SNTA Enchants, PRGO Picks Up ELN, Tech Glitches Mar CHTP, STXS On High Note

(RTTNews) - Anacor Pharmaceuticals (ANAC) submitted its New Drug Application for investigational topical treatment Tavaborole to the FDA, seeking approval in the indication of onychomycosis, on July 26, 2013. Whether or not the NDA has been accepted for review by the FDA will be known in 60 days.

Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.

ANAC closed Monday's trading at $7.25, up 1.83%.

Array BioPharma Inc. (ARRY) rose more than 8% to $6.79 in after-hours on Monday after it announced a strategic global R&D collaboration with Celgene Corp. (CELG).

Under the terms of the agreement, Array will receive an up-front payment of $11 million and Celgene will have an exclusive option to license multiple clinical development candidates. Array is entitled to receive potential milestone payments of up to $376 million based upon achieving certain development, regulatory and sales objectives. Array is also entitled to receive royalties on net sales of all drugs and will retain all rights to the program if Celgene does not exercise its option.

In what is seen as a move to increase its biologic manufacturing capacity, Bristol-Myers Squibb Co. (BMY) announced Monday that it has entered into a 10-year agreement with Samsung BioLogics. Under the agreement, Samsung BioLogics will manufacture a commercial antibody cancer drug for Bristol-Myers Squibb at its recently completed plant in Songdo Incheon, South Korea. Financial terms were not disclosed.

BMY closed Monday's trading at $43.76, down 1.04%.

Cangene Corp. (CNJ.TO) is all set to re-initiate ongoing studies and begin new studies with its investigational product - IB1001, a recombinant Factor IX (rFIX) product being developed for the treatment and prevention of bleeding episodes with hemophilia B, now that the FDA has lifted the clinical hold on the compound.

IB1001 was under a phase III trial to treat and prevent bleeding episodes in adults with hemophilia B, and a phase III study to treat and prevent bleeding episodes in previously treated pediatric subjects with hemophilia B, when it was put on clinical hold by the FDA last July.

The clinical hold was then imposed because a higher proportion of IB1001 treated individuals developed a positive response to testing of antibodies to Chinese Hamster Ovary, or CHO, protein, the product's host cell protein, or HCP, which was a matter of concern.

The company withdrew the Marketing Authorization Application for IB1001 in Europe last month as additional clinical data was requested by the European Medicines Agency. Cangene intends to re-file the MAA for IB1001 in Europe when the additional clinical data is available.

CNJ.TO closed Monday's trading at C$2.12, unchanged from the previous day's close.

The FDA has identified certain technical deficiencies in Chelsea Therapeutics International Ltd.'s (CHTP) resubmitted NDA seeking approval for NORTHERA as a treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure.

The deficiencies relate primarily to the formatting of certain submitted electronic datasets and statistical programs and are unrelated to study conduct, interpretability of study results, or validity of study conclusions, said the company.

Last week, the FDA had deemed the NDA resubmission a complete response to its March 28, 2012 Complete Response Letter and was assigned a decision date of January 3, 2014.

CHTP fell 8.14% on Monday's to close at $2.82.

Depomed Inc. (DEPO) said Monday that it has acquired all United States and Canadian rights to Lazanda nasal spray from Archimedes Pharma Ltd, thereby expanding its portfolio of pain products.

Lazanda is indicated for the management of breakthrough pain in cancer patients (BTPc) 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

The company also announced that the NDA for MNK-795 submitted by its licensee Mallinckrodt has been granted priority review by the FDA, triggering a $5 million milestone payment to Depomed.

DEPO gained 2.59% to close at $6.33.

Shares of Herbalife Ltd. (HLF) rose more than 5% in after-hours to touch a new 52-week high of $64 after reporting impressive Q2 results and boosting its full-year outlook. The company also announced that its Board of directors has approved a $0.30 per share quarterly dividend.

Shares of InspireMD Inc. (NSPR) closed Monday's trading 11% higher at $2.59 following the enrollment of the first patient in the company's U.S. registration trial for MGuard Prime Embolic Protection Stent in patients suffering from ST Elevation Myocardial Infarction.

The trial, known as known as MASTER II, is designed to enroll as many as 1,114 patients.

Novavax Inc. (NVAX) announced Monday that its virus-like particle vaccine candidate against A(H7N9) influenza provided 100% protection against lethal wild-type A(H7N9) influenza challenge versus 0% survival in control (H5N1) vaccine and placebo groups in a preclinical study. In addition, the vaccine candidate achieved complete cross-protection with its H7N3 VLP vaccine against H7N9 challenge in the study.

NVAX gained 0.80% to close at $2.51.

Perrigo Co. (PRGO) has agreed to acquire Irish firm Elan Corp. plc (ELN) in a cash and stock transaction, valued at roughly US$8.6 billion. Each Elan share is valued at $16.50, which represents a premium of about 10.5% compared to its closing price on 26 July 2013. The proposed transaction is expected to close by the end of calendar year 2013.

The acquisition would give Perrigo access to Elan's neuropsychiatric pipeline and royalties from multiple sclerosis treatment Tysabri. Elan currently earns a 12% royalty on global net sales of Tysabri. The royalty increases to 18% on annual net sales up to US$2.0 billion, and to 25% on annual net sales above this amount from 1 May 2014 onwards.

PRGO closed Monday's trading at $125.17, down 6.75%.

Stereotaxis Inc.'s (STXS) Vdrive Robotic Navigation System with V-Sono Intracardiac Echocardiography catheter manipulator has been granted FDA clearance, representing the first clearance for the Vdrive family of products in the U.S. The product has been utilized in Europe since 2011.

In Q1, 2013 revenue dropped 32% to $8.4 million from $12.3 million in the prior year quarter. Despite challenges to revenue performance, the operating expenses have been reined in, leading to significant year-over-year improvement in cash burn and operating loss, according to the company.

STXS rose over 45% in after-hours to $2.59.

Synta Pharmaceuticals Corp. (SNTA) closed Monday's trading more than 41 percent higher at $7.15, following its multicenter phase II proof of concept study of lead cancer drug candidate Ganetespib achieving the prespecified criteria for advancing to the second stage of the trial.

The study, dubbed ENCHANT-1, is evaluating Ganetespib monotherapy in women with metastatic HER2-positive or triple negative breast cancer. According to the study results, of the initial 10 triple negative breast cancer patients enrolled and evaluable for response, 2 patients achieved objective tumor response and 3 achieved stable disease following treatment with Ganetespib monotherapy.

The expansion of ENCHANT-1 trial will also allow for evaluation of the combination of weekly Paclitaxel and Ganetespib, said the company.

Vertex Pharmaceuticals Inc. (VRTX) said Monday that its approved cystic fibrosis drug Kalydeco showed statistically significant improvements in lung function in people with non-G551D gating mutations in an ongoing phase III label-expansion study.

Kalydeco, known generically as Ivacaftor, is already approved for the treatment of cystic fibrosis in patients age 6 years and older who have a G551D mutation in the CFTR gene.

Vertex plans to seek expanded approval for the use of Ivacaftor monotherapy in people with cystic fibrosis ages 6 and older who have at least one non-G551D CFTR gating mutation in the U.S. and Europe the second half of 2013. Last week, the FDA placed a partial clinical hold on the company's ongoing phase II U.S. study of its hepatitis C virus candidate, VX-135. VRTX was up 2.94% in after-hours at $82.

Viralytics Ltd. (VRACY.OB) said Monday that its phase II clinical trial of intratumourally administered investigational drug CAVATAK for the treatment of late-stage melanoma, dubbed the CALM study, will achieve full enrollment by the end of 2013.