Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced that the Therapeutic Goods Administration (TGA) ofAustralia has approved ORKAMBI® 200/125 (lumacaftor 200mg and ivacaftor 125mg), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation. In Australia, there are approximately 1,000 people with CF ages 12 and older who have two copies of this mutation. The Australian reimbursement process for ORKAMBI is already underway as part of the parallel regulatory and reimbursement processes between the TGA and the Pharmaceutical Benefits Advisory Committee (PBAC).

“We are pleased that the Therapeutic Goods Administration has recognised the ‘meaningful clinical benefit’ offered by ORKAMBI,” said Simon Bedson, Senior Vice President and International General Manager for Vertex. “Today’s approval is an important step toward making ORKAMBI available for eligible Australians who do not currently have a medicine to treat the underlying cause of their disease.”

The TGA approval is based on previously announced data from two 24-week global Phase 3 studies, TRAFFIC and TRANSPORT, and additional interim 24-week data from the subsequent extension study, PROGRESS, in people with CF ages 12 and older who have two copies of the F508del mutation and were already being treated with standard-of-care medicines. In the TRAFFIC and TRANSPORT studies, which enrolled more than 1,100 patients and were the largest CF studies ever conducted, those treated with the combination of lumacaftor and ivacaftor experienced significant improvements in lung function. Patients also experienced improvements in body mass index (BMI) and reductions in pulmonary exacerbations (acute lung infections), including those requiring hospitalisations and intravenous antibiotic use. Interim data from PROGRESS showed that these improvements were sustained through 48 total weeks of treatment (24 weeks in TRAFFIC/TRANSPORT + 24 weeks in PROGRESS). In addition, the pattern and magnitude of response observed after the initiation of combination treatment across all patients who received placebo in TRAFFIC and TRANSPORT and subsequently received a combination regimen in PROGRESS were similar to those seen among patients who received a combination regimen in TRAFFIC and TRANSPORT.

The combination of lumacaftor and ivacaftor was generally well tolerated in all three studies. In TRAFFIC and TRANSPORT, the most common adverse events included shortness of breath and/or chest tightness, upper respiratory tract infection (common cold) and gastrointestinal symptoms (including nausea, diarrhea, or gas). In the extension study, the safety and tolerability results, including the type and frequency of adverse events and serious adverse events, were consistent with those observed in TRAFFIC and TRANSPORT, and no new safety concerns were identified. Over 48 weeks, the most common adverse events were infective pulmonary exacerbation, cough and increased sputum. The incidence of serious adverse events during PROGRESS was generally similar to TRAFFIC and TRANSPORT. (Original Source)

Shares of Valeant are currently trading at $63.40, down $2.26 or -3.44%. VRX has a 1-year high of $263.81 and a 1-year low of $59.87. The stock’s 50-day moving average is $84.95 and its 200-day moving average is $126.34.

On the ratings front, Valeant has been the subject of a number of recent research reports. In a report issued on March 4, Jefferies Co. analyst David Steinberg maintained a Buy rating on VRX, with a price target of $106, which represents a potential upside of 62.1% from where the stock is currently trading. Separately, on March 2, Nomura’s Shibani Malhotra maintained a Buy rating on the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, David Steinberg and Shibani Malhotra have a total average return of -3.6% and 2.9% respectively. Steinberg has a success rate of 34.9% and is ranked #3064 out of 3698 analysts, while Malhotra has a success rate of 45.8% and is ranked #1053.

Overall, one research analyst has rated the stock with a Sell rating, 10 research analysts have assigned a Hold rating and 8 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $162.25 which is 148.1% above where the stock opened today.

Valeant Pharmaceuticals International Inc is a specialty pharmaceutical and medical device company that develops, manufactures, and markets a range of generic and branded generic pharmaceuticals, over-the-counter products and medical devices.