleven. At the beginning of 2014, the company had set for itself a target of submitting at least 10 ANDAs this year.

The company now has twenty-two submissions pending at the FDA.

Looking ahead, IGI Labs expect to average one to two topical ANDA submissions per month in 2015.

IG closed Tuesday's trading at $9.12, down 2.46%.

PTC Therapeutics Inc. (PTCT) has begun a rolling submission of Translarna New Drug Application to the FDA, a potential treatment for nonsense mutation Duchenne muscular dystrophy (nmDMD).

A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis.

The company expects to finalize the application in the fourth quarter of 2015 following the completion of a confirmatory phase III clinical trial of Translarna.

Translarna was granted a conditional approval in the EU in August of this year.

PTCT closed Tuesday's trading at $50.90, down 7.87%.

Beginning early 2015, there will be a new administration option for Teva Pharmaceutical Industries Ltd.'s (TEVA) GRANIX as the FDA has approved a label expansion for self-administration of the treatment marketed for chemotherapy-induced neutropenia.

GRANIX, which has been commercially available in the U.S. since November 2013, is indicated only for administration by a healthcare professional.

The self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers, says Lee Schwartzberg, Division Chief of Hematology Oncology at the University of Tennessee Health Science Center.

TEVA closed Tuesday's trading at $56.76, down 2.57%.

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