Baird Releases Comments After Vertex Earnings Call; Axxess to Expand North American Sales and Brand Exposure Through TapouT Ambassadorship Program Print E-mail
By William Kent   
Thursday, 29 January 2015 19:48
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 29, 2015.

Analysts at Baird released comments following Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)'s fourth quarter conference call that was held on Wednesday. The stock is trading down about 6 percent.

Kalydeco Sales  --  Vertex Kalydeco revenues were down on a quarter over quarter basis at $124.4 million. However, Kalydeco revenues did beat the consensus estimate of $122.6 million.

The analysts stated: "Efforts to increase access and expand the current label in certain geographies continue as Vertex pushes to maximize Kalydeco's earning potential. We believe that the progress made on these two fronts will translate into steady growth bringing our 2015 Kalydeco revenue estimates to $567.7m, in line with company guidance."

Drug Approval  --  Vertex is expecting to receive approval for the lumacaftor/ivacaftor combination drug that has a PDUFA date of July 5. The company is preparing to launch the drug in the second half of 2015.
The company is also expecting to receive European Union approval late in 2015.

Pipeline Progress  --  Some investors were hoping Vertex would release an interim analysis or give a positive update on the Phase 2b F508del homozygous trial. The company did not release any data, but did give guidance.

Baird analysts stated: "Interim analysis on the Phase 2b in F508del homozygous patients has begun with top-line data expected by the end of the quarter. In addition to this study, management is gearing up to kick off their Phase 3 program of ivacaftor/VX-661 featuring various populations outlined in their 2015 preview. Management guided that data from these studies probably wouldn't be seen until 2016."

Rating  --  Baird continues to rate Vertex as an Outperform and has a $131 price target on the stock.



Axxess Pharma Inc. (OTC PINK: AXXE)
, a specialty pharmaceutical and nutritional supplements company, is pleased to announce its wholly-owned subsidiary, AllStar Health Brands Inc., hosted a TapouT ambassadorship tryout for TapouT-branded products at the Extreme Couture gym and fitness Club in the Toronto area this past Sunday.

The select ambassadors that are offered this position are anticipated to further expand North American sales and exposure of the TapouT product line.

Ryan Jimmo, the MMA fighter, boasting the fastest knockout in MMA history and current TapouT spokesperson, put the candidates through workout routines and fitness evaluations. All of the candidates then tried the TapouT protein shakes. Similar to other test markets performed on the protein shakes, the candidates stated the shakes stood out from the other shakes due to the good taste.

Later this week, Axxess will choose several ambassadors to represent the TapouT product in Canada. In the coming months, Axxess Pharma, will also have US ambassador tryouts. All of the ambassadors will provide an extra focus on the female demographic. Several products in the TapouT lineup have features women find attractive such as added iron, omega-3 fish oil, L-carnitine for fat burning and the gluten-free formulation for less bloating. The Turbo Blend Protein powder 2-lb. tub contains all of these benefits.

Both Canadian and US ambassadors will represent the TapouT brand, furthering exposure and public knowledge of the protein shakes and overall product line. They will be doing two to three demos and store samplings per month, as well as representing the TapouT protein shakes at fitness and sporting events. Ambassadors may have possible work booths at major trade shows and introduce samples to stores who do not yet carry TapouT Muscle brands. All ambassadors will also spread the TapouT message on social media to their followers.

Dr. Bagi, President of Axxess Pharma, stated, "This is another big step forward for AllStar/Axxess Pharma as we continue to expand our brand awareness and sales across Canada and the United States. Our ambassadors will be an added force and not increasing our sales but the sales of stores that carry our brand." Dr. Bagi further states, "This comes at a perfect time given our recent relationship with Muscle Foods USA. We feel our Canadian ambassadors will expand our exposure in Canada with our soon to be US ambassador assisting Muscle Food USA sales people when needed while also generating new store sales on their own. This is one more sign of our continued product expansion."


Also Thursday:


Alcobra Ltd. (Nasdaq:ADHD)
, an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced that Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra, will provide a corporate overview at the upcoming BIO CEO & Investor Conference.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that novel data on the potential of its lead product candidate, NS2, to treat Sjögren-Larsson Syndrome (SLS) has been accepted for a poster presentation at the upcoming 2015 Society for Inherited Metabolic Disorders (SIMD) Annual Meeting, being held March 28-31, 2015 in Salt Lake City, Utah.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration (FDA) cleared an expanded indication for the Celerity tip location system.

Applied Genetic Technologies Corporation (Nasdaq:AGTC)
, a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced the appointment of Stephen W. Potter as its Vice President and Chief Business Officer.

Biota Pharmaceuticals, Inc. (Nasdaq:BOTA)
, a biopharmaceutical company focused on the discovery and development of products to prevent and treat serious and potentially life-threatening viral respiratory infectious diseases, announced today that management will host a conference call on Thursday, February 5, 2015 at 9:00 a.m. EST to review the Company's second quarter financial results and provide an update on recent corporate developments.

BSD Medical Corporation (Nasdaq:BSDM)
, a leading provider of medical systems that utilize heat therapy to treat cancer, today provided an update on its strategic plan for the Company first outlined on January 12, 2015.

Communication Intelligence Corporation (OTCQB:CICI)
, a leading supplier of electronic signature and other software solutions focused on the paperless, secure and cost-effective management of document-based transactions, today announced the expansion of its partnership with Cegedim SA (EURONEXT:CGM), a global technology and services company and a leader in electronic invoicing, global payments and dematerialization (the removal of paper-based processes).

Celldex Therapeutics, Inc. (Nasdaq:CLDX) and Bristol Myers-Squibb (NYSE:BMY)
today announced the initiation of a Phase 1/2 dose escalation and cohort expansion study examining the investigational combination of varlilumab, Celldex's CD27 targeting investigational immune-activating antibody and Bristol-Myers Squibb's immunotherapy Opdivo (nivolumab).

Cerner Corp. (Nasdaq:CERN)
has won six Best in KLAS 2014: Software and Services awards including "Best in KLAS" Remote Hosting for the sixth consecutive year.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
, a leader in point-of-care (POC) diagnostic tests for infectious diseases, has been awarded a grant from the Bill & Melinda Gates Foundation to expedite the feasibility testing and development of a DPP® Malaria POC rapid diagnostic to accurately identify individuals infected with Plasmodium falciparum parasite.

Connecture, Inc. (Nasdaq:CNXR)
, a provider of web-based information systems used to create health insurance marketplaces, today announced that Russ Thomas, a veteran executive with extensive experience in the health care information technology industry, will join the company's board of directors.

Dermira, Inc. (Nasdaq:DERM)
, a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced that it will present at the 2015 Leerink Global Healthcare Conference.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, announced that nine leading centers in Europe including SPZ Notwill in Switzerland, Institut Guttmann in Spain and The Clinic for Spinal Cord Injuries in Hornbaek, Denmark (now part of Rigshospitalet and Glostrup Hospital), are participating in a clinical study to include close to 70 participants.

Entellus Medical, Inc. (Nasdaq:ENTL)
, a medical technology company focused on products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, will visit the Nasdaq MarketSite in Times Square in celebration of its initial public offering (IPO), which will occur today, January 29.

Herborium® Group, Inc. (OTC Pink: HBRM)
, a Botanical Therapeutics® Company and the provider of unique all  botanical medicines (Botanical Therapeutics®)  announced today that its 2014 sales  of AcnEase®  proprietary acne treatment grew  over 75% in comparison to 2013.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that the United States District Court for the District of New Jersey in a putative class action lawsuit, styled Nasyrova v. Immunomedics, Inc., has granted the Company's motion to dismiss the complaint in its entirety.

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT)
, today announced that its investigational product obeticholic acid (OCA) has received "breakthrough therapy designation" from the U.S. Food and Drug Administration (FDA) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.

K2M Group Holdings, Inc. (Nasdaq:KTWO)
a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced the commencement of a follow-on public offering of its common stock.

Lombard Medical, Inc. (Nasdaq:EVAR)
, a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced the successful completion of a live EVAR case using Aorfix™ Endovascular Stent Graft during the 11th annual Leipzig Interventional Course (LINC) 2015.

Lumenis Ltd. (Nasdaq:LMNS)
, the world's largest medical laser company for surgical, ophthalmology and aesthetic applications, today announced plans to release its fourth quarter and fiscal year 2014 financial results on Thursday, February 12, 2015, before the market opens.

MediciNova, Inc., (Nasdaq:MNOV)
and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a new patent from the Japanese Patent Office which covers MN-029 (denibulin) di-hydrochloride.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Merge Cardio™ has been named Best in KLAS for the cardiology software category within the "2014 Best in KLAS: Software & Services" report. In addition, Merge Hemo™ has been named the KLAS Category Leader in Cardiology Hemodynamics.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that the U.S. Food and Drug Administration's Office of Orphan Products Development (OOPD) has granted orphan drug designation to tarextumab (anti-Notch 2/3, OMP-59R5) for the treatment of both pancreatic cancer and small cell lung cancer.

PharmaCyte Biotech, Inc. (OTCQB:PMCB)
, a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live cell encapsulation technology, Cell-in-a-Box®, announced today that its partner, Austrianova, has officially opened its new facilities at Synapse within Biopolis in Singapore.

Radius Health (Nasdaq:RDUS)
, today announced that the Annual Meeting Steering Committee of ENDO 2015 has selected the company's recently completed Phase 3 ACTIVE study of abaloparatide-SC in post menopausal osteoporosis for the Late-Breaker oral presentations session at the International Society of Endocrinology and the Endocrine Society (ICE/ENDO 2015) in San Diego from March 5-8, 2015.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL),
an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today provided an update on the progress with the ongoing RHB-104 Phase III development program for the treatment of Crohn's disease.

Urologix, Inc. (OTCQB:ULGX)
will host a conference call to present second quarter fiscal year 2015 results on Thursday, February 5, 2015 at 4:00 p.m. CT, following the Company's post-market press release on the same day.

Vericel Corporation (Nasdaq:VCEL)
, a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the completion of patient enrollment in the company's Phase 2b ixCELL-DCM clinical trial evaluating ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM).

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