AFFY Bleeds, DVAX Snubbed, FURX, MNOV On Fast Track, ONXX Gets Thumbs-Up

(RTTNews.com) - Actavis Inc. (ACT) has won FDA approval for Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the generic equivalent to Reckitt Benckiser Healthcare's Suboxone, indicated for maintenance treatment of opioid dependence.

Actavis said it intends to begin shipping the product immediately.

According to IMS Health data, Suboxone logged total U.S. sales of about $625 million in 2012.

Affymax Inc. (AFFY) tumbled 85% to a new low of $2.42 on Monday following the recall of anemia medication OMONTYS Injection due to reports of serious hypersensitivity reactions, including anaphylaxis.

OMONTYS Injection, co-developed by Affymax and Takeda Pharmaceutical Co. Ltd., is indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.

CEL-SCI Corp.'s (CVM) Taiwanese partner, Orient Europharma, has added two additional Taiwanese clinical centers in CEL-SCI's phase III head and neck cancer clinical trial for Multikine to further accelerate the enrollment of patients.

The phase III trial with Multikine is being conducted by CEL-SCI's partners Teva Pharmaceuticals and Orient Europharma in Israel and Taiwan respectively.

CVM was up 1.93% to $0.27 in extended trading on Monday.

Dynavax Technologies Corp. (DVAX) dropped over 32% to $2.01 on Monday following the receipt of FDA's complete response letter for its investigational adult hepatitis B vaccine - Heplisav.

Dynavax submitted a Biologics License Application to the FDA for Heplisav, seeking approval for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age, in April of 2012.

Last November, an FDA panel voted 13 to 1 that Heplisav data adequately demonstrated immunogenicity. But the panel voted 8 to 5 with one abstention that there was insufficient data to adequately support the safety of the vaccine.

In the complete response letter, the FDA specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group. The regulatory agency also continues to express concern that novel adjuvants may cause rare autoimmune events.

Furiex Pharmaceuticals Inc. (FURX) announced Monday that its investigational antibiotic Avarofloxacin has been granted Qualified Infectious Disease Product and Fast Track designations by the FDA.

Avarofloxacin is a phase III-ready broad-spectrum fluoroquinolone antibiotic for the treatment of acute bacterial skin and skin-structure infections, community-acquired pneumonia and has proven to be effective in treating methicillin-resistant staphylococcus aureus (MRSA) infections.

FURX touched a new 52-week high of $37.78 before closing at $36.26.

MediciNova Inc.'s (MNOV) investigational drug MN-166 (ibudilast) has been granted Fast Track designation by the FDA for the treatment of methamphetamine dependence. Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.

MN-166 is under clinical development for both methamphetamine addiction and opioid addiction.

MNOV closed Monday's trading 5.42% higher at $2.14.

NxStage Medical Inc.'s (NXTM) single needle technology, OneSite, has received CE Mark approval. The company also noted that initial patient experiences using this new product have demonstrated its benefits for dialysis patients.

NXTM closed Monday's trading at $11.13, down 1.24%.

Oncolytics Biotech Inc. (ONC.V) (ONCY) on Monday closed its previously announced underwritten public offering of 8.0 million common shares, at US$4.00 per share. The aggregate gross proceeds from the offering were about US$32.0 million.

ONCY closed Monday's trading at $3.91, down 1.26%.

Bayer HealthCare and Onyx Pharmaceuticals Inc. (ONXX) announced Monday that the FDA has approved Stivarga for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor.

Last September, Stivarga was approved by the FDA for the treatment of patients with metastatic colorectal cancer.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. Onyx receives a royalty from Bayer on all global net sales of Stivarga in oncology.

ONXX closed Monday's trading at $77.87, down 0.56%.

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